Warum ausgerechnet Accentia (ABPI)? - 500 Beiträge pro Seite
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Das Schema wiederholt sich, nur der Name ändert sich? Junges Biotech Unternehmen, Cash-Burn, wenig Geld, kleine MK usw., also alles schon einmal gehört. ALSO: Nichts für Anleger die "auf Sicherheit" Wert legen...
Ja, warum also eigentlich ABPI?
1.) SinuNase in Phase III - Behandlung chronischer Nasennebenhöhlenerkrankungen (CRS). Knapp 30 bis 35 Mil. Menschen alleine in den USA leiden darunter. Laut ABPI würde ein 1%-iger Markteinteil ein Blockbuster Produkt zur Folge haben. Möglicherweise wird SinuNase auslizensiert. Die Resultate werden wohl Anfang 2008 präsentiert werden. Anfang 2009 wäre ein möglicher Verkaufsstart.
2.) BiovaxID - ein Vaccine. Ende Juni konnte ABPI positive Vorabresultate aus einer Phase III-Studie (Start Sept. 2000) bei Non-Hodgkin-Lymphomen (NHL) präsentieren. BiovaxID könnte etwa 500 Mil. $ an Umsatz bringen. Möglicher "auf dem Markt" - Termin (Ziel ist ein acclerated approval): 2H 2009
3.) Revimmune - Ein Phase 3 IND Antrag ist im Juli gestellt worden (Anfang des Jahres einlizensiert). Zielgebiet: diverse Autoimmun Kranheiten, zuerst soll es bei Multiple Sklerose in die Phase 3 gehen.
4.) ungefähr 70%ige Beteiligung an Biovest (BVTI.OB). Von den Produkten Biovests soll es später Royality Zahlungen von knapp 20% geben. BiovaxID und AutovaxID sind "Eigentum" von Biovest.
5.) Insiderhandel: Am 14. Aug. kaufte Francis O'Donnell für 7,5 Mil. $ Aktien ein. Nichts besonderes? Der Kurs an diesem Tag war unter 2 Dollar - er kaufte zu 8,87 $ ein...
6.) ABPI macht schon Umsätze, "weiß wie man Produkte auf den Markt bringt" (MDTurbo)
7.) AllerNase - bei Nasenschleimhautentzündungen (über die "private" Collegium Pharmaceutical). 3 Mrd. $ (hart umkämpfter) Markt. Ein Approval für AllerNase ist 2008 zu erhoffen.
8.) Accentia besitzt zudem die TEAMM Pharmaceuticals. Die haben einige Produkte bereits vermartet und weitere (über Dritte) in der Pipeline. Eigentlich aber nichts erwähnenswerters!
Kommen wir zur Kehrseite:
1.) Fangen wir bei den Umätzen an: Letztes Jahr etwa 25 Mil. $, dieses Jahr wohl nur noch etwa 18 - 19 Mil.
2.) Wo ist das Cash? Warte schon seit Wochen auf die Meldung irgend einer Kapitalbeschaffungsmaßnahme. Zum 30. Juni waren nicht einmal 2 Mil. $ mehr vorhanden. Gleiches gilt für Biovest!
3.) gewohntes small-Biotech Bild: 2005 mit 50 Mil. Verlusten; 2006 knapp 44 Mil. $
4.) ... und auch noch Verbindlichkeiten (Schlimme Bilanzseite)!
5.) zudem die "normalen" Biotech Fragen: Wie stehts mit den Chancen einer Zulassung?
6.) Dillution - da werden wohl noch einige Aktien auf den Markt geschmissen (Warrants, convertible debts)
aktuell wurde gemeldet, dass der SinuNase Trial komplettiert wurde:
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-ne…
und zudem, dass NDA für Revimmune in MS
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-ne…
Ich beobachte Accentia schon ein wenig länger. ABPI ist seit Anfang August gut gelaufen (Tief war unter 1,70 $ aktuell ungefähr 2,50 $), dies war mit Sicherheit auch ein Grund, dass die letzten Meldungen keine Zugewinne für die Aktie bedeuteten.
Grüße
Ich werde in den nächsten Tagen noch 3 Berichte zu SinuNase hier reinstellen. Vorab aber einmal die neueste Präsentation:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
Ja, warum also eigentlich ABPI?
1.) SinuNase in Phase III - Behandlung chronischer Nasennebenhöhlenerkrankungen (CRS). Knapp 30 bis 35 Mil. Menschen alleine in den USA leiden darunter. Laut ABPI würde ein 1%-iger Markteinteil ein Blockbuster Produkt zur Folge haben. Möglicherweise wird SinuNase auslizensiert. Die Resultate werden wohl Anfang 2008 präsentiert werden. Anfang 2009 wäre ein möglicher Verkaufsstart.
2.) BiovaxID - ein Vaccine. Ende Juni konnte ABPI positive Vorabresultate aus einer Phase III-Studie (Start Sept. 2000) bei Non-Hodgkin-Lymphomen (NHL) präsentieren. BiovaxID könnte etwa 500 Mil. $ an Umsatz bringen. Möglicher "auf dem Markt" - Termin (Ziel ist ein acclerated approval): 2H 2009
3.) Revimmune - Ein Phase 3 IND Antrag ist im Juli gestellt worden (Anfang des Jahres einlizensiert). Zielgebiet: diverse Autoimmun Kranheiten, zuerst soll es bei Multiple Sklerose in die Phase 3 gehen.
4.) ungefähr 70%ige Beteiligung an Biovest (BVTI.OB). Von den Produkten Biovests soll es später Royality Zahlungen von knapp 20% geben. BiovaxID und AutovaxID sind "Eigentum" von Biovest.
5.) Insiderhandel: Am 14. Aug. kaufte Francis O'Donnell für 7,5 Mil. $ Aktien ein. Nichts besonderes? Der Kurs an diesem Tag war unter 2 Dollar - er kaufte zu 8,87 $ ein...
6.) ABPI macht schon Umsätze, "weiß wie man Produkte auf den Markt bringt" (MDTurbo)
7.) AllerNase - bei Nasenschleimhautentzündungen (über die "private" Collegium Pharmaceutical). 3 Mrd. $ (hart umkämpfter) Markt. Ein Approval für AllerNase ist 2008 zu erhoffen.
8.) Accentia besitzt zudem die TEAMM Pharmaceuticals. Die haben einige Produkte bereits vermartet und weitere (über Dritte) in der Pipeline. Eigentlich aber nichts erwähnenswerters!
Kommen wir zur Kehrseite:
1.) Fangen wir bei den Umätzen an: Letztes Jahr etwa 25 Mil. $, dieses Jahr wohl nur noch etwa 18 - 19 Mil.
2.) Wo ist das Cash? Warte schon seit Wochen auf die Meldung irgend einer Kapitalbeschaffungsmaßnahme. Zum 30. Juni waren nicht einmal 2 Mil. $ mehr vorhanden. Gleiches gilt für Biovest!
3.) gewohntes small-Biotech Bild: 2005 mit 50 Mil. Verlusten; 2006 knapp 44 Mil. $
4.) ... und auch noch Verbindlichkeiten (Schlimme Bilanzseite)!
5.) zudem die "normalen" Biotech Fragen: Wie stehts mit den Chancen einer Zulassung?
6.) Dillution - da werden wohl noch einige Aktien auf den Markt geschmissen (Warrants, convertible debts)
aktuell wurde gemeldet, dass der SinuNase Trial komplettiert wurde:
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-ne…
und zudem, dass NDA für Revimmune in MS
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-ne…
Ich beobachte Accentia schon ein wenig länger. ABPI ist seit Anfang August gut gelaufen (Tief war unter 1,70 $ aktuell ungefähr 2,50 $), dies war mit Sicherheit auch ein Grund, dass die letzten Meldungen keine Zugewinne für die Aktie bedeuteten.
Grüße
Ich werde in den nächsten Tagen noch 3 Berichte zu SinuNase hier reinstellen. Vorab aber einmal die neueste Präsentation:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
Da Fred Thompson heute einen weiteren Artikel zu ABPI im seekingalpha veröffentlicht hat, folgendes erstmal vorab:
http://seekingalpha.com/article/49405-accentia-biopharmaceut…
Accentia Biopharmaceuticals to Rise on Significant Developments
posted on: October 10, 2007
Things are really beginning to heat up at Accentia Biopharmaceuticals (ABPI) these days. Monday, the Tampa Florida company announced their completion of enrollment of their ongoing FDA fast-tracked Phase-3 trial for their lead compound, Sinunase, for the treatment of Chronic Rhino Sinusitis. The 300th patient has been enrolled. According to the company there is not one FDA approved treatment for CRS though it is estimated to have a larger market then Asthma with an estimated 37 million CRS sufferes in the United States alone.
The company stated:
Based on an interim blinded intent-to-treat analysis of the primary endpoint of complete resolution of the cardinal symptoms for the first approximately 147 patients to finish the trial, the Company believes that the trial at its conclusion will show a highly statistically significant outcome for SinuNase. There continues to be a strong positive correlation of symptom resolution and objective evidence of improvement by endoscopy and CT scan. The placebo control arm in the SinuNase study is essentially buffered water with a yellow dye, which has shown no antifungal activity in quantitative microbiologic tests. If no patients in the placebo control arm are achieving the primary endpoint of complete resolution of the cardinal symptoms, then the interim blinded results would infer that about 40% of SinuNase patients are reaching the primary endpoint, whereas only a 9% response rate would be needed to reach the required statistical threshold. Pursuant to Regulation Full Disclosure (Reg FD) the company will file on Oct 9, 2007 an 8-K containing its current investor presentation on SinuNase. This presentation will be used in investor meetings and in discussions with potential commercial partners. This presentation is also available at the Company's website (www.accentia.net). The Company, nevertheless, cautions that these are blinded results and that, as in any double-blinded placebo controlled clinical trial, the statistical analysis of the unblinded data at the conclusion of the trial could be adversely influenced if there is a greater than anticipated placebo effect in the control arm of the study.
Look for results to be announced in 18 weeks.
If Accentia can sucessfully bring Sinunase to the market with potential multi-billion dollar revenue potential I believe you could see a dramatic rise in the price per share.
In addition to the Sinunase update the company also announce that it met withthe FDA on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting for their compound Revimmune. The FDA confirmed it's support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi center clinical trial of Revimmune. Which is Accentia's potential theraputic for refractory, relapsing remitting Multiple Sclerosis.
The company stated:
The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune. Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.
The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.
In my opinion your are looking at a company that has current deeply discounted shares. Accentia already does about $20 million in current revenue that has 2 FDA Fast Tracked Phase 3 drugs in the end stages of their trials which both carry Multi-billion dollar potential. They also announced a new proposed Phase Three Trial for the treatment os Multiple Sclerosis which could be wrapped up by the second half of 2009 that has multi-billion dollar market potential as well. Shares can be had for just under $3.00 per share. If this company was to get the green light on on of these products I could see shares trading near $20.00 quickly.
Der Artikel, der mich erstmals auf ABPI aufmerksam machte, unter:
http://seekingalpha.com/article/44348-tiny-accentia-biopharm…
Grüße
http://seekingalpha.com/article/49405-accentia-biopharmaceut…
Accentia Biopharmaceuticals to Rise on Significant Developments
posted on: October 10, 2007
Things are really beginning to heat up at Accentia Biopharmaceuticals (ABPI) these days. Monday, the Tampa Florida company announced their completion of enrollment of their ongoing FDA fast-tracked Phase-3 trial for their lead compound, Sinunase, for the treatment of Chronic Rhino Sinusitis. The 300th patient has been enrolled. According to the company there is not one FDA approved treatment for CRS though it is estimated to have a larger market then Asthma with an estimated 37 million CRS sufferes in the United States alone.
The company stated:
Based on an interim blinded intent-to-treat analysis of the primary endpoint of complete resolution of the cardinal symptoms for the first approximately 147 patients to finish the trial, the Company believes that the trial at its conclusion will show a highly statistically significant outcome for SinuNase. There continues to be a strong positive correlation of symptom resolution and objective evidence of improvement by endoscopy and CT scan. The placebo control arm in the SinuNase study is essentially buffered water with a yellow dye, which has shown no antifungal activity in quantitative microbiologic tests. If no patients in the placebo control arm are achieving the primary endpoint of complete resolution of the cardinal symptoms, then the interim blinded results would infer that about 40% of SinuNase patients are reaching the primary endpoint, whereas only a 9% response rate would be needed to reach the required statistical threshold. Pursuant to Regulation Full Disclosure (Reg FD) the company will file on Oct 9, 2007 an 8-K containing its current investor presentation on SinuNase. This presentation will be used in investor meetings and in discussions with potential commercial partners. This presentation is also available at the Company's website (www.accentia.net). The Company, nevertheless, cautions that these are blinded results and that, as in any double-blinded placebo controlled clinical trial, the statistical analysis of the unblinded data at the conclusion of the trial could be adversely influenced if there is a greater than anticipated placebo effect in the control arm of the study.
Look for results to be announced in 18 weeks.
If Accentia can sucessfully bring Sinunase to the market with potential multi-billion dollar revenue potential I believe you could see a dramatic rise in the price per share.
In addition to the Sinunase update the company also announce that it met withthe FDA on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting for their compound Revimmune. The FDA confirmed it's support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi center clinical trial of Revimmune. Which is Accentia's potential theraputic for refractory, relapsing remitting Multiple Sclerosis.
The company stated:
The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune. Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.
The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.
In my opinion your are looking at a company that has current deeply discounted shares. Accentia already does about $20 million in current revenue that has 2 FDA Fast Tracked Phase 3 drugs in the end stages of their trials which both carry Multi-billion dollar potential. They also announced a new proposed Phase Three Trial for the treatment os Multiple Sclerosis which could be wrapped up by the second half of 2009 that has multi-billion dollar market potential as well. Shares can be had for just under $3.00 per share. If this company was to get the green light on on of these products I could see shares trading near $20.00 quickly.
Der Artikel, der mich erstmals auf ABPI aufmerksam machte, unter:
http://seekingalpha.com/article/44348-tiny-accentia-biopharm…
Grüße
Zu SinuNase: Ein wenig ausführlicher, hab' vorab ein paar allgemeine Sachen hierzu noch mitreinkopiert...
Sinusitis
aus Wikipedia, der freien Enzyklopädie
Als Sinusitis (lat. wörtlich Nasennebenhöhlenentzündung; Sinus=Nasennebenhöhle, - itis=Entzündung) wird die akute oder chronische Nasennebenhöhlenentzündung bezeichnet.
Chronische Sinusitis
Als chronische Sinusitis gilt eine mehr als 2-3 Monate (je nach Quelle) dauernde Sinusitis. Sie geht meist aus einer nicht ausgeheilten akuten oder subakuten Sinusitis hervor, meist sind Kieferhöhlen und Siebbeinzellen betroffen. Eine weitere Verlaufsform ist die rezidivierende akute Sinusitis.
Symptome sind langanhaltender Geruchsverlust (Anosmie), chronischer, meist wässriger Schnupfen (Rhinorrhoe), Sekretfluss in den Rachen (Post nasal drip), und dauerhafter, dumpfer Druck über den Nebenhöhlen oder hinter den Augen. Oft besteht zusätzlich das Wachstum entzündlicher Polypen in den Nasennebenhöhlen. Zur Behandlung werden Kortisonpräparate als Nasenspray oder in
Tablettenform angewendet. Bei Versagen der konservativen Therapie trotz einer Behandlungsdauer von mehr als 6 Wochen ist eine Operation angezeigt. Diese wird in 80% der Fälle das Befinden bessern, in 10% der Fälle kommt es zum Wiederauftreten der Erkrankung. Diese Operationen werden heute regelhaft von innerhalb der Nase ausgeführt, Schnitte im Gesicht (transfazialer Zugang) ist Einzelfällen vorbehalten. Patienten mit ausgedehnten Stirnhöhlenentzündungen haben eine schlechtere Prognose und ein schlechteres Risikoprofil. Risiken der Nasennebenhöhlenoperation bestehen aufgrund der räumlichen Nähe zu Augen und Gehirn in der Verletzung der Augenhöhle mit Ausbildung von Doppelbildern, dem Sehverlust, dem Abfließen von Hirnwasser, der Hirnhautentzündung und dem Einbluten in das Gehirn. Diese schwerwiegenden Komplikationen treten heute in weniger als 1% der Fälle auf.
Eine polypöse Sinusitis ist besonders häufig mit dem Auftreten eines Asthma bronchiale und einer Analgetika-Intoleranz vergesellschaftet. Das Vorkommen aller drei Erkrankungen bei einem Patienten nennt man Samter.-Trias. Diese Patienten haben mit der Standardtherapie eine deutlich erhöhte Rezidivneigung. Als neuere, unterstützende Therapie steht die adaptive Desaktivierung zur
Verfügung. Hierzu nimmt man nach Einstellung durch den Arzt dauerhaft Acetylsalicylsäure (ASS / Aspirin) ein und kann so erfolgreich der Polypenneubildung entgegen wirken. Eine Sanierung der Nasennebenhöhlen bei Asthmatikern führt bei diesen zu einer durchschnittlich um 5 mg verminderten Einnahme von Kortison, um das Asthma zu kontrollieren.
Als Folge einer chronischen Sinusitis können Erkrankungen der Lunge (Sinu-bronchiales-Syndrom) auftreten. Wenn die chronische Sinusitis trotz Therapie nicht ausheilt oder rezidiviert, sollte auch geklärt werden, ob eine Mukoviszidose vorliegen kann oder ob eventuell bisher unbemerkte Entzündungen der Zahnwurzeln in die Kieferhöhlen ausstrahlen (Panoramaröntgen!).
Erreger
- Viren,
- Haemophilus influenzae,
- Pneumokokken,
- Streptokokken,
- Staphylokokken
Kommen wir zur Wirkung von SinuNase, wo setzt es an?
http://www.accentia.net/science/sinunase.php
SinuNase™
SinuNase Therapy for Chronic Rhinosinusitis
Our first product candidate, SinuNase™, is an amphotericin B suspension that is self-administered into a patient’s nasal cavity for the treatment of chronic rhinosinusitis, or CRS. Rhinosinusitis is an inflammatory condition of the paranasal sinuses that results in a variety of symptoms, including nasal congestion, facial pain and pressure, nasal discharge, and headaches. Rhinosinusitis is estimated to affect approximately 35 million Americans, and an estimated 90% of all rhinosinusitis cases are chronic. Of CRS sufferers, up to 500,000 people resort to sinus surgery each year. Historically, the treatment of CRS has largely focused on addressing the symptoms of the condition through acute antibiotic therapy, intranasal or oral corticosteroids, and sinus surgery. While antibiotics are useful in treating the acute exacerbations that result from the bacterial invasion of the damaged paranasal tissue of CRS patients, no antibiotic has proven effective in eradicating the underlying cause of CRS. Intranasal and oral corticosteroids, which are potent anti-inflammatory hormones, have been used to reduce the inflammation that plays a role in CRS, but oral corticosteroids can cause serious side effects and must be avoided or cautiously used with patients that have certain conditions, such as gastrointestinal ulcers, renal disease, hypertension, diabetes, osteoporosis, thyroid disorders, and intestinal disease. Surgery is frequently used in CRS patients to improve the drainage of their sinuses based on the assumption that the disease can be reversed by identifying and correcting the obstruction that caused the condition, but while such surgery usually offers temporary relief of symptoms, it is typically not curative. If approved by the FDA, we expect that SinuNase would be the first pharmaceutical product indicated for the treatment of CRS.
SinuNase Studies at the Mayo Clinic
Mayo Clinic has conducted published studies on CRS demonstrating that airborne fungi play a significant role in CRS and that the condition can be substantially relieved by treating patients with a low-dose intranasal application of antifungals, such as an amphotericin B. Other formulations of amphotericin B are currently approved by the FDA as antifungals for other indications. In one open label study by Mayo Clinic with 51 CRS patients treated with an amphotericin B solution, 75% of the patients experienced improvement in sinus symptoms over a treatment course that averaged 11.3 months. In addition, in a study conducted by Mayo Clinic and published in the January 2005 Journal of Allergy and Clinical Immunology, Mayo Clinic reported results of a small controlled clinical trial that demonstrated a statistically significant difference between an amphotericin B treatment group and a control group. To date, the published clinical studies have not disclosed any serious adverse events associated with the intranasal application of amphotericin B.
In February 2004, we acquired a license from the Mayo Foundation for Medical Education and Research that, as amended, gives us the exclusive worldwide right to market and sell products based on Mayo Clinic’s patented treatment method using amphotericin B. Mayo Foundation holds an issued U.S. patent and a European Union counterpart patent application covering the use of intranasal antifungals for the treatment of CRS. It also holds a U.S. patent for the use of muco-administered antifungals for the treatment of asthma, and in December 2004, we amended our license with Mayo Foundation granting us rights to this therapy using amphotericin B. Under our license, we are developing SinuNase as a self-administered therapy delivered into the patient’s nasal cavity to relieve the symptoms associated with CRS.
We elected to license amphotericin B for our CRS therapy as a result of its favorable clinical and regulatory characteristics. To our knowledge, it is the only intranasal antifungal used by Mayo Clinic or others in their published studies on CRS, and amphotericin B is generally recognized as being very unlikely to induce drug resistance among fungi. As a fungicidal, amphotericin B is powerful enough to kill fungi, rather than merely impair their growth. Also, amphotericin B, when applied topically, has minimal absorption into a patient’s mucus membrane, which makes it possible to apply an effective dose to the fungi in the mucus with a low risk for systemic exposure to the patient. As an approved and extensively-characterized therapeutic for other indications, we believe the use of amphotericin B for our CRS therapy should provide for an expedited regulatory approval process.
Ob ein Pilzbefall verantwortlich gemacht werden kann, ist nach wie vor umstritten. Der Phase III Trial wird hier Aufschluss geben. Es gab von der Mayo Clinic Vermutungen, zuletzt gab es aber eine interessante Meldung:
Data in the SinuNase Phase 3 Clinical Trial Predicts That Virtually 100% of Chronic Sinusitis Cases Are Due to a Fungal-Induced Inflammation
Results Identify a Market Potential of Over 60 Million Patients in the U.S. and EU for SinuNase
TAMPA, Fla., Sep 10, 2007 (BUSINESS WIRE) -- Accentia Biopharmaceuticals (NASDAQ: ABPI) announces
evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as
originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company's
ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase(TM), an intranasal
formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical trial,
patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy
findings, and CT scan demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment,
all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic
major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic
protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly
support a fungal-induced inflammation as the cause of CS.
SinuTest(TM), the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at
the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO
Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The
Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of
having CS and who may be candidates for treatment with SinuNase, assuming FDA approval.
As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA)
for SinuNase, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with
severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and
only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an
Investigative New Drug (IND). The initial study population is with patients that have severe CS who have
undergone sinus surgery, but who are struggling with recurrent CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far
the most common chronic respiratory disease with a commercial market approximately twice the size of
asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If
approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo
discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus
of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an
eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the
mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of
CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is
uniquely detectable in the nasal mucin of patients with CS.
...
Kommen wir zum Schock. Diese Meldung hat nach wie vor Bestand und ist mein größter Zweifel an einem Erfolg von SinuNase:
Amphotericin B nasal lavages: Not a solution for patients with chronic rhinosinusitis
Fenna A. Ebbens, MDa, Glenis K. Scadding, MA, MD, FRCPb, Lydia Badia, MD, FRCSb, Peter W. Hellings, MD, PhDc, Mark Jorissen, MD, PhDc, Joaquim Mullol, MD, PhDd, Alda Cardesin, MDd, Claus Bachert, MD, PhDe, Thibaut P.J. van Zele, MDe, Marcel G.W. Dijkgraaf, MD, PhDf, Valerie Lund, MS, FRCS, FRCSEdb, Wytske J. Fokkens, MD, PhDa
Received 12 May 2006; received in revised form 13 July 2006; accepted 17 July 2006
Amsterdam, The Netherlands, London, United Kingdom, Leuven and Ghent, Belgium, and Barcelona, Spain
Background
Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Recently, it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease. On the basis of this hypothesis, intranasal treatment with amphotericin B should benefit patients with CRS. Data from 2 uncontrolled and 2 controlled trials are conflicting, however.
Objective
To clarify the role of intranasal antifungal drugs in the treatment of CRS, we conducted a large, double-blind, placebo-controlled, multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo.
Methods
A total of 116 randomly selected patients with CRS were instructed to instill 25 mL amphotericin B (100 µg/mL) or placebo to each nostril twice daily for 3 months. Primary outcomes included a reduction in total visual analog scale (VAS) score and nasal endoscopy score. Secondary outcome measures included peak nasal inspiratory flow, polyp score, quality of life (Short Form-36, Rhinosinusitis Outcome Measure-31), and individual VAS scores.
Results
Analysis was based on intention to treat and involved all patients randomly assigned. Mean VAS scores, Short Form-36 and Rhinosinusitis Outcome Measure-31 data, peak nasal inspiratory flow values, nasal endoscopy scores, and polyp scores were similar in both treatment groups at the time of randomization, and no significant differences were observed after 13 weeks of treatment.
Conclusion
Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS.
Clinical implications
Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS.
Hilft Amphotericin B also doch nicht bei CS?
Accentia results support fungal infection theory in chronic sinusitis
13th September 2007
By Sarah Routledge
Accentia Biopharmaceuticals has said that results from its ongoing phase III trial
provide evidence that most, if not all cases of chronic sinusitis are due to a fungalinduced
inflammation as originally proposed by investigators at the Mayo Clinic.
The data were collected as part of the company's ongoing pivotal trial for SinuNase, an intranasal
formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical
trial, patients must have had well-documented chronic sinusitis (CS) based on a history of the
requisite symptoms, nasal endoscopy findings, and CT scan demonstrating characteristic mucosal
changes in the sinuses. At the time of enrollment, all patients have had nasal mucin collected.
Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP). In the
first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by
inflammatory cells in response to fungi. Accentia believes that these findings strongly support a
fungal-induced inflammation as the cause of CS.
Mayo Clinic researchers discovered that the cause of chronic sinusitis was an immune reaction to a
fungal infection, not an allergy or a bacterial infection as was previously thought. In 2004, Accentia
acquired a license from the clinic that gave the company the exclusive worldwide right to market and
sell products based on Mayo Clinic's patented treatment method using amphotericin B.
... wird noch fortgesetzt ...
Sinusitis
aus Wikipedia, der freien Enzyklopädie
Als Sinusitis (lat. wörtlich Nasennebenhöhlenentzündung; Sinus=Nasennebenhöhle, - itis=Entzündung) wird die akute oder chronische Nasennebenhöhlenentzündung bezeichnet.
Chronische Sinusitis
Als chronische Sinusitis gilt eine mehr als 2-3 Monate (je nach Quelle) dauernde Sinusitis. Sie geht meist aus einer nicht ausgeheilten akuten oder subakuten Sinusitis hervor, meist sind Kieferhöhlen und Siebbeinzellen betroffen. Eine weitere Verlaufsform ist die rezidivierende akute Sinusitis.
Symptome sind langanhaltender Geruchsverlust (Anosmie), chronischer, meist wässriger Schnupfen (Rhinorrhoe), Sekretfluss in den Rachen (Post nasal drip), und dauerhafter, dumpfer Druck über den Nebenhöhlen oder hinter den Augen. Oft besteht zusätzlich das Wachstum entzündlicher Polypen in den Nasennebenhöhlen. Zur Behandlung werden Kortisonpräparate als Nasenspray oder in
Tablettenform angewendet. Bei Versagen der konservativen Therapie trotz einer Behandlungsdauer von mehr als 6 Wochen ist eine Operation angezeigt. Diese wird in 80% der Fälle das Befinden bessern, in 10% der Fälle kommt es zum Wiederauftreten der Erkrankung. Diese Operationen werden heute regelhaft von innerhalb der Nase ausgeführt, Schnitte im Gesicht (transfazialer Zugang) ist Einzelfällen vorbehalten. Patienten mit ausgedehnten Stirnhöhlenentzündungen haben eine schlechtere Prognose und ein schlechteres Risikoprofil. Risiken der Nasennebenhöhlenoperation bestehen aufgrund der räumlichen Nähe zu Augen und Gehirn in der Verletzung der Augenhöhle mit Ausbildung von Doppelbildern, dem Sehverlust, dem Abfließen von Hirnwasser, der Hirnhautentzündung und dem Einbluten in das Gehirn. Diese schwerwiegenden Komplikationen treten heute in weniger als 1% der Fälle auf.
Eine polypöse Sinusitis ist besonders häufig mit dem Auftreten eines Asthma bronchiale und einer Analgetika-Intoleranz vergesellschaftet. Das Vorkommen aller drei Erkrankungen bei einem Patienten nennt man Samter.-Trias. Diese Patienten haben mit der Standardtherapie eine deutlich erhöhte Rezidivneigung. Als neuere, unterstützende Therapie steht die adaptive Desaktivierung zur
Verfügung. Hierzu nimmt man nach Einstellung durch den Arzt dauerhaft Acetylsalicylsäure (ASS / Aspirin) ein und kann so erfolgreich der Polypenneubildung entgegen wirken. Eine Sanierung der Nasennebenhöhlen bei Asthmatikern führt bei diesen zu einer durchschnittlich um 5 mg verminderten Einnahme von Kortison, um das Asthma zu kontrollieren.
Als Folge einer chronischen Sinusitis können Erkrankungen der Lunge (Sinu-bronchiales-Syndrom) auftreten. Wenn die chronische Sinusitis trotz Therapie nicht ausheilt oder rezidiviert, sollte auch geklärt werden, ob eine Mukoviszidose vorliegen kann oder ob eventuell bisher unbemerkte Entzündungen der Zahnwurzeln in die Kieferhöhlen ausstrahlen (Panoramaröntgen!).
Erreger
- Viren,
- Haemophilus influenzae,
- Pneumokokken,
- Streptokokken,
- Staphylokokken
Kommen wir zur Wirkung von SinuNase, wo setzt es an?
http://www.accentia.net/science/sinunase.php
SinuNase™
SinuNase Therapy for Chronic Rhinosinusitis
Our first product candidate, SinuNase™, is an amphotericin B suspension that is self-administered into a patient’s nasal cavity for the treatment of chronic rhinosinusitis, or CRS. Rhinosinusitis is an inflammatory condition of the paranasal sinuses that results in a variety of symptoms, including nasal congestion, facial pain and pressure, nasal discharge, and headaches. Rhinosinusitis is estimated to affect approximately 35 million Americans, and an estimated 90% of all rhinosinusitis cases are chronic. Of CRS sufferers, up to 500,000 people resort to sinus surgery each year. Historically, the treatment of CRS has largely focused on addressing the symptoms of the condition through acute antibiotic therapy, intranasal or oral corticosteroids, and sinus surgery. While antibiotics are useful in treating the acute exacerbations that result from the bacterial invasion of the damaged paranasal tissue of CRS patients, no antibiotic has proven effective in eradicating the underlying cause of CRS. Intranasal and oral corticosteroids, which are potent anti-inflammatory hormones, have been used to reduce the inflammation that plays a role in CRS, but oral corticosteroids can cause serious side effects and must be avoided or cautiously used with patients that have certain conditions, such as gastrointestinal ulcers, renal disease, hypertension, diabetes, osteoporosis, thyroid disorders, and intestinal disease. Surgery is frequently used in CRS patients to improve the drainage of their sinuses based on the assumption that the disease can be reversed by identifying and correcting the obstruction that caused the condition, but while such surgery usually offers temporary relief of symptoms, it is typically not curative. If approved by the FDA, we expect that SinuNase would be the first pharmaceutical product indicated for the treatment of CRS.
SinuNase Studies at the Mayo Clinic
Mayo Clinic has conducted published studies on CRS demonstrating that airborne fungi play a significant role in CRS and that the condition can be substantially relieved by treating patients with a low-dose intranasal application of antifungals, such as an amphotericin B. Other formulations of amphotericin B are currently approved by the FDA as antifungals for other indications. In one open label study by Mayo Clinic with 51 CRS patients treated with an amphotericin B solution, 75% of the patients experienced improvement in sinus symptoms over a treatment course that averaged 11.3 months. In addition, in a study conducted by Mayo Clinic and published in the January 2005 Journal of Allergy and Clinical Immunology, Mayo Clinic reported results of a small controlled clinical trial that demonstrated a statistically significant difference between an amphotericin B treatment group and a control group. To date, the published clinical studies have not disclosed any serious adverse events associated with the intranasal application of amphotericin B.
In February 2004, we acquired a license from the Mayo Foundation for Medical Education and Research that, as amended, gives us the exclusive worldwide right to market and sell products based on Mayo Clinic’s patented treatment method using amphotericin B. Mayo Foundation holds an issued U.S. patent and a European Union counterpart patent application covering the use of intranasal antifungals for the treatment of CRS. It also holds a U.S. patent for the use of muco-administered antifungals for the treatment of asthma, and in December 2004, we amended our license with Mayo Foundation granting us rights to this therapy using amphotericin B. Under our license, we are developing SinuNase as a self-administered therapy delivered into the patient’s nasal cavity to relieve the symptoms associated with CRS.
We elected to license amphotericin B for our CRS therapy as a result of its favorable clinical and regulatory characteristics. To our knowledge, it is the only intranasal antifungal used by Mayo Clinic or others in their published studies on CRS, and amphotericin B is generally recognized as being very unlikely to induce drug resistance among fungi. As a fungicidal, amphotericin B is powerful enough to kill fungi, rather than merely impair their growth. Also, amphotericin B, when applied topically, has minimal absorption into a patient’s mucus membrane, which makes it possible to apply an effective dose to the fungi in the mucus with a low risk for systemic exposure to the patient. As an approved and extensively-characterized therapeutic for other indications, we believe the use of amphotericin B for our CRS therapy should provide for an expedited regulatory approval process.
Ob ein Pilzbefall verantwortlich gemacht werden kann, ist nach wie vor umstritten. Der Phase III Trial wird hier Aufschluss geben. Es gab von der Mayo Clinic Vermutungen, zuletzt gab es aber eine interessante Meldung:
Data in the SinuNase Phase 3 Clinical Trial Predicts That Virtually 100% of Chronic Sinusitis Cases Are Due to a Fungal-Induced Inflammation
Results Identify a Market Potential of Over 60 Million Patients in the U.S. and EU for SinuNase
TAMPA, Fla., Sep 10, 2007 (BUSINESS WIRE) -- Accentia Biopharmaceuticals (NASDAQ: ABPI) announces
evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as
originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company's
ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase(TM), an intranasal
formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical trial,
patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy
findings, and CT scan demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment,
all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic
major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic
protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly
support a fungal-induced inflammation as the cause of CS.
SinuTest(TM), the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at
the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO
Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The
Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of
having CS and who may be candidates for treatment with SinuNase, assuming FDA approval.
As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA)
for SinuNase, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with
severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and
only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an
Investigative New Drug (IND). The initial study population is with patients that have severe CS who have
undergone sinus surgery, but who are struggling with recurrent CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far
the most common chronic respiratory disease with a commercial market approximately twice the size of
asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If
approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo
discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus
of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an
eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the
mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of
CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is
uniquely detectable in the nasal mucin of patients with CS.
...
Kommen wir zum Schock. Diese Meldung hat nach wie vor Bestand und ist mein größter Zweifel an einem Erfolg von SinuNase:
Amphotericin B nasal lavages: Not a solution for patients with chronic rhinosinusitis
Fenna A. Ebbens, MDa, Glenis K. Scadding, MA, MD, FRCPb, Lydia Badia, MD, FRCSb, Peter W. Hellings, MD, PhDc, Mark Jorissen, MD, PhDc, Joaquim Mullol, MD, PhDd, Alda Cardesin, MDd, Claus Bachert, MD, PhDe, Thibaut P.J. van Zele, MDe, Marcel G.W. Dijkgraaf, MD, PhDf, Valerie Lund, MS, FRCS, FRCSEdb, Wytske J. Fokkens, MD, PhDa
Received 12 May 2006; received in revised form 13 July 2006; accepted 17 July 2006
Amsterdam, The Netherlands, London, United Kingdom, Leuven and Ghent, Belgium, and Barcelona, Spain
Background
Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Recently, it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease. On the basis of this hypothesis, intranasal treatment with amphotericin B should benefit patients with CRS. Data from 2 uncontrolled and 2 controlled trials are conflicting, however.
Objective
To clarify the role of intranasal antifungal drugs in the treatment of CRS, we conducted a large, double-blind, placebo-controlled, multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo.
Methods
A total of 116 randomly selected patients with CRS were instructed to instill 25 mL amphotericin B (100 µg/mL) or placebo to each nostril twice daily for 3 months. Primary outcomes included a reduction in total visual analog scale (VAS) score and nasal endoscopy score. Secondary outcome measures included peak nasal inspiratory flow, polyp score, quality of life (Short Form-36, Rhinosinusitis Outcome Measure-31), and individual VAS scores.
Results
Analysis was based on intention to treat and involved all patients randomly assigned. Mean VAS scores, Short Form-36 and Rhinosinusitis Outcome Measure-31 data, peak nasal inspiratory flow values, nasal endoscopy scores, and polyp scores were similar in both treatment groups at the time of randomization, and no significant differences were observed after 13 weeks of treatment.
Conclusion
Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS.
Clinical implications
Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS.
Hilft Amphotericin B also doch nicht bei CS?
Accentia results support fungal infection theory in chronic sinusitis
13th September 2007
By Sarah Routledge
Accentia Biopharmaceuticals has said that results from its ongoing phase III trial
provide evidence that most, if not all cases of chronic sinusitis are due to a fungalinduced
inflammation as originally proposed by investigators at the Mayo Clinic.
The data were collected as part of the company's ongoing pivotal trial for SinuNase, an intranasal
formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical
trial, patients must have had well-documented chronic sinusitis (CS) based on a history of the
requisite symptoms, nasal endoscopy findings, and CT scan demonstrating characteristic mucosal
changes in the sinuses. At the time of enrollment, all patients have had nasal mucin collected.
Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP). In the
first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by
inflammatory cells in response to fungi. Accentia believes that these findings strongly support a
fungal-induced inflammation as the cause of CS.
Mayo Clinic researchers discovered that the cause of chronic sinusitis was an immune reaction to a
fungal infection, not an allergy or a bacterial infection as was previously thought. In 2004, Accentia
acquired a license from the clinic that gave the company the exclusive worldwide right to market and
sell products based on Mayo Clinic's patented treatment method using amphotericin B.
... wird noch fortgesetzt ...
Antwort auf Beitrag Nr.: 31.942.541 von Ackergaul am 11.10.07 17:37:16Kommen wir zu den aktuelleren Fakten:
Vorab erst einmal, worum geht es in diesem Phase III Trial?
The trial will be a 16-week, double-blinded comparison with 300 patients randomized between SinuNase and placebo, with the primary endpoint being the resolution of the key cardinal symptoms of chronic sinusitis. Secondary endpoints include endoscopy scores and sinus mucosal thickening on CT scan.
(Die beiden "Schlüsselsymptome" sollen wohl headache und cognestion sein)
Fangen wir bei den letzten Meldungen zu SinuNase an:
Accentia Biopharmaceuticals Updates Interim Analysis of Blinded Clinical Results in the Fast-Tracked Pivotal Phase 3 Trial of SinuNase for the Treatment of Refractory Chronic Sinusitis
Trial has Reached 90% Enrollment and Positive Correlation of Symptom Resolution with Objective Evidence of Improvement Among Patients Suggests that SinuNase is Demonstrating the Anticipated Efficacy
TAMPA, Fla., Aug 15, 2007 (BUSINESS WIRE) -- Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI) reports interim analysis of the blinded data on patients who have now completed the 16-week Fast-Tracked Phase 3 placebo controlled clinical trial of SinuNase for the treatment of refractory chronic sinusitis (CS).
In order to put the blinded analysis into perspective, it is important to appreciate the study design. The study population is in patients who have undergone one or more sinus surgeries for CS, but who are struggling with recurrent severe CS as determined by symptoms, endoscopy, and CT scan of the sinuses. The trial is intended to test the efficacy and safety of SinuNase(TM) (intranasal amphotericin B 0.01% suspension) lavage for the treatment of severe refractory chronic sinusitis. All patients entering the trial and all patients after two weeks of saline irrigations must have the two cardinal symptoms of CS. To date, no patient has had resolution of either cardinal symptom after two weeks of saline irrigations. Subsequently, patients are randomized in a double-blind fashion on a 1:1 ratio with 50% of patients using SinuNase and 50% using a placebo control. The primary endpoint is complete resolution of both key cardinal symptoms of chronic sinusitis at 16 weeks. The protocol includes questions about symptoms and nasal endoscopy performed throughout the trial at scheduled intervals, with CT scans of the sinuses taken at the beginning and end of the trial for each patient.
Based on an interim blinded analysis of the first group of the more than 80 patients who have now completed the trial at 16 weeks, the study has shown improvement in polyposis by endoscopy in about 50% of patients (N=43) and improvement in sinus inflammation by CT scan in approximately 50% of patients (N=23).
Moreover, the interim data shows that almost 50% of these patients with objective evidence of improvement have achieved the primary endpoint of complete resolution of the two key cardinal symptoms. The Company cautions that these are blinded interim results and that although the positive correlation of symptom resolution
with objective evidence of improvement by endoscopy and CT scan suggests that SinuNase is demonstrating the anticipated efficacy compared to control, only unblinded data will determine if the SinuNase arm of the trial has achieved the primary endpoint versus control in a statistically significant manner. When Accentia designed the clinical trial, the Company projected that approximately 4% of all patients would need to achieve the primary endpoint assuming a null hypothesis (no effect) for the control group. The interim blinded data shows that approximately 23% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27% of all patients have achieved complete resolution of one or the other of the two cardinal symptoms (N=48).
Furthermore, Accentia reports that it appears that patients are experiencing substantial symptom resolution and reduction in polyposis by 2-4 weeks. Accordingly, the Company believes that if analysis of unblinded data at the conclusion of the trial documents that SinuNase is indeed effective by Week 4, the second pivotal Phase 3 trial may be adjusted to be an 8-week trial rather than 16-weeks.
...
Wenn ich mir diese Nachricht ansehe, was fällt mir auf? Erst einmal zum Placebo Effekt: Alle Patienten erhalten eine zwei-wöchige Vorbehandlung, bisher ist dort bei keinem eine Verbesserung der cardinal symptoms aufgetreten - finde ich schon einmal wichtig. Bei den bisher mehr als 80 Patienten bisher, sind bei 50% eine Verbesserung bei den Polypen (mittels Endoskopie geprüft) entstanden. 50% sollte hier bedeuten: 100% bei SinuNase und 0% bei der Placebo Gruppe - zumindest aus meiner Sicht. Ähnlich bei der zweiten Verbesserung (mit CT-Scan getestet), den Nasennebenhöhlen Entzündung. Hier sind 23 Patienten mit verbesserten Scans gesichtet worden, was auch ungefähr 50% entsprach...
Zu den cardinal symptoms: In dieser Zwischenbilanz erreichten 23% der Patienten, den primären Endpunkt (Verbesserung beider Symptome). Wenn hier angenommen wird, das 40% der SinuNase Gruppe und 6% in der Placebo Gruppe diesen Endpunkt erreicht hätten UND würde diese prozentuale Ergebnis am Ende der Studie ereicht, wäre dies hochsignifikant! ABPI hat mit 4% vs 0% in der Kontrollgruppe kalkuliert.
Nur mal zur Erläuterung: ich denke, dass zu diesem Zeitpunkt 48 Patienten komplett ausgewertet wurden (endoskopie und CT-Scan). 23 von 48 hatten eine Verbesserung des CT-Scans (ca. 48%). Zudem hatten von den 48 Patienten 23% (11) den primären Endpunkt erreicht. So zumindest erkläre ich mir dass Zahlenwerk.
Dazu noch eine Aussage von Frank E. O'Donnell (June 28, 2007) - auch zu einer Zwischenbilanz:
"The data reported is very encouraging," said Dr. Frank E. O'Donnell Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "While we cannot determine which patients are receiving SinuNase and which are receiving placebo control until the study is completed and unblinded, the fact that there are resolution of symptoms and improvement in endoscopy in a substantial percentage of patients suggests to me that we are on
track to reach our anticipated outcome for SinuNase in the Phase 3 study. It seems unlikely to me that patients receiving placebo would have a substantial improvement in polyps. In fact, in patients who experienced no resolution of symptoms, the endoscopy scores improved by just 2%. In patients who reported complete
resolution of one cardinal symptom there was an average improvement in endoscopy scores of 12%. In patients who reported resolution of both cardinal symptoms there was an average improvement in endoscopy scores of 23%."
Hierzu sollte man sich die Präsentation ABPIs noch anschauen (Seite 20 und 21 vor allem):
http://www.accentia.net/media/Jun27_2007_JEFCO_Accentia.pdf
und was aus Sicht der Mayo Clinic:
http://postbulletin.typepad.com/kiger/2007/08/mayo-pal-accen…
August 16, 2007
Mayo pal Accentia's SinuNase study
It looks like good news for Accentia Biopharmaceuticals Inc. and by extension, Mayo Clinic.
Accentia kicked out a report about " the 16-week Fast-Tracked Phase 3 placebo controlled clinical trial of SinuNase." This is the stuff that is designed to treat chronic sinusitis.
This new product could be worth more than a billion a year and Mayo would get 16 percent. That all depends on if it works, of course.
And the data from the Phase 3 trial makes that look likely. Here's some from the release. Reporter Jeff Hansel will have more on this in print Friday.
Subsequently, patients are randomized in a double-blind fashion on a 1:1 ratio with 50 per cent of patients using SinuNase and 50 per cent using a placebo control. The primary endpoint is complete resolution of both key cardinal symptoms of chronic sinusitis at 16 weeks.
When Accentia designed the clinical trial, the company projected that approximately four per cent of all patients would need to achieve the primary endpoint assuming a null hypothesis (no effect) for the control group. The interim blinded data shows that approximately 23 per cent of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27 per cent of all patients have achieved complete resolution of one or the other of the two cardinal symptoms.
Furthermore, Accentia reports that it appears that patients are experiencing substantial symptom resolution and reduction in polyposis by two to four weeks. Accordingly, the company believes that if analysis of unblinded data at the conclusion of the trial documents that SinuNase is indeed effective by Week 4, the second pivotal Phase 3 trial may be adjusted to be an eight-week trial rather than 16-weeks.
... wird noch fortgesetzt ...
Vorab erst einmal, worum geht es in diesem Phase III Trial?
The trial will be a 16-week, double-blinded comparison with 300 patients randomized between SinuNase and placebo, with the primary endpoint being the resolution of the key cardinal symptoms of chronic sinusitis. Secondary endpoints include endoscopy scores and sinus mucosal thickening on CT scan.
(Die beiden "Schlüsselsymptome" sollen wohl headache und cognestion sein)
Fangen wir bei den letzten Meldungen zu SinuNase an:
Accentia Biopharmaceuticals Updates Interim Analysis of Blinded Clinical Results in the Fast-Tracked Pivotal Phase 3 Trial of SinuNase for the Treatment of Refractory Chronic Sinusitis
Trial has Reached 90% Enrollment and Positive Correlation of Symptom Resolution with Objective Evidence of Improvement Among Patients Suggests that SinuNase is Demonstrating the Anticipated Efficacy
TAMPA, Fla., Aug 15, 2007 (BUSINESS WIRE) -- Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI) reports interim analysis of the blinded data on patients who have now completed the 16-week Fast-Tracked Phase 3 placebo controlled clinical trial of SinuNase for the treatment of refractory chronic sinusitis (CS).
In order to put the blinded analysis into perspective, it is important to appreciate the study design. The study population is in patients who have undergone one or more sinus surgeries for CS, but who are struggling with recurrent severe CS as determined by symptoms, endoscopy, and CT scan of the sinuses. The trial is intended to test the efficacy and safety of SinuNase(TM) (intranasal amphotericin B 0.01% suspension) lavage for the treatment of severe refractory chronic sinusitis. All patients entering the trial and all patients after two weeks of saline irrigations must have the two cardinal symptoms of CS. To date, no patient has had resolution of either cardinal symptom after two weeks of saline irrigations. Subsequently, patients are randomized in a double-blind fashion on a 1:1 ratio with 50% of patients using SinuNase and 50% using a placebo control. The primary endpoint is complete resolution of both key cardinal symptoms of chronic sinusitis at 16 weeks. The protocol includes questions about symptoms and nasal endoscopy performed throughout the trial at scheduled intervals, with CT scans of the sinuses taken at the beginning and end of the trial for each patient.
Based on an interim blinded analysis of the first group of the more than 80 patients who have now completed the trial at 16 weeks, the study has shown improvement in polyposis by endoscopy in about 50% of patients (N=43) and improvement in sinus inflammation by CT scan in approximately 50% of patients (N=23).
Moreover, the interim data shows that almost 50% of these patients with objective evidence of improvement have achieved the primary endpoint of complete resolution of the two key cardinal symptoms. The Company cautions that these are blinded interim results and that although the positive correlation of symptom resolution
with objective evidence of improvement by endoscopy and CT scan suggests that SinuNase is demonstrating the anticipated efficacy compared to control, only unblinded data will determine if the SinuNase arm of the trial has achieved the primary endpoint versus control in a statistically significant manner. When Accentia designed the clinical trial, the Company projected that approximately 4% of all patients would need to achieve the primary endpoint assuming a null hypothesis (no effect) for the control group. The interim blinded data shows that approximately 23% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27% of all patients have achieved complete resolution of one or the other of the two cardinal symptoms (N=48).
Furthermore, Accentia reports that it appears that patients are experiencing substantial symptom resolution and reduction in polyposis by 2-4 weeks. Accordingly, the Company believes that if analysis of unblinded data at the conclusion of the trial documents that SinuNase is indeed effective by Week 4, the second pivotal Phase 3 trial may be adjusted to be an 8-week trial rather than 16-weeks.
...
Wenn ich mir diese Nachricht ansehe, was fällt mir auf? Erst einmal zum Placebo Effekt: Alle Patienten erhalten eine zwei-wöchige Vorbehandlung, bisher ist dort bei keinem eine Verbesserung der cardinal symptoms aufgetreten - finde ich schon einmal wichtig. Bei den bisher mehr als 80 Patienten bisher, sind bei 50% eine Verbesserung bei den Polypen (mittels Endoskopie geprüft) entstanden. 50% sollte hier bedeuten: 100% bei SinuNase und 0% bei der Placebo Gruppe - zumindest aus meiner Sicht. Ähnlich bei der zweiten Verbesserung (mit CT-Scan getestet), den Nasennebenhöhlen Entzündung. Hier sind 23 Patienten mit verbesserten Scans gesichtet worden, was auch ungefähr 50% entsprach...
Zu den cardinal symptoms: In dieser Zwischenbilanz erreichten 23% der Patienten, den primären Endpunkt (Verbesserung beider Symptome). Wenn hier angenommen wird, das 40% der SinuNase Gruppe und 6% in der Placebo Gruppe diesen Endpunkt erreicht hätten UND würde diese prozentuale Ergebnis am Ende der Studie ereicht, wäre dies hochsignifikant! ABPI hat mit 4% vs 0% in der Kontrollgruppe kalkuliert.
Nur mal zur Erläuterung: ich denke, dass zu diesem Zeitpunkt 48 Patienten komplett ausgewertet wurden (endoskopie und CT-Scan). 23 von 48 hatten eine Verbesserung des CT-Scans (ca. 48%). Zudem hatten von den 48 Patienten 23% (11) den primären Endpunkt erreicht. So zumindest erkläre ich mir dass Zahlenwerk.
Dazu noch eine Aussage von Frank E. O'Donnell (June 28, 2007) - auch zu einer Zwischenbilanz:
"The data reported is very encouraging," said Dr. Frank E. O'Donnell Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "While we cannot determine which patients are receiving SinuNase and which are receiving placebo control until the study is completed and unblinded, the fact that there are resolution of symptoms and improvement in endoscopy in a substantial percentage of patients suggests to me that we are on
track to reach our anticipated outcome for SinuNase in the Phase 3 study. It seems unlikely to me that patients receiving placebo would have a substantial improvement in polyps. In fact, in patients who experienced no resolution of symptoms, the endoscopy scores improved by just 2%. In patients who reported complete
resolution of one cardinal symptom there was an average improvement in endoscopy scores of 12%. In patients who reported resolution of both cardinal symptoms there was an average improvement in endoscopy scores of 23%."
Hierzu sollte man sich die Präsentation ABPIs noch anschauen (Seite 20 und 21 vor allem):
http://www.accentia.net/media/Jun27_2007_JEFCO_Accentia.pdf
und was aus Sicht der Mayo Clinic:
http://postbulletin.typepad.com/kiger/2007/08/mayo-pal-accen…
August 16, 2007
Mayo pal Accentia's SinuNase study
It looks like good news for Accentia Biopharmaceuticals Inc. and by extension, Mayo Clinic.
Accentia kicked out a report about " the 16-week Fast-Tracked Phase 3 placebo controlled clinical trial of SinuNase." This is the stuff that is designed to treat chronic sinusitis.
This new product could be worth more than a billion a year and Mayo would get 16 percent. That all depends on if it works, of course.
And the data from the Phase 3 trial makes that look likely. Here's some from the release. Reporter Jeff Hansel will have more on this in print Friday.
Subsequently, patients are randomized in a double-blind fashion on a 1:1 ratio with 50 per cent of patients using SinuNase and 50 per cent using a placebo control. The primary endpoint is complete resolution of both key cardinal symptoms of chronic sinusitis at 16 weeks.
When Accentia designed the clinical trial, the company projected that approximately four per cent of all patients would need to achieve the primary endpoint assuming a null hypothesis (no effect) for the control group. The interim blinded data shows that approximately 23 per cent of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27 per cent of all patients have achieved complete resolution of one or the other of the two cardinal symptoms.
Furthermore, Accentia reports that it appears that patients are experiencing substantial symptom resolution and reduction in polyposis by two to four weeks. Accordingly, the company believes that if analysis of unblinded data at the conclusion of the trial documents that SinuNase is indeed effective by Week 4, the second pivotal Phase 3 trial may be adjusted to be an eight-week trial rather than 16-weeks.
... wird noch fortgesetzt ...
Es gibt nur eine logische Konsequenz aus dem
Phase III Trial. Sinunase wird demnaechst ein
voller Erfolg.
Phase III Trial. Sinunase wird demnaechst ein
voller Erfolg.
Antwort auf Beitrag Nr.: 31.954.084 von Ackergaul am 12.10.07 13:13:13Zusammenfassend also:
- Es wird vermutet (Mayo Clini und ABPI), dass letztendlich ein Pilz verantwortlich für CS ist.
- Daten sehen vielversprechend aus
- großes Fragezeichen aus der 2006er Studie "Amphotericin B nasal lavages: Not a solution for patients with chronic rhinosinusitis"
Accentia: uncertain role for SinuNase
11th September 2007
By Jonathan Angell
Accentia believes that it has evidence to support a theory that most, if not all, cases of chronic sinusitis are caused by fungal-induced inflammation. Preliminary analysis of samples taken as part of a Phase III trial for one of the company's developmental compounds suggest a link, but the role of the drug in disease management is less clear.
From sinusitis to severe asthma, fungal pathogens are becoming targets for clinical investigation. Accentia and BioDelivery Systems are currently developing SinuNase, an amphotericin B-based product specifically targeting respiratory carriage of fungal pathogens as the key to specific respiratory conditions.
Accentia's prospects for SinuNase are, at this stage, still relatively ambiguous. Although there are a substantial number of amphotericin-based products on the market, this new nasal delivery system offers potential not only in this indication, but possibly also as prophylaxis and treatment for Aspergillus infections of the respiratory tract. Aspergillus, a mold, is a fungal pathogen of increasingly acknowledged clinical importance characterized by respiratory colonization.
However, evidence of SinuNase's precise role in disease management is still unclear. Firstly, while the majority of early work on the drug focused on establishing its activity against Candida species, certainly for its nasal applications, it is more likely that if there is a link between fungal pathogens and the resulting sinusitis, Aspergillus is a more probable culprit.
Secondly, the trial design prompts questions over the drug's precise role. On the one hand, in the absence of other nasally administered products, the trial structure is appropriately both doubleblinded and placebo-controlled - although it is conceivable that future comparisons with a systemic antifungal could prove useful in determining whether the effects of SinuNase are due to the antifungal nature of the drug, or any other effect. On the other, however, the trials are spread over a large number of centers used (60) relative to the number of participants (300), which seems a disproportionate ratio given the relative frequency of chronic sinusitis.
Nevertheless, this is an area of particular interest among some of mycology's best-known academic and clinical names, so the drug's development is likely to generate substantial advocacy if trial results prove interesting. Additionally, the relative frequency of recurrent chronic sinusitis has facilitated a relatively rapid enrolment and progression of this Phase III trial, implying that Accentia and BioDelivery Sciences have the potential to augment these results with more focused trials if deemed necessary.
Aspergillus sollte also eher ein Ziel von Amphotericin B sein. Wie auch immer, die letzten Ergebnisse sehen (wahrscheinlich) vielversprechend zugunsten SinuNase in CS aus. Zu Ampho B und den Nebenwirkungen kurz:
Amphotericin B
aus Wikipedia, der freien Enzyklopädie
Amphotericin B ist ein Polyen-Makrolakton aus Streptomyces nodosum, einem Actinobacterium aus der Gattung der Streptomyceten. Es wird als Antimykotikum zur Behandlung von Pilzinfektionen eingesetzt. Amphotericin B wurde 1955 erstmals beschrieben.
Nebenwirkungen
Welche Nebenwirkungen auftreten, ist stark davon abhängig, ob das Präparat als Creme oder Salbe aufgetragen, als Tablette gelutscht (und geschluckt) oder als Infusionslösung infundiert wurde. Allgemein können jedoch Beschwerden im Verdauungstrakt sowie Ausschläge auftreten. Bei der Infusionslösung kann es u. a. zu Fieber, Schüttelfrost, Veränderungen des Blutbildes sowie zu Leber und Nierenschädigungen kommen, weshalb der Einsatz begrenzt ist. Vorsicht ist bei eingeschränkter Nierenfunktion geboten: eine Beobachtung von Nierenfunktionsparametern und Elektrolyten ist angezeigt.
Die neu verfügbaren Lipidformulierungen von Amphotericin B sind besser verträglich und zeigen eine leicht bessere Ansprechrate als die ursprüngliche Darreichungsform.
Ein paar Splitter:
- Hergestellt wird SinuNase im Übrigen von der Firma BioDelivery (BDSI). Dort sitzt der gute Herr O'Donnell auch "dick mit drin". BDSI sollte einen 14% Anteil von SinuNase dafür erhalten, 7% davon wurden aber an PPDI "abgetreten". Die Mayo Clinic bekommt nochmals 16%.
- Die Phase III (obwohl fast track Status) ist ziemlich langsam mit der rekrutierung. Eigentlich kein gutes Zeichen
- Der Sinn eines Placebo vs. SinuNase Tests ist sehr fragwürdig. Warum nicht gegenüber Antibiotika oder Kortison?
- Schätzungsweise würde die Behandlung eines Patienten zwischen 2.000 und 3.000 $ liegen!
Letzen Endes:
ABPI sollte beweisen können, das ein Pilz CS auslöst UND wie SinuNase genau dagegen wirkt, ansonsten wird es auch nach einem erfolgreichen Ausgang der Phase III wohl kein approval geben, da aktuell noch viele Fragezeichen im Raum stehen! Bedenken gegenüber den Nebenwirkungen könnte es auch geben, ist aber eher unwahrscheinlich, da Ampho B schon "auf dem Markt" ist. Dennoch, die Vertäglichkeit / Bekömmlichkeit von SinuNase ist damit nicht geklärt!
- Es wird vermutet (Mayo Clini und ABPI), dass letztendlich ein Pilz verantwortlich für CS ist.
- Daten sehen vielversprechend aus
- großes Fragezeichen aus der 2006er Studie "Amphotericin B nasal lavages: Not a solution for patients with chronic rhinosinusitis"
Accentia: uncertain role for SinuNase
11th September 2007
By Jonathan Angell
Accentia believes that it has evidence to support a theory that most, if not all, cases of chronic sinusitis are caused by fungal-induced inflammation. Preliminary analysis of samples taken as part of a Phase III trial for one of the company's developmental compounds suggest a link, but the role of the drug in disease management is less clear.
From sinusitis to severe asthma, fungal pathogens are becoming targets for clinical investigation. Accentia and BioDelivery Systems are currently developing SinuNase, an amphotericin B-based product specifically targeting respiratory carriage of fungal pathogens as the key to specific respiratory conditions.
Accentia's prospects for SinuNase are, at this stage, still relatively ambiguous. Although there are a substantial number of amphotericin-based products on the market, this new nasal delivery system offers potential not only in this indication, but possibly also as prophylaxis and treatment for Aspergillus infections of the respiratory tract. Aspergillus, a mold, is a fungal pathogen of increasingly acknowledged clinical importance characterized by respiratory colonization.
However, evidence of SinuNase's precise role in disease management is still unclear. Firstly, while the majority of early work on the drug focused on establishing its activity against Candida species, certainly for its nasal applications, it is more likely that if there is a link between fungal pathogens and the resulting sinusitis, Aspergillus is a more probable culprit.
Secondly, the trial design prompts questions over the drug's precise role. On the one hand, in the absence of other nasally administered products, the trial structure is appropriately both doubleblinded and placebo-controlled - although it is conceivable that future comparisons with a systemic antifungal could prove useful in determining whether the effects of SinuNase are due to the antifungal nature of the drug, or any other effect. On the other, however, the trials are spread over a large number of centers used (60) relative to the number of participants (300), which seems a disproportionate ratio given the relative frequency of chronic sinusitis.
Nevertheless, this is an area of particular interest among some of mycology's best-known academic and clinical names, so the drug's development is likely to generate substantial advocacy if trial results prove interesting. Additionally, the relative frequency of recurrent chronic sinusitis has facilitated a relatively rapid enrolment and progression of this Phase III trial, implying that Accentia and BioDelivery Sciences have the potential to augment these results with more focused trials if deemed necessary.
Aspergillus sollte also eher ein Ziel von Amphotericin B sein. Wie auch immer, die letzten Ergebnisse sehen (wahrscheinlich) vielversprechend zugunsten SinuNase in CS aus. Zu Ampho B und den Nebenwirkungen kurz:
Amphotericin B
aus Wikipedia, der freien Enzyklopädie
Amphotericin B ist ein Polyen-Makrolakton aus Streptomyces nodosum, einem Actinobacterium aus der Gattung der Streptomyceten. Es wird als Antimykotikum zur Behandlung von Pilzinfektionen eingesetzt. Amphotericin B wurde 1955 erstmals beschrieben.
Nebenwirkungen
Welche Nebenwirkungen auftreten, ist stark davon abhängig, ob das Präparat als Creme oder Salbe aufgetragen, als Tablette gelutscht (und geschluckt) oder als Infusionslösung infundiert wurde. Allgemein können jedoch Beschwerden im Verdauungstrakt sowie Ausschläge auftreten. Bei der Infusionslösung kann es u. a. zu Fieber, Schüttelfrost, Veränderungen des Blutbildes sowie zu Leber und Nierenschädigungen kommen, weshalb der Einsatz begrenzt ist. Vorsicht ist bei eingeschränkter Nierenfunktion geboten: eine Beobachtung von Nierenfunktionsparametern und Elektrolyten ist angezeigt.
Die neu verfügbaren Lipidformulierungen von Amphotericin B sind besser verträglich und zeigen eine leicht bessere Ansprechrate als die ursprüngliche Darreichungsform.
Ein paar Splitter:
- Hergestellt wird SinuNase im Übrigen von der Firma BioDelivery (BDSI). Dort sitzt der gute Herr O'Donnell auch "dick mit drin". BDSI sollte einen 14% Anteil von SinuNase dafür erhalten, 7% davon wurden aber an PPDI "abgetreten". Die Mayo Clinic bekommt nochmals 16%.
- Die Phase III (obwohl fast track Status) ist ziemlich langsam mit der rekrutierung. Eigentlich kein gutes Zeichen
- Der Sinn eines Placebo vs. SinuNase Tests ist sehr fragwürdig. Warum nicht gegenüber Antibiotika oder Kortison?
- Schätzungsweise würde die Behandlung eines Patienten zwischen 2.000 und 3.000 $ liegen!
Letzen Endes:
ABPI sollte beweisen können, das ein Pilz CS auslöst UND wie SinuNase genau dagegen wirkt, ansonsten wird es auch nach einem erfolgreichen Ausgang der Phase III wohl kein approval geben, da aktuell noch viele Fragezeichen im Raum stehen! Bedenken gegenüber den Nebenwirkungen könnte es auch geben, ist aber eher unwahrscheinlich, da Ampho B schon "auf dem Markt" ist. Dennoch, die Vertäglichkeit / Bekömmlichkeit von SinuNase ist damit nicht geklärt!
Antwort auf Beitrag Nr.: 31.956.587 von SunnyOst am 12.10.07 15:23:04Irgendwie sieht es mir auch fast zu einfach aus... In etwa 18 Wochen werden die Phase III Daten veröffentlicht!
Verfolge die Forschungen schon seit 2003, bin dort bei einem Aufenhalt in der Mayo Klinik aufmerksam geworden. Ich bin fest davon ueberzeugt,
die Ursache fuer die CRS Pilze sind. Die Phase III Daten werden es belegen und demzufolge wird der Kurs entsprechend reagieren.
die Ursache fuer die CRS Pilze sind. Die Phase III Daten werden es belegen und demzufolge wird der Kurs entsprechend reagieren.
Nur noch 17 Wochen, dann zuendet die Rakete.
Nochmals zur Ebbens und Fokkens Studie, die als Ergebnis hatte:
No significant differences were observed after 13 weeks of treatment
http://www.aspergillus.org.uk/secure/articles/pdfs/17088142.…
ABPI meint, dass das schlechte Studien Ergebniss am EMCUR System lag (nicht genügend Druck um zu Wirken).
http://www.emcur.co.uk
ABPI verwendet eine "Lavage Formulation". Auf der Mayo Klinik Seite gibt es ein kleines Video dazu...
http://www.mayoclinic.com/health/nasal-lavage/MM00552
Grüße
No significant differences were observed after 13 weeks of treatment
http://www.aspergillus.org.uk/secure/articles/pdfs/17088142.…
ABPI meint, dass das schlechte Studien Ergebniss am EMCUR System lag (nicht genügend Druck um zu Wirken).
http://www.emcur.co.uk
ABPI verwendet eine "Lavage Formulation". Auf der Mayo Klinik Seite gibt es ein kleines Video dazu...
http://www.mayoclinic.com/health/nasal-lavage/MM00552
Grüße
So ist es.
Aus aktuellen Anlass zu BiovaxID etwas. Gestern gaben Biovest (BVTI.OB) bzw. ABPI folgendes bekannt (eigentlich aber nichts grundlegend Neues):
Accentia Biopharmaceuticals Announces Unblinding and Analysis of Fast Tracked Phase 3 Trial for BiovaxID
http://biz.yahoo.com/bw/071016/20071016005909.html?.v=1
Es gibt einige Behandlungsmittel zum Non-Hodgkin’s Lymphom (NHL). An erster Stelle natürlich Rituxan zu nennen. Die Standradbehandlung ist eine Kombination aus mehreren Mitteln (auch Rituxan) kurz genannt R-CHOP. Hier will die Firma Biovest sich auch positionieren, mit einem Impf- oder Schutzstoff (vaccine) wie auch immer Ihr es nennen wollt. An Biovest ist ABPI noch mit etwa 70 % beteiligt. Von allen vermarkteten Produkten Biovests bekommt ABPI einen Anteil von 19,5 %.
BiovaxID heißt dass vaccine an dem Biovest seit einigen Jahren arbeitet. Ende Juni konnte ABPI positive Vorabresultate aus einer Phase III-Studie (Start war Sept. 2000!!) bei Non-Hodgkin-Lymphomen präsentieren:
Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma
Company Believes That When The Data is Unblinded it Will Support Planned Application for Accelerated Approval
WORCESTER, Mass.--(BUSINESS WIRE)--June 28, 2007--Biovest International, Inc. (OTCBB: BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), announced on June 27, 2007 blinded interim data from the start of its fast-tracked pivotal Phase 3 clinical trial of BiovaxID(TM) for Non-Hodgkin's lymphoma (NHL) from September 2000 through June 2006. This interim blinded data is the most recent data that has been made available to the Company prior to its latest meeting with the Data Monitoring Committee for the ongoing Phase 3 study. The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. Randomization was 2:1 in favor of BiovaxID. The blinded data in a Kaplan Meier disease-free survival curve for the per-protocol treatment group in the trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 months to almost 70 months.
Dr. Steve Arikian, Biovest Chairman and Chief Executive Officer, stated, "Biovest believes these results are consistent with the expected efficacy of BiovaxID vs. control. Moreover, BiovaxID has the longest Phase 3 follow-up data for patients receiving an active immunotherapy for follicular Non-Hodgkin's Lymphoma of any of the Phase 3 Non-Hodgkin's Lymphoma immunotherapy trials ongoing today. We are greatly encouraged by the blinded interim data presented at the Jeffries Healthcare Conference on June 27th, 2007."
BiovaxID is an anti-cancer vaccine undergoing testing in a Fast-Tracked pivotal Phase 3 clinical trial for a target indication of Non-Hodgkin's Lymphoma. BiovaxID is a personalized, patient-specific vaccine designed to stimulate the patient's own immune system to recognize and destroy residual cancerous Bcells that remain after the patient has undergone chemotherapy. Unlike many other approaches to treating NHL, BiovaxID is designed to target only cancerous B-cells. The BiovaxID Phase 3 clinical trial is being conducted at fourteen U.S. oncology centers and 8 centers in Russia.
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by mid-2008. The DMC has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved, BiovaxID could become commercially available in early 2009.
Soviel zu BiovaxID:
BiovaxID is a personalized targeted therapeutic. It stimulates the immune system to destroy only cancerous Bcell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells. BiovaxID stimulates the production of anti-tumor antibodies and induces an immune response to cancerous B-lymphocytes, but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.
BiovaxID is comprised of a tumor-derived protein (tumor-specific antigen) linked to KLH (keyhole limpet hemocyanin, a carrier protein) and administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered as an outpatient treatment in the oncologist's office by means of a subcutaneous injection similar to an insulin shot. By contrast, Rituxan(R)(1) (rituximab), a passive immunotherapeutic consisting of a monoclonal antibody, must be administered intravenously. Rituxan is directed to an antigen (CD20) present on all B-lymphocytes.
Accordingly, Rituxan promotes the elimination of both cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary, at intervals, in order to control the lymphoma. Annual sales for Rituxan are about $1.5 billion.
BiovaxID is produced using a hybridoma cell-line developed by Stanford University and licensed exclusively to Biovest. BiovaxID contains high-fidelity copies of the complete tumor-specific antigen unique to each patient and found exclusively on the surface of the malignant B-lymphocytes. These antigens are absent from normal -lymphocytes and other cells. Competing technologies undergoing tests by Genitope and Favrille use recombinant techniques that produce copies of only a portion of the tumor-specific antigen. Biovest believes that its Phase 2 data shows that BiovaxID leads to higher rates of immune responses in patients, as well as more robust clinical outcomes, including molecular remissions.
Was mir gefällt, ist das BiovaID auf jeden Patienten abgestimmt wird. Ob es der FDA gefällt ist eine andere sache, ich denke dass dies eine Zukunft hat. Ob BiovaxID eine Zukunft hat ist dagegen schwer zu sagen. Favrille (FVRL) mit FavId und Genitope (GTOP) mit MyVax haben auch vaccines in Ihrer Produktpipeline die mir auch von den disease-free survival Daten besser auseehen. Die 40 bis zu 70 Monate von BiovaxID sind gut, aber ob es reichen wird die Konkurenz auszustechen und die FDA zu überzeugen? Biovest zielt auf eine beschleuigte Zulassung an Hand von "molecular remissions" (Krebs im Grunde kaum mehr nachweisbar).
Ich schätzte die Behandlungskosten auf 10.000 $ pro Patienten. Analysten sehen für Biovest einen möglichen Umsatz von über 400 Mil. $ - davon dann etwa 20 % in Richtung ABPI. Die Chancen auf eine Zulassung sehe ich bei 20 %.
Accentia Biopharmaceuticals Announces Unblinding and Analysis of Fast Tracked Phase 3 Trial for BiovaxID
http://biz.yahoo.com/bw/071016/20071016005909.html?.v=1
Es gibt einige Behandlungsmittel zum Non-Hodgkin’s Lymphom (NHL). An erster Stelle natürlich Rituxan zu nennen. Die Standradbehandlung ist eine Kombination aus mehreren Mitteln (auch Rituxan) kurz genannt R-CHOP. Hier will die Firma Biovest sich auch positionieren, mit einem Impf- oder Schutzstoff (vaccine) wie auch immer Ihr es nennen wollt. An Biovest ist ABPI noch mit etwa 70 % beteiligt. Von allen vermarkteten Produkten Biovests bekommt ABPI einen Anteil von 19,5 %.
BiovaxID heißt dass vaccine an dem Biovest seit einigen Jahren arbeitet. Ende Juni konnte ABPI positive Vorabresultate aus einer Phase III-Studie (Start war Sept. 2000!!) bei Non-Hodgkin-Lymphomen präsentieren:
Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma
Company Believes That When The Data is Unblinded it Will Support Planned Application for Accelerated Approval
WORCESTER, Mass.--(BUSINESS WIRE)--June 28, 2007--Biovest International, Inc. (OTCBB: BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), announced on June 27, 2007 blinded interim data from the start of its fast-tracked pivotal Phase 3 clinical trial of BiovaxID(TM) for Non-Hodgkin's lymphoma (NHL) from September 2000 through June 2006. This interim blinded data is the most recent data that has been made available to the Company prior to its latest meeting with the Data Monitoring Committee for the ongoing Phase 3 study. The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. Randomization was 2:1 in favor of BiovaxID. The blinded data in a Kaplan Meier disease-free survival curve for the per-protocol treatment group in the trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 months to almost 70 months.
Dr. Steve Arikian, Biovest Chairman and Chief Executive Officer, stated, "Biovest believes these results are consistent with the expected efficacy of BiovaxID vs. control. Moreover, BiovaxID has the longest Phase 3 follow-up data for patients receiving an active immunotherapy for follicular Non-Hodgkin's Lymphoma of any of the Phase 3 Non-Hodgkin's Lymphoma immunotherapy trials ongoing today. We are greatly encouraged by the blinded interim data presented at the Jeffries Healthcare Conference on June 27th, 2007."
BiovaxID is an anti-cancer vaccine undergoing testing in a Fast-Tracked pivotal Phase 3 clinical trial for a target indication of Non-Hodgkin's Lymphoma. BiovaxID is a personalized, patient-specific vaccine designed to stimulate the patient's own immune system to recognize and destroy residual cancerous Bcells that remain after the patient has undergone chemotherapy. Unlike many other approaches to treating NHL, BiovaxID is designed to target only cancerous B-cells. The BiovaxID Phase 3 clinical trial is being conducted at fourteen U.S. oncology centers and 8 centers in Russia.
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by mid-2008. The DMC has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved, BiovaxID could become commercially available in early 2009.
Soviel zu BiovaxID:
BiovaxID is a personalized targeted therapeutic. It stimulates the immune system to destroy only cancerous Bcell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells. BiovaxID stimulates the production of anti-tumor antibodies and induces an immune response to cancerous B-lymphocytes, but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.
BiovaxID is comprised of a tumor-derived protein (tumor-specific antigen) linked to KLH (keyhole limpet hemocyanin, a carrier protein) and administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered as an outpatient treatment in the oncologist's office by means of a subcutaneous injection similar to an insulin shot. By contrast, Rituxan(R)(1) (rituximab), a passive immunotherapeutic consisting of a monoclonal antibody, must be administered intravenously. Rituxan is directed to an antigen (CD20) present on all B-lymphocytes.
Accordingly, Rituxan promotes the elimination of both cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary, at intervals, in order to control the lymphoma. Annual sales for Rituxan are about $1.5 billion.
BiovaxID is produced using a hybridoma cell-line developed by Stanford University and licensed exclusively to Biovest. BiovaxID contains high-fidelity copies of the complete tumor-specific antigen unique to each patient and found exclusively on the surface of the malignant B-lymphocytes. These antigens are absent from normal -lymphocytes and other cells. Competing technologies undergoing tests by Genitope and Favrille use recombinant techniques that produce copies of only a portion of the tumor-specific antigen. Biovest believes that its Phase 2 data shows that BiovaxID leads to higher rates of immune responses in patients, as well as more robust clinical outcomes, including molecular remissions.
Was mir gefällt, ist das BiovaID auf jeden Patienten abgestimmt wird. Ob es der FDA gefällt ist eine andere sache, ich denke dass dies eine Zukunft hat. Ob BiovaxID eine Zukunft hat ist dagegen schwer zu sagen. Favrille (FVRL) mit FavId und Genitope (GTOP) mit MyVax haben auch vaccines in Ihrer Produktpipeline die mir auch von den disease-free survival Daten besser auseehen. Die 40 bis zu 70 Monate von BiovaxID sind gut, aber ob es reichen wird die Konkurenz auszustechen und die FDA zu überzeugen? Biovest zielt auf eine beschleuigte Zulassung an Hand von "molecular remissions" (Krebs im Grunde kaum mehr nachweisbar).
Ich schätzte die Behandlungskosten auf 10.000 $ pro Patienten. Analysten sehen für Biovest einen möglichen Umsatz von über 400 Mil. $ - davon dann etwa 20 % in Richtung ABPI. Die Chancen auf eine Zulassung sehe ich bei 20 %.
nur eine Umfrage seitens ABPI. Ist wohl eher als Werbemaßnahme für den Kurs und SinuNase zu sehen:
Accentia Announces Results of Market Survey on Chronic Sinusitis Based on Responses From 750 ENT Specialists
Wednesday October 17, 8:00 am ET
Market Research Confirms Over 90% of ENT Respondents Believe That Fungal-Induced Inflammation Can Cause Chronic Sinusitis and That a Need Exists for an FDA-Approved Intranasal Antifungal for the Disease
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announces the results of a market research study conducted with ear, nose, and throat specialists (ENTs or otolaryngologists), concerning their attitudes about the causation of Chronic Sinusitis (CS), the diagnosis, and the management of the disease. Beechwood Associates, Inc., designed the survey, collected data, and performed the analysis. Accentia Pharmaceuticals' sales representatives called on 950 specialists to ask them to complete the survey and 750, or 78% of those specialists, elected to participate. There are an estimated ten thousand ENT specialists in the U.S., so the sample size represents about 7% of all ENT specialists.
The respondents as a group see over ten thousand patients with CS each week. The results show that there is a very substantial acceptance of a fungal-induced etiology for CS:
-> 91% of respondents indicated that they believe that a fungal-induced inflammation can cause CS (N=750)
-> 91% of respondents familiar with the secretion of eosinophilic major basic protein (eMBP) in the fungal-induced etiology of CS indicated their enthusiasm for a diagnostic, which detects eMBP in mucus (SinuTest(TM)) (N=497)
-> 53% of respondents indicated that they are currently prescribing off-label compounded intranasal antifungals for CS, and they identified the compounding pharmacies that they are using (N=750)
-> 96% of the respondents familiar with intranasal antifungal treatment for CS indicated that they believe there is a need for an FDA-approved intranasal antifungal for this indication (N=562)
Accentia Biopharmaceuticals has previously announced evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company's ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase(TM), an intranasal formulation of the antifungal amphotericin B 0.01% suspension. At the time of enrollment, all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP) and measurement of eMBP in nasal mucin is done using the diagnostic, SinuTest(TM).
SinuTest(TM) is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest(TM) will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase(TM), assuming Food and Drug Administration (FDA) approval.
To receive information on how physicians and patients can access SinuTest(TM), IMMCO has provided the following toll free number: 800-537-8378.
As previously announced, Accentia has received Fast Track status from the FDA for SinuNase(TM), and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS. The Company has previously announced that it has completed enrollment in its Phase 3 clinical trial of SinuNase for the treatment of CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest(TM) for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS.
Grüße
Accentia Announces Results of Market Survey on Chronic Sinusitis Based on Responses From 750 ENT Specialists
Wednesday October 17, 8:00 am ET
Market Research Confirms Over 90% of ENT Respondents Believe That Fungal-Induced Inflammation Can Cause Chronic Sinusitis and That a Need Exists for an FDA-Approved Intranasal Antifungal for the Disease
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announces the results of a market research study conducted with ear, nose, and throat specialists (ENTs or otolaryngologists), concerning their attitudes about the causation of Chronic Sinusitis (CS), the diagnosis, and the management of the disease. Beechwood Associates, Inc., designed the survey, collected data, and performed the analysis. Accentia Pharmaceuticals' sales representatives called on 950 specialists to ask them to complete the survey and 750, or 78% of those specialists, elected to participate. There are an estimated ten thousand ENT specialists in the U.S., so the sample size represents about 7% of all ENT specialists.
The respondents as a group see over ten thousand patients with CS each week. The results show that there is a very substantial acceptance of a fungal-induced etiology for CS:
-> 91% of respondents indicated that they believe that a fungal-induced inflammation can cause CS (N=750)
-> 91% of respondents familiar with the secretion of eosinophilic major basic protein (eMBP) in the fungal-induced etiology of CS indicated their enthusiasm for a diagnostic, which detects eMBP in mucus (SinuTest(TM)) (N=497)
-> 53% of respondents indicated that they are currently prescribing off-label compounded intranasal antifungals for CS, and they identified the compounding pharmacies that they are using (N=750)
-> 96% of the respondents familiar with intranasal antifungal treatment for CS indicated that they believe there is a need for an FDA-approved intranasal antifungal for this indication (N=562)
Accentia Biopharmaceuticals has previously announced evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company's ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase(TM), an intranasal formulation of the antifungal amphotericin B 0.01% suspension. At the time of enrollment, all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP) and measurement of eMBP in nasal mucin is done using the diagnostic, SinuTest(TM).
SinuTest(TM) is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest(TM) will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase(TM), assuming Food and Drug Administration (FDA) approval.
To receive information on how physicians and patients can access SinuTest(TM), IMMCO has provided the following toll free number: 800-537-8378.
As previously announced, Accentia has received Fast Track status from the FDA for SinuNase(TM), and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS. The Company has previously announced that it has completed enrollment in its Phase 3 clinical trial of SinuNase for the treatment of CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest(TM) for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS.
Grüße
Antwort auf Beitrag Nr.: 32.048.395 von Ackergaul am 17.10.07 15:37:48Hab schon schlechtere Umfragen gelesen. Bin gespannt wie die Amis
darauf reagieren.
darauf reagieren.
Netter Bericht...
http://ezinearticles.com/?Recurring-Sinus-Infection---An-Exp…
Recurring Sinus Infection - An Explanation?
By Walt Ballenberger
As part of our efforts to chronicle the experiences of sinusitis sufferers, a gentleman named Carlton contributed a "Sinusitis Treatment Success” story.
He pointed out a study conducted by the Mayo clinic and the University of Buffalo addressing the issue of recurring sinus infection. It states that "chronic sinusitis is an immune disorder caused by fungus." I asked Carlton in a follow-up email if he had tested positive for fungi in previous allergy tests, and here is his response:
“Hello Walt: I had 2 different allergy tests, both negative. The Mayo/U. of Buffalo research says this is not an allergic reaction like a pollen allergy, so it wouldn't show up in an allergy test. It's an over reaction to fungus by T-cells that damage the sinus lining and gives bacteria a place to grow. Most people have no reaction, but most people with chronic sinusitis do. Apparently there is a test, but ENT's are skeptical. Mine said the fungus idea was false and suggested surgery. If I was cynical, I might think his opinion was because there's no surgical solution. This is leading edge stuff. Mayo received a patent on anti-fungal treatments. I decided to try this approach after everything else failed. I don't want surgery, because I've never heard of one that worked. I'll let you know how it goes, but so far, I feel much better. Carlton”
Huge Implications in the Study Results There are huge implications in this study for those who suffer from recurring sinus infection. This work could lead to treatments that treat the root cause of the problem for the first time.
Another article in the Health Solutions Newsletter of Sept 2005 also referred to the Mayo Clinic/U. of Buffalo study and adds further clarification. Their article was entitled “Mayo Clinic Announces Startling New Sinus Discovery” “Jens Panikau, sinus researcher at Mayo Clinic, has published a new finding that explains why sinus disease persists despite so many new drugs. Dr Panikau found that the main cause of sinus symptoms was that the eosinophiles – your special cells that defend your body against infection, - get into the mucus and produce a toxic product called MBP that is made in order to kill bacteria. Unfortunately, among sinus sufferers, there is an excess of this MBP in the mucus that also damages the cells of the nose and impairs its ability to sweep bacteria out of the nose. Dr Panikau shows that it is the MBP that makes the patient sick, with fever, pain, fatigue, and secondary infections.”
Anyone who suffers from recurring sinus infection issues and who cannot find adequate relief after treatment by an otolaryngologist or after unsuccessful surgery are urged to do what Carlton has done:
1. Start using pulsating nasal irrigation to cleanse the nose of crusty old mucus which could be carrying toxins.
2. Test your environment to see if you are exposed to high levels of fungus.
3. If the tests are positive for fungus, try to improve your environment to lower the amount of fungus you are exposed to. There are numerous books and articles which address this subject.
Hopefully the follow-on work of the Mayo Clinic and University of Buffalo will identify antifungal treatments that can finally go after the root cause of recurring sinus infection. Sinus sufferers should be aware of these research efforts and be ready to discuss these findings with their ENT specialists. Maybe serious help is finally on the way.
Walt Ballenberger is founder of http://www.postnasaldrip.net. To find out more about how to test for fungus levels and using pulsating nasal irrigation, get a free report entitled “Sinus Treatment Success Stories” by visiting http://www.postnasaldrip.net and click on the Free Report link.
Grüße
http://ezinearticles.com/?Recurring-Sinus-Infection---An-Exp…
Recurring Sinus Infection - An Explanation?
By Walt Ballenberger
As part of our efforts to chronicle the experiences of sinusitis sufferers, a gentleman named Carlton contributed a "Sinusitis Treatment Success” story.
He pointed out a study conducted by the Mayo clinic and the University of Buffalo addressing the issue of recurring sinus infection. It states that "chronic sinusitis is an immune disorder caused by fungus." I asked Carlton in a follow-up email if he had tested positive for fungi in previous allergy tests, and here is his response:
“Hello Walt: I had 2 different allergy tests, both negative. The Mayo/U. of Buffalo research says this is not an allergic reaction like a pollen allergy, so it wouldn't show up in an allergy test. It's an over reaction to fungus by T-cells that damage the sinus lining and gives bacteria a place to grow. Most people have no reaction, but most people with chronic sinusitis do. Apparently there is a test, but ENT's are skeptical. Mine said the fungus idea was false and suggested surgery. If I was cynical, I might think his opinion was because there's no surgical solution. This is leading edge stuff. Mayo received a patent on anti-fungal treatments. I decided to try this approach after everything else failed. I don't want surgery, because I've never heard of one that worked. I'll let you know how it goes, but so far, I feel much better. Carlton”
Huge Implications in the Study Results There are huge implications in this study for those who suffer from recurring sinus infection. This work could lead to treatments that treat the root cause of the problem for the first time.
Another article in the Health Solutions Newsletter of Sept 2005 also referred to the Mayo Clinic/U. of Buffalo study and adds further clarification. Their article was entitled “Mayo Clinic Announces Startling New Sinus Discovery” “Jens Panikau, sinus researcher at Mayo Clinic, has published a new finding that explains why sinus disease persists despite so many new drugs. Dr Panikau found that the main cause of sinus symptoms was that the eosinophiles – your special cells that defend your body against infection, - get into the mucus and produce a toxic product called MBP that is made in order to kill bacteria. Unfortunately, among sinus sufferers, there is an excess of this MBP in the mucus that also damages the cells of the nose and impairs its ability to sweep bacteria out of the nose. Dr Panikau shows that it is the MBP that makes the patient sick, with fever, pain, fatigue, and secondary infections.”
Anyone who suffers from recurring sinus infection issues and who cannot find adequate relief after treatment by an otolaryngologist or after unsuccessful surgery are urged to do what Carlton has done:
1. Start using pulsating nasal irrigation to cleanse the nose of crusty old mucus which could be carrying toxins.
2. Test your environment to see if you are exposed to high levels of fungus.
3. If the tests are positive for fungus, try to improve your environment to lower the amount of fungus you are exposed to. There are numerous books and articles which address this subject.
Hopefully the follow-on work of the Mayo Clinic and University of Buffalo will identify antifungal treatments that can finally go after the root cause of recurring sinus infection. Sinus sufferers should be aware of these research efforts and be ready to discuss these findings with their ENT specialists. Maybe serious help is finally on the way.
Walt Ballenberger is founder of http://www.postnasaldrip.net. To find out more about how to test for fungus levels and using pulsating nasal irrigation, get a free report entitled “Sinus Treatment Success Stories” by visiting http://www.postnasaldrip.net and click on the Free Report link.
Grüße
Bericht baut einen doch echt auf. Leider ist ein kleiner Fehler enthalten. Der Researcher heisst Ponikau und nicht Panikau.
Antwort auf Beitrag Nr.: 32.061.620 von SunnyOst am 18.10.07 10:23:11Geduld ist wohl erst einmal angesagt... Ich bezweifle, das der nette Kursanstieg der letzten Wochen so weitergeht. Trotz positiver Meldungen klemmt es (Phase III SinuNase komplett; Revimmune in Phase III - MS; angestrebtes acclerated Approval für BiovaxID).
Mal ein Fahrplan zu SinuNase
- Oktober 07 (wie gemeldet): Phase III Trial "Refractory (post-surgical) CS" komplettiert
- Ende Februar 08: Daten aus diesem "Refractory (post-surgical) CS" Trial - Richtungsweisend für ABPI (und den Kurs)
- Ein "accelerated approval" wird wohl für den Refractory CS Trial gestellt (vielleicht kann schon vor 2009 ein wenig Geld mit SinuNase gemacht werden?)
- März 08: Start 2. Phase III (nenne ich mal: für dass Breite Spektrum bei CS)
- Ende Mai 08: Trial soll schon komplett sein. Wird auf jeden Fall schneller gehen als zuvor, da die Kriterien nicht mehr so streng sind...
- Irgendwann bis Mitte 08: Partnerschaftsmeldung SinuNase "für dass Breite Spektrum an CS Patienten" (Milestones & Royalities!)
- Oktober 2008: jede Menge Daten aus der 2. Phase III werden veröffentlicht (mit der ersten Phase III dann über 700 Patienten)
- ebenfalls dann wohl Oktober 2008: NDA für SinuNase
- April 2009: also 6 Monate später hoffentlich das approval!!!
- Dazu kommt irgendwann noch: mögliche Partnerschaft SinuNase "rest of the world" (Milestones & Royalities!)
Nochmals zum Oktober pdf SinuNase:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
- 2007 wurden bei CS mehr als 200.000 Patienten mit intranasalen ampho B behandelt! Ohne Genehmigung der Behörden (natürlich), so genannt dann "off-label"! Warum, wenn es nicht wirken würde?
- Jeffreys schätzt dass 2009 (möglicher Verkaufstart) 140.000 Patienten mit SinuNase behandelt werden könnten (etwa 70 % dieser off-Label Patienten, pro Jahr dann 30 % steigend). Kosten pro Monat etwa 200 $ - im Jahr also ca. 2.500 $!
- Dementsprechend werden Umsätze von 350 Mil. (2009); 450 Mil. (2010) und 590 Mil. $ (2010) erwartet! Ob dies konservativ, mutig oder wahnsinnig ist, überlasse ich jedem für sich!
- Vermarktung soll mittels kleinen ABPI Vertriebsteam an 15.000 Hals-, Nasen-, Ohrenärzten und Allerlogogen erfolgen zudem an die Breite Masse mit Hilfe eines Pharma Unternehmens (mit hoffentlich gutem Vertriebswegen - BIGGER IS BETTER!)
Grüße
Mal ein Fahrplan zu SinuNase
- Oktober 07 (wie gemeldet): Phase III Trial "Refractory (post-surgical) CS" komplettiert
- Ende Februar 08: Daten aus diesem "Refractory (post-surgical) CS" Trial - Richtungsweisend für ABPI (und den Kurs)
- Ein "accelerated approval" wird wohl für den Refractory CS Trial gestellt (vielleicht kann schon vor 2009 ein wenig Geld mit SinuNase gemacht werden?)
- März 08: Start 2. Phase III (nenne ich mal: für dass Breite Spektrum bei CS)
- Ende Mai 08: Trial soll schon komplett sein. Wird auf jeden Fall schneller gehen als zuvor, da die Kriterien nicht mehr so streng sind...
- Irgendwann bis Mitte 08: Partnerschaftsmeldung SinuNase "für dass Breite Spektrum an CS Patienten" (Milestones & Royalities!)
- Oktober 2008: jede Menge Daten aus der 2. Phase III werden veröffentlicht (mit der ersten Phase III dann über 700 Patienten)
- ebenfalls dann wohl Oktober 2008: NDA für SinuNase
- April 2009: also 6 Monate später hoffentlich das approval!!!
- Dazu kommt irgendwann noch: mögliche Partnerschaft SinuNase "rest of the world" (Milestones & Royalities!)
Nochmals zum Oktober pdf SinuNase:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
- 2007 wurden bei CS mehr als 200.000 Patienten mit intranasalen ampho B behandelt! Ohne Genehmigung der Behörden (natürlich), so genannt dann "off-label"! Warum, wenn es nicht wirken würde?
- Jeffreys schätzt dass 2009 (möglicher Verkaufstart) 140.000 Patienten mit SinuNase behandelt werden könnten (etwa 70 % dieser off-Label Patienten, pro Jahr dann 30 % steigend). Kosten pro Monat etwa 200 $ - im Jahr also ca. 2.500 $!
- Dementsprechend werden Umsätze von 350 Mil. (2009); 450 Mil. (2010) und 590 Mil. $ (2010) erwartet! Ob dies konservativ, mutig oder wahnsinnig ist, überlasse ich jedem für sich!
- Vermarktung soll mittels kleinen ABPI Vertriebsteam an 15.000 Hals-, Nasen-, Ohrenärzten und Allerlogogen erfolgen zudem an die Breite Masse mit Hilfe eines Pharma Unternehmens (mit hoffentlich gutem Vertriebswegen - BIGGER IS BETTER!)
Grüße
No risk no fun.
Ich versuch mich mal (m)eine SinuNase Erklärung (so wie ich es zumindest verstehe):
Nach Angaben von ABPI hat JEDER Mensch Pilze im Schleim (Mucus) der Nasengängen und Nebenhöhlen. Diese Pilze befinden sich in allen Teilen der Welt in der Luft. Die Mayo Klinik fand heraus, dass bestimmte "schwebstoff Pilze" (airborne fungi) zu Entzündungen bei CS Patienten führen: Die normalerweise harmlosen Pilze, lösen bei CS Patienten eine Immunreaktion in den Schleimhäuten aus, die zu einer Aktivierung von Eosinophil führt.
Kurz dazu:
eosinophiler Granulozyt [aus Wikipedia, der freien Enzyklopädie]
Eosinophile Granulozyten - kurz auch Eosinophile genannt - gehören zu den Leukozyten. Sie machen etwa 3 - 5% der Zellen im Differentialblutbild aus und sind an der zellulären Immunabwehr beteiligt. Ihren Namen beziehen sie vom Farbstoff Eosin, mit dem sie angefärbt werden können. Eos (altgriechisch) bedeutet Morgenröte.
In ihrem Inneren enthalten eosinophile Granulozyten Vesikel, auch Granula genannt, die basische Proteine enthalten, z. B. das Major Basic Protein. Der Inhalt der Granula kann durch Exozytose an die Umgebung abgegeben werden.
...
Eosinophile spielen eine wichtige Rolle bei der Parasitenabwehr. Das vollzieht sich folgendermaßen: Sobald die Oberfläche des Parasiten mit IgE besetzt ist, können auch Eosinophile sich daran heften. Durch einen speziell angepassten Mechanismus geben sie ihre toxischen Proteine direkt auf die Oberfläche des Parasiten ab und schädigen diesen. Gleichzeitig dienen die exozytierten Proteine für andere Eosinophile als Lockstoffe, so dass die Abwehr verstärkt werden kann.
Eosinophile können aber auch eine für den Organismus selbst schädigende Rolle spielen. Bei Asthma bronchiale beispielsweise wird das Lungenepithel durch die basischen Inhaltsstoffe der Eosinophilen angegriffen. Eine durch Eosinophile ausgelöste seltene Krankheit ist die eosinophile Fasciitis.
So, dass ist das Problem: Eosinophil setzt Major Basic Proteine (MBP) frei, diese greifen die Pilze an und beschädigen dadurch die Nasen- und Nebenhöhlenschichten. Das ganze führt dann zu Entzündungen und und und! Ebenfalls durch die Beschädigung der MBPs können nun Bakterien und Viren jetzt auch noch Infektionen auslösen...
--> Eine Frage bleibt bei mir offen: Warum haben CS Patienten diese übertrieben Immunreaktion auf airborne fungi?
Zumindest hört sich dies ansonsten logisch und konsequent an: Ampho B killt die Pilze, weniger Pilze im Schleim, weniger Eosinophile und damit MBPs!
So ungefähr stelle ich es mir vor...
Grüße
Nach Angaben von ABPI hat JEDER Mensch Pilze im Schleim (Mucus) der Nasengängen und Nebenhöhlen. Diese Pilze befinden sich in allen Teilen der Welt in der Luft. Die Mayo Klinik fand heraus, dass bestimmte "schwebstoff Pilze" (airborne fungi) zu Entzündungen bei CS Patienten führen: Die normalerweise harmlosen Pilze, lösen bei CS Patienten eine Immunreaktion in den Schleimhäuten aus, die zu einer Aktivierung von Eosinophil führt.
Kurz dazu:
eosinophiler Granulozyt [aus Wikipedia, der freien Enzyklopädie]
Eosinophile Granulozyten - kurz auch Eosinophile genannt - gehören zu den Leukozyten. Sie machen etwa 3 - 5% der Zellen im Differentialblutbild aus und sind an der zellulären Immunabwehr beteiligt. Ihren Namen beziehen sie vom Farbstoff Eosin, mit dem sie angefärbt werden können. Eos (altgriechisch) bedeutet Morgenröte.
In ihrem Inneren enthalten eosinophile Granulozyten Vesikel, auch Granula genannt, die basische Proteine enthalten, z. B. das Major Basic Protein. Der Inhalt der Granula kann durch Exozytose an die Umgebung abgegeben werden.
...
Eosinophile spielen eine wichtige Rolle bei der Parasitenabwehr. Das vollzieht sich folgendermaßen: Sobald die Oberfläche des Parasiten mit IgE besetzt ist, können auch Eosinophile sich daran heften. Durch einen speziell angepassten Mechanismus geben sie ihre toxischen Proteine direkt auf die Oberfläche des Parasiten ab und schädigen diesen. Gleichzeitig dienen die exozytierten Proteine für andere Eosinophile als Lockstoffe, so dass die Abwehr verstärkt werden kann.
Eosinophile können aber auch eine für den Organismus selbst schädigende Rolle spielen. Bei Asthma bronchiale beispielsweise wird das Lungenepithel durch die basischen Inhaltsstoffe der Eosinophilen angegriffen. Eine durch Eosinophile ausgelöste seltene Krankheit ist die eosinophile Fasciitis.
So, dass ist das Problem: Eosinophil setzt Major Basic Proteine (MBP) frei, diese greifen die Pilze an und beschädigen dadurch die Nasen- und Nebenhöhlenschichten. Das ganze führt dann zu Entzündungen und und und! Ebenfalls durch die Beschädigung der MBPs können nun Bakterien und Viren jetzt auch noch Infektionen auslösen...
--> Eine Frage bleibt bei mir offen: Warum haben CS Patienten diese übertrieben Immunreaktion auf airborne fungi?
Zumindest hört sich dies ansonsten logisch und konsequent an: Ampho B killt die Pilze, weniger Pilze im Schleim, weniger Eosinophile und damit MBPs!
So ungefähr stelle ich es mir vor...
Grüße
Schoener Beitrag.
Die Ursache warum CS Patienten diese übertrieben Immunreaktion auf airborne fungi haben hat man bei den Forschungen nicht herausgefunden.
Die Aussicht auf Linderung der CS bietet in der Tat zur Zeit nur Sinunase.
Die Ursache warum CS Patienten diese übertrieben Immunreaktion auf airborne fungi haben hat man bei den Forschungen nicht herausgefunden.
Die Aussicht auf Linderung der CS bietet in der Tat zur Zeit nur Sinunase.
--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry. For further information, visit the Company Web site at http://www.accentia.net.
Beharrlichkeit trägt den Sieg davon.
Antwort auf Beitrag Nr.: 32.118.858 von SunnyOst am 23.10.07 12:32:48ich hätte mit der Threaderöffnung noch 1 bis 2 Monate warten sollen. Naja... Folgendes noch (ist schon älter!!!):
Mayo Clinic Receives Patent for New Treatment of Chronic Sinus Infection
More than 32 million adults affected annually by disease
ROCHESTER, Minn. -- Mayo Clinic yesterday received broad patent coverage for a new treatment of chronic rhinosinusitis (CRS), commonly called "sinus infection," a disease that annually affects 32 million adults in the United States and currently has no Food and Drug Administration-approved treatment.
Studies at Mayo Clinic have found the cause of CRS -- a reaction to certain fungi -- and demonstrated that the delivery of antifungal drugs directly into the nose and sinuses is safe and significantly reduces patients? symptoms. Improvements in asthma symptoms were noted in the same patient group. Past medical treatments for chronic sinus infections have been unsuccessful or produced severe side effects.
"We?ve seen significant improvement in the quality of life for the large majority of patients with chronic sinus infection who were treated with antifungal drugs," says David Sherris, M.D., a Mayo Clinic ear, nose and throat specialist and one of the project researchers. "Many of them had been miserable for years and were severely hampered at work and in social situations by their illness. Many are pain-free and able to breathe effectively through their noses for the first time in years."
CRS is one of the most common chronic diseases in the United States. CRS produces nose and sinus problems characterized by nasal airway obstruction, loss of the sense of smell, postnasal drip, nasal congestion, nasal discharge, and head and face pain lasting three months or longer. It notably decreases the quality of patients? lives, impairing physical and social functioning, vitality and general health.
CRS has a significant impact on health care in the United States.
- The prevalence of CRS has increased by more than 50 percent in the past 10 years.
- CRS results in 18.3 million physician visits per year.
- Overall health-care expenditures attributable to CRS in the United States were estimated to be over $5.8 billion in 1996.
- In 2001, 27.9 million prescriptions were issued to treat CRS in the United States.
- Approximately $2 billion is spent annually to treat nasal and sinus disorders.
The road to the patents began with research at Mayo Clinic into the cause of the disease. Jens Ponikau, M.D., Eugene Kern, M.D., and Dr. Sherris, who are Mayo Clinic ear, nose and throat specialists, and Hirohito Kita, M.D., a Mayo Clinic allergic diseases researcher, led a group of investigators who demonstrated the presence of fungi in everyone?s nasal mucus. However, patients diagnosed with CRS have an immunologic response to the fungi causing activated white blood cells (eosinophils) to enter their mucus. The activated eosinophils release a major basic protein -- a toxic protein -- into the mucus, which attacks and kills the fungi but damages the nose and sinus membranes. The major basic protein also injures the epithelium, which allows bacteria to infect the tissues.
Mayo Clinic?s pioneering medical treatment for CRS is designed to stop antigen release by administering antifungal drugs. Without fungal antigens, the immune reaction does not occur, eosinophils do not enter the nasal mucus, major basic protein is not released and damage to the nasal and sinus linings is eliminated.
Clinical studies first conducted by Mayo Clinic found that this treatment provided greater improvement of symptoms than other treatments that have been used. Past treatments used by physicians include antibiotics and systemic or inhaled steroids, as well as endoscopic sinus surgery.
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
The National Institutes of Health has committed itself to further investigation of the fungal link to chronic sinus infection and the role of antifungal medications in treatment of the disease, as cited on http://www.niaid.nih.gov/director/congress/2002/cj/sigitems.…
So far, Mayo Clinic has received broad patent coverage that protects the delivery of antifungal drugs to mucus in the nose and sinuses. The patents are:
- 6,207,703 - Antifungal treatment of asthma - 6,291,500 - Antifungal treatment of colitis - 6,416,955 - Eosinophil degranulating conditions - 6,555,566 - Antifungal treatment of CRS
The issuance of the CRS treatment patent completes Mayo Clinic?s portfolio on antifungal treatment of inflammatory conditions such as CRS, asthma and colitis and may offer pharmaceutical companies an incentive to invest in this technology to make it widely available to patients. The U.S. Patent and Trademark Office also has allowed claims for treatment of asthma and CRS combined; the patent is expected to be forthcoming.
###
Lee Aase
Lisa Copeland
John Murphy
507-284-5005 (days)
507-284-2511(evenings)
email:newsbureau@mayo.edu
Was auch noch interessant sein könnte:
- 6,207,703 - Antifungal treatment of asthma - 6,291,500 - Antifungal treatment of colitis - 6,416,955 - Eosinophil degranulating conditions - 6,555,566 - Antifungal treatment of CRS
Bis Okt 2008 hat ABPI noch ein Lizenzrecht auf die Patente Asthma und Colitis.
Grüße
Mayo Clinic Receives Patent for New Treatment of Chronic Sinus Infection
More than 32 million adults affected annually by disease
ROCHESTER, Minn. -- Mayo Clinic yesterday received broad patent coverage for a new treatment of chronic rhinosinusitis (CRS), commonly called "sinus infection," a disease that annually affects 32 million adults in the United States and currently has no Food and Drug Administration-approved treatment.
Studies at Mayo Clinic have found the cause of CRS -- a reaction to certain fungi -- and demonstrated that the delivery of antifungal drugs directly into the nose and sinuses is safe and significantly reduces patients? symptoms. Improvements in asthma symptoms were noted in the same patient group. Past medical treatments for chronic sinus infections have been unsuccessful or produced severe side effects.
"We?ve seen significant improvement in the quality of life for the large majority of patients with chronic sinus infection who were treated with antifungal drugs," says David Sherris, M.D., a Mayo Clinic ear, nose and throat specialist and one of the project researchers. "Many of them had been miserable for years and were severely hampered at work and in social situations by their illness. Many are pain-free and able to breathe effectively through their noses for the first time in years."
CRS is one of the most common chronic diseases in the United States. CRS produces nose and sinus problems characterized by nasal airway obstruction, loss of the sense of smell, postnasal drip, nasal congestion, nasal discharge, and head and face pain lasting three months or longer. It notably decreases the quality of patients? lives, impairing physical and social functioning, vitality and general health.
CRS has a significant impact on health care in the United States.
- The prevalence of CRS has increased by more than 50 percent in the past 10 years.
- CRS results in 18.3 million physician visits per year.
- Overall health-care expenditures attributable to CRS in the United States were estimated to be over $5.8 billion in 1996.
- In 2001, 27.9 million prescriptions were issued to treat CRS in the United States.
- Approximately $2 billion is spent annually to treat nasal and sinus disorders.
The road to the patents began with research at Mayo Clinic into the cause of the disease. Jens Ponikau, M.D., Eugene Kern, M.D., and Dr. Sherris, who are Mayo Clinic ear, nose and throat specialists, and Hirohito Kita, M.D., a Mayo Clinic allergic diseases researcher, led a group of investigators who demonstrated the presence of fungi in everyone?s nasal mucus. However, patients diagnosed with CRS have an immunologic response to the fungi causing activated white blood cells (eosinophils) to enter their mucus. The activated eosinophils release a major basic protein -- a toxic protein -- into the mucus, which attacks and kills the fungi but damages the nose and sinus membranes. The major basic protein also injures the epithelium, which allows bacteria to infect the tissues.
Mayo Clinic?s pioneering medical treatment for CRS is designed to stop antigen release by administering antifungal drugs. Without fungal antigens, the immune reaction does not occur, eosinophils do not enter the nasal mucus, major basic protein is not released and damage to the nasal and sinus linings is eliminated.
Clinical studies first conducted by Mayo Clinic found that this treatment provided greater improvement of symptoms than other treatments that have been used. Past treatments used by physicians include antibiotics and systemic or inhaled steroids, as well as endoscopic sinus surgery.
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
The National Institutes of Health has committed itself to further investigation of the fungal link to chronic sinus infection and the role of antifungal medications in treatment of the disease, as cited on http://www.niaid.nih.gov/director/congress/2002/cj/sigitems.…
So far, Mayo Clinic has received broad patent coverage that protects the delivery of antifungal drugs to mucus in the nose and sinuses. The patents are:
- 6,207,703 - Antifungal treatment of asthma - 6,291,500 - Antifungal treatment of colitis - 6,416,955 - Eosinophil degranulating conditions - 6,555,566 - Antifungal treatment of CRS
The issuance of the CRS treatment patent completes Mayo Clinic?s portfolio on antifungal treatment of inflammatory conditions such as CRS, asthma and colitis and may offer pharmaceutical companies an incentive to invest in this technology to make it widely available to patients. The U.S. Patent and Trademark Office also has allowed claims for treatment of asthma and CRS combined; the patent is expected to be forthcoming.
###
Lee Aase
Lisa Copeland
John Murphy
507-284-5005 (days)
507-284-2511(evenings)
email:newsbureau@mayo.edu
Was auch noch interessant sein könnte:
- 6,207,703 - Antifungal treatment of asthma - 6,291,500 - Antifungal treatment of colitis - 6,416,955 - Eosinophil degranulating conditions - 6,555,566 - Antifungal treatment of CRS
Bis Okt 2008 hat ABPI noch ein Lizenzrecht auf die Patente Asthma und Colitis.
Grüße
Antwort auf Beitrag Nr.: 32.119.414 von Ackergaul am 23.10.07 13:17:22ach ja, vergleicht doch bitte mal diese Werte der Mayo Studie mit den Zwischenresultaten ABPIs (Bedenkt: 50 % Placebo mit drin!!!)
Mayo
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
ABPI (vom 15. August)
Based on an interim blinded analysis of the first group of the more than 80 patients who have now completed the trial at 16 weeks, the study has shown improvement in polyposis by endoscopy in about 50% of patients (N=43) and improvement in sinus inflammation by CT scan in approximately 50% of patients (N=23)... The interim blinded data shows that approximately 23% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27% of all patients have achieved complete resolution of one or the other of the two cardinal symptoms (N=48).
Die aktuellen Daten waren leider leicht schwächer (aus dem Oktober pdf):
@ 147 Personen: 20 % complete resolution und 20 % partial. Wie auch immer: Spekuliert man, dass dies 100 % SinuNase Patienten sind, wären dies jeweils 40 %. Dies dann mit den Mayo Ergebnissen vergleichen: 35 percent, of the patients became disease free; 39 percent, improved mildly
Hmmmh, irgendwie passt dass verdächtig...
Grüße
Mayo
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
ABPI (vom 15. August)
Based on an interim blinded analysis of the first group of the more than 80 patients who have now completed the trial at 16 weeks, the study has shown improvement in polyposis by endoscopy in about 50% of patients (N=43) and improvement in sinus inflammation by CT scan in approximately 50% of patients (N=23)... The interim blinded data shows that approximately 23% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and approximately 27% of all patients have achieved complete resolution of one or the other of the two cardinal symptoms (N=48).
Die aktuellen Daten waren leider leicht schwächer (aus dem Oktober pdf):
@ 147 Personen: 20 % complete resolution und 20 % partial. Wie auch immer: Spekuliert man, dass dies 100 % SinuNase Patienten sind, wären dies jeweils 40 %. Dies dann mit den Mayo Ergebnissen vergleichen: 35 percent, of the patients became disease free; 39 percent, improved mildly
Hmmmh, irgendwie passt dass verdächtig...
Grüße
Antwort auf Beitrag Nr.: 32.119.795 von Ackergaul am 23.10.07 13:52:49Man sollte alles so einfach wie moeglich sehen - aber auch nicht einfacher. Accentia ist auf dem richtigem Weg.
Gruss
Gruss
Antwort auf Beitrag Nr.: 32.119.414 von Ackergaul am 23.10.07 13:17:22Hi Ackergaul,
bin froh das es endlich einen Thread gibt. Warte schon seit 2005 das endlich mal einer Accentia bemerkt hat. Leider ist der Tread noch etwas einsam. Bin aber guter Dinge, das sich das bald aendert.
Gruss
PS
Die schwaecheren Daten aus dem Oktober resultieren aus einer nicht
100%igen Anwendung der Methode.
bin froh das es endlich einen Thread gibt. Warte schon seit 2005 das endlich mal einer Accentia bemerkt hat. Leider ist der Tread noch etwas einsam. Bin aber guter Dinge, das sich das bald aendert.
Gruss
PS
Die schwaecheren Daten aus dem Oktober resultieren aus einer nicht
100%igen Anwendung der Methode.
Antwort auf Beitrag Nr.: 32.126.038 von SunnyOst am 23.10.07 21:11:42Hi SunnyOst,
die "key symptoms" sind ein wenig schwächer, aber nach wie vor deuten diese ein Super-Ergebnis an!
Die im pdf gemeldeten Oktober Daten sind die aktuellsten Daten des Phase III Trials. Bei dem primären Zielpunkten (Kopfschmerz und "Nasen-Ausfluß") waren es halt 20 % bei BEIDEN und 20 % nur EIN Zielpunkt erfüllt - wollen wir darauf hoffen, dass dies 40 % jeweils durch SinuNase heißt (also, dann nur bei 20 % KEINE Verbesserung)!
Endoskopie und CT-Scan Ergebnisse dienen dazu dieses Ergebnis zu untermauern: Endoskopie zeigt bei den Oktober Daten: 34 % Verminderung in BEIDEN Nasenlöchern; 18 % Verminderung in EINEM! --> 100 % SinuNase?
CT Scan zeigte die Schleimhäute nahmen bei 57 % ALLER Patienten ab, ABER: Bei nur knapp 35 % wurde 10 % und mehr dieser Dicke verringert! Damit kann man vermuten: Bei Patienten, die SinuNase nehmen, werden CT und Endoskopie Ergebnisse BEI ALLEN (100 %) verbessert, wenn auch teilweise nur moderat!
Oder kann etwa ein Placebo diese Ergebnisse erreichen?
Gleichzeitig hat ABPI in dieser Präsentation gezeigt, dass Patienten deren Endoskopie und CT-Scan Werte verbessert wurden, davon profitieren, das entweder Kopfschmerz und "Nasen-Ausfluß" oder beide Symptome zurückgingen. Spricht dafür dass es KEIN Placebo Effekt gibt - DEUTET an die Ergebnisse werden richtig gut!
Knapp 600.000 OPs jährlich - bei ungefähr 25 % nutzt die OP nichts. Alleine diese 150 Tausend Leute benötigen SinuNase, denn ihnen hilft NICHTS mehr! Dieser Trial zeigt eines hilft: SinuNase!
Danach startet ABPI den nächsten Phase III Trial um zu belegen, dass SinuNase auch den restlichen CS Patienten nutzt: etwa 30 Milliarden Patienten!!!
Grüße
die "key symptoms" sind ein wenig schwächer, aber nach wie vor deuten diese ein Super-Ergebnis an!
Die im pdf gemeldeten Oktober Daten sind die aktuellsten Daten des Phase III Trials. Bei dem primären Zielpunkten (Kopfschmerz und "Nasen-Ausfluß") waren es halt 20 % bei BEIDEN und 20 % nur EIN Zielpunkt erfüllt - wollen wir darauf hoffen, dass dies 40 % jeweils durch SinuNase heißt (also, dann nur bei 20 % KEINE Verbesserung)!
Endoskopie und CT-Scan Ergebnisse dienen dazu dieses Ergebnis zu untermauern: Endoskopie zeigt bei den Oktober Daten: 34 % Verminderung in BEIDEN Nasenlöchern; 18 % Verminderung in EINEM! --> 100 % SinuNase?
CT Scan zeigte die Schleimhäute nahmen bei 57 % ALLER Patienten ab, ABER: Bei nur knapp 35 % wurde 10 % und mehr dieser Dicke verringert! Damit kann man vermuten: Bei Patienten, die SinuNase nehmen, werden CT und Endoskopie Ergebnisse BEI ALLEN (100 %) verbessert, wenn auch teilweise nur moderat!
Oder kann etwa ein Placebo diese Ergebnisse erreichen?
Gleichzeitig hat ABPI in dieser Präsentation gezeigt, dass Patienten deren Endoskopie und CT-Scan Werte verbessert wurden, davon profitieren, das entweder Kopfschmerz und "Nasen-Ausfluß" oder beide Symptome zurückgingen. Spricht dafür dass es KEIN Placebo Effekt gibt - DEUTET an die Ergebnisse werden richtig gut!
Knapp 600.000 OPs jährlich - bei ungefähr 25 % nutzt die OP nichts. Alleine diese 150 Tausend Leute benötigen SinuNase, denn ihnen hilft NICHTS mehr! Dieser Trial zeigt eines hilft: SinuNase!
Danach startet ABPI den nächsten Phase III Trial um zu belegen, dass SinuNase auch den restlichen CS Patienten nutzt: etwa 30 Milliarden Patienten!!!
Grüße
Neues Geld musste her: 5,6 Mil. $ wieder in der Kasse, für ein paar warrants (mal wieder). Dillution wird bei ABPI auf jeden Fall ein Thema werden.
Dass es auch schlechter geht, an Kapital zu gelangen, hat gestern PLX (Protalix) bewiesen. Zu 5 $ insgesamt 10 Mil. Aktien; dass Thema ist nur, der Kurs am Vortag stand bei 36 $.
Entry into a Material Definitive Agreement, Creation of a Direct
Item 1.01. Entry Into a Material Definitive Agreement.
In connection with the February 28, 2007 Convertible Debenture Financing (the "Financing"), the Company issued 4,670,412 warrants (the "Short-term Warrants") which, as amended, were scheduled to expire on October 19, 2007. The Company engaged in an effort to place limits on the exercise of the Short-term Warrants and as a consequence: (i) through October 19, 2007, the Company received an aggregate of $5.6 million in cash from the exercise of the Short-term Warrants at $2.67 per share, (ii) 2,568,564 Short-term Warrants expired unexercised and
(iii) on October 19, 2007, the Company issued warrants to certain of the investors in the Financing to purchase up to 1,895,133 shares of the Company's Common Stock with an exercise price of the $2.67 per share and with a term expiring on the first to occur of January 19, 2009 or three days following notice of the Company's Common Stock trading at $6 per share based on a 10-day volume weighted average.
The offers and sales of securities in the transactions described hereinabove were made pursuant to the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended, including pursuant to Rule 506 and/or Rule 144A thereunder. Such offers and sales were made solely to "accredited investors" under Rule 506 and/or "qualified institutional buyers" under Rule 144A and were made without any form of general solicitation and with full access to any information requested by the investors regarding the Company or the securities offered in these transactions.
Durch revimmune wird der Cash Burn wohl noch höher ausfallen. Die nächsten Q-Zahlen werden NICHT schön! Der Blick sollte mehr auf 2009 gerichtet werden, dass BiovaxID oder SinuNase möglicherweise in den nächsten 1 bis 2 Monaten auslizensiert werden, ist eher unwahrscheinlich.
Grüße
Dass es auch schlechter geht, an Kapital zu gelangen, hat gestern PLX (Protalix) bewiesen. Zu 5 $ insgesamt 10 Mil. Aktien; dass Thema ist nur, der Kurs am Vortag stand bei 36 $.
Entry into a Material Definitive Agreement, Creation of a Direct
Item 1.01. Entry Into a Material Definitive Agreement.
In connection with the February 28, 2007 Convertible Debenture Financing (the "Financing"), the Company issued 4,670,412 warrants (the "Short-term Warrants") which, as amended, were scheduled to expire on October 19, 2007. The Company engaged in an effort to place limits on the exercise of the Short-term Warrants and as a consequence: (i) through October 19, 2007, the Company received an aggregate of $5.6 million in cash from the exercise of the Short-term Warrants at $2.67 per share, (ii) 2,568,564 Short-term Warrants expired unexercised and
(iii) on October 19, 2007, the Company issued warrants to certain of the investors in the Financing to purchase up to 1,895,133 shares of the Company's Common Stock with an exercise price of the $2.67 per share and with a term expiring on the first to occur of January 19, 2009 or three days following notice of the Company's Common Stock trading at $6 per share based on a 10-day volume weighted average.
The offers and sales of securities in the transactions described hereinabove were made pursuant to the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended, including pursuant to Rule 506 and/or Rule 144A thereunder. Such offers and sales were made solely to "accredited investors" under Rule 506 and/or "qualified institutional buyers" under Rule 144A and were made without any form of general solicitation and with full access to any information requested by the investors regarding the Company or the securities offered in these transactions.
Durch revimmune wird der Cash Burn wohl noch höher ausfallen. Die nächsten Q-Zahlen werden NICHT schön! Der Blick sollte mehr auf 2009 gerichtet werden, dass BiovaxID oder SinuNase möglicherweise in den nächsten 1 bis 2 Monaten auslizensiert werden, ist eher unwahrscheinlich.
Grüße
Antwort auf Beitrag Nr.: 32.161.817 von Ackergaul am 26.10.07 13:52:13Endingen (aktiencheck.de AG) - Die Experten von "Global Insider Investing" haben die Aktie von Accentia Biopharmaceuticals (ISIN US00430L1035/ WKN A0EATH) in ihr Musterdepot aufgenommen.
Die Biotechgesellschaft verfüge über diverse vielversprechende Produkte. Da sei zum einem der Wirkstoff BiovaxID. Ende Juni habe das Unternehmen positive Vorabresultate aus einer Phase III-Studie bei Non-Hodgkin-Lymphomen präsentiert. Aber auch die Präparate Sinunase und Revimmune seien interessant.
Bei Sinunase handle es sich um einen Wirkstoff, der als erster seiner Art die Behandlung chronischer Nasennebenhöhlenerkrankungen (CRS) ermögliche. Der Absatzmarkt dafür sei enorm.
Doch Accentia Biopharmaceuticals müsse dringend Erfolge vorweisen. Denn per 30. Juni habe die Gesellschaft nur noch über Liquiditätsreserven von 8,7 Mio. USD verfügt. Diese würden nur noch für das laufende Fiskaljahr ausreichen. Doch die Analysten von Rodman & Renshaw würden dem Titel in ihrer ganz aktuellen Studie ein Kursziel von 8 USD zusprechen. Ihren Schätzungen nach sollte der Umsatz in diesem Jahr auf 18,5 Mio. USD und in 2008 auf 57,9 Mio. USD klettern.
Offensichtlich hege der CEO und Chairman von Accentia Biopharmaceuticals keine Zweifel am Erfolg seiner Gesellschaft. So habe er Mitte August über seine Investmentgesellschaft Hopkins Capital Partners 875.000 Aktien zu einem Kurs von 8,87 USD außerbörslich gekauft. Im SEC-Filing werde ausdrücklich darauf hingewiesen, dass es sich um eine außerbörsliche Kauftransaktion handle und der Käufer über wesentliche, nichtöffentliche Informationen über die Gesellschaft verfüge.
Die Experten von "Global Insider Investing" haben die Aktie von Accentia Biopharmaceuticals in ihr Musterdepot aufgenommen. (Ausgabe 16 vom 27.08.2007) (28.08.2007/ac/a/a
Die Biotechgesellschaft verfüge über diverse vielversprechende Produkte. Da sei zum einem der Wirkstoff BiovaxID. Ende Juni habe das Unternehmen positive Vorabresultate aus einer Phase III-Studie bei Non-Hodgkin-Lymphomen präsentiert. Aber auch die Präparate Sinunase und Revimmune seien interessant.
Bei Sinunase handle es sich um einen Wirkstoff, der als erster seiner Art die Behandlung chronischer Nasennebenhöhlenerkrankungen (CRS) ermögliche. Der Absatzmarkt dafür sei enorm.
Doch Accentia Biopharmaceuticals müsse dringend Erfolge vorweisen. Denn per 30. Juni habe die Gesellschaft nur noch über Liquiditätsreserven von 8,7 Mio. USD verfügt. Diese würden nur noch für das laufende Fiskaljahr ausreichen. Doch die Analysten von Rodman & Renshaw würden dem Titel in ihrer ganz aktuellen Studie ein Kursziel von 8 USD zusprechen. Ihren Schätzungen nach sollte der Umsatz in diesem Jahr auf 18,5 Mio. USD und in 2008 auf 57,9 Mio. USD klettern.
Offensichtlich hege der CEO und Chairman von Accentia Biopharmaceuticals keine Zweifel am Erfolg seiner Gesellschaft. So habe er Mitte August über seine Investmentgesellschaft Hopkins Capital Partners 875.000 Aktien zu einem Kurs von 8,87 USD außerbörslich gekauft. Im SEC-Filing werde ausdrücklich darauf hingewiesen, dass es sich um eine außerbörsliche Kauftransaktion handle und der Käufer über wesentliche, nichtöffentliche Informationen über die Gesellschaft verfüge.
Die Experten von "Global Insider Investing" haben die Aktie von Accentia Biopharmaceuticals in ihr Musterdepot aufgenommen. (Ausgabe 16 vom 27.08.2007) (28.08.2007/ac/a/a
Antwort auf Beitrag Nr.: 32.182.952 von SunnyOst am 29.10.07 07:34:36Insider Tip: Biodelivery Sciences Chairman Owns Accentia Biopharmaceutical
Thursday September 6, 11:22 pm ET
Biodelivery Sciences International (BDSI) announced Wednesay that they received a commercial partnership for their Bema Fetanyl drug candidate with Meda AB, which could add up to $90 million in payments for BDSI. This proves very rewarding for shareholders of BDSI, including the Chairman, Dr. Frank O'Donnel, who purchased 400,000 shares last January $2.68.00 per share, along with an additional 400,000 at $2.68, shares though his 100% owned VC firm Hopkins Capital Group.
Recently, Dr. O'Donnel purchased 875,000 shares of Accentia Biopharmaceuticals (ABPI) at $8.87.00 per share. The current market price is $2.20.00. Accentia Biopharmaceuticals recently provided interim blinded data on the ongoing clinical trial of Sinunase which showed that 50% of the people in the trial are responding positively.
We just don't know if it's the drug or the placebo. From what I understand, in order to participate in the trial one had to have failed surgery, antibiotics, and two weeks of saline irrigation. It is a 50/50 trial in which half are getting the drug and the other half a placebo. If they prove it works it will be a windfall for Accentia shareholders with a potential market of over $2 billion dollars. Dr. O'Donnel purchased the shares recently at a 400% premium to the current market price.
Thursday September 6, 11:22 pm ET
Biodelivery Sciences International (BDSI) announced Wednesay that they received a commercial partnership for their Bema Fetanyl drug candidate with Meda AB, which could add up to $90 million in payments for BDSI. This proves very rewarding for shareholders of BDSI, including the Chairman, Dr. Frank O'Donnel, who purchased 400,000 shares last January $2.68.00 per share, along with an additional 400,000 at $2.68, shares though his 100% owned VC firm Hopkins Capital Group.
Recently, Dr. O'Donnel purchased 875,000 shares of Accentia Biopharmaceuticals (ABPI) at $8.87.00 per share. The current market price is $2.20.00. Accentia Biopharmaceuticals recently provided interim blinded data on the ongoing clinical trial of Sinunase which showed that 50% of the people in the trial are responding positively.
We just don't know if it's the drug or the placebo. From what I understand, in order to participate in the trial one had to have failed surgery, antibiotics, and two weeks of saline irrigation. It is a 50/50 trial in which half are getting the drug and the other half a placebo. If they prove it works it will be a windfall for Accentia shareholders with a potential market of over $2 billion dollars. Dr. O'Donnel purchased the shares recently at a 400% premium to the current market price.
Zu Revimmune:
Revimmune basiert auf einem zugelassenene Wirkstoff (Cyclophosphamid) in einem neuen Verfahren das Immunsystem zu "rebooten": dadurch soll die Autoimmunität beseitigt werden. Heutige Therapien (einschließlich oralem Cyclophosphamid) werden chromisch verwendet, um Entzündungen der Autoimmunität zu unterdrücken. Beruhend auf langfristigen Untersuchungen die ein komplettes Ansprechen zeigten, gibt es Vermutungen, dass Revimmune Potential hat Fälle von schweren refraktären Autoimmunkrankheiten zu kurieren.
Cyclophosphamid
Das Phosphaoxinan Cyclophosphamid gehört zu der Gruppe der Stickstoff-Lost-Verbindungen mit alkylierender Wirkung. Außer für die Krebstherapie wird es auch zur Behandlung besonders schwer verlaufender Multiple Sklerose sowie zur immunsuppressiven Behandlung von Autoimmunerkrankungen wie Systemischer Lupus Erythematodes (SLE) oder der Wegener Granulomatose eingesetzt. Da Cyclophosphamid erst nach einer Aktivierung in der Leber zytotoxisch wirkt, ist es ein Prodrug.
Wirksamkeit:
Multiple Sklerose
Für die Behandlung der Multiple Sklerose steht leider keine randomisierte, doppelblinde, placebokontrollierte Studie zur Verfügung. In den vorliegenden Untersuchungen konnte aber eine Reduzierung der Progression beobachtet werden. Dabei waren Auffrischinfusionen besser wirksam als eine einmalige Induktionstherapie.
Wirkmechanismus
Cyclophosphamid führt zu Einzel- und Doppelstrangbrüchen in sich schnell teilenden Zellen. Daraus resultierend finden sich im Blut von behandelten Patienten mehr CD8-Supressorzellen und weniger CD4-Helferzellen
Nebenwirkungen
Es kommt häufig zu einer verminderten Leukozytenzahl (Dosislimitierende Knochenmarkdepression), Übelkeit, Haarausfall. Besonders bei hohen kumulierten Dosen ist das Krebsrisiko, speziell für Leukämie und Blasentumore erhöht. Außerdem kann es im Rahmen einer Chemotherapie mit Cyclophosphamid zu einer hämorrhagischen Zystitis kommen. Dagegen wird eine protektive Substanz parallel zur Cyclophosphamid Gabe verabreicht: MESNA (Mercapto-ethansulfonat-Natrium).
Impfungen mit Totimpfstoffen sind unter Cyclophosphamid-Behandlung aufgrund dessen immunsuppressiver und zytostatischer Wirkung nicht wirksam.
Zytostatika (Chemotherapeutika):
Alkylantien
Alkylantien verbinden sich in der Zelle mit der Erbsubstanz DNA. Die Stränge der DNA werden dabei eng miteinander vernetzt oder brechen auseinander, so dass die Erbinformation nicht mehr weitergegeben werden kann. Dann teilt sich die Zelle nicht mehr und stirbt ab.
Zu den Alkylantien gehören die Wirkstoffe Bendamustin, Busulfan, Carmustin, Chlorambucil, Cyclophosphamid, Dacarbazin, Estramustin, Ifosfamid, Lomustin, Melphalan, Mitomyzin C, Nimustin, Thiotepa, Treosulfan und Trofosfamid.
Grundsätzlich gelten alle allgemeinen Angaben zu Zytostatika. Im Folgenden werden zusätzlich die Besonderheiten bei den einzelnen Wirkstoffen beschrieben.
Cyclophosphamid (CYCLO-cell, Cyclophosphamid-biosyn, Cyclostin, Endoxan)
Zur Wirkung von Cyclophosphamid siehe Alkylantien.
Anwendung
Cyclophosphamid wird in sehr unterschiedlichen Dosierungen und Zeitabständen als Dragée oder Infusion gegeben.
Dragées sollten Sie morgens möglichst unzerkaut 1/2 Stunde vor dem Frühstück mit einem großen Glas Wasser einnehmen. Bei den Infusionen ist es egal, zu welcher Tageszeit sie gelegt werden.
Wegen des hohen Risikos für Blasenentzündungen müssen Sie während der Behandlung viel trinken, um die Blase häufig zu entleeren. Ratsam sind 2-3 Liter pro Tag, vorzugsweise Wasser (ohne Kohlensäure), verdünnte Obstsäfte, Kräutertee.
In sehr niedriger Dosierung (5 mg pro kg Körpergewicht) wird Cyclophosphamid gegen Autoimmunerkrankungen wie rheumatoide Arthritis oder Sklerodermie eingesetzt, vor allem, wenn keine anderen Wirkstoffe helfen. Bei dieser Dosierung treten die hier aufgeführten unerwünschten Wirkungen bis auf die Blutbildveränderungen kaum auf. Auch die angegebenen Gegenanzeigen gelten in diesen Fällen nicht unbedingt.
Autoimmunerkrankung
Autoimmunerkrankung ist in der Medizin ein Überbegriff für Krankheiten, deren Ursache eine überschießende Reaktion des Immunsystems gegen körpereigenes Gewebe ist. Irrtümlicherweise erkennt das Immunsystem körpereigenes Gewebe als zu bekämpfenden Fremdkörper. Dadurch kommt es zu schweren Entzündungsreaktionen, die zu Schäden an den betroffenen Organen führen.
Definition
T-Zellen sind für die Erkennung von Fremdstoffen verantwortlich. Im Thymus werden sie dafür geschult, nur an MHC-Moleküle anzudocken und körpereigene Strukturen zu tolerieren. Bei Autoimmunkrankheiten verhalten sich diese Zellen entgegen ihrer Natur. Anstatt eindringende Fremdkörper abzuwehren, greifen sie körpereigene Strukturen an. Organe werden als fremd empfunden, die lebensnotwendig für den Organismus und das Immunsystem sind. Das Immunsystem richtet seine ganze Abwehrstärke gegen diese Organe (zelluläre, wie auch humorale Abwehrreaktionen; Autoantikörper werden gebildet), was zur Folge hat, dass diese Organe im Laufe der Zeit ihre Funktion aufgeben müssen. Das Immunsystem wird geschwächt, und der Körper wird anfällig für allerlei Krankheiten. Die Fremdkörpererkennung wird gestört, was zur Folge hat, dass entartete Tumorzellen zu wuchern beginnen und bösartige Ausmaße erlangen (dies sind Symptome einer Immunmangelkrankheit). Im Körper bricht ein erbitterter Kampf aus: Immunzellen zerstören die körpereigenen Strukturen, während das Reparatur-System des Körpers die geschädigten Organteile zu erneuern versucht. Dieser „falsche“ Angriff des Abwehrsystems setzt sich ohne Behandlung in der Regel lebenslang oder bis zur vollständigen Zerstörung des Organs fort.
Immuntoleranz
Der erste Forscher, der den Unterschied zwischen „selbst“ und „nicht selbst“ erkannte war der deutsche Mikrobiologe Paul Ehrlich. Er wollte ursprünglich um 1900 herausfinden, was mit Blut, das nach inneren Blutungen zurückbleibt, geschieht. Daher startete er einen Versuch, indem er Ziegen Schafsblut injizierte. Das Erstaunliche war, dass das Immunsystem die fremden Blutzellen (Erythrozyten) sogleich vernichtete.
Als Ehrlich später den Versuch mit artgleichen Tieren durchführte, geschah dasselbe. Das Immunsystem wehrte sich gegen die fremden Blutzellen.
Erst als er eine Ziege mit ihrem eigenen Blut behandelte, erkannte Ehrlich, dass der Körper verstand, was körperfremd und körpereigen ist. Die Ziege zerstörte bei diesem Versuch die injizierten Blutzellen nicht (obwohl Ehrlich das Blut eine gewisse Zeit aufbewahrte). Obwohl dieser Versuch mit seinem Anfangsgedanken nun wenig in Verbindung stand, zog Ehrlich seine Schlüsse und stellte das biologische Prinzip der "horror autotoxicus" (Furcht vor Selbstzerstörung) auf. Obwohl dieses Prinzip äußerst simpel klingt, ist es dennoch lebensnotwendig für alle Lebewesen. Würde die Ziege ihr eigenes Blut abbauen, würde sie schon bei geringsten Verletzungen sterben (wenn ihr Immunsystem ihr eigenes Blut angreifen würde). Doch dieser Selbstschutz ist nicht immer von Vorteil. Körpereigene Krebszellen werden daher vor ihrer Zerstörung bewahrt. Denn der Körper greift sich im Normalfall nicht selbst an. Doch in der heutigen Medizin ist seit Neuestem bekannt, dass Krebszellen ebenso wie Antigene vom Immunsystem angegriffen werden, wenn sie sich nur deutlich genug von Nicht-Krebszellen (gesunden Zellen) unterscheiden. Wie kommt es dennoch dazu, dass der eigene Körper im Falle einer Autoimmunkrankheit seine Organe als fremd ansieht und angreift? Mit genau diesem Problem sind die heutigen Forscher und Mediziner konfrontiert.
Entstehung
Die genaue Ursache von Autoimmunerkrankungen ist trotz intensiver Forschung weiterhin unklar. Anerkannte Hypothesen gehen davon aus, dass Autoimmunkrankheiten durch die Kombination von angeborener "Empfänglichkeit" (Genetische Disposition z.B. durch das Vorhandensein bestimmter MHC-Molekül-Varianten). Gibt es im Körper des Betroffenen solche genetisch bedingte Faktoren und es kommen darüber hinaus ungünstige Umweltfaktoren wie starker Stress, Infektionen („molekulare Mimikry“s.u.), Schwangerschaft hinzu, kann es zum Ausbruch von Autoimmunerkrankungen kommen. ("Bad luck and bad genes": ungefähr: "Pech und falsche Gene") Die Zielstrukturen der Autoimmunreaktion kann sich auf ein bestimmtes Organ (von der Haarwurzel bis zur Leber) beschränken oder den ganzen Körper (mehrere Organe und Gefäßsystem) befallen. Mischformen mit mehreren Autoimmunerkrankungen sind nicht selten.
Autoimmunität:
Im eigenen Abwehrsystem (Immunsystem) werden fälschlicherweise und versehentlich Autoantikörper („autos“ ist griechisch und heißt „selbst“) gebildet. Antikörper sind spezielle Eiweiße die von Lymphozyten (weiße Blutkörperchen) produziert werden. Diese „Selbsteiweiße“ richten sich nun gegen körpereigenes Gewebe. Das Immunsystem betrachtet quasi Teile des eigenen Körpers als fremd. Dadurch entsteht in jenem Organ, gegen das sich die Autoantikörper richten, eine Autoimmunerkrankung. Die Autoantikörper werden zur Diagnose eingesetzt, können im Blut nachgewiesen werden und weisen so auf bestimmte Erkrankungen hin.
Die Wahrscheinlichkeit eine Autoimmunerkrankung zu bekommen, ist in der Altersgruppe der 30 bis 50 jährigen am höchsten. Auffällig ist, dass Frauen häufiger betroffen sind als Männer.
Revimmune hat Potential. Mit der FDA konnte ein direkter Start in die Phase III vereinbart worden, so wird einiges an Zeit und Geld eingespart. Mich wundert, dass gerade der gute Herr Dr. O'Donnell Revimmune ABPI hat zukommen lassen. Eigentlich ist ABPI bekanntlich mehr auf die Atemwegserkrankungen ausgerichtet... Wie auch immer, von der Hopkins Gruppe (einer der Direktoren davon ist unser guter Dr. O'Donnell - welch Zufall) ist Revimmune einlizensiert worden. Die genauen Details des Deals, habe ich leider nicht gefunden. Ein interessanter Bestandteil der Pipeline ABPIs!
Revimmune basiert auf einem zugelassenene Wirkstoff (Cyclophosphamid) in einem neuen Verfahren das Immunsystem zu "rebooten": dadurch soll die Autoimmunität beseitigt werden. Heutige Therapien (einschließlich oralem Cyclophosphamid) werden chromisch verwendet, um Entzündungen der Autoimmunität zu unterdrücken. Beruhend auf langfristigen Untersuchungen die ein komplettes Ansprechen zeigten, gibt es Vermutungen, dass Revimmune Potential hat Fälle von schweren refraktären Autoimmunkrankheiten zu kurieren.
Cyclophosphamid
Das Phosphaoxinan Cyclophosphamid gehört zu der Gruppe der Stickstoff-Lost-Verbindungen mit alkylierender Wirkung. Außer für die Krebstherapie wird es auch zur Behandlung besonders schwer verlaufender Multiple Sklerose sowie zur immunsuppressiven Behandlung von Autoimmunerkrankungen wie Systemischer Lupus Erythematodes (SLE) oder der Wegener Granulomatose eingesetzt. Da Cyclophosphamid erst nach einer Aktivierung in der Leber zytotoxisch wirkt, ist es ein Prodrug.
Wirksamkeit:
Multiple Sklerose
Für die Behandlung der Multiple Sklerose steht leider keine randomisierte, doppelblinde, placebokontrollierte Studie zur Verfügung. In den vorliegenden Untersuchungen konnte aber eine Reduzierung der Progression beobachtet werden. Dabei waren Auffrischinfusionen besser wirksam als eine einmalige Induktionstherapie.
Wirkmechanismus
Cyclophosphamid führt zu Einzel- und Doppelstrangbrüchen in sich schnell teilenden Zellen. Daraus resultierend finden sich im Blut von behandelten Patienten mehr CD8-Supressorzellen und weniger CD4-Helferzellen
Nebenwirkungen
Es kommt häufig zu einer verminderten Leukozytenzahl (Dosislimitierende Knochenmarkdepression), Übelkeit, Haarausfall. Besonders bei hohen kumulierten Dosen ist das Krebsrisiko, speziell für Leukämie und Blasentumore erhöht. Außerdem kann es im Rahmen einer Chemotherapie mit Cyclophosphamid zu einer hämorrhagischen Zystitis kommen. Dagegen wird eine protektive Substanz parallel zur Cyclophosphamid Gabe verabreicht: MESNA (Mercapto-ethansulfonat-Natrium).
Impfungen mit Totimpfstoffen sind unter Cyclophosphamid-Behandlung aufgrund dessen immunsuppressiver und zytostatischer Wirkung nicht wirksam.
Zytostatika (Chemotherapeutika):
Alkylantien
Alkylantien verbinden sich in der Zelle mit der Erbsubstanz DNA. Die Stränge der DNA werden dabei eng miteinander vernetzt oder brechen auseinander, so dass die Erbinformation nicht mehr weitergegeben werden kann. Dann teilt sich die Zelle nicht mehr und stirbt ab.
Zu den Alkylantien gehören die Wirkstoffe Bendamustin, Busulfan, Carmustin, Chlorambucil, Cyclophosphamid, Dacarbazin, Estramustin, Ifosfamid, Lomustin, Melphalan, Mitomyzin C, Nimustin, Thiotepa, Treosulfan und Trofosfamid.
Grundsätzlich gelten alle allgemeinen Angaben zu Zytostatika. Im Folgenden werden zusätzlich die Besonderheiten bei den einzelnen Wirkstoffen beschrieben.
Cyclophosphamid (CYCLO-cell, Cyclophosphamid-biosyn, Cyclostin, Endoxan)
Zur Wirkung von Cyclophosphamid siehe Alkylantien.
Anwendung
Cyclophosphamid wird in sehr unterschiedlichen Dosierungen und Zeitabständen als Dragée oder Infusion gegeben.
Dragées sollten Sie morgens möglichst unzerkaut 1/2 Stunde vor dem Frühstück mit einem großen Glas Wasser einnehmen. Bei den Infusionen ist es egal, zu welcher Tageszeit sie gelegt werden.
Wegen des hohen Risikos für Blasenentzündungen müssen Sie während der Behandlung viel trinken, um die Blase häufig zu entleeren. Ratsam sind 2-3 Liter pro Tag, vorzugsweise Wasser (ohne Kohlensäure), verdünnte Obstsäfte, Kräutertee.
In sehr niedriger Dosierung (5 mg pro kg Körpergewicht) wird Cyclophosphamid gegen Autoimmunerkrankungen wie rheumatoide Arthritis oder Sklerodermie eingesetzt, vor allem, wenn keine anderen Wirkstoffe helfen. Bei dieser Dosierung treten die hier aufgeführten unerwünschten Wirkungen bis auf die Blutbildveränderungen kaum auf. Auch die angegebenen Gegenanzeigen gelten in diesen Fällen nicht unbedingt.
Autoimmunerkrankung
Autoimmunerkrankung ist in der Medizin ein Überbegriff für Krankheiten, deren Ursache eine überschießende Reaktion des Immunsystems gegen körpereigenes Gewebe ist. Irrtümlicherweise erkennt das Immunsystem körpereigenes Gewebe als zu bekämpfenden Fremdkörper. Dadurch kommt es zu schweren Entzündungsreaktionen, die zu Schäden an den betroffenen Organen führen.
Definition
T-Zellen sind für die Erkennung von Fremdstoffen verantwortlich. Im Thymus werden sie dafür geschult, nur an MHC-Moleküle anzudocken und körpereigene Strukturen zu tolerieren. Bei Autoimmunkrankheiten verhalten sich diese Zellen entgegen ihrer Natur. Anstatt eindringende Fremdkörper abzuwehren, greifen sie körpereigene Strukturen an. Organe werden als fremd empfunden, die lebensnotwendig für den Organismus und das Immunsystem sind. Das Immunsystem richtet seine ganze Abwehrstärke gegen diese Organe (zelluläre, wie auch humorale Abwehrreaktionen; Autoantikörper werden gebildet), was zur Folge hat, dass diese Organe im Laufe der Zeit ihre Funktion aufgeben müssen. Das Immunsystem wird geschwächt, und der Körper wird anfällig für allerlei Krankheiten. Die Fremdkörpererkennung wird gestört, was zur Folge hat, dass entartete Tumorzellen zu wuchern beginnen und bösartige Ausmaße erlangen (dies sind Symptome einer Immunmangelkrankheit). Im Körper bricht ein erbitterter Kampf aus: Immunzellen zerstören die körpereigenen Strukturen, während das Reparatur-System des Körpers die geschädigten Organteile zu erneuern versucht. Dieser „falsche“ Angriff des Abwehrsystems setzt sich ohne Behandlung in der Regel lebenslang oder bis zur vollständigen Zerstörung des Organs fort.
Immuntoleranz
Der erste Forscher, der den Unterschied zwischen „selbst“ und „nicht selbst“ erkannte war der deutsche Mikrobiologe Paul Ehrlich. Er wollte ursprünglich um 1900 herausfinden, was mit Blut, das nach inneren Blutungen zurückbleibt, geschieht. Daher startete er einen Versuch, indem er Ziegen Schafsblut injizierte. Das Erstaunliche war, dass das Immunsystem die fremden Blutzellen (Erythrozyten) sogleich vernichtete.
Als Ehrlich später den Versuch mit artgleichen Tieren durchführte, geschah dasselbe. Das Immunsystem wehrte sich gegen die fremden Blutzellen.
Erst als er eine Ziege mit ihrem eigenen Blut behandelte, erkannte Ehrlich, dass der Körper verstand, was körperfremd und körpereigen ist. Die Ziege zerstörte bei diesem Versuch die injizierten Blutzellen nicht (obwohl Ehrlich das Blut eine gewisse Zeit aufbewahrte). Obwohl dieser Versuch mit seinem Anfangsgedanken nun wenig in Verbindung stand, zog Ehrlich seine Schlüsse und stellte das biologische Prinzip der "horror autotoxicus" (Furcht vor Selbstzerstörung) auf. Obwohl dieses Prinzip äußerst simpel klingt, ist es dennoch lebensnotwendig für alle Lebewesen. Würde die Ziege ihr eigenes Blut abbauen, würde sie schon bei geringsten Verletzungen sterben (wenn ihr Immunsystem ihr eigenes Blut angreifen würde). Doch dieser Selbstschutz ist nicht immer von Vorteil. Körpereigene Krebszellen werden daher vor ihrer Zerstörung bewahrt. Denn der Körper greift sich im Normalfall nicht selbst an. Doch in der heutigen Medizin ist seit Neuestem bekannt, dass Krebszellen ebenso wie Antigene vom Immunsystem angegriffen werden, wenn sie sich nur deutlich genug von Nicht-Krebszellen (gesunden Zellen) unterscheiden. Wie kommt es dennoch dazu, dass der eigene Körper im Falle einer Autoimmunkrankheit seine Organe als fremd ansieht und angreift? Mit genau diesem Problem sind die heutigen Forscher und Mediziner konfrontiert.
Entstehung
Die genaue Ursache von Autoimmunerkrankungen ist trotz intensiver Forschung weiterhin unklar. Anerkannte Hypothesen gehen davon aus, dass Autoimmunkrankheiten durch die Kombination von angeborener "Empfänglichkeit" (Genetische Disposition z.B. durch das Vorhandensein bestimmter MHC-Molekül-Varianten). Gibt es im Körper des Betroffenen solche genetisch bedingte Faktoren und es kommen darüber hinaus ungünstige Umweltfaktoren wie starker Stress, Infektionen („molekulare Mimikry“s.u.), Schwangerschaft hinzu, kann es zum Ausbruch von Autoimmunerkrankungen kommen. ("Bad luck and bad genes": ungefähr: "Pech und falsche Gene") Die Zielstrukturen der Autoimmunreaktion kann sich auf ein bestimmtes Organ (von der Haarwurzel bis zur Leber) beschränken oder den ganzen Körper (mehrere Organe und Gefäßsystem) befallen. Mischformen mit mehreren Autoimmunerkrankungen sind nicht selten.
Autoimmunität:
Im eigenen Abwehrsystem (Immunsystem) werden fälschlicherweise und versehentlich Autoantikörper („autos“ ist griechisch und heißt „selbst“) gebildet. Antikörper sind spezielle Eiweiße die von Lymphozyten (weiße Blutkörperchen) produziert werden. Diese „Selbsteiweiße“ richten sich nun gegen körpereigenes Gewebe. Das Immunsystem betrachtet quasi Teile des eigenen Körpers als fremd. Dadurch entsteht in jenem Organ, gegen das sich die Autoantikörper richten, eine Autoimmunerkrankung. Die Autoantikörper werden zur Diagnose eingesetzt, können im Blut nachgewiesen werden und weisen so auf bestimmte Erkrankungen hin.
Die Wahrscheinlichkeit eine Autoimmunerkrankung zu bekommen, ist in der Altersgruppe der 30 bis 50 jährigen am höchsten. Auffällig ist, dass Frauen häufiger betroffen sind als Männer.
Revimmune hat Potential. Mit der FDA konnte ein direkter Start in die Phase III vereinbart worden, so wird einiges an Zeit und Geld eingespart. Mich wundert, dass gerade der gute Herr Dr. O'Donnell Revimmune ABPI hat zukommen lassen. Eigentlich ist ABPI bekanntlich mehr auf die Atemwegserkrankungen ausgerichtet... Wie auch immer, von der Hopkins Gruppe (einer der Direktoren davon ist unser guter Dr. O'Donnell - welch Zufall) ist Revimmune einlizensiert worden. Die genauen Details des Deals, habe ich leider nicht gefunden. Ein interessanter Bestandteil der Pipeline ABPIs!
Antwort auf Beitrag Nr.: 32.198.725 von Ackergaul am 30.10.07 09:19:38BACKGROUND ON REVIMMUNE CLINICAL RESULTS
Studies at Johns Hopkins University School of Medicine by Dr. Jones, Dr. Brodsky, and colleagues have demonstrated the potential benefits of Revimmune in a variety of autoimmune diseases.
Multiple Sclerosis:
According to information from the National Multiple Sclerosis Society (http://nationalmssociety.org/), there are approximately 400,000 people in the U.S. with Multiple Sclerosis. For the clinical course, 85% of patients are in the category of relapsing-remitting. Based upon a paper by D. Hirtz et al. "How common are the 'common' neurologic disorders?," the annual incidence of Multiple Sclerosis in the U.S. was approximately 4.2 new cases per 100,000 population in 2005.
Revimmune treatment of 20 Multiple Sclerosis patients has resulted in the following successful outcomes in 2 published studies from C. Krishnan, D. Kerr et al. and D. Gladstone et al.:
-- All patients have had a reduction or elimination of new and
enhancing lesions on the MRI
-- No patient has had a clinical exacerbation following treatment
and most patients have had a reduction in EDSS and an improvement in the MSFC following treatment
-- During follow-up, no patients increased their baseline EDSS
scores by more than 1.0
-- No patient had a new lesion on brain magnetic resonance
imaging; no patient showed any enhancing lesions
Six medicines are currently approved for the treatment of RRMS: interferon (beta)-1b (Betaseron(R)), interferon (beta)-1a (Avonex(R) and Rebif(R)) glatiramer acetate (Copaxone(R)), mitoxantrone (Novantrone (R)) and natalizumab (TYSABRI(R)). A systematic review of 21 studies failed to reveal a difference among the interferons and glatirimer acetate in reducing the frequency of relapses (Galetta, Markowitz et al., 2002).
Interferons were found to be more potent than glatiramer acetate in reducing gadolinium enhancement on MRI, with an 82-89% reduction from pretreatment levels. Disability progression was found to decrease between 12 and 37% in all the pivotal Phase 3 trials compared to placebo treated patients. The vast majority of patients continued to accrue disability as defined by EDSS, MSFC, neuro-cognitive studies, and brain parenchymal fraction (BPF).
Studies at Johns Hopkins University School of Medicine by Dr. Jones, Dr. Brodsky, and colleagues have demonstrated the potential benefits of Revimmune in a variety of autoimmune diseases.
Multiple Sclerosis:
According to information from the National Multiple Sclerosis Society (http://nationalmssociety.org/), there are approximately 400,000 people in the U.S. with Multiple Sclerosis. For the clinical course, 85% of patients are in the category of relapsing-remitting. Based upon a paper by D. Hirtz et al. "How common are the 'common' neurologic disorders?," the annual incidence of Multiple Sclerosis in the U.S. was approximately 4.2 new cases per 100,000 population in 2005.
Revimmune treatment of 20 Multiple Sclerosis patients has resulted in the following successful outcomes in 2 published studies from C. Krishnan, D. Kerr et al. and D. Gladstone et al.:
-- All patients have had a reduction or elimination of new and
enhancing lesions on the MRI
-- No patient has had a clinical exacerbation following treatment
and most patients have had a reduction in EDSS and an improvement in the MSFC following treatment
-- During follow-up, no patients increased their baseline EDSS
scores by more than 1.0
-- No patient had a new lesion on brain magnetic resonance
imaging; no patient showed any enhancing lesions
Six medicines are currently approved for the treatment of RRMS: interferon (beta)-1b (Betaseron(R)), interferon (beta)-1a (Avonex(R) and Rebif(R)) glatiramer acetate (Copaxone(R)), mitoxantrone (Novantrone (R)) and natalizumab (TYSABRI(R)). A systematic review of 21 studies failed to reveal a difference among the interferons and glatirimer acetate in reducing the frequency of relapses (Galetta, Markowitz et al., 2002).
Interferons were found to be more potent than glatiramer acetate in reducing gadolinium enhancement on MRI, with an 82-89% reduction from pretreatment levels. Disability progression was found to decrease between 12 and 37% in all the pivotal Phase 3 trials compared to placebo treated patients. The vast majority of patients continued to accrue disability as defined by EDSS, MSFC, neuro-cognitive studies, and brain parenchymal fraction (BPF).
Accentia Biopharmaceuticals to Present at Rodman & Renshaw 9th Annual Healthcare Conference on November 6, 2007
TAMPA, Fla.--(BUSINESS WIRE)--Oct. 31, 2007--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) will present at the Rodman & Renshaw Acumen BioFin(TM) 9th Annual Healthcare Conference on Tuesday, November 6, at 12:40 PM in the Holmes I Room at the New York Palace Hotel. Dr. Frank E. O'Donnell Jr., Chairman and CEO, will update attendees on the Fast-Tracked Pivotal Phase 3 clinical trial of SinuNase(TM) for Chronic Sinusitis. The Company has recently announced completion of enrollment in the SinuNase(TM) Phase 3 clinical trial.
The conference will be held from November 5-7, 2007, at the New York Palace Hotel. Additional information regarding the conference can be found at http://www.rodmanandrenshaw.com/conferences?id=6.
The presentation will be simultaneously webcast, and then archived for 90 days. To access a live audio webcast or the subsequent archived recording, log on to http://www.wsw.com/webcast/rrshq12/abpi.
PS
Erwarte nur positives.
TAMPA, Fla.--(BUSINESS WIRE)--Oct. 31, 2007--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) will present at the Rodman & Renshaw Acumen BioFin(TM) 9th Annual Healthcare Conference on Tuesday, November 6, at 12:40 PM in the Holmes I Room at the New York Palace Hotel. Dr. Frank E. O'Donnell Jr., Chairman and CEO, will update attendees on the Fast-Tracked Pivotal Phase 3 clinical trial of SinuNase(TM) for Chronic Sinusitis. The Company has recently announced completion of enrollment in the SinuNase(TM) Phase 3 clinical trial.
The conference will be held from November 5-7, 2007, at the New York Palace Hotel. Additional information regarding the conference can be found at http://www.rodmanandrenshaw.com/conferences?id=6.
The presentation will be simultaneously webcast, and then archived for 90 days. To access a live audio webcast or the subsequent archived recording, log on to http://www.wsw.com/webcast/rrshq12/abpi.
PS
Erwarte nur positives.
WORCESTER, Mass.--(BUSINESS WIRE)--November 01, 2007--
Biovest International, Inc. (OTCBB:BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), will present at the Rodman & Renshaw Acumen BioFin(TM) 9th Annual Healthcare Conference on Wednesday, November 7, at 9:30 AM in the Kennedy II Room at the New York Palace Hotel. Dr. Steve Arikian, Chairman and CEO, will present an update on BiovaxID(TM), a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. The Company recently announced that it performed a data lock on its Phase III Clinical Trial in September 2007, and anticipates having an interim data analysis of unblinded data on the primary endpoint of disease-free survival for BiovaxID completed and publicly disclosed by March of 2008.
The conference will be held from November 5-7, 2007, at the New York Palace Hotel. Additional information regarding the conference can be found at http://www.rodmanandrenshaw.com/conferences?id=6.
Biovest International, Inc. (OTCBB:BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), will present at the Rodman & Renshaw Acumen BioFin(TM) 9th Annual Healthcare Conference on Wednesday, November 7, at 9:30 AM in the Kennedy II Room at the New York Palace Hotel. Dr. Steve Arikian, Chairman and CEO, will present an update on BiovaxID(TM), a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. The Company recently announced that it performed a data lock on its Phase III Clinical Trial in September 2007, and anticipates having an interim data analysis of unblinded data on the primary endpoint of disease-free survival for BiovaxID completed and publicly disclosed by March of 2008.
The conference will be held from November 5-7, 2007, at the New York Palace Hotel. Additional information regarding the conference can be found at http://www.rodmanandrenshaw.com/conferences?id=6.
Ich habe mal eine Überblick der Pipeline & Produkte ABPIs erstellt:
- SinuNase
Status: Phase III
Gebiet: chronische Nasennebenhöhlenentzündung (CS oder CRS)
Markt: etwa 5-6 Milliarden $
Fazit: Anfang 2008 Ergebnisse der Phase III (schwere CS), dann eine 2. Phase III. Im 4. Quartal 08 wohl die kompletten Ergebnisse (ungefähr 700 Patienten insgesamt)! Ein möglicher Blockbuster für ABPI! Möglicher Verkaufsstart vielleicht bereits im 2H 2008, wahrscheinlicher aber 2009...
- Revimmune
Status: Phase III
Gebiet: Autoimmunerkrankungen
Markt: RIESIG!
Fazit: In etwa 12 Monaten soll es bei der Indikation MS erste Ergebnisse geben. Revimmune baut auf einem zugelassenen Wirkstoff auf. Interessant! Allerdings auch ein hart umkämpfter Markt.
- BiovaxID (über BioVest)
Status: Phase III
Gebiet: follikulärer B-Zell Lymphom
Markt: etwa 2-3 Milliarden $
Fazit: Schwer einzuschätzen. Ergebnisse sehen zwar gut aus, dennoch halte ich einen Erfolg eher für unwahrscheinlich. Beschleunigte Zulassung angestrebt; Anfang, Mitte 2009 möglicher Verkaufsstart.
- Respi-TANN
Status: zugelassen
Gebiet: Hustenmittel
Markt: ?
Fazit: Bei Erkältungen, Grippe, Sinusitis und Brochitis. Nichts weltbewegendes, bringt ein paar Dollars...
- CRS Fungal Profile Test
Status: zugelassen
Gebiet: Pilz Nachweis
Markt: ?
Fazit: Ebenfalls ein paar Dollars...
- MD Turbo
Status: zugelassen
Gebiet: Inhaliergerät
Markt: ? (Umsatz-Ziel für MD Turbo waren 40 Mil. $ Umsatz jährlich)
Fazit: Asthma Hersteller haben ihre Produkte umgestellt, dadurch ist MD Turbo zum "sterben verdammt". Von Respirics vermarktet - haben schon angekündigt Verkauf und Vermarktung einzustellen. Enttäuschend!
- Allernase
Status: Phase III
Gebiet: allergischen Nasenschleimhautentzündungen
Markt: etwa 3 Milliarden $
Fazit: Approval wird 2008 erwartet - Partner ist Collegium Pharmaceutical. Schering, Aventis und AstraZeneca sind dick im Markt vertreten. Wird schwer Markt-Anteile zu ergattern: Nicht (zu)viel erwarten!
- AutovaxID (über BioVest)
Status: zugelassen
Gebiet: Zellwachstum-Gerät
Markt: ?
Fazit: Dass Gerät ist etwa 10x kleiner als vergleichbare seiner Art. Ich denke ganz netter (kleiner) Nebenverdienst für BioVest und ABPI.
- Emezine
Status: Phase III (in der "Schwebe")
Gebiet: Übelkeit / Erbrechen
Markt: ?
Fazit: Dass wird wohl nichts mehr...
Kurzes Fazit:
3 dicke Phase III Trials. Zwei davon in denen auf nähere Zeit eine Entscheidung ansteht. Hauptaugenmerk sollte ein jeder für sich ausmachen, meiner liegt auf SinuNase, da ich denke
a) die Ergebnisse werden gut ausfallen
b) es fehlt an Behandlungsalternativen bei CS
c) ampho b schon einmal zugelassen wurde
Revimmune, BiovaxID und SinuNase, dass nennt man dann wohl multiple shots... und alles bei einer MK von unter 100 Mil. $! Der Rest bei ABPI ist "Kleckerkram".
Grüße!
- SinuNase
Status: Phase III
Gebiet: chronische Nasennebenhöhlenentzündung (CS oder CRS)
Markt: etwa 5-6 Milliarden $
Fazit: Anfang 2008 Ergebnisse der Phase III (schwere CS), dann eine 2. Phase III. Im 4. Quartal 08 wohl die kompletten Ergebnisse (ungefähr 700 Patienten insgesamt)! Ein möglicher Blockbuster für ABPI! Möglicher Verkaufsstart vielleicht bereits im 2H 2008, wahrscheinlicher aber 2009...
- Revimmune
Status: Phase III
Gebiet: Autoimmunerkrankungen
Markt: RIESIG!
Fazit: In etwa 12 Monaten soll es bei der Indikation MS erste Ergebnisse geben. Revimmune baut auf einem zugelassenen Wirkstoff auf. Interessant! Allerdings auch ein hart umkämpfter Markt.
- BiovaxID (über BioVest)
Status: Phase III
Gebiet: follikulärer B-Zell Lymphom
Markt: etwa 2-3 Milliarden $
Fazit: Schwer einzuschätzen. Ergebnisse sehen zwar gut aus, dennoch halte ich einen Erfolg eher für unwahrscheinlich. Beschleunigte Zulassung angestrebt; Anfang, Mitte 2009 möglicher Verkaufsstart.
- Respi-TANN
Status: zugelassen
Gebiet: Hustenmittel
Markt: ?
Fazit: Bei Erkältungen, Grippe, Sinusitis und Brochitis. Nichts weltbewegendes, bringt ein paar Dollars...
- CRS Fungal Profile Test
Status: zugelassen
Gebiet: Pilz Nachweis
Markt: ?
Fazit: Ebenfalls ein paar Dollars...
- MD Turbo
Status: zugelassen
Gebiet: Inhaliergerät
Markt: ? (Umsatz-Ziel für MD Turbo waren 40 Mil. $ Umsatz jährlich)
Fazit: Asthma Hersteller haben ihre Produkte umgestellt, dadurch ist MD Turbo zum "sterben verdammt". Von Respirics vermarktet - haben schon angekündigt Verkauf und Vermarktung einzustellen. Enttäuschend!
- Allernase
Status: Phase III
Gebiet: allergischen Nasenschleimhautentzündungen
Markt: etwa 3 Milliarden $
Fazit: Approval wird 2008 erwartet - Partner ist Collegium Pharmaceutical. Schering, Aventis und AstraZeneca sind dick im Markt vertreten. Wird schwer Markt-Anteile zu ergattern: Nicht (zu)viel erwarten!
- AutovaxID (über BioVest)
Status: zugelassen
Gebiet: Zellwachstum-Gerät
Markt: ?
Fazit: Dass Gerät ist etwa 10x kleiner als vergleichbare seiner Art. Ich denke ganz netter (kleiner) Nebenverdienst für BioVest und ABPI.
- Emezine
Status: Phase III (in der "Schwebe")
Gebiet: Übelkeit / Erbrechen
Markt: ?
Fazit: Dass wird wohl nichts mehr...
Kurzes Fazit:
3 dicke Phase III Trials. Zwei davon in denen auf nähere Zeit eine Entscheidung ansteht. Hauptaugenmerk sollte ein jeder für sich ausmachen, meiner liegt auf SinuNase, da ich denke
a) die Ergebnisse werden gut ausfallen
b) es fehlt an Behandlungsalternativen bei CS
c) ampho b schon einmal zugelassen wurde
Revimmune, BiovaxID und SinuNase, dass nennt man dann wohl multiple shots... und alles bei einer MK von unter 100 Mil. $! Der Rest bei ABPI ist "Kleckerkram".
Grüße!
Hallo Ackergaul,
dein Fazit bezueglich Sinunase wird sich bestaetigen, da die Ergebnisse gut ausgefallen sind!
Gruss
dein Fazit bezueglich Sinunase wird sich bestaetigen, da die Ergebnisse gut ausgefallen sind!
Gruss
Ist leider mal wieder ein wenig viel zu lesen, ABER lohnenswert! Drei ältere Berichte aus ScienceDaily:
Mayo Clinic Study Implicates Fungus as Cause of Chronic Sinusitis
ScienceDaily (Sep. 10, 1999) — "We can now begin to treat the cause of the problem instead of the symptoms"
ROCHESTER, MINN. -- Mayo Clinic researchers say they have found the cause of most chronic sinus infections -- an immune system response to fungus. They say this discovery opens the door to the first effective treatment for this problem, the most common chronic disease in the United States.
An estimated 37 million people in the United States suffer from chronic sinusitis, an inflammation of the membranes of the nose and sinus cavity. Its incidence has been increasing steadily over the last decade. Common symptoms are runny nose, nasal congestion, loss of smell and headaches. Frequently the chronic inflammation leads to polyps, small growths in the nasal passages which hinder breathing.
"Up to now, the cause of chronic sinusitis has not been known," say the Mayo researchers: Drs. David Sherris, Eugene Kern and Jens Ponikau, Mayo Clinic ear, nose and throat specialists. Their report appears in the September issue of the journal Mayo Clinic Proceedings.
"Fungus allergy was thought to be involved in less than ten percent of cases," says Dr. Sherris. "Our studies indicate that, in fact, fungus is likely the cause of nearly all of these problems. And it is not an allergic reaction, but an immune reaction."
The researchers studied 210 patients with chronic sinusitis. Using new methods of collecting and testing mucus from the nose, they discovered fungus in 96 percent of the patients' mucus. They identified a total of 40 different kinds of fungi in these patients, with an average of 2.7 kinds per patient.
In a subset of 101 patients who had surgery to remove nasal polyps, the researchers found eosinophils (a type of white blood cell activated by the body's immune system) in the nasal tissue and mucus of 96 percent of the patients.
The results, the researchers say, clearly portray a disease process in which, in sensitive individuals, the body's immune system sends eosinophils to attack fungi and the eosinophils irritate the membranes in the nose. As long as fungi remain, so will the irritation.
"This is a potential breakthrough that offers great hope for the millions of people who suffer from this problem," says Dr. Kern. "We can now begin to treat the cause of the problem instead of the symptoms."
More research is underway at Mayo Clinic to confirm that the immune response to the fungus is the cause of the sinus inflammation. The researchers are also working with pharmaceutical companies to set up trials to test medications to control the fungus. They estimate that it will be at least two years before a treatment will be widely available.
The researchers distinguish chronic sinusitis -- sinusitis that lasts three months or longer -- from acute sinusitis, which lasts a month or less. They say that the cause of the acute condition is usually a bacterial infection.
Antibiotics and over-the-counter decongestants are widely used to treat chronic sinusitis. In most cases, antibiotics are not effective for chronic sinusitis because they target bacteria, not fungi. The over-the-counter drugs may offer some relief of symptoms, but they have no effect on the inflammation.
"Medications haven't worked for chronic sinusitis because we didn't know what the cause of the problem was," says Dr. Ponikau. "Finally we are on the trail of a treatment that may actually work."
Thousands of kinds of single-cell fungi (molds and yeasts) are found everywhere in the world. Fungal spores (the reproductive part of the organism) become airborne like pollen. Some people develop allergies to fungi. The new evidence from the Mayo study suggests that many people also develop a different kind of immune system response.
Adapted from materials provided by Mayo Clinic.
Researchers Show Chronic Sinusitis Is Immune Disorder; Antifungal Medicine Effective Treatment
ScienceDaily (Mar. 30, 2004) — BUFFALO, N.Y. -- Researchers at the University at Buffalo and the Mayo Clinic have shown that chronic sinusitis is an immune disorder caused by fungus, opening up a promising new avenue for treating this ubiquitous and debilitating condition, for which there is no FDA-approved therapy.
Results of their research suggest that common airborne fungi lodge in the mucus lining of the sinuses in most people, but initiate an immune response only in individuals prone to chronic sinusitis. The immune response causes the fungi to be attacked, which leads to damage of the sinus membranes, resulting in full-blown symptoms.
"We hope this study will lead to the first treatment aimed at the root cause of chronic sinusitis, rather than a treatment just to mask the symptoms," said David A. Sherris, M.D., interim chair of the UB Department of Otolaryngology.
Sherris presented the study findings today (March 23, 2004) at the annual meeting of the American Academy of Allergy, Asthma and Immunology in San Francisco. The research was conducted while Sherris was at the Mayo Clinic.
Through a randomized, placebo-controlled, double-blind pilot trial using the fungicide Amphotericin-B applied intranasally, the researchers found that the treatment group showed a significant decrease in the inflammatory thickening of the sinus membranes compared to the control group.
Inflammation in the mucus also decreased significantly in those receiving the drug, compared to placebo, and 70 percent of patients on the medication had a decrease in the amount of nasal swelling, results showed.
"We showed in 1999 that fungal organisms were present in the mucus of 96 percent of patients who had surgery for chronic sinusitis, and that inflammatory cells were clumped around the fungi, which indicated to us that the condition was an immune disorder caused by fungus, " said Sherris. "But many doctors didn't believe us."
"Next, we conducted various immunologic studies and an open trial using the fungicide treatment and found that 75 percent of patients improved on the new therapy. Now we have similar results from a randomized, blinded trial with a control group, which is the 'gold standard' in drug testing. Our next step is to conduct a multi-center trial using antifungals, which we hope will lead to FDA approval of antifungal treatment for this chronic disease."
Chronic sinusitis, a disease of the nasal passages and the surrounding sinus cavities, is thought to affect 16.8 percent of the adult population of the U.S. It causes long-term nasal congestion, production of thick mucus, loss of sense of smell and creates an environment for opportunistic bacterial infections that exacerbate those symptoms. Sherris said studies have shown that chronic sinusitis exceeds even congestive heart failure in its adverse effects on quality of life.
Little is known about the causes of this disease. Without a specific target for intervention, physicians often simply treated the secondary bacterial infections in hopes of providing a modicum of relief.
The current trial involved 24 patients with chronic sinusitis who were randomly assigned to receive the treatment or a placebo. Neither the patients nor the investigators knew who received the drug or the inactive agent. The final analysis involved data from 10 treatment patients and 14 controls, all of whom were in the trial for six months.
Researchers took CT scans (special x-rays of the sinuses) at baseline and at 6 months. They also graded patients' inflammation by direct exam with an endoscope in the nose at the start of the study, and at 3 and 6 months.
The CT scans showed that the treatment group had a mean 8.8 percent decrease in inflammatory mucus thickening, while the placebo group had an increase of 2.5 percent. Sherris said 70 percent of patients in the treatment group also showed significant improvement when their nasal passages were viewed through an endoscope, while the placebo group showed no change. Markers of inflammation in the mucus also decreased significantly in the treatment group, compared to the placebo group.
Additional researchers on the study, all from the Mayo Clinic, were Jens U. Ponikau, M.D., Amy Weaver, Evangelo Frigas, M.D., and Hirohito Kita, M.D.
The research was supported by grants from the National Institutes of Health and the Mayo Foundation for Education and Research.
The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York.
Adapted from materials provided by University At Buffalo.
Chronic Sinusitis Sufferers Have Enhanced Immune Responses to Fungi
ScienceDaily (Oct. 15, 2004) — October 8, 2004 -- Scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have discovered that people with chronic sinus inflammation have an exaggerated immune response to common airborne fungi. The results of their study appear online today in The Journal of Allergy and Clinical Immunology.
"This study is the first to show a possible immunologic basis for chronic sinusitis, an important starting point to better understand the etiology of the illness," says Marshall Plaut, M.D., chief of NIAID's allergic mechanisms section. Despite the enormous health impact of chronic sinusitis--nearly 30 million people were diagnosed with sinusitis in 2002, according to U.S. Centers for Disease Control and Prevention, and direct costs of the illness exceed $5.6 billion per year--the condition is very poorly understood, he says.
The researchers led by Hirohito Kita, M.D., of the Mayo Clinic in Rochester, MN, compared blood samples taken from 18 people diagnosed with chronic sinusitis with blood samples from 15 healthy volunteers. Nasal secretions from the two groups were also examined for the presence of fungal proteins and inflammation-causing immune system molecules.
Airborne microscopic fungi spores abound indoors and out. People may inhale a million or more fungal spores each day, notes Dr. Kita. The mere presence of such fungi in the airways, however, is not enough to cause sinusitis because these spores can be found in the upper respiratory tracts of both sinusitis sufferers and non-sufferers. Indeed, in this study, levels of fungal proteins in nasal secretions were similar in both groups.
The Mayo Clinic scientists looked for evidence that people with sinusitis respond abnormally to these harmless fungi. The investigators exposed immune cells derived from the blood samples to extracts of four common airborne fungi: Alternaria, Aspergillus, Penicillium and Cladosporium. The cells of chronic sinusitis sufferers released significant amounts of three immune-modulating chemicals, called cytokines, specifically interferon-gamma, interleukin-5 (IL-5) and IL-13. In contrast, cells from healthy volunteers released very little interferon-gamma and no IL-5 or IL-13. The most dramatic responses occurred after exposure to Alternaria.
Importantly, says Dr. Kita, the released cytokines represent both major classes of cytokines--interferon-gamma is in the Th1 group and IL-5 and IL-13 are in the Th2 class. This is notable because scientists have thought that allergic reactions involve only Th2 cytokines, Dr. Kita explains. (While chronic sinusitis is not considered to be an allergic disease, people with the condition also often have asthma and allergic rhinitis, giving scientists reason to suspect a link.) The current findings add to an evolving understanding of allergic diseases that suggests symptoms may stem from a combination of Th1 and Th2 cytokines.
The combined effect of excess Th2 and Th1 cytokines released in the presence of fungi may explain a number of chronic sinusitis symptoms, including persistent inflammation of sinus and nasal mucous passages, say the scientists.
Previously, Mayo clinic scientists used intranasal antifungal agents to successfully treat patients with chronic sinusitis. While those studies generated controversy, in part because other researchers were unable to replicate the findings, Dr. Kita says today's report supports the rationale of treating chronic sinusitis with antifungals. Clinical trials to further test antifungal therapy for chronic sinusitis are being planned, adds Dr. Kita.
###
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
Reference: S-H Shin et al. Chronic rhinosinusitis: An enhanced immune response to ubiquitous airborne fungi. The Journal of Allergy and Clinical Immunology. Published online Oct. 8, 2004. doi: 10.1016/j.jaci.2004.06.012.
Adapted from materials provided by NIH/National Institute Of Allergy And Infectious Diseases.
Mayo Clinic Study Implicates Fungus as Cause of Chronic Sinusitis
ScienceDaily (Sep. 10, 1999) — "We can now begin to treat the cause of the problem instead of the symptoms"
ROCHESTER, MINN. -- Mayo Clinic researchers say they have found the cause of most chronic sinus infections -- an immune system response to fungus. They say this discovery opens the door to the first effective treatment for this problem, the most common chronic disease in the United States.
An estimated 37 million people in the United States suffer from chronic sinusitis, an inflammation of the membranes of the nose and sinus cavity. Its incidence has been increasing steadily over the last decade. Common symptoms are runny nose, nasal congestion, loss of smell and headaches. Frequently the chronic inflammation leads to polyps, small growths in the nasal passages which hinder breathing.
"Up to now, the cause of chronic sinusitis has not been known," say the Mayo researchers: Drs. David Sherris, Eugene Kern and Jens Ponikau, Mayo Clinic ear, nose and throat specialists. Their report appears in the September issue of the journal Mayo Clinic Proceedings.
"Fungus allergy was thought to be involved in less than ten percent of cases," says Dr. Sherris. "Our studies indicate that, in fact, fungus is likely the cause of nearly all of these problems. And it is not an allergic reaction, but an immune reaction."
The researchers studied 210 patients with chronic sinusitis. Using new methods of collecting and testing mucus from the nose, they discovered fungus in 96 percent of the patients' mucus. They identified a total of 40 different kinds of fungi in these patients, with an average of 2.7 kinds per patient.
In a subset of 101 patients who had surgery to remove nasal polyps, the researchers found eosinophils (a type of white blood cell activated by the body's immune system) in the nasal tissue and mucus of 96 percent of the patients.
The results, the researchers say, clearly portray a disease process in which, in sensitive individuals, the body's immune system sends eosinophils to attack fungi and the eosinophils irritate the membranes in the nose. As long as fungi remain, so will the irritation.
"This is a potential breakthrough that offers great hope for the millions of people who suffer from this problem," says Dr. Kern. "We can now begin to treat the cause of the problem instead of the symptoms."
More research is underway at Mayo Clinic to confirm that the immune response to the fungus is the cause of the sinus inflammation. The researchers are also working with pharmaceutical companies to set up trials to test medications to control the fungus. They estimate that it will be at least two years before a treatment will be widely available.
The researchers distinguish chronic sinusitis -- sinusitis that lasts three months or longer -- from acute sinusitis, which lasts a month or less. They say that the cause of the acute condition is usually a bacterial infection.
Antibiotics and over-the-counter decongestants are widely used to treat chronic sinusitis. In most cases, antibiotics are not effective for chronic sinusitis because they target bacteria, not fungi. The over-the-counter drugs may offer some relief of symptoms, but they have no effect on the inflammation.
"Medications haven't worked for chronic sinusitis because we didn't know what the cause of the problem was," says Dr. Ponikau. "Finally we are on the trail of a treatment that may actually work."
Thousands of kinds of single-cell fungi (molds and yeasts) are found everywhere in the world. Fungal spores (the reproductive part of the organism) become airborne like pollen. Some people develop allergies to fungi. The new evidence from the Mayo study suggests that many people also develop a different kind of immune system response.
Adapted from materials provided by Mayo Clinic.
Researchers Show Chronic Sinusitis Is Immune Disorder; Antifungal Medicine Effective Treatment
ScienceDaily (Mar. 30, 2004) — BUFFALO, N.Y. -- Researchers at the University at Buffalo and the Mayo Clinic have shown that chronic sinusitis is an immune disorder caused by fungus, opening up a promising new avenue for treating this ubiquitous and debilitating condition, for which there is no FDA-approved therapy.
Results of their research suggest that common airborne fungi lodge in the mucus lining of the sinuses in most people, but initiate an immune response only in individuals prone to chronic sinusitis. The immune response causes the fungi to be attacked, which leads to damage of the sinus membranes, resulting in full-blown symptoms.
"We hope this study will lead to the first treatment aimed at the root cause of chronic sinusitis, rather than a treatment just to mask the symptoms," said David A. Sherris, M.D., interim chair of the UB Department of Otolaryngology.
Sherris presented the study findings today (March 23, 2004) at the annual meeting of the American Academy of Allergy, Asthma and Immunology in San Francisco. The research was conducted while Sherris was at the Mayo Clinic.
Through a randomized, placebo-controlled, double-blind pilot trial using the fungicide Amphotericin-B applied intranasally, the researchers found that the treatment group showed a significant decrease in the inflammatory thickening of the sinus membranes compared to the control group.
Inflammation in the mucus also decreased significantly in those receiving the drug, compared to placebo, and 70 percent of patients on the medication had a decrease in the amount of nasal swelling, results showed.
"We showed in 1999 that fungal organisms were present in the mucus of 96 percent of patients who had surgery for chronic sinusitis, and that inflammatory cells were clumped around the fungi, which indicated to us that the condition was an immune disorder caused by fungus, " said Sherris. "But many doctors didn't believe us."
"Next, we conducted various immunologic studies and an open trial using the fungicide treatment and found that 75 percent of patients improved on the new therapy. Now we have similar results from a randomized, blinded trial with a control group, which is the 'gold standard' in drug testing. Our next step is to conduct a multi-center trial using antifungals, which we hope will lead to FDA approval of antifungal treatment for this chronic disease."
Chronic sinusitis, a disease of the nasal passages and the surrounding sinus cavities, is thought to affect 16.8 percent of the adult population of the U.S. It causes long-term nasal congestion, production of thick mucus, loss of sense of smell and creates an environment for opportunistic bacterial infections that exacerbate those symptoms. Sherris said studies have shown that chronic sinusitis exceeds even congestive heart failure in its adverse effects on quality of life.
Little is known about the causes of this disease. Without a specific target for intervention, physicians often simply treated the secondary bacterial infections in hopes of providing a modicum of relief.
The current trial involved 24 patients with chronic sinusitis who were randomly assigned to receive the treatment or a placebo. Neither the patients nor the investigators knew who received the drug or the inactive agent. The final analysis involved data from 10 treatment patients and 14 controls, all of whom were in the trial for six months.
Researchers took CT scans (special x-rays of the sinuses) at baseline and at 6 months. They also graded patients' inflammation by direct exam with an endoscope in the nose at the start of the study, and at 3 and 6 months.
The CT scans showed that the treatment group had a mean 8.8 percent decrease in inflammatory mucus thickening, while the placebo group had an increase of 2.5 percent. Sherris said 70 percent of patients in the treatment group also showed significant improvement when their nasal passages were viewed through an endoscope, while the placebo group showed no change. Markers of inflammation in the mucus also decreased significantly in the treatment group, compared to the placebo group.
Additional researchers on the study, all from the Mayo Clinic, were Jens U. Ponikau, M.D., Amy Weaver, Evangelo Frigas, M.D., and Hirohito Kita, M.D.
The research was supported by grants from the National Institutes of Health and the Mayo Foundation for Education and Research.
The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York.
Adapted from materials provided by University At Buffalo.
Chronic Sinusitis Sufferers Have Enhanced Immune Responses to Fungi
ScienceDaily (Oct. 15, 2004) — October 8, 2004 -- Scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have discovered that people with chronic sinus inflammation have an exaggerated immune response to common airborne fungi. The results of their study appear online today in The Journal of Allergy and Clinical Immunology.
"This study is the first to show a possible immunologic basis for chronic sinusitis, an important starting point to better understand the etiology of the illness," says Marshall Plaut, M.D., chief of NIAID's allergic mechanisms section. Despite the enormous health impact of chronic sinusitis--nearly 30 million people were diagnosed with sinusitis in 2002, according to U.S. Centers for Disease Control and Prevention, and direct costs of the illness exceed $5.6 billion per year--the condition is very poorly understood, he says.
The researchers led by Hirohito Kita, M.D., of the Mayo Clinic in Rochester, MN, compared blood samples taken from 18 people diagnosed with chronic sinusitis with blood samples from 15 healthy volunteers. Nasal secretions from the two groups were also examined for the presence of fungal proteins and inflammation-causing immune system molecules.
Airborne microscopic fungi spores abound indoors and out. People may inhale a million or more fungal spores each day, notes Dr. Kita. The mere presence of such fungi in the airways, however, is not enough to cause sinusitis because these spores can be found in the upper respiratory tracts of both sinusitis sufferers and non-sufferers. Indeed, in this study, levels of fungal proteins in nasal secretions were similar in both groups.
The Mayo Clinic scientists looked for evidence that people with sinusitis respond abnormally to these harmless fungi. The investigators exposed immune cells derived from the blood samples to extracts of four common airborne fungi: Alternaria, Aspergillus, Penicillium and Cladosporium. The cells of chronic sinusitis sufferers released significant amounts of three immune-modulating chemicals, called cytokines, specifically interferon-gamma, interleukin-5 (IL-5) and IL-13. In contrast, cells from healthy volunteers released very little interferon-gamma and no IL-5 or IL-13. The most dramatic responses occurred after exposure to Alternaria.
Importantly, says Dr. Kita, the released cytokines represent both major classes of cytokines--interferon-gamma is in the Th1 group and IL-5 and IL-13 are in the Th2 class. This is notable because scientists have thought that allergic reactions involve only Th2 cytokines, Dr. Kita explains. (While chronic sinusitis is not considered to be an allergic disease, people with the condition also often have asthma and allergic rhinitis, giving scientists reason to suspect a link.) The current findings add to an evolving understanding of allergic diseases that suggests symptoms may stem from a combination of Th1 and Th2 cytokines.
The combined effect of excess Th2 and Th1 cytokines released in the presence of fungi may explain a number of chronic sinusitis symptoms, including persistent inflammation of sinus and nasal mucous passages, say the scientists.
Previously, Mayo clinic scientists used intranasal antifungal agents to successfully treat patients with chronic sinusitis. While those studies generated controversy, in part because other researchers were unable to replicate the findings, Dr. Kita says today's report supports the rationale of treating chronic sinusitis with antifungals. Clinical trials to further test antifungal therapy for chronic sinusitis are being planned, adds Dr. Kita.
###
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
Reference: S-H Shin et al. Chronic rhinosinusitis: An enhanced immune response to ubiquitous airborne fungi. The Journal of Allergy and Clinical Immunology. Published online Oct. 8, 2004. doi: 10.1016/j.jaci.2004.06.012.
Adapted from materials provided by NIH/National Institute Of Allergy And Infectious Diseases.
Hallo Ackergaul,
was hast du fuer ein Gefuehl, nach Mitteilung des CEO ueber die
positiven Ergebnisse in der naechsten Woche, wohin der Kurs gehen koennte?
was hast du fuer ein Gefuehl, nach Mitteilung des CEO ueber die
positiven Ergebnisse in der naechsten Woche, wohin der Kurs gehen koennte?
Antwort auf Beitrag Nr.: 32.252.240 von SunnyOst am 02.11.07 11:51:34Mahlzeit SunnyOst,
Man sollte wirklich vorsichtig damit sein, das Fell des Bären zu verteilen, bevor er erlegt worden ist, darum bitte ich bereits jetzt um Nachsicht:
Ich gehe davon aus, das BioaxID NICHT zugelassen wird, Revimmune könnte frühestens 2010 / 2011 verkauft werden, somit lasse ich auch Revimmune außen vor.
2009:
Ich gehe von einem späten Verkaufsstart in 2009 für SinuNase aus, schätze dann etwa 60.000 Patienten (wären dann 0,19 % ALLER CS Patinten). Behandlungskosten pro Patient 200 $ monatlich - grob 2.500 $ im Jahr würden dann 150 Mil. $ Umsatz bedeuten. 15 % Herstellungskosten, 16 % Royalities für Mayo und jeweils 7 % für PPDI und BDSI - somit blieben ABPI "nur" noch etwa 86 Mil. vom Kuchen. Jeweils ca 32 Mil. $ für G&A sowie S&M und nochmals 16 Mil für R&D - blieben nur noch 6 Mil. $ übrig...
Nach Steuern (?) dann vielleicht 4,5 Mil. bei 2009 geschätzten 50 Mil. Aktien im Umlauf also gut 10 Cent pro Aktie!
2010:
145.000 SinuNase Patienten (unterm Strich dann 208 Mil. $ Einnahmen an SinuNase). Die Ausgaben dürften sich auf 120 bis 130 mil. $ belaufen. Nach Steuern vielleicht ein Gewinn von 1,1 bis 1,2 $ möglich. Dass heißt bei einem 20er KGV Kurse über 20 $ möglich.
Ich habe ohne einen weitern Lizenz Partner gerechnet, dieser wird aber kommen, genauso wie einer für den Rest Of the World... Also sollte man ein paar Prozente noch von den SinuNase Umsätzen abziehen, dafür wird die Cash Position von ABPI wohl in näherer Zukunft gestärkt!
Der Haken ist, wieviele Patienten sind wahrscheinlich? Analyst Jeffries rechnet mit 140.000 in 2009 jährlich 30 % steigend. Rodman & Renshaw rechnen mit ähnlichen Zahlen, wenn nicht höher. Beide haben etwa 8 $ Kursziele ausgegeben.
Ist nur ein Szenario, ein anderes wäre, dass ABPI morgen Insolvenz anmeldet oder etwa die FDA sagt "wir haben kein Bock auf SinuNase". Ich tendiere momentan noch zum oben beschriebenen.
Grüße
Man sollte wirklich vorsichtig damit sein, das Fell des Bären zu verteilen, bevor er erlegt worden ist, darum bitte ich bereits jetzt um Nachsicht:
Ich gehe davon aus, das BioaxID NICHT zugelassen wird, Revimmune könnte frühestens 2010 / 2011 verkauft werden, somit lasse ich auch Revimmune außen vor.
2009:
Ich gehe von einem späten Verkaufsstart in 2009 für SinuNase aus, schätze dann etwa 60.000 Patienten (wären dann 0,19 % ALLER CS Patinten). Behandlungskosten pro Patient 200 $ monatlich - grob 2.500 $ im Jahr würden dann 150 Mil. $ Umsatz bedeuten. 15 % Herstellungskosten, 16 % Royalities für Mayo und jeweils 7 % für PPDI und BDSI - somit blieben ABPI "nur" noch etwa 86 Mil. vom Kuchen. Jeweils ca 32 Mil. $ für G&A sowie S&M und nochmals 16 Mil für R&D - blieben nur noch 6 Mil. $ übrig...
Nach Steuern (?) dann vielleicht 4,5 Mil. bei 2009 geschätzten 50 Mil. Aktien im Umlauf also gut 10 Cent pro Aktie!
2010:
145.000 SinuNase Patienten (unterm Strich dann 208 Mil. $ Einnahmen an SinuNase). Die Ausgaben dürften sich auf 120 bis 130 mil. $ belaufen. Nach Steuern vielleicht ein Gewinn von 1,1 bis 1,2 $ möglich. Dass heißt bei einem 20er KGV Kurse über 20 $ möglich.
Ich habe ohne einen weitern Lizenz Partner gerechnet, dieser wird aber kommen, genauso wie einer für den Rest Of the World... Also sollte man ein paar Prozente noch von den SinuNase Umsätzen abziehen, dafür wird die Cash Position von ABPI wohl in näherer Zukunft gestärkt!
Der Haken ist, wieviele Patienten sind wahrscheinlich? Analyst Jeffries rechnet mit 140.000 in 2009 jährlich 30 % steigend. Rodman & Renshaw rechnen mit ähnlichen Zahlen, wenn nicht höher. Beide haben etwa 8 $ Kursziele ausgegeben.
Ist nur ein Szenario, ein anderes wäre, dass ABPI morgen Insolvenz anmeldet oder etwa die FDA sagt "wir haben kein Bock auf SinuNase". Ich tendiere momentan noch zum oben beschriebenen.
Grüße
Antwort auf Beitrag Nr.: 32.254.086 von Ackergaul am 02.11.07 13:18:25Danke fuer dein Statement.
Schoenes Wochenende.
Schoenes Wochenende.
ich glaube BiovaxID hätte die besseren chancen auf eine zulassung, da da jetzt seit 9 jahren oder so die trials laufen. das problem bei biovest ist, dass sie so gut wie alle mitarbeiter entlassen haben und quasi nur noch ein paarhunderttausend dollar cash besitzen. von den banken bekommt biovest nichts mehr, jetzt springen die boardmembers ein.
bei sinunase muss man einfach warten was die testergebnisse anfang februar zeigen. wenns gut läuft, könnte hier bereits die big pharma zuschlagen.
teamm kannst du total vergessen, das ist ein zusammenrationalisierter laden von schwachköpfen (vgl. cafepharma.com board: teamm), der an notorischer geldknappheit leidet.
das größte problem bei abpi und allem was da dranhängt ist die schlechste cash-situation, die vorallem darin begründet ist, dass das ipo in 2005 nicht zu 14 $ per share durchgezogen werden konnte, sondern irgendwo bei 6-8 $. dadurch musste man ein paar unvorteilhafte kapitalerhöhungen durchziehen und mdturbo zu grabe tragen. durch die geldknappheit haben sich meiner meinung nach die patientenaushebungen für das phase III trial von sinunase rausgezögert und biovaxID quasi auf eis gelegt. denn in den risk-beschreibungen in den sec-fillings geht klar hervor, dass man lieber biovaxID sterben lassen würde als sinunase aufzugeben.
bei sinunase muss man einfach warten was die testergebnisse anfang februar zeigen. wenns gut läuft, könnte hier bereits die big pharma zuschlagen.
teamm kannst du total vergessen, das ist ein zusammenrationalisierter laden von schwachköpfen (vgl. cafepharma.com board: teamm), der an notorischer geldknappheit leidet.
das größte problem bei abpi und allem was da dranhängt ist die schlechste cash-situation, die vorallem darin begründet ist, dass das ipo in 2005 nicht zu 14 $ per share durchgezogen werden konnte, sondern irgendwo bei 6-8 $. dadurch musste man ein paar unvorteilhafte kapitalerhöhungen durchziehen und mdturbo zu grabe tragen. durch die geldknappheit haben sich meiner meinung nach die patientenaushebungen für das phase III trial von sinunase rausgezögert und biovaxID quasi auf eis gelegt. denn in den risk-beschreibungen in den sec-fillings geht klar hervor, dass man lieber biovaxID sterben lassen würde als sinunase aufzugeben.
Antwort auf Beitrag Nr.: 32.266.483 von Thismeanswar am 03.11.07 16:08:01Moin Thismeanswar,
BiovaxiD soll an Hand des molekular nachweisbaren Ansprechens zugelassen werden (zumindest ist dass acclerated approval darauf ausgerichtet). Ich denke, dass die FDA aber die pfs und os Zeiten noch sehen will - und dass sehe ich als Knackpunkt an. Glaube dass Favrille mit seinem Vaccine bessere Chancen auf Zulassung hat...
Cash - ist ein großes Problem! Ich würde sagen, dass das alles Finanzhaie sind bei denen sich ABPI zur Zeit die liquiden Mittel besorgt. Obwohl ich die Konditionen noch "tragbar" finde... Warum ABPI zu diesem kritischen Zeitpunkt nun Revimmune in Phase III startet, würde ich mit SEHR optimistisch einstufen.
Zu SinuNase: Ich gehe davon aus, dass die Ergebnisse hervoragend werden! Zwei Bedenken jedoch: Der Lizenzpartner von ABPI wird ein NoName Pharma (sowas wie Respirics...) oder es werden letztendlich nicht so viele Patienten mit SinuNase behandelt (wie ich z.B. geschätzt habe - auch auf Grund des Preises).
Grüße
BiovaxiD soll an Hand des molekular nachweisbaren Ansprechens zugelassen werden (zumindest ist dass acclerated approval darauf ausgerichtet). Ich denke, dass die FDA aber die pfs und os Zeiten noch sehen will - und dass sehe ich als Knackpunkt an. Glaube dass Favrille mit seinem Vaccine bessere Chancen auf Zulassung hat...
Cash - ist ein großes Problem! Ich würde sagen, dass das alles Finanzhaie sind bei denen sich ABPI zur Zeit die liquiden Mittel besorgt. Obwohl ich die Konditionen noch "tragbar" finde... Warum ABPI zu diesem kritischen Zeitpunkt nun Revimmune in Phase III startet, würde ich mit SEHR optimistisch einstufen.
Zu SinuNase: Ich gehe davon aus, dass die Ergebnisse hervoragend werden! Zwei Bedenken jedoch: Der Lizenzpartner von ABPI wird ein NoName Pharma (sowas wie Respirics...) oder es werden letztendlich nicht so viele Patienten mit SinuNase behandelt (wie ich z.B. geschätzt habe - auch auf Grund des Preises).
Grüße
Antwort auf Beitrag Nr.: 32.273.662 von Ackergaul am 04.11.07 11:37:55Am Freitag gab es noch Meldungen bezüglich der Finanzseite (ABPI & BVTI)
ABPI:
Entry into a Material Definitive Agreement, Creation of a Direct
Item 1.01. Entry Into a Material Definitive Agreement.
On October 30, 2007, Accentia Biopharmaceuticals, Inc. (the "Company") entered into an amendment to its revolving credit facility with Laurus Master Fund, Ltd. ("Laurus") to extend the Company's access to its expanded borrowing availability under this revolving credit facility through March 31, 2008. In consideration of the extension, the Company issued to Laurus a redeemable warrant to purchase up to 4,024,398 shares with an exercise price of $2.67 per share until October 31, 2014 with piggy back registration rights. The Company has the right to terminate and cancel the warrant by making a cash payment in an amount equal to $0.99 for each share underlying the warrant. The Company's right to terminate and cancel the Warrant expires on the earlier of April 30, 2008 or the date of public release of unblinded clinical trial data from the current Phase 3 clinical trial of SinuNase™. The terms of the amendment and warrant are set forth in Exhibits 10.1 and 10.2 respectively to this Current Report on Form 8-K.
On October 31, 2007, the Company and holders of 84% of the 8% Convertible Debenture Financing dated September 29, 2006 (the "September Debentures") agreed to defer required monthly redemption payments under the September Debentures from November 1, 2007 through May 1, 2008 and to allow any unconverted balance of those amounts to be redeemed on the Maturity Date of the September Debentures.
On October 31, 2007, the Company executed a Subordination Agreement in favor of Valens U.S. SPV I, LLC and Valens Offshore SPV II, Corp. in connection with a financing transaction closed by the Company's majority-owned subsidiary, Biovest International, Inc. ("Biovest"). The details of this financing transaction are set forth in the text of the Current Report on Form 8-K filed by Biovest on November 2, 2007, which is attached as Exhibit 99.1 hereto.
On November 2, 2007, Biovest entered into a Forbearance Agreement (the "Forbearance") with Laurus Master Fund, Ltd. ("Laurus"), formalizing certain understandings previously reached by Laurus and Biovest with respect to Biovest's existing Promissory Note to Laurus dated March 31, 2006 (the "Note"). The details of the Forbearance are included in the Form 8-K, which was filed on November 2, 2007 by Biovest with the SEC which is attached as Exhibit 99.1.
The offers and sales of securities in the transactions described hereinabove were made pursuant to the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended, including pursuant to Rule 506 and/or Rule 144A thereunder. Such offers and sales were made solely to "accredited investors" under Rule 506 and/or "qualified institutional buyers" under Rule 144A and were made without any form of general solicitation and with full access to any information requested by the investors regarding the Company or the securities offered in these transactions.
Zu Laurus:
http://www.laurusfunds.com/test/laurus_SelectedInvestments_G…
BVTI:
Entry into a Material Definitive Agreement, Creation of a Direct Financ
Item 1.01. Entry Into a Material Definitive Agreement.
On October 30, 2007, Biovest International, Inc., a Delaware corporation (the "Company"), completed the closing of a financing transaction (the "Transaction") with Valens Offshore SPV II, Corp., a Delaware corporation and Valens U.S. SPV I, LLC., a Delaware corporation (collectively "Valens"), pursuant to which Valens purchased from the Company two secured promissory notes in the aggregate principal amount of $500,000 (the "Notes") and entered into two royalty agreements (the "Royalty Agreements") whereby Valens has been granted royalty interests in the worldwide net sales and license revenues from the Company's BiovaxID™ anti-cancer vaccine.
The Notes were purchased pursuant to Note Purchase Agreements between the Company and Valens (the "Purchase Agreement"). The following describes certain material terms of the Transaction:
• The Notes are non-amortizing and payable in a single payment of principal plus accrued interest at maturity.
• The Notes will become due and payable on March 31, 2009. The Notes can be prepaid by the Company at any time without penalty.
• The outstanding principal amount of the Notes will bear interest at a rate equal to prime rate plus 2% per annum. In addition to the interest on the Notes, the Company paid Valens a closing payment in the amount of $17,500 upon the closing of the Transaction. The obligations pursuant to the Notes are secured by a lien against all assets of the Company.
• The Royalty Agreements provide that Valens shall receive an aggregate royalty equal to two percent (2%) of the Company's direct worldwide net sales of biologic products and of license revenues from commercial sales of the Company's biologic products, including without limitation the Company's BiovaxID™ anti-cancer vaccine.
Additionally, on October 31, 2007 the Company issued to Pulaski Bank & Trust Company, St. Louis ("Pulaski") a Warrant to purchase 45,218 shares of the Company's Common Stock at a purchase price of $1.10 per share, exercisable immediately with a five-year term. This Warrant was issued in connection with the Company's confirmation of the extension of the maturity date of the Promissory Note to Pulaski dated April 22, 2007 in the principal amount of $750,000 through October 21, 2007. The Company did not make payment on the maturity date; however, no demand for payment has been made in connection with this Promissory Note.
On November 2, 2007, Biovest entered into a Forbearance Agreement (the "Forbearance") with Laurus Master Fund, Ltd. ("Laurus"), formalizing the understandings previously reached by Laurus and Biovest with respect to Biovest's Promissory Note to Laurus dated March 31, 2006 (the "Note") with current outstanding principal balance of $7,195,613. The Forbearance confirms that no Event of Default currently exists under the Note, and defers all payments of principal and interest due for the period of
March, 2007 through December 31, 2007 until the earlier of a closing of a financing with defined level of proceeds or at the Maturity Date of the Note. In consideration for the Forbearance Biovest has agreed to pay to Laurus the additional sum of approximately $1.7 million payable at the Maturity Date of the Note.
Each of the notes and securities described above were issued by the Company as described above in transactions that were exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), by virtue of
Section 4(2) of the Securities Act and by virtue of Rule 506 of Regulation D under the Securities Act. Such sale and issuance did not involve any public offering, was made without general solicitation or advertising, and all parties to the transactions are accredited investors with access to all relevant information necessary to evaluate the investment and represented to us that the Notes and Common Stock were being acquired for investment.
Also: Biovest hat Valens Royalities von BiovaxID zugesichert...
ABPI:
Entry into a Material Definitive Agreement, Creation of a Direct
Item 1.01. Entry Into a Material Definitive Agreement.
On October 30, 2007, Accentia Biopharmaceuticals, Inc. (the "Company") entered into an amendment to its revolving credit facility with Laurus Master Fund, Ltd. ("Laurus") to extend the Company's access to its expanded borrowing availability under this revolving credit facility through March 31, 2008. In consideration of the extension, the Company issued to Laurus a redeemable warrant to purchase up to 4,024,398 shares with an exercise price of $2.67 per share until October 31, 2014 with piggy back registration rights. The Company has the right to terminate and cancel the warrant by making a cash payment in an amount equal to $0.99 for each share underlying the warrant. The Company's right to terminate and cancel the Warrant expires on the earlier of April 30, 2008 or the date of public release of unblinded clinical trial data from the current Phase 3 clinical trial of SinuNase™. The terms of the amendment and warrant are set forth in Exhibits 10.1 and 10.2 respectively to this Current Report on Form 8-K.
On October 31, 2007, the Company and holders of 84% of the 8% Convertible Debenture Financing dated September 29, 2006 (the "September Debentures") agreed to defer required monthly redemption payments under the September Debentures from November 1, 2007 through May 1, 2008 and to allow any unconverted balance of those amounts to be redeemed on the Maturity Date of the September Debentures.
On October 31, 2007, the Company executed a Subordination Agreement in favor of Valens U.S. SPV I, LLC and Valens Offshore SPV II, Corp. in connection with a financing transaction closed by the Company's majority-owned subsidiary, Biovest International, Inc. ("Biovest"). The details of this financing transaction are set forth in the text of the Current Report on Form 8-K filed by Biovest on November 2, 2007, which is attached as Exhibit 99.1 hereto.
On November 2, 2007, Biovest entered into a Forbearance Agreement (the "Forbearance") with Laurus Master Fund, Ltd. ("Laurus"), formalizing certain understandings previously reached by Laurus and Biovest with respect to Biovest's existing Promissory Note to Laurus dated March 31, 2006 (the "Note"). The details of the Forbearance are included in the Form 8-K, which was filed on November 2, 2007 by Biovest with the SEC which is attached as Exhibit 99.1.
The offers and sales of securities in the transactions described hereinabove were made pursuant to the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended, including pursuant to Rule 506 and/or Rule 144A thereunder. Such offers and sales were made solely to "accredited investors" under Rule 506 and/or "qualified institutional buyers" under Rule 144A and were made without any form of general solicitation and with full access to any information requested by the investors regarding the Company or the securities offered in these transactions.
Zu Laurus:
http://www.laurusfunds.com/test/laurus_SelectedInvestments_G…
BVTI:
Entry into a Material Definitive Agreement, Creation of a Direct Financ
Item 1.01. Entry Into a Material Definitive Agreement.
On October 30, 2007, Biovest International, Inc., a Delaware corporation (the "Company"), completed the closing of a financing transaction (the "Transaction") with Valens Offshore SPV II, Corp., a Delaware corporation and Valens U.S. SPV I, LLC., a Delaware corporation (collectively "Valens"), pursuant to which Valens purchased from the Company two secured promissory notes in the aggregate principal amount of $500,000 (the "Notes") and entered into two royalty agreements (the "Royalty Agreements") whereby Valens has been granted royalty interests in the worldwide net sales and license revenues from the Company's BiovaxID™ anti-cancer vaccine.
The Notes were purchased pursuant to Note Purchase Agreements between the Company and Valens (the "Purchase Agreement"). The following describes certain material terms of the Transaction:
• The Notes are non-amortizing and payable in a single payment of principal plus accrued interest at maturity.
• The Notes will become due and payable on March 31, 2009. The Notes can be prepaid by the Company at any time without penalty.
• The outstanding principal amount of the Notes will bear interest at a rate equal to prime rate plus 2% per annum. In addition to the interest on the Notes, the Company paid Valens a closing payment in the amount of $17,500 upon the closing of the Transaction. The obligations pursuant to the Notes are secured by a lien against all assets of the Company.
• The Royalty Agreements provide that Valens shall receive an aggregate royalty equal to two percent (2%) of the Company's direct worldwide net sales of biologic products and of license revenues from commercial sales of the Company's biologic products, including without limitation the Company's BiovaxID™ anti-cancer vaccine.
Additionally, on October 31, 2007 the Company issued to Pulaski Bank & Trust Company, St. Louis ("Pulaski") a Warrant to purchase 45,218 shares of the Company's Common Stock at a purchase price of $1.10 per share, exercisable immediately with a five-year term. This Warrant was issued in connection with the Company's confirmation of the extension of the maturity date of the Promissory Note to Pulaski dated April 22, 2007 in the principal amount of $750,000 through October 21, 2007. The Company did not make payment on the maturity date; however, no demand for payment has been made in connection with this Promissory Note.
On November 2, 2007, Biovest entered into a Forbearance Agreement (the "Forbearance") with Laurus Master Fund, Ltd. ("Laurus"), formalizing the understandings previously reached by Laurus and Biovest with respect to Biovest's Promissory Note to Laurus dated March 31, 2006 (the "Note") with current outstanding principal balance of $7,195,613. The Forbearance confirms that no Event of Default currently exists under the Note, and defers all payments of principal and interest due for the period of
March, 2007 through December 31, 2007 until the earlier of a closing of a financing with defined level of proceeds or at the Maturity Date of the Note. In consideration for the Forbearance Biovest has agreed to pay to Laurus the additional sum of approximately $1.7 million payable at the Maturity Date of the Note.
Each of the notes and securities described above were issued by the Company as described above in transactions that were exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), by virtue of
Section 4(2) of the Securities Act and by virtue of Rule 506 of Regulation D under the Securities Act. Such sale and issuance did not involve any public offering, was made without general solicitation or advertising, and all parties to the transactions are accredited investors with access to all relevant information necessary to evaluate the investment and represented to us that the Notes and Common Stock were being acquired for investment.
Also: Biovest hat Valens Royalities von BiovaxID zugesichert...
Public release date: 10-Sep-2007
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Contact: Adam Holdsworth
aholdsworth@investorrelationsgroup.com
212-825-3210
The Investor Relations Group
SinuNase Phase 3 show almost 100 percent of chronic sinusitis cases are from fungal-induced inflamma
Results identify a market potential of over 60 million patients in the US and EU for SinuNase
TAMPA, Fla.—September 10, 2007--Accentia Biopharmaceuticals (NASDAQ: ABPI) announces evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company’s ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase™, an intranasal formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical trial, patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy findings, and CT scan demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment, all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly support a fungal-induced inflammation as the cause of CS.
SinuTest™, the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase, assuming FDA approval.
As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNase, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS.
[ Print Article | E-mail Article | Close Window ]
Contact: Adam Holdsworth
aholdsworth@investorrelationsgroup.com
212-825-3210
The Investor Relations Group
SinuNase Phase 3 show almost 100 percent of chronic sinusitis cases are from fungal-induced inflamma
Results identify a market potential of over 60 million patients in the US and EU for SinuNase
TAMPA, Fla.—September 10, 2007--Accentia Biopharmaceuticals (NASDAQ: ABPI) announces evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company’s ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase™, an intranasal formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical trial, patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy findings, and CT scan demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment, all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly support a fungal-induced inflammation as the cause of CS.
SinuTest™, the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase, assuming FDA approval.
As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNase, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS.
Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS.
Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS.
Bericht zu Revimmune, von Kerr (MD, PhD) und Kaplin (MD, PhD) (beide von der Johns Hopkins):
http://www.accentia.net/revimmune/Revimmune_spec_pharma-3.pd…
Hört sich erst einmal nicht schlecht an:
Two published studies of Revimmune in 20 MS patients found a reduction or elimination of new and enhancing lesions in all patients. Furthermore, no patient experienced a clinical exacerbation following treatment, and most showed reductions or stabilization of clinical markers for the disease. In clinical studies, the drug regimen improves function in most patients and stops progression in over 90% of cases refractory to standard therapies.
Natürlich müssen solche Ergebnisse in der Phase III bestätigt werden (eben auch die Bedenken, die ich bei BiovaxID habe). 12 Monate dauert etwa die Studie, zwischendurch mit Sicherheit Wasserstandsmeldungen, ob Revimmune sicher und wirksam ist.
Schon irgendwie bewundernswert wie und woher ABPI Ihre Pipeline auffüllt:
SinuNase - Mayo Clinic
BiovaxID - National Cancer Institute
Revimmune - Johns Hopkins University
http://www.accentia.net/revimmune/Revimmune_spec_pharma-3.pd…
Hört sich erst einmal nicht schlecht an:
Two published studies of Revimmune in 20 MS patients found a reduction or elimination of new and enhancing lesions in all patients. Furthermore, no patient experienced a clinical exacerbation following treatment, and most showed reductions or stabilization of clinical markers for the disease. In clinical studies, the drug regimen improves function in most patients and stops progression in over 90% of cases refractory to standard therapies.
Natürlich müssen solche Ergebnisse in der Phase III bestätigt werden (eben auch die Bedenken, die ich bei BiovaxID habe). 12 Monate dauert etwa die Studie, zwischendurch mit Sicherheit Wasserstandsmeldungen, ob Revimmune sicher und wirksam ist.
Schon irgendwie bewundernswert wie und woher ABPI Ihre Pipeline auffüllt:
SinuNase - Mayo Clinic
BiovaxID - National Cancer Institute
Revimmune - Johns Hopkins University
Der CEO hat doch nur Positives zu berichten gehabt und der
Kurs ist weiterhin zum
Kurs ist weiterhin zum
Nur wenig interessant, der Barron's Artikel in dem PPDI und damit auch ABPI kurz erwähnt wird. Enttäuschend die Kursentwicklung von ABPI in den letzten Tagen! Die kommenden (wohl schlechten) Quartalszahlen werden vermutlich auch keine Besserung bringen...
AMERICANS FILL ROUGHLY 3.5 BILLION prescriptions a year, and Big Pharma is being pressured by Washington to pare prices and by Wall Street to boost profits.
That's great news for the 40 to 50 contract research organizations (CROs) in the U.S. and abroad, including two large publicly traded ones: Covance (ticker: CVD) and Pharmaceutical Product Development (PPDI).
With drug makers increasingly farming out pharmaceutical testing, the businesses -- and stock prices -- of the two have soared.
Since January, Covance, based in Princeton, N.J., has climbed from under 60 to 82, where it trades at some 31 times estimated 2007 earnings. In the same span, PPD, headquartered in Wilmington, N.C., has risen from 34 to 41, giving it a 2007 P/E of 30. On estimated 2008 earnings, the two companies' multiples drop to 25.8 and 23.9.
These multiples reflect exceptional long-term growth prospects. Pharma and biotech companies' R&D spending is expected to top $90 billion this year, with two-thirds of it focused on testing. Analyst John Kreger of William Blair reckons that the number of compounds in the global testing pipeline has jumped from around 150 in 2000 to 275 now. And Barath Shankar, an analyst with the consulting firm of Frost & Sullivan, estimates that "global CRO revenues have climbed from under $10 billion in 2003 to about $15 billion this year, and continue to grow at over 15% a year."
Drug testing -- which sometimes takes a decade to complete -- is complicated, requiring sophisticated labs and dedicated computer systems to track the data. For late-stage testing, one challenge is to find enough suitable subjects with a specific disease or condition. This gives CROs with a global reach a distinct edge.
Covance is one of them, and its work is split roughly 50-50 between early-development and late-stage testing. "The growth in pre-clinical business is running at close to 20%, at the high end of our expectations," says CEO Joe Herring. "The biotech industry is funded at record levels, and the large pharmaceutical houses are looking at ways to reduce their costs. As for late-stage trials, biotech doesn't have the infrastructure [to conduct them], and the pharmaceutical firms find is easier, cheaper and quicker for us to do the work. We run close to 6,000 projects at any one time, and we have the infrastructure to run the tests and the global contacts to find patients. I can't name a large company in either biotech or the pharma industry that we don't do business with. We are in a sweet spot."
Unlike Covance, PPD's business is heavily weighted to late-stage human testing, which contributes roughly 80% of revenues. "Pre-clinical is a tough business," says Steve Smith, the company's vice president for corporate finance. "Our focus is on later-stage testing, where we can help clients maximize their return on research. One way or another, we do business with at least 45 of the top pharmaceutical and biotech firms."
PPD differs from its rivals in being willing to take a stake in some compounds being tested, in exchange for free or cut-price services. Unger sees "potential for three compounds to generate royalties for the firm in the next 16 months. These include alogliptin, a Type-2 diabetes drug owned by Japan's Takeda [4502.Japan]; dapoxetine, a Johnson & Johnson [JNJ] treatment for male sexual dysfunction; and SinuNase, Accentia's [ABPI] chronic sinusitis compound. In 2008, these programs could add up to $85 million of profit to PPD."
With an approaching U.S. presidential election in which health care will be a major issue, the drug makers are clearly in the political cross-hairs. That can only accelerate the flow of new drug testing to the CROs, making Covance and PPD good long-term bets.
Auf bessere Tage hoffend...
AMERICANS FILL ROUGHLY 3.5 BILLION prescriptions a year, and Big Pharma is being pressured by Washington to pare prices and by Wall Street to boost profits.
That's great news for the 40 to 50 contract research organizations (CROs) in the U.S. and abroad, including two large publicly traded ones: Covance (ticker: CVD) and Pharmaceutical Product Development (PPDI).
With drug makers increasingly farming out pharmaceutical testing, the businesses -- and stock prices -- of the two have soared.
Since January, Covance, based in Princeton, N.J., has climbed from under 60 to 82, where it trades at some 31 times estimated 2007 earnings. In the same span, PPD, headquartered in Wilmington, N.C., has risen from 34 to 41, giving it a 2007 P/E of 30. On estimated 2008 earnings, the two companies' multiples drop to 25.8 and 23.9.
These multiples reflect exceptional long-term growth prospects. Pharma and biotech companies' R&D spending is expected to top $90 billion this year, with two-thirds of it focused on testing. Analyst John Kreger of William Blair reckons that the number of compounds in the global testing pipeline has jumped from around 150 in 2000 to 275 now. And Barath Shankar, an analyst with the consulting firm of Frost & Sullivan, estimates that "global CRO revenues have climbed from under $10 billion in 2003 to about $15 billion this year, and continue to grow at over 15% a year."
Drug testing -- which sometimes takes a decade to complete -- is complicated, requiring sophisticated labs and dedicated computer systems to track the data. For late-stage testing, one challenge is to find enough suitable subjects with a specific disease or condition. This gives CROs with a global reach a distinct edge.
Covance is one of them, and its work is split roughly 50-50 between early-development and late-stage testing. "The growth in pre-clinical business is running at close to 20%, at the high end of our expectations," says CEO Joe Herring. "The biotech industry is funded at record levels, and the large pharmaceutical houses are looking at ways to reduce their costs. As for late-stage trials, biotech doesn't have the infrastructure [to conduct them], and the pharmaceutical firms find is easier, cheaper and quicker for us to do the work. We run close to 6,000 projects at any one time, and we have the infrastructure to run the tests and the global contacts to find patients. I can't name a large company in either biotech or the pharma industry that we don't do business with. We are in a sweet spot."
Unlike Covance, PPD's business is heavily weighted to late-stage human testing, which contributes roughly 80% of revenues. "Pre-clinical is a tough business," says Steve Smith, the company's vice president for corporate finance. "Our focus is on later-stage testing, where we can help clients maximize their return on research. One way or another, we do business with at least 45 of the top pharmaceutical and biotech firms."
PPD differs from its rivals in being willing to take a stake in some compounds being tested, in exchange for free or cut-price services. Unger sees "potential for three compounds to generate royalties for the firm in the next 16 months. These include alogliptin, a Type-2 diabetes drug owned by Japan's Takeda [4502.Japan]; dapoxetine, a Johnson & Johnson [JNJ] treatment for male sexual dysfunction; and SinuNase, Accentia's [ABPI] chronic sinusitis compound. In 2008, these programs could add up to $85 million of profit to PPD."
With an approaching U.S. presidential election in which health care will be a major issue, the drug makers are clearly in the political cross-hairs. That can only accelerate the flow of new drug testing to the CROs, making Covance and PPD good long-term bets.
Auf bessere Tage hoffend...
Ich fand folgendes Statement aus dem Y! Board zur Finanzlage ABPIs gut:
I'm not sure you're quite understanding what is going on.
First of all, they just got over $5MM from a warrant exercise and they have a line of credit of another $8MM. Also, their cash burn rate will be a lot lower going forward as enrollment for the sinunase trial is done and results set to be unblinded in early 08. There's no way Hopkins Cap, Laurus and the other unsecured lenders will sit idle while this goes into bankruptcy when results are set to be unblinded in a several months. Think about it: If you're an equity investor that's invested and waited this much, would you abandon this within months of seeing the results! That would be crazy..
All this debt isn't so bad. With strong results, they can redeem it and reduce the potential dilution compared to doing a PIPE or secondary equity offering.
As far as the science goes:
Check out the company's website to see the studies done on Revimmune for MS. On 2 published studies on treatment with 20 MS patients, all patients had a reduction or elimination of new and enhancing lesions on the MRI and no patient had a clinical exacerbation following treatment. I don't think there's another drug that's been more or as effective on MS.
On Biovaxid, the DMC, based on their review of the available unblinded clinical trial data, recommended implementation of a data lock on the clinical trial data to take effect in September 2007 and requested that an interim analysis of the study's efficacy endpoints and overall safety profile be performed. The DMC also confirmed at that time that there were no safety concerns. My guess is that they see potential for something here. I view this as an exceptionally good thing!!
Jaja, 2 fast-track Phase III Studien plus nun die Revimune Phase III Studie. Daten der BiovaxID Phase III ungefähr im März und in 12 Wochen (Mitte Februar) die (refractory CS) SinuNase Phase III Ergebnisse. Für mich momentan kaum nachvollziehbar die aktuelle Kursschwäche (trotz schlechten Marktumfeld), da die Chancen doch erheblich sind - natürlich aber auch die Risiken!
Grüße
I'm not sure you're quite understanding what is going on.
First of all, they just got over $5MM from a warrant exercise and they have a line of credit of another $8MM. Also, their cash burn rate will be a lot lower going forward as enrollment for the sinunase trial is done and results set to be unblinded in early 08. There's no way Hopkins Cap, Laurus and the other unsecured lenders will sit idle while this goes into bankruptcy when results are set to be unblinded in a several months. Think about it: If you're an equity investor that's invested and waited this much, would you abandon this within months of seeing the results! That would be crazy..
All this debt isn't so bad. With strong results, they can redeem it and reduce the potential dilution compared to doing a PIPE or secondary equity offering.
As far as the science goes:
Check out the company's website to see the studies done on Revimmune for MS. On 2 published studies on treatment with 20 MS patients, all patients had a reduction or elimination of new and enhancing lesions on the MRI and no patient had a clinical exacerbation following treatment. I don't think there's another drug that's been more or as effective on MS.
On Biovaxid, the DMC, based on their review of the available unblinded clinical trial data, recommended implementation of a data lock on the clinical trial data to take effect in September 2007 and requested that an interim analysis of the study's efficacy endpoints and overall safety profile be performed. The DMC also confirmed at that time that there were no safety concerns. My guess is that they see potential for something here. I view this as an exceptionally good thing!!
Jaja, 2 fast-track Phase III Studien plus nun die Revimune Phase III Studie. Daten der BiovaxID Phase III ungefähr im März und in 12 Wochen (Mitte Februar) die (refractory CS) SinuNase Phase III Ergebnisse. Für mich momentan kaum nachvollziehbar die aktuelle Kursschwäche (trotz schlechten Marktumfeld), da die Chancen doch erheblich sind - natürlich aber auch die Risiken!
Grüße
Kiger's Notebook
By Jeff Kiger, Post-Bulletin business columnist
« New crystal store stocking shelves | Main | Do you know best? »
November 14, 2007
Mayo pal Accentia + SinuNase clinical study
Accentia Biopharmaceuticals is still moving forward with SinuNase, a product thst could be worth more than a billion a year.
Accentia_logo
Mayo Clinic would get 16 percent. That all depends on if it works, of course.
To determine that, the company just completed enrollment of its Pase III trial of SinuNase. The study has 300 patients.
According to the National Center for Health Statistics, 31 million adults in the U.S. have chronic sinusitis, an often debilitating, painful inflammation of the sinuses. Accentia is the only company with rights from Mayo to develop such a drug.
Sinunaselogo
Adam Walsh, senior biotech analyst for Jefferies & Company, Inc. of New York., gave this estimate in September 2006.:
Walsh estimates Accentia would tap 1 percent of the 4 million patients with failed sinus surgeries, taking in $67 million in 2008, $173 million in 2009 and $308 million in 2010. That would net Mayo 16 percent of the profits each year, or $608,000 in 2010 alone.
A mere 14 percent penetration into the sinusitis surgery market would yield Accentia annual sales “in excess of $1 billion,” assuming annual costs of $1,800 per patient, according to Jefferies.
Posted on November 14, 2007 at 01:44 PM
By Jeff Kiger, Post-Bulletin business columnist
« New crystal store stocking shelves | Main | Do you know best? »
November 14, 2007
Mayo pal Accentia + SinuNase clinical study
Accentia Biopharmaceuticals is still moving forward with SinuNase, a product thst could be worth more than a billion a year.
Accentia_logo
Mayo Clinic would get 16 percent. That all depends on if it works, of course.
To determine that, the company just completed enrollment of its Pase III trial of SinuNase. The study has 300 patients.
According to the National Center for Health Statistics, 31 million adults in the U.S. have chronic sinusitis, an often debilitating, painful inflammation of the sinuses. Accentia is the only company with rights from Mayo to develop such a drug.
Sinunaselogo
Adam Walsh, senior biotech analyst for Jefferies & Company, Inc. of New York., gave this estimate in September 2006.:
Walsh estimates Accentia would tap 1 percent of the 4 million patients with failed sinus surgeries, taking in $67 million in 2008, $173 million in 2009 and $308 million in 2010. That would net Mayo 16 percent of the profits each year, or $608,000 in 2010 alone.
A mere 14 percent penetration into the sinusitis surgery market would yield Accentia annual sales “in excess of $1 billion,” assuming annual costs of $1,800 per patient, according to Jefferies.
Posted on November 14, 2007 at 01:44 PM
Antwort auf Beitrag Nr.: 32.434.622 von SunnyOst am 15.11.07 10:50:03Die letzten Jefferies Schätzungen waren (@ $2500/pt/yr for first year) - aus der ABPI Präsentation -:
Year / Revenues / Mkt % (4M pt’s) / Mkt % (30M pt’s)
2009 / $350M / 3.5% / 0.47%
2010 / $455M / 4.5% / 0.61%
2011 / $592M / 5.9% / 0.79%
Wen es interessiert, dies ist dass letzte Update dass ich von Jefferies gefunden hatte (aus dem Healthcare Conference Book):
June 26 - 28, 2007 (Priced as of June 20, 2007)
Accentia Biopharmaceuticals, Inc.
Ticker: ABPI
Rating: BUY
Price: $3.12
Price Target: $9.00
Analyst: Adam A. Walsh, M.D.
Accentia Biopharmaceuticals, Inc. is a compelling biopharmaceutical story with two innovative products in
late-stage development targeting large market opportunities and unmet medical needs. SinuNase is a potential
blockbuster product in Phase 3 development for chronic sinusitis (CS), a disease affecting 33 million patients
in the U.S. for which there is no FDA approved therapy. Assuming positive Phase 3 results, we estimate
SinuNase could be approved and launched in CY-2H09 and believe sales could top $1B. Biovaxid is
Accentia's cancer vaccine in Phase 3 trials for patients with non-Hodgkin's lymphoma (NHL). Assuming
positive Phase 3 results, we estimate Biovaxid could be approved and launched in CY-4Q09 and believe sales
could exceed $400M. In addition to its late-stage pipeline, Accentia has an underlying specialty
pharmaceuticals business and a pharma services business.
Grüße
Year / Revenues / Mkt % (4M pt’s) / Mkt % (30M pt’s)
2009 / $350M / 3.5% / 0.47%
2010 / $455M / 4.5% / 0.61%
2011 / $592M / 5.9% / 0.79%
Wen es interessiert, dies ist dass letzte Update dass ich von Jefferies gefunden hatte (aus dem Healthcare Conference Book):
June 26 - 28, 2007 (Priced as of June 20, 2007)
Accentia Biopharmaceuticals, Inc.
Ticker: ABPI
Rating: BUY
Price: $3.12
Price Target: $9.00
Analyst: Adam A. Walsh, M.D.
Accentia Biopharmaceuticals, Inc. is a compelling biopharmaceutical story with two innovative products in
late-stage development targeting large market opportunities and unmet medical needs. SinuNase is a potential
blockbuster product in Phase 3 development for chronic sinusitis (CS), a disease affecting 33 million patients
in the U.S. for which there is no FDA approved therapy. Assuming positive Phase 3 results, we estimate
SinuNase could be approved and launched in CY-2H09 and believe sales could top $1B. Biovaxid is
Accentia's cancer vaccine in Phase 3 trials for patients with non-Hodgkin's lymphoma (NHL). Assuming
positive Phase 3 results, we estimate Biovaxid could be approved and launched in CY-4Q09 and believe sales
could exceed $400M. In addition to its late-stage pipeline, Accentia has an underlying specialty
pharmaceuticals business and a pharma services business.
Grüße
Eine recht informative Seite: http://www.sinuses.com/
Hier gibts auch folgendes zu entdecken: http://www.sinuses.com/fungal.htm
Fungal Sinusitis
W. S. Tichenor, M. D.
New York, New York
An article published in the Mayo Clinic Proceedings in September, 1999 by the Mayo Clinic suggests that fungal sinusitis may be much more common than previously thought. The disease is now know as EFRS (eosinophilic fungal rhinosinusitis) or EMRS (eosinophilic mucinous rhinosinusitis).
Fungal growth was found in washings from the sinuses in 96% of patients with chronic sinusitis. Normal controls had almost as much growth, the difference being that those patients with chronic sinusitis had eosinophiles ( a type of white blood cell involved in allergic and other reactions) which had become activated. As a result of the activation, the eosinophiles released a product called MBP (Major Basic Protein) into the mucus which attacks and kills the fungus but is very irritating to the lining of the sinuses. We believe that MBP injures the lining of the sinuses and allows the bacteria to proliferate.
The injury to the lining of the sinuses by the fungus and mucus led to the belief that treatment of chronic sinusitis should be directed at the fungus rather than the bacteria. Obviously the optimal treatment would address the reason the eosinophiles attack the fungus, however, at the present time, we do not know the reason.
There has been much speculation about why people develop the sensitivity to fungi. Some people believe that it is as a result of extensive use of antibiotics causing overgrowth of fungi. Others believe that it is the result of extensive exposure to mold and fungi in the environment, both due to water leaks from roofs and plumbing as well as more efficient homes with less air exchange. Needless to say it is important to fix leaks and repair damage immediately so that this exposure doesn't occur. None of these fully explain the problem, however.
Unfortunately the discussion above was not included in the original article by the Mayo clinic. As a result, the article was not well received initially. There was also no information about the success of treatment in the original article, and there was very little discussed about mechanisms. As more data has accumulated, there is more evidence that the problem may be as important as the Mayo Clinic suggests and the significance is starting to be accepted.
Prior to the Mayo group's work on fungal sinusitis, it was recognized that there were several types of fungal sinusitis, which we will discuss later in this webpage.
Whenever a new finding is discovered in medicine, it is often met with resistance. It becomes important for that finding to be confirmed by an independent group. This has now been accomplished by a well respected group from Graz, Austria, They were able to show positive fungal cultures in 92 % of their patients. Almost as many of the controls also had fungi. Clusters of eosinophiles were found around fungi in 94 % of patients. This is important because we believe that this shows that the eosinophiles are involved in attacking and killing the fungi.
The Mayo Clinic researchers have done elegant work on the interaction of eosinophils and fungi in patients with chronic sinusitis. They have been able to film videos of eosinophils from patients with chronic sinusitis in which the eosinophils are shown attacking and killing the fungi, as contrasted to patients without sinusitis in whom the eosinophils will "sniff" the fungus (as Dr. Ponikau suggests) and then ignore it. Current techniques make it difficult for doctors who are not in research institutions to clearly determine that it is the fungus which is causing the problem. For example, it is possible to tell by electron microscopy that the degranulation of the eosinophile is in response to fungus. Unfortunately, however, there is not a good way to tell that the eosinophile is degranulating in response to the fungus by methods that most physicians can use. Those techniques are under investigation.
At the present time, patients are being treated with irrigation with topical antifungals such as Amphotericin B. The Mayo clinic has found that 75 % have an improvement. A paper was presented at the American Academy of Allergy, Asthma and Immunology meeting in 2004 which compared 6 months of irrigation with Amphotericin (250 micrograms/ml) vs. a placebo. There was a statisticly significant difference in the amount of mucosal thickening on the CT scan as well as endoscopic scores. In addition there were changes in levels of interleukin-5 and eosinophil-derived neurotoxin. There has long been a concern that there were no double blind studies done on use of antifungal agents. This should help in that regard. The Mayo clinic is now recommending a concentration of 100 micrograms/ml, however.
A study has begun which will hopefully lead to the approval by the FDA of the first treatment for chronic sinusitis. This involves a new formulation of Amphotericin B. For more information on the study, please contact Accentia Pharmeuticals. If you are in the New York area, you can contact our office (212-517-6611).
Itraconazole (Sporanox) can also be used topically, but it is very difficult to make up since most mixtures cause the itraconazole to be inactivated immediately. Although many pharmacies claim to be able to make up the itraconazole, almost all pharmacies are unable to make it up correctly and be able to ensure that there is active drug in the mixture. It must be made up by Anazao pharmaceuticals or Sinucare. (The Mayo clinic is no longer making up itraconazole.) (If your local pharmacy thinks that they are able to make it up, I would suggest that you insist that they provide you with an outside analysis that shows that there is active drug in the formulation.) Many patients require other agents such as nasal or systemic steroids, however many patients in the Mayo clinic trial were able to stop treatment with oral steroids .
Although when given intravenously there are serious side effects with Amphotericin B, topically it causes minimal problems. These can include burning due to the fact that it must be mixed with sterile water. It cannot be mixed with saline, and must be protected from light and refrigerated. It is therefore very inconvenient to use. More acceptable formulations are being evaluated. We anticipate that patients will need to be treated indefinitely, or at least until we understand better why these problems are occuring.
Some patients seem to respond to treatment with oral antifungals, including Sporanox, Diflucan, and possibly Nizoral or Lamisil. We are working on other treatments which we hope will be able to be used in the near future.
Because irrigation must get into the sinuses in order to be effective, it is often necessary for patients to have endoscopic sinus surgery before irrigation can be effective. It is possible that by using an irrigation device such as the Grossan irrigator, it will be possible to irrigate effectively without surgery.
Some doctors have added antifungals ( or antibiotics ) to the Grossan irrigator. One method is to add 1 tsp of salt ( or Breathease, or salt-baking soda solution ) to 500 cc of water in the Hydropulse and irrigate. When the solution is almost gone, it is possible to add the antifungal to the irrigation fluid and continue irrigating. The antifungal solution should not be added at the beginning because it may become too diluted.
It is speculated by some that since almost half of patients with EFRS have a positive allergy skin test for fungi or mold it may be possible to treat them by standard allergy management. Since we cannot allergy test for all of the fungi, it can be a difficult proposition, but we now test and give allergy immunotherapy for a much larger number of molds and fungi.
We are also concerned that fungal sinusitis may be caused or made worse by exposure to fungi in the environment, or by extensive antibiotic use. The literature now seems to indicate that patients with more exposure to fungi are more likely to develop markers suggestive of greater fungal senstivity.
Prior to the reports from the Mayo clinic, fungal sinusitis was well known, but thought to be much less common. Those other types of fungal sinusitis are discussed below.
Patients who have repeated bouts of sinusitis, as well as those who are immunocompromised should be considered to possibly have a fungal sinusitis. A CT scan will sometimes show calcification, but MRI is more sensitive in diagnosis. Cultures are best obtained from the sinuses, as nasal cultures are unreliable.
Fungal sinusitis is broken down into several categories: Allergic, Fungus balls (Mycetoma), and Invasive.
Allergic fungal sinusitis (AFS) is commonly caused by Aspergillus, as well as Fusarium, Curvularia, and others. Patients often have associated asthma. The criteria include CT or MRI confirmation, a dark green or black material the consistency of peanut butter called "allergic mucin" which typically contain a few hyphae, no invasion, and no predisposing systemic disease. Charcot-Leyden crystals, which are breakdown products of eosinophiles are often found. Usually patients are found to be allergic to the fungus, although this is controversial. This disease is analogous to Allergic Bronchopulmonary Aspergillosis. This problem is most similar to the type described at the Mayo clinic, but these patients have a much different character to their mucus.
Fungus balls often involve the maxillary sinus and may present similarly to other causes of sinusitis including a foul smelling breath. In addition to radiological abnormalities, thick pus or a clay-like substance is found in the sinuses. There is no allergic mucin, but dense hyphae are found. There is no invasion. There is an inflammatory response in the mucosa. Upon looking into the sinus, the fungus ball can vary in size from 1 mm or smaller to a size which completely occupies the sinus. It may have a greenish-black appearance. Removal of the fungus ball is the typical treatment.
Invasive sinusitis can progress rapidly, and typically necessitates surgery, often on a emergent basis and often requiring Amphotericin B intravenously as well. There have been some forms of invasive sinusitis which can cause proptosis. There is a form of chronic invasive fungal sinusitis which is associated with visual abnormalities due to bony erosion from the ethmoids.
Fungal sinusitis should obviously be treated by someone with extensive experience in treatment of that disease.
Hier gibts auch folgendes zu entdecken: http://www.sinuses.com/fungal.htm
Fungal Sinusitis
W. S. Tichenor, M. D.
New York, New York
An article published in the Mayo Clinic Proceedings in September, 1999 by the Mayo Clinic suggests that fungal sinusitis may be much more common than previously thought. The disease is now know as EFRS (eosinophilic fungal rhinosinusitis) or EMRS (eosinophilic mucinous rhinosinusitis).
Fungal growth was found in washings from the sinuses in 96% of patients with chronic sinusitis. Normal controls had almost as much growth, the difference being that those patients with chronic sinusitis had eosinophiles ( a type of white blood cell involved in allergic and other reactions) which had become activated. As a result of the activation, the eosinophiles released a product called MBP (Major Basic Protein) into the mucus which attacks and kills the fungus but is very irritating to the lining of the sinuses. We believe that MBP injures the lining of the sinuses and allows the bacteria to proliferate.
The injury to the lining of the sinuses by the fungus and mucus led to the belief that treatment of chronic sinusitis should be directed at the fungus rather than the bacteria. Obviously the optimal treatment would address the reason the eosinophiles attack the fungus, however, at the present time, we do not know the reason.
There has been much speculation about why people develop the sensitivity to fungi. Some people believe that it is as a result of extensive use of antibiotics causing overgrowth of fungi. Others believe that it is the result of extensive exposure to mold and fungi in the environment, both due to water leaks from roofs and plumbing as well as more efficient homes with less air exchange. Needless to say it is important to fix leaks and repair damage immediately so that this exposure doesn't occur. None of these fully explain the problem, however.
Unfortunately the discussion above was not included in the original article by the Mayo clinic. As a result, the article was not well received initially. There was also no information about the success of treatment in the original article, and there was very little discussed about mechanisms. As more data has accumulated, there is more evidence that the problem may be as important as the Mayo Clinic suggests and the significance is starting to be accepted.
Prior to the Mayo group's work on fungal sinusitis, it was recognized that there were several types of fungal sinusitis, which we will discuss later in this webpage.
Whenever a new finding is discovered in medicine, it is often met with resistance. It becomes important for that finding to be confirmed by an independent group. This has now been accomplished by a well respected group from Graz, Austria, They were able to show positive fungal cultures in 92 % of their patients. Almost as many of the controls also had fungi. Clusters of eosinophiles were found around fungi in 94 % of patients. This is important because we believe that this shows that the eosinophiles are involved in attacking and killing the fungi.
The Mayo Clinic researchers have done elegant work on the interaction of eosinophils and fungi in patients with chronic sinusitis. They have been able to film videos of eosinophils from patients with chronic sinusitis in which the eosinophils are shown attacking and killing the fungi, as contrasted to patients without sinusitis in whom the eosinophils will "sniff" the fungus (as Dr. Ponikau suggests) and then ignore it. Current techniques make it difficult for doctors who are not in research institutions to clearly determine that it is the fungus which is causing the problem. For example, it is possible to tell by electron microscopy that the degranulation of the eosinophile is in response to fungus. Unfortunately, however, there is not a good way to tell that the eosinophile is degranulating in response to the fungus by methods that most physicians can use. Those techniques are under investigation.
At the present time, patients are being treated with irrigation with topical antifungals such as Amphotericin B. The Mayo clinic has found that 75 % have an improvement. A paper was presented at the American Academy of Allergy, Asthma and Immunology meeting in 2004 which compared 6 months of irrigation with Amphotericin (250 micrograms/ml) vs. a placebo. There was a statisticly significant difference in the amount of mucosal thickening on the CT scan as well as endoscopic scores. In addition there were changes in levels of interleukin-5 and eosinophil-derived neurotoxin. There has long been a concern that there were no double blind studies done on use of antifungal agents. This should help in that regard. The Mayo clinic is now recommending a concentration of 100 micrograms/ml, however.
A study has begun which will hopefully lead to the approval by the FDA of the first treatment for chronic sinusitis. This involves a new formulation of Amphotericin B. For more information on the study, please contact Accentia Pharmeuticals. If you are in the New York area, you can contact our office (212-517-6611).
Itraconazole (Sporanox) can also be used topically, but it is very difficult to make up since most mixtures cause the itraconazole to be inactivated immediately. Although many pharmacies claim to be able to make up the itraconazole, almost all pharmacies are unable to make it up correctly and be able to ensure that there is active drug in the mixture. It must be made up by Anazao pharmaceuticals or Sinucare. (The Mayo clinic is no longer making up itraconazole.) (If your local pharmacy thinks that they are able to make it up, I would suggest that you insist that they provide you with an outside analysis that shows that there is active drug in the formulation.) Many patients require other agents such as nasal or systemic steroids, however many patients in the Mayo clinic trial were able to stop treatment with oral steroids .
Although when given intravenously there are serious side effects with Amphotericin B, topically it causes minimal problems. These can include burning due to the fact that it must be mixed with sterile water. It cannot be mixed with saline, and must be protected from light and refrigerated. It is therefore very inconvenient to use. More acceptable formulations are being evaluated. We anticipate that patients will need to be treated indefinitely, or at least until we understand better why these problems are occuring.
Some patients seem to respond to treatment with oral antifungals, including Sporanox, Diflucan, and possibly Nizoral or Lamisil. We are working on other treatments which we hope will be able to be used in the near future.
Because irrigation must get into the sinuses in order to be effective, it is often necessary for patients to have endoscopic sinus surgery before irrigation can be effective. It is possible that by using an irrigation device such as the Grossan irrigator, it will be possible to irrigate effectively without surgery.
Some doctors have added antifungals ( or antibiotics ) to the Grossan irrigator. One method is to add 1 tsp of salt ( or Breathease, or salt-baking soda solution ) to 500 cc of water in the Hydropulse and irrigate. When the solution is almost gone, it is possible to add the antifungal to the irrigation fluid and continue irrigating. The antifungal solution should not be added at the beginning because it may become too diluted.
It is speculated by some that since almost half of patients with EFRS have a positive allergy skin test for fungi or mold it may be possible to treat them by standard allergy management. Since we cannot allergy test for all of the fungi, it can be a difficult proposition, but we now test and give allergy immunotherapy for a much larger number of molds and fungi.
We are also concerned that fungal sinusitis may be caused or made worse by exposure to fungi in the environment, or by extensive antibiotic use. The literature now seems to indicate that patients with more exposure to fungi are more likely to develop markers suggestive of greater fungal senstivity.
Prior to the reports from the Mayo clinic, fungal sinusitis was well known, but thought to be much less common. Those other types of fungal sinusitis are discussed below.
Patients who have repeated bouts of sinusitis, as well as those who are immunocompromised should be considered to possibly have a fungal sinusitis. A CT scan will sometimes show calcification, but MRI is more sensitive in diagnosis. Cultures are best obtained from the sinuses, as nasal cultures are unreliable.
Fungal sinusitis is broken down into several categories: Allergic, Fungus balls (Mycetoma), and Invasive.
Allergic fungal sinusitis (AFS) is commonly caused by Aspergillus, as well as Fusarium, Curvularia, and others. Patients often have associated asthma. The criteria include CT or MRI confirmation, a dark green or black material the consistency of peanut butter called "allergic mucin" which typically contain a few hyphae, no invasion, and no predisposing systemic disease. Charcot-Leyden crystals, which are breakdown products of eosinophiles are often found. Usually patients are found to be allergic to the fungus, although this is controversial. This disease is analogous to Allergic Bronchopulmonary Aspergillosis. This problem is most similar to the type described at the Mayo clinic, but these patients have a much different character to their mucus.
Fungus balls often involve the maxillary sinus and may present similarly to other causes of sinusitis including a foul smelling breath. In addition to radiological abnormalities, thick pus or a clay-like substance is found in the sinuses. There is no allergic mucin, but dense hyphae are found. There is no invasion. There is an inflammatory response in the mucosa. Upon looking into the sinus, the fungus ball can vary in size from 1 mm or smaller to a size which completely occupies the sinus. It may have a greenish-black appearance. Removal of the fungus ball is the typical treatment.
Invasive sinusitis can progress rapidly, and typically necessitates surgery, often on a emergent basis and often requiring Amphotericin B intravenously as well. There have been some forms of invasive sinusitis which can cause proptosis. There is a form of chronic invasive fungal sinusitis which is associated with visual abnormalities due to bony erosion from the ethmoids.
Fungal sinusitis should obviously be treated by someone with extensive experience in treatment of that disease.
Blogged by probber on Tuesday November 27th, 2007 at 5:11 am in Sinusitis |
Questions and answers about Diaper bondage.
Irrigation using a saline solution is more effective than expensive nasal sprays in treating chronic nasal and sinus symptoms, according to new research. Scientists say daily nasal irrigation using large amounts of saline solution can considerably improve the chronic sinonasal symptoms.
Sinusitis is the medical term for inflammation irritation and swelling of the sinuses. Proven relief of respiratory ailments from salt caves finally in. And cold are the main diseases that affect these individuals during this period. These can lead to episodes of sinusitis and may even trigger attacks of. Patients fight sinustis with surgery, at home remedies. She burnt the soles of her feet badly enough to not be able to walk back to her hotel, but it cured her of her chronic sinusitis and migraines she matched. Estimates are sinusitis affects upwards of million individuals. Inhalation of coriander is useful in treating sinusitis and colds. It is often hard to diagnose because people eat wheat products all the time.
In the united states, our current nasal spray has been aimed at helping the million people who suffer from chronic sinusitis, quot. The embarrassing health problems no one talks about. Another common trigger sinusitis and postnasal drip. Delay no american is denied health care in america.
Government approved woefully inadequate funds to address the permanent health problems, such as sinusitis and asthma, associated with work at the site. Radio nicaragua?
The members of katatonia have now since about two weeks been struggling with everything from the flu, ear infections, pneumonia and sinusitis. We are also building and strengthening our research pipeline. New gel to reduce surgical bleeding. Take care it is spider time. Half a million endoscopic sinus operations to relieve sinusitis are performed every year in the united states alone.
Including herself, suffered chronic sinusitis, skin ailments and numerous other allergies because of smoke coming from the ever burning tip. With the exception of headache, nausea, sinusitis. Asthmatic bronchitis, allergic rhinitis, sinusitis, knee joint and low back pain. S allergy cost is not to be sneezed at.
Anaphylaxis, a severe allergic reaction which triggers a life threatening body quot. Prdomain Business Register press release, nbsp. Multi drug resistant strep pneumo strain on the rise in many parts. Macau doctors want vaccines against quot. Bacteremia if they invade the bloodstream and meningitis if they end up in the brain. Discontinuations due to adverse events were percent for humira and percent for placebo.
Making sense of cilia and flagella. Journal of Cell Biology subscription nbsp. Squid gel can reduce surgical scarring and bleeding. This discovery will not only help surgery related to sinusitis but also many other surgeries. Many pharmaceutical industries are vying for its large scale.
Flu, bronchitis, sinusitis and sore throats are signs of immune deficiency. What you choose to eat accounts for your first line of defence against. Several others had chronic sinusitis and upper respiratory problems. Acupuncture weight loss with acuaids proven effective. Potentially dangerous anaphylaxis mainly due to food as well.
Getting a head start on relaxing. Tension, fatigue, insomnia, headaches, migraine and sinusitis. You may notice a runny nose, cough, drainage in the throat, scratchy throat, congestion, and an inability to.
Smoking aggravates conditions like allergies and sinusitis. Sinusitis, urticaria and angioedema, atopic dermatitis, and drug allergy. A few examples first generation antihistamines can cause driving impairment. Toothache can also be a sign of heart attacks, ear infections, and sinusitis. Even these particles in themselves can cause a host of breathing related problems, ranging from sinusitis and wheezing, to shortness of breath and chest. Breakthrough diagnostic kits for viral pandemics developed by. Million in their first financing round from a group of. Net hlys, lcav, lgcy, nstk, xfml, arga have also been. Health expert over the counter pain relievers safe if used wisely. B opel rekord!
Ve taken me a couple of days to get an appointment, with my regular doctor, for just sinusitis. Baylor University The Lariat Online, nbsp. Some are related to pneumonia, bacteremia, sinusitis, urinary tract infections and traumatic wounds, which keating defined as gunshot or stab wounds. Who won the other semi final against a sinusitis stricken breathless fourth seed tania bailey of england in minutes. New superbug it’s causing ear problems in children. What Doctors Don’t Tell You, nbsp. Responsible for pneumonia, meningitis, sinusitis and otitis media middle ear infe.
Ear ache jabs for all two new examples of medical overkill. Will update attendees on the fast tracked pivotal phase clinical trial of sinunase tm for chronic sinusitis. Susceptibility testing of new agents against streptococcus pneumoniae responsible for the majority of sinusitis, otitis media. Research anesthesia can cause respirator problems for children. S number two seed natalie grinham in madrid. Fatigue , sinusitis , upper respiratory tract infections , nasopharyngitis , somnolence , headache , dizziness. In order to show you the most relevant results, we have omitted some entries very similar to the already displayed. .
Questions and answers about Diaper bondage.
Irrigation using a saline solution is more effective than expensive nasal sprays in treating chronic nasal and sinus symptoms, according to new research. Scientists say daily nasal irrigation using large amounts of saline solution can considerably improve the chronic sinonasal symptoms.
Sinusitis is the medical term for inflammation irritation and swelling of the sinuses. Proven relief of respiratory ailments from salt caves finally in. And cold are the main diseases that affect these individuals during this period. These can lead to episodes of sinusitis and may even trigger attacks of. Patients fight sinustis with surgery, at home remedies. She burnt the soles of her feet badly enough to not be able to walk back to her hotel, but it cured her of her chronic sinusitis and migraines she matched. Estimates are sinusitis affects upwards of million individuals. Inhalation of coriander is useful in treating sinusitis and colds. It is often hard to diagnose because people eat wheat products all the time.
In the united states, our current nasal spray has been aimed at helping the million people who suffer from chronic sinusitis, quot. The embarrassing health problems no one talks about. Another common trigger sinusitis and postnasal drip. Delay no american is denied health care in america.
Government approved woefully inadequate funds to address the permanent health problems, such as sinusitis and asthma, associated with work at the site. Radio nicaragua?
The members of katatonia have now since about two weeks been struggling with everything from the flu, ear infections, pneumonia and sinusitis. We are also building and strengthening our research pipeline. New gel to reduce surgical bleeding. Take care it is spider time. Half a million endoscopic sinus operations to relieve sinusitis are performed every year in the united states alone.
Including herself, suffered chronic sinusitis, skin ailments and numerous other allergies because of smoke coming from the ever burning tip. With the exception of headache, nausea, sinusitis. Asthmatic bronchitis, allergic rhinitis, sinusitis, knee joint and low back pain. S allergy cost is not to be sneezed at.
Anaphylaxis, a severe allergic reaction which triggers a life threatening body quot. Prdomain Business Register press release, nbsp. Multi drug resistant strep pneumo strain on the rise in many parts. Macau doctors want vaccines against quot. Bacteremia if they invade the bloodstream and meningitis if they end up in the brain. Discontinuations due to adverse events were percent for humira and percent for placebo.
Making sense of cilia and flagella. Journal of Cell Biology subscription nbsp. Squid gel can reduce surgical scarring and bleeding. This discovery will not only help surgery related to sinusitis but also many other surgeries. Many pharmaceutical industries are vying for its large scale.
Flu, bronchitis, sinusitis and sore throats are signs of immune deficiency. What you choose to eat accounts for your first line of defence against. Several others had chronic sinusitis and upper respiratory problems. Acupuncture weight loss with acuaids proven effective. Potentially dangerous anaphylaxis mainly due to food as well.
Getting a head start on relaxing. Tension, fatigue, insomnia, headaches, migraine and sinusitis. You may notice a runny nose, cough, drainage in the throat, scratchy throat, congestion, and an inability to.
Smoking aggravates conditions like allergies and sinusitis. Sinusitis, urticaria and angioedema, atopic dermatitis, and drug allergy. A few examples first generation antihistamines can cause driving impairment. Toothache can also be a sign of heart attacks, ear infections, and sinusitis. Even these particles in themselves can cause a host of breathing related problems, ranging from sinusitis and wheezing, to shortness of breath and chest. Breakthrough diagnostic kits for viral pandemics developed by. Million in their first financing round from a group of. Net hlys, lcav, lgcy, nstk, xfml, arga have also been. Health expert over the counter pain relievers safe if used wisely. B opel rekord!
Ve taken me a couple of days to get an appointment, with my regular doctor, for just sinusitis. Baylor University The Lariat Online, nbsp. Some are related to pneumonia, bacteremia, sinusitis, urinary tract infections and traumatic wounds, which keating defined as gunshot or stab wounds. Who won the other semi final against a sinusitis stricken breathless fourth seed tania bailey of england in minutes. New superbug it’s causing ear problems in children. What Doctors Don’t Tell You, nbsp. Responsible for pneumonia, meningitis, sinusitis and otitis media middle ear infe.
Ear ache jabs for all two new examples of medical overkill. Will update attendees on the fast tracked pivotal phase clinical trial of sinunase tm for chronic sinusitis. Susceptibility testing of new agents against streptococcus pneumoniae responsible for the majority of sinusitis, otitis media. Research anesthesia can cause respirator problems for children. S number two seed natalie grinham in madrid. Fatigue , sinusitis , upper respiratory tract infections , nasopharyngitis , somnolence , headache , dizziness. In order to show you the most relevant results, we have omitted some entries very similar to the already displayed. .
Moin-Moin oder Mahlzeit,
hatte heute morgen dass Y! Board überflogen. Dabei gab es einen interessanten Hinweis bzgl. der Partnerschaft zu SinuNase. In der Oktober Präsentation http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu… ist auf der Seite 30 der Hinweis aufgeführt:
Commercial partnership finalized = also abgeschlossen!
Ist für mich nicht gerade unwichtig, da dies als Vertrauensbeweis angesehen werden kann / darf. Die anderen kritischen Sachen in meinen Augen wären (wie schon mal erwähnt):
- Preis 200 $ monatlich ist eine stolze Summe (bisher kamen Patienten mit der Hälfte weg)
- 200.000 Behandlungen jährlich - wird SinuNase es
a) schaffen ähnlich viele oder vielleicht mehr Patienten zu behandeln? und
b) Behandlungsdauer. Die Phase 3 ging über 4 Monate. Ist die spätere Behandlung der Patienten genau so lange oder doch über ein ganzes Jahr?
Noch einen schönen Sonntag!
Grüße
hatte heute morgen dass Y! Board überflogen. Dabei gab es einen interessanten Hinweis bzgl. der Partnerschaft zu SinuNase. In der Oktober Präsentation http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu… ist auf der Seite 30 der Hinweis aufgeführt:
Commercial partnership finalized = also abgeschlossen!
Ist für mich nicht gerade unwichtig, da dies als Vertrauensbeweis angesehen werden kann / darf. Die anderen kritischen Sachen in meinen Augen wären (wie schon mal erwähnt):
- Preis 200 $ monatlich ist eine stolze Summe (bisher kamen Patienten mit der Hälfte weg)
- 200.000 Behandlungen jährlich - wird SinuNase es
a) schaffen ähnlich viele oder vielleicht mehr Patienten zu behandeln? und
b) Behandlungsdauer. Die Phase 3 ging über 4 Monate. Ist die spätere Behandlung der Patienten genau so lange oder doch über ein ganzes Jahr?
Noch einen schönen Sonntag!
Grüße
Antwort auf Beitrag Nr.: 32.639.789 von Ackergaul am 02.12.07 12:06:00http://snowman1546.blogspot.com/2007/12/sinusitis-cures-new-…
Tuesday, December 4, 2007
Sinusitis Cures- A New Treatment Therapy is Available
I am one of the 35,000,000 Americans who suffer from chronic sinusitis. Ive looked at numerous potential sinusitis cures over the years and have undergone two painful sinus operations. I still was coming down with sinus infections after that, which was pretty discouraging, and I had to make lifestyle changes I wasnt pleased with. Over the past four years or so Ive found help using pulsating nasal irrigation with a saline solution, and the situation is relatively under control. I still get clogged up most nights, however, and have to take several medications, including a steroid spray.
Research has been done by the Mayo Clinic in the hope of finding new sinusitis cures. Ive been in touch with one of the physicians on the Mayo Clinic research team who advised me that there is a new therapy which may actually treat the root cause of chronic sinusitis in many people. In this article Ill summarize in laymans terms the results of the research.
The research showed that people with chronic sinusitis have a different immune response in their nasal cavities to naturally occurring fungi, which they showed is present in the nasal cavities of almost everyone. The research team was able to demonstrate that in some people (chronic sinusitis sufferers) certain white blood cells, known as eosinophites, activate and thereby produce a chemical, called MBP, which causes damage to nasal membranes. Bacteria can then invade the damaged areas and cause sinus infections. It therefore made sense that an option in the search for new sinusitis cures would be to treat the fungus rather than treat the bacteria with an antibiotic, which is often the therapy followed conventionally.
Mayo Clinic studies have shown that 75% of chronic sinusitis sufferers saw improvement when treated with a topical fungicide. The Therapy is called topical antifungal therapy. An antifungal called Amphotericin B has already been approved by the FDA for other treatments and is normally administered to patients as an injection. For sinusitis cures it is made into a topical nasal spray and applied daily. The recommended dose is 100 micrograms/ml. This medication is generally not available in most pharmacies today. One must get the prescription filled through a compounding pharmacy such as Anazao.
The best thing to do is find a physician who is trained in administering this therapy, and that doctor can no doubt explain how to obtain the medication prescribed.
In some people the eosinophiles do not react to fungi present in the nasal mucus, and these people generally do not have chronic sinusitis. Why the eosinophiles act differently in different people is not yet known. Also, it is difficult to administer a test which will tell if one person has this type of reaction occur in his body or not. However, this theory would explain why some people are chronic sinusitis sufferers even after extensive conventional treatments or sinus operations. The conventional therapies and surgeries to date have simply not addressed this issue, since it was not known prior to the Mayo Clinic studies and patient tests.
Chronic sinusitis sufferers should be aware that this new therapy is available today in some locations, that it is gaining popularity, and it is becoming part of the arsenal of sinusitis cures available. People desperate for help should try to locate a physician who has been trained to administer this treatment and determine if it would help in their case. If you cannot locate such treatment in your area, please go to http://www.postnasaldrip.net and click the Contact Us button and well try to help, but travel may be required.
Walt Ballenberger is founder of http://www.postnasaldrip.net a resource web site for sinusitis sufferers like himself. For a free report entitled Sinus Treatment Success Stories, visit http://www.postnasaldrip.net and click on the Free Report link. This resource can be of significant help to chronic sinus sufferers.
Mal abwarten, wie Anfang 2008 die Ergebnisse des Trials ausschauen und wie sich später der mögliche Verkauf gestaltet...
Grüße
Tuesday, December 4, 2007
Sinusitis Cures- A New Treatment Therapy is Available
I am one of the 35,000,000 Americans who suffer from chronic sinusitis. Ive looked at numerous potential sinusitis cures over the years and have undergone two painful sinus operations. I still was coming down with sinus infections after that, which was pretty discouraging, and I had to make lifestyle changes I wasnt pleased with. Over the past four years or so Ive found help using pulsating nasal irrigation with a saline solution, and the situation is relatively under control. I still get clogged up most nights, however, and have to take several medications, including a steroid spray.
Research has been done by the Mayo Clinic in the hope of finding new sinusitis cures. Ive been in touch with one of the physicians on the Mayo Clinic research team who advised me that there is a new therapy which may actually treat the root cause of chronic sinusitis in many people. In this article Ill summarize in laymans terms the results of the research.
The research showed that people with chronic sinusitis have a different immune response in their nasal cavities to naturally occurring fungi, which they showed is present in the nasal cavities of almost everyone. The research team was able to demonstrate that in some people (chronic sinusitis sufferers) certain white blood cells, known as eosinophites, activate and thereby produce a chemical, called MBP, which causes damage to nasal membranes. Bacteria can then invade the damaged areas and cause sinus infections. It therefore made sense that an option in the search for new sinusitis cures would be to treat the fungus rather than treat the bacteria with an antibiotic, which is often the therapy followed conventionally.
Mayo Clinic studies have shown that 75% of chronic sinusitis sufferers saw improvement when treated with a topical fungicide. The Therapy is called topical antifungal therapy. An antifungal called Amphotericin B has already been approved by the FDA for other treatments and is normally administered to patients as an injection. For sinusitis cures it is made into a topical nasal spray and applied daily. The recommended dose is 100 micrograms/ml. This medication is generally not available in most pharmacies today. One must get the prescription filled through a compounding pharmacy such as Anazao.
The best thing to do is find a physician who is trained in administering this therapy, and that doctor can no doubt explain how to obtain the medication prescribed.
In some people the eosinophiles do not react to fungi present in the nasal mucus, and these people generally do not have chronic sinusitis. Why the eosinophiles act differently in different people is not yet known. Also, it is difficult to administer a test which will tell if one person has this type of reaction occur in his body or not. However, this theory would explain why some people are chronic sinusitis sufferers even after extensive conventional treatments or sinus operations. The conventional therapies and surgeries to date have simply not addressed this issue, since it was not known prior to the Mayo Clinic studies and patient tests.
Chronic sinusitis sufferers should be aware that this new therapy is available today in some locations, that it is gaining popularity, and it is becoming part of the arsenal of sinusitis cures available. People desperate for help should try to locate a physician who has been trained to administer this treatment and determine if it would help in their case. If you cannot locate such treatment in your area, please go to http://www.postnasaldrip.net and click the Contact Us button and well try to help, but travel may be required.
Walt Ballenberger is founder of http://www.postnasaldrip.net a resource web site for sinusitis sufferers like himself. For a free report entitled Sinus Treatment Success Stories, visit http://www.postnasaldrip.net and click on the Free Report link. This resource can be of significant help to chronic sinus sufferers.
Mal abwarten, wie Anfang 2008 die Ergebnisse des Trials ausschauen und wie sich später der mögliche Verkauf gestaltet...
Grüße
Obs wirklich "revolutionär" ist, wird man wohl gegen Mitte 2009 feststellen. Ein wenig sehr optimistisch...
Revolutionary treatment for multiple sclerosis
December 6, 2007
Accentia Biopharmaceuticals announces that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune™. The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune, the company’s potential therapeutic for refractory, relapsing-remitting Multiple Sclerosis (MS).
The FDA indicated that they support the proposed submission from Accentia and that they are in overall agreement with the proposed design of the Accentia clinical program.
The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial ’s design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune.
Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to “reboot” a patient’s immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data. The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.-The Investor Relations Group
Revolutionary treatment for multiple sclerosis
December 6, 2007
Accentia Biopharmaceuticals announces that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune™. The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune, the company’s potential therapeutic for refractory, relapsing-remitting Multiple Sclerosis (MS).
The FDA indicated that they support the proposed submission from Accentia and that they are in overall agreement with the proposed design of the Accentia clinical program.
The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial ’s design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune.
Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to “reboot” a patient’s immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data. The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.-The Investor Relations Group
Neues Geld für Biovest:
Accentia Announces That Biovest Has Closed an $8.5M Financing to Support Unblinding and Data Analysis of Fast Tracked Pivotal Phase 3 Study of BiovaxID for Non-Hodgkin's Lymphoma with Public Release of Results Anticipated by April 2008
TAMPA, Fla.FL-ACCENTIA/BIOVEST
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that its majority owned subsidiary, Biovest International, Inc. (OTCBB:BVTI) (?Biovest?), has secured an $8.5M debt financing from two institutional investors.
The proceeds from the loan will be used in part to finance the analysis of unblinded data on BiovaxIDTM, an active immunotherapeutic in a pivotal Phase 3 study of Non-Hodgkin?s Lymphoma. Biovest has closed the trial to new enrollment and downsized its vaccine production staffing in Worcester, MA, as it unblinds the study for the independent Data Monitoring Committee?s (DMC) review and performs analysis of the trial data. The trial was initiated by the National Cancer Institute in 2000 then acquired by Biovest in 2005. Accordingly, some patients in the trial have now been followed for nearly 7 years.
An independent clinical study at the University of Navarra in Spain, results of which were published in October 2006, has demonstrated that the administration of a BiovaxID formulation given to patients with relapsed follicular Non-Hodgkin?s Lymphoma following chemotherapy can induce complete long-lasting remissions. The median Duration of the second complete response has not been reached after nearly 3 years of follow-up and, as a result, 100% of those immunologic responding patients are sustaining significant disease free survival benefit measured in terms of years.
In the Phase 2 BiovaxID clinical study conducted at the National Cancer Institute (NCI), 20 patients in continuous first complete remission (CR) after chemotherapy treatment were treated with a series of 5 monthly vaccinations of BiovaxID conjugated to KLH and administered with local GM-CSF. After vaccination, 95% of patients showed autologous tumor-specific cellular T-cell responses and 75% of patients showed humoral antibody responses. With a median follow-up of 9.2 years, 45% of patients remained in continuous first CR and the median Disease Free Survival (DFS) for the cohort was 96.5 months, 8.0 years (American Society of Hematology, December 2005, Abstract #2441). Furthermore, 73% of evaluable patients were converted into molecular remission (bcl-2 negative) after the administration of BiovaxID and, thus, cleared their blood of residual cancer cells (American Society of Clinical Oncology, June 2006). At 9.2 years of follow-up, 95% of the patients remained alive, comparing favorably to historical controls where an approximate 50% survival would be expected at that time.
Furthermore, a Phase 2 trial conducted by the NCI shows BiovaxID yielded an 89% survival rate in mantle cell lymphoma patients. The median follow-up was 3.8 years. Historically, patients with this type of lymphoma only have had a 50% chance of surviving 3 years and a 20% chance of surviving 5 years. The data were published in a recent edition of Nature Medicine (Nat Med.2005; 11(9):986-91).
Biovest believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the US under subpart E and conditional approval in the EU. The company may use molecular data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the US and EU, respectively, where it has orphan status.
The financing was provided to Biovest by two of Biovest?s existing secured lenders, Valens Offshore SPV II, Corp. (?Valens Offshore?) and Valens U.S. SPV I, LLC. (?Valens US? and collectively ?Valens?) pursuant to a Note Purchase Agreement. Biovest issued secured Promissory Notes in the aggregate amount of $8,500,000 to Valens, which bear interest at Prime + 2% with a six-month term. Biovest paid closing fees and costs of approximately $300,000 and a portion of the loan proceeds was used to prepay interest and principal due to Biovest?s senior secured lender, Laurus Master Fund Ltd., with the balance of the proceeds to be used for operating capital and to complete the interim analysis of the BiovaxID clinical trial data. Biovest also granted a royalty in the aggregate amount of seven percent (7%) of worldwide net sales of the BiovaxID vaccine to Valens Offshore and Valens U.S. pursuant to a Royalty Agreement. The loan is secured by a security interest in all assets of Biovest and its subsidiaries.
Accentia and Biovest utilize a shared resource model for certain administrative, investor relations, accounting, and legal functions. James A. McNulty, CPA, serves as Secretary and Treasurer of Accentia and has been Biovest?s Chief Financial Officer since Accentia Biopharmaceuticals? Investment in June 2003, along with officer responsibilities in other related companies. Due to the requirement to devote more time to non-Biovest matters, Mr. McNulty will relinquish his Biovest CFO responsibilities effective December 31, 2007. Alan Pearce, CFO for Accentia, will assume the CFO role for Biovest at that time.
Accentia Announces That Biovest Has Closed an $8.5M Financing to Support Unblinding and Data Analysis of Fast Tracked Pivotal Phase 3 Study of BiovaxID for Non-Hodgkin's Lymphoma with Public Release of Results Anticipated by April 2008
TAMPA, Fla.FL-ACCENTIA/BIOVEST
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that its majority owned subsidiary, Biovest International, Inc. (OTCBB:BVTI) (?Biovest?), has secured an $8.5M debt financing from two institutional investors.
The proceeds from the loan will be used in part to finance the analysis of unblinded data on BiovaxIDTM, an active immunotherapeutic in a pivotal Phase 3 study of Non-Hodgkin?s Lymphoma. Biovest has closed the trial to new enrollment and downsized its vaccine production staffing in Worcester, MA, as it unblinds the study for the independent Data Monitoring Committee?s (DMC) review and performs analysis of the trial data. The trial was initiated by the National Cancer Institute in 2000 then acquired by Biovest in 2005. Accordingly, some patients in the trial have now been followed for nearly 7 years.
An independent clinical study at the University of Navarra in Spain, results of which were published in October 2006, has demonstrated that the administration of a BiovaxID formulation given to patients with relapsed follicular Non-Hodgkin?s Lymphoma following chemotherapy can induce complete long-lasting remissions. The median Duration of the second complete response has not been reached after nearly 3 years of follow-up and, as a result, 100% of those immunologic responding patients are sustaining significant disease free survival benefit measured in terms of years.
In the Phase 2 BiovaxID clinical study conducted at the National Cancer Institute (NCI), 20 patients in continuous first complete remission (CR) after chemotherapy treatment were treated with a series of 5 monthly vaccinations of BiovaxID conjugated to KLH and administered with local GM-CSF. After vaccination, 95% of patients showed autologous tumor-specific cellular T-cell responses and 75% of patients showed humoral antibody responses. With a median follow-up of 9.2 years, 45% of patients remained in continuous first CR and the median Disease Free Survival (DFS) for the cohort was 96.5 months, 8.0 years (American Society of Hematology, December 2005, Abstract #2441). Furthermore, 73% of evaluable patients were converted into molecular remission (bcl-2 negative) after the administration of BiovaxID and, thus, cleared their blood of residual cancer cells (American Society of Clinical Oncology, June 2006). At 9.2 years of follow-up, 95% of the patients remained alive, comparing favorably to historical controls where an approximate 50% survival would be expected at that time.
Furthermore, a Phase 2 trial conducted by the NCI shows BiovaxID yielded an 89% survival rate in mantle cell lymphoma patients. The median follow-up was 3.8 years. Historically, patients with this type of lymphoma only have had a 50% chance of surviving 3 years and a 20% chance of surviving 5 years. The data were published in a recent edition of Nature Medicine (Nat Med.2005; 11(9):986-91).
Biovest believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the US under subpart E and conditional approval in the EU. The company may use molecular data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the US and EU, respectively, where it has orphan status.
The financing was provided to Biovest by two of Biovest?s existing secured lenders, Valens Offshore SPV II, Corp. (?Valens Offshore?) and Valens U.S. SPV I, LLC. (?Valens US? and collectively ?Valens?) pursuant to a Note Purchase Agreement. Biovest issued secured Promissory Notes in the aggregate amount of $8,500,000 to Valens, which bear interest at Prime + 2% with a six-month term. Biovest paid closing fees and costs of approximately $300,000 and a portion of the loan proceeds was used to prepay interest and principal due to Biovest?s senior secured lender, Laurus Master Fund Ltd., with the balance of the proceeds to be used for operating capital and to complete the interim analysis of the BiovaxID clinical trial data. Biovest also granted a royalty in the aggregate amount of seven percent (7%) of worldwide net sales of the BiovaxID vaccine to Valens Offshore and Valens U.S. pursuant to a Royalty Agreement. The loan is secured by a security interest in all assets of Biovest and its subsidiaries.
Accentia and Biovest utilize a shared resource model for certain administrative, investor relations, accounting, and legal functions. James A. McNulty, CPA, serves as Secretary and Treasurer of Accentia and has been Biovest?s Chief Financial Officer since Accentia Biopharmaceuticals? Investment in June 2003, along with officer responsibilities in other related companies. Due to the requirement to devote more time to non-Biovest matters, Mr. McNulty will relinquish his Biovest CFO responsibilities effective December 31, 2007. Alan Pearce, CFO for Accentia, will assume the CFO role for Biovest at that time.
Research on Chronic Sinusitis
Mayo Clinic researchers have proposed that most chronic sinus infections may be caused by an immune system response to fungi.
Many studies at Mayo Clinic have added evidence to the thinking that chronic rhinosinusitis is caused by an immune reaction to fungi in the nose. Our original study linking chronic rhinosinusitis to fungi in the nose, which was published in the Mayo Clinic Proceedings in September 1999, has been reproduced and confirmed by a sinus center in Europe (ENT University Hospital in Graz, Austria).
There are currently 16 studies at Mayo Clinic Rochester to further investigate the role of fungi in inflammatory diseases of the respiratory tract.
In addition, researchers from the Allergic Diseases Research Laboratory at the Mayo Clinic in Rochester found that certain white blood cells called T-Lymphocytes are reacting to the fungi and were producing the kind of inflammation we see in the sinuses, and that healthy people did not react in that way. This work was presented at the 2001 Annual Meeting of the American Academy of Allergy, Asthma and Immunology and will be published soon.
The evidence was so convincing that the National Institute of Health (NIH) has given Mayo Clinic a $2.5 million grant to further investigate the mechanisms behind this immunologic response to the fungi.
If you have chronic sinusitis — that is, a sinus inflammation that persists for three months or longer — we recommend that you see your personal physician or an ear, nose and throat specialist (otorhinolaryngologist) for the appropriate treatment for this disease. Many times the disease is associated with asthma or allergies and treatment of those associated problems tends to help the chronic sinusitis.
Antibiotics do not help chronic sinusitis in the long run because they target bacteria, which are not usually the cause of chronic sinusitis. Anti-histamines, nasal steroid sprays and systemic steroids are the mainstays of treatment today, depending on the symptoms of the patient.
Over-the-counter medications, including salt-water nasal washes and mist sprays, are useful in treating the symptoms of chronic sinusitis, but do not eliminate the inflammation.
Dept of Otorhinolaryngology
Mayo Clinic
Rochester, Minnesota
Mayo Clinic researchers have proposed that most chronic sinus infections may be caused by an immune system response to fungi.
Many studies at Mayo Clinic have added evidence to the thinking that chronic rhinosinusitis is caused by an immune reaction to fungi in the nose. Our original study linking chronic rhinosinusitis to fungi in the nose, which was published in the Mayo Clinic Proceedings in September 1999, has been reproduced and confirmed by a sinus center in Europe (ENT University Hospital in Graz, Austria).
There are currently 16 studies at Mayo Clinic Rochester to further investigate the role of fungi in inflammatory diseases of the respiratory tract.
In addition, researchers from the Allergic Diseases Research Laboratory at the Mayo Clinic in Rochester found that certain white blood cells called T-Lymphocytes are reacting to the fungi and were producing the kind of inflammation we see in the sinuses, and that healthy people did not react in that way. This work was presented at the 2001 Annual Meeting of the American Academy of Allergy, Asthma and Immunology and will be published soon.
The evidence was so convincing that the National Institute of Health (NIH) has given Mayo Clinic a $2.5 million grant to further investigate the mechanisms behind this immunologic response to the fungi.
If you have chronic sinusitis — that is, a sinus inflammation that persists for three months or longer — we recommend that you see your personal physician or an ear, nose and throat specialist (otorhinolaryngologist) for the appropriate treatment for this disease. Many times the disease is associated with asthma or allergies and treatment of those associated problems tends to help the chronic sinusitis.
Antibiotics do not help chronic sinusitis in the long run because they target bacteria, which are not usually the cause of chronic sinusitis. Anti-histamines, nasal steroid sprays and systemic steroids are the mainstays of treatment today, depending on the symptoms of the patient.
Over-the-counter medications, including salt-water nasal washes and mist sprays, are useful in treating the symptoms of chronic sinusitis, but do not eliminate the inflammation.
Dept of Otorhinolaryngology
Mayo Clinic
Rochester, Minnesota
Was aktuelles zur BiovaxID Konkurenz:
Gestern hat es Genitope zerissen! Der Phase III Trial zeigt keine statistischen Veränderungen der MyVax Gruppe im Vergleich zur Kontrollgruppe. Eröffnet hatten die Aktien noch über 4 Dollar, im After Hours Handel ging es bis 1,21 $ zuletzt! Favrille wurde dadurch ebenfalls im After Hours Handel um über 30 % heruntergezogen. Es könnte also sein, dass Biovest heute stark unter die Räder gerät...
Favrille hatte übrigens keine Ergebnisse veröffentlicht. Das GTOPs MyVax Ergebnisse eher schlecht ausfallen, wurde in vielen Kreisen und Foren bereits hochgewettet. Letztendlich ist der Folgeschluss erst einmal, dass Biovest ein Konkurent weniger hat, es heißt nicht dass ein vaccine keine Nutzen bringen kann.
Grüße
Gestern hat es Genitope zerissen! Der Phase III Trial zeigt keine statistischen Veränderungen der MyVax Gruppe im Vergleich zur Kontrollgruppe. Eröffnet hatten die Aktien noch über 4 Dollar, im After Hours Handel ging es bis 1,21 $ zuletzt! Favrille wurde dadurch ebenfalls im After Hours Handel um über 30 % heruntergezogen. Es könnte also sein, dass Biovest heute stark unter die Räder gerät...
Favrille hatte übrigens keine Ergebnisse veröffentlicht. Das GTOPs MyVax Ergebnisse eher schlecht ausfallen, wurde in vielen Kreisen und Foren bereits hochgewettet. Letztendlich ist der Folgeschluss erst einmal, dass Biovest ein Konkurent weniger hat, es heißt nicht dass ein vaccine keine Nutzen bringen kann.
Grüße
Antwort auf Beitrag Nr.: 32.834.734 von Ackergaul am 21.12.07 09:22:42in Zuge auf die gestrigen Geschehnisse um GTOP gibt es heute von ABPI sogar eine Meldung:
Accentia Biopharmaceuticals Reaffirms its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients
Friday, December 21, 2007; Posted: 09:04 AM
TAMPA, Fla., Dec 21, 2007 (BUSINESS WIRE) -- GTOP | charts | news | PowerRating -- Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that it is reaffirming its confidence in the results of the ongoing unblinding of the BiovaxID(TM) pivotal Phase 3 results. Yesterday, Genitope Corporation announced that its recombinant partial copy of the tumor specific antigen for non-Hodgkins lymphoma, MyVax(R), elicited an immune response in just 40% of patients and that its Phase 3 clinical study of MyVax failed to meets its primary endpoint of statistically significant progression free survival vs control group.
Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.
According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International, the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.
The public release of the unblinding of the BiovaxID data is expected in April, 2008.
Accentia Biopharmaceuticals Reaffirms its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients
Friday, December 21, 2007; Posted: 09:04 AM
TAMPA, Fla., Dec 21, 2007 (BUSINESS WIRE) -- GTOP | charts | news | PowerRating -- Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that it is reaffirming its confidence in the results of the ongoing unblinding of the BiovaxID(TM) pivotal Phase 3 results. Yesterday, Genitope Corporation announced that its recombinant partial copy of the tumor specific antigen for non-Hodgkins lymphoma, MyVax(R), elicited an immune response in just 40% of patients and that its Phase 3 clinical study of MyVax failed to meets its primary endpoint of statistically significant progression free survival vs control group.
Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.
According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International, the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.
The public release of the unblinding of the BiovaxID data is expected in April, 2008.
Eye on Accentia Biopharmaceuticals
posted on: December 23, 2007
Last Thursday, Genitope (GTOP) released news that it Phase 3 Clinical trial for its anti-cancer vaccine MyVax did not meet its primary endpoint. The next morning there were numerous reports discussing two other companies that are releasing Phase 3 data for their own NHL anti-cancer vaccines. The two companies slated to report phase 3 data are Favrille (FVRL) and Biovest International (BVTI.OB). Accentia Biopharmaceuticals (ABPI), who is the majority shareholder of Biovest International, had this to report in regards to Biovest's NHL anti-cancer vaccine.
Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.
According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International, the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.
From what I understand, this drug was the first of the three NHL anti-cancer vaccines to be fast-tracked by the FDA. I believe if they can prove their vaccine is effective it could be a generous windfall for Accentia shareholders.
Putting the anti-cancer vaccine aside, before they release the unblinded data for Biovaxid they will be releasing unblinded data for their Fast tracked Phase 3 clinical trial of Sinunase for the treatment of Chronic Rhinosinusitis. CRS is a disease that is estimated to affect up to 39 million Americans. Apparently there are zero FDA approved treatment for CRS. Through research at the Mayo , they believe that it is a common airborne mold, fungus, from which a large part of our population is affected by.
The lead drug in Sinunase is Amphotericin-b. Amphotericin-b has been FDA approved for over 20 years to be injected into the body in fairly high doses. Yet, when applied to the skin it is not easily, if at all, absorbed into the body. Basically, the drug is flushed into the sinuses and is expected to kill the fungus that the Mayo clinic believes is causing the Eosinophils in tissue to migrate into the mucus attacking the fungus causing the CRS.
An amazing statistic is that currently there are over 200,000 prescriptions of Amphotericin-b written every year by doctors off-label to treat CRS. At a cost of around $2400.00 per year that is over $400M a year in potential instant revenue for Accentia if the trial proves effective.
With 2 Fast-tracked phase 3 clinical trials putting data out in the first 4 months of 2008, the opportunity is very real. Both drugs have the potential to be blockbusters. With Accentia's stock trading near $2.50.00 per share and a tiny $80M market cap, in my opinion if they show positive results on Sinunase we could see the stock near $20.00 right away and if Biovaxid proves effective we will see it near $30.00.
By the way, take a look at their other drug, Revimmune, which you may see in a Phase 3 trial starting in mid 2008 for the treatment of MS. I won't go into Revimmune just yet until we see the results of the two trials in early 08.
Disclosure: Author has a long position in ABPI
posted on: December 23, 2007
Last Thursday, Genitope (GTOP) released news that it Phase 3 Clinical trial for its anti-cancer vaccine MyVax did not meet its primary endpoint. The next morning there were numerous reports discussing two other companies that are releasing Phase 3 data for their own NHL anti-cancer vaccines. The two companies slated to report phase 3 data are Favrille (FVRL) and Biovest International (BVTI.OB). Accentia Biopharmaceuticals (ABPI), who is the majority shareholder of Biovest International, had this to report in regards to Biovest's NHL anti-cancer vaccine.
Accentia's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study at the University of Navarra to elicit an immune response in 80% of patients.
According to Dr. Steve Arikian, M.D., Chairman and CEO of Biovest International, the majority-owned subsidiary of Accentia that holds the worldwide exclusive rights to BiovaxID, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response."
Accordingly, Accentia reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Accentia believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively.
From what I understand, this drug was the first of the three NHL anti-cancer vaccines to be fast-tracked by the FDA. I believe if they can prove their vaccine is effective it could be a generous windfall for Accentia shareholders.
Putting the anti-cancer vaccine aside, before they release the unblinded data for Biovaxid they will be releasing unblinded data for their Fast tracked Phase 3 clinical trial of Sinunase for the treatment of Chronic Rhinosinusitis. CRS is a disease that is estimated to affect up to 39 million Americans. Apparently there are zero FDA approved treatment for CRS. Through research at the Mayo , they believe that it is a common airborne mold, fungus, from which a large part of our population is affected by.
The lead drug in Sinunase is Amphotericin-b. Amphotericin-b has been FDA approved for over 20 years to be injected into the body in fairly high doses. Yet, when applied to the skin it is not easily, if at all, absorbed into the body. Basically, the drug is flushed into the sinuses and is expected to kill the fungus that the Mayo clinic believes is causing the Eosinophils in tissue to migrate into the mucus attacking the fungus causing the CRS.
An amazing statistic is that currently there are over 200,000 prescriptions of Amphotericin-b written every year by doctors off-label to treat CRS. At a cost of around $2400.00 per year that is over $400M a year in potential instant revenue for Accentia if the trial proves effective.
With 2 Fast-tracked phase 3 clinical trials putting data out in the first 4 months of 2008, the opportunity is very real. Both drugs have the potential to be blockbusters. With Accentia's stock trading near $2.50.00 per share and a tiny $80M market cap, in my opinion if they show positive results on Sinunase we could see the stock near $20.00 right away and if Biovaxid proves effective we will see it near $30.00.
By the way, take a look at their other drug, Revimmune, which you may see in a Phase 3 trial starting in mid 2008 for the treatment of MS. I won't go into Revimmune just yet until we see the results of the two trials in early 08.
Disclosure: Author has a long position in ABPI
Wünsche allen ein schönes Weihnachtsfest!!!
Antwort auf Beitrag Nr.: 32.859.632 von Ackergaul am 24.12.07 09:36:00dto.
Ich denke in etwa 7 Wochen werden wir die entblindeten SinuNase Ergebnisse mitgeteilt bekommen - es geht also langsam auf die Zielgerade.
Vielleicht auch einer der Gründe dafür, dass gestriges Handelsvolumen mehr als 3x höher als normal ausfiel und heute auch ein reger Handelstag bevorsteht. Dann noch die BiovaxID News im März und der Start der Revimmune Phase III Mitte 2008...
2008 könnte ein ABPI Jahr werden...
Grüße!
Vielleicht auch einer der Gründe dafür, dass gestriges Handelsvolumen mehr als 3x höher als normal ausfiel und heute auch ein reger Handelstag bevorsteht. Dann noch die BiovaxID News im März und der Start der Revimmune Phase III Mitte 2008...
2008 könnte ein ABPI Jahr werden...
Grüße!
In meinem allerersten Posting hier hatte ich zum Umsatz folgendes geschrieben: 1.) Fangen wir bei den Umätzen an: Letztes Jahr etwa 25 Mil. $, dieses Jahr wohl nur noch etwa 18 - 19 Mil.
Nun sind es 18,3 mil. $ geworden, eigentlich ein Grund für ein 30 % Kursverlust. Dazu wird es wohl eher nicht kommen. Es war klar, dass der Umsatz stark fallen wird (auch wegen MDTurbo = totes Produkt) und die Verluste ausgeweitet werden (auch wegen der 2 aktuellen Phase III Trials). Eines ist zumindest klar, eine SinuNase Partnerschaftsmeldung muss her, gleichbedeutend mit einer fetten Vorabzahlung! Dies wird aber vorraussichtlich erst nach den SinuNase Ergebnissen geschehen.
Accentia FY07 Consolidated Net Loss Widens [ABPI]
12/28/2007 6:45:32 PM Accentia Biopharmaceuticals, Inc. (ABPI) reported a consolidated net loss for the fiscal year 2007 of $76.0 million or $2.21 per share, compared to consolidated net loss of $43.4 million or $1.56 per share for the fiscal year 2006.
Out of the loss of $2.21 per share in the fiscal year 2007, $1.11 per share was the result of non-cash charges and $0.95 per share reflected losses by Biovest International, Inc. (BVTI.OB) in which Accentia has a 76% stake.
Consolidated net sales for fiscal 2007 fell to $18.3 million from $25.1 million in the prior fiscal year.
Accentia said it main focus is dedicated to the late-stage, Phase III clinical development of its three potential blockbuster therapeutics; SinuNase for the treatment of chronic sinusitis; Revimmune for the treatment of up to 80 autoimmune diseases, with an initial indication of multiple sclerosis; and BiovaxID, a personalized anti-cancer vaccine initially targeting non-Hodgkin's lymphoma.
The company said it plans to report phase 3 trial results for SinuNase and BiovaxID in the first half of 2008, with positive data expected to accelerate U.S. and European regulatory approvals.
Additionally, Accentia announced that Todd Thomason has resigned as a director of the company, effective December 31, as a result of his decision to accept employment with a company in the healthcare industry.
Viel Glück Euch allen!!!
Nun sind es 18,3 mil. $ geworden, eigentlich ein Grund für ein 30 % Kursverlust. Dazu wird es wohl eher nicht kommen. Es war klar, dass der Umsatz stark fallen wird (auch wegen MDTurbo = totes Produkt) und die Verluste ausgeweitet werden (auch wegen der 2 aktuellen Phase III Trials). Eines ist zumindest klar, eine SinuNase Partnerschaftsmeldung muss her, gleichbedeutend mit einer fetten Vorabzahlung! Dies wird aber vorraussichtlich erst nach den SinuNase Ergebnissen geschehen.
Accentia FY07 Consolidated Net Loss Widens [ABPI]
12/28/2007 6:45:32 PM Accentia Biopharmaceuticals, Inc. (ABPI) reported a consolidated net loss for the fiscal year 2007 of $76.0 million or $2.21 per share, compared to consolidated net loss of $43.4 million or $1.56 per share for the fiscal year 2006.
Out of the loss of $2.21 per share in the fiscal year 2007, $1.11 per share was the result of non-cash charges and $0.95 per share reflected losses by Biovest International, Inc. (BVTI.OB) in which Accentia has a 76% stake.
Consolidated net sales for fiscal 2007 fell to $18.3 million from $25.1 million in the prior fiscal year.
Accentia said it main focus is dedicated to the late-stage, Phase III clinical development of its three potential blockbuster therapeutics; SinuNase for the treatment of chronic sinusitis; Revimmune for the treatment of up to 80 autoimmune diseases, with an initial indication of multiple sclerosis; and BiovaxID, a personalized anti-cancer vaccine initially targeting non-Hodgkin's lymphoma.
The company said it plans to report phase 3 trial results for SinuNase and BiovaxID in the first half of 2008, with positive data expected to accelerate U.S. and European regulatory approvals.
Additionally, Accentia announced that Todd Thomason has resigned as a director of the company, effective December 31, as a result of his decision to accept employment with a company in the healthcare industry.
Viel Glück Euch allen!!!
Erst einmal noch ein frohes neues Jahr...
Am 27.12. hat Francis O'Donnell über "seine" Hopkins Capital Group 175.000 Aktien (zu 2,91 $ je Stück) geordert. Dem Vorstand selber ist der Handel mit den eigenen Aktien ja zur Zeit nicht erlaubt.
http://sec.gov/Archives/edgar/data/1066040/00011814310707821…
Dass Handels Volumen ist in den letzten Tagen stark gestiegen, dem Kurs ist es gut bekommen.
Kritisches:
In der Nachricht vom 28.12. stand nebenbei bemerkt, dass Todd Thomason (Board of Directors) ABPI verlässt. Kann man natürlich nun hinterfragen, warum gerade jetzt, kurz vor einer vermeintlich positiven Firmenentwicklung...
aus dem annual report mal die negativen Seiten:
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx…
zum Schuldenstand:
As of December 27, 2007, our debt includes the following:
• $3.9 million in principal amount outstanding under our term note with Laurus
• $5.0 million in principal amount outstanding under Biovest’s term note with Laurus
• $12.9 million in principal amount outstanding under our September 29, 2006 convertible debentures.
• $24.6 million in principal amount outstanding under our February 27, 2007 convertible debentures.
• $1.0 million in principal outstanding under the Hopkins II line of credit
• $4.0 million in principal outstanding under the Southwest line of credit
• $7.4 million in principal outstanding under the Laurus line of credit
• $1.8 million in principal outstanding under Biovest’s Pulaski Notes
• $9.0 million in principal outstanding under Biovest’s notes with the Valens Funds
• $1.0 million in principal outstanding under Biovest’s other notes payable
• $0.6 million in principal outstanding under other long-term debt
Under the $3.9 million term note with Laurus, assuming that Laurus does not convert the note, we are obligated to make equal monthly payments of principal and interest of $0.3 million each through the period ending in April 2008 of which $1.7 million is being held in a restricted account. Under the $3.9 million term note with Laurus, we are obligated to make equal monthly payments of principal and interest of $0.3 million each through the period ending in March 2009. The Valens U.S. SPV I, LLC and Valens Offshore SPV II, Corp. notes are due in full in March 2009. Principal payments commenced on the September 2006 convertible debenture in October 2007 and will continue through maturity in September 2010 assuming that the balance is not converted. Principal payments will commence on the February 2007 debenture in March 2008 assuming the balance is not converted. Our level of debt affects our operations in several important ways, including the following:
...
und auch jede Menge Aktien werden noch auf den Markt gelangen:
• 2,777,783 shares issuable upon exercise of options and warrants to purchase our common stock were vested and eligible for sale;
• 1,984,345 shares issuable upon the conversion of convertible notes and the exercise of warrants held by Laurus are eligible for immediate sale under a currently effective registration statement covering the resale of such shares by Laurus (but only if Laurus elects to convert or exercise such notes and warrants and subject to certain volume limitations on conversion and exercise); and
• 8,343,415 shares issuable upon the conversion of convertible debentures and the exercise of warrants held by investors in our September 2006 private placement are eligible for immediate sale (but only if such investors elect to convert or exercise such debentures and warrants).
• 9,041,198 shares issuable upon the conversion of convertible debentures and the exercise of warrants held by investors in our February 2007 private placement are eligible for immediate sale (but only if such investors elect to convert or exercise such debentures and warrants).
Grüße
Am 27.12. hat Francis O'Donnell über "seine" Hopkins Capital Group 175.000 Aktien (zu 2,91 $ je Stück) geordert. Dem Vorstand selber ist der Handel mit den eigenen Aktien ja zur Zeit nicht erlaubt.
http://sec.gov/Archives/edgar/data/1066040/00011814310707821…
Dass Handels Volumen ist in den letzten Tagen stark gestiegen, dem Kurs ist es gut bekommen.
Kritisches:
In der Nachricht vom 28.12. stand nebenbei bemerkt, dass Todd Thomason (Board of Directors) ABPI verlässt. Kann man natürlich nun hinterfragen, warum gerade jetzt, kurz vor einer vermeintlich positiven Firmenentwicklung...
aus dem annual report mal die negativen Seiten:
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx…
zum Schuldenstand:
As of December 27, 2007, our debt includes the following:
• $3.9 million in principal amount outstanding under our term note with Laurus
• $5.0 million in principal amount outstanding under Biovest’s term note with Laurus
• $12.9 million in principal amount outstanding under our September 29, 2006 convertible debentures.
• $24.6 million in principal amount outstanding under our February 27, 2007 convertible debentures.
• $1.0 million in principal outstanding under the Hopkins II line of credit
• $4.0 million in principal outstanding under the Southwest line of credit
• $7.4 million in principal outstanding under the Laurus line of credit
• $1.8 million in principal outstanding under Biovest’s Pulaski Notes
• $9.0 million in principal outstanding under Biovest’s notes with the Valens Funds
• $1.0 million in principal outstanding under Biovest’s other notes payable
• $0.6 million in principal outstanding under other long-term debt
Under the $3.9 million term note with Laurus, assuming that Laurus does not convert the note, we are obligated to make equal monthly payments of principal and interest of $0.3 million each through the period ending in April 2008 of which $1.7 million is being held in a restricted account. Under the $3.9 million term note with Laurus, we are obligated to make equal monthly payments of principal and interest of $0.3 million each through the period ending in March 2009. The Valens U.S. SPV I, LLC and Valens Offshore SPV II, Corp. notes are due in full in March 2009. Principal payments commenced on the September 2006 convertible debenture in October 2007 and will continue through maturity in September 2010 assuming that the balance is not converted. Principal payments will commence on the February 2007 debenture in March 2008 assuming the balance is not converted. Our level of debt affects our operations in several important ways, including the following:
...
und auch jede Menge Aktien werden noch auf den Markt gelangen:
• 2,777,783 shares issuable upon exercise of options and warrants to purchase our common stock were vested and eligible for sale;
• 1,984,345 shares issuable upon the conversion of convertible notes and the exercise of warrants held by Laurus are eligible for immediate sale under a currently effective registration statement covering the resale of such shares by Laurus (but only if Laurus elects to convert or exercise such notes and warrants and subject to certain volume limitations on conversion and exercise); and
• 8,343,415 shares issuable upon the conversion of convertible debentures and the exercise of warrants held by investors in our September 2006 private placement are eligible for immediate sale (but only if such investors elect to convert or exercise such debentures and warrants).
• 9,041,198 shares issuable upon the conversion of convertible debentures and the exercise of warrants held by investors in our February 2007 private placement are eligible for immediate sale (but only if such investors elect to convert or exercise such debentures and warrants).
Grüße
<<<<SinuNase™
Progressing at an accelerated pace via FDA Fast-Track Status, we reported the successful completion of patient enrollment in October 2007 for our pivotal Phase 3 clinical trial for SinuNase, which we expect will be the first ever product approved for chronic sinusitis (CS), a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
I am pleased to report that we now have interim, blinded, intent-to-treat data on the primary endpoint (complete resolution of both cardinal symptoms) at the conclusion of the study for approximately 80% of the patients in the study. This interim blinded data shows that approximately 20% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and another 23% of patients are achieving complete resolution of one or the other cardinal symptom at 16 weeks. To put these results in perspective, it is important to remember that 50% of the patients received SinuNase and that 50% received a placebo control that had no antifungal activity.
For more information on SinuNase Phase 3 interim, blinded results to date, see http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
As previously reported, there continues to be a very strong positive correlation of symptom resolution and objective evidence of reduced inflammation by endoscopy and/or CT scan, which we believe indicates that patients are experiencing a therapeutic effect rather than a placebo effect. Patients who achieved the primary endpoint, meaning those who experienced complete resolution of both cardinal symptoms, had on average more than a 300% greater reduction in polyps as measured by endoscopy and on average more than a 500% greater reduction in sinus inflammation as measured by CT scan than patients who had no symptom resolution.
Accordingly, I personally believe that the final results, due to be unblinded and reported in March, will show a highly statistically significant outcome for SinuNase; thus paving the way for its approval. Initially, we plan to seek an expedited approval through an FDA pathway called Subpart H, which allows for accelerated, conditional approval of therapeutics for serious unmet clinical indications. This approval would make SinuNase available to be prescribed for the most serious cases of CS. To significantly expand upon that market, we intend to conduct a second, confirmatory Phase 3 study, for which we have already identified a potential pool of approximately 200 CS patients. It is our goal to complete the confirmatory trial and submit a New Drug Application (NDA) with the FDA, seeking broad, unconditional approval for SinuNase, before the end of 2008.
Pending Milestones for SinuNase in 2008:
Report results from the unblinding and complete analysis of the pivotal Phase 3 clinical trial in March 2008
File with FDA for accelerated, conditional approval for SinuNase in mid-calendar year 2008
Concurrent with seeking FDA approval, seek European regulatory approval via EMEA registration pathway
Launch marketing and sales initiatives upon conditional approval in late-calendar year 2008
Conduct and complete confirmatory Phase 3 clinical trial in late-calendar year 2008
Upon positive confirmatory trial results, file with the FDA for unconditional approval
Announce key commercial license agreement(s) for the U.S. and foreign markets
SinuNase is especially unique because it is the first product to target the true cause of CS – a fungal-induced inflammation – based on breakthrough findings discovered at the Mayo Clinic, from whom we licensed the worldwide, exclusive, commercial rights to SinuNase.
Researchers at Mayo determined that CS is actually caused by a normally innocuous mold, but which in CS patients elicits a destructive, inflammatory response. This was confirmed by testing for the presence of eMBP (eosinophillic major basic protein), which is a toxic protein released by inflammatory cells in response to the fungi.
Mayo’s research leads us to believe that most, if not all cases of CS are due to fungal-induced inflammation. SinuNase is the only intranasal, anti-fungal CS product that has been submitted as an Investigative New Drug (IND) to the FDA. We also continue to strengthen our patent portfolio for SinuNase with key patents being granted in the U.S. and EU covering the treatment of CS with intranasal anti-fungals, including the active ingredient in SinuNase. Additionally, we have an agreement with IMMCO Diagnostics to commercialize SinuTest™, which is a diagnostic used to measure eMBP in the nasal mucin of suspected CS patients. This diagnostic is expected to provide physicians with a valuable tool to predict those patient candidates best suited to benefit from treatment with SinuNase – a comprehensive approach to diagnosis and treatment.
>>>>
Quelle: http://biz.yahoo.com/bw/080107/20080107005910.html?.v=1
Progressing at an accelerated pace via FDA Fast-Track Status, we reported the successful completion of patient enrollment in October 2007 for our pivotal Phase 3 clinical trial for SinuNase, which we expect will be the first ever product approved for chronic sinusitis (CS), a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
I am pleased to report that we now have interim, blinded, intent-to-treat data on the primary endpoint (complete resolution of both cardinal symptoms) at the conclusion of the study for approximately 80% of the patients in the study. This interim blinded data shows that approximately 20% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and another 23% of patients are achieving complete resolution of one or the other cardinal symptom at 16 weeks. To put these results in perspective, it is important to remember that 50% of the patients received SinuNase and that 50% received a placebo control that had no antifungal activity.
For more information on SinuNase Phase 3 interim, blinded results to date, see http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
As previously reported, there continues to be a very strong positive correlation of symptom resolution and objective evidence of reduced inflammation by endoscopy and/or CT scan, which we believe indicates that patients are experiencing a therapeutic effect rather than a placebo effect. Patients who achieved the primary endpoint, meaning those who experienced complete resolution of both cardinal symptoms, had on average more than a 300% greater reduction in polyps as measured by endoscopy and on average more than a 500% greater reduction in sinus inflammation as measured by CT scan than patients who had no symptom resolution.
Accordingly, I personally believe that the final results, due to be unblinded and reported in March, will show a highly statistically significant outcome for SinuNase; thus paving the way for its approval. Initially, we plan to seek an expedited approval through an FDA pathway called Subpart H, which allows for accelerated, conditional approval of therapeutics for serious unmet clinical indications. This approval would make SinuNase available to be prescribed for the most serious cases of CS. To significantly expand upon that market, we intend to conduct a second, confirmatory Phase 3 study, for which we have already identified a potential pool of approximately 200 CS patients. It is our goal to complete the confirmatory trial and submit a New Drug Application (NDA) with the FDA, seeking broad, unconditional approval for SinuNase, before the end of 2008.
Pending Milestones for SinuNase in 2008:
Report results from the unblinding and complete analysis of the pivotal Phase 3 clinical trial in March 2008
File with FDA for accelerated, conditional approval for SinuNase in mid-calendar year 2008
Concurrent with seeking FDA approval, seek European regulatory approval via EMEA registration pathway
Launch marketing and sales initiatives upon conditional approval in late-calendar year 2008
Conduct and complete confirmatory Phase 3 clinical trial in late-calendar year 2008
Upon positive confirmatory trial results, file with the FDA for unconditional approval
Announce key commercial license agreement(s) for the U.S. and foreign markets
SinuNase is especially unique because it is the first product to target the true cause of CS – a fungal-induced inflammation – based on breakthrough findings discovered at the Mayo Clinic, from whom we licensed the worldwide, exclusive, commercial rights to SinuNase.
Researchers at Mayo determined that CS is actually caused by a normally innocuous mold, but which in CS patients elicits a destructive, inflammatory response. This was confirmed by testing for the presence of eMBP (eosinophillic major basic protein), which is a toxic protein released by inflammatory cells in response to the fungi.
Mayo’s research leads us to believe that most, if not all cases of CS are due to fungal-induced inflammation. SinuNase is the only intranasal, anti-fungal CS product that has been submitted as an Investigative New Drug (IND) to the FDA. We also continue to strengthen our patent portfolio for SinuNase with key patents being granted in the U.S. and EU covering the treatment of CS with intranasal anti-fungals, including the active ingredient in SinuNase. Additionally, we have an agreement with IMMCO Diagnostics to commercialize SinuTest™, which is a diagnostic used to measure eMBP in the nasal mucin of suspected CS patients. This diagnostic is expected to provide physicians with a valuable tool to predict those patient candidates best suited to benefit from treatment with SinuNase – a comprehensive approach to diagnosis and treatment.
>>>>
Quelle: http://biz.yahoo.com/bw/080107/20080107005910.html?.v=1
Antwort auf Beitrag Nr.: 32.967.526 von Erbse1 am 07.01.08 15:31:57Accentia's CEO Provides Outlook for 2008 including Update on SinuNase Phase 3 Blinded Trial Results on 80% of Patients
Phase III Trial Results Pending for SinuNase and BiovaxID Expected
to Expedite Regulatory Pathway for U.S. and EU Approvals
TAMPA, Fla.--(BUSINESS WIRE)--Jan. 7, 2008--The following letter is from Dr. Francis E. O'Donnell, Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals (NASDAQ:ABPI). In addition to these comments, stockholders and potential investors are referred to: the Company's SEC filings, including Form 10-K and Form 10-Q (Annual and Quarterly Reports); press releases; website; and other publicly disseminated information, which is available free of charge upon request by contacting the Company.
Dear Valued Shareholders,
I am extremely pleased and proud to report to you that 2007 was a year of extraordinary accomplishment, which included obtaining the worldwide exclusive commercial rights to Revimmune(TM) for autoimmune diseases, adding yet another "disruptive" drug product with enormous potential to our portfolio, as this novel therapeutic regimen targets up to 80 autoimmune diseases, including multiple sclerosis. We also continued to make great strides, both from a scientific and regulatory perspective, advancing the tremendous commercial promise of our two primary product candidates, SinuNase(TM) and BiovaxID(TM), with multiple milestones achieved, thus setting the stage to report, what we believe to be, unprecedented Phase 3 clinical results for both products in early 2008.
Operationally, we are in the best shape we have ever been. With the anticipated approval of AllerNase(TM), an intra-nasal steroid in our product pipeline, in 2008, we anticipate our Specialty Pharmaceuticals business segment will achieve operating profitability by year-end while sustaining a sales force focused on ear, nose and throat specialists (ENTs), allergists, and other respiratory specialists, which will also ideally position us for a successful launch of SinuNase when it is approved. Additionally, our Analytica subsidiary, which provides consulting services to the biopharmaceutical industry just completed a profitable year and is expected to show further growth in 2008. And our Biovest subsidiary is anticipated to reach profitability by year-end, as a consequence of reduced clinical trial expenditures as it pursues its regulatory approval strategy for BiovaxID and as we anticipate growth in commercial sales of our recently launched AutovaxID(TM), a unique automated cell production instrument. We believe that these favorable developments will help ensure that we have a substantial source of revenues to help support our operations, as we work towards U.S. and international approvals for our potential blockbuster immunotherapies.
It is my privilege to provide this report to you regarding each of these valuable drugs and technologies, including outlining our strategic vision moving forward, as we build a dynamic and thriving business providing "best-in-class" therapies for chronic and life-threatening diseases. I am convinced that we are poised to make 2008 a breakthrough year for Accentia Biopharmaceuticals, and for our valued shareholders.
SinuNase(TM)
Progressing at an accelerated pace via FDA Fast-Track Status, we reported the successful completion of patient enrollment in October 2007 for our pivotal Phase 3 clinical trial for SinuNase, which we expect will be the first ever product approved for chronic sinusitis (CS), a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
I am pleased to report that we now have interim, blinded, intent-to-treat data on the primary endpoint (complete resolution of both cardinal symptoms) at the conclusion of the study for approximately 80% of the patients in the study. This interim blinded data shows that approximately 20% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and another 23% of patients are achieving complete resolution of one or the other cardinal symptom at 16 weeks. To put these results in perspective, it is important to remember that 50% of the patients received SinuNase and that 50% received a placebo control that had no antifungal activity.
For more information on SinuNase Phase 3 interim, blinded results to date, see http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
As previously reported, there continues to be a very strong positive correlation of symptom resolution and objective evidence of reduced inflammation by endoscopy and/or CT scan, which we believe indicates that patients are experiencing a therapeutic effect rather than a placebo effect. Patients who achieved the primary endpoint, meaning those who experienced complete resolution of both cardinal symptoms, had on average more than a 300% greater reduction in polyps as measured by endoscopy and on average more than a 500% greater reduction in sinus inflammation as measured by CT scan than patients who had no symptom resolution.
Accordingly, I personally believe that the final results, due to be unblinded and reported in March, will show a highly statistically significant outcome for SinuNase; thus paving the way for its approval. Initially, we plan to seek an expedited approval through an FDA pathway called Subpart H, which allows for accelerated, conditional approval of therapeutics for serious unmet clinical indications. This approval would make SinuNase available to be prescribed for the most serious cases of CS. To significantly expand upon that market, we intend to conduct a second, confirmatory Phase 3 study, for which we have already identified a potential pool of approximately 200 CS patients. It is our goal to complete the confirmatory trial and submit a New Drug Application (NDA) with the FDA, seeking broad, unconditional approval for SinuNase, before the end of 2008.
Pending Milestones for SinuNase in 2008:
-- Report results from the unblinding and complete analysis of
the pivotal Phase 3 clinical trial in March 2008
-- File with FDA for accelerated, conditional approval for
SinuNase in mid-calendar year 2008
-- Concurrent with seeking FDA approval, seek European regulatory
approval via EMEA registration pathway
-- Launch marketing and sales initiatives upon conditional
approval in late-calendar year 2008
-- Conduct and complete confirmatory Phase 3 clinical trial in
late-calendar year 2008
-- Upon positive confirmatory trial results, file with the FDA
for unconditional approval
-- Announce key commercial license agreement(s) for the U.S. and
foreign markets
SinuNase is especially unique because it is the first product to target the true cause of CS - a fungal-induced inflammation - based on breakthrough findings discovered at the Mayo Clinic, from whom we licensed the worldwide, exclusive, commercial rights to SinuNase.
Researchers at Mayo determined that CS is actually caused by a normally innocuous mold, but which in CS patients elicits a destructive, inflammatory response. This was confirmed by testing for the presence of eMBP (eosinophillic major basic protein), which is a toxic protein released by inflammatory cells in response to the fungi.
Mayo's research leads us to believe that most, if not all cases of CS are due to fungal-induced inflammation. SinuNase is the only intranasal, anti-fungal CS product that has been submitted as an Investigative New Drug (IND) to the FDA. We also continue to strengthen our patent portfolio for SinuNase with key patents being granted in the U.S. and EU covering the treatment of CS with intranasal anti-fungals, including the active ingredient in SinuNase. Additionally, we have an agreement with IMMCO Diagnostics to commercialize SinuTest(TM), which is a diagnostic used to measure eMBP in the nasal mucin of suspected CS patients. This diagnostic is expected to provide physicians with a valuable tool to predict those patient candidates best suited to benefit from treatment with SinuNase - a comprehensive approach to diagnosis and treatment.
BiovaxID(TM)
Through our majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), we are extremely optimistic and excited regarding the progress of BiovaxID, a personalized cancer vaccine, now in a pivotal Phase 3 Fast-Tracked trial, that is initially targeting non-Hodgkin's lymphoma, with the potential to treat many difficult-to-treat B-cell related cancers such as multiple myeloma and chronic lymphocytic leukemia. BiovaxID is nearing the completion of an interim analysis for BiovaxID, and we expect to report the analysis of the unblinded results by the end of April 2008. Based on very favorable follow-up data from previous Phase 2 studies reported by the National Cancer Institute and independent research conducted in Spain, coupled with statistical evidence from blinded data suggesting that BiovaxID is achieving efficacy endpoints with an excellent overall safety profile, we remain confident that we will report statistically significant survival benefits; such positive results would allow us to move forward in seeking accelerated and conditional approvals in the U.S. and Europe later this year.
Pending Milestones for BiovaxID in 2008:
-- Report results from the unblinding and complete analysis of
the pivotal Phase III clinical trial by the end of April 2008
-- Meet with the FDA to present data and determine registration
pathways for accelerated approval in the U.S. by mid-calendar
year 2008
-- Meet with the EMEA to present data and determine expedited
registration pathways for conditional approval in EU by
mid-calendar year 2008
-- Launch marketing and sales initiatives upon conditional
approval
-- Announce strategic, multi-national, marketing partnership
BiovaxID is a customized therapy, unique from any other cancer vaccine, in the manner in which it is derived from a patient's own cancer cells; designed to harness the power of the patient's immune system, by "training" it to recognize and selectively destroy just cancerous lymphoma cells. As such, BiovaxID is positioned to be a valuable complement to existing standards of care, and not a competitor.
Dr. Steven Arikian, Chairman and CEO of Biovest, will soon be issuing his letter to shareholders, providing a comprehensive update on the status and potential of BiovaxID. I will defer to his pending report for more complete details regarding the great promise of BiovaxID and its potential to revolutionize the treatment of non-Hodgkin's lymphoma by inducing indefinitely prolonged remissions.
Suffice it to say, BiovaxID is expected to be a significant driver of growth, and a catalyst for partnering and licensing opportunities for Accentia and Biovest, as we progress this product to market - a major breakthrough opportunity to save and prolong the lives of those suffering from this insidious kind of cancer.
Revimmune(TM)
I was especially excited when we announced in 2007 that Accentia had acquired the worldwide exclusive license to Revimmune for autoimmune diseases, a technology developed at the Johns Hopkins University School of Medicine, believed to offer unprecedented benefits for the treatment of up to 80 autoimmune diseases, including multiple sclerosis (MS).
Justifying my enthusiasm, in a pre-Investigational New Drug meeting (IND), the FDA indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized, controlled, multi-center clinical trial of Revimmune, evaluating the treatment of MS.
I need to stress how important this planned trial is because it differs dramatically from the protocol of any previously conducted MS trial. All of the products currently on the market for MS were approved based on their ability to slow the progression of disability, not improve the patient's functional status. In contrast, we aim to show that Revimmune is capable of reversing the disease's effects and reducing disability.
As you can imagine, this kind of accomplishment would catapult Accentia to become a worldwide leader in the treatment of autoimmune disease, forever changing the way in which these diseases are treated - with an aim to actually improve the patient's condition and eliminate the autoimmunity.
Pending Milestones for Revimmune in 2008:
-- File IND application with FDA in March / April 2008
-- Commence enrollment for Phase 3 clinical trial by mid-calendar
year 2008
-- Cultivate relationships with potential strategic,
multi-national, marketing partners
We anticipate that the Revimmune Phase 3 clinical trial protocol will include a comprehensive and proprietary risk management program to enhance patient safety by ensuring appropriate patient selection and by including specially designed supportive care, with these key aspects also enhancing the product's patent protections.
Revimmune therapy consists of an ultra-high intensity, short-course, intravenous formulation of an already approved pharmaceutical, cyclophosphamide. In previous studies, Revimmune has been shown to "reboot" a patient's immune system, thereby typically eliminating the autoimmunity. The "rebooting" process is achieved because Revimmune eliminates the cells causing the autoimmunity and spares the stem cells in the bone marrow. These surviving stem cells are then able to repopulate a restored, uncompromised immune system.
Simply said, there is no approved drug product that eliminates autoimmunity, and Revimmune would be the world's first therapy to propose the restoration of neurologic function as the primary endpoint and offer the potential for the elimination of autoimmunity.
Blockbuster Potential
I do not believe that our current market valuation comes remotely close to reflecting our growth prospects, considering our portfolio possesses such tremendous blockbuster potential, and especially with two of those products on the verge of reporting Phase 3 results. Based upon the anticipated unconditional approval of SinuNase, we forecast the market opportunity for peak year sales could exceed $1 billion. Based upon the anticipated unconditional approval of BiovaxID, we also forecast that the market opportunity for peak year sales could exceed $1 billion. We believe that Revimmune has the potential to be a blockbuster, as it is expected to show utility in up to 80 autoimmune diseases. And AllerNase also represents handsome near-term potential. While I believe the shares of Accentia are currently dramatically undervalued, I am also convinced this will be a temporary situation.
Driving Shareholder Value
Based on the magnitude of the milestones we expect to report throughout 2008, we plan to enhance the Company's visibility within the investment community. We have launched an investor relations campaign in order to effectively articulate Management's strategic vision and generate awareness and support from institutional and retail investors, both on Wall Street and internationally. Mr. Douglas Calder has joined us in the role of Director of Investor Relations and Public Relations, and I invite you to contact him to discuss our plans to broadly communicate Accentia's compelling investment case; plans expected to play an important role in creating significant shareholder value.
Closing Comments
We believe that the execution of Accentia's business plan through fiscal 2007 has created a solid foundation for the Company's dramatic and sustainable growth. Today, we have a robust product pipeline of drugs and technologies which provide short, medium and long-term potential, targeting several multi-billion dollar markets. These products offer the potential for superior efficacy and safety, as compared to competitive therapies, in addressing chronic and life-threatening diseases.
In summary, we will focus our efforts on completing the clinical development and obtaining regulatory approvals for SinuNase, BiovaxID and Revimmune. We will continue to seek to add new late-stage "disruptive" clinical products and technologies to strengthen our already impressive portfolio. And we will pursue key strategic partnerships to effectively develop and market our products worldwide.
Our accomplishments to date, and our ambitious and realizable plans, are a direct result of the tireless work performed by our highly talented and dedicated employees, and I congratulate all of them for their passion and their daily contributions.
And I also thank our shareholders for their enduring support, as we will continue to strive to reward their understanding of the goals which we have set out to achieve.
Sincerely,
Francis E. O'Donnell, Jr., M.D.
Chairman and Chief Executive Officer
For further information, please visit: http://www.Accentia.net
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM), AllerNase(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
MULTIMEDIA AVAILABLE:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
CONTACT: Accentia Biopharmaceuticals, Inc., Tampa
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554, ext.258
Email: dwcalder@accentia.net
or
Susan Bonitz, Ph.D., Director, Program Coordination
813-864-2554, ext.277
Email: sbonitz@accentia.net
SOURCE: Accentia Biopharmaceuticals, Inc
Phase III Trial Results Pending for SinuNase and BiovaxID Expected
to Expedite Regulatory Pathway for U.S. and EU Approvals
TAMPA, Fla.--(BUSINESS WIRE)--Jan. 7, 2008--The following letter is from Dr. Francis E. O'Donnell, Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals (NASDAQ:ABPI). In addition to these comments, stockholders and potential investors are referred to: the Company's SEC filings, including Form 10-K and Form 10-Q (Annual and Quarterly Reports); press releases; website; and other publicly disseminated information, which is available free of charge upon request by contacting the Company.
Dear Valued Shareholders,
I am extremely pleased and proud to report to you that 2007 was a year of extraordinary accomplishment, which included obtaining the worldwide exclusive commercial rights to Revimmune(TM) for autoimmune diseases, adding yet another "disruptive" drug product with enormous potential to our portfolio, as this novel therapeutic regimen targets up to 80 autoimmune diseases, including multiple sclerosis. We also continued to make great strides, both from a scientific and regulatory perspective, advancing the tremendous commercial promise of our two primary product candidates, SinuNase(TM) and BiovaxID(TM), with multiple milestones achieved, thus setting the stage to report, what we believe to be, unprecedented Phase 3 clinical results for both products in early 2008.
Operationally, we are in the best shape we have ever been. With the anticipated approval of AllerNase(TM), an intra-nasal steroid in our product pipeline, in 2008, we anticipate our Specialty Pharmaceuticals business segment will achieve operating profitability by year-end while sustaining a sales force focused on ear, nose and throat specialists (ENTs), allergists, and other respiratory specialists, which will also ideally position us for a successful launch of SinuNase when it is approved. Additionally, our Analytica subsidiary, which provides consulting services to the biopharmaceutical industry just completed a profitable year and is expected to show further growth in 2008. And our Biovest subsidiary is anticipated to reach profitability by year-end, as a consequence of reduced clinical trial expenditures as it pursues its regulatory approval strategy for BiovaxID and as we anticipate growth in commercial sales of our recently launched AutovaxID(TM), a unique automated cell production instrument. We believe that these favorable developments will help ensure that we have a substantial source of revenues to help support our operations, as we work towards U.S. and international approvals for our potential blockbuster immunotherapies.
It is my privilege to provide this report to you regarding each of these valuable drugs and technologies, including outlining our strategic vision moving forward, as we build a dynamic and thriving business providing "best-in-class" therapies for chronic and life-threatening diseases. I am convinced that we are poised to make 2008 a breakthrough year for Accentia Biopharmaceuticals, and for our valued shareholders.
SinuNase(TM)
Progressing at an accelerated pace via FDA Fast-Track Status, we reported the successful completion of patient enrollment in October 2007 for our pivotal Phase 3 clinical trial for SinuNase, which we expect will be the first ever product approved for chronic sinusitis (CS), a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
I am pleased to report that we now have interim, blinded, intent-to-treat data on the primary endpoint (complete resolution of both cardinal symptoms) at the conclusion of the study for approximately 80% of the patients in the study. This interim blinded data shows that approximately 20% of all patients are achieving the primary endpoint of complete resolution of both cardinal symptoms and another 23% of patients are achieving complete resolution of one or the other cardinal symptom at 16 weeks. To put these results in perspective, it is important to remember that 50% of the patients received SinuNase and that 50% received a placebo control that had no antifungal activity.
For more information on SinuNase Phase 3 interim, blinded results to date, see http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
As previously reported, there continues to be a very strong positive correlation of symptom resolution and objective evidence of reduced inflammation by endoscopy and/or CT scan, which we believe indicates that patients are experiencing a therapeutic effect rather than a placebo effect. Patients who achieved the primary endpoint, meaning those who experienced complete resolution of both cardinal symptoms, had on average more than a 300% greater reduction in polyps as measured by endoscopy and on average more than a 500% greater reduction in sinus inflammation as measured by CT scan than patients who had no symptom resolution.
Accordingly, I personally believe that the final results, due to be unblinded and reported in March, will show a highly statistically significant outcome for SinuNase; thus paving the way for its approval. Initially, we plan to seek an expedited approval through an FDA pathway called Subpart H, which allows for accelerated, conditional approval of therapeutics for serious unmet clinical indications. This approval would make SinuNase available to be prescribed for the most serious cases of CS. To significantly expand upon that market, we intend to conduct a second, confirmatory Phase 3 study, for which we have already identified a potential pool of approximately 200 CS patients. It is our goal to complete the confirmatory trial and submit a New Drug Application (NDA) with the FDA, seeking broad, unconditional approval for SinuNase, before the end of 2008.
Pending Milestones for SinuNase in 2008:
-- Report results from the unblinding and complete analysis of
the pivotal Phase 3 clinical trial in March 2008
-- File with FDA for accelerated, conditional approval for
SinuNase in mid-calendar year 2008
-- Concurrent with seeking FDA approval, seek European regulatory
approval via EMEA registration pathway
-- Launch marketing and sales initiatives upon conditional
approval in late-calendar year 2008
-- Conduct and complete confirmatory Phase 3 clinical trial in
late-calendar year 2008
-- Upon positive confirmatory trial results, file with the FDA
for unconditional approval
-- Announce key commercial license agreement(s) for the U.S. and
foreign markets
SinuNase is especially unique because it is the first product to target the true cause of CS - a fungal-induced inflammation - based on breakthrough findings discovered at the Mayo Clinic, from whom we licensed the worldwide, exclusive, commercial rights to SinuNase.
Researchers at Mayo determined that CS is actually caused by a normally innocuous mold, but which in CS patients elicits a destructive, inflammatory response. This was confirmed by testing for the presence of eMBP (eosinophillic major basic protein), which is a toxic protein released by inflammatory cells in response to the fungi.
Mayo's research leads us to believe that most, if not all cases of CS are due to fungal-induced inflammation. SinuNase is the only intranasal, anti-fungal CS product that has been submitted as an Investigative New Drug (IND) to the FDA. We also continue to strengthen our patent portfolio for SinuNase with key patents being granted in the U.S. and EU covering the treatment of CS with intranasal anti-fungals, including the active ingredient in SinuNase. Additionally, we have an agreement with IMMCO Diagnostics to commercialize SinuTest(TM), which is a diagnostic used to measure eMBP in the nasal mucin of suspected CS patients. This diagnostic is expected to provide physicians with a valuable tool to predict those patient candidates best suited to benefit from treatment with SinuNase - a comprehensive approach to diagnosis and treatment.
BiovaxID(TM)
Through our majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), we are extremely optimistic and excited regarding the progress of BiovaxID, a personalized cancer vaccine, now in a pivotal Phase 3 Fast-Tracked trial, that is initially targeting non-Hodgkin's lymphoma, with the potential to treat many difficult-to-treat B-cell related cancers such as multiple myeloma and chronic lymphocytic leukemia. BiovaxID is nearing the completion of an interim analysis for BiovaxID, and we expect to report the analysis of the unblinded results by the end of April 2008. Based on very favorable follow-up data from previous Phase 2 studies reported by the National Cancer Institute and independent research conducted in Spain, coupled with statistical evidence from blinded data suggesting that BiovaxID is achieving efficacy endpoints with an excellent overall safety profile, we remain confident that we will report statistically significant survival benefits; such positive results would allow us to move forward in seeking accelerated and conditional approvals in the U.S. and Europe later this year.
Pending Milestones for BiovaxID in 2008:
-- Report results from the unblinding and complete analysis of
the pivotal Phase III clinical trial by the end of April 2008
-- Meet with the FDA to present data and determine registration
pathways for accelerated approval in the U.S. by mid-calendar
year 2008
-- Meet with the EMEA to present data and determine expedited
registration pathways for conditional approval in EU by
mid-calendar year 2008
-- Launch marketing and sales initiatives upon conditional
approval
-- Announce strategic, multi-national, marketing partnership
BiovaxID is a customized therapy, unique from any other cancer vaccine, in the manner in which it is derived from a patient's own cancer cells; designed to harness the power of the patient's immune system, by "training" it to recognize and selectively destroy just cancerous lymphoma cells. As such, BiovaxID is positioned to be a valuable complement to existing standards of care, and not a competitor.
Dr. Steven Arikian, Chairman and CEO of Biovest, will soon be issuing his letter to shareholders, providing a comprehensive update on the status and potential of BiovaxID. I will defer to his pending report for more complete details regarding the great promise of BiovaxID and its potential to revolutionize the treatment of non-Hodgkin's lymphoma by inducing indefinitely prolonged remissions.
Suffice it to say, BiovaxID is expected to be a significant driver of growth, and a catalyst for partnering and licensing opportunities for Accentia and Biovest, as we progress this product to market - a major breakthrough opportunity to save and prolong the lives of those suffering from this insidious kind of cancer.
Revimmune(TM)
I was especially excited when we announced in 2007 that Accentia had acquired the worldwide exclusive license to Revimmune for autoimmune diseases, a technology developed at the Johns Hopkins University School of Medicine, believed to offer unprecedented benefits for the treatment of up to 80 autoimmune diseases, including multiple sclerosis (MS).
Justifying my enthusiasm, in a pre-Investigational New Drug meeting (IND), the FDA indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized, controlled, multi-center clinical trial of Revimmune, evaluating the treatment of MS.
I need to stress how important this planned trial is because it differs dramatically from the protocol of any previously conducted MS trial. All of the products currently on the market for MS were approved based on their ability to slow the progression of disability, not improve the patient's functional status. In contrast, we aim to show that Revimmune is capable of reversing the disease's effects and reducing disability.
As you can imagine, this kind of accomplishment would catapult Accentia to become a worldwide leader in the treatment of autoimmune disease, forever changing the way in which these diseases are treated - with an aim to actually improve the patient's condition and eliminate the autoimmunity.
Pending Milestones for Revimmune in 2008:
-- File IND application with FDA in March / April 2008
-- Commence enrollment for Phase 3 clinical trial by mid-calendar
year 2008
-- Cultivate relationships with potential strategic,
multi-national, marketing partners
We anticipate that the Revimmune Phase 3 clinical trial protocol will include a comprehensive and proprietary risk management program to enhance patient safety by ensuring appropriate patient selection and by including specially designed supportive care, with these key aspects also enhancing the product's patent protections.
Revimmune therapy consists of an ultra-high intensity, short-course, intravenous formulation of an already approved pharmaceutical, cyclophosphamide. In previous studies, Revimmune has been shown to "reboot" a patient's immune system, thereby typically eliminating the autoimmunity. The "rebooting" process is achieved because Revimmune eliminates the cells causing the autoimmunity and spares the stem cells in the bone marrow. These surviving stem cells are then able to repopulate a restored, uncompromised immune system.
Simply said, there is no approved drug product that eliminates autoimmunity, and Revimmune would be the world's first therapy to propose the restoration of neurologic function as the primary endpoint and offer the potential for the elimination of autoimmunity.
Blockbuster Potential
I do not believe that our current market valuation comes remotely close to reflecting our growth prospects, considering our portfolio possesses such tremendous blockbuster potential, and especially with two of those products on the verge of reporting Phase 3 results. Based upon the anticipated unconditional approval of SinuNase, we forecast the market opportunity for peak year sales could exceed $1 billion. Based upon the anticipated unconditional approval of BiovaxID, we also forecast that the market opportunity for peak year sales could exceed $1 billion. We believe that Revimmune has the potential to be a blockbuster, as it is expected to show utility in up to 80 autoimmune diseases. And AllerNase also represents handsome near-term potential. While I believe the shares of Accentia are currently dramatically undervalued, I am also convinced this will be a temporary situation.
Driving Shareholder Value
Based on the magnitude of the milestones we expect to report throughout 2008, we plan to enhance the Company's visibility within the investment community. We have launched an investor relations campaign in order to effectively articulate Management's strategic vision and generate awareness and support from institutional and retail investors, both on Wall Street and internationally. Mr. Douglas Calder has joined us in the role of Director of Investor Relations and Public Relations, and I invite you to contact him to discuss our plans to broadly communicate Accentia's compelling investment case; plans expected to play an important role in creating significant shareholder value.
Closing Comments
We believe that the execution of Accentia's business plan through fiscal 2007 has created a solid foundation for the Company's dramatic and sustainable growth. Today, we have a robust product pipeline of drugs and technologies which provide short, medium and long-term potential, targeting several multi-billion dollar markets. These products offer the potential for superior efficacy and safety, as compared to competitive therapies, in addressing chronic and life-threatening diseases.
In summary, we will focus our efforts on completing the clinical development and obtaining regulatory approvals for SinuNase, BiovaxID and Revimmune. We will continue to seek to add new late-stage "disruptive" clinical products and technologies to strengthen our already impressive portfolio. And we will pursue key strategic partnerships to effectively develop and market our products worldwide.
Our accomplishments to date, and our ambitious and realizable plans, are a direct result of the tireless work performed by our highly talented and dedicated employees, and I congratulate all of them for their passion and their daily contributions.
And I also thank our shareholders for their enduring support, as we will continue to strive to reward their understanding of the goals which we have set out to achieve.
Sincerely,
Francis E. O'Donnell, Jr., M.D.
Chairman and Chief Executive Officer
For further information, please visit: http://www.Accentia.net
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM), AllerNase(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
MULTIMEDIA AVAILABLE:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5579018
CONTACT: Accentia Biopharmaceuticals, Inc., Tampa
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554, ext.258
Email: dwcalder@accentia.net
or
Susan Bonitz, Ph.D., Director, Program Coordination
813-864-2554, ext.277
Email: sbonitz@accentia.net
SOURCE: Accentia Biopharmaceuticals, Inc
Antwort auf Beitrag Nr.: 32.967.768 von SunnyOst am 07.01.08 15:46:30Market Report -- In Play (ABPI)January 7, 2008 9:06 AM ET
Accentia Biopharmaceuticals provides Y08 oulook Co sees Specialty Pharmaceuticals business segment will achieve operating profitability by year-end due to anticipated approval of AllerNase inter-nasal steroid. Co sees Analytica subsidiary to show further growth in Y08, Biovest subsidiary to reach profitability by year-end, as a consequence of reduced clinical trial expenditures as it pursues its regulatory approval strategy for BiovaxID and as we anticipate growth in commercial sales of co's recently launched AutovaxID. Based upon the anticipated unconditional approval of SinuNase, co sees market opportunity for peak year sales could exceed $1 bln. Based upon the anticipated unconditional approval of BiovaxID, co also forecast that the market opportunity for peak year sales could exceed $1 bln.
Hört sich natürlich alles sehr gut an (fast schon zu gut). Dass AllerNase ausreicht um für ein profitables Ergebnis zu sorgen, sehe ich skeptisch. Wenn aber oben genannte peak sales für SinuNase und BiovaxID in einigen Jahren erreicht würden, kann sich ein jeder den Kursverlauf vorstellen - Vorraussetzung natürlich: gute Ergebnisse der Studien und ein approval! Bei BiovaxID sehe ich da ein wenig skeptischer als SinuNase.
Dann gibt es ja auch noch Revimmune. Mich hat gewundert, dass O'Donnell seinen jüngsten Clou noch vor SinuNase und BiovaxID erwähnt hatte (Posting von SunnyOst). Deutet auf viel Vertrauen...
Die Daten zu SinuNase werden also etwa Anfang März erwartet, heißt also dass etwa 3-4 Wochen an Zeit benötigt wird um die Daten auszuwerten. Und dann wird es um die Zukunft von ABPI gehen...
Rosarot oder dunkelschwarz?
Grüße
Accentia Biopharmaceuticals provides Y08 oulook Co sees Specialty Pharmaceuticals business segment will achieve operating profitability by year-end due to anticipated approval of AllerNase inter-nasal steroid. Co sees Analytica subsidiary to show further growth in Y08, Biovest subsidiary to reach profitability by year-end, as a consequence of reduced clinical trial expenditures as it pursues its regulatory approval strategy for BiovaxID and as we anticipate growth in commercial sales of co's recently launched AutovaxID. Based upon the anticipated unconditional approval of SinuNase, co sees market opportunity for peak year sales could exceed $1 bln. Based upon the anticipated unconditional approval of BiovaxID, co also forecast that the market opportunity for peak year sales could exceed $1 bln.
Hört sich natürlich alles sehr gut an (fast schon zu gut). Dass AllerNase ausreicht um für ein profitables Ergebnis zu sorgen, sehe ich skeptisch. Wenn aber oben genannte peak sales für SinuNase und BiovaxID in einigen Jahren erreicht würden, kann sich ein jeder den Kursverlauf vorstellen - Vorraussetzung natürlich: gute Ergebnisse der Studien und ein approval! Bei BiovaxID sehe ich da ein wenig skeptischer als SinuNase.
Dann gibt es ja auch noch Revimmune. Mich hat gewundert, dass O'Donnell seinen jüngsten Clou noch vor SinuNase und BiovaxID erwähnt hatte (Posting von SunnyOst). Deutet auf viel Vertrauen...
Die Daten zu SinuNase werden also etwa Anfang März erwartet, heißt also dass etwa 3-4 Wochen an Zeit benötigt wird um die Daten auszuwerten. Und dann wird es um die Zukunft von ABPI gehen...
Rosarot oder dunkelschwarz?
Grüße
http://sinusinfocenter.blogspot.com/2008/01/sinusitis-treatm…
Monday, January 7, 2008
Sinusitis Treatment- Help is on the Way
Mayo Clinic researchers have made great strides in recent years regarding sinusitis treatment and have come up with a new therapy for chronic sufferers called topical antifungal therapy. This particular sinusitis treatment is still new and is not widely practiced. This author, a sinusitis sufferer of long standing with two painful operations under his belt, has been in contact with one of the Mayo Clinic research physicians. I was pointed to several papers and articles describing the research completed thus far, the theory behind the research, and the resulting therapy.
In simple and general terms, the Mayo Clinic research showed that some people (i.e., chronic sinusitis sufferers), have a harmful immune reaction to fungi that others do not experience. The research demonstrated that fungi are present in the air and show up in the nasal mucus of just about everyone. In the noses of chronic sinus sufferers, it showed that certain types of white blood cells will attack the fungi that are present. In doing so these cells create a compound that damages nasal membranes. Once damaged, bacteria can easily enter and cause pain, inflammation and infection. Conventional sinusitis treatment often includes antibiotics to attack the bacteria. This new sinusitis treatment aims to attack the fungi instead, thus avoiding the nasal membrane damage in the first place. One drawback is that it is not easy to determine if a patient is someone whose white blood cells attack fungi in the nose or not. It is also not known why this white blood cell reaction occurs in some people and not in others.
Antifungals such as Amphotericin B and Itraconazole are used in this sinusitis treatment regimen. These have already been approved by the FDA for other uses, and they can be mixed by a compounding pharmacy such as Anazao to make the topical solution needed for this new therapy. Amphotericin B, for example, was only available in my local pharmacy as an injection medication. The pharmacist was not aware that it is sometimes reformulated as a topical spray for sinusitis treatment. Patients spray the antifungal into their nostrils daily. About 75% of the chronic sinus sufferers in one of the Mayo Clinic studies saw significant improvement in their conditions following this regimen.
I also contacted Accentia, the biopharmaceutical company who has obtained a license from the Mayo Foundation to produce and market medications based on the Mayo Clinic research. They informed me that they plan to market a product based on Amphotericin B, which will have the brand name SinuNase. They will start clinical trials soon, and I submitted my name as a possible participant. Apparently I would be a good candidate since I?ve had sinus surgeries that didn?t cure my problems.
Topical antifungal therapy is a new form of sinusitis treatment. It takes time for a new approach to become accepted in the medical community at large. I asked the Mayo research physician if he knew of a colleague in the Denver area, where I reside, who was utilizing this approach. He responded that he didn?t know anyone there, but gave me two names of physicians in Texas, which I also asked about. So it is obvious that this approach to sinusitis treatment is not yet mainstream therapy, but it does have momentum. For people who have received sinusitis treatment which has not improved their suffering, more details regarding this and other sinus related subjects can be found at Post Nasal Drip.
Walt Ballenberger is founder of Post Nasal Drip a resource web site for sinusitis sufferers like himself. For a free report entitled ?Sinus Treatment Success Stories?, visit Post Nasal Drip and click on the Free Report link. This resource can be of significant help to chronic sinus sufferers.
Wer ein wenig noch Walts Beiträge nachlesen oder einfach nur stöbern will:
http://www.postnasaldrip.net/
Nur mal so nebenbei bemerkt:
Würden SinuNase und BiovaxID ein approval erlangen und würden sich beide ähnlich den Vorstellungen von O'Donnell zu Blockbustern entwickeln, habe ich schon einmal das Fell des Bären vorab verteilt (peak-sales für 2012):
SinuNase 450T Patienten @ 2.400 $/Monat = 1.080 Mil. $ Umsatz abzgl. etwa 45% an Milestones und Herstellungskosten = 620 Mil. $
BiovaxID 85T Patienten @ 10.000 $/Monat = 850 Mil. $ Umsatz --> 19,5 % an ABPI = 140 Mil. $
Ausgaben etwa 350 Mil. $ ergibt Gewinn von knapp 410 Mil. $ abzgl. 35 % Steuern = 270 Mil. $
Wären 2012 etwa 60 Mil. ABPI Aktien im Umlauf, wäre dass ein Ergebnis pro Aktie von 4,5 $!!! Dann reicht eine 10er KGV Bewertung aus um Glücklich zu sein - ohne Revimmune und sonstigen Produkten!
Natürlich ist dieses Zahlenwerk NUR Spielerei und ist SEEEHHR ambitioniert gerechnet, aber durchaus denkbar (ich gehe aber davon aus, dass die SinuNase Einnahmen nicht so hoch ausfallen werden, auf Grund Partnerschaften...). Erster Schritt sind überzeugende Ergebnisse aus den jeweiligen Studien, ein zweiter wäre ein guter Absatz der Produkte. Aber alles in allem ist ABPI doch ein gutes Chance/Risiko Verhältnis - oder?
Grüße
Monday, January 7, 2008
Sinusitis Treatment- Help is on the Way
Mayo Clinic researchers have made great strides in recent years regarding sinusitis treatment and have come up with a new therapy for chronic sufferers called topical antifungal therapy. This particular sinusitis treatment is still new and is not widely practiced. This author, a sinusitis sufferer of long standing with two painful operations under his belt, has been in contact with one of the Mayo Clinic research physicians. I was pointed to several papers and articles describing the research completed thus far, the theory behind the research, and the resulting therapy.
In simple and general terms, the Mayo Clinic research showed that some people (i.e., chronic sinusitis sufferers), have a harmful immune reaction to fungi that others do not experience. The research demonstrated that fungi are present in the air and show up in the nasal mucus of just about everyone. In the noses of chronic sinus sufferers, it showed that certain types of white blood cells will attack the fungi that are present. In doing so these cells create a compound that damages nasal membranes. Once damaged, bacteria can easily enter and cause pain, inflammation and infection. Conventional sinusitis treatment often includes antibiotics to attack the bacteria. This new sinusitis treatment aims to attack the fungi instead, thus avoiding the nasal membrane damage in the first place. One drawback is that it is not easy to determine if a patient is someone whose white blood cells attack fungi in the nose or not. It is also not known why this white blood cell reaction occurs in some people and not in others.
Antifungals such as Amphotericin B and Itraconazole are used in this sinusitis treatment regimen. These have already been approved by the FDA for other uses, and they can be mixed by a compounding pharmacy such as Anazao to make the topical solution needed for this new therapy. Amphotericin B, for example, was only available in my local pharmacy as an injection medication. The pharmacist was not aware that it is sometimes reformulated as a topical spray for sinusitis treatment. Patients spray the antifungal into their nostrils daily. About 75% of the chronic sinus sufferers in one of the Mayo Clinic studies saw significant improvement in their conditions following this regimen.
I also contacted Accentia, the biopharmaceutical company who has obtained a license from the Mayo Foundation to produce and market medications based on the Mayo Clinic research. They informed me that they plan to market a product based on Amphotericin B, which will have the brand name SinuNase. They will start clinical trials soon, and I submitted my name as a possible participant. Apparently I would be a good candidate since I?ve had sinus surgeries that didn?t cure my problems.
Topical antifungal therapy is a new form of sinusitis treatment. It takes time for a new approach to become accepted in the medical community at large. I asked the Mayo research physician if he knew of a colleague in the Denver area, where I reside, who was utilizing this approach. He responded that he didn?t know anyone there, but gave me two names of physicians in Texas, which I also asked about. So it is obvious that this approach to sinusitis treatment is not yet mainstream therapy, but it does have momentum. For people who have received sinusitis treatment which has not improved their suffering, more details regarding this and other sinus related subjects can be found at Post Nasal Drip.
Walt Ballenberger is founder of Post Nasal Drip a resource web site for sinusitis sufferers like himself. For a free report entitled ?Sinus Treatment Success Stories?, visit Post Nasal Drip and click on the Free Report link. This resource can be of significant help to chronic sinus sufferers.
Wer ein wenig noch Walts Beiträge nachlesen oder einfach nur stöbern will:
http://www.postnasaldrip.net/
Nur mal so nebenbei bemerkt:
Würden SinuNase und BiovaxID ein approval erlangen und würden sich beide ähnlich den Vorstellungen von O'Donnell zu Blockbustern entwickeln, habe ich schon einmal das Fell des Bären vorab verteilt (peak-sales für 2012):
SinuNase 450T Patienten @ 2.400 $/Monat = 1.080 Mil. $ Umsatz abzgl. etwa 45% an Milestones und Herstellungskosten = 620 Mil. $
BiovaxID 85T Patienten @ 10.000 $/Monat = 850 Mil. $ Umsatz --> 19,5 % an ABPI = 140 Mil. $
Ausgaben etwa 350 Mil. $ ergibt Gewinn von knapp 410 Mil. $ abzgl. 35 % Steuern = 270 Mil. $
Wären 2012 etwa 60 Mil. ABPI Aktien im Umlauf, wäre dass ein Ergebnis pro Aktie von 4,5 $!!! Dann reicht eine 10er KGV Bewertung aus um Glücklich zu sein - ohne Revimmune und sonstigen Produkten!
Natürlich ist dieses Zahlenwerk NUR Spielerei und ist SEEEHHR ambitioniert gerechnet, aber durchaus denkbar (ich gehe aber davon aus, dass die SinuNase Einnahmen nicht so hoch ausfallen werden, auf Grund Partnerschaften...). Erster Schritt sind überzeugende Ergebnisse aus den jeweiligen Studien, ein zweiter wäre ein guter Absatz der Produkte. Aber alles in allem ist ABPI doch ein gutes Chance/Risiko Verhältnis - oder?
Grüße
Antwort auf Beitrag Nr.: 32.976.424 von Ackergaul am 08.01.08 10:24:15Am Mittwoch gab es von PPDI ein Conference Call. Eschelmann (der Chairman) spekuliert für 2011 mit Einnahmen von 600 Mil. $ durch SinuNase - davon würden dann 7 % (von ABPI) in Richtung PPDI gehen.
Zum anderen, wurden zahlreiche Stock Options bei ABPI ausgeführt:
2 x 275T und einmal 100T!
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-se…
Zu BiovaxID noch mal etwas:
Erst einmal Allgemeines zum follicular lymphoma. Bei Behandlung mit Rituxan und CHOP weisen etwa 85 % ein Ansprechen (darunter 30 % CR) auf. Median OS 8 bis 10 Jahre; OS @ 5 Jahren bei 72-77 %. Median PFS gut 52 Monate.
Dagegen BiovaxID:
BiovaxID - Therapeutic Vaccine Treatment of Follicular Non-Hodgkin’s Lymphoma: Phase II Clinical Trial Results & Phase III Clinical Trial Update
...
Results:
Phase II: After a median follow-up of 9.2 years, 9/20 subjects (45%) remained in continuous first CR, with median DFS of 96.5 months and overall survival of 95%. After vaccination 95% of patients showed autologous tumor-specific CD4+ and CD8+ T-cell responses and 75% of patients showed anti-Id Ab responses. 11 patients were initially t(14;18)+ and maintained their status post-chemotherapy. 1 month following final BiovaxID vaccination, 8/11 patients (72%) converted to t(14;18)-. As of last observed follow-up, 47.1% of t(14;18)- (median DFS of 60 months) patients and 100% of t(14;18)+ (median DFS of 91 months) patients have relapsed (p=.089). Phase III: 226 subjects have been accrued to the trial to date, with 171 (76%) achieving CR and subsequently randomized and followed.
Conclusions:
Long-term follow-up of phase II study data indicates that BiovaxID vaccination can induce durable long-term remissions for fNHL patients, may result in greater duration of DFS and overall survival. Data also show possible association between t(14;18) negativity following vaccination and prolonged DFS in patients in first CR post-chemotherapy. Currently ongoing phase III study will seek to confirm safety and efficacy of BiovaxID.
Aus einer Zwischenmeldung:
...
The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine.
The trial showed that approximately 40% of the evaluable patients in the study remained disease-free
from 40 months to almost 70 months.
...
Und eben die Zwischenmeldung machte mir ein wenig Sorgen. Bei 9 von 20 Personen in der Phase II war das DFS 96,5 Monate, in den Meldungen lag das DFS bei 40 % lediglich noch bei 40 bis 70 Monaten.
Der Trial zur Übersicht:
http://clinicaltrials.gov/ct2/show/NCT00091676?term=biovaxid…
Zum anderen, wurden zahlreiche Stock Options bei ABPI ausgeführt:
2 x 275T und einmal 100T!
http://phx.corporate-ir.net/phoenix.zhtml?c=188615&p=irol-se…
Zu BiovaxID noch mal etwas:
Erst einmal Allgemeines zum follicular lymphoma. Bei Behandlung mit Rituxan und CHOP weisen etwa 85 % ein Ansprechen (darunter 30 % CR) auf. Median OS 8 bis 10 Jahre; OS @ 5 Jahren bei 72-77 %. Median PFS gut 52 Monate.
Dagegen BiovaxID:
BiovaxID - Therapeutic Vaccine Treatment of Follicular Non-Hodgkin’s Lymphoma: Phase II Clinical Trial Results & Phase III Clinical Trial Update
...
Results:
Phase II: After a median follow-up of 9.2 years, 9/20 subjects (45%) remained in continuous first CR, with median DFS of 96.5 months and overall survival of 95%. After vaccination 95% of patients showed autologous tumor-specific CD4+ and CD8+ T-cell responses and 75% of patients showed anti-Id Ab responses. 11 patients were initially t(14;18)+ and maintained their status post-chemotherapy. 1 month following final BiovaxID vaccination, 8/11 patients (72%) converted to t(14;18)-. As of last observed follow-up, 47.1% of t(14;18)- (median DFS of 60 months) patients and 100% of t(14;18)+ (median DFS of 91 months) patients have relapsed (p=.089). Phase III: 226 subjects have been accrued to the trial to date, with 171 (76%) achieving CR and subsequently randomized and followed.
Conclusions:
Long-term follow-up of phase II study data indicates that BiovaxID vaccination can induce durable long-term remissions for fNHL patients, may result in greater duration of DFS and overall survival. Data also show possible association between t(14;18) negativity following vaccination and prolonged DFS in patients in first CR post-chemotherapy. Currently ongoing phase III study will seek to confirm safety and efficacy of BiovaxID.
Aus einer Zwischenmeldung:
...
The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine.
The trial showed that approximately 40% of the evaluable patients in the study remained disease-free
from 40 months to almost 70 months.
...
Und eben die Zwischenmeldung machte mir ein wenig Sorgen. Bei 9 von 20 Personen in der Phase II war das DFS 96,5 Monate, in den Meldungen lag das DFS bei 40 % lediglich noch bei 40 bis 70 Monaten.
Der Trial zur Übersicht:
http://clinicaltrials.gov/ct2/show/NCT00091676?term=biovaxid…
Diskussionauszug aus dem Amiland.
---------------------------------
Trial design and FDA issues are being well managed by ABPI 16-Jan-08 01:04 pm
If these postings from pharm reps are legitimate its clear why their reps and not scientists or investors.
1. GCP guidelines are more tha met in the current phase III dual arm,blinded, multi-center placebo controlled trial
2. Phase I min/max doseage concentration studies are not necessary with a 505(b)2 drug with a defined dose shown to have excellent clinical effect in a disesase process where no other therapeis exist (CRS).If this were a new chemical entity or if high systemic absorbtion or a negative side effect profile were present this could have been an issue but its not. Pre-trial design review by FDA raised no such issues.
3. Phase I/II trials will not be required "to meet GCP" Can you cite an example of a 505 (b)2 where this occcured?
4 FDA "hammering' of a trial for accepting only placebo non responders. This appears ludicrous. This process leads to cleaner data collection and will only strengthen the NDA.
Furthermore Dr. Arikian the ABPI president has designed and implemented research projects in the United States, Canada, Latin America and Europe. He founded Analytica International, a global provider of research and communications services to the pharmaceutical and biotechnology industries in 1997.Take a look at the history and expertise of the Analytica team (a now wholly owned ABPI subsidiary). Analytica's depth of experience in trial design and in successful FDA approvals is extensive.
---------------------------------
Trial design and FDA issues are being well managed by ABPI 16-Jan-08 01:04 pm
If these postings from pharm reps are legitimate its clear why their reps and not scientists or investors.
1. GCP guidelines are more tha met in the current phase III dual arm,blinded, multi-center placebo controlled trial
2. Phase I min/max doseage concentration studies are not necessary with a 505(b)2 drug with a defined dose shown to have excellent clinical effect in a disesase process where no other therapeis exist (CRS).If this were a new chemical entity or if high systemic absorbtion or a negative side effect profile were present this could have been an issue but its not. Pre-trial design review by FDA raised no such issues.
3. Phase I/II trials will not be required "to meet GCP" Can you cite an example of a 505 (b)2 where this occcured?
4 FDA "hammering' of a trial for accepting only placebo non responders. This appears ludicrous. This process leads to cleaner data collection and will only strengthen the NDA.
Furthermore Dr. Arikian the ABPI president has designed and implemented research projects in the United States, Canada, Latin America and Europe. He founded Analytica International, a global provider of research and communications services to the pharmaceutical and biotechnology industries in 1997.Take a look at the history and expertise of the Analytica team (a now wholly owned ABPI subsidiary). Analytica's depth of experience in trial design and in successful FDA approvals is extensive.
Antwort auf Beitrag Nr.: 33.076.917 von SunnyOst am 17.01.08 06:10:07Lese auch des öfteren das Y! Board durch, obwohl 80-90 % davon wirklich ... ist. Ich stelle mal für diejenigen die dass Posting nicht kennen die Fragen rein, auf die Riley seine (gute) Antwort gegeben hat:
"Even if the Sinunase data is positive, the FDA will never buy it...
1) Only other supportive studies were done by Mayo...university studies are notorious for NOT meeting Good Clinical Practice standards required by FDA.
2) No formal dose response studies done. FDA will come back and say "Fine, now go figure out what the most effective dose is". Might be lower, might be higher.
3) FDA is going to require at least one other pivotal trial, since there are no GCP Phase 1 or 2 trials.
4) Trial design issues (letting only placebo non responders in, no validated patient diary, etc.) will be hammered hard by the FDA.
So if the stock bumps after results...sell. As soon as the FDA gets involved, it will be good night nurse."
Die 4. Frage hatte ich vor geraumer Zeit mir selber schon gestellt, konnte keine gute Antwort darauf finden. Ob es so ist, wie der gute Riley geschrieben hat? Doch sollte man sich vor Augen halten, dass die FDA mit ABPI zusammen den Trial in dieser Form aufgebaut haben! Die restlichen Sachen sehe ich eher als hohle Phrasen an - wie zu der Dosierung... stellt euch vor die FDA würde sagen, gebt mal ein paar mg mehr oder weniger dazu??? Frage 3 nochmals ??? es wird doch eine zweite Phase III geben...
Aber dennoch - Was kann denn schiefgehen?
- Die Placebo Daten werden gleich ausfallen wie SinuNase
Glaube ich persönlich nicht, da CT-Scan und Endoskopie Werte darauf schliessen, dass das verwendete Placebo höchstens minimal "wirkt" (wie in der vergangenen Tests bewiesen) und die Werte (wie auch der Aufbau des Trial) dem der Mayo Klinik stark gleichen.
- Sicherheitsbedenken
Ebenfalls eher unwahrscheinlich, da amphotericin nicht injiziert wird und nur eine geringe Dosis pro Tag (8 mg) verwendet wird. Aber es könnte sein, dass die FDA hier noch Ergebnisse nachfordern wird... Patienten klagen teilweise über ein Brennen, denoch hatte keiner bisher abbrechen müssen.
- Daten gut, Kurs hebt nicht ab...
Nicht unmöglich. Viel Fragen stehen noch im Raum: Wie würde der Markt SinuNase aufnehmen? Wen kann ABPI zur Vermarktung und Verkauf gewinnen? Ist der Preis akzeptabel?
Klar ist: ABPI verkauft Warrants um seine Schulden begleichen zu können und hat in der vergangenheit noch NICHTS richtig auf die Beine gestellt bekommen (gutes Beispiel MD Turbo). SinuNase KÖNNTE ein Anfang sein. Aber möglich ist auch, dass nach einer Zulassung lediglich 100 ENTs Ihren 100 Patienten SinuNase verschreiben (= 25 Mil. $) - dass war dann NICHTS!
Grüße
"Even if the Sinunase data is positive, the FDA will never buy it...
1) Only other supportive studies were done by Mayo...university studies are notorious for NOT meeting Good Clinical Practice standards required by FDA.
2) No formal dose response studies done. FDA will come back and say "Fine, now go figure out what the most effective dose is". Might be lower, might be higher.
3) FDA is going to require at least one other pivotal trial, since there are no GCP Phase 1 or 2 trials.
4) Trial design issues (letting only placebo non responders in, no validated patient diary, etc.) will be hammered hard by the FDA.
So if the stock bumps after results...sell. As soon as the FDA gets involved, it will be good night nurse."
Die 4. Frage hatte ich vor geraumer Zeit mir selber schon gestellt, konnte keine gute Antwort darauf finden. Ob es so ist, wie der gute Riley geschrieben hat? Doch sollte man sich vor Augen halten, dass die FDA mit ABPI zusammen den Trial in dieser Form aufgebaut haben! Die restlichen Sachen sehe ich eher als hohle Phrasen an - wie zu der Dosierung... stellt euch vor die FDA würde sagen, gebt mal ein paar mg mehr oder weniger dazu??? Frage 3 nochmals ??? es wird doch eine zweite Phase III geben...
Aber dennoch - Was kann denn schiefgehen?
- Die Placebo Daten werden gleich ausfallen wie SinuNase
Glaube ich persönlich nicht, da CT-Scan und Endoskopie Werte darauf schliessen, dass das verwendete Placebo höchstens minimal "wirkt" (wie in der vergangenen Tests bewiesen) und die Werte (wie auch der Aufbau des Trial) dem der Mayo Klinik stark gleichen.
- Sicherheitsbedenken
Ebenfalls eher unwahrscheinlich, da amphotericin nicht injiziert wird und nur eine geringe Dosis pro Tag (8 mg) verwendet wird. Aber es könnte sein, dass die FDA hier noch Ergebnisse nachfordern wird... Patienten klagen teilweise über ein Brennen, denoch hatte keiner bisher abbrechen müssen.
- Daten gut, Kurs hebt nicht ab...
Nicht unmöglich. Viel Fragen stehen noch im Raum: Wie würde der Markt SinuNase aufnehmen? Wen kann ABPI zur Vermarktung und Verkauf gewinnen? Ist der Preis akzeptabel?
Klar ist: ABPI verkauft Warrants um seine Schulden begleichen zu können und hat in der vergangenheit noch NICHTS richtig auf die Beine gestellt bekommen (gutes Beispiel MD Turbo). SinuNase KÖNNTE ein Anfang sein. Aber möglich ist auch, dass nach einer Zulassung lediglich 100 ENTs Ihren 100 Patienten SinuNase verschreiben (= 25 Mil. $) - dass war dann NICHTS!
Grüße
Ausschnitt aus dem Yahoo Message Bord
when you see the CEO invest nearly $7.8 million from his own pocket to buy 875,000 shares at $8.87 or almost $7 per share above the share price at the time, you have to believe that good things are coming.
Welche Beweggruende stehen dahinter?
when you see the CEO invest nearly $7.8 million from his own pocket to buy 875,000 shares at $8.87 or almost $7 per share above the share price at the time, you have to believe that good things are coming.
Welche Beweggruende stehen dahinter?
News Release
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Accentia Biopharmaceuticals Announces $8.7 Million Financing to Support Accelerated Drug Commercialization Strategies
TAMPA, Fla.--(BUSINESS WIRE)--Jan. 18, 2008--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced that it has entered into definitive agreements for a private placement offering of convertible preferred stock and warrants to new and existing institutional investors for gross proceeds of approximately $8.7 million before fees and expenses. Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ:RODM) acted as the exclusive placement agent.
Accentia intends to use the proceeds as working capital, including supporting drug development, regulatory strategies and marketing plans. Chairman and CEO, Dr. Frank O'Donnell, elaborated, "We believe we are on the verge of achieving a series of very important milestones, including reporting the unblinded results from our pivotal Phase 3 clinical trial of SinuNase(TM) in March. In order to be best positioned to take advantage of anticipated positive results, there are time-sensitive priorities that, if started immediately, should accelerate our commercialization strategies. We expect that this funding will support such activities for SinuNase including preparations for a potential New Drug Application (NDA), commencing an 8-week clinical study of a pump spray formulation for mild-to-moderate sinusitis and organizing a confirmatory Phase 3 study for the lavage formulation." SinuNase targets the treatment of chronic sinusitis, a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
The financing provides investors with the right to convert their shares of preferred stock into shares of the Company's common stock at $2.67 per share. The offering includes short-term warrants allowing investors to purchase that number of common shares into which the purchaser's preferred stock is convertible. These short-term warrants will be exercisable for cash only at $2.67 per share for a period of 30 days after the Company's initial press release announcing the unblinded results of the completed Phase 3 clinical trial for SinuNase. If no such press release is made, then the exercise period shall be the 30-day period commencing December 2, 2008. Additionally, the offering includes long-term warrants allowing investors to purchase 50% of the number of common shares into which the purchaser's preferred stock is convertible. These long-term warrants have an exercise price of $2.67 per share and are exercisable for a period of 6 years. The Company has agreed to file a registration statement under the Securities Act of 1933 (the "Act") for the common shares to be issued upon conversion of the preferred stock and the exercise of the warrants and maintain the effectiveness of the registration statement for a minimum of 5 years.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful. The securities offered in the private placement to the investors were not registered under the Act, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act. Complete terms of this private transaction are available in a Form 8-K to be filed with the Securities and Exchange Commission.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune(TM), to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
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Accentia Biopharmaceuticals Announces $8.7 Million Financing to Support Accelerated Drug Commercialization Strategies
TAMPA, Fla.--(BUSINESS WIRE)--Jan. 18, 2008--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced that it has entered into definitive agreements for a private placement offering of convertible preferred stock and warrants to new and existing institutional investors for gross proceeds of approximately $8.7 million before fees and expenses. Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ:RODM) acted as the exclusive placement agent.
Accentia intends to use the proceeds as working capital, including supporting drug development, regulatory strategies and marketing plans. Chairman and CEO, Dr. Frank O'Donnell, elaborated, "We believe we are on the verge of achieving a series of very important milestones, including reporting the unblinded results from our pivotal Phase 3 clinical trial of SinuNase(TM) in March. In order to be best positioned to take advantage of anticipated positive results, there are time-sensitive priorities that, if started immediately, should accelerate our commercialization strategies. We expect that this funding will support such activities for SinuNase including preparations for a potential New Drug Application (NDA), commencing an 8-week clinical study of a pump spray formulation for mild-to-moderate sinusitis and organizing a confirmatory Phase 3 study for the lavage formulation." SinuNase targets the treatment of chronic sinusitis, a debilitating disease that affects more than 60 million sufferers in the U.S. and Europe.
The financing provides investors with the right to convert their shares of preferred stock into shares of the Company's common stock at $2.67 per share. The offering includes short-term warrants allowing investors to purchase that number of common shares into which the purchaser's preferred stock is convertible. These short-term warrants will be exercisable for cash only at $2.67 per share for a period of 30 days after the Company's initial press release announcing the unblinded results of the completed Phase 3 clinical trial for SinuNase. If no such press release is made, then the exercise period shall be the 30-day period commencing December 2, 2008. Additionally, the offering includes long-term warrants allowing investors to purchase 50% of the number of common shares into which the purchaser's preferred stock is convertible. These long-term warrants have an exercise price of $2.67 per share and are exercisable for a period of 6 years. The Company has agreed to file a registration statement under the Securities Act of 1933 (the "Act") for the common shares to be issued upon conversion of the preferred stock and the exercise of the warrants and maintain the effectiveness of the registration statement for a minimum of 5 years.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful. The securities offered in the private placement to the investors were not registered under the Act, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act. Complete terms of this private transaction are available in a Form 8-K to be filed with the Securities and Exchange Commission.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune(TM), to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
Antwort auf Beitrag Nr.: 33.097.585 von SunnyOst am 18.01.08 16:14:06ich habe täglich (seit August) erwartet, dass dieser Schritt kommt und nun bin ich doch überrascht. Will man mit dem Revimmune Trial doch so bald wie möglich starten oder kann man von einer möglichen SinuNase Partnerschaft vorab kein Geld bekommen oder...?
Der Zeitpunkt überrascht mich vorsichtig gesagt.
Grüße
Der Zeitpunkt überrascht mich vorsichtig gesagt.
Grüße
Antwort auf Beitrag Nr.: 33.098.703 von Ackergaul am 18.01.08 17:29:39Ist das aus deiner Sicht positiv oder negativ?
Antwort auf Beitrag Nr.: 33.098.878 von SunnyOst am 18.01.08 17:39:14Um März herum will ABPI die SinuNase Daten veröffentlichen. Sollte alles nach O'Donnells Vorstellungen laufen werden die Daten Spitze und der Kurs sollte sich stark Richtung Norden bewegen. Dass sind also noch knapp 6 bis 7 Wochen bis dato.
Ich stelle mir nun die Frage, warum nicht nach den SinuNase Ergebnissen die Aktien rausschmeissen, zu wesentlich besseren Konditionen. Wir wissen dass ABPI finanziell am Krückstock geht, ist es also dieser Grund gewesen oder weiß O'Donnell etwas unschönes?
Muss nichts bedeuten, es sind einige Sachen hier schwer zu erklären (Stichwort: O'Donnells Insider Kauf), aber so ganz werde ich aus diesem Schritt nicht klug.
Kann aber auch bedeuten:
- O'Donnell will JETZT schon Revimune in die Phase III bringen oder
- ABPI will jetzt schon ein Verkaufs- und Marketing Team zusammenstellen für SinuNase oder
- konnten Ihre Firmenwagen und Kaffeemaschinen nicht mehr zahlen oder oder oder
Klar ist, dass ganze Zulassungs-hack-mack braucht auch Geld. Außerdem, mit dem Geld kommt ABPI auch nicht weit, dass ist in einem Quartal verbrannt. Ich kanns weder positiv noch negativ sehen, einfach nur überraschend...
Grüße
Ich stelle mir nun die Frage, warum nicht nach den SinuNase Ergebnissen die Aktien rausschmeissen, zu wesentlich besseren Konditionen. Wir wissen dass ABPI finanziell am Krückstock geht, ist es also dieser Grund gewesen oder weiß O'Donnell etwas unschönes?
Muss nichts bedeuten, es sind einige Sachen hier schwer zu erklären (Stichwort: O'Donnells Insider Kauf), aber so ganz werde ich aus diesem Schritt nicht klug.
Kann aber auch bedeuten:
- O'Donnell will JETZT schon Revimune in die Phase III bringen oder
- ABPI will jetzt schon ein Verkaufs- und Marketing Team zusammenstellen für SinuNase oder
- konnten Ihre Firmenwagen und Kaffeemaschinen nicht mehr zahlen oder oder oder
Klar ist, dass ganze Zulassungs-hack-mack braucht auch Geld. Außerdem, mit dem Geld kommt ABPI auch nicht weit, dass ist in einem Quartal verbrannt. Ich kanns weder positiv noch negativ sehen, einfach nur überraschend...
Grüße
Es ist halt alles ein bischen kompliziert in Sachen SinuNase. Es gibt mehrere Tests die besagen, dass ampho b @ CS wirkt (vor allem Ponikau / Mayo Klinik), andere weisen dass Gegenteil nach (Ebbens und Fokkens).
Zur Ebbens und Fokkens Studie noch mal etwas:
Klar ist dass Ponikau in Sachen SinuNase befangen ist - er wird reich wenn es zugelassen wird. Aber auch Fokkens steht meiner Ansicht nach unter dem gleichen Licht:
...has consulting arrangements with GlaxoSmithKline and Schering-Plough and has received grant support from GlaxoSmithKline, Schering-Plough, and Optinose.
Schering-Plough z.B. verkauft Clarinex das auch in den Bereichen CS eingesetzt wird.
http://www.sch-plough.com/schering_plough/news/release.jsp?r…
http://www.12buys.com/category.asp?Pcat=0048
Gleichwohl muss ich sagen, dass Frau Ebbens und Herr Fokkens eigentlich den ersten "richtigen" SinuNase Test durchgeführt haben (genug Patienten, double-blind, placebo-controlled...). Also woran lag es?
- EMCUR System? ABPIs Aussage hierzu ist, dass der Druck ungenügend ist, um den Wirkstoff am Zielort zu bringen
- Ungenauigkeiten bei der Patienteinschreibung? Ebbens und Fokkens haben nicht einmal die Veränderung des Fungus gemessen, vom Start bis zum Ende der Behandlung
- Dosis? 20 ml (250 µg/ml) vs. 25 ml (100 µg/ml) - obwohl hier zu bemerken ist, dass Ponikau selber auch die 100 µg/ml bevorzugt.
Zu dem Mayo Test:
...
Clinical studies first conducted by Mayo Clinic found that this treatment provided greater improvement of symptoms than other treatments that have been used. Past treatments used by physicians include antibiotics and systemic or inhaled steroids, as well as endoscopic sinus surgery.
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
...
Man sollte den Placebo Effekt NIE unterschätzen, dennoch ähneln die Werte des damaligen Mayo Tests doch denen der aktuellen Zwischendaten. Beim Ausblick 2008 teilte ABPI / O'Donnell nebenbei mit, dass beim Stande von 239 behandelten Patienten, bei 23 % sich eines der beiden Symptome verbesserten und 20 % bei BEIDEN (Headache und congestion). Behält man im Hinterkopf, dass die Hälfte mit Placebo behandelt wurde und dies dann MÖGLICHERWEISE kein Erfolg bedeutet, hieße dass im Besten Fall bei 86 % der SinuNase Patienten eine Verbesserung bei mind. einem Symptom aufweisen.
Kommen wir jetzt noch einmal auf die SinuNase Oktober Präsentation zurück:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
Seite 23 Endoskopie Werte - Polypen (143 Patienten insg.):
- Bei 86 (60 %) verringerten sich die Werte im Durchschnitt um 13,6 %, davon bei keinem eine Verbesserung eines Symptoms
- Bei 28 (20 %) verringerten sich die Werte im Durchschnitt um 32,8 %, davon eine Verbesserung EINES Symptoms
- Bei 29 (20 %) verringerten sich die Werte im Durchschnitt um 52,0 %, davon eine Verbesserung BEIDER Symptome
Seite 25 zur Schleimhaut Dicke (CT Scan) (109 Patienten insg.):
- Bei 59 (54 %) vergrößerten sich die Werte im Durchschnitt um 0,3 %, davon bei keinem eine Verbesserung eines Symptoms
- Bei 25 (23 %) verringerten sich die Werte im Durchschnitt um 4,1 %, davon eine Verbesserung EINES Symptoms
- Bei 25 (23 %) verringerten sich die Werte im Durchschnitt um 13,1 %, davon eine Verbesserung BEIDER Symptome
Übrigends Ponikau hatte 2005 dokumentiert, dass bei seinem Test die Placebo Gruppe um etwa 2 bis 3 % Anstieg, während SinuNase um etwa 10 % sank. (Treatment of chronic rhinosinusitis with intranasal amphotericin B: A randomized, placebo-controlled, double-blind pilot trial)
Seite 27:
Laut dreier verschiedener Test konnte eine salzhaltige - oder eine Wasser Spülung (dass Placebo) nicht nachweisen die Schleimhaut Dicke oder Polypen (Endoskopie) zu verringern.
Generell sollte also die Formel heißen, je besser CT Scan und Endoskopie Werte umso höher die Wahrscheinlichkeit eines oder sogar beide Symptome zu erledigen. Ganz so wird der Hase aber auch wohl nicht laufen... Wirft man einen Blick auf Seite 28, so erkennt man, z.B. bei 6 Patienten mehr als 30 % und bei 10 zwischen 20 und 30 % reduktion der Schleimhäute. Wir gehen natürlich davon aus, dass SinuNase dies geschafft hat. Erechnet man sich nun den Durchschnitt der 25 Patienten mit den besten Ergebnissen, würde man auf deutlich mehr als „nur“ 13,1 % kommen (wohl etwa das doppelte). Mit anderen Worten, es ist auch nicht so, dass diejenigen die vom Ergebnis (CT und Endoskopie) am Besten sind wohl auch am meisten profitieren!
Wo liegt nun die Wahrheit?
Klar ist:
- Egal was es nun ist, aber der trial zeigt Wirkung (primärer und sekundäre Endpunkte)
- über 200.000 Amphotericin B Rezepte wurden im vergangen Jahr ausgestellt
Anbei noch mal 2 eher unbekanntere Berichte:
http://www.pslgroup.com/dg/264de6.htm
Amphotericin B Nasal Spray Helps Prevent Need for Repeat Chronic Sinusitis Surgery: Presented at AAO-HNSF
By Louise Gagnon
TORONTO, CANADA -- September 19, 2006 -- A chart review shows that the use of an antifungal nasal spray in patients who do not have good long-term benefit from surgery for chronic sinusitis can prevent the need for repeat surgery.
Presented here at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF), the retrospective study examined 70 patient cases of patients who had undergone surgery for chronic sinusitis, but whose symptoms returned and were seeking further treatment.
The investigators evaluated the safety of amphotericin B nasal spray (AmB NS) and its impact on the need for repeat surgery.
The spray is commercially available for other indications. Amphotericin B is approved by the Food and Drug Administration for intravenous treatment of systemic fungal infections. Research looking at the effects of amphotericin B nasal spray to treat chronic sinusitis have so far obtained conflicting results (J Allergy Clin Immunol. 2005 Jan;115(1):125-31. J Allergy Clin Immunol. 2004 Jun;113(6):1122-8).
"The focus [of research] was to develop therapies that focus on the fungal component of chronic sinusitis," explained principal investigator B. Manrin Rains III, MD, director, Mid-South Sinus Center, and assistant clinical professor, department of otolaryngology, University of Tennessee, Memphis, Tennessee.
"The etiology of chronic sinusitis is still a subject of controversy," he explained. "There is not a clear consensus on what is causing it. I have come to believe in clinical experience that there is a fungus involved in its development."
Dr. Rains noted that in his clinical experience, many patients' symptoms return after they have undergone surgery for chronic sinusitis. He has used the spray in an off-label fashion to treat these patients. "A lot of these patients have had surgery, but the surgery has not been able to adequately treat them," he said. "It also represents an option where they may not have to use steroids."
For their chart review, Dr. Rains and colleagues enrolled 70 patients with a mean age of 51.2 years, (52.9% female). The majority had a positive culture/stain for bacterial infection. Concomitant medications used by patients at baseline included steroids (39), antibiotics (34), oral/topical antifungals (25), and saline nasal spray (25).
Patients were treated with AmB NS for a mean of 13.7 months. A total of 40 patients used a dosage of 0.5 mg/mL, 13 patients used a dosage of 1.0 mg/dL, 11 took a dosage of 0.1 mg/dL, and 6 used a dosage of 5.0 mg/dL.
The most effective dosage was 0.5 mg/mL, with patients on this dose having the least need for repeat surgery (14.3%). Among patients who continued their AmB NS therapy for the duration of the study, 16.1% underwent a repeat sinus surgery.
There were 6 cases of adverse effects, with these patients reporting minor events such as irritated nose, burning sensation, cough, headache, and anosmia, Dr. Rains noted. He added that patients could stop the therapy for certain periods of time if they feel their symptoms were improved significantly.
A prospective study will be conducted to examine more definitively the effect of this therapy. "It may be that the therapy is effective on its own without patients undergoing surgery," Dr. Rains said.
[Presentation title: Amphotericin B Nasal Spray in Chronic Sinusitis Chart Review. Poster 182]
http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=70911&Ausgabe=229221&ProduktNr=224147
Nasal polyposis (NP) is considered as the ultimate stage of chronic rhinosinusitis. The exact pathogenesis of NP is unknown, but recent studies have suggested that allergic fungal rhinosinusitis could be involved in the development of NP. The aim of the present study was to evaluate the effects on NP of an intranasal administration of a fungicide suspension. One hundred and fifteen consecutive patients suffering from NP over 6 months were included. Patients in group I (n = 75) performed nasal lavages with 20 ml of a 1 amphotericin B suspension in each nostril, twice a day, during 4 weeks. Patients in group II (n = 40) used the same amphotericin B suspension as a nasal spray twice a day (total volume 800 µl) for 4 weeks. All patients continued their saline nasal lavages and their treatment with a conventional topical corticosteroid spray (400 µl/day). After antifungal nasal lavages, total disappearance of NP was observed in 29 patients (39%). Following fungicide nasal spray, total disappearance of NP was found in 17 patients (43%). In patients who had had previous endoscopic sinus surgery, total disappearance of NP was seen in 48 and 64% of patients from groups I and II, respectively. The beneficial effects of nasal lavage versus nasal spray with a fungicidal suspension are similar. Hyperreactivity to fungal organisms could be one of the mechanisms underlying the development of NP. However, a direct effect of amphotericin B suspension on the integrity of the cell membranes of the polyp epithelium could not be excluded.
Also: Spray genauso effektiv wie Lavage; ungefähr jeweils 40 % Reduktion der Polypen NACH 4 Wochen --> Auffällig: aktuelle Phase III könnte in einem ähnlichen Bereich liegen, nimmt man beim Placebo kein Effekt an.
Grüße
Zur Ebbens und Fokkens Studie noch mal etwas:
Klar ist dass Ponikau in Sachen SinuNase befangen ist - er wird reich wenn es zugelassen wird. Aber auch Fokkens steht meiner Ansicht nach unter dem gleichen Licht:
...has consulting arrangements with GlaxoSmithKline and Schering-Plough and has received grant support from GlaxoSmithKline, Schering-Plough, and Optinose.
Schering-Plough z.B. verkauft Clarinex das auch in den Bereichen CS eingesetzt wird.
http://www.sch-plough.com/schering_plough/news/release.jsp?r…
http://www.12buys.com/category.asp?Pcat=0048
Gleichwohl muss ich sagen, dass Frau Ebbens und Herr Fokkens eigentlich den ersten "richtigen" SinuNase Test durchgeführt haben (genug Patienten, double-blind, placebo-controlled...). Also woran lag es?
- EMCUR System? ABPIs Aussage hierzu ist, dass der Druck ungenügend ist, um den Wirkstoff am Zielort zu bringen
- Ungenauigkeiten bei der Patienteinschreibung? Ebbens und Fokkens haben nicht einmal die Veränderung des Fungus gemessen, vom Start bis zum Ende der Behandlung
- Dosis? 20 ml (250 µg/ml) vs. 25 ml (100 µg/ml) - obwohl hier zu bemerken ist, dass Ponikau selber auch die 100 µg/ml bevorzugt.
Zu dem Mayo Test:
...
Clinical studies first conducted by Mayo Clinic found that this treatment provided greater improvement of symptoms than other treatments that have been used. Past treatments used by physicians include antibiotics and systemic or inhaled steroids, as well as endoscopic sinus surgery.
Mayo Clinic conducted a prospective open-label trial using amphotericin B, an antifungal drug, in 51 randomly selected CRS patients. Treatment with amphotericin B resulted in an improvement of CRS symptoms in 38 of 51, or 75 percent, of the patients. Endoscopically, 18 of 51, or 35 percent, of the patients became disease free; an additional 20 patients, or 39 percent, improved mildly; no effect was seen in 13, or 25 percent, of the patients. Researchers in Switzerland conducted a similar open trial and confirmed Mayo Clinic?s results.
...
Man sollte den Placebo Effekt NIE unterschätzen, dennoch ähneln die Werte des damaligen Mayo Tests doch denen der aktuellen Zwischendaten. Beim Ausblick 2008 teilte ABPI / O'Donnell nebenbei mit, dass beim Stande von 239 behandelten Patienten, bei 23 % sich eines der beiden Symptome verbesserten und 20 % bei BEIDEN (Headache und congestion). Behält man im Hinterkopf, dass die Hälfte mit Placebo behandelt wurde und dies dann MÖGLICHERWEISE kein Erfolg bedeutet, hieße dass im Besten Fall bei 86 % der SinuNase Patienten eine Verbesserung bei mind. einem Symptom aufweisen.
Kommen wir jetzt noch einmal auf die SinuNase Oktober Präsentation zurück:
http://www.accentia.net/media/ABPI_SinunaseOct2007/ABPI_Sinu…
Seite 23 Endoskopie Werte - Polypen (143 Patienten insg.):
- Bei 86 (60 %) verringerten sich die Werte im Durchschnitt um 13,6 %, davon bei keinem eine Verbesserung eines Symptoms
- Bei 28 (20 %) verringerten sich die Werte im Durchschnitt um 32,8 %, davon eine Verbesserung EINES Symptoms
- Bei 29 (20 %) verringerten sich die Werte im Durchschnitt um 52,0 %, davon eine Verbesserung BEIDER Symptome
Seite 25 zur Schleimhaut Dicke (CT Scan) (109 Patienten insg.):
- Bei 59 (54 %) vergrößerten sich die Werte im Durchschnitt um 0,3 %, davon bei keinem eine Verbesserung eines Symptoms
- Bei 25 (23 %) verringerten sich die Werte im Durchschnitt um 4,1 %, davon eine Verbesserung EINES Symptoms
- Bei 25 (23 %) verringerten sich die Werte im Durchschnitt um 13,1 %, davon eine Verbesserung BEIDER Symptome
Übrigends Ponikau hatte 2005 dokumentiert, dass bei seinem Test die Placebo Gruppe um etwa 2 bis 3 % Anstieg, während SinuNase um etwa 10 % sank. (Treatment of chronic rhinosinusitis with intranasal amphotericin B: A randomized, placebo-controlled, double-blind pilot trial)
Seite 27:
Laut dreier verschiedener Test konnte eine salzhaltige - oder eine Wasser Spülung (dass Placebo) nicht nachweisen die Schleimhaut Dicke oder Polypen (Endoskopie) zu verringern.
Generell sollte also die Formel heißen, je besser CT Scan und Endoskopie Werte umso höher die Wahrscheinlichkeit eines oder sogar beide Symptome zu erledigen. Ganz so wird der Hase aber auch wohl nicht laufen... Wirft man einen Blick auf Seite 28, so erkennt man, z.B. bei 6 Patienten mehr als 30 % und bei 10 zwischen 20 und 30 % reduktion der Schleimhäute. Wir gehen natürlich davon aus, dass SinuNase dies geschafft hat. Erechnet man sich nun den Durchschnitt der 25 Patienten mit den besten Ergebnissen, würde man auf deutlich mehr als „nur“ 13,1 % kommen (wohl etwa das doppelte). Mit anderen Worten, es ist auch nicht so, dass diejenigen die vom Ergebnis (CT und Endoskopie) am Besten sind wohl auch am meisten profitieren!
Wo liegt nun die Wahrheit?
Klar ist:
- Egal was es nun ist, aber der trial zeigt Wirkung (primärer und sekundäre Endpunkte)
- über 200.000 Amphotericin B Rezepte wurden im vergangen Jahr ausgestellt
Anbei noch mal 2 eher unbekanntere Berichte:
http://www.pslgroup.com/dg/264de6.htm
Amphotericin B Nasal Spray Helps Prevent Need for Repeat Chronic Sinusitis Surgery: Presented at AAO-HNSF
By Louise Gagnon
TORONTO, CANADA -- September 19, 2006 -- A chart review shows that the use of an antifungal nasal spray in patients who do not have good long-term benefit from surgery for chronic sinusitis can prevent the need for repeat surgery.
Presented here at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF), the retrospective study examined 70 patient cases of patients who had undergone surgery for chronic sinusitis, but whose symptoms returned and were seeking further treatment.
The investigators evaluated the safety of amphotericin B nasal spray (AmB NS) and its impact on the need for repeat surgery.
The spray is commercially available for other indications. Amphotericin B is approved by the Food and Drug Administration for intravenous treatment of systemic fungal infections. Research looking at the effects of amphotericin B nasal spray to treat chronic sinusitis have so far obtained conflicting results (J Allergy Clin Immunol. 2005 Jan;115(1):125-31. J Allergy Clin Immunol. 2004 Jun;113(6):1122-8).
"The focus [of research] was to develop therapies that focus on the fungal component of chronic sinusitis," explained principal investigator B. Manrin Rains III, MD, director, Mid-South Sinus Center, and assistant clinical professor, department of otolaryngology, University of Tennessee, Memphis, Tennessee.
"The etiology of chronic sinusitis is still a subject of controversy," he explained. "There is not a clear consensus on what is causing it. I have come to believe in clinical experience that there is a fungus involved in its development."
Dr. Rains noted that in his clinical experience, many patients' symptoms return after they have undergone surgery for chronic sinusitis. He has used the spray in an off-label fashion to treat these patients. "A lot of these patients have had surgery, but the surgery has not been able to adequately treat them," he said. "It also represents an option where they may not have to use steroids."
For their chart review, Dr. Rains and colleagues enrolled 70 patients with a mean age of 51.2 years, (52.9% female). The majority had a positive culture/stain for bacterial infection. Concomitant medications used by patients at baseline included steroids (39), antibiotics (34), oral/topical antifungals (25), and saline nasal spray (25).
Patients were treated with AmB NS for a mean of 13.7 months. A total of 40 patients used a dosage of 0.5 mg/mL, 13 patients used a dosage of 1.0 mg/dL, 11 took a dosage of 0.1 mg/dL, and 6 used a dosage of 5.0 mg/dL.
The most effective dosage was 0.5 mg/mL, with patients on this dose having the least need for repeat surgery (14.3%). Among patients who continued their AmB NS therapy for the duration of the study, 16.1% underwent a repeat sinus surgery.
There were 6 cases of adverse effects, with these patients reporting minor events such as irritated nose, burning sensation, cough, headache, and anosmia, Dr. Rains noted. He added that patients could stop the therapy for certain periods of time if they feel their symptoms were improved significantly.
A prospective study will be conducted to examine more definitively the effect of this therapy. "It may be that the therapy is effective on its own without patients undergoing surgery," Dr. Rains said.
[Presentation title: Amphotericin B Nasal Spray in Chronic Sinusitis Chart Review. Poster 182]
http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=70911&Ausgabe=229221&ProduktNr=224147
Nasal polyposis (NP) is considered as the ultimate stage of chronic rhinosinusitis. The exact pathogenesis of NP is unknown, but recent studies have suggested that allergic fungal rhinosinusitis could be involved in the development of NP. The aim of the present study was to evaluate the effects on NP of an intranasal administration of a fungicide suspension. One hundred and fifteen consecutive patients suffering from NP over 6 months were included. Patients in group I (n = 75) performed nasal lavages with 20 ml of a 1 amphotericin B suspension in each nostril, twice a day, during 4 weeks. Patients in group II (n = 40) used the same amphotericin B suspension as a nasal spray twice a day (total volume 800 µl) for 4 weeks. All patients continued their saline nasal lavages and their treatment with a conventional topical corticosteroid spray (400 µl/day). After antifungal nasal lavages, total disappearance of NP was observed in 29 patients (39%). Following fungicide nasal spray, total disappearance of NP was found in 17 patients (43%). In patients who had had previous endoscopic sinus surgery, total disappearance of NP was seen in 48 and 64% of patients from groups I and II, respectively. The beneficial effects of nasal lavage versus nasal spray with a fungicidal suspension are similar. Hyperreactivity to fungal organisms could be one of the mechanisms underlying the development of NP. However, a direct effect of amphotericin B suspension on the integrity of the cell membranes of the polyp epithelium could not be excluded.
Also: Spray genauso effektiv wie Lavage; ungefähr jeweils 40 % Reduktion der Polypen NACH 4 Wochen --> Auffällig: aktuelle Phase III könnte in einem ähnlichen Bereich liegen, nimmt man beim Placebo kein Effekt an.
Grüße
Halte die Studie von der Mayo fuer serioeser.
noch ein paar Auszüge:
Effect of anti-fungal nasal lavage with amphotericin B on nasal polyposis
Alma Ricchetti M.D. a1, Basile N. Landis M.D. a1, Alessandra Maffioli M.D. a1, Roland Giger M.D. a1, Chungkuan Zeng M.D. a1 and Jean-Silvain Lacroix M.D., Ph.D a1
a1 Rhinology Unit, Department of Otorhinolaryngology - Head and Neck Surgery, Geneva University Hospital, Switzerland.
Abstract
Recent studies have suggested that allergic fungal rhino-sinusitis could be involved in the development of nasal polyposis. The aim of this study was to evaluate the response of anti-fungal nasal lavages. Patients performed nasal lavage with 20 ml of a one per one thousand amphotericin B suspension in each nostril, twice a day, for four weeks. In addition, all patients continued their saline nasal lavage and their conventional topical corticosteroid spray. This study included 74 patients, with a mean age of 46 years (range from 19 to 73). Before anti-fungal treatment, the distribution of nasal polyposis, according to Malm, was: 13 patients in stage I (17.5 per cent), 48 patients in stage II (65 per cent) and 13 patients in stage III (17.5 per cent). After anti-fungal nasal lavages, the total disappearance of nasal polyposis was observed in 29 patients (39 per cent). Eight patients were stage I, 21 stage II, and none stage III. In patients who have had previous endoscopic polypectomy and functional endoscopic sinus surgery, total disappearance of nasal polyposis was seen in 24 patients (47 per cent). Hyper-reactivity to fungal organisms could be one of the mechanisms underlying the development of nasal polyposis. A direct effect of amphotericin B suspension on the integrity of the cell membrane of the polyps’
--> nur 4 Wochen Behandlung Ampho b plus saline & corticosteroid spray und dass Ergebnis kann sich sehen lassen...
der "vorher auf nachher" Vergleich:
stage III: von 13 auf 0
stage II: von 48 auf 21
stage I: von 13 auf 8
total disappearance: von 0 auf 29
Leider sind hierbei nach der Behandlung 16 Personen anscheinend verlorengegangen. Ob es zu früh war Schlüsse zu ziehen, die Behandlung abgebrochen wurde oder keine Zuordnung möglich war?
The fungal debate: where do we stand today?
Ebbens FA, Georgalas C, Rinia AB, van Drunen CM, Lund VJ, Fokkens WJ.
Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands. f.a.ebbens@amc.uva.nl
Chronic rhinosinusitis (CRS) is an inflammatory disorder affecting the nose and paranasal sinuses. Although bacteria have long been implicated as pathogens in most forms of CRS, it has been recognized that fungi may be responsible for some forms of CRS. Recent studies have shown that under optimal conditions, fungi can be identified within the nose and paranasal sinuses of nearly every individual. Considerable controversy exists concerning the proper diagnosis of and potential overlap between 'allergic fungal rhinosinusitis' and 'chronic rhinosinusitis'. Although the disease name 'allergic fungal rhinosinusitis' is suggestive of an immunoglobulin E (IgE) mediated reaction to fungi, recent studies demonstrate the presence of elevated serum IgE levels to one fungus while another fungus is present in CRS mucin of the same individual, questioning the role of type I hypersensitivity. Several mechanisms explaining the role of fungi in the pathogenesis of CRS, all requiring additional investigations with adequate controls, have been suggested and will be reviewed. Although preliminary trials suggest a beneficial effect of topical and oral antifungal agents in the treatment of CRS patients, several double-blind placebo controlled trials do not. Presently, in the absence of convincing immunological data and evidence of clinical improvement of CRS upon therapy with antifungal agents, the case against the fungus remains unproven.
PMID: 17956015 [PubMed - indexed for MEDLINE]
--> Hört sich nicht mehr 100 %-ig nach "Not a solution..." an.
Dass ist die Kurzzusammenfassung (dass Abstract) Ponikaus 24 Personen Trial
Treatment of chronic rhinosinusitis with intranasal amphotericin b: a randomized, placebo-controlled, double-blind pilot trial.
Personal Authors: Ponikau, J. U., Sherris, D. A., Weaver, A., Kita, H.
Author Affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA.
Editors: No editors
Document Title: Journal of Allergy and Clinical Immunology, 2005 (Vol. 115) (No. 1) 125-131
Abstract:
Background: Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its aetiology is unknown, and there is a paucity of effective medical treatments.
Objective: We tested the hypothesis that intranasal antifungal treatment improves the objective computed tomography (CT) findings (inflammatory mucosal thickening), nasal endoscopy stages, and symptoms of CRS.
Methods: A randomized, placebo-controlled, double-blind, single-centre trial used amphotericin B to treat 30 randomly selected patients with CRS. Patients were instructed to instill 20 ml amphotericin B (250 µg/ml) or placebo to each nostril twice daily for 6 months. The primary outcome was a quantitative reduction in inflammatory mucosal thickening on CT scans of a standardized coronal cut. Secondary outcome measures were endoscopic scores, patient symptom scores, and levels of intranasal inflammatory mediators.
Results: 24 patients completed the 6 months of treatment. Patients receiving amphotericin B achieved a relative reduction in the percentage of mucosal thickening on CT scans (n=10; -8.8%) compared with placebo (n=14; +2.5%; P=0.030). Likewise, the changes in the endoscopic scores improved in the amphotericin B group compared with placebo (P=0.038). Between-group comparisons of the changes in the intranasal mucus levels of eosinophil-derived neurotoxin showed a reduction in the amphotericin B group and an increase in the placebo group (P=0.046); levels of IL-5 showed similar tendencies (P=0.082).
Conclusion: Intranasal amphotericin B reduced inflammatory mucosal thickening on both CT scan and nasal endoscopy and decreased the levels of intranasal markers for eosinophilic inflammation in patients with CRS.
--> Wie erwähnt: CT-Scan Werte (könnten) ähneln aktuellen Zwischenergebnissen. Vor allem wichtig IL-5 und eosinophile gehen runter im Vergleich zur Placebo Gruppe! Dass sind die Auslöser der Chronischen Sinusitis.
Grüße
Effect of anti-fungal nasal lavage with amphotericin B on nasal polyposis
Alma Ricchetti M.D. a1, Basile N. Landis M.D. a1, Alessandra Maffioli M.D. a1, Roland Giger M.D. a1, Chungkuan Zeng M.D. a1 and Jean-Silvain Lacroix M.D., Ph.D a1
a1 Rhinology Unit, Department of Otorhinolaryngology - Head and Neck Surgery, Geneva University Hospital, Switzerland.
Abstract
Recent studies have suggested that allergic fungal rhino-sinusitis could be involved in the development of nasal polyposis. The aim of this study was to evaluate the response of anti-fungal nasal lavages. Patients performed nasal lavage with 20 ml of a one per one thousand amphotericin B suspension in each nostril, twice a day, for four weeks. In addition, all patients continued their saline nasal lavage and their conventional topical corticosteroid spray. This study included 74 patients, with a mean age of 46 years (range from 19 to 73). Before anti-fungal treatment, the distribution of nasal polyposis, according to Malm, was: 13 patients in stage I (17.5 per cent), 48 patients in stage II (65 per cent) and 13 patients in stage III (17.5 per cent). After anti-fungal nasal lavages, the total disappearance of nasal polyposis was observed in 29 patients (39 per cent). Eight patients were stage I, 21 stage II, and none stage III. In patients who have had previous endoscopic polypectomy and functional endoscopic sinus surgery, total disappearance of nasal polyposis was seen in 24 patients (47 per cent). Hyper-reactivity to fungal organisms could be one of the mechanisms underlying the development of nasal polyposis. A direct effect of amphotericin B suspension on the integrity of the cell membrane of the polyps’
--> nur 4 Wochen Behandlung Ampho b plus saline & corticosteroid spray und dass Ergebnis kann sich sehen lassen...
der "vorher auf nachher" Vergleich:
stage III: von 13 auf 0
stage II: von 48 auf 21
stage I: von 13 auf 8
total disappearance: von 0 auf 29
Leider sind hierbei nach der Behandlung 16 Personen anscheinend verlorengegangen. Ob es zu früh war Schlüsse zu ziehen, die Behandlung abgebrochen wurde oder keine Zuordnung möglich war?
The fungal debate: where do we stand today?
Ebbens FA, Georgalas C, Rinia AB, van Drunen CM, Lund VJ, Fokkens WJ.
Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands. f.a.ebbens@amc.uva.nl
Chronic rhinosinusitis (CRS) is an inflammatory disorder affecting the nose and paranasal sinuses. Although bacteria have long been implicated as pathogens in most forms of CRS, it has been recognized that fungi may be responsible for some forms of CRS. Recent studies have shown that under optimal conditions, fungi can be identified within the nose and paranasal sinuses of nearly every individual. Considerable controversy exists concerning the proper diagnosis of and potential overlap between 'allergic fungal rhinosinusitis' and 'chronic rhinosinusitis'. Although the disease name 'allergic fungal rhinosinusitis' is suggestive of an immunoglobulin E (IgE) mediated reaction to fungi, recent studies demonstrate the presence of elevated serum IgE levels to one fungus while another fungus is present in CRS mucin of the same individual, questioning the role of type I hypersensitivity. Several mechanisms explaining the role of fungi in the pathogenesis of CRS, all requiring additional investigations with adequate controls, have been suggested and will be reviewed. Although preliminary trials suggest a beneficial effect of topical and oral antifungal agents in the treatment of CRS patients, several double-blind placebo controlled trials do not. Presently, in the absence of convincing immunological data and evidence of clinical improvement of CRS upon therapy with antifungal agents, the case against the fungus remains unproven.
PMID: 17956015 [PubMed - indexed for MEDLINE]
--> Hört sich nicht mehr 100 %-ig nach "Not a solution..." an.
Dass ist die Kurzzusammenfassung (dass Abstract) Ponikaus 24 Personen Trial
Treatment of chronic rhinosinusitis with intranasal amphotericin b: a randomized, placebo-controlled, double-blind pilot trial.
Personal Authors: Ponikau, J. U., Sherris, D. A., Weaver, A., Kita, H.
Author Affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA.
Editors: No editors
Document Title: Journal of Allergy and Clinical Immunology, 2005 (Vol. 115) (No. 1) 125-131
Abstract:
Background: Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Its aetiology is unknown, and there is a paucity of effective medical treatments.
Objective: We tested the hypothesis that intranasal antifungal treatment improves the objective computed tomography (CT) findings (inflammatory mucosal thickening), nasal endoscopy stages, and symptoms of CRS.
Methods: A randomized, placebo-controlled, double-blind, single-centre trial used amphotericin B to treat 30 randomly selected patients with CRS. Patients were instructed to instill 20 ml amphotericin B (250 µg/ml) or placebo to each nostril twice daily for 6 months. The primary outcome was a quantitative reduction in inflammatory mucosal thickening on CT scans of a standardized coronal cut. Secondary outcome measures were endoscopic scores, patient symptom scores, and levels of intranasal inflammatory mediators.
Results: 24 patients completed the 6 months of treatment. Patients receiving amphotericin B achieved a relative reduction in the percentage of mucosal thickening on CT scans (n=10; -8.8%) compared with placebo (n=14; +2.5%; P=0.030). Likewise, the changes in the endoscopic scores improved in the amphotericin B group compared with placebo (P=0.038). Between-group comparisons of the changes in the intranasal mucus levels of eosinophil-derived neurotoxin showed a reduction in the amphotericin B group and an increase in the placebo group (P=0.046); levels of IL-5 showed similar tendencies (P=0.082).
Conclusion: Intranasal amphotericin B reduced inflammatory mucosal thickening on both CT scan and nasal endoscopy and decreased the levels of intranasal markers for eosinophilic inflammation in patients with CRS.
--> Wie erwähnt: CT-Scan Werte (könnten) ähneln aktuellen Zwischenergebnissen. Vor allem wichtig IL-5 und eosinophile gehen runter im Vergleich zur Placebo Gruppe! Dass sind die Auslöser der Chronischen Sinusitis.
Grüße
Antwort auf Beitrag Nr.: 33.178.278 von Ackergaul am 26.01.08 12:02:391. Punkt: erst einmal eine Korrektur, zu meiner Schlußfolgerung bezüglich Ricchettis Trials
Dass ganze ist schon richtig ausgewertet, aber von mir falsch aufgefasst worden. 74 (13 x I; 48 x II; 13 x III) Patienten wurden behandelt - geheilt wurden davon 29 (8 x I; 21 x II; 0 x III). Also stage III Patienten wurden NICHT geheilt, aber insgesamt 40 % der stage I und II Patienten.
2. Punkt: Revimmune (HiCy)
Biovest hatte zuletzt eine Miteilung veröffentlicht, auch eine Phase III (Abstoßungsreaktionen nach Knochenmarktransplantation) zu initiieren.
http://biz.yahoo.com/bw/080122/20080122005879.html?.v=1
ABPI selber startet bekanntlich bei RRMS. Ein richtiger guter Artikel ist hier zu finden:
http://www.hopkinscap.com/media/HighTimeforHiCy-JHU2008.pdf
Dass ganze ist schon richtig ausgewertet, aber von mir falsch aufgefasst worden. 74 (13 x I; 48 x II; 13 x III) Patienten wurden behandelt - geheilt wurden davon 29 (8 x I; 21 x II; 0 x III). Also stage III Patienten wurden NICHT geheilt, aber insgesamt 40 % der stage I und II Patienten.
2. Punkt: Revimmune (HiCy)
Biovest hatte zuletzt eine Miteilung veröffentlicht, auch eine Phase III (Abstoßungsreaktionen nach Knochenmarktransplantation) zu initiieren.
http://biz.yahoo.com/bw/080122/20080122005879.html?.v=1
ABPI selber startet bekanntlich bei RRMS. Ein richtiger guter Artikel ist hier zu finden:
http://www.hopkinscap.com/media/HighTimeforHiCy-JHU2008.pdf
Antwort auf Beitrag Nr.: 33.189.587 von Ackergaul am 28.01.08 12:55:40Am 28. Februar ist die Hauptversammlung ABPIs. Wichtige Entscheidungen stehen dort aus meiner Sicht nicht an. Möglicherweise sickert aber schon etwas von den Enddaten des Phase III Trials durch, wahrscheinlicher aber werden die Daten erst ein bis zwei Wochen später bekanntgegeben.
http://www.accentia.net/investors/sec.php
Zur Aktionärsstruktur ABPIs:
Hopkins Capital; PPDI und ein gewisser Timothy Ryll besitzen alle jeweils knapp 10 %. Die Executive Officers und Directors besitzen zusammen nochmals 25 % der ABPI Aktien - also zusammen etwa 55 %! O'Donnell alleine hat über 18 % der Anteilsscheine.
Grüße
http://www.accentia.net/investors/sec.php
Zur Aktionärsstruktur ABPIs:
Hopkins Capital; PPDI und ein gewisser Timothy Ryll besitzen alle jeweils knapp 10 %. Die Executive Officers und Directors besitzen zusammen nochmals 25 % der ABPI Aktien - also zusammen etwa 55 %! O'Donnell alleine hat über 18 % der Anteilsscheine.
Grüße
Antwort auf Beitrag Nr.: 33.247.572 von Ackergaul am 02.02.08 13:21:5912.02.2008 08:46
Accentia Biopharmaceuticals ein Schnäppchen (Global Biotech Investing)
Endingen (aktiencheck.de AG) - Aus Sicht der Experten von "Global Biotech Investing" ist die Aktie von Accentia Biopharmaceuticals (ISIN US00430L1035 (News)/ WKN A0EATH) fundamental ein richtiges Schnäppchen.
Das Unternehmen habe sich darauf spezialisiert, "lediglich" bereits gut ausgetestete, bestehende Wirkstoffe weiterzuentwickeln und zu optimieren. Auf den ersten Blick erscheine das eher langweilig und zeige keinerlei Fantasie. Vor allem wenn man bedenke, dass das führende Präparat in der Forschung SinuNase heiße und zur Linderung von Nasennebenhöhlenentzündungen diene.
Auf den zweiten Blick erscheine Accentia Biopharmaceuticals schon sympathischer. Ab diesem Jahr könnte das Unternehmen mit der anstehenden Vermarktung erster größerer Präparate auf eine Umsatzexplosion zusteuern. Damit würde Accentia Biopharmaceuticals auf Sicht der nächsten 3-4 Jahre in eine ganz andere Liga katapultiert. Aber das sei noch nicht alles. Für 2011 kalkuliere man mit einem Net Profit von rund 57 Mio. USD. Die aktuelle Market Cap belaufe sich auf 110 Mio. USD. Durch diese beiden Kriterien sei das ein KGV von weniger als 2.
Es gebe jedoch noch weitere interessante Aspekte die für die Accentia Biopharmaceuticals-Aktie sprechen würden. Das Unternehmen habe eine 78%-Beteiligung an Biovest International. Die Experten hätten bereits im vergangenen Jahr auf dieses Unternehmen im Zusammenhang mit deren visionärer Krebsvakzin-Forschung aufmerksam gemacht. Nach den Rückschlägen von Dendreon und IDM Pharma, habe der jüngste Reinfall von Genitope nun erst mal für den Rest gesorgt. Keiner setze nun mehr auch nur einen Pfifferling auf den Forschungserfolg in diesem Bereich.
MyVax von Genitope habe in jüngsten Tests bei einer im Schnitt 40% liegenden Immunantwortquote gelegen. BiovaxID von Biovest habe dagegen bei rund 80% gelegen. Diese Bestätigung stehe in aktuell laufenden Phase-III-Tests ebenso auf der Agenda wie die Frage, ob damit ein therapeutisch signifikanter Nutzen nachweisbar sei. Erste Zwischendaten stünden im April an und damit auch erste Antworten auf die alles entscheidende Frage. Am Markt sei rein gar nichts von Fantasie und Spekulation zu sehen. Das sei verständlich, aber nicht allein deswegen unbedingt richtig.
Nach Ansicht der Experten von "Global Biotech Investing" ist die Accentia Biopharmaceuticals-Aktie fundamental gesehen ein Schnäppchen. (Ausgabe 03 vom 11.02.2008) (11.02.2008/ac/a/a)
Analyse-Datum: 11.02.2008
Klicken Sie hier, um weitere aktuelle Nachrichten zum Unternehmen zu finden:
ACCENTIA BIOPHARMACEUTICALS
jethor
Accentia Biopharmaceuticals ein Schnäppchen (Global Biotech Investing)
Endingen (aktiencheck.de AG) - Aus Sicht der Experten von "Global Biotech Investing" ist die Aktie von Accentia Biopharmaceuticals (ISIN US00430L1035 (News)/ WKN A0EATH) fundamental ein richtiges Schnäppchen.
Das Unternehmen habe sich darauf spezialisiert, "lediglich" bereits gut ausgetestete, bestehende Wirkstoffe weiterzuentwickeln und zu optimieren. Auf den ersten Blick erscheine das eher langweilig und zeige keinerlei Fantasie. Vor allem wenn man bedenke, dass das führende Präparat in der Forschung SinuNase heiße und zur Linderung von Nasennebenhöhlenentzündungen diene.
Auf den zweiten Blick erscheine Accentia Biopharmaceuticals schon sympathischer. Ab diesem Jahr könnte das Unternehmen mit der anstehenden Vermarktung erster größerer Präparate auf eine Umsatzexplosion zusteuern. Damit würde Accentia Biopharmaceuticals auf Sicht der nächsten 3-4 Jahre in eine ganz andere Liga katapultiert. Aber das sei noch nicht alles. Für 2011 kalkuliere man mit einem Net Profit von rund 57 Mio. USD. Die aktuelle Market Cap belaufe sich auf 110 Mio. USD. Durch diese beiden Kriterien sei das ein KGV von weniger als 2.
Es gebe jedoch noch weitere interessante Aspekte die für die Accentia Biopharmaceuticals-Aktie sprechen würden. Das Unternehmen habe eine 78%-Beteiligung an Biovest International. Die Experten hätten bereits im vergangenen Jahr auf dieses Unternehmen im Zusammenhang mit deren visionärer Krebsvakzin-Forschung aufmerksam gemacht. Nach den Rückschlägen von Dendreon und IDM Pharma, habe der jüngste Reinfall von Genitope nun erst mal für den Rest gesorgt. Keiner setze nun mehr auch nur einen Pfifferling auf den Forschungserfolg in diesem Bereich.
MyVax von Genitope habe in jüngsten Tests bei einer im Schnitt 40% liegenden Immunantwortquote gelegen. BiovaxID von Biovest habe dagegen bei rund 80% gelegen. Diese Bestätigung stehe in aktuell laufenden Phase-III-Tests ebenso auf der Agenda wie die Frage, ob damit ein therapeutisch signifikanter Nutzen nachweisbar sei. Erste Zwischendaten stünden im April an und damit auch erste Antworten auf die alles entscheidende Frage. Am Markt sei rein gar nichts von Fantasie und Spekulation zu sehen. Das sei verständlich, aber nicht allein deswegen unbedingt richtig.
Nach Ansicht der Experten von "Global Biotech Investing" ist die Accentia Biopharmaceuticals-Aktie fundamental gesehen ein Schnäppchen. (Ausgabe 03 vom 11.02.2008) (11.02.2008/ac/a/a)
Analyse-Datum: 11.02.2008
Klicken Sie hier, um weitere aktuelle Nachrichten zum Unternehmen zu finden:
ACCENTIA BIOPHARMACEUTICALS
jethor
Sieht so aus, das endlich mal Bewegung in
die Angelegenheit kommt.
die Angelegenheit kommt.
Langsam wird es Ernst! Am 8. Okt 2007 wurde gemeldet, dass der letzte Patient rekrutiert wurde. 16 Wochen Behandlungsdauer bedeutet, dass am 28.1. diese Jahres alle 300 Patienten behandelt wurden. 2 Wochen später wollte ABPI die Entblindung des Trials komplettiert haben - bedeutet den 11.2. als Termin. Die Auswertung, Analyse und Zusammenstellung der Daten sollte in etwa 4 Wochen möglich sein, so dass wir wohl spätestens bis zum 10. März diese dann präsentiert bekommen.
Anbei noch 3 gesammelte Kleinigkeiten.
1.)
Ein 4-seitiger Bericht Ponikaus (2007) über Zytokine und Eosinophile und die dadurch entstehenden Probleme bei fungus sensitiven Menschen... Guter Artikel, der sich hoffentlich in der Auswertung der Phase III auch bald begründet.
http://www.touchbriefings.com/pdf/2901/ponikan.pdf
Understanding the Role of Fungi in the Pathophysiology and Treatment of Chronic Rhinosinusitis
...
Conclusion
Alternaria, a ubiquitous airborne mold, is present in CRS patients as well as in healthy controls. However, only the immune cells of CRS patients react to the presence of Alternaria with the production of cytokines crucial for inciting the eosinophilic inflammation seen in this disease. This cytokine-driven immune response occurs independent of IgE production. In addition, Alternaria induces the degranulation of eosinophils and the release of their toxic protein. In CRS patients one can appreciate the migration, cluster formation, degranulation, and targeting of extramucosal fungi by the eosinophils. Antifungal therapy shows promise in reducing the trigger for the eosinophilic inflammation, and consequently the inflammatory mucosal thickening. However, drug delivery, dosage, and frequency and duration of treatment must be further optimized.
2.)
Desweiteren von Corradini (2006) noch eine kleine Studie. ABPI hatte in der Oktober Präsentation 5 Beispiel präsentiert: 2 x Mayo sowie 2 x eine Genfer sowie eben diese Corradini Studie.
http://www.jiaci.org/issues/vol16issue03/7.pdf
Amphotericin B and Lysine Acetylsalicylate in the Combined Treatment of Nasal Polyposis Associated With Mycotic Infection
Zu der Auswertung dieses Versuchs: 89 Personen in 4 Gruppen. Gruppe A (25 Pers.) und B (25 Pers.) ohne Ampho B; Gruppe C (16 Pers.) und D (23 Pers.) mit. Patienten der Gruppe A und C kamen zusätzlich unters Messer. Ziel war es sozusagen, dass Wiederauftreten von Polypen und begleitende Infektionen zu verhindern.
zur Gruppe A: Erfolg bei 48 %
zur Gruppe B: Erfolg bei 40 %
zur Gruppe C: Erfolg bei 69 %
zur Gruppe D: Erfolg bei 70 %
3.)
Und etwas zu Ponikaus Person:
www.earnosethroat-associates.com
Published on: 11/1/2006 Last Visited: 3/21/2007
When Jens Ponikau left Germany 10 years ago to do research in the United States on chronic sinus inflammation, he expected to stay nine months.
Then a major breakthrough, uncovering the root cause of a persistent sinus ailment that, despite its effect on 37 million people in the United States alone, has no FDA, approved treatment, changed everything.
"Not many people have the chance to make a significant change for the better," says Ponikau, clinical assistant professor in the Department of Otolaryngology, School of Medicine and Biomedical Sciences. "I felt that it came to me, that I could make a significant influence or change, so I took it and I ran with it."
His research - conducted over the course of nine years at the Mayo Clinic and continuing now at UB - shows that chronic sinus inflammation, or sinusitis, is caused by a reaction to fungus in nasal mucus. Ponikau was the first to discover the fungus in sinusitis sufferers because he was the first to examine not only tissue samples from patients' nostrils, but the mucus inside as well.
"We had never found the fungus because we had never looked at the snot," he explains.
While previous research had focused on nasal tissue because sinusitis sufferers get frequent bacterial infections, Ponikau says nasal infections are merely a symptom caused by an underlying fungal reaction.
"Antibiotics have never worked long, term in chronic sinusitis," he points out. "We found an underlying inflammation in the tissue, which erodes away the protective layer. Patients had secondary bacterial infections - not because bad bacteria were there, but because the nasal skin was eroded away."
Ponikau recalls the actual moment he realized he might hold the key to unlocking a condition affecting about 15 percent of the population. It happened late one night, while he was alone burning the midnight oil in a lab at the Mayo Clinic.
"I always tell people there was this eureka moment when I was looking at snot under an electron microscope," he laughs.
Although the initial discovery of fungus in sinusitis sufferers came in 1994 while he was a fourth, year German medical student studying at Mayo, Ponikau explains the significant breakthrough, the one that kept him in the U.S., came after he returned to the famous Minnesota research hospital fresh from a two year residency at his father's small ear, nose and throat clinic in Hof, Germany. He then uncovered the fundamental connection between the fungus'; presence in patients' mucus and the actual nasal infections that characterize the condition.
Under the electron microscope, Ponikau noticed an unusual level of inflammatory white blood cells, called eosinophils, in the mucus of sinusitis sufferers. These cells had been noted in the nasal tissue of some sinusitis patients, he says, but no one had explained their presence.
Studying the mucus, he realized the true target of the destructive cells lay outside the body. The eosinophils were traveling though the tissue to cluster around the fungus in the mucus.
"That was the big breakthrough," he says. "I saw that the inflammatory cells were destroying the fungi and releasing all their toxins in that process."
But pinning sinusitis on fungus, rather than bacteria, represented such a "big step out of the box" that Ponikau spent years convincing the medical community.
"When we introduced it, the whole scientific field was up in arms," he says. Since then, however, support has started pouring in from such prestigious organizations as the National Institutes of Health, which has contributed about $5 million to the project.
...
Ponikau followed Sherris to UB this fall to direct the research branch of the department and guide the projects of its medical residents, the first of whom will join the program in July 2007.
...
"I think there's a lot of excitement about having the residency program back," Ponikau says, noting that a good medical program provides students with a combination of experience in the classroom, a clinical environment and a research lab.
"You cannot have a department without having a research arm," he points out. "We're in the process of getting a team together here focusing on fungal sinusitis."
In addition to his UB duties, Ponikau serves as president of Gromo L.L.C., an intellectual property holding company that protects the rights to his discoveries. He says the license to market the first ever fungal sinusitis test has been granted to a Buffalo based biomedical company, Immco Diagnostics Inc., which currently processes several hundred of the tests per month.
On top of the business and research opportunities offered by Buffalo and UB, Ponikau notes that settling in New York State' second largest city has been a welcome change from living in Rochester, Minn., a city of less than 100,000. Today, he resides in Amherst with his wife, Ragna, and three children: Sidney, 8, Felicia, 7, and Isabella, 2.
"I think Buffalo is great," he says.
Grüße
Anbei noch 3 gesammelte Kleinigkeiten.
1.)
Ein 4-seitiger Bericht Ponikaus (2007) über Zytokine und Eosinophile und die dadurch entstehenden Probleme bei fungus sensitiven Menschen... Guter Artikel, der sich hoffentlich in der Auswertung der Phase III auch bald begründet.
http://www.touchbriefings.com/pdf/2901/ponikan.pdf
Understanding the Role of Fungi in the Pathophysiology and Treatment of Chronic Rhinosinusitis
...
Conclusion
Alternaria, a ubiquitous airborne mold, is present in CRS patients as well as in healthy controls. However, only the immune cells of CRS patients react to the presence of Alternaria with the production of cytokines crucial for inciting the eosinophilic inflammation seen in this disease. This cytokine-driven immune response occurs independent of IgE production. In addition, Alternaria induces the degranulation of eosinophils and the release of their toxic protein. In CRS patients one can appreciate the migration, cluster formation, degranulation, and targeting of extramucosal fungi by the eosinophils. Antifungal therapy shows promise in reducing the trigger for the eosinophilic inflammation, and consequently the inflammatory mucosal thickening. However, drug delivery, dosage, and frequency and duration of treatment must be further optimized.
2.)
Desweiteren von Corradini (2006) noch eine kleine Studie. ABPI hatte in der Oktober Präsentation 5 Beispiel präsentiert: 2 x Mayo sowie 2 x eine Genfer sowie eben diese Corradini Studie.
http://www.jiaci.org/issues/vol16issue03/7.pdf
Amphotericin B and Lysine Acetylsalicylate in the Combined Treatment of Nasal Polyposis Associated With Mycotic Infection
Zu der Auswertung dieses Versuchs: 89 Personen in 4 Gruppen. Gruppe A (25 Pers.) und B (25 Pers.) ohne Ampho B; Gruppe C (16 Pers.) und D (23 Pers.) mit. Patienten der Gruppe A und C kamen zusätzlich unters Messer. Ziel war es sozusagen, dass Wiederauftreten von Polypen und begleitende Infektionen zu verhindern.
zur Gruppe A: Erfolg bei 48 %
zur Gruppe B: Erfolg bei 40 %
zur Gruppe C: Erfolg bei 69 %
zur Gruppe D: Erfolg bei 70 %
3.)
Und etwas zu Ponikaus Person:
www.earnosethroat-associates.com
Published on: 11/1/2006 Last Visited: 3/21/2007
When Jens Ponikau left Germany 10 years ago to do research in the United States on chronic sinus inflammation, he expected to stay nine months.
Then a major breakthrough, uncovering the root cause of a persistent sinus ailment that, despite its effect on 37 million people in the United States alone, has no FDA, approved treatment, changed everything.
"Not many people have the chance to make a significant change for the better," says Ponikau, clinical assistant professor in the Department of Otolaryngology, School of Medicine and Biomedical Sciences. "I felt that it came to me, that I could make a significant influence or change, so I took it and I ran with it."
His research - conducted over the course of nine years at the Mayo Clinic and continuing now at UB - shows that chronic sinus inflammation, or sinusitis, is caused by a reaction to fungus in nasal mucus. Ponikau was the first to discover the fungus in sinusitis sufferers because he was the first to examine not only tissue samples from patients' nostrils, but the mucus inside as well.
"We had never found the fungus because we had never looked at the snot," he explains.
While previous research had focused on nasal tissue because sinusitis sufferers get frequent bacterial infections, Ponikau says nasal infections are merely a symptom caused by an underlying fungal reaction.
"Antibiotics have never worked long, term in chronic sinusitis," he points out. "We found an underlying inflammation in the tissue, which erodes away the protective layer. Patients had secondary bacterial infections - not because bad bacteria were there, but because the nasal skin was eroded away."
Ponikau recalls the actual moment he realized he might hold the key to unlocking a condition affecting about 15 percent of the population. It happened late one night, while he was alone burning the midnight oil in a lab at the Mayo Clinic.
"I always tell people there was this eureka moment when I was looking at snot under an electron microscope," he laughs.
Although the initial discovery of fungus in sinusitis sufferers came in 1994 while he was a fourth, year German medical student studying at Mayo, Ponikau explains the significant breakthrough, the one that kept him in the U.S., came after he returned to the famous Minnesota research hospital fresh from a two year residency at his father's small ear, nose and throat clinic in Hof, Germany. He then uncovered the fundamental connection between the fungus'; presence in patients' mucus and the actual nasal infections that characterize the condition.
Under the electron microscope, Ponikau noticed an unusual level of inflammatory white blood cells, called eosinophils, in the mucus of sinusitis sufferers. These cells had been noted in the nasal tissue of some sinusitis patients, he says, but no one had explained their presence.
Studying the mucus, he realized the true target of the destructive cells lay outside the body. The eosinophils were traveling though the tissue to cluster around the fungus in the mucus.
"That was the big breakthrough," he says. "I saw that the inflammatory cells were destroying the fungi and releasing all their toxins in that process."
But pinning sinusitis on fungus, rather than bacteria, represented such a "big step out of the box" that Ponikau spent years convincing the medical community.
"When we introduced it, the whole scientific field was up in arms," he says. Since then, however, support has started pouring in from such prestigious organizations as the National Institutes of Health, which has contributed about $5 million to the project.
...
Ponikau followed Sherris to UB this fall to direct the research branch of the department and guide the projects of its medical residents, the first of whom will join the program in July 2007.
...
"I think there's a lot of excitement about having the residency program back," Ponikau says, noting that a good medical program provides students with a combination of experience in the classroom, a clinical environment and a research lab.
"You cannot have a department without having a research arm," he points out. "We're in the process of getting a team together here focusing on fungal sinusitis."
In addition to his UB duties, Ponikau serves as president of Gromo L.L.C., an intellectual property holding company that protects the rights to his discoveries. He says the license to market the first ever fungal sinusitis test has been granted to a Buffalo based biomedical company, Immco Diagnostics Inc., which currently processes several hundred of the tests per month.
On top of the business and research opportunities offered by Buffalo and UB, Ponikau notes that settling in New York State' second largest city has been a welcome change from living in Rochester, Minn., a city of less than 100,000. Today, he resides in Amherst with his wife, Ragna, and three children: Sidney, 8, Felicia, 7, and Isabella, 2.
"I think Buffalo is great," he says.
Grüße
Accentia Biopharmaceuticals Reports Fiscal First Quarter 2008 Financial Results
Company Affirms Plans to Unblind and Report Fast Track Pivotal
Phase 3 Results for SinuNase(TM) in March
TAMPA, Fla.--(BUSINESS WIRE)--Feb. 14, 2008--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its first fiscal quarter ended December 31, 2007. The Company also provided an update on its anticipated timetable to unblind and publicly-release results on the primary end-point for its Fast Track pivotal Phase 3 clinical trial for SinuNase(TM), intending to unveil the data on or before March 24, 2008. The Company is scheduled to present at the BioCentury "Future Leaders in the Biotech Industry" Conference on March 27th in New York City. In other news related to the Company's strategic focus on Ear, Nose and Throat (ENT) products, Accentia announced that is has entered into an agreement with Arbor Pharmaceuticals, Inc., granting Accentia U.S. commercial marketing rights to Neotic(TM), a novel, patented, prescription solution indicated for acute middle ear infections (acute otitis media).
Accentia reports that the interim blinded Intent-To-Treat (ITT) results in the randomized clinical trial in which 50% of patients receive SinuNase and 50% receive a placebo-control shows that in the more than 250 patients who have finished the trial (approximately 84% of enrolled patients), there continues to be evidence of significant therapeutic effect with about 22% achieving the primary endpoint of complete resolution of both cardinal symptoms of chronic sinusitis and another 23% achieving a complete resolution of at least one of the two cardinal symptoms. Also, as previously reported, there continues to be a strong positive correlation of complete symptom resolution and objective evidence of reduced inflammation as judged by reduction in polyposis by endoscopy and by reduction in sinus mucosal inflammation as measured by CT scan. As previously announced, the last enrollee in the clinical trial completes the 16-week endpoint assessment during this month.
For more information on SinuNase Phase 3 interim, blinded results to date, see: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5611646.
Accentia continued to build its specialty pharmaceuticals sales and marketing division which focuses on ENT products by obtaining the rights to Neotic, a patient-convenient, patent-protected topical ear product that comprehensively addresses the symptoms associated with acute middle ear infections and is the only ear product with a unique three-mode mechanism of action to optimize symptom control. Preferred practice guidelines have shifted away from the dependence on oral antibiotics for the treatment of otitis media based on evidence showing their relative lack of clinical efficacy and a significant rise in antibiotic resistance. Accentia and Arbor expect to launch the product in the fourth calendar quarter of this year, targeting an indication that is the cause of more than 30 million doctor office visits in the U.S. annually. The topical otic analgesic market generates more than 2 million prescriptions each year for various products, representing an estimated $500 million per year market. Neotic becomes the second product that Accentia is commercializing for Arbor, as Arbor previously granted Accentia the exclusive U.S. commercial marketing rights to Zinotic(TM), a novel topical solution indicated for use in common outer ear infections (acute otitis externa).
For more information on the BioCentury Conference, please visit: www.biocentury.com/BCApp/BioCenturyCommon/BCConferences.aspx?ss=1.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB: BVTI), which is consolidated for reporting purposes with Accentia's product development and market service business.
On a fully consolidated basis, including Biovest, net sales for the three months ended December 31, 2007 were $4.3 million, compared with $5.9 million for the same period ended December 31, 2006. This decrease was primarily attributed to a decrease of $1.3 million in net sales in our Specialty Pharmaceuticals segment primarily due to the divestiture of our Xodol and Histex product lines, the discontinuance of our Respi-Tann G product line, product returns and, to a lesser extent, a decrease in net sales of our Analytica subsidiary.
Consolidated research and development costs were $3.8 million for the first fiscal quarter, compared with $4.4 million for the same fiscal quarter in 2007. This 13% decrease was largely due to our Biovest subsidiary reducing R&D expenses as its clinical trial costs have declined considerably in advance of the pending interim analysis of Phase 3 results for BiovaxID(TM). Biovest expects to file for conditional approval for BiovaxID in the U.S. and Europe, assuming positive results. The Biovest decrease in R&D expenses of $2.0 million was partially offset by an increase of $1.4 million in the Phase 3 clinical trial expense for SinuNase.
Accentia's first quarter net loss, on a fully consolidated basis, including Biovest, was $24.8 million, compared to $30.6 million reported for the same three month period in fiscal 2007. Of this loss, $17.6 million, or approximately 71% was the result of non-cash charges such as accretion of capitalized finance cost, derivative loss and loss on extinguishment of debt.
The fully consolidated loss per share for the quarter was $0.60, of which $0.42 per share was the result of non-cash charges and $0.09 per share reflected losses by Biovest, which are consolidated in Accentia's financial statements, although since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.97 of which $0.68 was the result of non-cash charges and $0.76 per share reflected losses by Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest's decision in conjunction with the Data Monitoring Committee to temporarily halt enrollment in the BiovaxID Fast-Tracked pivotal Phase 3 trial for data lock and unblinding, and in part due to continued operating profitability in its cell culture and instrumentation divisions.
At December 31, 2007, Accentia had approximately $0.6 million of cash and cash equivalents, and approximately $5.0 million in restricted cash, of which $3.2 million was attributed to Biovest. As previously reported, Biovest secured an $8.5 million financing in December. Subsequent to December 31, Accentia received proceeds from a private placement of approximately $8.7 million of convertible preferred stock. The Company expects to have access to additional sources of capital following the unblinding of the SinuNase and BiovaxID Phase 3 clinical trials data, including through potential corporate collaborations and licensing agreements.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune(TM), to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
For further information, please visit: http://www.Accentia.net.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM), AllerNase(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Company Affirms Plans to Unblind and Report Fast Track Pivotal
Phase 3 Results for SinuNase(TM) in March
TAMPA, Fla.--(BUSINESS WIRE)--Feb. 14, 2008--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its first fiscal quarter ended December 31, 2007. The Company also provided an update on its anticipated timetable to unblind and publicly-release results on the primary end-point for its Fast Track pivotal Phase 3 clinical trial for SinuNase(TM), intending to unveil the data on or before March 24, 2008. The Company is scheduled to present at the BioCentury "Future Leaders in the Biotech Industry" Conference on March 27th in New York City. In other news related to the Company's strategic focus on Ear, Nose and Throat (ENT) products, Accentia announced that is has entered into an agreement with Arbor Pharmaceuticals, Inc., granting Accentia U.S. commercial marketing rights to Neotic(TM), a novel, patented, prescription solution indicated for acute middle ear infections (acute otitis media).
Accentia reports that the interim blinded Intent-To-Treat (ITT) results in the randomized clinical trial in which 50% of patients receive SinuNase and 50% receive a placebo-control shows that in the more than 250 patients who have finished the trial (approximately 84% of enrolled patients), there continues to be evidence of significant therapeutic effect with about 22% achieving the primary endpoint of complete resolution of both cardinal symptoms of chronic sinusitis and another 23% achieving a complete resolution of at least one of the two cardinal symptoms. Also, as previously reported, there continues to be a strong positive correlation of complete symptom resolution and objective evidence of reduced inflammation as judged by reduction in polyposis by endoscopy and by reduction in sinus mucosal inflammation as measured by CT scan. As previously announced, the last enrollee in the clinical trial completes the 16-week endpoint assessment during this month.
For more information on SinuNase Phase 3 interim, blinded results to date, see: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5611646.
Accentia continued to build its specialty pharmaceuticals sales and marketing division which focuses on ENT products by obtaining the rights to Neotic, a patient-convenient, patent-protected topical ear product that comprehensively addresses the symptoms associated with acute middle ear infections and is the only ear product with a unique three-mode mechanism of action to optimize symptom control. Preferred practice guidelines have shifted away from the dependence on oral antibiotics for the treatment of otitis media based on evidence showing their relative lack of clinical efficacy and a significant rise in antibiotic resistance. Accentia and Arbor expect to launch the product in the fourth calendar quarter of this year, targeting an indication that is the cause of more than 30 million doctor office visits in the U.S. annually. The topical otic analgesic market generates more than 2 million prescriptions each year for various products, representing an estimated $500 million per year market. Neotic becomes the second product that Accentia is commercializing for Arbor, as Arbor previously granted Accentia the exclusive U.S. commercial marketing rights to Zinotic(TM), a novel topical solution indicated for use in common outer ear infections (acute otitis externa).
For more information on the BioCentury Conference, please visit: www.biocentury.com/BCApp/BioCenturyCommon/BCConferences.aspx?ss=1.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB: BVTI), which is consolidated for reporting purposes with Accentia's product development and market service business.
On a fully consolidated basis, including Biovest, net sales for the three months ended December 31, 2007 were $4.3 million, compared with $5.9 million for the same period ended December 31, 2006. This decrease was primarily attributed to a decrease of $1.3 million in net sales in our Specialty Pharmaceuticals segment primarily due to the divestiture of our Xodol and Histex product lines, the discontinuance of our Respi-Tann G product line, product returns and, to a lesser extent, a decrease in net sales of our Analytica subsidiary.
Consolidated research and development costs were $3.8 million for the first fiscal quarter, compared with $4.4 million for the same fiscal quarter in 2007. This 13% decrease was largely due to our Biovest subsidiary reducing R&D expenses as its clinical trial costs have declined considerably in advance of the pending interim analysis of Phase 3 results for BiovaxID(TM). Biovest expects to file for conditional approval for BiovaxID in the U.S. and Europe, assuming positive results. The Biovest decrease in R&D expenses of $2.0 million was partially offset by an increase of $1.4 million in the Phase 3 clinical trial expense for SinuNase.
Accentia's first quarter net loss, on a fully consolidated basis, including Biovest, was $24.8 million, compared to $30.6 million reported for the same three month period in fiscal 2007. Of this loss, $17.6 million, or approximately 71% was the result of non-cash charges such as accretion of capitalized finance cost, derivative loss and loss on extinguishment of debt.
The fully consolidated loss per share for the quarter was $0.60, of which $0.42 per share was the result of non-cash charges and $0.09 per share reflected losses by Biovest, which are consolidated in Accentia's financial statements, although since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.97 of which $0.68 was the result of non-cash charges and $0.76 per share reflected losses by Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest's decision in conjunction with the Data Monitoring Committee to temporarily halt enrollment in the BiovaxID Fast-Tracked pivotal Phase 3 trial for data lock and unblinding, and in part due to continued operating profitability in its cell culture and instrumentation divisions.
At December 31, 2007, Accentia had approximately $0.6 million of cash and cash equivalents, and approximately $5.0 million in restricted cash, of which $3.2 million was attributed to Biovest. As previously reported, Biovest secured an $8.5 million financing in December. Subsequent to December 31, Accentia received proceeds from a private placement of approximately $8.7 million of convertible preferred stock. The Company expects to have access to additional sources of capital following the unblinding of the SinuNase and BiovaxID Phase 3 clinical trials data, including through potential corporate collaborations and licensing agreements.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune(TM), to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
For further information, please visit: http://www.Accentia.net.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM), AllerNase(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Antwort auf Beitrag Nr.: 33.376.274 von SunnyOst am 15.02.08 04:57:39Schnell ist was anderes
Am 7.1. waren 239 Patienten ausgewertet, über 4 Wochen später (am 14.2.) meldet man die Zahl 250. In diesem Tempo wirds auch nichts mit dem 24. März. Bei diesen 11 neuen Patienten müssen übrigends bei 7 beide Symptome verbessert worden sein, denn am 14.2. hatten wir einen 22% Anteil (primärer Endpunkt)! Könnte jetzt die Schlußfolgerung sein, dass Placebo doch nutzt (7 von 11 und jeder zweite nimmt Placebo), MUSS aber nicht. Ist nicht so, dass unbedingt abwechselnd in Placebo und SinuNase Behandlung eingeteilt wird.
Zur Partnerschaftsmeldung
Also ist zumindest doch größtenteils hier nichts in trockenen Tüchern (wie auch zu erwarten). Ein möglicher Partner wird zuerst die Ergebnisse begutachten wollen. Durch Lizenzzahlungen, sollte ABPI für die kommenden Monate genügend Geld einnehmen. Obs an einen oder mehrere Partner verteilt wird, bleibt offen. Gespannt bin ich auf den Betrag den ABPI hierfür erhält. Ein zweistelliger Millionenbetrga sollte drinsitzen.
Die Zahlen
.. waren mal wieder erschreckend, gäbe es die beiden Phase III Trials nicht, sollte dass Kapitel ABPI schnell beendet sein. Einnahmen waren 4,3 Mil; kosten hierfür 2,6 Mil. Desweitern: Forschung; S&M sowie G&A 11,1 Mil Ausgaben - wäre eigentlich ein Verlust von 8,5 Mil. Wäre, weil noch unter "interest expense" 13 Mil Miese anfielen und zusätzliche Kosten vorhanden waren. So wars unterm Strich knapp 25 Mil $ für 3 Monate (bei einem Umsatz von knapp 4 Mil)!!! die Kapitalerhöhung kann zumindest nun begründet werden, dass ABPI nicht die Daten so schnell ausgewertet bekommt, wie gewollt oder gedacht...
Nach Zinotic nun auch Neotic
Ich halte von beiden persönlich nicht viel. Ziontic ist alles andere als ein Renner ABPIs, ich befürchte dass mit Neotic ähnliches bevorsteht. Ärzte werden wohl lieber auf Antibiotika zurückgreifen. Wie auch immer, kurzfristig wird es kein Geld bringen - ein Verkaufsstart ist gegen Ende des Jahres geplant. Entäuscht bin ich, dass immer noch kein Zulassungsantrag zu Allernase in die Wege geleitet wurde. Bedeutet wohl, dass hier Probleme vorhanden sind.
Grüße
Am 7.1. waren 239 Patienten ausgewertet, über 4 Wochen später (am 14.2.) meldet man die Zahl 250. In diesem Tempo wirds auch nichts mit dem 24. März. Bei diesen 11 neuen Patienten müssen übrigends bei 7 beide Symptome verbessert worden sein, denn am 14.2. hatten wir einen 22% Anteil (primärer Endpunkt)! Könnte jetzt die Schlußfolgerung sein, dass Placebo doch nutzt (7 von 11 und jeder zweite nimmt Placebo), MUSS aber nicht. Ist nicht so, dass unbedingt abwechselnd in Placebo und SinuNase Behandlung eingeteilt wird.
Zur Partnerschaftsmeldung
Also ist zumindest doch größtenteils hier nichts in trockenen Tüchern (wie auch zu erwarten). Ein möglicher Partner wird zuerst die Ergebnisse begutachten wollen. Durch Lizenzzahlungen, sollte ABPI für die kommenden Monate genügend Geld einnehmen. Obs an einen oder mehrere Partner verteilt wird, bleibt offen. Gespannt bin ich auf den Betrag den ABPI hierfür erhält. Ein zweistelliger Millionenbetrga sollte drinsitzen.
Die Zahlen
.. waren mal wieder erschreckend, gäbe es die beiden Phase III Trials nicht, sollte dass Kapitel ABPI schnell beendet sein. Einnahmen waren 4,3 Mil; kosten hierfür 2,6 Mil. Desweitern: Forschung; S&M sowie G&A 11,1 Mil Ausgaben - wäre eigentlich ein Verlust von 8,5 Mil. Wäre, weil noch unter "interest expense" 13 Mil Miese anfielen und zusätzliche Kosten vorhanden waren. So wars unterm Strich knapp 25 Mil $ für 3 Monate (bei einem Umsatz von knapp 4 Mil)!!! die Kapitalerhöhung kann zumindest nun begründet werden, dass ABPI nicht die Daten so schnell ausgewertet bekommt, wie gewollt oder gedacht...
Nach Zinotic nun auch Neotic
Ich halte von beiden persönlich nicht viel. Ziontic ist alles andere als ein Renner ABPIs, ich befürchte dass mit Neotic ähnliches bevorsteht. Ärzte werden wohl lieber auf Antibiotika zurückgreifen. Wie auch immer, kurzfristig wird es kein Geld bringen - ein Verkaufsstart ist gegen Ende des Jahres geplant. Entäuscht bin ich, dass immer noch kein Zulassungsantrag zu Allernase in die Wege geleitet wurde. Bedeutet wohl, dass hier Probleme vorhanden sind.
Grüße
Mahlzeit,
1: Am J Otolaryngol. 2008 Jan-Feb;29(1):24-30.
Combination antifungal therapy for invasive aspergillosis: can it replace high-risk surgery at the skull base?
Panda NK, Saravanan K, Chakrabarti A.
Department of Otolaryngology and Head and Neck Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India. npanda59@yahoo.co.in
OBJECTIVE: The increasing volume of literature on Aspergillus sinus infection is confusing because different authors stress different aspects of the disease. It is generally accepted that standard therapy consists of surgical debridement and medication with systemic amphotericin B. Patients who fail the standard therapy or those who cannot tolerate amphotericin B pose a dilemma. This study attempted to address the issues concerning combination therapy in invasive aspergillosis.
MATERIALS AND METHODS: We conducted a prospective randomized study on 6 apparently immunocompetent patients with invasive aspergillosis complicated by orbital and intracranial spread. All the patients were treated with a combination of amphotericin B (2.5 g) and itraconazole (6 months). They were monitored clinically and radiologically before, during, and after their combined antifungal therapy management.
RESULTS: Among the 6 immunocompetent patients, orbital involvement was seen in 5, skull base erosion with intracranial extension was seen in 2, and infratemporal fossa extension was seen in 2. After completion of treatment with 1.5 g of amphotericin, the paranasal sinus part of the lesion disappeared. However, there was residual lesion in the intracranial part that completely disappeared only after treatment with 2.5 g of amphotericin and 6 months of itraconazole therapy.
CONCLUSIONS: Invasive aspergillosis has been increasingly reported among immunocompetent patients. No single surgical or medical maneuver, including orbital exenteration, guarantees cure. The combination of amphotericin B and itraconazole for skull base aspergillosis represents a real step forward in the treatment of invasive aspergillosis.
Sehr interessant ist folgendes Poster von O’Donnells Research Fund:
http://www.accentia.net/crs/AFS_CRS%20poster%202007.pdf
Er selber unterscheidet also AFS und CRS. Interessanter ist jedoch natürlich die Auswertung der 84 Patienten. Hier wurden knapp 78 % (66 Patienten) als AFS und 22 % (18 Patienten) als CRS klassifiziert. Die sehr hohen eosinophil Werte erklären Ponikaus Theorie wiederum. Wie man dass Kind auch nennt, ob AFS oder CRS (CS): SinuNase kann eine Hilfe bei Nasennebenhöhlenentzündung sein…
Grüße
1: Am J Otolaryngol. 2008 Jan-Feb;29(1):24-30.
Combination antifungal therapy for invasive aspergillosis: can it replace high-risk surgery at the skull base?
Panda NK, Saravanan K, Chakrabarti A.
Department of Otolaryngology and Head and Neck Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India. npanda59@yahoo.co.in
OBJECTIVE: The increasing volume of literature on Aspergillus sinus infection is confusing because different authors stress different aspects of the disease. It is generally accepted that standard therapy consists of surgical debridement and medication with systemic amphotericin B. Patients who fail the standard therapy or those who cannot tolerate amphotericin B pose a dilemma. This study attempted to address the issues concerning combination therapy in invasive aspergillosis.
MATERIALS AND METHODS: We conducted a prospective randomized study on 6 apparently immunocompetent patients with invasive aspergillosis complicated by orbital and intracranial spread. All the patients were treated with a combination of amphotericin B (2.5 g) and itraconazole (6 months). They were monitored clinically and radiologically before, during, and after their combined antifungal therapy management.
RESULTS: Among the 6 immunocompetent patients, orbital involvement was seen in 5, skull base erosion with intracranial extension was seen in 2, and infratemporal fossa extension was seen in 2. After completion of treatment with 1.5 g of amphotericin, the paranasal sinus part of the lesion disappeared. However, there was residual lesion in the intracranial part that completely disappeared only after treatment with 2.5 g of amphotericin and 6 months of itraconazole therapy.
CONCLUSIONS: Invasive aspergillosis has been increasingly reported among immunocompetent patients. No single surgical or medical maneuver, including orbital exenteration, guarantees cure. The combination of amphotericin B and itraconazole for skull base aspergillosis represents a real step forward in the treatment of invasive aspergillosis.
Sehr interessant ist folgendes Poster von O’Donnells Research Fund:
http://www.accentia.net/crs/AFS_CRS%20poster%202007.pdf
Er selber unterscheidet also AFS und CRS. Interessanter ist jedoch natürlich die Auswertung der 84 Patienten. Hier wurden knapp 78 % (66 Patienten) als AFS und 22 % (18 Patienten) als CRS klassifiziert. Die sehr hohen eosinophil Werte erklären Ponikaus Theorie wiederum. Wie man dass Kind auch nennt, ob AFS oder CRS (CS): SinuNase kann eine Hilfe bei Nasennebenhöhlenentzündung sein…
Grüße
Antwort auf Beitrag Nr.: 33.446.342 von Ackergaul am 22.02.08 12:48:01Knapp einen Monat noch, bis zur Entblindung der gesammelten Daten.
Hier mal ein Konkurent ABPIs, die auf "Aerosolized Amphotericin B" setzen. Ob dies patentrechtlich so in Ordnung ist? Habe auf der Webseite auch keine Angaben zu deren Produkten gefunden... So wie ich es mittlerweile verstehe, setzt ABPI übrigends bei den weniger schweren CS (AFS) Fällen auf ein Spray (dass dann von BioDelivery produzuiert wird) - also hier keine lavage.
http://www.myhealthcollection.com/sinus.htm
New Approach for Fungal Sinusitis Using Aerosolized Amphotericin B
Camarillo, CA (PRWEB) August 21, 2007 -- Inhaled Amphotericin B may be the answer to eradicating Allergic Fungal Sinusitis. It has been proven that Amphotericin B kills fungus and is currently being used in liquid form by the irrigation method (squirting it up your nose). Some patients find this practice cumbersome, painful and sometimes messy. Aerosolized Amphotericin B is an alternative that can be easily inhaled into the sinuses as easily as smoking a cigarette, but without the side effects of liquid irrigations. Aerosolized Amphotericin B can help prevent and control Allergic Fungal Sinusitis.
This new aerosolized intranasal application, developed by Aerosol Science Laboratories Inc. (Camarillo, CA) is an alternative approach for successfully treating Allergic Fungal Sinusitis. The formulation is available in 5mg and 10mg doses with a dosing frequency of 2-3 times per day. Amphotericin B is known for being an unstable drug; however, ASL's formula is extremely stable in unit dose vials for 35 days at refrigerated temperatures. Each dose aerosolizes in only 3.5 minutes, which increases safety & patient compliance.
Unlike with the irrigation method, aerosolized Amphotericin B stays in the sinuses and does not flow out during treatment, improving patient compliance. For added safety and stability, each unit dose vial is sealed in a non-latex plastic vial and is protected from exposure to light.
Aerosol Science Laboratories has monitored patients on Amphotericin B for the past 16 months and has observed these findings: 1) Patients using aerosolized inhalant drugs easily accept and comply with their therapy. 2) Aerosolized drugs are easy to administer at a "mid-day" dose at work or school. Patients are often unlikely to irrigate at work or school due to embarrassment or peer pressure. 3) After symptoms subside, the dosing frequency can be reduced without loss of effectiveness.
The most important features of ASL's new aerosolized inhalant Amphotericin B formula are that 1) It is covered by most insurance drug plans and patient co-payments are relatively small. 2) Patient compliance is high due to the ease of use of the therapy. 3) Clinical studies have proven the effectiveness of Amphotericin B in eradicating fungus. 4) You do not have to be a sinus surgeon to prescribe this therapy. Any MD can prescribe aerosolized medications through ASL Pharmacy (http://www.aslrx.com).
For more detailed public press information please contact Cal Tarrant at 805-236-1679.
http://www.nutrichem.com/Ask-The-Expert/Chronic-Sinusitis-Fu…
Chronic Sinusitis, Fungal Infection is the cause in over 93% of cases
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Drug Selection Amphotericin B and Compounding Options
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Chronic Sinusitis is the most common chronic disease that is refractory to treatment. In fact one out of every seven Americans suffer from chronic sinusitis.(1)
Nasal polyps are often associated with chronic sinusitis.
In 1999 Mayo clinic researchers studied 210 patients and found that the cause of 93% of chronic Rhinosinusitis is due to allergic fungal sinusitis (AFS) a delayed immune reaction to fungi. They identified 40 different varieties of fungi in these patients and an average of 2.7 types per patient (2).
This is a potential breakthrough that offers great hope for the millions of people who suffer from this problem, said Dr. Eugene Kern of the Mayo Clinic. We can now begin to treat the cause of the problem instead of the symptoms. These finding may also help to explain why antibiotics are often not effective for chronic sinusitis.
Treatment
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Amphotericin B compounded nasal solution (twice daily each nostril for 6 months)
3. Richetti et al 74 patients with I,II or III nasal polyposis. Total disappearance of nasal polyps were seen in 39% with amphotericin B nasal solution.
4. Ponikau et el 51 patients with chronic rhinosinusitis. Open study. Improvement of sinusitis in 75% of patients (39 patients ). Endoscopically 35% of patients were disease free. No effect in 25% of patients
5. Ponikau et al Radomized double blind controlled trial 30 Patients with Chronic Rhinusitis treated with amphtericin B intranasally or placebo saline. 24 patients completed the 6 months of treatment.
Results Reduction of mucosal thickening in amphotericin b ( group minus 8.8%) vs plus 2.5% in placebo group. Similarly there were beneficial changes in endoscopic examination, inflammatory markers (eosinophil infiltration) in the treated group versus worsening in all domains in the placebo group.
1. Clin Exp allergy 1996 May 26 Suppl 3 23-30
2. Mayo clinic Proc 1999 Sept74(9):877-84
3. J Laryngol Otol 2002 April 116(4):261-3
4. J Allergy Clin Immunol 110(6): 862-6 2002
5. J Allergy Clin Immunol 115(1): 125-31 2005
There are a number of other options over the counter and by prescription that can be compounded that can treat chronic sinusitis.
Contact us for more information: info@nutrichem.com This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
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Grüße
Hier mal ein Konkurent ABPIs, die auf "Aerosolized Amphotericin B" setzen. Ob dies patentrechtlich so in Ordnung ist? Habe auf der Webseite auch keine Angaben zu deren Produkten gefunden... So wie ich es mittlerweile verstehe, setzt ABPI übrigends bei den weniger schweren CS (AFS) Fällen auf ein Spray (dass dann von BioDelivery produzuiert wird) - also hier keine lavage.
http://www.myhealthcollection.com/sinus.htm
New Approach for Fungal Sinusitis Using Aerosolized Amphotericin B
Camarillo, CA (PRWEB) August 21, 2007 -- Inhaled Amphotericin B may be the answer to eradicating Allergic Fungal Sinusitis. It has been proven that Amphotericin B kills fungus and is currently being used in liquid form by the irrigation method (squirting it up your nose). Some patients find this practice cumbersome, painful and sometimes messy. Aerosolized Amphotericin B is an alternative that can be easily inhaled into the sinuses as easily as smoking a cigarette, but without the side effects of liquid irrigations. Aerosolized Amphotericin B can help prevent and control Allergic Fungal Sinusitis.
This new aerosolized intranasal application, developed by Aerosol Science Laboratories Inc. (Camarillo, CA) is an alternative approach for successfully treating Allergic Fungal Sinusitis. The formulation is available in 5mg and 10mg doses with a dosing frequency of 2-3 times per day. Amphotericin B is known for being an unstable drug; however, ASL's formula is extremely stable in unit dose vials for 35 days at refrigerated temperatures. Each dose aerosolizes in only 3.5 minutes, which increases safety & patient compliance.
Unlike with the irrigation method, aerosolized Amphotericin B stays in the sinuses and does not flow out during treatment, improving patient compliance. For added safety and stability, each unit dose vial is sealed in a non-latex plastic vial and is protected from exposure to light.
Aerosol Science Laboratories has monitored patients on Amphotericin B for the past 16 months and has observed these findings: 1) Patients using aerosolized inhalant drugs easily accept and comply with their therapy. 2) Aerosolized drugs are easy to administer at a "mid-day" dose at work or school. Patients are often unlikely to irrigate at work or school due to embarrassment or peer pressure. 3) After symptoms subside, the dosing frequency can be reduced without loss of effectiveness.
The most important features of ASL's new aerosolized inhalant Amphotericin B formula are that 1) It is covered by most insurance drug plans and patient co-payments are relatively small. 2) Patient compliance is high due to the ease of use of the therapy. 3) Clinical studies have proven the effectiveness of Amphotericin B in eradicating fungus. 4) You do not have to be a sinus surgeon to prescribe this therapy. Any MD can prescribe aerosolized medications through ASL Pharmacy (http://www.aslrx.com).
For more detailed public press information please contact Cal Tarrant at 805-236-1679.
http://www.nutrichem.com/Ask-The-Expert/Chronic-Sinusitis-Fu…
Chronic Sinusitis, Fungal Infection is the cause in over 93% of cases
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Drug Selection Amphotericin B and Compounding Options
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Chronic Sinusitis is the most common chronic disease that is refractory to treatment. In fact one out of every seven Americans suffer from chronic sinusitis.(1)
Nasal polyps are often associated with chronic sinusitis.
In 1999 Mayo clinic researchers studied 210 patients and found that the cause of 93% of chronic Rhinosinusitis is due to allergic fungal sinusitis (AFS) a delayed immune reaction to fungi. They identified 40 different varieties of fungi in these patients and an average of 2.7 types per patient (2).
This is a potential breakthrough that offers great hope for the millions of people who suffer from this problem, said Dr. Eugene Kern of the Mayo Clinic. We can now begin to treat the cause of the problem instead of the symptoms. These finding may also help to explain why antibiotics are often not effective for chronic sinusitis.
Treatment
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Amphotericin B compounded nasal solution (twice daily each nostril for 6 months)
3. Richetti et al 74 patients with I,II or III nasal polyposis. Total disappearance of nasal polyps were seen in 39% with amphotericin B nasal solution.
4. Ponikau et el 51 patients with chronic rhinosinusitis. Open study. Improvement of sinusitis in 75% of patients (39 patients ). Endoscopically 35% of patients were disease free. No effect in 25% of patients
5. Ponikau et al Radomized double blind controlled trial 30 Patients with Chronic Rhinusitis treated with amphtericin B intranasally or placebo saline. 24 patients completed the 6 months of treatment.
Results Reduction of mucosal thickening in amphotericin b ( group minus 8.8%) vs plus 2.5% in placebo group. Similarly there were beneficial changes in endoscopic examination, inflammatory markers (eosinophil infiltration) in the treated group versus worsening in all domains in the placebo group.
1. Clin Exp allergy 1996 May 26 Suppl 3 23-30
2. Mayo clinic Proc 1999 Sept74(9):877-84
3. J Laryngol Otol 2002 April 116(4):261-3
4. J Allergy Clin Immunol 110(6): 862-6 2002
5. J Allergy Clin Immunol 115(1): 125-31 2005
There are a number of other options over the counter and by prescription that can be compounded that can treat chronic sinusitis.
Contact us for more information: info@nutrichem.com This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
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Grüße
Antwort auf Beitrag Nr.: 33.475.001 von Ackergaul am 26.02.08 09:49:38Einer der Lizenznehmer hat schon mal veroeffentlicht.
http://www.jcblabs.com/pdf/AntifungalInfo.pdf
http://www.jcblabs.com/pdf/AntifungalInfo.pdf
Antwort auf Beitrag Nr.: 33.486.388 von SunnyOst am 27.02.08 06:25:01da gab es bestimmt eine SEC Mitteilung im September dazu. Hab ich wohl überlesen.
Wie auch immer - nichts gegen JCB - aber dass ist nicht gerade meine Traumvorstellung eines Partners.
http://pharmtech.findpharma.com/pharmtech/News/Company-and-P…
Wichita, KS (Sept. 4)—JCB Laboratories was granted a sublicense from Accentia Specialty Pharmacy and Mayo Medical Ventures (Rochester, MN) to compound antifungal nasal solutions and irrigations for patients undergoing treatment for chronic rhinosinusitis. Only two pharmacies in the country are currently licensed to compound the solutions.
Wie auch immer - nichts gegen JCB - aber dass ist nicht gerade meine Traumvorstellung eines Partners.
http://pharmtech.findpharma.com/pharmtech/News/Company-and-P…
Wichita, KS (Sept. 4)—JCB Laboratories was granted a sublicense from Accentia Specialty Pharmacy and Mayo Medical Ventures (Rochester, MN) to compound antifungal nasal solutions and irrigations for patients undergoing treatment for chronic rhinosinusitis. Only two pharmacies in the country are currently licensed to compound the solutions.
Antwort auf Beitrag Nr.: 33.552.405 von SunnyOst am 05.03.08 06:38:22
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&kind=&timefra…
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&kind=&timefra…
Accentia Biopharmaceutical's SinuNase Featured as ``Future Blockbuster'' in Med Ad News Cover Story
Tuesday March 11, 12:45 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) today announced that Med Ad News, a leading pharmaceutical business and marketing magazine, has published a cover story featuring SinuNase™, as an intranasal therapy for chronic sinusitis expected to garner FDA approval and break the annual billion-dollar sales barrier.
The article, entitled, “Eighth Annual Report – Future Blockbusters”, reports that SinuNase is anticipated to become the first product to be approved for fungal-induced inflammation chronic sinusitis, a debilitating disease that affects more than 60 million people in the U.S. and Europe.
To access the article, which is posted on the Accentia website with permission from Med Ad News, February 2008, please visit: http://www.accentia.net/media/MedAdNews2008.pdf
Accentia expects to publicly-release results on the primary end-point for its Fast Track pivotal Phase 3 clinical trial for SinuNase this month, and is scheduled to present at the BioCentury “Future Leaders in the Biotech Industry” Conference on March 27th in New York City at the Millennium Broadway Hotel & Conference Center.
Tuesday March 11, 12:45 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) today announced that Med Ad News, a leading pharmaceutical business and marketing magazine, has published a cover story featuring SinuNase™, as an intranasal therapy for chronic sinusitis expected to garner FDA approval and break the annual billion-dollar sales barrier.
The article, entitled, “Eighth Annual Report – Future Blockbusters”, reports that SinuNase is anticipated to become the first product to be approved for fungal-induced inflammation chronic sinusitis, a debilitating disease that affects more than 60 million people in the U.S. and Europe.
To access the article, which is posted on the Accentia website with permission from Med Ad News, February 2008, please visit: http://www.accentia.net/media/MedAdNews2008.pdf
Accentia expects to publicly-release results on the primary end-point for its Fast Track pivotal Phase 3 clinical trial for SinuNase this month, and is scheduled to present at the BioCentury “Future Leaders in the Biotech Industry” Conference on March 27th in New York City at the Millennium Broadway Hotel & Conference Center.
Nach den MedAd News zu SinuNase (die mir ein bischen zu schamlos optimistich vorgestellt wurden), gibt es von Frost & Sullivan eine Auszeichnung für Revimmune.
Accentia Biopharmaceutical's Revimmune Receives the Frost & Sullivan Multiple Sclerosis Product Innovation of the Year Award
Thursday March 13, 8:30 am ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) today announced that Revimmune™, its potential blockbuster therapeutic candidate designed to treat up to 80 autoimmune diseases, has been awarded the Frost & Sullivan 2007 North American Multiple Sclerosis Product Innovation of the Year Award. If approved, Revimmune would be the first product capable of restoring neurological function in patients with relapsing-remitting multiple sclerosis (MS). Accentia intends to file an Investigational New Drug Application (IND), aiming to commence a Phase 3 MS clinical trial this year.
The selection of the Frost & Sullivan Award comes through in-depth interviews and primary market analysis conducted by their industry analyst team. Nominations or submissions for Frost & Sullivan Awards are not accepted.
Frost & Sullivan Analyst, Barath Shankar Subramanian, stated, “The primary endpoint for Accentia’s planned Revimmune Phase 3 study is the restoration of neurological function, which is a paradigm shift from traditional therapies that focus on reducing relapses. Accentia’s innovative positioning and approach to treating autoimmune disease is likely to propel the company as a strong participant in the MS market. In recognition of these factors, Frost & Sullivan is pleased to present Accentia with this Award.”
According to Barath Shankar, the mechanism of action of Revimmune is highly innovative, focusing on eliminating the peripheral immune cells, which include the cells that are causing MS. The therapy selectively spares the hematopoetic stem cells, which then regenerate as a new immune system in two to three weeks that lacks the previous autoimmunity. This could potentially improve neurological function and eliminate the disease.
Revimmune could also potentially alter the high cost of therapy for patients. For those patients utilizing traditional therapies, they incur a lifetime of treatment costs, while with Revimmune there is just a one time cost of the treatment regimen. Additionally, Revimmune has the potential to emerge as an effective treatment for several other autoimmune disorders, giving Accentia the potential of addressing a significantly larger patient population that lacks significant therapies.
Accentia holds the worldwide, exclusive license to Revimmune for the treatment of autoimmune diseases, and the Company intends to file an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune for the treatment of refractory, relapsing-remitting multiple sclerosis.
Grüße!
Accentia Biopharmaceutical's Revimmune Receives the Frost & Sullivan Multiple Sclerosis Product Innovation of the Year Award
Thursday March 13, 8:30 am ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) today announced that Revimmune™, its potential blockbuster therapeutic candidate designed to treat up to 80 autoimmune diseases, has been awarded the Frost & Sullivan 2007 North American Multiple Sclerosis Product Innovation of the Year Award. If approved, Revimmune would be the first product capable of restoring neurological function in patients with relapsing-remitting multiple sclerosis (MS). Accentia intends to file an Investigational New Drug Application (IND), aiming to commence a Phase 3 MS clinical trial this year.
The selection of the Frost & Sullivan Award comes through in-depth interviews and primary market analysis conducted by their industry analyst team. Nominations or submissions for Frost & Sullivan Awards are not accepted.
Frost & Sullivan Analyst, Barath Shankar Subramanian, stated, “The primary endpoint for Accentia’s planned Revimmune Phase 3 study is the restoration of neurological function, which is a paradigm shift from traditional therapies that focus on reducing relapses. Accentia’s innovative positioning and approach to treating autoimmune disease is likely to propel the company as a strong participant in the MS market. In recognition of these factors, Frost & Sullivan is pleased to present Accentia with this Award.”
According to Barath Shankar, the mechanism of action of Revimmune is highly innovative, focusing on eliminating the peripheral immune cells, which include the cells that are causing MS. The therapy selectively spares the hematopoetic stem cells, which then regenerate as a new immune system in two to three weeks that lacks the previous autoimmunity. This could potentially improve neurological function and eliminate the disease.
Revimmune could also potentially alter the high cost of therapy for patients. For those patients utilizing traditional therapies, they incur a lifetime of treatment costs, while with Revimmune there is just a one time cost of the treatment regimen. Additionally, Revimmune has the potential to emerge as an effective treatment for several other autoimmune disorders, giving Accentia the potential of addressing a significantly larger patient population that lacks significant therapies.
Accentia holds the worldwide, exclusive license to Revimmune for the treatment of autoimmune diseases, and the Company intends to file an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune for the treatment of refractory, relapsing-remitting multiple sclerosis.
Grüße!
Die Woche der Entscheidung naht...
Wer noch einmal die Sachlage komprimiert auf 2 Seiten nachlesen will, sollte auf folgender Seite DRINGEND nachschlagen:
http://www.entoday.com/pt/re/entoday/pdfhandler.01265117-200…
Wie es ausgeht? Ich hatte zuletzt Keryx über einen längeren Zeitraum beobachtet, da ich dem Wirkstoff Sulonex gute Chancen eingeräumt hatte. Überaus enttäuschende Daten (Placebo und Sulonex zeigten KEINEN Unterschied) zerlegten den Kurs aber um 90 %!!! Einen so radikalen Abschlag wird ABPI bei Mißerfolg wohl nicht ausgesetzt, denn in der Hinterhand gibt es schließlich noch BiovaxID (Daten kommen im April).
Mittlerweile habe ich über 20 MB alleine an SinuNase Daten und Publikationen gesammelt. Es spricht einiges für aber auch so manches gegen SinuNase (Ebbens und Fokkens sowie Weschta vor allem). Der obere Artikel fasst alle Punkte gut zusammen, die Antwort nach dem Ausgang sollte sich ein Jeder selber stellen, ob sich dass Wagnis ABPI lohnt...
Ich persönlich denke es ist gut, dass die Daten noch nicht veröffentlicht wurden (frühe Veröffentlichung deutet auf Mißerfolg - siehe Beispiel KERX) und schätze zu 70 % dass SinuNase ein statistisch signifikantes Ergebnis vorweisen wird - die nächste Woche wird aber spätestens Klärung bringen!
Grüße
Wer noch einmal die Sachlage komprimiert auf 2 Seiten nachlesen will, sollte auf folgender Seite DRINGEND nachschlagen:
http://www.entoday.com/pt/re/entoday/pdfhandler.01265117-200…
Wie es ausgeht? Ich hatte zuletzt Keryx über einen längeren Zeitraum beobachtet, da ich dem Wirkstoff Sulonex gute Chancen eingeräumt hatte. Überaus enttäuschende Daten (Placebo und Sulonex zeigten KEINEN Unterschied) zerlegten den Kurs aber um 90 %!!! Einen so radikalen Abschlag wird ABPI bei Mißerfolg wohl nicht ausgesetzt, denn in der Hinterhand gibt es schließlich noch BiovaxID (Daten kommen im April).
Mittlerweile habe ich über 20 MB alleine an SinuNase Daten und Publikationen gesammelt. Es spricht einiges für aber auch so manches gegen SinuNase (Ebbens und Fokkens sowie Weschta vor allem). Der obere Artikel fasst alle Punkte gut zusammen, die Antwort nach dem Ausgang sollte sich ein Jeder selber stellen, ob sich dass Wagnis ABPI lohnt...
Ich persönlich denke es ist gut, dass die Daten noch nicht veröffentlicht wurden (frühe Veröffentlichung deutet auf Mißerfolg - siehe Beispiel KERX) und schätze zu 70 % dass SinuNase ein statistisch signifikantes Ergebnis vorweisen wird - die nächste Woche wird aber spätestens Klärung bringen!
Grüße
Antwort auf Beitrag Nr.: 32.193.899 von SunnyOst am 29.10.07 19:18:15Super vielen Dank für zahlreich zusammengetragenen Informationen von "Ackergaul", der hier lange Zeit mit "SunnyOst" den Accentia Alleinunterhalter spielte.
Über die Produkte kann man sich schon seine Meinung bilden. In meiner Argumentationskette, warum Accentia ein gutes Investment ist, spielen die Insiderkäufe eine wichtige Rolle. Eine Sache habe ich jedoch nicht verstanden. Warum hat O'Donnel im Oktober 2007 Aktien deutlich überteuert gegenüber dem Marktpreis gekauft?
Oktober 2007
"Recently, [Chairman] Dr. O'Donnel purchased 875,000 shares of Accentia Biopharmaceuticals (ABPI) at $8.87 per share. The current market price is $2.20."
(Aktuelles tägliches Durchschnittsvolumen an der Nasdaq liegt bei 208.000, der Titel wird also ausreichend liquide gehandelt, so dass Einiges als direkter Kauf am Markt möglich gewesen wäre.)
Hat da jemand von den ABPI-Thread-Spezialisten eine Erklärung für?
Danke vorab.
Über die Produkte kann man sich schon seine Meinung bilden. In meiner Argumentationskette, warum Accentia ein gutes Investment ist, spielen die Insiderkäufe eine wichtige Rolle. Eine Sache habe ich jedoch nicht verstanden. Warum hat O'Donnel im Oktober 2007 Aktien deutlich überteuert gegenüber dem Marktpreis gekauft?
Oktober 2007
"Recently, [Chairman] Dr. O'Donnel purchased 875,000 shares of Accentia Biopharmaceuticals (ABPI) at $8.87 per share. The current market price is $2.20."
(Aktuelles tägliches Durchschnittsvolumen an der Nasdaq liegt bei 208.000, der Titel wird also ausreichend liquide gehandelt, so dass Einiges als direkter Kauf am Markt möglich gewesen wäre.)
Hat da jemand von den ABPI-Thread-Spezialisten eine Erklärung für?
Danke vorab.
Antwort auf Beitrag Nr.: 33.694.524 von KillingJoke am 20.03.08 10:53:49Hi,
Zu der Zeit als O'Donnell seine Geldbörse aufgemacht hatte und die 875 T Aktien zu 8,87 $ zukaufte, war die (ich glaube Selbsterlegte) Black-Out Periode bereits am laufen. Der Vorstand hatte sich selber auferlegt während dieser Phase am offenen Markt nicht mit Aktien zu handeln BIS zur Entblindung der SinuNase Daten. Der CEO hat nun in einer "privaten Transaktion" - der Verkäufer wurde aufgeklärt, dass ein Insider zukaufen würde - zugeschlagen. So zumindest verstehe ich diese Aktion...
Ob dass eine sinnvolle Sache des Vorstandes war / ist, sich selber eine Handelspause aufzuerlegen, stelle ich mal in Frage. Zumal die Anzahl von über 800 T Aktien auch bestimmt nicht einfach aufzutreiben war. Kein Insider hatte übrigends verkauft (und auch nicht die Hopkins Group).
Grüße!
Zu der Zeit als O'Donnell seine Geldbörse aufgemacht hatte und die 875 T Aktien zu 8,87 $ zukaufte, war die (ich glaube Selbsterlegte) Black-Out Periode bereits am laufen. Der Vorstand hatte sich selber auferlegt während dieser Phase am offenen Markt nicht mit Aktien zu handeln BIS zur Entblindung der SinuNase Daten. Der CEO hat nun in einer "privaten Transaktion" - der Verkäufer wurde aufgeklärt, dass ein Insider zukaufen würde - zugeschlagen. So zumindest verstehe ich diese Aktion...
Ob dass eine sinnvolle Sache des Vorstandes war / ist, sich selber eine Handelspause aufzuerlegen, stelle ich mal in Frage. Zumal die Anzahl von über 800 T Aktien auch bestimmt nicht einfach aufzutreiben war. Kein Insider hatte übrigends verkauft (und auch nicht die Hopkins Group).
Grüße!
Antwort auf Beitrag Nr.: 33.697.514 von Ackergaul am 20.03.08 14:43:20Mahlzeit Allerseits,
am kommenden Montag wir die Katze wohl aus dem Sack gelassen.
Schoenes Wochenende.
am kommenden Montag wir die Katze wohl aus dem Sack gelassen.
Schoenes Wochenende.
Accentia Biopharmaceuticals to Announce Top-Line SinuNase Phase 3 Clinical Trial Results Later Today
Monday March 24, 8:52 am ET
CEO Conference Call/Webcast Scheduled for 5:00 p.m. (EDT)
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced that at shortly after 4:00 p.m. (EDT) this afternoon, the Company will report the results for the primary endpoint in its Fast Track pivotal Phase 3 clinical trial evaluating the Company’s intranasal, low-dose antifungal lavage product, SinuNase™ (topical amphotericin B 0.01% suspension) for the treatment of chronic sinusitis. The news announcement will be followed by a conference call / webcast scheduled for 5:00 p.m. (EDT) today, hosted by Accentia’s Chairman, CEO and Founder, Dr. Frank O’Donnell, Jr.
Monday March 24, 8:52 am ET
CEO Conference Call/Webcast Scheduled for 5:00 p.m. (EDT)
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced that at shortly after 4:00 p.m. (EDT) this afternoon, the Company will report the results for the primary endpoint in its Fast Track pivotal Phase 3 clinical trial evaluating the Company’s intranasal, low-dose antifungal lavage product, SinuNase™ (topical amphotericin B 0.01% suspension) for the treatment of chronic sinusitis. The news announcement will be followed by a conference call / webcast scheduled for 5:00 p.m. (EDT) today, hosted by Accentia’s Chairman, CEO and Founder, Dr. Frank O’Donnell, Jr.
Antwort auf Beitrag Nr.: 33.712.175 von Erbse1 am 24.03.08 14:05:01Eine Ankündigung für die heutige Ergebnispräsentation? Sachen gibts...
Daten nach Börsenschluss - schaut man auf die ABPI Vergangenheit, sollte klar sein, dass einige jetzt wohl beunruhigt sind. Denn so manche böseren Finanzresultate wurden von ABPI ebenfalls im After-Hours Bereich veröffentlicht. Wie auch immer, 1 Stunde nach Veröffentlichung soll es dann noch einen Konferenz geben - lohnt sich diese wenn die Daten schlecht wären?
Abwarten und Tee trinken... werde wohl erste heute abend mal wieder die News überfliegen...
Grüße
Daten nach Börsenschluss - schaut man auf die ABPI Vergangenheit, sollte klar sein, dass einige jetzt wohl beunruhigt sind. Denn so manche böseren Finanzresultate wurden von ABPI ebenfalls im After-Hours Bereich veröffentlicht. Wie auch immer, 1 Stunde nach Veröffentlichung soll es dann noch einen Konferenz geben - lohnt sich diese wenn die Daten schlecht wären?
Abwarten und Tee trinken... werde wohl erste heute abend mal wieder die News überfliegen...
Grüße
Wer KEINE Hoffnung mehr auf BiovaxID legt, sollte abspringen. Der SinuNase Test ist VOLLKOMMEN gescheitert!
Ein p Wert von 0,15 ist alles andere als gewünschte Resultat!
http://biz.yahoo.com/bw/080324/20080324005883.html?.v=1
Rechnet mit einem primären Endpunkt von 20% - bei 300 Patienten wären dies demnach 60 Patienten.
BEISPIEL:
Bei Fisher's Exact Test für SinuNase (36 Patienten mit primären Endpunkt vs. 114) und Placebo (24 Patienten mit primären Endpunkt vs. 126) läge der p Wert z.B. bei 0.11! In einem ähnlichen Bereich wird sich wohl die Real Verteilung bewegen... Dass ist alles andere als Zulassungswürdig und demnach ein Mißerfolg!!!
Ich selber hätte ein Ergebnis in der Größenordnung von p=0.00002 erwartet: SinuNase 45 pE vs 105 kein Effekt und Placebo 15 pE vs 145 kein effekt = also einen effektiven Placebo Effekt von 10 %
Im Prinzip heiß dass, der komplette SinuNase Trial sollte geschlossen werden und zu den Akten gelegt werden.
Trotzdem noch einen Schönen Abend
Ich glaube dass war die mit Abstand größte Fehlspekulation meines Portfolios bisher, denn mit über 7 % bin ich hierdrin und werds zumindest bis nach den BiovaxID Ergebnissen durchsitzen...
Ein p Wert von 0,15 ist alles andere als gewünschte Resultat!
http://biz.yahoo.com/bw/080324/20080324005883.html?.v=1
Rechnet mit einem primären Endpunkt von 20% - bei 300 Patienten wären dies demnach 60 Patienten.
BEISPIEL:
Bei Fisher's Exact Test für SinuNase (36 Patienten mit primären Endpunkt vs. 114) und Placebo (24 Patienten mit primären Endpunkt vs. 126) läge der p Wert z.B. bei 0.11! In einem ähnlichen Bereich wird sich wohl die Real Verteilung bewegen... Dass ist alles andere als Zulassungswürdig und demnach ein Mißerfolg!!!
Ich selber hätte ein Ergebnis in der Größenordnung von p=0.00002 erwartet: SinuNase 45 pE vs 105 kein Effekt und Placebo 15 pE vs 145 kein effekt = also einen effektiven Placebo Effekt von 10 %
Im Prinzip heiß dass, der komplette SinuNase Trial sollte geschlossen werden und zu den Akten gelegt werden.
Trotzdem noch einen Schönen Abend
Ich glaube dass war die mit Abstand größte Fehlspekulation meines Portfolios bisher, denn mit über 7 % bin ich hierdrin und werds zumindest bis nach den BiovaxID Ergebnissen durchsitzen...
Mund abwischen...
Habe mir das CC gestern nicht mehr angetan, nur kurz die News des Y! Board überblickt. Demnach hat O'Donnell die Niederlage nicht eingesehen. Seine Hoffnungen legt er nun auf die 2. Phase III (Spray) die in etwa 6 Wochen gestartet werden soll. Dass lavage soll zu gut gewirkt haben, so dass auch die "Placebo Spülung" den fungus beseitigte... klingt für mich wenig nachvollziehbar. Zumindest steht fest, dass der therapeutische Effekt des PLACEBOS doch immnes hoch ist (liegt wahrscheinlich bei 16 bis 17% bei denen sich beide Symptome verringerten).
Ich stelle mir nun die Frage: Wie sehen die kompletten Daten aus? CT-Scan und auch Endoskopie? Sind diese Werte vergleichbar mit der Aufteilung des primären Endpunktes? - Ist sehr wahrscheinlich. Im April werden die Antworten hierauf gegeben!
Ich denke wir werden heute um gut 80 %...
Habe mir das CC gestern nicht mehr angetan, nur kurz die News des Y! Board überblickt. Demnach hat O'Donnell die Niederlage nicht eingesehen. Seine Hoffnungen legt er nun auf die 2. Phase III (Spray) die in etwa 6 Wochen gestartet werden soll. Dass lavage soll zu gut gewirkt haben, so dass auch die "Placebo Spülung" den fungus beseitigte... klingt für mich wenig nachvollziehbar. Zumindest steht fest, dass der therapeutische Effekt des PLACEBOS doch immnes hoch ist (liegt wahrscheinlich bei 16 bis 17% bei denen sich beide Symptome verringerten).
Ich stelle mir nun die Frage: Wie sehen die kompletten Daten aus? CT-Scan und auch Endoskopie? Sind diese Werte vergleichbar mit der Aufteilung des primären Endpunktes? - Ist sehr wahrscheinlich. Im April werden die Antworten hierauf gegeben!
Ich denke wir werden heute um gut 80 %...
14-Aug-07 ODONNELL FRANCIS E JR
Officer 875,000 Indirect Purchase at $8.87 - $8.87 per share. $7,761,0002
Dieser ODonnell scheint ein richtiger Geschäftsmann zu sein
ABPI ist überschuldet und hat so gut wie kein Geld mehr ich sehe keine zukunft für diese schrottaktie .
Sorry für die dabei waren...
Officer 875,000 Indirect Purchase at $8.87 - $8.87 per share. $7,761,0002
Dieser ODonnell scheint ein richtiger Geschäftsmann zu sein
ABPI ist überschuldet und hat so gut wie kein Geld mehr ich sehe keine zukunft für diese schrottaktie .
Sorry für die dabei waren...
Antwort auf Beitrag Nr.: 33.716.597 von StaatsKnecht am 25.03.08 09:38:31Danke fuer das Mitgefuehl.
Antwort auf Beitrag Nr.: 33.716.597 von StaatsKnecht am 25.03.08 09:38:31Mahlzeit,
Unfähiger Geschäftsmann? Möglich, aber hmmh...
Friday, November 25, 2005
St. Louis Character: Dr. Frank O'Donnell
St. Louis Business Journal - by Rick Desloge
BRIAN CASSIDY
Dr. Frank O'Donnell has an eye for opportunity. He saw promise in life science research that helped him evolve from a leading eye surgeon to a leading area medical investor.
O'Donnell, 55, is former chairman of the Saint Louis University School of Medicine's Department of Ophthalmology. He cofounded The O'Donnell Eye Institute and holds a dozen patents.
He also is the driving force -- chairman and chief executive -- behind Accentia, a medical company in Florida that completed a $19 million public stock offering earlier this month.
When he's not launching new health-care businesses, the father of five likes to collect what he calls significant sports memorabilia. Ask him about Milan High School's 1954 Indiana state basketball championship, and he'll gladly push an hour meeting into overtime to explain why that was an important event.
What influenced you growing up?
The biggest influences would be my grandfather, Harmon McCauley, and my mother, Doris O'Donnell. My grandfather was an aeronautical engineer and a patent attorney for McDonnell Douglas. We lived with my grandparents from the time I was 5 until I was 12. Then we moved to south St. Louis. My mom was a single parent. She raised four kids single handed -- she's very devoted to her faith, her family and she's a hard worker.
What drew you to medicine?
I was headed for an appointment at the U.S. Air Force Academy. I wanted to be a pilot. I was about to enter my senior year at St. Louis U. High and I had a very good friend injured in a motorcycle accident. He regained the use of his leg after he almost lost it. I was inspired by what his medical and surgical care meant for him. At that point I decided I wanted to be a physician. I went to Saint Louis U. and had two great years there. Johns Hopkins had an accelerated program where you could save at least a year of school. So I transferred after my sophomore year at SLU to Johns Hopkins.
Why did you become an eye surgeon?
I'd done a rotation in ophthalmology as a sophomore medical student. I had a good experience and was interviewed by the chairman of the program, who offered me a residency. This was before medical students had matching programs for residency assignments as they do now.
How does practicing medicine compare with investing in medical businesses?
My current role allows me to indulge my broader interest and love of medicine, but I don't regret having done ophthalmology. I was able to start investing in medical businesses passively. But as you become increasingly involved in the companies, you can't do both.
You show up as one of the more generous contributors to St. Louis U. High, between $250,000 and $500,000.
I could never have gone there had it not been for scholarships. My Jesuit education made everything else in school seem like skiing downhill. I support scholarships at SLUH, targeting kids that need the assistance to afford the tuition, which the school has done a good job of moderating. But at $8,600 a year, it's a real stretch for a middle-class family.
Do you have other favorite causes?
Saint Louis University has been the largest beneficiary from my wife, Katie, and me. Another charity that has been a sweet spot for us is Boys Hope-Girls Hope. It provides at-risk children with a stable home and high quality education. We support K-Life, which is providing support for 10 counselors to live and work in the inner city.
What prompted you to start Accentia?
I'm managing partner of Hopkins Capital Group, a private equity venture capital group that focuses on disruptive technologies in health care. These are the technologies that, when they get approval, have almost no competition, they are so revolutionary. About three years ago, I recognized there were a significant number of late-stage product opportunities in universities, with the National Cancer Institute and other research foundations, but they had no commercial partners for their work. I formed Accentia to focus on these late-stage opportunities.
What are the chances the company will move here?
Many of our investors are in the St. Louis area. Many of our independent directors are from the St. Louis area, and at least one of the investment banking firms that underwrote the offering, Stifel Nicolaus, is in the St. Louis area. I don't know how it all will evolve, but I would like Accentia to have a growing presence in St. Louis. We'll certainly look at competing proposals. We have heard from Tampa.
How does Hopkins Capital fit in with your investments?
Hopkins Capital has been my main focus for about the last 10 years. Three years ago we began to assemble components of what became Accentia. Since then I've focused exclusively on Accentia, and Hopkins has made no new outside investments.
How much does Hopkins have under management?
The amounts are confidential. We have many of the same partners as those who invested in Accentia. We're not structured like other venture capital funds. In a typical private equity fund, there's a management fee paid, about 1 to 2 percent a year on committed capital, and managers receive about 20 percent of profits. Managers have everything to gain, if there is a gain. But they don't take a loss if there is a loss. I have some issues about that traditional model. We never charged a management fee, and our share of any gain is proportional to the amount of money we invested.
What would you tell someone entering medicine who wanted to do what you do?
I don't think I'm a role model for anyone. I found my pathway by trial and error. I was able to make the transition first as a passive investor, not participating in the management of the companies. I took a long-term perspective and was focused on these disruptive technologies.
Who are your role models?
In terms of my immediate contacts, the people I hold in high esteem are the people I've sought as friends and co-investors. By co-investing with friends, it makes it a lot easier to justify the impact this has on my personal life.
Are you as fit as you look?
I exercise routinely. It's important for stress management. I don't think you can function optimally -- either intellectually, emotionally or spiritually -- if you neglect your health.
What do you do when you're not starting businesses?
I collect sports memorabilia. Among my favorites is a basketball signed by the Milan High School team from Indiana. It's the team that won the 1954 state high school championship. They won the game with a last-minute shot. The movie "Hoosiers" was based on their story. Milan High School is arguably the best sports story ever.
Auf jeden Fall war O'Donnell zu optimistisch im Falle SinuNase! Da er mit über 10 % an ABPI beteiligt ist, wird der gute Frank auch gestern nicht froh gewesen sein. Ich bin einzig und alleine gespannt, wie die nächste Finanzierungsrunde aussieht. Dass Geld der letzten Kapitalerhöhung müsste bald aufgebraucht sein. Und was macht eigentlich PPDI?
Tja, 5 Patienten mehr beim primären Endpunkt bei SinuNase statt auf der Placebo Seite und wir hätten ein signifikantes Ergebnis erreicht... Soll kein Schönreden sein, dass Ergebnis IST und BLEIBT zu wenig!!!
Wie auch immer... schönen Tag Euch noch!
Unfähiger Geschäftsmann? Möglich, aber hmmh...
Friday, November 25, 2005
St. Louis Character: Dr. Frank O'Donnell
St. Louis Business Journal - by Rick Desloge
BRIAN CASSIDY
Dr. Frank O'Donnell has an eye for opportunity. He saw promise in life science research that helped him evolve from a leading eye surgeon to a leading area medical investor.
O'Donnell, 55, is former chairman of the Saint Louis University School of Medicine's Department of Ophthalmology. He cofounded The O'Donnell Eye Institute and holds a dozen patents.
He also is the driving force -- chairman and chief executive -- behind Accentia, a medical company in Florida that completed a $19 million public stock offering earlier this month.
When he's not launching new health-care businesses, the father of five likes to collect what he calls significant sports memorabilia. Ask him about Milan High School's 1954 Indiana state basketball championship, and he'll gladly push an hour meeting into overtime to explain why that was an important event.
What influenced you growing up?
The biggest influences would be my grandfather, Harmon McCauley, and my mother, Doris O'Donnell. My grandfather was an aeronautical engineer and a patent attorney for McDonnell Douglas. We lived with my grandparents from the time I was 5 until I was 12. Then we moved to south St. Louis. My mom was a single parent. She raised four kids single handed -- she's very devoted to her faith, her family and she's a hard worker.
What drew you to medicine?
I was headed for an appointment at the U.S. Air Force Academy. I wanted to be a pilot. I was about to enter my senior year at St. Louis U. High and I had a very good friend injured in a motorcycle accident. He regained the use of his leg after he almost lost it. I was inspired by what his medical and surgical care meant for him. At that point I decided I wanted to be a physician. I went to Saint Louis U. and had two great years there. Johns Hopkins had an accelerated program where you could save at least a year of school. So I transferred after my sophomore year at SLU to Johns Hopkins.
Why did you become an eye surgeon?
I'd done a rotation in ophthalmology as a sophomore medical student. I had a good experience and was interviewed by the chairman of the program, who offered me a residency. This was before medical students had matching programs for residency assignments as they do now.
How does practicing medicine compare with investing in medical businesses?
My current role allows me to indulge my broader interest and love of medicine, but I don't regret having done ophthalmology. I was able to start investing in medical businesses passively. But as you become increasingly involved in the companies, you can't do both.
You show up as one of the more generous contributors to St. Louis U. High, between $250,000 and $500,000.
I could never have gone there had it not been for scholarships. My Jesuit education made everything else in school seem like skiing downhill. I support scholarships at SLUH, targeting kids that need the assistance to afford the tuition, which the school has done a good job of moderating. But at $8,600 a year, it's a real stretch for a middle-class family.
Do you have other favorite causes?
Saint Louis University has been the largest beneficiary from my wife, Katie, and me. Another charity that has been a sweet spot for us is Boys Hope-Girls Hope. It provides at-risk children with a stable home and high quality education. We support K-Life, which is providing support for 10 counselors to live and work in the inner city.
What prompted you to start Accentia?
I'm managing partner of Hopkins Capital Group, a private equity venture capital group that focuses on disruptive technologies in health care. These are the technologies that, when they get approval, have almost no competition, they are so revolutionary. About three years ago, I recognized there were a significant number of late-stage product opportunities in universities, with the National Cancer Institute and other research foundations, but they had no commercial partners for their work. I formed Accentia to focus on these late-stage opportunities.
What are the chances the company will move here?
Many of our investors are in the St. Louis area. Many of our independent directors are from the St. Louis area, and at least one of the investment banking firms that underwrote the offering, Stifel Nicolaus, is in the St. Louis area. I don't know how it all will evolve, but I would like Accentia to have a growing presence in St. Louis. We'll certainly look at competing proposals. We have heard from Tampa.
How does Hopkins Capital fit in with your investments?
Hopkins Capital has been my main focus for about the last 10 years. Three years ago we began to assemble components of what became Accentia. Since then I've focused exclusively on Accentia, and Hopkins has made no new outside investments.
How much does Hopkins have under management?
The amounts are confidential. We have many of the same partners as those who invested in Accentia. We're not structured like other venture capital funds. In a typical private equity fund, there's a management fee paid, about 1 to 2 percent a year on committed capital, and managers receive about 20 percent of profits. Managers have everything to gain, if there is a gain. But they don't take a loss if there is a loss. I have some issues about that traditional model. We never charged a management fee, and our share of any gain is proportional to the amount of money we invested.
What would you tell someone entering medicine who wanted to do what you do?
I don't think I'm a role model for anyone. I found my pathway by trial and error. I was able to make the transition first as a passive investor, not participating in the management of the companies. I took a long-term perspective and was focused on these disruptive technologies.
Who are your role models?
In terms of my immediate contacts, the people I hold in high esteem are the people I've sought as friends and co-investors. By co-investing with friends, it makes it a lot easier to justify the impact this has on my personal life.
Are you as fit as you look?
I exercise routinely. It's important for stress management. I don't think you can function optimally -- either intellectually, emotionally or spiritually -- if you neglect your health.
What do you do when you're not starting businesses?
I collect sports memorabilia. Among my favorites is a basketball signed by the Milan High School team from Indiana. It's the team that won the 1954 state high school championship. They won the game with a last-minute shot. The movie "Hoosiers" was based on their story. Milan High School is arguably the best sports story ever.
Auf jeden Fall war O'Donnell zu optimistisch im Falle SinuNase! Da er mit über 10 % an ABPI beteiligt ist, wird der gute Frank auch gestern nicht froh gewesen sein. Ich bin einzig und alleine gespannt, wie die nächste Finanzierungsrunde aussieht. Dass Geld der letzten Kapitalerhöhung müsste bald aufgebraucht sein. Und was macht eigentlich PPDI?
Tja, 5 Patienten mehr beim primären Endpunkt bei SinuNase statt auf der Placebo Seite und wir hätten ein signifikantes Ergebnis erreicht... Soll kein Schönreden sein, dass Ergebnis IST und BLEIBT zu wenig!!!
Wie auch immer... schönen Tag Euch noch!
O'Donnell says, we can still try this as a pump spray...what a load of crap. I knew this was going to be a bumpy ride, because what these clowns proposed was a complete rethinking of the causes of CS, and there was a good chance that they wouldn't be able to run their own p3 test...and they obviously couldn't, but I still think they have the rights to the mold test, and eventually they will figure out how to produce a CS test that meets the FDA endpoint. Maybe I'm just shellshocked, but his explanations almost seem to make sense; to a lunatic like me who will still be long tomorrow.
Mahlzeit,
17% der Patienten haben die Behandlung, aus welchen Gruenden auch immer, vorzeitig abgebrochen. Laut Statistik werden diese aber auch
beruecksichtigt, leider auf der "Falschen Seite".
Ohne Beruecksichtigung der 17% haette Accentia ein hervorragendes
Ergebnis erzielt!
17% der Patienten haben die Behandlung, aus welchen Gruenden auch immer, vorzeitig abgebrochen. Laut Statistik werden diese aber auch
beruecksichtigt, leider auf der "Falschen Seite".
Ohne Beruecksichtigung der 17% haette Accentia ein hervorragendes
Ergebnis erzielt!
habe in dass CC auch mal reingehört.
Was mich überrascht ist, dass O'Donnell weiterhin mehr als zuversichtlich bezüglich SinuNase ist, aber was bleibt Ihm und ABPI auch anderes über... Auf jeden Fall will ABPI den normal geplanten Weg weiterhin gehen, sprich dass Gespräch mit der FDA suchen um über einen Zulassung zu diskutieren. Dies setzt natürlich voraus, dass bis dato die kompletten Daten ausgewertet sind. O'Donnell betonte, dass er es für möglich hält, dass das lavage die fungi im Mucus herausgewaschen haben und es somit auch dem Placebo gelungen ist primäre Endpunkte zu erzielen. Es wird darauf gesetzt, dass die Placebo Daten bei der Auswertung nicht fundamental hinterlegt sind. Damit meine ich keine Verbesserung bei CT Scan und Endoskopie - obwohl ich hier sagen muss, wenn dass Lavage auch beim Placebo den fungi herausgespült hat, müssten die Werte sich hier auch verbessert haben. Also abwarten...
Zum Geldproblem hielt er sich recht bedeckt. Es fiel mehrfach dass Wort Partnerschaft (und dadurch wohl Lizenzeinahmen) auf dass spekuliert wird. Es sind auch (angeblich) Verhandlungen am laufen. Letztendlich wird hier aber VOR dem kompletten Entblinden der Daten NICHTS passieren (bzgl. Partnerschaft).
Zum Fahrplan: Als nächstes werden in der 2. April Woche die BiovaxID Ergebnisse veröffentlicht, Ende April die kompletten SinuNase Daten. Bis dahin ist es leider noch ein wenig...
Ach ja: Details zu den SinuNase Daten wurden nicht besprochen, da noch nicht vorhanden. Es wurde lediglich bestätigt 299 Patienten behandelt und ein p Wert von 0,14 zu Gunsten SinuNase
Grüße
Was mich überrascht ist, dass O'Donnell weiterhin mehr als zuversichtlich bezüglich SinuNase ist, aber was bleibt Ihm und ABPI auch anderes über... Auf jeden Fall will ABPI den normal geplanten Weg weiterhin gehen, sprich dass Gespräch mit der FDA suchen um über einen Zulassung zu diskutieren. Dies setzt natürlich voraus, dass bis dato die kompletten Daten ausgewertet sind. O'Donnell betonte, dass er es für möglich hält, dass das lavage die fungi im Mucus herausgewaschen haben und es somit auch dem Placebo gelungen ist primäre Endpunkte zu erzielen. Es wird darauf gesetzt, dass die Placebo Daten bei der Auswertung nicht fundamental hinterlegt sind. Damit meine ich keine Verbesserung bei CT Scan und Endoskopie - obwohl ich hier sagen muss, wenn dass Lavage auch beim Placebo den fungi herausgespült hat, müssten die Werte sich hier auch verbessert haben. Also abwarten...
Zum Geldproblem hielt er sich recht bedeckt. Es fiel mehrfach dass Wort Partnerschaft (und dadurch wohl Lizenzeinahmen) auf dass spekuliert wird. Es sind auch (angeblich) Verhandlungen am laufen. Letztendlich wird hier aber VOR dem kompletten Entblinden der Daten NICHTS passieren (bzgl. Partnerschaft).
Zum Fahrplan: Als nächstes werden in der 2. April Woche die BiovaxID Ergebnisse veröffentlicht, Ende April die kompletten SinuNase Daten. Bis dahin ist es leider noch ein wenig...
Ach ja: Details zu den SinuNase Daten wurden nicht besprochen, da noch nicht vorhanden. Es wurde lediglich bestätigt 299 Patienten behandelt und ein p Wert von 0,14 zu Gunsten SinuNase
Grüße
Antwort auf Beitrag Nr.: 33.715.091 von Ackergaul am 24.03.08 22:10:38Ackergaul, Du schriebst in #103, Du würdest nun die BiovaxID Ergebnisse aussitzen.
Ich hätte ja eher darauf spekuliert, dass SinuNase eine Zulassung bekommt und BiovaxID keine.
Ein Aktionär mit dieser Meinung dürfte eigentlich auch nicht die BiovaxID Ergebnisse aussitzen und müßte vor der Veröffentlichung der Daten zu BiovaxID in der zweiten Aprilwoche seine Aktien verkaufen.
Was meinst Du?
Ich hätte ja eher darauf spekuliert, dass SinuNase eine Zulassung bekommt und BiovaxID keine.
Ein Aktionär mit dieser Meinung dürfte eigentlich auch nicht die BiovaxID Ergebnisse aussitzen und müßte vor der Veröffentlichung der Daten zu BiovaxID in der zweiten Aprilwoche seine Aktien verkaufen.
Was meinst Du?
Antwort auf Beitrag Nr.: 33.749.745 von KillingJoke am 28.03.08 13:21:58Mahlzeit,
bezüglich BiovaxID bin ich eher skeptisch... Die Chancen die ich bei SinuNase geshen habe (zu 70 % Erfolg) sehe ich hier als Mißerfolg an. Müstte dann eigentlich bedeuten dass die Ergebnisse hervoragend werden - oder?
Sind die BiovaxID Ergebnisse gut, (signifikant) heißt dass auch nicht, dass die FDA eine Zulassung erteilt. Ich kann mir vorstellen, dass die FDA noch mehr Daten (mehr Patienten) sehen will.
Ich werde bis Ende April mind. voraussichtlich dabeibleiben, bis die kompletten Daten des SinuNase Trials erscheinen. Ein wenig optimistisch bin ich noch, dass die sekundären Endpunkte mehr für SinuNase sprechen werden. Wenn dieser Beweis gezeigt werden könnte, wäre so einiges wieder im Lot - z.B. der geplante Phase III Start des Sprays der wieder Hoffnung geben könnte (bei CS Patienten mit "geringeren Krankheitsgraden").
Was mich positiv gewundert hat, ist der Kurs den ich heute eher bei 0,60 $ als 1,20 $ gesehen habe. Naja...
Schönen Tag noch!
bezüglich BiovaxID bin ich eher skeptisch... Die Chancen die ich bei SinuNase geshen habe (zu 70 % Erfolg) sehe ich hier als Mißerfolg an. Müstte dann eigentlich bedeuten dass die Ergebnisse hervoragend werden - oder?
Sind die BiovaxID Ergebnisse gut, (signifikant) heißt dass auch nicht, dass die FDA eine Zulassung erteilt. Ich kann mir vorstellen, dass die FDA noch mehr Daten (mehr Patienten) sehen will.
Ich werde bis Ende April mind. voraussichtlich dabeibleiben, bis die kompletten Daten des SinuNase Trials erscheinen. Ein wenig optimistisch bin ich noch, dass die sekundären Endpunkte mehr für SinuNase sprechen werden. Wenn dieser Beweis gezeigt werden könnte, wäre so einiges wieder im Lot - z.B. der geplante Phase III Start des Sprays der wieder Hoffnung geben könnte (bei CS Patienten mit "geringeren Krankheitsgraden").
Was mich positiv gewundert hat, ist der Kurs den ich heute eher bei 0,60 $ als 1,20 $ gesehen habe. Naja...
Schönen Tag noch!
Antwort auf Beitrag Nr.: 33.750.335 von Ackergaul am 28.03.08 14:10:05Hallo Ackergaul,
also das was Du beschreibst müsste ja eine andere Handlungsweise nach sich ziehen.
1) ABPI verkaufen bis zum 04.04.08.
Du sagtest selbst, dass Du den aktuellen Kurs bei 1,20 USD hervorragend hoch bewertet siehst.
2) Negative BiovaxID Meldung in der 15. KW (bis 11.04.08)
Die Aktie fällt ins Bodenlose.
3) Aufsammeln der zuvor verkauften Aktien zum Niedrigstpreis in der 16 KW (bis 18.04.08) und 17. KW.
Selbstverständlich hast Du Dir vorher in Ruhe darüber Gedanken gemacht, wo dieser Niedrigstpreis liegt.
4) Ende April Veröffentlichung der kompletten Daten und Hoffnungsschimmer für SinuNase.
Denk mal drüber nach.
also das was Du beschreibst müsste ja eine andere Handlungsweise nach sich ziehen.
1) ABPI verkaufen bis zum 04.04.08.
Du sagtest selbst, dass Du den aktuellen Kurs bei 1,20 USD hervorragend hoch bewertet siehst.
2) Negative BiovaxID Meldung in der 15. KW (bis 11.04.08)
Die Aktie fällt ins Bodenlose.
3) Aufsammeln der zuvor verkauften Aktien zum Niedrigstpreis in der 16 KW (bis 18.04.08) und 17. KW.
Selbstverständlich hast Du Dir vorher in Ruhe darüber Gedanken gemacht, wo dieser Niedrigstpreis liegt.
4) Ende April Veröffentlichung der kompletten Daten und Hoffnungsschimmer für SinuNase.
Denk mal drüber nach.
Super,
kommt hier vielleicht ein bisschen Bewegung in
den Thread?
Schoenes Wochenende allerseits.
kommt hier vielleicht ein bisschen Bewegung in
den Thread?
Schoenes Wochenende allerseits.
Antwort auf Beitrag Nr.: 33.751.518 von KillingJoke am 28.03.08 15:35:23Für mich ist die ABPI Position ein klares HOLD zur Zeit.
Wenn BiovaxID floppen wird, wird es nochmals 40 - 50 % heruntersausen - allerdings sollte der Gegenteil der Fall sein, wird es sehr teuer werden sich wieder in ABPI einzukaufen.
Die zweite Sache ist halt: Kann man auf die Terminabgaben ABPIs setzen? Von Mitte April kann schnell ein Ende April werden. Zudem könnten noch unerwartete Wendungen eintreten.
Grüße
Wenn BiovaxID floppen wird, wird es nochmals 40 - 50 % heruntersausen - allerdings sollte der Gegenteil der Fall sein, wird es sehr teuer werden sich wieder in ABPI einzukaufen.
Die zweite Sache ist halt: Kann man auf die Terminabgaben ABPIs setzen? Von Mitte April kann schnell ein Ende April werden. Zudem könnten noch unerwartete Wendungen eintreten.
Grüße
Antwort auf Beitrag Nr.: 33.757.815 von Ackergaul am 29.03.08 13:54:49Hallo Ackergaul,
Du hast natürlich umgekehrt vollkommen recht, dass es quasi unbezahlbar wäre, in ABPI nach positiv ausfallenden BiovaxID-Ergebnissen wieder einzusteigen.
Auch bleibt festzuhalten, dass an der Börse alles möglich ist, z.B. auch noch ein Übernahmeangebot.
Also für mich ist es schwierig einzuschätzen, wieviel Potential ABPI hat, falls BiovaxID tatsächlich floppen sollte.
Das sollte momentan die entscheidende Frage sein.
Ist Deine Annahme, wir sähen nach einem (natürlich nicht wünschenswerten aber) gut möglichen BiovaxID-Flop einen ABPI-Kurs bei noch 60 US-Cent nicht ein wenig zu optimistisch?
Vielleicht ist es jetzt ein interessanter Zeitpunkt, mal zusammenzurechnen wieviel Accentia ohne BiovaxID (und gemäß der aktuellen Nachrichtenlage hinsichtlich SinuNase) Wert ist.
Ich frage also nach einem Aktienkurs zum rein theoretischen "Worst-Case-Szenario" in zwei-drei Wochen.
Du hast natürlich umgekehrt vollkommen recht, dass es quasi unbezahlbar wäre, in ABPI nach positiv ausfallenden BiovaxID-Ergebnissen wieder einzusteigen.
Auch bleibt festzuhalten, dass an der Börse alles möglich ist, z.B. auch noch ein Übernahmeangebot.
Also für mich ist es schwierig einzuschätzen, wieviel Potential ABPI hat, falls BiovaxID tatsächlich floppen sollte.
Das sollte momentan die entscheidende Frage sein.
Ist Deine Annahme, wir sähen nach einem (natürlich nicht wünschenswerten aber) gut möglichen BiovaxID-Flop einen ABPI-Kurs bei noch 60 US-Cent nicht ein wenig zu optimistisch?
Vielleicht ist es jetzt ein interessanter Zeitpunkt, mal zusammenzurechnen wieviel Accentia ohne BiovaxID (und gemäß der aktuellen Nachrichtenlage hinsichtlich SinuNase) Wert ist.
Ich frage also nach einem Aktienkurs zum rein theoretischen "Worst-Case-Szenario" in zwei-drei Wochen.
Antwort auf Beitrag Nr.: 33.765.683 von KillingJoke am 31.03.08 13:49:09Was hat ABPI noch Gegenzusetzen - unter der Voraussetzung dass BiovaxID fehlschlägt:
- Revimmune - Indikation MS: IND voraussichtlich noch im April; Phase III Start in der 2H 2008. Möglich dass man sich einen Partner ins Boot holt um die Kosten zu teilen...
- nochmals Revimmune - Indikation Elimination of Transplant Rejection. Wann Biovest dass IND einreicht ist unklar, vielleicht noch in diesem Halbjahr.
- Allernase: Allernase wird von Collegium entwickelt. Wurde einlizensiert, als der damalige Wirkstoff vom Markt genommen wurde (Stabilitäts Problem). Wann (und ob) dass approval kommt ist unklar, kann jederzeit passieren, aber möglich dass hier etwas schief gelaufen ist. Einen zweistelligen Millionenumsatz halte ich hier für möglich.
- Man hat ein bestehendes Vertriebssystem (Teamm Pharm.)
- Umsätze von etwa 18 Mio $ jährlich - dennoch nur ein Tropfen auf dem heißen Stein, auf Grund der enormen Forschungskosten und auch Vertriebskosten!
- SinuNase: Daten der Phase III werden wohl Ende April veröffentlicht. Sekundäre Endpunkte könnten signifikant sein, möglich ist noch ein acclerated approval bei den refractory CS Fällen - ABER unwahrscheinlich!
- nochmals SinuNase: Die Sprayformulierung für die minder schlimmen CS Fälle. Falls die Annahme ABPIs stimmig ist, dass durch das lavage die Placebo Endpunkte so hoch waren, ist dies der größte Hoffnungspunkt. Wenn die Daten Ende April einen deutlichen Trend zugunsten SinuNase zeigen, wird es wohl zügig in die zweite Phase III gehen.
Problem ist der Schuldenberg bei gleichzeitiger Cash-Armut! Also: Hoffnungen liegen auf Partnerschaften (ob SinuNase oder andere Produkte). Ansonsten riecht es sehr nach einer Kapitalerhöhung, bei der der Kurs wohl nochmals bluten wird...
Grüße
It ain't over 'til the fat lady sings
- Revimmune - Indikation MS: IND voraussichtlich noch im April; Phase III Start in der 2H 2008. Möglich dass man sich einen Partner ins Boot holt um die Kosten zu teilen...
- nochmals Revimmune - Indikation Elimination of Transplant Rejection. Wann Biovest dass IND einreicht ist unklar, vielleicht noch in diesem Halbjahr.
- Allernase: Allernase wird von Collegium entwickelt. Wurde einlizensiert, als der damalige Wirkstoff vom Markt genommen wurde (Stabilitäts Problem). Wann (und ob) dass approval kommt ist unklar, kann jederzeit passieren, aber möglich dass hier etwas schief gelaufen ist. Einen zweistelligen Millionenumsatz halte ich hier für möglich.
- Man hat ein bestehendes Vertriebssystem (Teamm Pharm.)
- Umsätze von etwa 18 Mio $ jährlich - dennoch nur ein Tropfen auf dem heißen Stein, auf Grund der enormen Forschungskosten und auch Vertriebskosten!
- SinuNase: Daten der Phase III werden wohl Ende April veröffentlicht. Sekundäre Endpunkte könnten signifikant sein, möglich ist noch ein acclerated approval bei den refractory CS Fällen - ABER unwahrscheinlich!
- nochmals SinuNase: Die Sprayformulierung für die minder schlimmen CS Fälle. Falls die Annahme ABPIs stimmig ist, dass durch das lavage die Placebo Endpunkte so hoch waren, ist dies der größte Hoffnungspunkt. Wenn die Daten Ende April einen deutlichen Trend zugunsten SinuNase zeigen, wird es wohl zügig in die zweite Phase III gehen.
Problem ist der Schuldenberg bei gleichzeitiger Cash-Armut! Also: Hoffnungen liegen auf Partnerschaften (ob SinuNase oder andere Produkte). Ansonsten riecht es sehr nach einer Kapitalerhöhung, bei der der Kurs wohl nochmals bluten wird...
Grüße
It ain't over 'til the fat lady sings
Siegfried trifft Hagens Speer in den Rücken. Die Leiche Siegfrieds wird an den Gibichungenhof zurückgebracht. Dort entbrennt ein hässlicher Streit um den Ring. Hagen will ihn als gerechte Beute an sich nehmen. Doch Gunther beansprucht ihn als Gutrunes Erbe und wird deswegen von Hagen sofort getötet.
Brünnhilde tritt hervor, nimmt den Ring an sich und schenkt ihn den Rheintöchtern zurück, die ihn wieder zum Rheingolde auflösen sollen. Brünnhilde selbst hat einen großen Scheiterhaufen errichten lassen, in dessen Feuer die Leiche Siegfrieds verbrennen soll. Als die Flammen auflodern, stürzt sie sich selbst mit ihrem Pferd Grane hinein.
Hagen wird bei dem Versuch, den Ring aus den Fluten des Rheins zu retten, von den Rheintöchtern ins Wasser gezogen. Die Flammen greifen auf das am Himmel erscheinende Walhall über, ergriffen staunende Menschen sehen dem Untergang der Götter zu.
Naja, so schlimm wird’s schon nicht kommen...
Brünnhilde tritt hervor, nimmt den Ring an sich und schenkt ihn den Rheintöchtern zurück, die ihn wieder zum Rheingolde auflösen sollen. Brünnhilde selbst hat einen großen Scheiterhaufen errichten lassen, in dessen Feuer die Leiche Siegfrieds verbrennen soll. Als die Flammen auflodern, stürzt sie sich selbst mit ihrem Pferd Grane hinein.
Hagen wird bei dem Versuch, den Ring aus den Fluten des Rheins zu retten, von den Rheintöchtern ins Wasser gezogen. Die Flammen greifen auf das am Himmel erscheinende Walhall über, ergriffen staunende Menschen sehen dem Untergang der Götter zu.
Naja, so schlimm wird’s schon nicht kommen...
„Ausdauer wird früher oder später belohnt ? meistens aber später.”
???
Bema Fentanyl already has beat the placebo. We just need the FDA to approve it. Best in class status would be real sweet also. Then its off to the races.
Kommt aus dem Yahoo-Finance-Board.
Wissen die mehr?
Bema Fentanyl already has beat the placebo. We just need the FDA to approve it. Best in class status would be real sweet also. Then its off to the races.
Kommt aus dem Yahoo-Finance-Board.
Wissen die mehr?
Antwort auf Beitrag Nr.: 33.790.378 von SunnyOst am 02.04.08 16:40:58Best in class status would be real sweet also
Orexo´s Rapinyl wirkt schneller als Bema und das ist wohl entscheidend bei Schmerzen .
http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-ne…
The data from the analysis of 61 patients demonstrated that RAPINYL met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). In addition, all the secondary endpoints were met. Statistically significant separation from placebo on mean pain intensity difference was seen as early as 10 minutes.
----------
http://www.bdsinternational.com/news/index.html
Results were based on the company’s continuing analysis of the secondary efficacy endpoints from the study. A key secondary endpoint was the SPID 15 (Summary of Pain Intensity Difference at 15 minutes), a measure of the speed of onset of the medication. The study data indicate that the SPID 15 was significantly higher on BEMATM Fentanyl than with placebo.
Orexo´s Rapinyl wirkt schneller als Bema und das ist wohl entscheidend bei Schmerzen .
http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-ne…
The data from the analysis of 61 patients demonstrated that RAPINYL met its primary endpoint, the Sum of Pain Intensity Difference from baseline to 30 minutes (SPID 0-30), and the results were highly statistically significant (p=0.0004). In addition, all the secondary endpoints were met. Statistically significant separation from placebo on mean pain intensity difference was seen as early as 10 minutes.
----------
http://www.bdsinternational.com/news/index.html
Results were based on the company’s continuing analysis of the secondary efficacy endpoints from the study. A key secondary endpoint was the SPID 15 (Summary of Pain Intensity Difference at 15 minutes), a measure of the speed of onset of the medication. The study data indicate that the SPID 15 was significantly higher on BEMATM Fentanyl than with placebo.
Sunny,
kasst Du mich mal aufklären, was "Bema Fentanyl" mit ABPI zu tun hat ausser der Tatsache, dass O´Donell auch bei BioDelivery Sciences (BDSI) investiert ist?
kasst Du mich mal aufklären, was "Bema Fentanyl" mit ABPI zu tun hat ausser der Tatsache, dass O´Donell auch bei BioDelivery Sciences (BDSI) investiert ist?
Antwort auf Beitrag Nr.: 33.798.160 von KillingJoke am 03.04.08 13:05:56Hi KJ,
war etwas von der Rolle. Hat damit nix zu tun.
Gelobe Besserung.
Gruss
war etwas von der Rolle. Hat damit nix zu tun.
Gelobe Besserung.
Gruss
Antwort auf Beitrag Nr.: 33.798.160 von KillingJoke am 03.04.08 13:05:56Er ist nicht nur investiert sondern auch Chairman von BDSI .
Frank E. O'Donnell, Jr. MD
Chairman
Frank E. O'Donnell, Jr. MD. has been our Chairman of the Board and a Director on a full time basis since 2002. He is our former President and Chief Executive Officer. Dr. O'Donnell serves as managing director of The Hopkins Capital Group, an affiliation of limited liability companies which engage in private equity and venture capital investing in disruptive technologies in healthcare. He is a co-founder and chairman of RetinaPharma Technologies, Inc. which now includes Tatton Technologies, LLC, and a co-founder of Biotech Specialty Partners, LLC, an alliance of specialty pharmaceutical and biotechnology companies. He serves as Chairman and CEO of Accentia Biopharmaceuticals, Inc. Dr. O'Donnell is a graduate of The Johns Hopkins School of Medicine and received his residency training at the Wilmer Ophthalmological Institute, Johns Hopkins Hospital. Dr. O'Donnell is a former professor and Chairman of the Department of Ophthalmology, St. Louis University School of Medicine. Dr. O'Donnell holds 34 U.S. Patents. Dr. O'Donnell is the 2000 Recipient of the Jules Stein Vision Award sponsored by Retinitis Pigmentosa International. He is a trustee of the Health Careers Foundation and of St Louis University.
Frank E. O'Donnell, Jr. MD
Chairman
Frank E. O'Donnell, Jr. MD. has been our Chairman of the Board and a Director on a full time basis since 2002. He is our former President and Chief Executive Officer. Dr. O'Donnell serves as managing director of The Hopkins Capital Group, an affiliation of limited liability companies which engage in private equity and venture capital investing in disruptive technologies in healthcare. He is a co-founder and chairman of RetinaPharma Technologies, Inc. which now includes Tatton Technologies, LLC, and a co-founder of Biotech Specialty Partners, LLC, an alliance of specialty pharmaceutical and biotechnology companies. He serves as Chairman and CEO of Accentia Biopharmaceuticals, Inc. Dr. O'Donnell is a graduate of The Johns Hopkins School of Medicine and received his residency training at the Wilmer Ophthalmological Institute, Johns Hopkins Hospital. Dr. O'Donnell is a former professor and Chairman of the Department of Ophthalmology, St. Louis University School of Medicine. Dr. O'Donnell holds 34 U.S. Patents. Dr. O'Donnell is the 2000 Recipient of the Jules Stein Vision Award sponsored by Retinitis Pigmentosa International. He is a trustee of the Health Careers Foundation and of St Louis University.
Antwort auf Beitrag Nr.: 33.800.968 von BrauchGeld am 03.04.08 16:54:00Was fuer ein besch... Kursverlauf.
Sunny,
Accentia kam von 2,5-3 USD. Schlußkurs am 24.04.08 war 2,99 Euro.
Open am 25.03.08 nach den SinuNase Ergebnissen war 0,70 USD, low 0,65 USD und Schlußkurs 0,97 USD.
Wer da reingegriffen hat, hat mit dem Aufbäumen einen schönen Schnitt machen können, nämlich 70% in zwei Tagen: 27.03.08 Close 1,28 USD.
Jetzt sind wir bei 0,96 USD. Falls Du vor den (mehr als riskanten) BiovaxID Ergbnissen Ende April aussteigen willst, dann wäre das Timing natürlich etwas ungünstig.
Wenn Du den April aussitzen willst, wovon ich ausgehe, dann ist der jetzige Kurs als Zwischenstation nach oben oder eben auch unten eher uninteressant.
Gruß
KJ
Accentia kam von 2,5-3 USD. Schlußkurs am 24.04.08 war 2,99 Euro.
Open am 25.03.08 nach den SinuNase Ergebnissen war 0,70 USD, low 0,65 USD und Schlußkurs 0,97 USD.
Wer da reingegriffen hat, hat mit dem Aufbäumen einen schönen Schnitt machen können, nämlich 70% in zwei Tagen: 27.03.08 Close 1,28 USD.
Jetzt sind wir bei 0,96 USD. Falls Du vor den (mehr als riskanten) BiovaxID Ergbnissen Ende April aussteigen willst, dann wäre das Timing natürlich etwas ungünstig.
Wenn Du den April aussitzen willst, wovon ich ausgehe, dann ist der jetzige Kurs als Zwischenstation nach oben oder eben auch unten eher uninteressant.
Gruß
KJ
Antwort auf Beitrag Nr.: 33.845.346 von KillingJoke am 09.04.08 13:37:34Danke.
AGENs Oncophage wurde in Russland zugelassen:
http://seekingalpha.com/article/71605-world-s-first-cancer-v…
World's First Cancer Vaccine Approved; Expect Interest in Antigenics, Dendreon
posted on: April 08, 2008 | about stocks: AGEN / DNDN
The tiny biotechnology company Antigenics Inc (NASDAQ:AGEN) said on Tuesday that it has won approval to market its kidney cancer vaccine, Oncophage, in Russia, making it the only cancer vaccine available in the world.
The product was approved despite failing to win approval in the United States. It is the first time the Russian government has approved a foreign drug that was not first cleared in its country of origin, Antigenics said. Antigenics is also planning to file for approval of the vaccine in Europe by the end of the year.
Notablecalls: Phew! This is unbelievable! The world's 1st cancer vaccine is approved. This is historic. I expect to see some buy interest in other cancer vaccine names, mainly Dendreon (NASDAQNDN).
Hat nichts mit ABPI und BVTI zu tun, zeigt aber das Vaccines mittlerweile als zulassungswürdig betrachtet werden...
ABPIs Aussage zu BiovaxID war: Daten in der 2. April Woche.
Grüße
(Daumen drücken)
http://seekingalpha.com/article/71605-world-s-first-cancer-v…
World's First Cancer Vaccine Approved; Expect Interest in Antigenics, Dendreon
posted on: April 08, 2008 | about stocks: AGEN / DNDN
The tiny biotechnology company Antigenics Inc (NASDAQ:AGEN) said on Tuesday that it has won approval to market its kidney cancer vaccine, Oncophage, in Russia, making it the only cancer vaccine available in the world.
The product was approved despite failing to win approval in the United States. It is the first time the Russian government has approved a foreign drug that was not first cleared in its country of origin, Antigenics said. Antigenics is also planning to file for approval of the vaccine in Europe by the end of the year.
Notablecalls: Phew! This is unbelievable! The world's 1st cancer vaccine is approved. This is historic. I expect to see some buy interest in other cancer vaccine names, mainly Dendreon (NASDAQNDN).
Hat nichts mit ABPI und BVTI zu tun, zeigt aber das Vaccines mittlerweile als zulassungswürdig betrachtet werden...
ABPIs Aussage zu BiovaxID war: Daten in der 2. April Woche.
Grüße
(Daumen drücken)
Hallo Ackergaul,
also man sollte nicht vergessen, dass Antigenics heute wohl ganz wo anders stehen würde, wenn die Ihren Oncophage Zulassungsantrag statt jetzt auf Umwegen über Russland (und Europa geplant) in den USA bei der FDA durch bekommen hätten.
Leider hatte das damals im März 2006 nicht geklappt wiel die Zielsetzung des Versuchs nicht erfüllt wurde.
Die FDA will immer sehr viel sehen.
also man sollte nicht vergessen, dass Antigenics heute wohl ganz wo anders stehen würde, wenn die Ihren Oncophage Zulassungsantrag statt jetzt auf Umwegen über Russland (und Europa geplant) in den USA bei der FDA durch bekommen hätten.
Leider hatte das damals im März 2006 nicht geklappt wiel die Zielsetzung des Versuchs nicht erfüllt wurde.
Die FDA will immer sehr viel sehen.
Antwort auf Beitrag Nr.: 33.846.450 von Ackergaul am 09.04.08 15:29:52Ackergaul,
wo war das mit der zweiten April-Woche eigentlich genau her.
In der Ankündigung vom 26.03.08 heiß es nur April:
"Accentia anticipates reporting a significant milestone in April, as the Company’s majority-owned subsidiary, Biovest International, Inc. (BVTI), is preparing to report the interim unblinded results of its pivotal Phase 3 study for the anti-cancer vaccine, BiovaxID™.
These results, if positive, are expected to poise BiovaxID to become the first personalized anti-cancer vaccine to ever be granted approval for the treatment of non-Hodgkin’s lymphoma."
wo war das mit der zweiten April-Woche eigentlich genau her.
In der Ankündigung vom 26.03.08 heiß es nur April:
"Accentia anticipates reporting a significant milestone in April, as the Company’s majority-owned subsidiary, Biovest International, Inc. (BVTI), is preparing to report the interim unblinded results of its pivotal Phase 3 study for the anti-cancer vaccine, BiovaxID™.
These results, if positive, are expected to poise BiovaxID to become the first personalized anti-cancer vaccine to ever be granted approval for the treatment of non-Hodgkin’s lymphoma."
Antwort auf Beitrag Nr.: 33.847.566 von KillingJoke am 09.04.08 16:53:43Im Anschluss zu den SinuNase Daten gab es ein Conference Call. Dort wurde die 2. KW im April gennant. Restliche SinuNase Daten gegen Ende April. So ist es zumindet geplant...
Dass die FDA oberkritisch ist (vielleicht auch zu Recht) steht außer Frage. Aber soweit ist man bei ABPI/BVTI bei weitem noch nicht! Erst mal kommen die Daten und dann schaun wa mal...
Grüße
Dass die FDA oberkritisch ist (vielleicht auch zu Recht) steht außer Frage. Aber soweit ist man bei ABPI/BVTI bei weitem noch nicht! Erst mal kommen die Daten und dann schaun wa mal...
Grüße
Also ich bin immer interessiert an "Möglichkeiten" und insbesondere wieder sehr gespannt auf Ackergauls Einschätzung.
Wie entwickeln sich Biovest (BVTI) und Accentia (ABPI) wenn in Kürze die Daten zu BiovaxID veröffentlicht werden und a) sehr gut oder b) sehr schlecht ausfallen?
---
Wir wissen: Accentia hat eine 78%-Beteiligung an Biovest. So gesehen schlagen die News nicht zu 100% auf den Kurs durch. Umgekehrt hat Accentia viel mehr Alternativen zu bieten als Biovest die als Sicherheit gegen Totalabsturz dienen. Ackergaul war so freundlich und hatte das Potential kürzlich in Beitrag #117 zusammengestellt. Wie ein Totalabsturz aussieht, habe ich in #118 dargelegt
---
Accentia hat eine Marktkapitalisierung von 44,04 Mio USD bei einem Kurs von 1,02 USD, aber auch entsetzlich viele Schulden wie in Beitrag #66 schön zusammengestellt (71 Mio USD, 22 Mio Aktien). Accentia wies in der Bilanz zum 31.12.2007 Gesamtverbindlichkeiten in Höhe von 112 Mio USD auf, Tendenz steigend.
Biovest hat eine Marktkapitalisierung von 57,44 Mio USD bei einem Kurs von 0,60 USD. Die Gesamtverbindlichkeiten in der Bilanz zum 31.12.2007 betragen 46 Mio USD.
---
Was passiert also, wenn die Daten sehr schlecht ausfallen und den Aktionär hoffnungslos in die Zukunft blicken lassen? Wohin fällt der Kurs von BVTI und ABPI?
BVTI wird meiner Meinung nach wertlos. Wo soll da noch Hoffnung herkommen? Die Schulden sind quasi nicht mehr aufzufangen.
ABPI hätte nach den schlechten SinuNase-Daten den zweiten Fehlschlag beim zweiten Blockbusterkandidaten. Das sieht bei dem hohen Schuldenstand dann meiner Meinung nach gar nicht gut aus. Man erkennt, wie wichtig die Resthoffnung für SinuNase sein wird: Neuer Phase III Trial und doch noch Blockbuster wird den Kurs vielleicht bei 0,30-0,40 USD halten? Weitere Meinungen??
---
Was passiert, wenn die Daten sehr gut ausfallen und den Aktionär von sicherer FDA Zulassung träumen lassen? Das wäre natürlich ein Riesending.
BVTI 4 USD, ABPI 6 USD und nochmalige Verdopplung bei tatsächlicher Zulassung?
Weitere Meinungen??
---
Ich bin mir natürlich bewußt, dass ich mit meiner Fragestellung Schwarz-Weiß Malerei betreibe und dass so ein Ausgang wie mittelschlechte Daten mit Hoffnungsschimmer üblicherweise der Biotech-Realität entsprechen.
Jedoch - wenn nicht jetzt wann dann schätzen?
KJ
Wie entwickeln sich Biovest (BVTI) und Accentia (ABPI) wenn in Kürze die Daten zu BiovaxID veröffentlicht werden und a) sehr gut oder b) sehr schlecht ausfallen?
---
Wir wissen: Accentia hat eine 78%-Beteiligung an Biovest. So gesehen schlagen die News nicht zu 100% auf den Kurs durch. Umgekehrt hat Accentia viel mehr Alternativen zu bieten als Biovest die als Sicherheit gegen Totalabsturz dienen. Ackergaul war so freundlich und hatte das Potential kürzlich in Beitrag #117 zusammengestellt. Wie ein Totalabsturz aussieht, habe ich in #118 dargelegt
---
Accentia hat eine Marktkapitalisierung von 44,04 Mio USD bei einem Kurs von 1,02 USD, aber auch entsetzlich viele Schulden wie in Beitrag #66 schön zusammengestellt (71 Mio USD, 22 Mio Aktien). Accentia wies in der Bilanz zum 31.12.2007 Gesamtverbindlichkeiten in Höhe von 112 Mio USD auf, Tendenz steigend.
Biovest hat eine Marktkapitalisierung von 57,44 Mio USD bei einem Kurs von 0,60 USD. Die Gesamtverbindlichkeiten in der Bilanz zum 31.12.2007 betragen 46 Mio USD.
---
Was passiert also, wenn die Daten sehr schlecht ausfallen und den Aktionär hoffnungslos in die Zukunft blicken lassen? Wohin fällt der Kurs von BVTI und ABPI?
BVTI wird meiner Meinung nach wertlos. Wo soll da noch Hoffnung herkommen? Die Schulden sind quasi nicht mehr aufzufangen.
ABPI hätte nach den schlechten SinuNase-Daten den zweiten Fehlschlag beim zweiten Blockbusterkandidaten. Das sieht bei dem hohen Schuldenstand dann meiner Meinung nach gar nicht gut aus. Man erkennt, wie wichtig die Resthoffnung für SinuNase sein wird: Neuer Phase III Trial und doch noch Blockbuster wird den Kurs vielleicht bei 0,30-0,40 USD halten? Weitere Meinungen??
---
Was passiert, wenn die Daten sehr gut ausfallen und den Aktionär von sicherer FDA Zulassung träumen lassen? Das wäre natürlich ein Riesending.
BVTI 4 USD, ABPI 6 USD und nochmalige Verdopplung bei tatsächlicher Zulassung?
Weitere Meinungen??
---
Ich bin mir natürlich bewußt, dass ich mit meiner Fragestellung Schwarz-Weiß Malerei betreibe und dass so ein Ausgang wie mittelschlechte Daten mit Hoffnungsschimmer üblicherweise der Biotech-Realität entsprechen.
Jedoch - wenn nicht jetzt wann dann schätzen?
KJ
Antwort auf Beitrag Nr.: 33.851.016 von KillingJoke am 09.04.08 21:31:48Sowas ist natürlich schwer einzuschätzen. Ich denke bei positiven Daten, (Hohe Anzahl von molekularen Remissionen - wie in der Phase II) werden wir maximal das Jahres-Hoch ABPIs wiedersehen - also um die 3 $ Marke. Bei nicht erreichen dieser Daten gehts klar unter 50 cent.
Für BVTI sehe ich max 2 Dollar, im anderen Fall einstelliger Cent Bereich (also 90 % runter).
Zum Zweiten muss man dann sehen, ob die FDA dem acclerated approval stattgibt oder zB noch sagt "wir brauchen mehr Daten / Patienten".
Problem in beiden Fällen ist dass fehlende Cash und die Schulden. Da kann Revimmune noch so hoffnungsvoll sein, wenn BiovaxID floppt und die SinuNase Daten ergeben, dass die objektiven Sekundärziele nicht signifikant sind, wirds zappenduster...
Grüße
Für BVTI sehe ich max 2 Dollar, im anderen Fall einstelliger Cent Bereich (also 90 % runter).
Zum Zweiten muss man dann sehen, ob die FDA dem acclerated approval stattgibt oder zB noch sagt "wir brauchen mehr Daten / Patienten".
Problem in beiden Fällen ist dass fehlende Cash und die Schulden. Da kann Revimmune noch so hoffnungsvoll sein, wenn BiovaxID floppt und die SinuNase Daten ergeben, dass die objektiven Sekundärziele nicht signifikant sind, wirds zappenduster...
Grüße
Antwort auf Beitrag Nr.: 33.855.406 von Ackergaul am 10.04.08 11:49:18Hallo Ackergaul,
Danke für Deine Einschätzung.
Ja es kostet immer Überwindung, sich auf Preisvorstellungen festzulegen. Ist aber sehr hilfreich, wenn dann wirklich die Szenarien eintreffen und der Preis am Markt bestimmt wird.
Das hilft dann, aus dem Wert raus- oder in den Wert reinzugehen.
Wenn man sich die Schuldenseite ansieht, dann erkennt man auch, dass man sich bei Fehlschlägen und stark fallenden Preisen von den optisch niedrigen Marktkapitaliserungen nicht blenden lassen darf.
Wenn man die Biovest-Schulden sieht, dann versteht man auch, warum Accentia nur Biovest-Mehrheitsaktionär ist und keine Übernahme in Erwägung gezogen hat.
KJ
Danke für Deine Einschätzung.
Ja es kostet immer Überwindung, sich auf Preisvorstellungen festzulegen. Ist aber sehr hilfreich, wenn dann wirklich die Szenarien eintreffen und der Preis am Markt bestimmt wird.
Das hilft dann, aus dem Wert raus- oder in den Wert reinzugehen.
Wenn man sich die Schuldenseite ansieht, dann erkennt man auch, dass man sich bei Fehlschlägen und stark fallenden Preisen von den optisch niedrigen Marktkapitaliserungen nicht blenden lassen darf.
Wenn man die Biovest-Schulden sieht, dann versteht man auch, warum Accentia nur Biovest-Mehrheitsaktionär ist und keine Übernahme in Erwägung gezogen hat.
KJ
Antwort auf Beitrag Nr.: 33.841.875 von SunnyOst am 09.04.08 06:30:58Sunny,
nun fehlt Deine BiovacID "Best Case" / "Worst Case" Preisvorstellung noch
nun fehlt Deine BiovacID "Best Case" / "Worst Case" Preisvorstellung noch
Friday, March 28, 2008
Frank O'Donnell's medical gamble falters
Accentia stock tanks following clinical trials
St. Louis Business Journal - by Angela Mueller
Local ophthalmologist-turned-entrepreneur Dr. Frank O'Donnell has another hurdle in his
sights.
Accentia Biopharmaceuticals Inc., a Tampa-based company where O'Donnell serves
as chairman and chief executive, received disappointing clinical trial results for one of its
key products -- a treatment touted to relieve sinus congestion. The SinuNase treatment
didn't meet goals in the late-stage trials, causing Accentia's share price to plummet and
raising concerns about the company's future.
Accentia reported March 25 that SinuNase was not significantly more effective than a
placebo in treating the symptoms of chronic sinusitis. Upon the news, the company's stock,
which closed at $3.06 March 24, fell to a new 52-week low of 65 cents, a 78.8 percent drop.
The stock closed at $1.20 March 26.
While the company is "obviously disappointed" that SinuNase did not reach the required
level of statistical significance to meet the clinical study goals, O'Donnell classifies the
dramatic movement in the stock price as an overreaction.
amueller@bizjournals.com
Frank O'Donnell's medical gamble falters
Accentia stock tanks following clinical trials
St. Louis Business Journal - by Angela Mueller
Local ophthalmologist-turned-entrepreneur Dr. Frank O'Donnell has another hurdle in his
sights.
Accentia Biopharmaceuticals Inc., a Tampa-based company where O'Donnell serves
as chairman and chief executive, received disappointing clinical trial results for one of its
key products -- a treatment touted to relieve sinus congestion. The SinuNase treatment
didn't meet goals in the late-stage trials, causing Accentia's share price to plummet and
raising concerns about the company's future.
Accentia reported March 25 that SinuNase was not significantly more effective than a
placebo in treating the symptoms of chronic sinusitis. Upon the news, the company's stock,
which closed at $3.06 March 24, fell to a new 52-week low of 65 cents, a 78.8 percent drop.
The stock closed at $1.20 March 26.
While the company is "obviously disappointed" that SinuNase did not reach the required
level of statistical significance to meet the clinical study goals, O'Donnell classifies the
dramatic movement in the stock price as an overreaction.
amueller@bizjournals.com
Antwort auf Beitrag Nr.: 33.855.965 von KillingJoke am 10.04.08 12:34:14Hi KJ,
Worst Case = Penny Stock
Best Case = 4-5$
Mal schauen was passiert.
Worst Case = Penny Stock
Best Case = 4-5$
Mal schauen was passiert.
Antwort auf Beitrag Nr.: 33.882.400 von SunnyOst am 14.04.08 19:06:18"Accentia Biopharmaceuticals
to Announce
Top-Line BiovaxID
Phase 3 Clinical Trial Results
Later Today"
Ich bin schon alleine gespannt ob es wieder so eine tolle Vorankündigung geben wird
... wenn es denn so weit ist. Die zweite Aprilwoche ist ja bekanntlich vorbei und endete mit einer ganz anderen Meldung zu Revimmune (Revimmune Therapy for Bone Marrow Transplant).
Die Meldung verweist auf ein altes Zeitungsinterview vom 30.03.08 der Baltimore Sun. Ob die Verzögerung Absicht war, damit man noch was hat, wenn Ende der zweiten Aprilwoche noch keine BiovaxID kommen.
Ein Schelm wer Böses dabei denkt.
to Announce
Top-Line BiovaxID
Phase 3 Clinical Trial Results
Later Today"
Ich bin schon alleine gespannt ob es wieder so eine tolle Vorankündigung geben wird
... wenn es denn so weit ist. Die zweite Aprilwoche ist ja bekanntlich vorbei und endete mit einer ganz anderen Meldung zu Revimmune (Revimmune Therapy for Bone Marrow Transplant).
Die Meldung verweist auf ein altes Zeitungsinterview vom 30.03.08 der Baltimore Sun. Ob die Verzögerung Absicht war, damit man noch was hat, wenn Ende der zweiten Aprilwoche noch keine BiovaxID kommen.
Ein Schelm wer Böses dabei denkt.
Antwort auf Beitrag Nr.: 33.887.806 von KillingJoke am 15.04.08 13:36:34Wenn es zu dieser Meldung kommen sollte, hoffe ich dass ich weder etwas am Trinken noch oder Essen bin wenn ich diese News erfahren sollte. Ansonsten doht starke Verschluckungsgefahr...
Obwohl die Übertragungsqualität des Calls miserabel war, wurde eindeutig die "second week" genannt. Naja, vielleicht gibt es diese Woche dann noch etwas.
Grüße
Obwohl die Übertragungsqualität des Calls miserabel war, wurde eindeutig die "second week" genannt. Naja, vielleicht gibt es diese Woche dann noch etwas.
Grüße
Antwort auf Beitrag Nr.: 33.887.806 von KillingJoke am 15.04.08 13:36:34Hi KJ,
sind jetzt etwas vorsichtiger
geworden, um nicht noch mal so ein
traumatisches Erlebnis wie bei
den Sinunasedaten zu erleben.
Gruss Sunny
sind jetzt etwas vorsichtiger
geworden, um nicht noch mal so ein
traumatisches Erlebnis wie bei
den Sinunasedaten zu erleben.
Gruss Sunny
Quelle Yahoo Board
Changing Dynamics in the European Non-Hodgkin’s Lymphoma Market
NHL Overview
There are about 1.8 million people worldwide living with non-Hodgkin’s lymphoma (NHL). It is the sixth most common form of cancer in Europe. The disease is complicated in nature with about 25-30 sub types. Its incidence in Europe varies from 4 to 14 for every 100,000 people. In the European Union alone approximately 50,000 new cases are diagnosed each year. The risk of developing the disease increases with age, especially among the 55-85 year group. The incidence rate peaks between the ages of 75 and 85 years. With rising life expectancy levels across Europe, the demand for NHL drugs is set to grow.
Monopoly Market
The European non-Hodgkin’s lymphoma therapeutics market has been monopolised by MabThera, also known as Rituxan in the US. MabThera is a monoclonal antibody, co-marketed by Genentech and Biogen Idec in the US. In Europe and rest of the world it is marketed by Roche and Chugai in Japan.
Over the years, MabThera has been recognised as a ‘wonder drug’ for NHL treatment. Consequently, it has become the biggest cash cow for Roche/Genentech/Biogen Idec with global sales of about $5 billion in 2007. In fact, the penetration of MabThera for the treatment of first line aggressive cases in the key five European countries of U.K, France, Germany, Spain and Italy is about a staggering 84%.
CHOP chemotherapy is the major therapy indicated for most forms of NHL. The drugs used in this regimen are: Cyclophosphamide, Adriamycin,Vincristine, Prednisone. However, it is highly genericised with limited prospects for revenue growth. Currently MabThera with CHOP chemotherapy is the standard treatment for NHL. However, market dynamics are poised to change in the near future due to the anticipated launch of many promising pipeline drugs.
European NHL Market
The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2 billion in 2013 from the current size of $2.2 billion. The relapsing nature of NHL is impelling the need for new therapeutic options. Though MabThera is very popular and gained widespread acceptance among oncologists, there still exists a high unmet need among NHL patients. This could be a major driver of growth for this market.
Non-Hodgkin's Lymphoma Therapeutics Market: Market Share Analysis by Revenues (Europe), 2006
Source: Frost & Sullivan
Changing Dynamics in the European Non-Hodgkin’s Lymphoma Market
NHL Overview
There are about 1.8 million people worldwide living with non-Hodgkin’s lymphoma (NHL). It is the sixth most common form of cancer in Europe. The disease is complicated in nature with about 25-30 sub types. Its incidence in Europe varies from 4 to 14 for every 100,000 people. In the European Union alone approximately 50,000 new cases are diagnosed each year. The risk of developing the disease increases with age, especially among the 55-85 year group. The incidence rate peaks between the ages of 75 and 85 years. With rising life expectancy levels across Europe, the demand for NHL drugs is set to grow.
Monopoly Market
The European non-Hodgkin’s lymphoma therapeutics market has been monopolised by MabThera, also known as Rituxan in the US. MabThera is a monoclonal antibody, co-marketed by Genentech and Biogen Idec in the US. In Europe and rest of the world it is marketed by Roche and Chugai in Japan.
Over the years, MabThera has been recognised as a ‘wonder drug’ for NHL treatment. Consequently, it has become the biggest cash cow for Roche/Genentech/Biogen Idec with global sales of about $5 billion in 2007. In fact, the penetration of MabThera for the treatment of first line aggressive cases in the key five European countries of U.K, France, Germany, Spain and Italy is about a staggering 84%.
CHOP chemotherapy is the major therapy indicated for most forms of NHL. The drugs used in this regimen are: Cyclophosphamide, Adriamycin,Vincristine, Prednisone. However, it is highly genericised with limited prospects for revenue growth. Currently MabThera with CHOP chemotherapy is the standard treatment for NHL. However, market dynamics are poised to change in the near future due to the anticipated launch of many promising pipeline drugs.
European NHL Market
The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2 billion in 2013 from the current size of $2.2 billion. The relapsing nature of NHL is impelling the need for new therapeutic options. Though MabThera is very popular and gained widespread acceptance among oncologists, there still exists a high unmet need among NHL patients. This could be a major driver of growth for this market.
Non-Hodgkin's Lymphoma Therapeutics Market: Market Share Analysis by Revenues (Europe), 2006
Source: Frost & Sullivan
Antwort auf Beitrag Nr.: 33.889.274 von SunnyOst am 15.04.08 16:05:31Hallo Sunny,
ich glaube nicht, dass Dich jetzt noch irgendetwas aufhalten wird, Deine Longposition glattzustellen.
Börsenpsychologie besagt so Sachen wie: "Die Hoffnung stirbt zuletzt".
Bei bereits gefallenen Kursen sagen Aktionäre "Jetzt ist es auch schon egal" und empfinden ein weiteres Risiko als nicht mehr so riskant.
Verluste glattzustellen ist für Aktionäre schmerzhaft, weil Sie sich der Chance beraubt sehen, das mögliche Potential doch noch auszunutzen. Und wir wissen wie hoch das "Potential" gerade bei den Biotechs ist.
Wenn tatsächlich wieder eine Vorankündigung kommt, wirst Du sicher abwarten. Vorankündigung heißt ja nicht automatisch "Ihr habt jetzt noch die Chance, alles rauszuhauen, bevor wir die negativen Meldungen veröffentlichen."
Ackergaul hatte übrigens vollkommen recht, dass man sich nicht auf den vorgegeben Zeitplan richten kann. Vielleicht kommt ja doch noch die SinuNase Datenauswertung vor den BiovaxID Ergebnissen.
ich glaube nicht, dass Dich jetzt noch irgendetwas aufhalten wird, Deine Longposition glattzustellen.
Börsenpsychologie besagt so Sachen wie: "Die Hoffnung stirbt zuletzt".
Bei bereits gefallenen Kursen sagen Aktionäre "Jetzt ist es auch schon egal" und empfinden ein weiteres Risiko als nicht mehr so riskant.
Verluste glattzustellen ist für Aktionäre schmerzhaft, weil Sie sich der Chance beraubt sehen, das mögliche Potential doch noch auszunutzen. Und wir wissen wie hoch das "Potential" gerade bei den Biotechs ist.
Wenn tatsächlich wieder eine Vorankündigung kommt, wirst Du sicher abwarten. Vorankündigung heißt ja nicht automatisch "Ihr habt jetzt noch die Chance, alles rauszuhauen, bevor wir die negativen Meldungen veröffentlichen."
Ackergaul hatte übrigens vollkommen recht, dass man sich nicht auf den vorgegeben Zeitplan richten kann. Vielleicht kommt ja doch noch die SinuNase Datenauswertung vor den BiovaxID Ergebnissen.
Antwort auf Beitrag Nr.: 33.890.062 von KillingJoke am 15.04.08 17:12:33Für Börsenspekulationen ist der Februar einer der gefährlichsten Monate. Die anderen sind Juli, Januar, September, April, November, Mai, März, Juni, Dezember, August und Oktober.
Antwort auf Beitrag Nr.: 33.890.062 von KillingJoke am 15.04.08 17:12:33Hi KJ,
meinst du es ist ein guter Zeitpunkt um noch
mal etwas nachzulegen?
meinst du es ist ein guter Zeitpunkt um noch
mal etwas nachzulegen?
Antwort auf Beitrag Nr.: 33.895.921 von SunnyOst am 16.04.08 10:54:15Nein.
Antwort auf Beitrag Nr.: 33.897.393 von KillingJoke am 16.04.08 13:04:21Sind ja heute eine Menge Leser im Forum.
Schade ist, das keiner seine Meinung kundtut.
Schade ist, das keiner seine Meinung kundtut.
Antwort auf Beitrag Nr.: 33.889.865 von SunnyOst am 15.04.08 16:55:16Malzeit,
bin in der Mittagspause nochmal über den Brief an die Aktionäre von Biovest CEO Steven Arikian gestolpert. Der Brief ist aus Januar 2008, eine "flammende" Rede für das Potential von BiovaxID.
Ich habe diesen Brief auf den Teil reduziert, der sich auf BiovaxID bezieht.
Ich dachte, jetzt wäre nochmal ein schöner Zeitpunkt zum durchlesen, bevor die Hosen runtergelassen werden.
Biovest's CEO Anticipates Significant Milestone Achievements Throughout 2008
Wednesday January 30, 10:30 am ET
TAMPA, Fla.--(BUSINESS WIRE)--The following letter is from Dr. Steven Arikian, Chairman and Chief Executive Officer of Biovest International, Inc.
To Our Shareholders,
This is, without question, the most exciting time that I have experienced in steering the business and scientific initiatives of Biovest.
As a result of our expertise, focus, perseverance, and ultimately the excellence of our science and technologies, I believe that 2008 should be the year in which we begin to realize our most ambitious goals, including:
- Reporting interim unblinded results of our pivotal Phase 3 clinical trial for BiovaxID™ - a major milestone that is magnified by the fact that BiovaxID commenced its Phase 3 clinical trial more than seven years ago, yielding long-term clinical trial data and representing significant development cost;
- Assuming positive results, we will meet with the FDA to prepare filings to seek conditional regulatory approval for BiovaxID, as we continue to advance our regulatory strategy to market BiovaxID as the first personalized anti-cancer vaccine to ever be granted approval for the treatment of non-Hodgkin’s lymphoma;
(…)
With the potential to report unprecedented clinical data, pursue U.S. and European regulatory approvals, strengthen our product portfolio, and increase revenues, I believe that our current market valuation is just a fraction of what it should be. I expect that such successes will help us attract the key partnering and licensing opportunities that will exponentially grow our business.
BiovaxID™: Originally developed by researchers at the National Cancer Institute and Stanford University, BiovaxID holds the potential to be the very first anti-cancer vaccine to achieve FDA approval. Of the 130,000 new cases of non-Hodgkin’s lymphoma (NHL) diagnosed every year in the U.S. and Europe, approximately 30% fall into the category of indolent, follicular B-cell NHL, which is the segment that BiovaxID is initially targeting. Although chemotherapy, radiation and certain immunotherapies are routinely used to treat indolent, follicular B-cell NHL, such treatments are by no means considered a cure and often very difficult to tolerate, with relapse likely if not inevitable. There is an urgent need to improve existing regimens in order to indefinitely sustain remission rates, thus representing an excellent opportunity for BiovaxID.
I have been frequently asked if there is a difference between BiovaxID and other anti-cancer vaccines that are in development targeting NHL, some of which have made recent headlines for failing to meet their primary endpoint in clinical trials, and the answer is a resounding – Yes!
BiovaxID is a hybridoma vaccine, which means it is manufactured using the entire biomarker, or idiotype, that is expressed on the cancerous B-cells. The biomarker expressed on the diseased B-cells is completely different than those on the healthy cells, and we obtain the biomarker from each individual patient when tumor samples are extracted by biopsy, meaning each vaccine is truly patient-specific. Other anti-cancer vaccines are recombinant, meaning that they are produced by only using a segment of the biomarker, or idiotype. This is an extremely important distinction, as we believe that using the entire structure of the biomarker is vitally important in stimulating the immune system in a potent enough manner to destroy the cancer with long-lasting results. However, vaccines that only use a segment of the biomarker may just not be able to completely activate the immune system to effectively recognize cancerous lymphoma cells. It is important to note that based on our solid family of patent protections, I believe we are the only Company that can produce a hybridoma anti-cancer vaccine that contains a high-fidelity copy of the complete biomarker – a huge competitive advantage.
When BiovaxID is administered, the patient’s immune system is “trained” to specifically target and attack the diseased B-cells in a robust manner, thereby resulting in a more complete immune response and much lower relapse rate. It even appears that BiovaxID gives rise to “memory” T-cells that enable the immune system to respond to the presence of cancerous cells long after therapy has been stopped. In our previously reported Phase 2 clinical trial, the long-term BiovaxID results were nothing less than remarkable. After follow-up at nine years post BiovaxID vaccination, 19 of 20 patients remained alive, and 9 of 20 patients remained in complete continuous remission. And now we are on the verge of reporting the results from our pivotal Phase 3 clinical trial.
In order to confirm the safety and efficacy of BiovaxID, and pave the way for U.S. and international regulatory approvals, we will need positive results from our Phase 3 study, demonstrating that a statistically significant percentage of BiovaxID patients remained in long-term remission without any signs of the disease (disease-free survival). While there are no assurances, I am convinced that the Phase 3 study will provide strong evidence supporting BiovaxID for accelerated approval in the U.S. and conditional approval in the EU. This pivotal data is expected to be publicly reported by the end of April, and based on conditional approval, we would expect to commercially launch the product in 2009.
Appreciating Our Shareholders: The business of biotechnology is perhaps the most rigorous and regulated in the world, with only a small fraction of drug products in development ever proving successful. Over the years, we too have endured and navigated many of the challenges which are typical in our industry, but I am convinced that we are now strongly positioned to deliver the critical and key achievements that I believe will significantly drive growth for our business, as we evolve into an industry leader.
The Management of Biovest expresses our sincere thanks to our shareholders for your patience and perseverance, as I believe our work to date will ultimately result in major achievements throughout 2008 and beyond, as we build the kind of respected, successful Company that our shareholders can be proud of.
Sincerely,
Steven Arikian, M.D.
Chairman and Chief Executive Officer
bin in der Mittagspause nochmal über den Brief an die Aktionäre von Biovest CEO Steven Arikian gestolpert. Der Brief ist aus Januar 2008, eine "flammende" Rede für das Potential von BiovaxID.
Ich habe diesen Brief auf den Teil reduziert, der sich auf BiovaxID bezieht.
Ich dachte, jetzt wäre nochmal ein schöner Zeitpunkt zum durchlesen, bevor die Hosen runtergelassen werden.
Biovest's CEO Anticipates Significant Milestone Achievements Throughout 2008
Wednesday January 30, 10:30 am ET
TAMPA, Fla.--(BUSINESS WIRE)--The following letter is from Dr. Steven Arikian, Chairman and Chief Executive Officer of Biovest International, Inc.
To Our Shareholders,
This is, without question, the most exciting time that I have experienced in steering the business and scientific initiatives of Biovest.
As a result of our expertise, focus, perseverance, and ultimately the excellence of our science and technologies, I believe that 2008 should be the year in which we begin to realize our most ambitious goals, including:
- Reporting interim unblinded results of our pivotal Phase 3 clinical trial for BiovaxID™ - a major milestone that is magnified by the fact that BiovaxID commenced its Phase 3 clinical trial more than seven years ago, yielding long-term clinical trial data and representing significant development cost;
- Assuming positive results, we will meet with the FDA to prepare filings to seek conditional regulatory approval for BiovaxID, as we continue to advance our regulatory strategy to market BiovaxID as the first personalized anti-cancer vaccine to ever be granted approval for the treatment of non-Hodgkin’s lymphoma;
(…)
With the potential to report unprecedented clinical data, pursue U.S. and European regulatory approvals, strengthen our product portfolio, and increase revenues, I believe that our current market valuation is just a fraction of what it should be. I expect that such successes will help us attract the key partnering and licensing opportunities that will exponentially grow our business.
BiovaxID™: Originally developed by researchers at the National Cancer Institute and Stanford University, BiovaxID holds the potential to be the very first anti-cancer vaccine to achieve FDA approval. Of the 130,000 new cases of non-Hodgkin’s lymphoma (NHL) diagnosed every year in the U.S. and Europe, approximately 30% fall into the category of indolent, follicular B-cell NHL, which is the segment that BiovaxID is initially targeting. Although chemotherapy, radiation and certain immunotherapies are routinely used to treat indolent, follicular B-cell NHL, such treatments are by no means considered a cure and often very difficult to tolerate, with relapse likely if not inevitable. There is an urgent need to improve existing regimens in order to indefinitely sustain remission rates, thus representing an excellent opportunity for BiovaxID.
I have been frequently asked if there is a difference between BiovaxID and other anti-cancer vaccines that are in development targeting NHL, some of which have made recent headlines for failing to meet their primary endpoint in clinical trials, and the answer is a resounding – Yes!
BiovaxID is a hybridoma vaccine, which means it is manufactured using the entire biomarker, or idiotype, that is expressed on the cancerous B-cells. The biomarker expressed on the diseased B-cells is completely different than those on the healthy cells, and we obtain the biomarker from each individual patient when tumor samples are extracted by biopsy, meaning each vaccine is truly patient-specific. Other anti-cancer vaccines are recombinant, meaning that they are produced by only using a segment of the biomarker, or idiotype. This is an extremely important distinction, as we believe that using the entire structure of the biomarker is vitally important in stimulating the immune system in a potent enough manner to destroy the cancer with long-lasting results. However, vaccines that only use a segment of the biomarker may just not be able to completely activate the immune system to effectively recognize cancerous lymphoma cells. It is important to note that based on our solid family of patent protections, I believe we are the only Company that can produce a hybridoma anti-cancer vaccine that contains a high-fidelity copy of the complete biomarker – a huge competitive advantage.
When BiovaxID is administered, the patient’s immune system is “trained” to specifically target and attack the diseased B-cells in a robust manner, thereby resulting in a more complete immune response and much lower relapse rate. It even appears that BiovaxID gives rise to “memory” T-cells that enable the immune system to respond to the presence of cancerous cells long after therapy has been stopped. In our previously reported Phase 2 clinical trial, the long-term BiovaxID results were nothing less than remarkable. After follow-up at nine years post BiovaxID vaccination, 19 of 20 patients remained alive, and 9 of 20 patients remained in complete continuous remission. And now we are on the verge of reporting the results from our pivotal Phase 3 clinical trial.
In order to confirm the safety and efficacy of BiovaxID, and pave the way for U.S. and international regulatory approvals, we will need positive results from our Phase 3 study, demonstrating that a statistically significant percentage of BiovaxID patients remained in long-term remission without any signs of the disease (disease-free survival). While there are no assurances, I am convinced that the Phase 3 study will provide strong evidence supporting BiovaxID for accelerated approval in the U.S. and conditional approval in the EU. This pivotal data is expected to be publicly reported by the end of April, and based on conditional approval, we would expect to commercially launch the product in 2009.
Appreciating Our Shareholders: The business of biotechnology is perhaps the most rigorous and regulated in the world, with only a small fraction of drug products in development ever proving successful. Over the years, we too have endured and navigated many of the challenges which are typical in our industry, but I am convinced that we are now strongly positioned to deliver the critical and key achievements that I believe will significantly drive growth for our business, as we evolve into an industry leader.
The Management of Biovest expresses our sincere thanks to our shareholders for your patience and perseverance, as I believe our work to date will ultimately result in major achievements throughout 2008 and beyond, as we build the kind of respected, successful Company that our shareholders can be proud of.
Sincerely,
Steven Arikian, M.D.
Chairman and Chief Executive Officer
Antwort auf Beitrag Nr.: 33.897.393 von KillingJoke am 16.04.08 13:04:21Danke.
Antwort auf Beitrag Nr.: 33.908.385 von SunnyOst am 17.04.08 14:22:01Ach Du sch... ziehen die hoch...
Die Kernaussage der heutige Meldung, ist die Überschrift:
Biovest Reports that Independent Data Monitoring Committee Recommends Unblinding of Phase 3 Clinical Results for its Anti-Cancer Vaccine, BiovaxID(R)
Die Entblindung wird vom unabhängigen / neutralen DMC empfohlen... Mit meiner 3 $ Tendenz im Erfolgsfall liege ich vielleicht doch noch zu konservativ. Also ohne die eigentlichen Daten, schon eine solche Kursbewegegung...
BIG Pharma ich höre dich lizensieren!
Biovest Reports that Independent Data Monitoring Committee Recommends Unblinding of Phase 3 Clinical Results for its Anti-Cancer Vaccine, BiovaxID(R)
Die Entblindung wird vom unabhängigen / neutralen DMC empfohlen... Mit meiner 3 $ Tendenz im Erfolgsfall liege ich vielleicht doch noch zu konservativ. Also ohne die eigentlichen Daten, schon eine solche Kursbewegegung...
BIG Pharma ich höre dich lizensieren!
Antwort auf Beitrag Nr.: 33.908.614 von KillingJoke am 17.04.08 14:43:09Hi KJ,
heute Morgen waere wohl der richtige Zeitpunkt
gewesen. Schade.
gruss sunny
heute Morgen waere wohl der richtige Zeitpunkt
gewesen. Schade.
gruss sunny
Antwort auf Beitrag Nr.: 33.908.821 von SunnyOst am 17.04.08 15:07:03Alter Schwede,
Ackergaul und Sunny,
Accentia sind vorbörslich hoch bis 3 USD,
da waren die Eröffnungskurse eher ernüchternd.
ABPI Eröffnung 1,50 USD (Vortag 0.807 USD +85%)
BVTI Eröffnung 0,75 USD (Vortag 0,52 USD +44%)
KJ
Ackergaul und Sunny,
Accentia sind vorbörslich hoch bis 3 USD,
da waren die Eröffnungskurse eher ernüchternd.
ABPI Eröffnung 1,50 USD (Vortag 0.807 USD +85%)
BVTI Eröffnung 0,75 USD (Vortag 0,52 USD +44%)
KJ
Antwort auf Beitrag Nr.: 33.908.385 von SunnyOst am 17.04.08 14:22:01Accentia shares jump on positive view of cancer vaccine
Thu Apr 17, 2008 9:27am EDT
April 17 (Reuters) - Accentia Biopharmaceuticals Inc's stock more than doubled after the small biotechnology company said a committee recommended its majority-owned unit's cancer vaccine be further developed.
Accentia said an independent data monitoring committee (DMC) ruled its unit, Biovest International Inc (BVTI.OB: Quote, Profile, Research), could go ahead with the final analysis of late-stage safety and effectiveness data of the vaccine, BiovaxID, in treating non-Hodgkin's lymphoma.
Accentia owns about 76 percent of Biovest, and is eligible for royalties of 19.5 percent on global sales of BiovaxID.
Biovest is in discussions with regulatory agencies for the path ahead for potential accelerated or conditional approvals for BiovaxID, the unit's CEO Steven Arikian said in a news release.
Thu Apr 17, 2008 9:27am EDT
April 17 (Reuters) - Accentia Biopharmaceuticals Inc's stock more than doubled after the small biotechnology company said a committee recommended its majority-owned unit's cancer vaccine be further developed.
Accentia said an independent data monitoring committee (DMC) ruled its unit, Biovest International Inc (BVTI.OB: Quote, Profile, Research), could go ahead with the final analysis of late-stage safety and effectiveness data of the vaccine, BiovaxID, in treating non-Hodgkin's lymphoma.
Accentia owns about 76 percent of Biovest, and is eligible for royalties of 19.5 percent on global sales of BiovaxID.
Biovest is in discussions with regulatory agencies for the path ahead for potential accelerated or conditional approvals for BiovaxID, the unit's CEO Steven Arikian said in a news release.
Antwort auf Beitrag Nr.: 33.908.806 von Ackergaul am 17.04.08 15:05:38Als Shortseller verdient man heute morgen ganz gut...
Kurse bröckeln weiter, bin man gespannt wo es sich einpendelt.
Kurse bröckeln weiter, bin man gespannt wo es sich einpendelt.
Antwort auf Beitrag Nr.: 33.909.415 von KillingJoke am 17.04.08 16:05:29ABPI Schluß 1,38 USD (Vortag 0.807 USD +71%), Tages-Vol 4,31 Mio
BVTI Schluß 0,75 USD (Vortag 0,625 USD +20,2%), Tages-Vol 0,932 Mio
Ich stelle schonmal ein Ungleichgewicht in der Reaktion der beiden Aktien fest. In Beiträgen #132 bis 137 antizipierten die hier postenden Personen eigentlich die höheren Steigerungsraten im Fall von positiven BiovaxID-Spekulationen für BVTI.
BVTI sollte (!) mehr profitieren, gleichzeitig ist BVTI aber, falls BiovaxID floppt, nicht durch alternative Projekte abgesichert.
BVTI Schluß 0,75 USD (Vortag 0,625 USD +20,2%), Tages-Vol 0,932 Mio
Ich stelle schonmal ein Ungleichgewicht in der Reaktion der beiden Aktien fest. In Beiträgen #132 bis 137 antizipierten die hier postenden Personen eigentlich die höheren Steigerungsraten im Fall von positiven BiovaxID-Spekulationen für BVTI.
BVTI sollte (!) mehr profitieren, gleichzeitig ist BVTI aber, falls BiovaxID floppt, nicht durch alternative Projekte abgesichert.
Antwort auf Beitrag Nr.: 33.914.639 von KillingJoke am 18.04.08 08:11:58Ich habe letztendlich auch noch keine passende Antwort gefunden, doch vielleicht erklärt die Situation folgendes:
http://stlouis.bizjournals.com/stlouis/stories/2008/04/14/da…
BiovaxID is being developed by Biovest International Inc. (OTCBB: BVTI), a subsidiary in
which Accentia holds a 76 percent ownership stake. Accentia also maintains a 19.5 percent
royalty interest in global sales of BiovaxID.
19,5 % Royalities von den Weltweiten Verkäufen BiovaxIDs gehen also an ABPI. Nehmen wir mal an Biovest lizensiert (eine eigene Vermarktung steht außer Frage) BiovaxID an Big Pharma und handelt 25 % Royalities heraus - würde dies nicht bedeuten 19,5 % an ABPI und 5,5 % an BVTI? Ich bin bisher davon ausgegegangen, dass ABPI einen Anteil von BVTI von deren Einnahmen bekommt. Also bei BiovaxID Royalities von 25 % würde ABPI dadrauf einen Anteil von 19,5 % bekommen, was demnach "effekiv" dann nur 4,875 % wären...
Denoch bin ich ein bischen verwirrt, dass wir noch keine Daten erhalten haben. Nur das DMC kennt die Auswertung bisher! Wir können immer noch nicht sagen, ob die Daten "in Ordnung"; "Gut" oder "Excellent" (wie bei Phase 2) waren - zumindest schlecht sind diese nicht!
Indolent Follicular NHL Fälle jährlich (weltweit): ca 34.000 (pro Jahr +5 %)
Kosten pro Jahr, denke ich bei 10.000 $ pro Patient. Dies meine ich in iregndeinem 10K gelesen zu haben! Allerdings sollte man hier abwarten - Rituxan kostet etwa 60.000 $ im Vergleich!
Bei "nur" 10.000 $ Kosten hätten wir ein Umsatz Potential von 340 Mil. $!!! Soweit sind wir aber (leider) noch lange nicht...
Grüße
http://stlouis.bizjournals.com/stlouis/stories/2008/04/14/da…
BiovaxID is being developed by Biovest International Inc. (OTCBB: BVTI), a subsidiary in
which Accentia holds a 76 percent ownership stake. Accentia also maintains a 19.5 percent
royalty interest in global sales of BiovaxID.
19,5 % Royalities von den Weltweiten Verkäufen BiovaxIDs gehen also an ABPI. Nehmen wir mal an Biovest lizensiert (eine eigene Vermarktung steht außer Frage) BiovaxID an Big Pharma und handelt 25 % Royalities heraus - würde dies nicht bedeuten 19,5 % an ABPI und 5,5 % an BVTI? Ich bin bisher davon ausgegegangen, dass ABPI einen Anteil von BVTI von deren Einnahmen bekommt. Also bei BiovaxID Royalities von 25 % würde ABPI dadrauf einen Anteil von 19,5 % bekommen, was demnach "effekiv" dann nur 4,875 % wären...
Denoch bin ich ein bischen verwirrt, dass wir noch keine Daten erhalten haben. Nur das DMC kennt die Auswertung bisher! Wir können immer noch nicht sagen, ob die Daten "in Ordnung"; "Gut" oder "Excellent" (wie bei Phase 2) waren - zumindest schlecht sind diese nicht!
Indolent Follicular NHL Fälle jährlich (weltweit): ca 34.000 (pro Jahr +5 %)
Kosten pro Jahr, denke ich bei 10.000 $ pro Patient. Dies meine ich in iregndeinem 10K gelesen zu haben! Allerdings sollte man hier abwarten - Rituxan kostet etwa 60.000 $ im Vergleich!
Bei "nur" 10.000 $ Kosten hätten wir ein Umsatz Potential von 340 Mil. $!!! Soweit sind wir aber (leider) noch lange nicht...
Grüße
Antwort auf Beitrag Nr.: 33.917.383 von Ackergaul am 18.04.08 12:30:53Hallo Ackergaul,
diese Herleitung würde in der Tat das vermeitliche Ungleichgewicht erklären.
Ich hatte nach Erläuterungen nicht in den Royalities gesucht, sondern vermutet, dass z.B. einer der anderen instutitionellen Investoren die Gelegenheit der hohen Umsätze genutzt hat, aus Biovest auszusteigen.
Sowas sieht man in Zeiten von Kreditmarktkrise immer wieder.
BVTI Umsatz Durchschnitt nur 63 T, gestern 1,4 Mio.(!).
Der zweite Tag nach einer positiven Meldung ist meist schon wesentlich umsatzärmer. Das könnte erklären, warum zum Ende der Sitzung in der letzten halbe Stunde bei BVTI nochmals viel rausgehauen wurde. Der Kurs schloss auf Tagestief bei 0,652 obwohl der zuvor fast die ganze Zeit bei 0,70 lag.
Wir kennen den genauen Vertrag natürlich nicht, aber bist Du Dir 100% sicher mit der Royalities-Vermutung?
KJ
diese Herleitung würde in der Tat das vermeitliche Ungleichgewicht erklären.
Ich hatte nach Erläuterungen nicht in den Royalities gesucht, sondern vermutet, dass z.B. einer der anderen instutitionellen Investoren die Gelegenheit der hohen Umsätze genutzt hat, aus Biovest auszusteigen.
Sowas sieht man in Zeiten von Kreditmarktkrise immer wieder.
BVTI Umsatz Durchschnitt nur 63 T, gestern 1,4 Mio.(!).
Der zweite Tag nach einer positiven Meldung ist meist schon wesentlich umsatzärmer. Das könnte erklären, warum zum Ende der Sitzung in der letzten halbe Stunde bei BVTI nochmals viel rausgehauen wurde. Der Kurs schloss auf Tagestief bei 0,652 obwohl der zuvor fast die ganze Zeit bei 0,70 lag.
Wir kennen den genauen Vertrag natürlich nicht, aber bist Du Dir 100% sicher mit der Royalities-Vermutung?
KJ
Antwort auf Beitrag Nr.: 33.918.937 von KillingJoke am 18.04.08 14:40:30Zu den Royalities: Genau Wissen? – bestimmt nicht... ist nur meine Interpretation. Hier steht nichts von den Umsätzen BVTIs, sondern derer Produkte:
Aus dem BVTI 10-K
On October 31, 2006, we entered into a Royalty Agreement with Accentia that terminated and superseded the Biologics Products Commercialization Agreement. The new Royalty Agreement provides that Accentia is no longer our exclusive commercialization partner and replaces the share of net profits with a 19.5% royalty based on net sales and license revenue of biologics products. The products and territory subject to the Royalty Agreement remain identical to those terms previously contained in the Biologics Commercialization Agreement. In consideration for Accentia entering into this Royalty Agreement, we issued to Accentia five million shares of our common stock, representing the independently appraised value to us of the new agreement.
Zu den Kosten BiovaxID: Dies ist denke ich Entscheidend bei der Umsatzbetrachtung. Wie viel kostet eine „Jahresbehandlung“
Aus dem ABPI 10-K
The agreement also gives us the right to sublicense or transfer the licensed biological materials to collaborators in the licensed fields. Under our agreement with Stanford, we paid Stanford an up-front license fee of $15,000 and are obligated to pay a yearly maintenance fee of $10,000 per year thereafter. The agreement also provides that we will pay Stanford $100,000 within one year following FDA approval of BiovaxID or five years following the agreement date (whichever occurs first), and following approval we will pay Stanford a running royalty of the higher of $50.00 per patient or 0.05% of the amount received by us for each BiovaxID patient treated using this cell line. This running royalty will be creditable against the yearly maintenance fee. Our agreement with Stanford obligates us to diligently develop, manufacture, market, and sell BiovaxID and to provide progress reports to Stanford regarding these activities. We can terminate this agreement at any time upon 30 days prior written notice, and Stanford can terminate the agreement upon a breach of the agreement by us that remains uncured for 30 days after written notice of the breach from Stanford.
Hier wird Standford ein Anteil von 50 $ oder 0,05 % der Kosten zugesichert. Aus meiner Sicht gibt dies den Schlüssel zu den Kosten der „Jahresbehandlung“ wieder. Diese Marke würden dann 100.000 $ bedeuten (100.000 $ x 0,05 % = 50 $) - und nicht meine kalkulierten 10.000 $! Letztendlich habe ich aber kein Gefühl daür in welche Richtung wir uns mehr bewegen...
Patienten die für BiovaxID in Frage kommen: Weltweit 34.000; davon 16T in den USA und 11,5T in Europa. Aber mit Sicherheit werden davon nicht 100 % mit BiovaxID behandelt...
Naja, abwarten und Tee trinken. Wie erwähnt sind wir so weit noch lange nicht.
Grüße
PS: Es lohnt sich nicht, jetzt schon einen "dicken Kopf" zu machen. Ohne genauere Daten ist dies eh nur Hellseherei
Aus dem BVTI 10-K
On October 31, 2006, we entered into a Royalty Agreement with Accentia that terminated and superseded the Biologics Products Commercialization Agreement. The new Royalty Agreement provides that Accentia is no longer our exclusive commercialization partner and replaces the share of net profits with a 19.5% royalty based on net sales and license revenue of biologics products. The products and territory subject to the Royalty Agreement remain identical to those terms previously contained in the Biologics Commercialization Agreement. In consideration for Accentia entering into this Royalty Agreement, we issued to Accentia five million shares of our common stock, representing the independently appraised value to us of the new agreement.
Zu den Kosten BiovaxID: Dies ist denke ich Entscheidend bei der Umsatzbetrachtung. Wie viel kostet eine „Jahresbehandlung“
Aus dem ABPI 10-K
The agreement also gives us the right to sublicense or transfer the licensed biological materials to collaborators in the licensed fields. Under our agreement with Stanford, we paid Stanford an up-front license fee of $15,000 and are obligated to pay a yearly maintenance fee of $10,000 per year thereafter. The agreement also provides that we will pay Stanford $100,000 within one year following FDA approval of BiovaxID or five years following the agreement date (whichever occurs first), and following approval we will pay Stanford a running royalty of the higher of $50.00 per patient or 0.05% of the amount received by us for each BiovaxID patient treated using this cell line. This running royalty will be creditable against the yearly maintenance fee. Our agreement with Stanford obligates us to diligently develop, manufacture, market, and sell BiovaxID and to provide progress reports to Stanford regarding these activities. We can terminate this agreement at any time upon 30 days prior written notice, and Stanford can terminate the agreement upon a breach of the agreement by us that remains uncured for 30 days after written notice of the breach from Stanford.
Hier wird Standford ein Anteil von 50 $ oder 0,05 % der Kosten zugesichert. Aus meiner Sicht gibt dies den Schlüssel zu den Kosten der „Jahresbehandlung“ wieder. Diese Marke würden dann 100.000 $ bedeuten (100.000 $ x 0,05 % = 50 $) - und nicht meine kalkulierten 10.000 $! Letztendlich habe ich aber kein Gefühl daür in welche Richtung wir uns mehr bewegen...
Patienten die für BiovaxID in Frage kommen: Weltweit 34.000; davon 16T in den USA und 11,5T in Europa. Aber mit Sicherheit werden davon nicht 100 % mit BiovaxID behandelt...
Naja, abwarten und Tee trinken. Wie erwähnt sind wir so weit noch lange nicht.
Grüße
PS: Es lohnt sich nicht, jetzt schon einen "dicken Kopf" zu machen. Ohne genauere Daten ist dies eh nur Hellseherei
Antwort auf Beitrag Nr.: 33.919.704 von Ackergaul am 18.04.08 15:47:25Behandlungskosten
Biovest veröffentlichte schonmal was zu den Größenordungen:
http://sec.gov/Archives/edgar/data/704384/000119312506152662…
Durchschnittspreise von Konkurrenzprodukten:
Average Price per year or treatment course($US)
Avastin® / Metastatic Colorectal: $52,250
Erbitux® / Metastatic Colorectal: $121,000
Herceptin® / Breast Cancer: $64,000
Rituxan® / Follicular NHL: $59,080
Zevalin® / NHL: $60,000
Source:Redbook,IMShealth,ING–April2005;Companies’websites–Nov. 2005
BiovaxID
Angabe alternativer Behandlungskosten in einer Tabelle.
Es wurden drei Werte angegeben:
Implied Annual Market Size For Various Treatment Costs
(For illustrative purposes only)
$70,000 / $100,000 / $120,000
Biovest veröffentlichte schonmal was zu den Größenordungen:
http://sec.gov/Archives/edgar/data/704384/000119312506152662…
Durchschnittspreise von Konkurrenzprodukten:
Average Price per year or treatment course($US)
Avastin® / Metastatic Colorectal: $52,250
Erbitux® / Metastatic Colorectal: $121,000
Herceptin® / Breast Cancer: $64,000
Rituxan® / Follicular NHL: $59,080
Zevalin® / NHL: $60,000
Source:Redbook,IMShealth,ING–April2005;Companies’websites–Nov. 2005
BiovaxID
Angabe alternativer Behandlungskosten in einer Tabelle.
Es wurden drei Werte angegeben:
Implied Annual Market Size For Various Treatment Costs
(For illustrative purposes only)
$70,000 / $100,000 / $120,000
Antwort auf Beitrag Nr.: 33.919.704 von Ackergaul am 18.04.08 15:47:25Der Sachverhalt mit dem Royalty Agreement wird im letzten Jahresbericht von Biovest wie folgt beschrieben:
http://studio-5.financialcontent.com/edgar?accesscode=119312…
In August 2004, we entered into a Biologics Products Commercialization Agreement with Accentia whereby Accentia was to be our exclusive commercialization partner for the vaccine we are currently developing and any other similar products developed or acquired by us. Under that agreement, Accentia was entitled to 49% of our net profits from the sale of biologic products. On October 31, 2006, we entered into a Royalty Agreement with Accentia that terminated and superseded the Biologics Products Commercialization Agreement. The new Royalty Agreement provides that Accentia is no longer our exclusive commercialization partner and replaces the share of net profits with a 19.5% royalty based on net sales and license revenue of biologics products. The products and territory subject to the Royalty Agreement remain identical to those terms previously contained in the Biologics Commercialization Agreement. In consideration for Accentia entering into this Royalty Agreement, we issued to Accentia five million shares of our common stock, representing the independently appraised value to us of the new agreement.
http://studio-5.financialcontent.com/edgar?accesscode=119312…
In August 2004, we entered into a Biologics Products Commercialization Agreement with Accentia whereby Accentia was to be our exclusive commercialization partner for the vaccine we are currently developing and any other similar products developed or acquired by us. Under that agreement, Accentia was entitled to 49% of our net profits from the sale of biologic products. On October 31, 2006, we entered into a Royalty Agreement with Accentia that terminated and superseded the Biologics Products Commercialization Agreement. The new Royalty Agreement provides that Accentia is no longer our exclusive commercialization partner and replaces the share of net profits with a 19.5% royalty based on net sales and license revenue of biologics products. The products and territory subject to the Royalty Agreement remain identical to those terms previously contained in the Biologics Commercialization Agreement. In consideration for Accentia entering into this Royalty Agreement, we issued to Accentia five million shares of our common stock, representing the independently appraised value to us of the new agreement.
Dieser Artikel ist wohl in Verbindung mit BiovaxID zu setzen (vaccine; follicular lymphoma; Stanford; idiotype antibodies):
http://www.time.com/time/magazine/article/0,9171,1608965,00.…
The Disease is the Remedy
By LISA ABEND/Pamplona
Dr. Maurizio Bendandi pokes fun at advertising slogans. "Pharmaceutical companies love to say,
'Treating cancer, one patient at a time,'" the 43-year-old observes. "But those companies are
mass-producing drugs. We're the ones really doing it."
The "we" to whom Bendandi refers are the nine scientists on his team at work on customized
cancer vaccines. A treatment that uses a patient's own tumor cells to provoke an immunological
response, vaccines are one of the most promising developments in the fight against cancer, and a
goal hotly pursued by researchers around the world. Bendandi and his colleagues at Spain's
Center for Applied Medical Research and the University of Navarre Hospital have gone farther
than most. In a five-year-long study — its results were described as "remarkable" by the Journal o
the National Cancer Institute which published the report last September — the Pamplona-based
group demonstrated that a customized vaccine could extend, perhaps indefinitely, the cancer-free
period for patients with follicular lymphoma. In the wake of that success, Bendandi is preparing
another study, one with an even more ambitious goal.
A cancer vaccine is not like the measles shot you get as a kid. Instead of inoculating a healthy
person against a foreign body like a virus, cancer vaccines use parts of tumors to help the patients
immune systems recognize diseased cells. Follicular lymphoma, a generally slow-moving cancer
of the immune system that affects roughly 5,000 Spaniards each year, presents an especially
enticing target for vaccine researchers because its cells all carry a protein, called an idiotype, that
distinguishes them from their healthy counterparts. Mixing the idiotype with other substances
that trigger immunological responses, "the vaccine presents a tumor protein to the patients in
such a way that their immune systems recognize it and destroy any cells bearing that protein,"
explains Larry Kwak, associate director of Cancer Immunology Research at Houston's MD
Anderson Cancer Center and a leading vaccine researcher.
A vaccine for follicular lymphoma is not new. Stanford University's Ron Levy pioneered the effort
more than 25 years ago, demonstrating that anti-idiotype antibodies could be produced in a
laboratory and used to create a vaccine for humans that would trigger an immune response. In
1999 Kwak, then working at the National Institutes of Health (nih), modified the vaccine in a way
that makes it easier for the immune system to recognize. His results were striking: the vaccine
eliminated the residual tumor cells left after chemotherapy in 15 of his 20 patients. Now
Bendandi, who worked with Kwak at the nih, has erected what he calls "the third pillar" of
customized therapy by demonstrating that the vaccine produces not just molecular benefits, but
clinical ones as well. In other words, the patients in his study lived cancer free for longer than
expected.
Follicular lymphoma cannot currently be cured, but with chemotherapy and other treatments, a
patient can usually achieve remission. The cancer almost always returns, however, and each
subsequent remission tends to be shorter than the previous one. In 2001, Bendandi began vaccin
therapy on 25 patients who had achieved a second remission with chemotherapy. The vaccine did
not have any effect on five of the subjects, but the other 20 who did respond received a total of 10
vaccinations over 26 months. "Partway through the study, one of my patients — a hairdresser —
came to me and said, 'I know the treatment is working,'" Bendandi recounts. "I asked her how she
knew, because I had nothing conclusive yet. She said she knew because her first remission lasted
18 months, and her second remission had just reached 19 months." In fact, none of the 20
subjects relapsed while receiving the vaccine, and all had remissions that lasted significantly
longer than their previous ones. Indeed, although the average second remission in follicular
lymphoma lasts 13 months (in comparison with an average first remission of about two years),
only a few of Bendandi's patients have relapsed since the vaccines stopped. All the rest are still in
remission — including three who have been cancer free over five years.
In addition to showing that the vaccine can prolong remission, Bendandi's trial attempted to solv
the long-standing problem of quantifying the results of custom-made treatments. Advanced drug
trials require a control group, one whose members share key characteristics with those in the
experimental arm, but who receive a placebo or another treatment rather than the one under
study. According to Bendandi, randomized testing of custom-made vaccines would be
meaningless because each patient in the experimental arm receives a different treatment. So he
set about proving efficacy in another way. "The course of the study design was the first
innovation," writes Dr. Dan Longo in an editorial appearing in the same journal that published
Bendandi's study. "Each patient would be his or her own control. Second remissions longer than
first would be an indication of therapeutic effect."
Not everyone is convinced by that logic. Dr. Robert Schwartz, an editor at the New England
Journal of Medicine, says, "Using patients as their own control is a bit shaky, especially for
follicular lymphoma." A Phase III randomized trial, more difficult but still possible to conduct
even with customized vaccines remains, he says, "the gold standard for proof of efficacy." Dr.
Kwak, who is conducting his own Phase III trial of a vaccine for the American pharmaceutical
company Biovest, believes his former trainee's results support the case for a therapeutic
lymphoma vaccine, but is skeptical about his methods. "Dr. Bendandi's study is important
because it confirms previously reported results. But taken in isolation, it's a small study with no
control group. It's not definitive."
Bendandi's vaccine also faces challenges common to other customized treatments: it's expensive
(an estimated $34,000 per patient), it's difficult to make, and not all pharmaceutical companies
(which make profits by mass-producing drugs) are able — or willing — to take on the work of
producing a different vaccine for every patient. But with three Phase III clinical trials for idiotype
vaccines under way in the U.S., and several other types of custom treatments in development (on
March 29, an fda advisory committee found "substantial evidence" that a prostate cancer vaccine
is effective, increasing the likelihood of its approval), hopes for cancer vaccines are running high.
Especially among the researchers developing them. "My trial was designed to have every chance
to fail," says Bendandi. "If just one patient relapsed while receiving the vaccine, it would have
been over. I would have needed a new job," he jokes. But the Italian-born physician is still
working. In a few weeks he starts his new study, which is designed to test the vaccine's
effectiveness in follicular lymphoma patients with an especially poor prognosis. Bendandi plans t
administer the vaccine to participants until they relapse or die from a cause other than
lymphoma. "This time," he says, "I'm going after a cure."
Gestrige Meldung noch (Auf die Delisting News gehe ich mal nicht ein = Non-event)…
Biovest's CEO to Discuss Pending Milestones for its Anti-Cancer Vaccine, BiovaxID(R), on Wall Street TV and at Las Vegas Small Cap Investment Conference
Thursday April 24, 3:30 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB:BVTI - News), a majority-owned subsidiary
of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), today announced that its Chairman and CEO, Dr.
Steven Arikian, is scheduled to be interviewed on the “3 Minute Press Show,” an internet financial news program
hosted by Tracee Tolentino and featured on Wall Street TV. The broadcast will air on Friday, April 25, 2008 and
can be accessed at: http://tv.wallst.net
Additionally, Biovest announced that Dr. Arikian is scheduled to present at the Big Dog IV Small Cap Conference
to be hosted at the Wynn Hotel in Las Vegas on Thursday, May 1, 2008 at 9:00 a.m.
Dr. Arikian commented, “Based on our recent news, it is not surprising that we are being asked to participate in
media interviews and present at key investor events. I believe it is fair to say that BiovaxID is on track to
potentially become the first ever cancer vaccine approved in the U.S. and/or Europe, initially targeting the
treatment of non-Hodgkin's lymphoma (NHL), an insidious and often fatal cancer. The independent Data
Monitoring Committee (DMC) just last week recommended stopping our Phase 3 clinical trial early and
unblinding the results. The DMC has offered to meet with the FDA to assist in presenting the data and discussing
accelerated and/or conditional approval. We are in the process of unblinding the results at this time. In addition to
NHL, we believe the vaccine is capable of treating other forms of B-cell malignancy, covering many kinds of
cancers.”
If qualified investors are interested in meeting with Dr. Arikian at the Big Dog IV Small Cap Conference in Las
Vegas, please contact Douglas Calder at 813-864-2558 or dwcalder@biovest.com.
Ziehen wir mal wieder Zwischenfazit:
Die Daten werden erst im August präsentiert = SCHLECHT! Aus zwei Gründen: Zum einen, dass gute alte Cash Problem und Favrille (Konkurrenz) wird wohl bis dato auch noch ihre Daten preisgeben.
ABER: Die Daten von ABPI / BVTI werden vermutlich gut ausfallen. Soll heißen im Besten Fall gibt es im August ein acclerated approval und damit möglicherweise ein Verkaufsstart (ab 4Q 2008) von BiovaxID und auch vermehrter Verkauf von AutovaxID. Zulassung wird es erstmal nur für Indolent Follicular NHL geben - relativ kleine Patientenzahlen: US 16.000 / EU 11.500 / RoW 6.800 = WW 34.300
Des Weiteren würden nach einer Zulassung noch folgende Gruppen für eine BiovaxID Behandlung in Frage kommen:
Indolent Follicular NHL - Other subtypes: US 6.150 / EU 4.800 / RoW 2.800 = WW 13.750
Aggressive NHLs US 29.000 / EU 22.000 / RoW 12.600 = WW 63.600
Multiple Myeloma US 17.500 / EU 19.000 / RoW 15.500 = WW 52.000
Bedeutet insg. Ein “Potential” von etwa 163.650 Patienten. Die lassen wir aber erst einmal alle außer Acht. Wir betrachten nur Indolent Follicular NHL US und EU, was etwa 27.500 Patienten entspräche. Bei einer 10 %igen Anteil mit BiovaxID wären dies 2.750 Patienten. Mit den oben angenommenen 34.000 $ Behandlungskosten, könnte somit alleine schon 94 Mil $ umgesetzt werden (= 18 Mil an ABPI). Ich denke nach 2 bis 3 Jahren wären diese Zahlen wohl mind. denkbar…
Grüße
http://www.time.com/time/magazine/article/0,9171,1608965,00.…
The Disease is the Remedy
By LISA ABEND/Pamplona
Dr. Maurizio Bendandi pokes fun at advertising slogans. "Pharmaceutical companies love to say,
'Treating cancer, one patient at a time,'" the 43-year-old observes. "But those companies are
mass-producing drugs. We're the ones really doing it."
The "we" to whom Bendandi refers are the nine scientists on his team at work on customized
cancer vaccines. A treatment that uses a patient's own tumor cells to provoke an immunological
response, vaccines are one of the most promising developments in the fight against cancer, and a
goal hotly pursued by researchers around the world. Bendandi and his colleagues at Spain's
Center for Applied Medical Research and the University of Navarre Hospital have gone farther
than most. In a five-year-long study — its results were described as "remarkable" by the Journal o
the National Cancer Institute which published the report last September — the Pamplona-based
group demonstrated that a customized vaccine could extend, perhaps indefinitely, the cancer-free
period for patients with follicular lymphoma. In the wake of that success, Bendandi is preparing
another study, one with an even more ambitious goal.
A cancer vaccine is not like the measles shot you get as a kid. Instead of inoculating a healthy
person against a foreign body like a virus, cancer vaccines use parts of tumors to help the patients
immune systems recognize diseased cells. Follicular lymphoma, a generally slow-moving cancer
of the immune system that affects roughly 5,000 Spaniards each year, presents an especially
enticing target for vaccine researchers because its cells all carry a protein, called an idiotype, that
distinguishes them from their healthy counterparts. Mixing the idiotype with other substances
that trigger immunological responses, "the vaccine presents a tumor protein to the patients in
such a way that their immune systems recognize it and destroy any cells bearing that protein,"
explains Larry Kwak, associate director of Cancer Immunology Research at Houston's MD
Anderson Cancer Center and a leading vaccine researcher.
A vaccine for follicular lymphoma is not new. Stanford University's Ron Levy pioneered the effort
more than 25 years ago, demonstrating that anti-idiotype antibodies could be produced in a
laboratory and used to create a vaccine for humans that would trigger an immune response. In
1999 Kwak, then working at the National Institutes of Health (nih), modified the vaccine in a way
that makes it easier for the immune system to recognize. His results were striking: the vaccine
eliminated the residual tumor cells left after chemotherapy in 15 of his 20 patients. Now
Bendandi, who worked with Kwak at the nih, has erected what he calls "the third pillar" of
customized therapy by demonstrating that the vaccine produces not just molecular benefits, but
clinical ones as well. In other words, the patients in his study lived cancer free for longer than
expected.
Follicular lymphoma cannot currently be cured, but with chemotherapy and other treatments, a
patient can usually achieve remission. The cancer almost always returns, however, and each
subsequent remission tends to be shorter than the previous one. In 2001, Bendandi began vaccin
therapy on 25 patients who had achieved a second remission with chemotherapy. The vaccine did
not have any effect on five of the subjects, but the other 20 who did respond received a total of 10
vaccinations over 26 months. "Partway through the study, one of my patients — a hairdresser —
came to me and said, 'I know the treatment is working,'" Bendandi recounts. "I asked her how she
knew, because I had nothing conclusive yet. She said she knew because her first remission lasted
18 months, and her second remission had just reached 19 months." In fact, none of the 20
subjects relapsed while receiving the vaccine, and all had remissions that lasted significantly
longer than their previous ones. Indeed, although the average second remission in follicular
lymphoma lasts 13 months (in comparison with an average first remission of about two years),
only a few of Bendandi's patients have relapsed since the vaccines stopped. All the rest are still in
remission — including three who have been cancer free over five years.
In addition to showing that the vaccine can prolong remission, Bendandi's trial attempted to solv
the long-standing problem of quantifying the results of custom-made treatments. Advanced drug
trials require a control group, one whose members share key characteristics with those in the
experimental arm, but who receive a placebo or another treatment rather than the one under
study. According to Bendandi, randomized testing of custom-made vaccines would be
meaningless because each patient in the experimental arm receives a different treatment. So he
set about proving efficacy in another way. "The course of the study design was the first
innovation," writes Dr. Dan Longo in an editorial appearing in the same journal that published
Bendandi's study. "Each patient would be his or her own control. Second remissions longer than
first would be an indication of therapeutic effect."
Not everyone is convinced by that logic. Dr. Robert Schwartz, an editor at the New England
Journal of Medicine, says, "Using patients as their own control is a bit shaky, especially for
follicular lymphoma." A Phase III randomized trial, more difficult but still possible to conduct
even with customized vaccines remains, he says, "the gold standard for proof of efficacy." Dr.
Kwak, who is conducting his own Phase III trial of a vaccine for the American pharmaceutical
company Biovest, believes his former trainee's results support the case for a therapeutic
lymphoma vaccine, but is skeptical about his methods. "Dr. Bendandi's study is important
because it confirms previously reported results. But taken in isolation, it's a small study with no
control group. It's not definitive."
Bendandi's vaccine also faces challenges common to other customized treatments: it's expensive
(an estimated $34,000 per patient), it's difficult to make, and not all pharmaceutical companies
(which make profits by mass-producing drugs) are able — or willing — to take on the work of
producing a different vaccine for every patient. But with three Phase III clinical trials for idiotype
vaccines under way in the U.S., and several other types of custom treatments in development (on
March 29, an fda advisory committee found "substantial evidence" that a prostate cancer vaccine
is effective, increasing the likelihood of its approval), hopes for cancer vaccines are running high.
Especially among the researchers developing them. "My trial was designed to have every chance
to fail," says Bendandi. "If just one patient relapsed while receiving the vaccine, it would have
been over. I would have needed a new job," he jokes. But the Italian-born physician is still
working. In a few weeks he starts his new study, which is designed to test the vaccine's
effectiveness in follicular lymphoma patients with an especially poor prognosis. Bendandi plans t
administer the vaccine to participants until they relapse or die from a cause other than
lymphoma. "This time," he says, "I'm going after a cure."
Gestrige Meldung noch (Auf die Delisting News gehe ich mal nicht ein = Non-event)…
Biovest's CEO to Discuss Pending Milestones for its Anti-Cancer Vaccine, BiovaxID(R), on Wall Street TV and at Las Vegas Small Cap Investment Conference
Thursday April 24, 3:30 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB:BVTI - News), a majority-owned subsidiary
of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), today announced that its Chairman and CEO, Dr.
Steven Arikian, is scheduled to be interviewed on the “3 Minute Press Show,” an internet financial news program
hosted by Tracee Tolentino and featured on Wall Street TV. The broadcast will air on Friday, April 25, 2008 and
can be accessed at: http://tv.wallst.net
Additionally, Biovest announced that Dr. Arikian is scheduled to present at the Big Dog IV Small Cap Conference
to be hosted at the Wynn Hotel in Las Vegas on Thursday, May 1, 2008 at 9:00 a.m.
Dr. Arikian commented, “Based on our recent news, it is not surprising that we are being asked to participate in
media interviews and present at key investor events. I believe it is fair to say that BiovaxID is on track to
potentially become the first ever cancer vaccine approved in the U.S. and/or Europe, initially targeting the
treatment of non-Hodgkin's lymphoma (NHL), an insidious and often fatal cancer. The independent Data
Monitoring Committee (DMC) just last week recommended stopping our Phase 3 clinical trial early and
unblinding the results. The DMC has offered to meet with the FDA to assist in presenting the data and discussing
accelerated and/or conditional approval. We are in the process of unblinding the results at this time. In addition to
NHL, we believe the vaccine is capable of treating other forms of B-cell malignancy, covering many kinds of
cancers.”
If qualified investors are interested in meeting with Dr. Arikian at the Big Dog IV Small Cap Conference in Las
Vegas, please contact Douglas Calder at 813-864-2558 or dwcalder@biovest.com.
Ziehen wir mal wieder Zwischenfazit:
Die Daten werden erst im August präsentiert = SCHLECHT! Aus zwei Gründen: Zum einen, dass gute alte Cash Problem und Favrille (Konkurrenz) wird wohl bis dato auch noch ihre Daten preisgeben.
ABER: Die Daten von ABPI / BVTI werden vermutlich gut ausfallen. Soll heißen im Besten Fall gibt es im August ein acclerated approval und damit möglicherweise ein Verkaufsstart (ab 4Q 2008) von BiovaxID und auch vermehrter Verkauf von AutovaxID. Zulassung wird es erstmal nur für Indolent Follicular NHL geben - relativ kleine Patientenzahlen: US 16.000 / EU 11.500 / RoW 6.800 = WW 34.300
Des Weiteren würden nach einer Zulassung noch folgende Gruppen für eine BiovaxID Behandlung in Frage kommen:
Indolent Follicular NHL - Other subtypes: US 6.150 / EU 4.800 / RoW 2.800 = WW 13.750
Aggressive NHLs US 29.000 / EU 22.000 / RoW 12.600 = WW 63.600
Multiple Myeloma US 17.500 / EU 19.000 / RoW 15.500 = WW 52.000
Bedeutet insg. Ein “Potential” von etwa 163.650 Patienten. Die lassen wir aber erst einmal alle außer Acht. Wir betrachten nur Indolent Follicular NHL US und EU, was etwa 27.500 Patienten entspräche. Bei einer 10 %igen Anteil mit BiovaxID wären dies 2.750 Patienten. Mit den oben angenommenen 34.000 $ Behandlungskosten, könnte somit alleine schon 94 Mil $ umgesetzt werden (= 18 Mil an ABPI). Ich denke nach 2 bis 3 Jahren wären diese Zahlen wohl mind. denkbar…
Grüße
SinuNase(TM) Fast-Tracked Pivotal Phase 3 Study in Chronic Sinusitis Shows Statistically Significant Objective Evidence of Superiority of SinuNase Over Control Lavage in Severe CasesWednesday April 30, 8:30 am ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced today that continued analysis of the unblinded full data set on its pivotal Fast-Tracked Phase 3 Trial of SinuNase™ (topical amphotericin B 0.01% suspension) for chronic sinusitis has demonstrated that among patients with objective evidence of more intense inflammation in chronic sinusitis at the time of enrollment, the efficacy of SinuNase compared to control lavage in reducing inflammation is statistically significant. In particular, among those patients who started the trial with more severe nasal inflammation causing greater polyposis and more severe sinus inflammation causing greater mucosal thickening on CT scan at enrollment, patients in the SinuNase arm of the study achieved a statistically significant reduction in fungal-induced inflammation as judged by a reduction in eMBP in the mucus and nasal polyposis reduction (p-value = 0.03). The eMBP is a test for an inflammatory cytokine found in the nasal mucus and which is specific for fungal-induced inflammation, and polyposis is an inflammatory manifestation that is specific for chronic sinusitis. The unblinded data set has shown, also, that patients with more intense inflammation and symptom severity at baseline were more likely to benefit from SinuNase with a statistically significant reduction in a patient reported outcome (PRO) for chronic sinusitis compared to the control lavage.
Based on these additional findings, the Company continues to believe that the control arm which used vigorous positive-pressure lavage with buffered water was able to achieve a limited therapeutic effect by means of washing out fungi, but that when patients with severe disease are separately analyzed, the additional benefit of the intranasal antifungal in the SinuNase lavage becomes apparent.
Furthermore, the analysis of the full data set has shown that the subjective primary endpoint of complete resolution of the cardinal symptoms of sinus headache and nasal congestion as reported by study participants at the conclusion of the 16 week trial is not reliable. In particular, almost 50% of patients who reported complete resolution of both cardinal symptoms nevertheless scored one or both of these symptoms as having a severity of greater than zero on a symptom severity scale being validated during the clinical trial. Accordingly, the Company cautions that the lack of a statistically significant superiority of SinuNase versus control lavage on this subjective primary endpoint should not be used to infer that SinuNase lacks efficacy.
The Phase 3 study on SinuNase is the first and only Phase 3 study ever conducted on any pharmaceutical for chronic sinusitis anywhere in the world and accordingly, there is a wealth of new data being gleaned from the trial. The Company continues to analyze the unblinded data, noting that there are approximately 60 variables that were measured at each of ten office visits.
Based on ongoing analyses of the full data set, the Company is formulating its go-forward strategy with respect to SinuNase regulatory approval and commercialization. At this time, the Company intends to pursue development of the SinuNase lavage for severe cases of inflammation. For less severely inflamed patients, the Company believes that the delivery of SinuNase in an ultra low-volume or mini-lavage should be able to control the symptoms and signs of patients with chronic sinusitis while eliminating the confounding effect in these less-inflamed cases of a high-volume positive-pressure lavage. Representing just 5% of the volume of the SinuNase lavage used in the pivotal Phase 3 study, the mini-lavage should have the added benefit of being more patient-friendly. Importantly, the mini-lavage uses the same formulation as the original SinuNase lavage (100 ug/cc of amphotericin B).
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced today that continued analysis of the unblinded full data set on its pivotal Fast-Tracked Phase 3 Trial of SinuNase™ (topical amphotericin B 0.01% suspension) for chronic sinusitis has demonstrated that among patients with objective evidence of more intense inflammation in chronic sinusitis at the time of enrollment, the efficacy of SinuNase compared to control lavage in reducing inflammation is statistically significant. In particular, among those patients who started the trial with more severe nasal inflammation causing greater polyposis and more severe sinus inflammation causing greater mucosal thickening on CT scan at enrollment, patients in the SinuNase arm of the study achieved a statistically significant reduction in fungal-induced inflammation as judged by a reduction in eMBP in the mucus and nasal polyposis reduction (p-value = 0.03). The eMBP is a test for an inflammatory cytokine found in the nasal mucus and which is specific for fungal-induced inflammation, and polyposis is an inflammatory manifestation that is specific for chronic sinusitis. The unblinded data set has shown, also, that patients with more intense inflammation and symptom severity at baseline were more likely to benefit from SinuNase with a statistically significant reduction in a patient reported outcome (PRO) for chronic sinusitis compared to the control lavage.
Based on these additional findings, the Company continues to believe that the control arm which used vigorous positive-pressure lavage with buffered water was able to achieve a limited therapeutic effect by means of washing out fungi, but that when patients with severe disease are separately analyzed, the additional benefit of the intranasal antifungal in the SinuNase lavage becomes apparent.
Furthermore, the analysis of the full data set has shown that the subjective primary endpoint of complete resolution of the cardinal symptoms of sinus headache and nasal congestion as reported by study participants at the conclusion of the 16 week trial is not reliable. In particular, almost 50% of patients who reported complete resolution of both cardinal symptoms nevertheless scored one or both of these symptoms as having a severity of greater than zero on a symptom severity scale being validated during the clinical trial. Accordingly, the Company cautions that the lack of a statistically significant superiority of SinuNase versus control lavage on this subjective primary endpoint should not be used to infer that SinuNase lacks efficacy.
The Phase 3 study on SinuNase is the first and only Phase 3 study ever conducted on any pharmaceutical for chronic sinusitis anywhere in the world and accordingly, there is a wealth of new data being gleaned from the trial. The Company continues to analyze the unblinded data, noting that there are approximately 60 variables that were measured at each of ten office visits.
Based on ongoing analyses of the full data set, the Company is formulating its go-forward strategy with respect to SinuNase regulatory approval and commercialization. At this time, the Company intends to pursue development of the SinuNase lavage for severe cases of inflammation. For less severely inflamed patients, the Company believes that the delivery of SinuNase in an ultra low-volume or mini-lavage should be able to control the symptoms and signs of patients with chronic sinusitis while eliminating the confounding effect in these less-inflamed cases of a high-volume positive-pressure lavage. Representing just 5% of the volume of the SinuNase lavage used in the pivotal Phase 3 study, the mini-lavage should have the added benefit of being more patient-friendly. Importantly, the mini-lavage uses the same formulation as the original SinuNase lavage (100 ug/cc of amphotericin B).
Antwort auf Beitrag Nr.: 34.002.348 von Erbse1 am 30.04.08 14:55:19Dass ist leider nicht die Meldung die ich erhofft / erwartet habe...
Man betrachtet hier lediglich die schwereren Fälle der Phase III. Wieviele dass sind (50 %,30 % oder weniger?) oder wer dazu gezählt werden kann bleibt unerwähnt. Schön ist, dass man hier ein deutlich signifikantes Ergebnis berichten kann p=0.03.
Was mir fehlt sind die kompletten Auswertungen der Endoskopie und CT-Scan Ergebnisse. Wie sieht hier die Verteilung aus? Und immer wenn solche Daten weggelassen sind, ist klar, dass diese Daten nicht besonders aussagekräftig sind bzw. schlecht sind. OK, dass ganze war zu vermuten (auch durch ABPIs Klärungsversuch): Das Placebo-Lavage spült den Fungi raus, dadurch verminderung der Symptome...
Zumindest geben die Daten wieder ein wenig Resthoffnung. Es wird weiterhin versucht den normal geplanten Zulassungsweg weiterzugehen. Die Spray Formulierung soll auch wie geplant gestartet werden. Einzig die Frage bleibt: Sind die Daten gut genug um ein Partner / Investor mit ins Boot zu holen, der seine Geldbörse aufmacht? Hmmmh...
Grüße
Man betrachtet hier lediglich die schwereren Fälle der Phase III. Wieviele dass sind (50 %,30 % oder weniger?) oder wer dazu gezählt werden kann bleibt unerwähnt. Schön ist, dass man hier ein deutlich signifikantes Ergebnis berichten kann p=0.03.
Was mir fehlt sind die kompletten Auswertungen der Endoskopie und CT-Scan Ergebnisse. Wie sieht hier die Verteilung aus? Und immer wenn solche Daten weggelassen sind, ist klar, dass diese Daten nicht besonders aussagekräftig sind bzw. schlecht sind. OK, dass ganze war zu vermuten (auch durch ABPIs Klärungsversuch): Das Placebo-Lavage spült den Fungi raus, dadurch verminderung der Symptome...
Zumindest geben die Daten wieder ein wenig Resthoffnung. Es wird weiterhin versucht den normal geplanten Zulassungsweg weiterzugehen. Die Spray Formulierung soll auch wie geplant gestartet werden. Einzig die Frage bleibt: Sind die Daten gut genug um ein Partner / Investor mit ins Boot zu holen, der seine Geldbörse aufmacht? Hmmmh...
Grüße
Antwort auf Beitrag Nr.: 34.002.713 von Ackergaul am 30.04.08 15:30:24Ich stelle mich jetzt gleich mal in Frage:
Ist dass eine Mißdeutung meinerseits gewesen? Der erste Phase III Trial ist bekanntlich für die schwereren Fälle ausgelegt worden. Bedeutet die heutige Meldung ein p=0.03 auf die komplette 300 Patienten starke Gruppe oder auf einen davon wieder schlimmer betroffenen Teil...
Falls der erste Punkt eintrifft, bin ich schon einmal wesentlich hoffnungsfroher, da die Senkung der eMBP's vermutlich ein wesentlicher Schritt ist.
Und nochmals
Grüße
Erst lesen, dann denken, dann schreiben... und dann wieder von vorne
Ist dass eine Mißdeutung meinerseits gewesen? Der erste Phase III Trial ist bekanntlich für die schwereren Fälle ausgelegt worden. Bedeutet die heutige Meldung ein p=0.03 auf die komplette 300 Patienten starke Gruppe oder auf einen davon wieder schlimmer betroffenen Teil...
Falls der erste Punkt eintrifft, bin ich schon einmal wesentlich hoffnungsfroher, da die Senkung der eMBP's vermutlich ein wesentlicher Schritt ist.
Und nochmals
Grüße
Erst lesen, dann denken, dann schreiben... und dann wieder von vorne
Hatte ABPI gar nicht gemeldet, halte ich für nicht ganz unwichtig...
AllerNase sNDA Filed
Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled
Steroid for the Treatment of Allergic Rhinitis
CUMBERLAND, R.I.--(BUSINESS WIRE)--April 8, 2008 - Collegium Pharmaceutical, Inc., a
specialty pharmaceutical company with a focus on respiratory and CNS disorders, today
announced that it filed a Supplemental New Drug Application (sNDA) with the U.S. Federal Drug
Administration (FDA) for the approval of AllerNase (triamcinolone acetonide, USP) Nasal Spray,
50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal
symptoms associated with both seasonal and perennial allergic rhinitis in adults and children
twelve years of age and older.
Background:
Collegium acquired the rights, title and interest in Tri-Nasal (triamcinolone acetonide, USP) Nasal
Spray, including the product's approved NDA and the right to market the product, from Muro
Pharmaceutical, Inc. The efficacy and safety of Tri-Nasal Nasal Spray in both seasonal allergic
rhinitis and perennial allergic rhinitis have been well established in 14 clinical trials involving
almost 1,200 subjects. Tri-Nasal received FDA approval as a once-daily, intranasal steroid
medication for the treatment of seasonal and perennial allergic rhinitis in adults and children over
age 12. The Product was then the subject of two Class III voluntary recalls, one for product
leakage and the other for low potency. The product was indefinitely removed from the market in
2002.
Since acquiring Tri-Nasal, Collegium has initiated a comprehensive development program
including the re-formulation of the product to address both the recall issues. The reformulated
product has been named AllerNase Nasal Spray. It has a pending patent application covering the
product's new formulation.
Market Opportunity:
AllerNase competes in the approximately $2.5 billion a year U.S. market for nasal inhaled steroids
for the treatment of allergic rhinitis. Allergic rhinitis is the most common allergic condition and is
increasing in prevalence. Estimates suggest that as many as 20-25% of the U.S. population are
currently affected. The most common treatments include nasal inhaled steroids and
antihistamines. Competing inhaled steroid products in this category include Nasonex (Schering),
Nasacort (Aventis), Rhinocort Aqua (AstraZeneca) and Veramyst (Glaxo).
The Company is in the process of identifying potential strategic marketing partners for both the
U.S and international markets.
"We are very pleased to have filed this sNDA and advanced AllerNase Nasal Spray closer to the
commercial stage" said Michael Heffernan, President of Collegium. "We believe that the benefits
of AllerNase's novel aqueous based solution formulation containing a proven safe and effective
active ingredient (triamcinolone acetonide) will provide another alternative to the currently
available options for the treatment of allergic rhinitis. We intend to direct our focus on identifying
the best commercial marketing partner for the product".
Zu den Vermarktungs-Rechten noch kurz:
The Company, in cooperation with Accentia Biopharmaceuticals, Inc. which currently holds the US commercial rights to AllerNase™, is exploring options with other potential US partners for commercialization of the product.
Dennoch, wichtiger bleibt natürlich SinuNase und BiovaxID. AllerNase ist maximal ein nettes kleines zubrot... Die Frage bleibt immer noch: woher soll dass Geld zur weiteren Finanzierung ABPIs kommen?
Grüße
AllerNase sNDA Filed
Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled
Steroid for the Treatment of Allergic Rhinitis
CUMBERLAND, R.I.--(BUSINESS WIRE)--April 8, 2008 - Collegium Pharmaceutical, Inc., a
specialty pharmaceutical company with a focus on respiratory and CNS disorders, today
announced that it filed a Supplemental New Drug Application (sNDA) with the U.S. Federal Drug
Administration (FDA) for the approval of AllerNase (triamcinolone acetonide, USP) Nasal Spray,
50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal
symptoms associated with both seasonal and perennial allergic rhinitis in adults and children
twelve years of age and older.
Background:
Collegium acquired the rights, title and interest in Tri-Nasal (triamcinolone acetonide, USP) Nasal
Spray, including the product's approved NDA and the right to market the product, from Muro
Pharmaceutical, Inc. The efficacy and safety of Tri-Nasal Nasal Spray in both seasonal allergic
rhinitis and perennial allergic rhinitis have been well established in 14 clinical trials involving
almost 1,200 subjects. Tri-Nasal received FDA approval as a once-daily, intranasal steroid
medication for the treatment of seasonal and perennial allergic rhinitis in adults and children over
age 12. The Product was then the subject of two Class III voluntary recalls, one for product
leakage and the other for low potency. The product was indefinitely removed from the market in
2002.
Since acquiring Tri-Nasal, Collegium has initiated a comprehensive development program
including the re-formulation of the product to address both the recall issues. The reformulated
product has been named AllerNase Nasal Spray. It has a pending patent application covering the
product's new formulation.
Market Opportunity:
AllerNase competes in the approximately $2.5 billion a year U.S. market for nasal inhaled steroids
for the treatment of allergic rhinitis. Allergic rhinitis is the most common allergic condition and is
increasing in prevalence. Estimates suggest that as many as 20-25% of the U.S. population are
currently affected. The most common treatments include nasal inhaled steroids and
antihistamines. Competing inhaled steroid products in this category include Nasonex (Schering),
Nasacort (Aventis), Rhinocort Aqua (AstraZeneca) and Veramyst (Glaxo).
The Company is in the process of identifying potential strategic marketing partners for both the
U.S and international markets.
"We are very pleased to have filed this sNDA and advanced AllerNase Nasal Spray closer to the
commercial stage" said Michael Heffernan, President of Collegium. "We believe that the benefits
of AllerNase's novel aqueous based solution formulation containing a proven safe and effective
active ingredient (triamcinolone acetonide) will provide another alternative to the currently
available options for the treatment of allergic rhinitis. We intend to direct our focus on identifying
the best commercial marketing partner for the product".
Zu den Vermarktungs-Rechten noch kurz:
The Company, in cooperation with Accentia Biopharmaceuticals, Inc. which currently holds the US commercial rights to AllerNase™, is exploring options with other potential US partners for commercialization of the product.
Dennoch, wichtiger bleibt natürlich SinuNase und BiovaxID. AllerNase ist maximal ein nettes kleines zubrot... Die Frage bleibt immer noch: woher soll dass Geld zur weiteren Finanzierung ABPIs kommen?
Grüße
Accentia Biopharmaceuticals Reports Fiscal Second Quarter Financial Results
Company to Present at Jefferies Healthcare Conference
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its second fiscal quarter ended March 31, 2008. The Company also announced that it is scheduled to present at the Jefferies & Co. 2nd Annual Healthcare Conference in New York City.
Accentia’s Chairman and CEO, Dr. Frank E. O’Donnell Jr., will present at the Jefferies Healthcare Conference on June 25, 2008, at 2:30 p.m. (EDT) at the Mandarin Oriental Hotel in New York City. Dr. O’Donnell commented on the Company’s pending milestones leading up to the Conference, “I believe we are on the verge of reporting a series of near-term achievements for SinuNase™, BiovaxID® and Revimmune™, and we are striving to be able to report multiple accomplishments prior to the Jefferies Conference, including possible new corporate collaborations, which I envision will dramatically contribute to our growth.”
If qualified investors are interested in meeting with Dr. O’Donnell at the Jefferies & Co. Healthcare Conference, please contact Douglas Calder at 813-864-2558 or at dwcalder@accentia.net.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI), which is consolidated for reporting purposes with Accentia’s product development and market service business.
On a fully consolidated basis, including Biovest, net revenues for the three months ended March 31, 2008 were $4.2 million, compared with $4.6 million for the same period ended March 31, 2007. Although revenues for our Analytica subsidiary improved, the overall decrease in net revenues was primarily attributed to a decrease in net sales in our Specialty Pharmaceuticals segment primarily due to the discontinuance of our Respi-Tann G product line.
Consolidated research and development costs were $2.7 million for the second fiscal quarter, compared with $5.5 million for the same fiscal quarter in 2007. This 52% decrease was largely due to our Biovest subsidiary reducing research and development expenses as its clinical trial costs have declined considerably, as a result of our decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the U.S. Food and Drug Administration (FDA) and European regulatory authorities. There was also a decrease in SinuNase research and development expenses due to the near completion of its Fast-Tracked Phase 3 clinical trial, which demonstrated statistically significant objective evidence based on secondary endpoint analysis measuring the most severe cases of polyposis and inflammation.
Accentia’s second quarter net loss, on a fully consolidated basis, including Biovest, was $8.3 million, compared to $8.0 million reported for the same three month period in fiscal 2007. Of this loss, approximately $1.9 million was due to non-cash charges.
The fully consolidated loss per share for the quarter was $0.20, of which $0.10 per share was attributed to Biovest, which is consolidated in Accentia’s financial statements. Since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.25, of which $0.17 per share was attributed to Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest’s decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the FDA and European regulatory authorities.
At March 31, 2008, Accentia had approximately $1.5 million in cash, excluding restricted cash. Subsequent to March 31, 2008, Biovest raised $1 million through the issuance of a convertible promissory note subscribed to by one of the Company’s directors. With the recent news related to positive Phase 3 objective results reported for SinuNase and the pending unblinding of the BiovaxID Phase 3 results, Accentia and Biovest are currently evaluating financing opportunities, including potential partnering and licensing agreements which are expected to be significant commercial events, providing access to additional sources of capital.
Accentia also reported on plans to resolve its NASDAQ compliance issue, as the Company is non-compliant with Rule 4450(b)(1)(A), which requires a listed security to maintain a minimum $50 million market capitalization for continued trading on the NASDAQ Global Market. To resolve this matter, the Company has filed an application to transfer the listing of the Company's common stock from the NASDAQ Global Market to the NASDAQ Capital Market. The Company filed the application on May 15, 2008 and expects to maintain its current NASDAQ Global Market status pending completion of the transfer application.
Keine richtigen News oder Überaschungen...
Grüße
Company to Present at Jefferies Healthcare Conference
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its second fiscal quarter ended March 31, 2008. The Company also announced that it is scheduled to present at the Jefferies & Co. 2nd Annual Healthcare Conference in New York City.
Accentia’s Chairman and CEO, Dr. Frank E. O’Donnell Jr., will present at the Jefferies Healthcare Conference on June 25, 2008, at 2:30 p.m. (EDT) at the Mandarin Oriental Hotel in New York City. Dr. O’Donnell commented on the Company’s pending milestones leading up to the Conference, “I believe we are on the verge of reporting a series of near-term achievements for SinuNase™, BiovaxID® and Revimmune™, and we are striving to be able to report multiple accomplishments prior to the Jefferies Conference, including possible new corporate collaborations, which I envision will dramatically contribute to our growth.”
If qualified investors are interested in meeting with Dr. O’Donnell at the Jefferies & Co. Healthcare Conference, please contact Douglas Calder at 813-864-2558 or at dwcalder@accentia.net.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI), which is consolidated for reporting purposes with Accentia’s product development and market service business.
On a fully consolidated basis, including Biovest, net revenues for the three months ended March 31, 2008 were $4.2 million, compared with $4.6 million for the same period ended March 31, 2007. Although revenues for our Analytica subsidiary improved, the overall decrease in net revenues was primarily attributed to a decrease in net sales in our Specialty Pharmaceuticals segment primarily due to the discontinuance of our Respi-Tann G product line.
Consolidated research and development costs were $2.7 million for the second fiscal quarter, compared with $5.5 million for the same fiscal quarter in 2007. This 52% decrease was largely due to our Biovest subsidiary reducing research and development expenses as its clinical trial costs have declined considerably, as a result of our decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the U.S. Food and Drug Administration (FDA) and European regulatory authorities. There was also a decrease in SinuNase research and development expenses due to the near completion of its Fast-Tracked Phase 3 clinical trial, which demonstrated statistically significant objective evidence based on secondary endpoint analysis measuring the most severe cases of polyposis and inflammation.
Accentia’s second quarter net loss, on a fully consolidated basis, including Biovest, was $8.3 million, compared to $8.0 million reported for the same three month period in fiscal 2007. Of this loss, approximately $1.9 million was due to non-cash charges.
The fully consolidated loss per share for the quarter was $0.20, of which $0.10 per share was attributed to Biovest, which is consolidated in Accentia’s financial statements. Since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.25, of which $0.17 per share was attributed to Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest’s decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the FDA and European regulatory authorities.
At March 31, 2008, Accentia had approximately $1.5 million in cash, excluding restricted cash. Subsequent to March 31, 2008, Biovest raised $1 million through the issuance of a convertible promissory note subscribed to by one of the Company’s directors. With the recent news related to positive Phase 3 objective results reported for SinuNase and the pending unblinding of the BiovaxID Phase 3 results, Accentia and Biovest are currently evaluating financing opportunities, including potential partnering and licensing agreements which are expected to be significant commercial events, providing access to additional sources of capital.
Accentia also reported on plans to resolve its NASDAQ compliance issue, as the Company is non-compliant with Rule 4450(b)(1)(A), which requires a listed security to maintain a minimum $50 million market capitalization for continued trading on the NASDAQ Global Market. To resolve this matter, the Company has filed an application to transfer the listing of the Company's common stock from the NASDAQ Global Market to the NASDAQ Capital Market. The Company filed the application on May 15, 2008 and expects to maintain its current NASDAQ Global Market status pending completion of the transfer application.
Keine richtigen News oder Überaschungen...
Grüße
Biovest hat in einer SEC Veröffentlichung eine Präsentation erstellt:
http://www.sec.gov/Archives/edgar/data/704384/00011931250812…
Vielleicht einfach mal überfliegen.
Grüße
http://www.sec.gov/Archives/edgar/data/704384/00011931250812…
Vielleicht einfach mal überfliegen.
Grüße
Nach GTOP ist nun auch der FVRL vaccine Trial gefloppt! Eigentlich hatte ich beiden Firmen bessere Chancen zugedacht als BVTI. Die entgültigen Daten sollen gegen Ende August veröffentlicht werden - und sind demnach ABPIs größter Trumpf...
UPDATE 2-Favrille stops lead cancer drug trials; shares sink
Tue May 27, 2008 11:10am
By Jennifer Robin Raj
BANGALORE, May 27 (Reuters) - Favrille Inc (FVRL.O: Quote, Profile, Research) said it will end development of its lead experimental cancer drug, Specifid, as it failed to meet the main goal in a late-stage trial, wiping out more than 85 percent of the company's market value.
In the trial, the company was evaluating Specifid in patients who had already received Rituxan, the current standard of care, for the treatment of follicular B-cell non-Hodgkin's lymphoma, a cancer that affects the lymphatic system.
Specifid is an active immunotherapy agent that is based upon genetic information extracted from a patient's tumor and is designed to stimulate the immune system, according to the company's website.
Following standard treatment with Genentech's (DNA.N: Quote, Profile, Research) Rituxan, patients received Specifid plus Bayer AG's (BAYG.DE: Quote, Profile, Research) Leukine in the treatment arm or placebo plus Leukine in the control arm.
The company said analysis of time to progression, the primary endpoint of the trial, failed to show a statistically significant improvement in the treatment arm compared to the control arm.
"Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors," Favrille said.
Brean Murray Carret & Co analyst Jonathan Aschoff said he was not surprised by the trial results and had been expecting it to fail given the company's approach to immunotherapy.
In a note dated May 9, Aschoff had said that the inclusion of Rituxan would make it very difficult to ascertain the contribution of Specifid in disease progression.
ACTIVE AGENT?
Chief Executive John Longenecker said in a conference call with analysts, "What we have seen in the phase III trial is that the control arm did moderately better than expected, the treatment arm did moderately poorer than expected based on the phase II data, and the results of the two arms turned out to be not statistically different."
While some analysts questioned if Specifid could still be considered an active agent, Longenecker said, "although we still believe Specifid to be an active agent, this clinical approach failed to show that and our resources would not allow us to explore alternative approaches."
The biopharmaceutical company said it was currently evaluating steps to conserve cash and recognize value on its assets.
Company spokesman Pete De Spain said the company has other drugs in its pipeline but Specifid was the only drug in late-stage development.
De Spain said "among other things", the company was looking at options for its products in development.
As of March 31, the San Diego-based company had $19.7 million in cash, but under its debt agreement, it needs to have $14.5 million in available cash and equivalents.
Shares of Favrille were down more than 85 percent at 25 cents a share in morning trade on Nasdaq. It touched a low of 19 cents a share earlier in the session. (Editing by Himani Sarkar)
Grüße
UPDATE 2-Favrille stops lead cancer drug trials; shares sink
Tue May 27, 2008 11:10am
By Jennifer Robin Raj
BANGALORE, May 27 (Reuters) - Favrille Inc (FVRL.O: Quote, Profile, Research) said it will end development of its lead experimental cancer drug, Specifid, as it failed to meet the main goal in a late-stage trial, wiping out more than 85 percent of the company's market value.
In the trial, the company was evaluating Specifid in patients who had already received Rituxan, the current standard of care, for the treatment of follicular B-cell non-Hodgkin's lymphoma, a cancer that affects the lymphatic system.
Specifid is an active immunotherapy agent that is based upon genetic information extracted from a patient's tumor and is designed to stimulate the immune system, according to the company's website.
Following standard treatment with Genentech's (DNA.N: Quote, Profile, Research) Rituxan, patients received Specifid plus Bayer AG's (BAYG.DE: Quote, Profile, Research) Leukine in the treatment arm or placebo plus Leukine in the control arm.
The company said analysis of time to progression, the primary endpoint of the trial, failed to show a statistically significant improvement in the treatment arm compared to the control arm.
"Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors," Favrille said.
Brean Murray Carret & Co analyst Jonathan Aschoff said he was not surprised by the trial results and had been expecting it to fail given the company's approach to immunotherapy.
In a note dated May 9, Aschoff had said that the inclusion of Rituxan would make it very difficult to ascertain the contribution of Specifid in disease progression.
ACTIVE AGENT?
Chief Executive John Longenecker said in a conference call with analysts, "What we have seen in the phase III trial is that the control arm did moderately better than expected, the treatment arm did moderately poorer than expected based on the phase II data, and the results of the two arms turned out to be not statistically different."
While some analysts questioned if Specifid could still be considered an active agent, Longenecker said, "although we still believe Specifid to be an active agent, this clinical approach failed to show that and our resources would not allow us to explore alternative approaches."
The biopharmaceutical company said it was currently evaluating steps to conserve cash and recognize value on its assets.
Company spokesman Pete De Spain said the company has other drugs in its pipeline but Specifid was the only drug in late-stage development.
De Spain said "among other things", the company was looking at options for its products in development.
As of March 31, the San Diego-based company had $19.7 million in cash, but under its debt agreement, it needs to have $14.5 million in available cash and equivalents.
Shares of Favrille were down more than 85 percent at 25 cents a share in morning trade on Nasdaq. It touched a low of 19 cents a share earlier in the session. (Editing by Himani Sarkar)
Grüße
Friday, May 30, 2008
Bottom of the Ninth, and Now Two Away: Is the Game Over for Personalized Immunotherapy?
San Diego – Specifid, a therapeutic agent once poised to be not only be first in class, but first in concept, has failed to meet its primary endpoint in a phase III registration trial of patients with non-Hodgkin’s lymphoma (NHL). This result, announced May 27th has prompted Specifid’s manufacturer, Favrille, to discontinue any further development of the compound. “With respect to getting any useful positive information that would lead to approval out of this data set,” said John Longenecker, PhD, President and CEO of Favrille, “that’s not going to happen.”
Specifid is the second such personalized immunotherapy to be abandoned in the last six months, the other being Genitope’s product, MyVax, which was withdrawn from development last December. Despite that cautionary event, Longenecker had remained confident in his molecule’s ability to perform. “Unlike MyVax, which was expressed in mammalian cells, our patient-specific idiotype (antigen) protein was made in a baculovirus/insect-cell expression system. That meant the protein was only glycosylated with mannose sugars, which is far more antigenic than that produced by mammalian cells.” Specifid was also produced as a nano-particulate formulation, which theoretically allows a patient’s immune system to more easily “see” the antigen. But these distinctions, impressive on the benchtop, bore no statistical significance in the clinic.
In Specifid’s pivotal trial, patients with follicular B-cell non-Hodgkin’s lymphoma were pretreated with rituximab – the current gold standard in this setting – and then randomized in a 1:1 fashion to either Specifid plus GM-CSF (granulocyte-macrophage colony-stimulating factor) or GM-CSF plus placebo (N=349). Following treatment induction, patients with stable disease or disease remission at six months were continued on a maintenance program consisting of the assigned randomized treatment every two months for one year, and then every three months thereafter in the absence of disease progression. The study endpoint was a comparison of times to disease progression for the two treatment arms. Results showed that, even in a mixed cohort of treatment naïve, treatment refractory, and relapsed patients, no clinical outcome was superior for active treatment. “We did a very thorough analysis,” says Longenecker, “All the sub group analysis… we looked at progression as assessed by a number of criteria, but all of the data is consistent and shows no difference between the placebo and treatment arms.”
This newest failure of a personalized therapy is perhaps more striking than the demise of dissimilar novel compounds because an immunotherapy should work in much the same way as a vaccine – of which we have many. As long as the antigen is well defined and consistent, as would be expected in a clonal population of tumor cells, inducing an immune response should be relatively straightforward. So… why isn’t it working? “The short answer is, we don’t know,” admitted Longenecker. He has a suspicion or two, one being the timing of the immunotherapeutic dose after treatment with rituximab – an agent which depletes the B-cell population required for an immune response. Favrille’s strategy was to dose with the active immunotherapy at a time of minimal tumor burden, which would be within a few months of rituximab administration, yet prior to full B-cell recovery. “There’s a theory that you need B-cells to recover from Rituxan in order to get a maximum immune response… but that remains an area of speculation.”
Longenecker is not the only one giving the matter some thought. Investigators at BioVest, makers of the last remaining personalized immunotherapy in development for NHL, BioVaxID, have their own ideas. “We believe the only way to get an effective reaction out of the immune system is to use true copies of the tumor markers,” said Steve Arikian, M.D. Chairman and CEO of BioVest. And this has to be done through the use of hybridoma technology. “You get high fidelity copies of the tumor idiotype (antigen) which is how we got such strong immune response data from our phase II trial.” Arikian wonders if Favrille had the right idea, but the wrong method – their recombinant idiotype product was simply too imprecise to efficiently mimic the endogenous target.
BioVest’s own trial, which began enrollment in 2000, differs for the Favrille investigation in that it used an adriamycin-based chemotherapy to induce the initial disease remission, and the active immunotherapy was only administered after a six month “holiday” in order to allow time for the patient’s immune system to recover. Arikian believes this difference will be critical to producing a significant outcome in the active treatment arm.
The unblinding of BioVest’s trial is slated for late June, yet, even a positive result may not matter. As Favrille’s CEO points out, “We live in a Rituxan dominated world.” The two trials combining immunotherapy with chemotherapy-induced remission were extremely difficult to enroll, and essentially, behind the times. “Genitope took 4 years, and BioVest took 8 years – both programs excluded Rituxan. That will complicate whether [a positive outcome] will find a place in the market.” Rituximab rules. The order of the day is not to rescue chemotherapy, but to find a way to use your drug in a rituximab combination.
For now, Longenecker thinks that anyone looking to enter the patient-specific immunotherapeutic field should first return to the drawing board. Is B-cell recovery necessary? Are T-cells down-regulating a therapeutic immune response? “Our trial has demonstrated that it is possible to develop an immune response against your own idiotype proteins. The question is, how do you take that observation and convert it into a clinically useful approach?”
Schaun wer mal, wie es ausgeht... Nebenbei hatte ich bzw. versuche immer noch ABPI bzgl. der SinuNase Ergebnisse anzumailen. Entweder scheinen die im Bereich Investor Relations stark eingespart zu haben oder sie wollen nicht antworten. Ich denke diese Kapitel kann man schließen. Bis heute gibt es keine News, dass man Kontakt mit der FDA gesucht hat oder den zwiten Phase III Trial (dass Spray) geöffnet hat. Bitte vergleicht auch einmal, den 2008er Outlook (Ziele und Pläne) mit dem heutigen Stand...
Grüße
Wie erwähnt: Ende August werden die BiovaxID Ergebnisse veröffentlicht. Sehr wahrscheinlich werden einige wenige im Vorfeld schon wissen, wohin die Ergebnisse tendieren...
Bottom of the Ninth, and Now Two Away: Is the Game Over for Personalized Immunotherapy?
San Diego – Specifid, a therapeutic agent once poised to be not only be first in class, but first in concept, has failed to meet its primary endpoint in a phase III registration trial of patients with non-Hodgkin’s lymphoma (NHL). This result, announced May 27th has prompted Specifid’s manufacturer, Favrille, to discontinue any further development of the compound. “With respect to getting any useful positive information that would lead to approval out of this data set,” said John Longenecker, PhD, President and CEO of Favrille, “that’s not going to happen.”
Specifid is the second such personalized immunotherapy to be abandoned in the last six months, the other being Genitope’s product, MyVax, which was withdrawn from development last December. Despite that cautionary event, Longenecker had remained confident in his molecule’s ability to perform. “Unlike MyVax, which was expressed in mammalian cells, our patient-specific idiotype (antigen) protein was made in a baculovirus/insect-cell expression system. That meant the protein was only glycosylated with mannose sugars, which is far more antigenic than that produced by mammalian cells.” Specifid was also produced as a nano-particulate formulation, which theoretically allows a patient’s immune system to more easily “see” the antigen. But these distinctions, impressive on the benchtop, bore no statistical significance in the clinic.
In Specifid’s pivotal trial, patients with follicular B-cell non-Hodgkin’s lymphoma were pretreated with rituximab – the current gold standard in this setting – and then randomized in a 1:1 fashion to either Specifid plus GM-CSF (granulocyte-macrophage colony-stimulating factor) or GM-CSF plus placebo (N=349). Following treatment induction, patients with stable disease or disease remission at six months were continued on a maintenance program consisting of the assigned randomized treatment every two months for one year, and then every three months thereafter in the absence of disease progression. The study endpoint was a comparison of times to disease progression for the two treatment arms. Results showed that, even in a mixed cohort of treatment naïve, treatment refractory, and relapsed patients, no clinical outcome was superior for active treatment. “We did a very thorough analysis,” says Longenecker, “All the sub group analysis… we looked at progression as assessed by a number of criteria, but all of the data is consistent and shows no difference between the placebo and treatment arms.”
This newest failure of a personalized therapy is perhaps more striking than the demise of dissimilar novel compounds because an immunotherapy should work in much the same way as a vaccine – of which we have many. As long as the antigen is well defined and consistent, as would be expected in a clonal population of tumor cells, inducing an immune response should be relatively straightforward. So… why isn’t it working? “The short answer is, we don’t know,” admitted Longenecker. He has a suspicion or two, one being the timing of the immunotherapeutic dose after treatment with rituximab – an agent which depletes the B-cell population required for an immune response. Favrille’s strategy was to dose with the active immunotherapy at a time of minimal tumor burden, which would be within a few months of rituximab administration, yet prior to full B-cell recovery. “There’s a theory that you need B-cells to recover from Rituxan in order to get a maximum immune response… but that remains an area of speculation.”
Longenecker is not the only one giving the matter some thought. Investigators at BioVest, makers of the last remaining personalized immunotherapy in development for NHL, BioVaxID, have their own ideas. “We believe the only way to get an effective reaction out of the immune system is to use true copies of the tumor markers,” said Steve Arikian, M.D. Chairman and CEO of BioVest. And this has to be done through the use of hybridoma technology. “You get high fidelity copies of the tumor idiotype (antigen) which is how we got such strong immune response data from our phase II trial.” Arikian wonders if Favrille had the right idea, but the wrong method – their recombinant idiotype product was simply too imprecise to efficiently mimic the endogenous target.
BioVest’s own trial, which began enrollment in 2000, differs for the Favrille investigation in that it used an adriamycin-based chemotherapy to induce the initial disease remission, and the active immunotherapy was only administered after a six month “holiday” in order to allow time for the patient’s immune system to recover. Arikian believes this difference will be critical to producing a significant outcome in the active treatment arm.
The unblinding of BioVest’s trial is slated for late June, yet, even a positive result may not matter. As Favrille’s CEO points out, “We live in a Rituxan dominated world.” The two trials combining immunotherapy with chemotherapy-induced remission were extremely difficult to enroll, and essentially, behind the times. “Genitope took 4 years, and BioVest took 8 years – both programs excluded Rituxan. That will complicate whether [a positive outcome] will find a place in the market.” Rituximab rules. The order of the day is not to rescue chemotherapy, but to find a way to use your drug in a rituximab combination.
For now, Longenecker thinks that anyone looking to enter the patient-specific immunotherapeutic field should first return to the drawing board. Is B-cell recovery necessary? Are T-cells down-regulating a therapeutic immune response? “Our trial has demonstrated that it is possible to develop an immune response against your own idiotype proteins. The question is, how do you take that observation and convert it into a clinically useful approach?”
Schaun wer mal, wie es ausgeht... Nebenbei hatte ich bzw. versuche immer noch ABPI bzgl. der SinuNase Ergebnisse anzumailen. Entweder scheinen die im Bereich Investor Relations stark eingespart zu haben oder sie wollen nicht antworten. Ich denke diese Kapitel kann man schließen. Bis heute gibt es keine News, dass man Kontakt mit der FDA gesucht hat oder den zwiten Phase III Trial (dass Spray) geöffnet hat. Bitte vergleicht auch einmal, den 2008er Outlook (Ziele und Pläne) mit dem heutigen Stand...
Grüße
Wie erwähnt: Ende August werden die BiovaxID Ergebnisse veröffentlicht. Sehr wahrscheinlich werden einige wenige im Vorfeld schon wissen, wohin die Ergebnisse tendieren...
Etwas aktuelles zu Revimmune (HiCy)
High-Dose Cyclophosphamide Shows Promise for Aggressive MS
By Charles Bankhead, Staff Writer, MedPage Today
Published: June 09, 2008
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
BALTIMORE, June 9 -- Aggressive relapsing-remitting multiple sclerosis responded significantly to high-dose cyclophosphamide with reduced disease activity and disability, a small trial showed.
Action Points
High-Dose Cyclophosphamide Shows Promise for Aggressive MS
By Charles Bankhead, Staff Writer, MedPage Today
Published: June 09, 2008
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
BALTIMORE, June 9 -- Aggressive relapsing-remitting multiple sclerosis responded significantly to high-dose cyclophosphamide with reduced disease activity and disability, a small trial showed.
Action Points
Antwort auf Beitrag Nr.: 34.280.831 von Ackergaul am 11.06.08 12:59:45Heute bekommen wie wieder Spass...
vgl. 27.04.08, Beitrag #149 ff.
Biovest Reports Blinded Results for Phase 3 Study Evaluating Anti-Cancer Vaccine, BiovaxID(R), which Shows 100% Difference in Disease-Free Survival at 36 Months in the Comparative Arms
meint
KJ
Grüsse!
vgl. 27.04.08, Beitrag #149 ff.
Biovest Reports Blinded Results for Phase 3 Study Evaluating Anti-Cancer Vaccine, BiovaxID(R), which Shows 100% Difference in Disease-Free Survival at 36 Months in the Comparative Arms
meint
KJ
Grüsse!
Antwort auf Beitrag Nr.: 34.281.806 von KillingJoke am 11.06.08 15:02:11hatte mir vor ein paar Tagen welche gekauft
und jetzt das...
habe vor 15 min. leider zu früh verkauft
weil ich das Unternehmen zu wenig kenne
Viel Spaß noch
und jetzt das...
habe vor 15 min. leider zu früh verkauft
weil ich das Unternehmen zu wenig kenne
Viel Spaß noch
mal ein paar Anmerkungen hierzu:
* Erst einmal erinnert mich diese Meldung stark an SinuNase. Wie auch immer. Nehmen wir an Gruppe B steht für BiovaxID. Dann haben wir ein Median disease free survival von etwa 29 Monaten zu 21 in der Kontrollgruppe. Noch einmal: Angenommen dass BiovaxID die obere Kurve abbildet!
* Aus der BiovaxID Phase II Studie:
...
The abstract, entitled (2441) "BiovaxID Vaccine Therapy of Follicular Lymphoma in First Remission: Long-Term Follow-Up of a Phase II Trial and Status of a Controlled, Randomized Phase III Trial" by C. Santos, L. Stern, L. Katz, T. Watson, and B. Gause also provides an update on the progress of the Company's ongoing Phase III trial. In the Phase III trial, patients with follicular B-cell non-Hodgkin's lymphoma are being treated with BiovaxID immunotherapy following PACE [Prednisone, Doxorubicin, Cyclophosphamide, and Etoposide (ProMACE without methotrexate)] chemotherapy. At the meeting of the American Society for Hematology, Biovest will provide an update on patients who were treated with BiovaxID in its Phase II clinical trial. The patients have now been followed for a median time of 9.2 years. Nine patients (45 %) remain in clinical remission at their most recent follow-up, and overall survival is 95%. Median disease free survival for the group is 96.5 months (8.04 years). To date there have been no additional reported mortalities. Additional analysis of the Phase II trial data will be presented by Biovest at the American Society for Hematology meeting.
...
-->Wir hatten damals unglaubliche 96 Monate. Laut dem Diagramm
sind es in der Phase III höchstens nur noch etwa 30 Monate...
* habe momentan noch nichts 100 %iges zum vergleich gefunden, aber:
Basel, 10 August 2004
Roche gets European approval for MabThera in first line treatment of indolent non-Hodgkin’s lymphoma
...
• Freedom from disease progression was nearly doubled: 27 months versus 15 months
...
--> also hatte Rituxan+CVP ähnliche DFS Daten. Bei R+CHOP liegen diese höher...
Warten wir einfach erst einmal die "Entblindung" ab und schaun dann weiter. Ein Wort noch hierzu: Hier steht noch 6 Monate nach randomisierung - ob diese 6 Monate noch zugerechnet werden müssen?
Grüße
* Erst einmal erinnert mich diese Meldung stark an SinuNase. Wie auch immer. Nehmen wir an Gruppe B steht für BiovaxID. Dann haben wir ein Median disease free survival von etwa 29 Monaten zu 21 in der Kontrollgruppe. Noch einmal: Angenommen dass BiovaxID die obere Kurve abbildet!
* Aus der BiovaxID Phase II Studie:
...
The abstract, entitled (2441) "BiovaxID Vaccine Therapy of Follicular Lymphoma in First Remission: Long-Term Follow-Up of a Phase II Trial and Status of a Controlled, Randomized Phase III Trial" by C. Santos, L. Stern, L. Katz, T. Watson, and B. Gause also provides an update on the progress of the Company's ongoing Phase III trial. In the Phase III trial, patients with follicular B-cell non-Hodgkin's lymphoma are being treated with BiovaxID immunotherapy following PACE [Prednisone, Doxorubicin, Cyclophosphamide, and Etoposide (ProMACE without methotrexate)] chemotherapy. At the meeting of the American Society for Hematology, Biovest will provide an update on patients who were treated with BiovaxID in its Phase II clinical trial. The patients have now been followed for a median time of 9.2 years. Nine patients (45 %) remain in clinical remission at their most recent follow-up, and overall survival is 95%. Median disease free survival for the group is 96.5 months (8.04 years). To date there have been no additional reported mortalities. Additional analysis of the Phase II trial data will be presented by Biovest at the American Society for Hematology meeting.
...
-->Wir hatten damals unglaubliche 96 Monate. Laut dem Diagramm
sind es in der Phase III höchstens nur noch etwa 30 Monate...
* habe momentan noch nichts 100 %iges zum vergleich gefunden, aber:
Basel, 10 August 2004
Roche gets European approval for MabThera in first line treatment of indolent non-Hodgkin’s lymphoma
...
• Freedom from disease progression was nearly doubled: 27 months versus 15 months
...
--> also hatte Rituxan+CVP ähnliche DFS Daten. Bei R+CHOP liegen diese höher...
Warten wir einfach erst einmal die "Entblindung" ab und schaun dann weiter. Ein Wort noch hierzu: Hier steht noch 6 Monate nach randomisierung - ob diese 6 Monate noch zugerechnet werden müssen?
Grüße
Mahlzeit,
ich denke es ist schwer einzuschätzen, wie gestrige Meldung mit den (wenigen) Ergebnissen zu werten ist. Nach 36 monaten liegt B gegenüber A etwa 100 % höher bei den DFS Werten. Letztendlich muss man auch sehen, das in beiden Gruppen die Patienten am Anfang mit CHOP+R oder PACE behandelt wurden... Insgesamt hätte ich trotzdem bei BiovaxID mehr erhofft (vorausgesetzt B steht für BiovaxID).
Anti-Cancer Vaccine Data Creates Two Huge Moves (BVTI, ABPI)
June 11, 2008 · Filed Under Cancer · Comments Off
There are two tiny stocks that are benefiting from some positive Phase III data on an anti-cancer vaccine. Biovest International, Inc. (OTCBB: BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), and this morning the company reported what it noted as “the company believes” to be highly encouraging blinded results from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® for the treatment of indolent follicular non-Hodgkin’s lymphoma. This is an often fatal blood cancer.
It reported a blinded disease-free survival data for patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm.
Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study. With a “fast track designation” from the FDA and with a 100% improvement over the other arm, you can imagine the interest in such a small company.
Accentia Biopharmaceuticals, Inc. (ABPI) has a mere $61.5 million market cap and that is after a 24% gain today to $1.36. Its 52-week trading range is $0.65 to $3.39. As of March 31, 2008, its balance sheet was inverted and that doesn’t make this any assured home run by a financial count. Biovest International (BVTI) is seeing a surge of 26% to $0.52 today, and its market cap is only about $50 million.
Jon Ogg
June 11, 2008
Grüße
ich denke es ist schwer einzuschätzen, wie gestrige Meldung mit den (wenigen) Ergebnissen zu werten ist. Nach 36 monaten liegt B gegenüber A etwa 100 % höher bei den DFS Werten. Letztendlich muss man auch sehen, das in beiden Gruppen die Patienten am Anfang mit CHOP+R oder PACE behandelt wurden... Insgesamt hätte ich trotzdem bei BiovaxID mehr erhofft (vorausgesetzt B steht für BiovaxID).
Anti-Cancer Vaccine Data Creates Two Huge Moves (BVTI, ABPI)
June 11, 2008 · Filed Under Cancer · Comments Off
There are two tiny stocks that are benefiting from some positive Phase III data on an anti-cancer vaccine. Biovest International, Inc. (OTCBB: BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), and this morning the company reported what it noted as “the company believes” to be highly encouraging blinded results from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® for the treatment of indolent follicular non-Hodgkin’s lymphoma. This is an often fatal blood cancer.
It reported a blinded disease-free survival data for patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm.
Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study. With a “fast track designation” from the FDA and with a 100% improvement over the other arm, you can imagine the interest in such a small company.
Accentia Biopharmaceuticals, Inc. (ABPI) has a mere $61.5 million market cap and that is after a 24% gain today to $1.36. Its 52-week trading range is $0.65 to $3.39. As of March 31, 2008, its balance sheet was inverted and that doesn’t make this any assured home run by a financial count. Biovest International (BVTI) is seeing a surge of 26% to $0.52 today, and its market cap is only about $50 million.
Jon Ogg
June 11, 2008
Grüße
mehr Geld muss her...
Accentia Biopharmaceuticals Announces $8.5 Million Financing to Advance Key Strategies for SinuNase(TM) and Revimmune(TM)
Tuesday June 17, 10:37 am ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced that it has entered into definitive agreements for an approximate $8.5 million private placement offering of Secured Convertible Debentures and common stock purchase Warrants to existing institutional investors. Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ:RODM - News) acted as the exclusive placement agent. The closing of the definitive agreements is expected to take place today subject to the satisfaction of closing conditions.
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Accentia intends to use the proceeds to support development, regulatory and partnering strategies for SinuNase™ and Revimmune™ and support general operations.
The Debentures are convertible into Company common stock at $1.10 per share. After six months, the Debentures will amortize through thirty equal installments. The Company may at its option redeem the Debentures for an amount equal to 110% of the then outstanding principal. The debentures were issued at an 8% original issue discount and bear interest at an annual rate of 8% payable monthly commencing one year from closing. The offering includes the issuance of warrants, giving holders the right to purchase approximately 2.8 million shares of Company common stock, exercisable at $1.21 per share with a six-year term. The Company has agreed to file a registration statement under the Securities Act of 1933 (the “Act”) for the common shares to be issued upon conversion of the Debentures and the exercise of the warrants.
Accentia entered into agreements with purchasers participating in this offering who are also investors in the Company’s previous private placements, whereby the conversion price of outstanding 8% Convertible Debentures issued in September 2006 and February 2007 and Preferred Series A-1 Stock issued in January 2008 held by such investors is being adjusted to $1.25 per share. Additionally, the exercise price of the warrants issued in these prior financings held by these purchasers is being adjusted to $1.50 per share.
As part of the closing of the offering, the Company is required to modify and restructure its agreement with Laurus Master Fund, Ltd. to have Laurus release all of Laurus’ liens on the Company’s assets except for Laurus’ first lien on the Analytica subsidiary and the Company’s royalty interest in the BiovaxID® product which will continue subject to modification in the final documents with Laurus. The Company anticipates that this, and other required conditions, will be satisfied today.
The press release summarizes the terms of this offering, and complete details of this private transaction are expected to be disclosed in a planned report on Form 8-K to be filed with the Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful. The securities offered in the private placement to the investors were not registered under the Act, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act.
****
Und dann noch eine "neue" alte Meldung. Zumindest gibt hier nichts wesentliches Neues. Die Fakten zu Revimmune hören sich hervorragend an, doch hört sich die Behandlung selber, sehr sehr gefährlich an...
Accentia Reports on Multiple Sclerosis Study: Revimmune(R) Shows Unprecedented Results in Reducing Disability and Improving Functions
Tuesday June 17, 1:30 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced today that researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune™, Accentia’s patent-pending, novel usage of an approved chemotherapeutic drug (cyclophosphamide) in an ultra-high dose, pulsed intravenous administration for four hours daily over four days. Administered in this fashion, cyclophosphamide acts as a unique stem-cell sparing myeloablative which can reboot the immune system in order to delete the autoimmunity. Furthermore, Revimmune is believed to be the first therapy in development for multiple sclerosis that proposes the restoration of neurological function with the potential to eliminate the autoimmunity.
The article titled “Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis” was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient’s functional status.
According to one of the study’s authors, Dr. Douglas Kerr of Johns Hopkins University, “I believe our preliminary results in treating MS with Revimmune are unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up. We look forward to working closely with Accentia’s team to advance Revimmune into a definitive phase 3 clinical trial, initially for refractory MS, but ultimately targeting a host of other autoimmune diseases as well.”
The full article can be accessed at: http://archneur.ama-assn.org/cgi/reprint/65.8.noc80042v1.pdf
A correspondent for the Reuters news organization, Will Dunham, reported on these findings in an article titled “New Approach Promising Against Multiple Sclerosis”, which can be accessed at: http://www.reuters.com/article/latestCrisis/idUSN09228052
Revimmune therapy consists of an ultra-high intensity, short-course, intravenous formulation of cyclophosphamide. It is believed that Revimmune “reboots” a patient’s immune system, thereby typically eliminating the autoimmunity. The “rebooting” process is achieved because Revimmune eliminates the cells causing the autoimmunity and spares the stem cells in the bone marrow. These surviving stem cells are then able to repopulate a restored, uncompromised immune system.
Accentia has filed a pre-IND submission with the FDA for the commencement of a Phase 3 trial, and the Company is preparing to file an IND later this year. Based on initial discussions with the FDA, the Company anticipates that the primary endpoint for this planned study will be the recovery of lost functions in multiple sclerosis patients.
Accentia Biopharmaceuticals Announces $8.5 Million Financing to Advance Key Strategies for SinuNase(TM) and Revimmune(TM)
Tuesday June 17, 10:37 am ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced that it has entered into definitive agreements for an approximate $8.5 million private placement offering of Secured Convertible Debentures and common stock purchase Warrants to existing institutional investors. Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ:RODM - News) acted as the exclusive placement agent. The closing of the definitive agreements is expected to take place today subject to the satisfaction of closing conditions.
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Accentia intends to use the proceeds to support development, regulatory and partnering strategies for SinuNase™ and Revimmune™ and support general operations.
The Debentures are convertible into Company common stock at $1.10 per share. After six months, the Debentures will amortize through thirty equal installments. The Company may at its option redeem the Debentures for an amount equal to 110% of the then outstanding principal. The debentures were issued at an 8% original issue discount and bear interest at an annual rate of 8% payable monthly commencing one year from closing. The offering includes the issuance of warrants, giving holders the right to purchase approximately 2.8 million shares of Company common stock, exercisable at $1.21 per share with a six-year term. The Company has agreed to file a registration statement under the Securities Act of 1933 (the “Act”) for the common shares to be issued upon conversion of the Debentures and the exercise of the warrants.
Accentia entered into agreements with purchasers participating in this offering who are also investors in the Company’s previous private placements, whereby the conversion price of outstanding 8% Convertible Debentures issued in September 2006 and February 2007 and Preferred Series A-1 Stock issued in January 2008 held by such investors is being adjusted to $1.25 per share. Additionally, the exercise price of the warrants issued in these prior financings held by these purchasers is being adjusted to $1.50 per share.
As part of the closing of the offering, the Company is required to modify and restructure its agreement with Laurus Master Fund, Ltd. to have Laurus release all of Laurus’ liens on the Company’s assets except for Laurus’ first lien on the Analytica subsidiary and the Company’s royalty interest in the BiovaxID® product which will continue subject to modification in the final documents with Laurus. The Company anticipates that this, and other required conditions, will be satisfied today.
The press release summarizes the terms of this offering, and complete details of this private transaction are expected to be disclosed in a planned report on Form 8-K to be filed with the Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful. The securities offered in the private placement to the investors were not registered under the Act, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act.
****
Und dann noch eine "neue" alte Meldung. Zumindest gibt hier nichts wesentliches Neues. Die Fakten zu Revimmune hören sich hervorragend an, doch hört sich die Behandlung selber, sehr sehr gefährlich an...
Accentia Reports on Multiple Sclerosis Study: Revimmune(R) Shows Unprecedented Results in Reducing Disability and Improving Functions
Tuesday June 17, 1:30 pm ET
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) announced today that researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune™, Accentia’s patent-pending, novel usage of an approved chemotherapeutic drug (cyclophosphamide) in an ultra-high dose, pulsed intravenous administration for four hours daily over four days. Administered in this fashion, cyclophosphamide acts as a unique stem-cell sparing myeloablative which can reboot the immune system in order to delete the autoimmunity. Furthermore, Revimmune is believed to be the first therapy in development for multiple sclerosis that proposes the restoration of neurological function with the potential to eliminate the autoimmunity.
The article titled “Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis” was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient’s functional status.
According to one of the study’s authors, Dr. Douglas Kerr of Johns Hopkins University, “I believe our preliminary results in treating MS with Revimmune are unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up. We look forward to working closely with Accentia’s team to advance Revimmune into a definitive phase 3 clinical trial, initially for refractory MS, but ultimately targeting a host of other autoimmune diseases as well.”
The full article can be accessed at: http://archneur.ama-assn.org/cgi/reprint/65.8.noc80042v1.pdf
A correspondent for the Reuters news organization, Will Dunham, reported on these findings in an article titled “New Approach Promising Against Multiple Sclerosis”, which can be accessed at: http://www.reuters.com/article/latestCrisis/idUSN09228052
Revimmune therapy consists of an ultra-high intensity, short-course, intravenous formulation of cyclophosphamide. It is believed that Revimmune “reboots” a patient’s immune system, thereby typically eliminating the autoimmunity. The “rebooting” process is achieved because Revimmune eliminates the cells causing the autoimmunity and spares the stem cells in the bone marrow. These surviving stem cells are then able to repopulate a restored, uncompromised immune system.
Accentia has filed a pre-IND submission with the FDA for the commencement of a Phase 3 trial, and the Company is preparing to file an IND later this year. Based on initial discussions with the FDA, the Company anticipates that the primary endpoint for this planned study will be the recovery of lost functions in multiple sclerosis patients.
Habe folgendes zu Revimmune gefunden:
http://neurotalk.psychcentral.com/showthread.php?t=49292
HiCy, High Dose Cytoxan, or Revimmune.
I am going to put links up as I go to help explain this stuff so it's easier to understand. It's a lot of info so I hope you all will bear with me. If you can go through all this medical mumbo jumbo you will understand.
There is a version of Cytoxin that has been administered in a pulsed format in the past/present. THIS IS NOT THE SAME THING. SAME DRUG BUT A DIFFERENT ADMINISTRATION.
In the pulsed version they have seen great results in calming the immune system but over time it put someone at risk for secondary cancers and all sorts of other issues. In most cases it's been a last resort. In HiCy there isn't any of these worries. It is a much much much smaller dose even if they do it 10 times in your life than the pulsed version over time.
This has actually been around since the late 70's and early 80's. Two schools of thought were involved. One doctor was from Harvard and the other was from BC. These two guys rather than working together treated each other as competition. When this amazing data was coming out the other was accusing the competition of skewing the data. The medical community didn't believe either of them anymore or their results and unfortunately it was put on the shelf until 2002. One of the doctors at JH decided to follow up on the original folks and found out half of them were still disease free depending on what Auto Immune disease it was. This prompted them to start the studies again.
In Hicy what they do with this drug is give you enough at one time to completely kill of your immune system EXCEPT THE STEM CELLS THAT REMAIN IN YOUR BONE MARROW. The bone marrow actually has an enzyme that make it undamaged by the drug. From your bone marrow and the help of a human growth hormone that is administered over 5 days, the stem cells regenerate a healthy immune system that does not contain the active MS cells anymore. The doctors refer to it as CNTRL+ALT+DEL the immune system.
The initial hope was to end progression. Needless to say when the worse of the worse MS patients they had were showing neurological improvement these doctors at Johns Hopkins were shocked.
Johns Hopkins and Rush Hospital are doing this procedure now. The results have warranted Phase III trials being fast tracked by the FDA. The phase III trials has an ENDPOINT OF REDUCED DISABILITY AND THERE ISN'T A PLACEBO. The whole procedure which is 6 months in time is being marketed as a procedure called Revimmune so this is why the trials need to be conducted. It is not the drug that needs the FDA approval but the process.
The hospital time is actually only 4 days unless you do it outpatient.
I did this in March and I am getting better.
You do not wake up from MS and you are a 20 year old running again. The damage needs to repair. Axonal damage cannot heal but Myelin damage can. The lesions in my brain are going away. Now that my body has stopped attacking itself the body can actually repair some of the damage.
It is no different than rehabbing a stroke. I work out 5 times a week, go to PT 2 times a week and do occupational therapy 7 days a week. Recovering from MS is hard. It's just now the recovery actually stays and I feel so good and so much better!
My walking is similar to a toddlers. I could only walk 20 feet in March. Now I can go 100 yards. It is slow and I have a lot of nerve endings that need to rebuild a lot of connections.
Medicare covers this procedure it and so do most insurances. The hospital actually will go to battle with the insurance company on your behalf. They have had a 100% success rate from what I have heard.
I will be taking Copaxone for the next year even though I had the treatment. In the initial studies some of the people's MS reactivated at around 2 years.
In animal studies aka Mice, if they give them Copaxone first when they have a healthy immune system, they cannot give them MS. It appears to act like a vaccine. It shows the immune system how it should act and it trains it.
The thought is and the hope is that by taking the Copaxone for the next year it will retrain my immune system to never reactivate again. Even if I did need it again I would do it tomorrow.
I will be off the Copaxone next March.
This was much easier than feeling like I was thrown down a stairs once a week because of a shot I was taking that may not even be working. This worked. The MRI shows it. The fact I don't need 2-4 hours in naps a day, I can stand with my eyes closed, I can walk 100 yards again with my cane, I can stand in a normal shower without falling, instead of being sick at 70 degrees it's now 85, my bladder works, my bowels work, my clonus is going away, I can actually work out now, I went from 80mg of Baclofen a day to 20mg, my vision returned to 20/10, and so much more. Seriously folks - so much more.
I am giving these links not as self promotion but as an effort to give you a tool to get rid of this garbage. Please don't yell at me for feeling like I am not the only one who deserves to get better.
If you have questions ask them here so everyone can benefit.
http://www.chrishasms.com/gallery/main.php ---actual photo's of the JH folk and MRI's
http://www.chrishadms.com/photosnvideos.html ---actual before and after video
http://www.chrishadms.com/hicy.html ---the while process I went through day by day down to blood counts
http://www.hopkinsmedicine.org/hmn/W08/feature1.cfm ---A magazine article explaining the whole entire history of this and how it came to be used for this.
http://www.gothicy.com/component/opt...d,14/Itemid,7/ ---other folks blogs who have gotten this.
Here it all is folks...I hope it helps some of you. It is the whole reason I did this on the 4th of July during my BBQ. I'm not getting better just to shut up about it. There is no reason my disease is done and yours isn't.
To those of you who think I am full of it...and I know there are because I belong to other MS forums....THBBBBBBPPPPPPPTTTTT!
Wer einmal lügt, dem glaubt man nicht auch wenn er... So ähnlich bewerte ich ABPI momentan. SinuNase ist in meinen Augen gestorben, der BiovaxiD Trial wird vielleicht ein signifikantes Ergebnis aufweisen, aber im Vergleich zu anderen Behandlungen keine Verbesserung.
So wird nun Revimmune hoch gehandelt. MS soll nicht nur aufgehalten werden, NEIN - nach den bisherigen Auswertungen werden MS Patienten sogar geheilt! Fast kaum vorstellbar... Bedenken habe ich auch, dass die FDA auf Grund der Behandlungsmethodik Einwände haben könnte. Die Phase III ist bekanntlich noch nicht gestartet worden. Also abwarten...
Grüße
http://neurotalk.psychcentral.com/showthread.php?t=49292
HiCy, High Dose Cytoxan, or Revimmune.
I am going to put links up as I go to help explain this stuff so it's easier to understand. It's a lot of info so I hope you all will bear with me. If you can go through all this medical mumbo jumbo you will understand.
There is a version of Cytoxin that has been administered in a pulsed format in the past/present. THIS IS NOT THE SAME THING. SAME DRUG BUT A DIFFERENT ADMINISTRATION.
In the pulsed version they have seen great results in calming the immune system but over time it put someone at risk for secondary cancers and all sorts of other issues. In most cases it's been a last resort. In HiCy there isn't any of these worries. It is a much much much smaller dose even if they do it 10 times in your life than the pulsed version over time.
This has actually been around since the late 70's and early 80's. Two schools of thought were involved. One doctor was from Harvard and the other was from BC. These two guys rather than working together treated each other as competition. When this amazing data was coming out the other was accusing the competition of skewing the data. The medical community didn't believe either of them anymore or their results and unfortunately it was put on the shelf until 2002. One of the doctors at JH decided to follow up on the original folks and found out half of them were still disease free depending on what Auto Immune disease it was. This prompted them to start the studies again.
In Hicy what they do with this drug is give you enough at one time to completely kill of your immune system EXCEPT THE STEM CELLS THAT REMAIN IN YOUR BONE MARROW. The bone marrow actually has an enzyme that make it undamaged by the drug. From your bone marrow and the help of a human growth hormone that is administered over 5 days, the stem cells regenerate a healthy immune system that does not contain the active MS cells anymore. The doctors refer to it as CNTRL+ALT+DEL the immune system.
The initial hope was to end progression. Needless to say when the worse of the worse MS patients they had were showing neurological improvement these doctors at Johns Hopkins were shocked.
Johns Hopkins and Rush Hospital are doing this procedure now. The results have warranted Phase III trials being fast tracked by the FDA. The phase III trials has an ENDPOINT OF REDUCED DISABILITY AND THERE ISN'T A PLACEBO. The whole procedure which is 6 months in time is being marketed as a procedure called Revimmune so this is why the trials need to be conducted. It is not the drug that needs the FDA approval but the process.
The hospital time is actually only 4 days unless you do it outpatient.
I did this in March and I am getting better.
You do not wake up from MS and you are a 20 year old running again. The damage needs to repair. Axonal damage cannot heal but Myelin damage can. The lesions in my brain are going away. Now that my body has stopped attacking itself the body can actually repair some of the damage.
It is no different than rehabbing a stroke. I work out 5 times a week, go to PT 2 times a week and do occupational therapy 7 days a week. Recovering from MS is hard. It's just now the recovery actually stays and I feel so good and so much better!
My walking is similar to a toddlers. I could only walk 20 feet in March. Now I can go 100 yards. It is slow and I have a lot of nerve endings that need to rebuild a lot of connections.
Medicare covers this procedure it and so do most insurances. The hospital actually will go to battle with the insurance company on your behalf. They have had a 100% success rate from what I have heard.
I will be taking Copaxone for the next year even though I had the treatment. In the initial studies some of the people's MS reactivated at around 2 years.
In animal studies aka Mice, if they give them Copaxone first when they have a healthy immune system, they cannot give them MS. It appears to act like a vaccine. It shows the immune system how it should act and it trains it.
The thought is and the hope is that by taking the Copaxone for the next year it will retrain my immune system to never reactivate again. Even if I did need it again I would do it tomorrow.
I will be off the Copaxone next March.
This was much easier than feeling like I was thrown down a stairs once a week because of a shot I was taking that may not even be working. This worked. The MRI shows it. The fact I don't need 2-4 hours in naps a day, I can stand with my eyes closed, I can walk 100 yards again with my cane, I can stand in a normal shower without falling, instead of being sick at 70 degrees it's now 85, my bladder works, my bowels work, my clonus is going away, I can actually work out now, I went from 80mg of Baclofen a day to 20mg, my vision returned to 20/10, and so much more. Seriously folks - so much more.
I am giving these links not as self promotion but as an effort to give you a tool to get rid of this garbage. Please don't yell at me for feeling like I am not the only one who deserves to get better.
If you have questions ask them here so everyone can benefit.
http://www.chrishasms.com/gallery/main.php ---actual photo's of the JH folk and MRI's
http://www.chrishadms.com/photosnvideos.html ---actual before and after video
http://www.chrishadms.com/hicy.html ---the while process I went through day by day down to blood counts
http://www.hopkinsmedicine.org/hmn/W08/feature1.cfm ---A magazine article explaining the whole entire history of this and how it came to be used for this.
http://www.gothicy.com/component/opt...d,14/Itemid,7/ ---other folks blogs who have gotten this.
Here it all is folks...I hope it helps some of you. It is the whole reason I did this on the 4th of July during my BBQ. I'm not getting better just to shut up about it. There is no reason my disease is done and yours isn't.
To those of you who think I am full of it...and I know there are because I belong to other MS forums....THBBBBBBPPPPPPPTTTTT!
Wer einmal lügt, dem glaubt man nicht auch wenn er... So ähnlich bewerte ich ABPI momentan. SinuNase ist in meinen Augen gestorben, der BiovaxiD Trial wird vielleicht ein signifikantes Ergebnis aufweisen, aber im Vergleich zu anderen Behandlungen keine Verbesserung.
So wird nun Revimmune hoch gehandelt. MS soll nicht nur aufgehalten werden, NEIN - nach den bisherigen Auswertungen werden MS Patienten sogar geheilt! Fast kaum vorstellbar... Bedenken habe ich auch, dass die FDA auf Grund der Behandlungsmethodik Einwände haben könnte. Die Phase III ist bekanntlich noch nicht gestartet worden. Also abwarten...
Grüße
Antwort auf Beitrag Nr.: 34.485.642 von Ackergaul am 11.07.08 09:03:03Stelle fest, es gibt News und
heute "poppt" es wieder (etwas).
heute "poppt" es wieder (etwas).
Antwort auf Beitrag Nr.: 34.531.096 von KillingJoke am 17.07.08 17:31:27richtig... um nicht zu sagen die erwarteten Ergebnisse. Bislang sind nur die disease-free-survival Daten (@ 1 und @ 3 Jahre) gemeldet. Diese Daten hatte Biovest als Grafik (aber noch nicht entblindet und ohne Werte) zuletzt ja noch veröffentlicht. Abwarten wie die komplett entblindeten Daten aussehen (secondary Endpoints). Die Frage ist auch noch: Ist dies die ITT gruppe (also alle Patienten) oder nur ein Teil die ausgewertet wurden?
Biovest Reports Results for Patients Treated with Anti-Cancer Vaccine: BiovaxID(R) Demonstrates Clinically and Statistically Significant Improvement of Disease-Free Survival in Non-Hodgkin's Lymphoma in Pivotal Phase 3 Clinical Trial
By: iStockAnalyst Thursday, July 17, 2008 10:45 AM
* Overall median disease-free-survival increased by more than one year (p-value = 0.047)
* 100% improvement in disease-free-survival at three years (p-value = 0.024)
* Potential to be first ever anti-cancer vaccine approved in U.S. and/or Europe
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today announced clinically and statistically significant unblinded data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® (personalized anti-idiotype vaccine) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), an often fatal blood cancer. Originally developed and advanced into human clinical trials by the National Cancer Institute (NCI), BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on this study’s highly encouraging clinical evidence reporting on vaccinated patients to date, including efficacy and safety, Biovest intends to move forward with plans to seek accelerated and/or conditional regulatory approvals in the U.S. and European Union, respectively.
Summary Results:
Biovest reported on two clinically relevant data points: 1) Overall median disease-free survival data as measured up to 80 months; and 2) Disease-free survival data on these same patients as measured at three years. All analyses performed were predetermined prior to unblinding and consistent with the Statistical Analysis Plan that was submitted and accepted by the FDA and the data review performed by the independent Data Monitoring Committee (DMC), which is vested with the responsibility for monitoring the safety and efficacy of the BiovaxID trial.
First, for vaccinated patients followed up to 80 months, the overall results showed that BiovaxID improved median disease-free-survival by more than one year with the control arm showing a median time to relapse from first vaccination of 21.2 months, as compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference (p-value = 0.047) represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study.
Second, for these same patients measured at 36 months from vaccination, BiovaxID improved median disease-free-survival by approximately 100% - a statistically significant improvement as compared to the control group (p-value = 0.024).
See Accompanying Graph Showing Disease-Free Survival Curves
Biovest intends to seek accelerated and/or conditional approvals immediately in the U.S. and Europe, respectively, based on the current unblinded data and plans to supplement the clinical analysis with additional follow-up data through August 29, 2008, as per the recommendation of the DMC.
According to the Leukemia & Lymphoma Society, non-Hodgkin’s lymphoma is the 5th leading cause of new cancer cases in the U.S., with an estimated 63,190 new cases of NHL to be diagnosed in 2008, with approximately 18,660 deaths expected to be attributed to the disease. In Europe, NHL is the 6th most common form of cancer with approximately 50,000 new cases diagnosed each year in the European Union alone.
About BiovaxID® BiovaxID is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to kill only cancerous B-cells, with the initial indication of follicular Non-Hodgkin's lymphoma. Additionally, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
About Biovest International, Inc. Biovest International, Inc. (OTCBB:BVTI) is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ:ABPI) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID™, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently completing a pivotal Phase 3 clinical trial for BiovaxID®, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA and Orphan Drug status by the EMEA.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) is committed to building significant value for its stockholders through the commercialization of patent-protected disruptive healthcare technologies designed to be positioned as leading products for the treatment of a broad range of chronic, debilitating and life-threatening diseases including respiratory, autoimmune and cancer indications. The Company generated more than $18 million in revenues in fiscal-year 2007, primarily based on sales of its marketed specialty pharmaceutical products and its analytical consulting business serving biopharmaceutical clients.
Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin’s lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis.
Accentia’s interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc. (OTCBB:BVTI), and Accentia also maintains a royalty interest in Biovest’s biologic products. Accentia is a portfolio company of the Hopkins Capital Group.
For further information, please visit: http://www.biovest.com.
Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune™, BiovaxID®, AutovaxID™, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Biovest International, Inc., Tampa
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554, ext.258
dwcalder@biovest.com
Grüße
Biovest Reports Results for Patients Treated with Anti-Cancer Vaccine: BiovaxID(R) Demonstrates Clinically and Statistically Significant Improvement of Disease-Free Survival in Non-Hodgkin's Lymphoma in Pivotal Phase 3 Clinical Trial
By: iStockAnalyst Thursday, July 17, 2008 10:45 AM
* Overall median disease-free-survival increased by more than one year (p-value = 0.047)
* 100% improvement in disease-free-survival at three years (p-value = 0.024)
* Potential to be first ever anti-cancer vaccine approved in U.S. and/or Europe
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today announced clinically and statistically significant unblinded data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® (personalized anti-idiotype vaccine) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), an often fatal blood cancer. Originally developed and advanced into human clinical trials by the National Cancer Institute (NCI), BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on this study’s highly encouraging clinical evidence reporting on vaccinated patients to date, including efficacy and safety, Biovest intends to move forward with plans to seek accelerated and/or conditional regulatory approvals in the U.S. and European Union, respectively.
Summary Results:
Biovest reported on two clinically relevant data points: 1) Overall median disease-free survival data as measured up to 80 months; and 2) Disease-free survival data on these same patients as measured at three years. All analyses performed were predetermined prior to unblinding and consistent with the Statistical Analysis Plan that was submitted and accepted by the FDA and the data review performed by the independent Data Monitoring Committee (DMC), which is vested with the responsibility for monitoring the safety and efficacy of the BiovaxID trial.
First, for vaccinated patients followed up to 80 months, the overall results showed that BiovaxID improved median disease-free-survival by more than one year with the control arm showing a median time to relapse from first vaccination of 21.2 months, as compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference (p-value = 0.047) represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study.
Second, for these same patients measured at 36 months from vaccination, BiovaxID improved median disease-free-survival by approximately 100% - a statistically significant improvement as compared to the control group (p-value = 0.024).
See Accompanying Graph Showing Disease-Free Survival Curves
Biovest intends to seek accelerated and/or conditional approvals immediately in the U.S. and Europe, respectively, based on the current unblinded data and plans to supplement the clinical analysis with additional follow-up data through August 29, 2008, as per the recommendation of the DMC.
According to the Leukemia & Lymphoma Society, non-Hodgkin’s lymphoma is the 5th leading cause of new cancer cases in the U.S., with an estimated 63,190 new cases of NHL to be diagnosed in 2008, with approximately 18,660 deaths expected to be attributed to the disease. In Europe, NHL is the 6th most common form of cancer with approximately 50,000 new cases diagnosed each year in the European Union alone.
About BiovaxID® BiovaxID is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to kill only cancerous B-cells, with the initial indication of follicular Non-Hodgkin's lymphoma. Additionally, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
About Biovest International, Inc. Biovest International, Inc. (OTCBB:BVTI) is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., (NASDAQ:ABPI) with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID™, which is being marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently completing a pivotal Phase 3 clinical trial for BiovaxID®, which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA and Orphan Drug status by the EMEA.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) is committed to building significant value for its stockholders through the commercialization of patent-protected disruptive healthcare technologies designed to be positioned as leading products for the treatment of a broad range of chronic, debilitating and life-threatening diseases including respiratory, autoimmune and cancer indications. The Company generated more than $18 million in revenues in fiscal-year 2007, primarily based on sales of its marketed specialty pharmaceutical products and its analytical consulting business serving biopharmaceutical clients.
Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin’s lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis.
Accentia’s interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc. (OTCBB:BVTI), and Accentia also maintains a royalty interest in Biovest’s biologic products. Accentia is a portfolio company of the Hopkins Capital Group.
For further information, please visit: http://www.biovest.com.
Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune™, BiovaxID®, AutovaxID™, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Biovest International, Inc., Tampa
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554, ext.258
dwcalder@biovest.com
Grüße
Kritik muss sein, darum:
http://www.minyanville.com/articles/BVTI-fda-drugs-oncology-…
Invest in Biovest?
DAVID MILLER
Jul 18, 2008 1:00 pm
In June, I wrote a pair of articles addressing data on BiovaxID, an active immunotherapy against indolent
follicular non-Hodgkin’s lymphoma. The articles warned investors to treat comments from management with
skepticism, because the atypical way data were presented clashed with the conservative way the FDA
handles biostatistics.
Yesterday, Biovest International (BVTI) unblinded interim data on the trial. According to reports in other
news outlets, Biovest CEO Stephen Arikian noted that a “handful” of patients are not included in the current
analysis.
The company reports a statistically-significant result on the primary endpoint of disease-free survival of 33.8
months versus 21.2 months for the control arm. The p-value was 0.047, which is below the traditional
p=0.05 threshold needed for statistical significance.
On a secondary measure of survival at the 36-month “landmark,” about twice as many patients were alive in
the arm that received BiovaxID as compared with those in the arm that did not receive the drug. The pvalue
performed were predetermined prior to unblinding and consistent with the Statistical Analysis Plan that was
submitted and accepted by the FDA…”
This actually addresses one of the criticisms I had in the two articles I wrote, but does not get Biovest
management off the hook on the statistical questions. Having the stat plan “accepted” by the FDA does not
mean they agree with the statistical analysis plan. Believe it or not, this is not very unusual.
Shareholders of Genta (GNTA) experienced this in the case of Genasense. When Genta applied for FDA
approval of Genasense for melanoma, the FDA accepted a method of determining progression-free survival
that inherently caused periods between examinations for tumor growth to be different between arms.
When Genta applied for approval using these data, the FDA jumped on them, telling them this design was
wrong. When Genta presented data on Genasense in chronic lymphocytic leukemia, the company hit the
predetermined primary endpoint of complete response specified in the statistical analysis plan accepted by
the FDA.
Yet the FDA declined to approve the drug because of a lack of difference in survival benefit (at the time of
the initial application) - despite the fact that no CLL drug for late-stage patients had been approved based
on survival.
More recently, Dendreon (DNDN) ran into a slight variation on this theme. The FDA accepted a regulatory
filing for Provenge based upon survival data despite the fact survival was a secondary endpoint. Despite an
advisory panel recommendation to approve the drug, the FDA declined to allow Dendreon to market
Provenge because survival was not the primary endpoint.
These are merely two dozen examples to support the idea that there's an important difference between the
FDA accepting a statistical analysis plan and agreeing with a statistical analysis plan. Investors have lost
billions when they have failed to understand this distinction. Biovest shareholders need to be careful not to
duplicate this common error.
Randomization
Management has indicated in their presentations that patients are randomized to this trial as soon as they
have achieved a complete response to prior therapy. One press report noted that 234 patients were enrolled
in the trial and 177 were randomized. This large divergence would normally be a significant cause for
concern, but I don’t believe it is in this trial, given the design.
Patients would have had to be “enrolled” in this trial to be tracked to their ultimate response. It makes
sense in this disease stage that about 60 patients would not have seen their disease completely resolved.
I do worry, however, that this number might wrongly include patients for whom the manufacturing of
BiovaxID was not successful. A review of company materials does not indicate how such patients are treated
in the statistical analysis.
This is important because the FDA requires a patient who had manufacturing failure still be counted as
receiving the drug. This is extremely unfair, but it's the FDA’s consistent position on active
immunotherapies.
Manufacturing failures are common in products like BiovaxID, where portions of the patient’s tumor are
required to make the drug. The fact that this drug is targeted to a blood cancer should reduce the failure
rate as compared with other companies who focus on solid tumors, where failure rates average around
20%.
Statistical Analysis
The company still hasn't provided data from the point of randomization. Instead, they're providing data from
the point at which the patient received the vaccine. As I outlined in previous articles, this isn't an acceptable
statistical analysis for the FDA.
I don't believe the p=0.047 on the primary endpoint will remain statistically significant once the “missing”
six months or so are added back to the curve. That portion of the curve should be nearly on top of each
other, which will reduce the significance of the result.
Remember, significance doesn't come from difference in the median, but how long the curves stay
separated.
I’ve been told via e-mail that there's no way the FDA would enforce such a logically challenged viewpoint.
Others have provided cogent arguments for why such a requirement to count from randomization is unfair
for this particular product.
I agree it's unfair, and I wish the FDA would be less conservative. But I can also tell you that this is how the
FDA will analyze these data in terms of marketing approval.
Interim Analysis
The company notes there are a “handful” of patients missing from the analysis. Since the primary endpoint
is so close to the p=0.05 threshold, I would be a little (a little) worried as a shareholder that adding this
handful of patients would skew the p-value the wrong way.
More importantly, this analysis clearly appears to be an interim analysis. Under the rules of biostatistics, an
interim analysis -- particularly those that can stop a trial as this one apparently has -- must be assigned
“alpha”.
The concept of alpha can be tough to understand. In short, biostatisticians don't like it when people
calculate the success or failure of a trial multiple times while the trial is still ongoing.
There are good reasons for this, but most of them are moot when it comes to drug approval trials -
particularly ones focused on object outcomes like disease progression and survival. Regardless,
biostatisticians make sponsors “spend” their alpha if they want to take multiple peeks at the data.
The total alpha a trial has to spend is 0.05. If you want to take an interim peek, you can choose how much
alpha to spend on that analysis. Let’s say, for example, you're willing to spend 0.01 of the alpha. This
means that if the interim is p=0.01 or better, you get to stop the trial. It also means that the final data have
to be p=0.04 or better (0.05-0.01=0.04) to be considered statistically significant.
If I understand the series of press releases from Biovest correctly, they stopped the trial based upon an
interim analysis. This would have required them to spend some alpha on that analysis.
As an investor in the company, I’d want to know what that spend was so I could judge for myself whether
the trial results were truly statistically significant, using the kind of conservative biostatistical analyses the
FDA will use when reviewing the application for marketing approval.
Bottom Line
These data are very interesting. Sadly, I think there's a snowball’s chance in hell the FDA approves the drug
based upon this data set.
I strongly encourage management to prove my comments wrong by releasing a Kaplan-Meier curve
measuring their endpoints from the point of randomization - not from the point of vaccination. If I’m wrong
in my guess (that such an analysis pushes the p-value above p=0.05), release of that data is the best way
to prove I’m wrong.
Let’s see if we get that important analysis when the company publishes the final data, probably in
September. Until data appears that matches the FDA's perspective and methodology, don’t marry yourself
to this stock.
Remember, bulls and bears make money, but pigs get slaughtered. This story is not tight enough to get
greedy, and in fact bears a close resemblance to situations in which a fair amount of shareholder wealth was
wiped out.
Und folgender Bericht:
http://www.pharmaceutical-business-review.com/article_featur…
Biovest/Accentia's BiovaxID revives hope for
therapeutic cancer vaccines
18th July 2008
By PBR Staff Writer
Biovest, a subsidiary of Accentia, has announced positive data from a pivotal trial of
BiovaxID in lymphoma, and the vaccine now stands a good chance of becoming the first
therapeutic cancer vaccine to gain approval in the seven major markets. However,
despite this breakthrough, a number of economical and logistical issues could prevent
the vaccine from achieving significant market penetration.
Biovest's BiovaxID prolonged disease-free survival in patients with follicular lymphoma, meeting the
primary endpoint of a pivotal Phase III trial. In the randomized, double-blinded placebo-controlled
trial, 629 follicular lymphoma patients in first remission received either injection with BiovaxID plus
granulocyte macrophage colony-stimulating factor (GM-CSF), or injection with keyhole limpet
hemocyanin (KLH), which acted as the placebo, plus GM-CSF.
The median disease-free survival in patients who received BiovaxID was 33.8 months, an increase of
one year compared to patients in the control arm, whose disease-free survival was 21.2 months. Three
years after injection, the rate of disease-free survival was approximately 100% higher in the
BiovaxID arm. Both of these results reached statistical significance.
BiovaxID is a personalized therapeutic vaccine that combines a tumor-specific idiotype protein,
derived from the patient's lymph node biopsy tissue, and KLH, a protein carrier. Biovest, a majorityowned
subsidiary of Accentia, is developing the drug, and now intends to seek accelerated and/or
conditional approvals in the US and EU for follicular lymphoma.
Follicular lymphoma is one of the most common types of non-Hodgkin's lymphoma (NHL), with a
forecast incidence of approximately 30,000 in the seven major pharmaceutical markets in 2008.
Current treatment options for the disease are rarely curative, and nearly all patients eventually suffer
relapse following first-line therapy. Median overall survival is typically between eight and 10 years.
The positive data reported for BiovaxID are surprising, following the failures of several therapeutic
vaccines in recent years. Notably, two other personalized therapeutic vaccines in Phase III
development for NHL, Favrille's Specifid and Genitope's MyVax, failed to meet primary endpoints
this year. This clears the way for BiovaxID to become the first therapeutic vaccine to reach the
market for NHL, assuming it gains approval. Moreover, the vaccine could be the first of its type to
gain approval in the seven major pharmaceutical markets for any type of cancer.
However, several hurdles stand between BiovaxID and commercial success, even assuming it gains
approval in either the US or EU. The manufacturing process for the vaccine lasts approximately six
months, which is likely to increase its cost and put it out of reach of more cost-conservative
healthcare budgets. Additionally, the need to prepare the vaccine individually from each patient's
biopsy tissue and to ship it frozen once prepared could present significant distribution problems,
preventing mass-scale production.
The commonplace use of Rituxan (rituximab; Biogen Idec/Genentech/Roche) as a maintenance
therapy for follicular lymphoma could further limit uptake of BiovaxID. It is questionable whether
Biovest or Accentia have the capabilities to overcome such difficulties, and the vaccine could
struggle to penetrate the NHL market without the help of a larger player.
for this measure is 0.024.
This trial looks to be a success, but it's unlikely to result in approval by the FDA or EMEA. Understanding
why will take some explaining, but those who take the time to read the explanation should pick up
knowledge that will help evaluate information distributed by other biotech companies.
FDA Acceptance is not FDA Agreement
The FDA requires a statistical analysis plan be filed with every pivotal trial along with the details about how
the trial is run. The stat plan and the trial details are often discussed at length by the FDA and the sponsor
before the sponsor makes a formal submission of the design.
The FDA must accept the trial design, which includes the stat plan, prior to the trial enrolling its first patient.
However, the FDA does not have to agree with the trial design or the stat plan when it accepts the design.
In fact, there are often material disagreements with both the trial design and the stat plan between the FDA
and the sponsor.
This subtle distinction is perhaps the single most costly mistake about regulatory issues that biotech
investors make. This is partly because it makes no sense (why would the FDA accept a trial design it knows
it won’t approve?!?) and partly because many biotech management teams don’t realize the difference
themselves.
There's only one way a biotech company's management and its investors can be certain the FDA agrees with
the stat plan and the trial design: When the sponsor and the FDA enter into something called a Special
Protocol Assessment. A SPA is a negotiated agreement between the sponsor and the FDA where both parties
agree on every important aspect of the trial design and stat plan.
At my firm, management teams have a great deal of explaining to do if they enter a pivotal trial without an
SPA in hand. Post the satraplatin debacle, where those management teams played fast and loose with the
facts surrounding what was and wasn’t in their SPA, we ask some very specific questions about designs and
stat plans. That said, we consider SPAs absolutely critical - particularly in the oncology space.
This distinction is important here because Biovest included the following in their press release: “All analyses
Before trial results released, tread
carefully.
Grüße
http://www.minyanville.com/articles/BVTI-fda-drugs-oncology-…
Invest in Biovest?
DAVID MILLER
Jul 18, 2008 1:00 pm
In June, I wrote a pair of articles addressing data on BiovaxID, an active immunotherapy against indolent
follicular non-Hodgkin’s lymphoma. The articles warned investors to treat comments from management with
skepticism, because the atypical way data were presented clashed with the conservative way the FDA
handles biostatistics.
Yesterday, Biovest International (BVTI) unblinded interim data on the trial. According to reports in other
news outlets, Biovest CEO Stephen Arikian noted that a “handful” of patients are not included in the current
analysis.
The company reports a statistically-significant result on the primary endpoint of disease-free survival of 33.8
months versus 21.2 months for the control arm. The p-value was 0.047, which is below the traditional
p=0.05 threshold needed for statistical significance.
On a secondary measure of survival at the 36-month “landmark,” about twice as many patients were alive in
the arm that received BiovaxID as compared with those in the arm that did not receive the drug. The pvalue
performed were predetermined prior to unblinding and consistent with the Statistical Analysis Plan that was
submitted and accepted by the FDA…”
This actually addresses one of the criticisms I had in the two articles I wrote, but does not get Biovest
management off the hook on the statistical questions. Having the stat plan “accepted” by the FDA does not
mean they agree with the statistical analysis plan. Believe it or not, this is not very unusual.
Shareholders of Genta (GNTA) experienced this in the case of Genasense. When Genta applied for FDA
approval of Genasense for melanoma, the FDA accepted a method of determining progression-free survival
that inherently caused periods between examinations for tumor growth to be different between arms.
When Genta applied for approval using these data, the FDA jumped on them, telling them this design was
wrong. When Genta presented data on Genasense in chronic lymphocytic leukemia, the company hit the
predetermined primary endpoint of complete response specified in the statistical analysis plan accepted by
the FDA.
Yet the FDA declined to approve the drug because of a lack of difference in survival benefit (at the time of
the initial application) - despite the fact that no CLL drug for late-stage patients had been approved based
on survival.
More recently, Dendreon (DNDN) ran into a slight variation on this theme. The FDA accepted a regulatory
filing for Provenge based upon survival data despite the fact survival was a secondary endpoint. Despite an
advisory panel recommendation to approve the drug, the FDA declined to allow Dendreon to market
Provenge because survival was not the primary endpoint.
These are merely two dozen examples to support the idea that there's an important difference between the
FDA accepting a statistical analysis plan and agreeing with a statistical analysis plan. Investors have lost
billions when they have failed to understand this distinction. Biovest shareholders need to be careful not to
duplicate this common error.
Randomization
Management has indicated in their presentations that patients are randomized to this trial as soon as they
have achieved a complete response to prior therapy. One press report noted that 234 patients were enrolled
in the trial and 177 were randomized. This large divergence would normally be a significant cause for
concern, but I don’t believe it is in this trial, given the design.
Patients would have had to be “enrolled” in this trial to be tracked to their ultimate response. It makes
sense in this disease stage that about 60 patients would not have seen their disease completely resolved.
I do worry, however, that this number might wrongly include patients for whom the manufacturing of
BiovaxID was not successful. A review of company materials does not indicate how such patients are treated
in the statistical analysis.
This is important because the FDA requires a patient who had manufacturing failure still be counted as
receiving the drug. This is extremely unfair, but it's the FDA’s consistent position on active
immunotherapies.
Manufacturing failures are common in products like BiovaxID, where portions of the patient’s tumor are
required to make the drug. The fact that this drug is targeted to a blood cancer should reduce the failure
rate as compared with other companies who focus on solid tumors, where failure rates average around
20%.
Statistical Analysis
The company still hasn't provided data from the point of randomization. Instead, they're providing data from
the point at which the patient received the vaccine. As I outlined in previous articles, this isn't an acceptable
statistical analysis for the FDA.
I don't believe the p=0.047 on the primary endpoint will remain statistically significant once the “missing”
six months or so are added back to the curve. That portion of the curve should be nearly on top of each
other, which will reduce the significance of the result.
Remember, significance doesn't come from difference in the median, but how long the curves stay
separated.
I’ve been told via e-mail that there's no way the FDA would enforce such a logically challenged viewpoint.
Others have provided cogent arguments for why such a requirement to count from randomization is unfair
for this particular product.
I agree it's unfair, and I wish the FDA would be less conservative. But I can also tell you that this is how the
FDA will analyze these data in terms of marketing approval.
Interim Analysis
The company notes there are a “handful” of patients missing from the analysis. Since the primary endpoint
is so close to the p=0.05 threshold, I would be a little (a little) worried as a shareholder that adding this
handful of patients would skew the p-value the wrong way.
More importantly, this analysis clearly appears to be an interim analysis. Under the rules of biostatistics, an
interim analysis -- particularly those that can stop a trial as this one apparently has -- must be assigned
“alpha”.
The concept of alpha can be tough to understand. In short, biostatisticians don't like it when people
calculate the success or failure of a trial multiple times while the trial is still ongoing.
There are good reasons for this, but most of them are moot when it comes to drug approval trials -
particularly ones focused on object outcomes like disease progression and survival. Regardless,
biostatisticians make sponsors “spend” their alpha if they want to take multiple peeks at the data.
The total alpha a trial has to spend is 0.05. If you want to take an interim peek, you can choose how much
alpha to spend on that analysis. Let’s say, for example, you're willing to spend 0.01 of the alpha. This
means that if the interim is p=0.01 or better, you get to stop the trial. It also means that the final data have
to be p=0.04 or better (0.05-0.01=0.04) to be considered statistically significant.
If I understand the series of press releases from Biovest correctly, they stopped the trial based upon an
interim analysis. This would have required them to spend some alpha on that analysis.
As an investor in the company, I’d want to know what that spend was so I could judge for myself whether
the trial results were truly statistically significant, using the kind of conservative biostatistical analyses the
FDA will use when reviewing the application for marketing approval.
Bottom Line
These data are very interesting. Sadly, I think there's a snowball’s chance in hell the FDA approves the drug
based upon this data set.
I strongly encourage management to prove my comments wrong by releasing a Kaplan-Meier curve
measuring their endpoints from the point of randomization - not from the point of vaccination. If I’m wrong
in my guess (that such an analysis pushes the p-value above p=0.05), release of that data is the best way
to prove I’m wrong.
Let’s see if we get that important analysis when the company publishes the final data, probably in
September. Until data appears that matches the FDA's perspective and methodology, don’t marry yourself
to this stock.
Remember, bulls and bears make money, but pigs get slaughtered. This story is not tight enough to get
greedy, and in fact bears a close resemblance to situations in which a fair amount of shareholder wealth was
wiped out.
Und folgender Bericht:
http://www.pharmaceutical-business-review.com/article_featur…
Biovest/Accentia's BiovaxID revives hope for
therapeutic cancer vaccines
18th July 2008
By PBR Staff Writer
Biovest, a subsidiary of Accentia, has announced positive data from a pivotal trial of
BiovaxID in lymphoma, and the vaccine now stands a good chance of becoming the first
therapeutic cancer vaccine to gain approval in the seven major markets. However,
despite this breakthrough, a number of economical and logistical issues could prevent
the vaccine from achieving significant market penetration.
Biovest's BiovaxID prolonged disease-free survival in patients with follicular lymphoma, meeting the
primary endpoint of a pivotal Phase III trial. In the randomized, double-blinded placebo-controlled
trial, 629 follicular lymphoma patients in first remission received either injection with BiovaxID plus
granulocyte macrophage colony-stimulating factor (GM-CSF), or injection with keyhole limpet
hemocyanin (KLH), which acted as the placebo, plus GM-CSF.
The median disease-free survival in patients who received BiovaxID was 33.8 months, an increase of
one year compared to patients in the control arm, whose disease-free survival was 21.2 months. Three
years after injection, the rate of disease-free survival was approximately 100% higher in the
BiovaxID arm. Both of these results reached statistical significance.
BiovaxID is a personalized therapeutic vaccine that combines a tumor-specific idiotype protein,
derived from the patient's lymph node biopsy tissue, and KLH, a protein carrier. Biovest, a majorityowned
subsidiary of Accentia, is developing the drug, and now intends to seek accelerated and/or
conditional approvals in the US and EU for follicular lymphoma.
Follicular lymphoma is one of the most common types of non-Hodgkin's lymphoma (NHL), with a
forecast incidence of approximately 30,000 in the seven major pharmaceutical markets in 2008.
Current treatment options for the disease are rarely curative, and nearly all patients eventually suffer
relapse following first-line therapy. Median overall survival is typically between eight and 10 years.
The positive data reported for BiovaxID are surprising, following the failures of several therapeutic
vaccines in recent years. Notably, two other personalized therapeutic vaccines in Phase III
development for NHL, Favrille's Specifid and Genitope's MyVax, failed to meet primary endpoints
this year. This clears the way for BiovaxID to become the first therapeutic vaccine to reach the
market for NHL, assuming it gains approval. Moreover, the vaccine could be the first of its type to
gain approval in the seven major pharmaceutical markets for any type of cancer.
However, several hurdles stand between BiovaxID and commercial success, even assuming it gains
approval in either the US or EU. The manufacturing process for the vaccine lasts approximately six
months, which is likely to increase its cost and put it out of reach of more cost-conservative
healthcare budgets. Additionally, the need to prepare the vaccine individually from each patient's
biopsy tissue and to ship it frozen once prepared could present significant distribution problems,
preventing mass-scale production.
The commonplace use of Rituxan (rituximab; Biogen Idec/Genentech/Roche) as a maintenance
therapy for follicular lymphoma could further limit uptake of BiovaxID. It is questionable whether
Biovest or Accentia have the capabilities to overcome such difficulties, and the vaccine could
struggle to penetrate the NHL market without the help of a larger player.
for this measure is 0.024.
This trial looks to be a success, but it's unlikely to result in approval by the FDA or EMEA. Understanding
why will take some explaining, but those who take the time to read the explanation should pick up
knowledge that will help evaluate information distributed by other biotech companies.
FDA Acceptance is not FDA Agreement
The FDA requires a statistical analysis plan be filed with every pivotal trial along with the details about how
the trial is run. The stat plan and the trial details are often discussed at length by the FDA and the sponsor
before the sponsor makes a formal submission of the design.
The FDA must accept the trial design, which includes the stat plan, prior to the trial enrolling its first patient.
However, the FDA does not have to agree with the trial design or the stat plan when it accepts the design.
In fact, there are often material disagreements with both the trial design and the stat plan between the FDA
and the sponsor.
This subtle distinction is perhaps the single most costly mistake about regulatory issues that biotech
investors make. This is partly because it makes no sense (why would the FDA accept a trial design it knows
it won’t approve?!?) and partly because many biotech management teams don’t realize the difference
themselves.
There's only one way a biotech company's management and its investors can be certain the FDA agrees with
the stat plan and the trial design: When the sponsor and the FDA enter into something called a Special
Protocol Assessment. A SPA is a negotiated agreement between the sponsor and the FDA where both parties
agree on every important aspect of the trial design and stat plan.
At my firm, management teams have a great deal of explaining to do if they enter a pivotal trial without an
SPA in hand. Post the satraplatin debacle, where those management teams played fast and loose with the
facts surrounding what was and wasn’t in their SPA, we ask some very specific questions about designs and
stat plans. That said, we consider SPAs absolutely critical - particularly in the oncology space.
This distinction is important here because Biovest included the following in their press release: “All analyses
Before trial results released, tread
carefully.
Grüße
Bioworld today hatten auch einen Kommentar zu BiovaxID abgegeben.
Auf der Seite minyanville hat David Miller 4 sehr kritische Kommentare bezüglich BiovaxID hinterlassen:
http://www.minyanville.com/library/search.htm?search=Article…
A Win for Cancer Vaccines (Finally!)
Biovest's BiovaxID Improves Survival in Phase III NHL Trial
By Trista Morrison
Biovest International Inc. said cancer vaccine BiovaxID (personalized anti-idiotype vaccine) met its primary endpoint of significantly improving disease-free survival in a multicenter, randomized, controlled Phase III trial of patients with indolent follicular non-Hodgkin's lymphoma (NHL).
Analyst Joseph Pantginis, of Canaccord Adams Inc., wrote in a report that the data are "clearly a positive result for the cancer immunotherapy space" and represent "the first definitive Phase III positive outcome in the space."
Shares of Tampa, Fla.-based Biovest (OTC BB:BVTI) jumped 33 percent Thursday before setting back at 37 cents for a gain of 4 cents, or 12 percent. The company is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI), which rose 4 cents to close at 89 cents.
Wall Street's reaction, while positive, was not as monumental as one might have expected for such potentially transformational data.
One reason could be that shares of Biovest and Accentia already had jumped twice this year in anticipation of the positive data. In April, the independent data monitoring committee for the Phase III trial decided at its annual meeting, after reviewing interim data, that the trial should be halted early and unblinded - a step both Biovest and its investors viewed as positive. Then last month, Biovest revealed that the still-blinded data showed a clear separation between the vaccine and control arms of the trial. The company interpreted that separation as an indication that BiovaxID was improving disease-free survival. (See BioWorld Today, April 18, 2008, and June 12, 2008.)
That interpretation was confirmed Thursday. The predetermined primary endpoint of the trial was improvement in the duration of disease-free survival (also known as progression-free survival, or PFS) between randomization and the first confirmed relapse. All patients in the trial received prior treatment with chemotherapy and were in sustained complete remission for six months prior to being randomized to receive either BiovaxID plus the carrier protein KLH and the adjuvant GMCSF or KLH and GMCSF alone.
The data showed that BiovaxID improved median PFS by more than one year. Patients receiving the vaccine had a median PFS of 33.8 months compared to 21.2 months in the control arm (p = 0.047). Additionally, at 36 months from vaccination, BiovaxID improved median PFS by approximately 100 percent (p = 0.024).
An update on the data will be provided in early September, when all randomized patients will have completed 12 months of follow-up. A total of 234 patients were enrolled in the trial, and 177 were randomized. Biovest Chairman and CEO Stephen Arikian said "only a handful" of the patients were not yet included in the analysis released Thursday.
Arikian also told BioWorld Today that Biovest "did not segment the data in any way" - the trial achieved statistical significance in the entire intent-to-treat population.
Analyst Ren Benjamin, of Rodman & Renshaw noted that "many [cancer vaccine] trials have shown activity in subsets of patients and have never obtained FDA approval." He added that he believes the Biovest results "are suggestive of activity," but he has many questions regarding "the patients that are being evaluated and whether or not a subset of patients are driving the PFS curves."
Dendreon Corp. knows all about cancer vaccines with positive subset analyses that aren't quite enough for approval. The company's prostate cancer vaccine Provenge (sipuleucel T) missed its primary endpoint of time to disease progression in two Phase III trials, but showed positive effects in a subset as well as overall survival benefits in a later analysis. Despite a positive recommendation from the FDA's advisory committee, the agency asked for more data. An interim analysis for Dendreon's ongoing Phase III trial is expected later this year, and positive findings could pave the way to approval. If not, investors - and patients - will have to wait for the final analysis, likely in the second half of 2009. (See BioWorld Today, June 1, 2007.)
Also expected in the second half of 2009 are data from Cell Genesys Inc.'s ongoing Phase III trial with prostate cancer vaccine GVAX.
Investors can hardly be blamed for being skeptical about cancer vaccines. In the NHL vaccine space, Favrille Inc. recently failed in its Phase III trial with Specifid, and Genitope Corp. failed in its Phase III trial with MyVax. (See BioWorld Today, Dec. 26, 2007, and May 28, 2008.)
Just last week, Oxford BioMedica plc's Phase III trial with renal cancer vaccine TroVax also imploded. (See BioWorld Today, July 14, 2008.)
Add to that old failures by the likes of CancerVax Corp. and Antigenics Inc., and it is easy to see why "cancer vaccine" has become a dirty word on Wall Street.
Arikian said that sentiment has affected Biovest's partnering activities for BiovaxID. Although the firm is in discussions with several companies, he noted that all were "anxious to see the data."
Arikian emphasized that BiovaxID is different from other cancer vaccines in that it is hybridoma-produced rather than recombinant, which allows the company to produce the entire idiotype from the patient's cancerous B cells rather than just a segment of the idiotype.
Published July 18, 2008
Im zweiten Artikel von bioworld today, setze man sich auch mit den Kommentaren Millers auseinander:
Separating the Trees from the Forest
Cancer Vaccine Contenders Lurk Among the Casualties
By Trista Morrison
Staff Writer
Between the negative Phase III news on Oxford BioMedica plc's TroVax and the positive Phase III news on Biovest International Inc.'s BiovaxID, it's been a big month for cancer vaccines.
Oxford saw its stock tumble 60 percent after an interim analysis revealed that the TroVax trial was unlikely to meet its endpoints - adding one more to the long and painful list of setbacks in the cancer vaccine field. And while Biovest may turn out to have the first statistically significant survival data in the intent-to-treat population in a randomized, controlled cancer vaccine trial, the results released this month were plagued by statistical questions that left many investors skeptical.
But despite all the failures and amid all the skepticism, 10 cancer vaccines are in Phase III trials, and some are approaching the finish line. Canaccord Adams Inc. analyst Joseph Pantginis predicted the field will be "defined or broken" by events playing out over the next 12 to 18 months.
Hard Lessons Learned
Investors tend to lump cancer vaccines into a single dubious-at-best category, but there are a lot of different approaches, Pantginis told BioWorld Financial Watch.
Perhaps the most important variable is vaccine design. Is it autologous (personalized) or allogeneic (off-the-shelf)? Does it target a single antigen or multiple antigens? Which antigens? And what about other approaches like whole cell, dendritic cell, DNA or idiotype?
There are arguments for and against almost every one of those strategies. Pantginis favors allogeneic products because of the "significantly lower" cost of goods. Yet David Miller, CEO of independent research firm Biotech Stock Research LLC, argued that the manufacturing process for some personalized products, such as Dendreon Corp.'s Provenge (sipuleucel-T), is "not as complicated as people think."
In terms of antigen selection, Rodman & Renshaw analyst Ren Benjamin wrote in a recent report that "many in the field believe that exposure to a broad array of tumor antigens is important to elicit a long-lasting, augmented, immune response."
Biovest used an argument along those lines to explain why it believes BiovaxID will succeed in non-Hodgkin's lymphoma where Favrille Inc.'s Specifid and Genitope Corp.'s MyVax both failed in Phase III. Although all three products are idiotype vaccines, BiovaxID is hybridoma-produced rather than recombinant, which Biovest said allows production of the entire idiotype rather than just a segment, potentially resulting in a better immune response.
Beyond vaccine design, adjuvant choice also can factor into the success or failure of a program. Pantginis said that even though CancerVax Corp.'s melanoma vaccine Canvaxin used a whole-cell design, the choice of BCG as an adjuvant led to a "suboptimal" product and contributed to its Phase III failure.
Then there's the question of which tumors to target. Some companies "might actually have a vaccine that is well-designed scientifically but pick a cancer population that is not alive long enough to show the immune response," Pantginis said. Targeting aggressive tumors like melanoma might have contributed to the Phase III failures of Antigenics Inc.'s Oncophage and Progenics Pharmaceuticals Inc.'s GMK. Ditto for the Phase III failure of Therion Biologics Corp.'s Panvac-VF in pancreatic cancer.
And even if a company manages to design a promising product targeting a potentially receptive patient population, a poorly designed trial could spoil the chances for success. Miller said many cancer vaccine failures have been caused by trial design issues, pointing to Provenge as an example. Time to progression might have been a valid endpoint when Dendreon originally designed its Phase III prostate cancer trials for Provenge, but the emphasis has since shifted to survival, he said.
The administration schedule for the vaccine also can be a thorny issue, as Oxford found when its latest interim analysis indicated that fewer doses actually may be needed to achieve optimal efficacy.
Deciding whether or not to give the drug in combination with chemotherapy, which chemotherapy to pair with and how to manage the administration schedule also can affect a trial's outcome. Although many cancer vaccines are given after chemotherapy, Benjamin noted that "chemotherapeutic regimens are often immunosuppressive and may decrease or delay the immunotherapeutic efficacy."
Into the Backstretch
The good news is that today's cancer vaccine companies seem to have learned from the mistakes of the past and "have designed better mouse traps," Benjamin said, adding that he expects to see the first therapeutic cancer vaccine achieve FDA approval possibly as early as 2009.
Thanks to its recent Phase III data, Biovest's BiovaxID is in the running. The drug met the primary endpoint of significantly improving disease-free survival in the multicenter, randomized, controlled Phase III trial in indolent follicular non-Hodgkin's lymphoma (NHL). Patients receiving the vaccine had a median progression-free survival of 33.8 months compared to 21.2 months in the control arm (p = 0.047).
Yet Miller cautioned that while a "p" value of less than 0.05 normally would be sufficient, the "p" value specified in the trial's statistical analysis plan was 0.01. Add to that the fact that the analysis wasn't quite final and started with treatment rather than randomization, and Miller said BiovaxID is "not likely to get approved," although falling victim to trial design issues "doesn't mean the drug doesn't work."
In Miller's opinion, Dendreon's autologous dendritic cell vaccine Provenge "clearly has a shot to be first across the finish line." Interim data from an ongoing, confirmatory Phase III prostate cancer trial are expected in October, and positive findings could pave the way to approval. Otherwise, investors will have to wait for the final analysis, likely in the second half of 2009.
Also expected in the second half of 2009 are data from Cell Genesys Inc.'s ongoing Phase III trial with prostate cancer vaccine GVAX. Pantginis noted that GVAX's allogeneic, whole-cell design has generated better median survival data than Provenge, but Miller questioned the Phase II trials supporting the drug.
Behind those front runners, several other cancer vaccines are coming down the pipeline. AVAX Technologies Inc. expects data in 2010 from its Phase III melanoma trial with M-Vax, while Bioniche Life Sciences Inc. is enrolling a Phase III bladder cancer trial with Urocidin. Oncothyreon Inc. (formerly Biomira Inc.) is enrolling patients in a Phase III non-small-cell lung cancer (NSCLC) trial with Stimuvax, and GlaxoSmithKline plc is in Phase III for NSCLC with its MAGE-A3 ASCI. Vical Inc. is enrolling a Phase III melanoma trial with Allovectin-7, while Receptor BioLogix Inc. is in Phase III for pancreatic cancer with Insegia and The Vaccine Co.'s Proteinase 3 PR1 peptide vaccine is in Phase III in acute myeloid leukemia.
To Profitability and Beyond
In addition to the 10 cancer vaccines in Phase III, Rodman & Renshaw reports that there are more than 50 other companies with cancer vaccines in development. With so many shots on goal, it's likely that some will eventually gain approval.
But will they make money?
While expensive to make (and most likely expensive to take, as well), Benjamin predicts that cancer vaccines will "represent a paradigm shift in the treatment and chronic management of cancer" thanks to their potential to increase survival with minimal side effects. Although most are being tested in late-stage cancers, Benjamin said their use after approval will shift to earlier-stage patients with healthier immune systems, providing "multibillion dollar opportunities."
Miller also thinks cancer vaccines will find a multi-billion-dollar market, as physicians likely will use them as a first-line option before moving on to chemotherapy, given their relatively benign side-effect profile.
Pantginis agreed that the market potential is significant, drawing a comparison to monoclonal antibodies, another class of biologics that are expensive to make but have proven extremely profitable.
Published July 28, 2008
Bis die Daten nicht vollständig (komplett) veröffentlicht sind, ist dass alles nur Kaffeesatz lesen. Ende August bis September werden diese veröffentlicht, dann wird man weitersehen. In einem Stimme ich Miller zu, ich glaube auch nicht, dass diese Daten ausreichen (geringe Größe des "abgebrochenen" trials) ausreichen, damit die FDA es genehmigt. Trotz allem gute Daten wären natürlich auch für die BIG Pharma interessant...
Grüße
Auf der Seite minyanville hat David Miller 4 sehr kritische Kommentare bezüglich BiovaxID hinterlassen:
http://www.minyanville.com/library/search.htm?search=Article…
A Win for Cancer Vaccines (Finally!)
Biovest's BiovaxID Improves Survival in Phase III NHL Trial
By Trista Morrison
Biovest International Inc. said cancer vaccine BiovaxID (personalized anti-idiotype vaccine) met its primary endpoint of significantly improving disease-free survival in a multicenter, randomized, controlled Phase III trial of patients with indolent follicular non-Hodgkin's lymphoma (NHL).
Analyst Joseph Pantginis, of Canaccord Adams Inc., wrote in a report that the data are "clearly a positive result for the cancer immunotherapy space" and represent "the first definitive Phase III positive outcome in the space."
Shares of Tampa, Fla.-based Biovest (OTC BB:BVTI) jumped 33 percent Thursday before setting back at 37 cents for a gain of 4 cents, or 12 percent. The company is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI), which rose 4 cents to close at 89 cents.
Wall Street's reaction, while positive, was not as monumental as one might have expected for such potentially transformational data.
One reason could be that shares of Biovest and Accentia already had jumped twice this year in anticipation of the positive data. In April, the independent data monitoring committee for the Phase III trial decided at its annual meeting, after reviewing interim data, that the trial should be halted early and unblinded - a step both Biovest and its investors viewed as positive. Then last month, Biovest revealed that the still-blinded data showed a clear separation between the vaccine and control arms of the trial. The company interpreted that separation as an indication that BiovaxID was improving disease-free survival. (See BioWorld Today, April 18, 2008, and June 12, 2008.)
That interpretation was confirmed Thursday. The predetermined primary endpoint of the trial was improvement in the duration of disease-free survival (also known as progression-free survival, or PFS) between randomization and the first confirmed relapse. All patients in the trial received prior treatment with chemotherapy and were in sustained complete remission for six months prior to being randomized to receive either BiovaxID plus the carrier protein KLH and the adjuvant GMCSF or KLH and GMCSF alone.
The data showed that BiovaxID improved median PFS by more than one year. Patients receiving the vaccine had a median PFS of 33.8 months compared to 21.2 months in the control arm (p = 0.047). Additionally, at 36 months from vaccination, BiovaxID improved median PFS by approximately 100 percent (p = 0.024).
An update on the data will be provided in early September, when all randomized patients will have completed 12 months of follow-up. A total of 234 patients were enrolled in the trial, and 177 were randomized. Biovest Chairman and CEO Stephen Arikian said "only a handful" of the patients were not yet included in the analysis released Thursday.
Arikian also told BioWorld Today that Biovest "did not segment the data in any way" - the trial achieved statistical significance in the entire intent-to-treat population.
Analyst Ren Benjamin, of Rodman & Renshaw noted that "many [cancer vaccine] trials have shown activity in subsets of patients and have never obtained FDA approval." He added that he believes the Biovest results "are suggestive of activity," but he has many questions regarding "the patients that are being evaluated and whether or not a subset of patients are driving the PFS curves."
Dendreon Corp. knows all about cancer vaccines with positive subset analyses that aren't quite enough for approval. The company's prostate cancer vaccine Provenge (sipuleucel T) missed its primary endpoint of time to disease progression in two Phase III trials, but showed positive effects in a subset as well as overall survival benefits in a later analysis. Despite a positive recommendation from the FDA's advisory committee, the agency asked for more data. An interim analysis for Dendreon's ongoing Phase III trial is expected later this year, and positive findings could pave the way to approval. If not, investors - and patients - will have to wait for the final analysis, likely in the second half of 2009. (See BioWorld Today, June 1, 2007.)
Also expected in the second half of 2009 are data from Cell Genesys Inc.'s ongoing Phase III trial with prostate cancer vaccine GVAX.
Investors can hardly be blamed for being skeptical about cancer vaccines. In the NHL vaccine space, Favrille Inc. recently failed in its Phase III trial with Specifid, and Genitope Corp. failed in its Phase III trial with MyVax. (See BioWorld Today, Dec. 26, 2007, and May 28, 2008.)
Just last week, Oxford BioMedica plc's Phase III trial with renal cancer vaccine TroVax also imploded. (See BioWorld Today, July 14, 2008.)
Add to that old failures by the likes of CancerVax Corp. and Antigenics Inc., and it is easy to see why "cancer vaccine" has become a dirty word on Wall Street.
Arikian said that sentiment has affected Biovest's partnering activities for BiovaxID. Although the firm is in discussions with several companies, he noted that all were "anxious to see the data."
Arikian emphasized that BiovaxID is different from other cancer vaccines in that it is hybridoma-produced rather than recombinant, which allows the company to produce the entire idiotype from the patient's cancerous B cells rather than just a segment of the idiotype.
Published July 18, 2008
Im zweiten Artikel von bioworld today, setze man sich auch mit den Kommentaren Millers auseinander:
Separating the Trees from the Forest
Cancer Vaccine Contenders Lurk Among the Casualties
By Trista Morrison
Staff Writer
Between the negative Phase III news on Oxford BioMedica plc's TroVax and the positive Phase III news on Biovest International Inc.'s BiovaxID, it's been a big month for cancer vaccines.
Oxford saw its stock tumble 60 percent after an interim analysis revealed that the TroVax trial was unlikely to meet its endpoints - adding one more to the long and painful list of setbacks in the cancer vaccine field. And while Biovest may turn out to have the first statistically significant survival data in the intent-to-treat population in a randomized, controlled cancer vaccine trial, the results released this month were plagued by statistical questions that left many investors skeptical.
But despite all the failures and amid all the skepticism, 10 cancer vaccines are in Phase III trials, and some are approaching the finish line. Canaccord Adams Inc. analyst Joseph Pantginis predicted the field will be "defined or broken" by events playing out over the next 12 to 18 months.
Hard Lessons Learned
Investors tend to lump cancer vaccines into a single dubious-at-best category, but there are a lot of different approaches, Pantginis told BioWorld Financial Watch.
Perhaps the most important variable is vaccine design. Is it autologous (personalized) or allogeneic (off-the-shelf)? Does it target a single antigen or multiple antigens? Which antigens? And what about other approaches like whole cell, dendritic cell, DNA or idiotype?
There are arguments for and against almost every one of those strategies. Pantginis favors allogeneic products because of the "significantly lower" cost of goods. Yet David Miller, CEO of independent research firm Biotech Stock Research LLC, argued that the manufacturing process for some personalized products, such as Dendreon Corp.'s Provenge (sipuleucel-T), is "not as complicated as people think."
In terms of antigen selection, Rodman & Renshaw analyst Ren Benjamin wrote in a recent report that "many in the field believe that exposure to a broad array of tumor antigens is important to elicit a long-lasting, augmented, immune response."
Biovest used an argument along those lines to explain why it believes BiovaxID will succeed in non-Hodgkin's lymphoma where Favrille Inc.'s Specifid and Genitope Corp.'s MyVax both failed in Phase III. Although all three products are idiotype vaccines, BiovaxID is hybridoma-produced rather than recombinant, which Biovest said allows production of the entire idiotype rather than just a segment, potentially resulting in a better immune response.
Beyond vaccine design, adjuvant choice also can factor into the success or failure of a program. Pantginis said that even though CancerVax Corp.'s melanoma vaccine Canvaxin used a whole-cell design, the choice of BCG as an adjuvant led to a "suboptimal" product and contributed to its Phase III failure.
Then there's the question of which tumors to target. Some companies "might actually have a vaccine that is well-designed scientifically but pick a cancer population that is not alive long enough to show the immune response," Pantginis said. Targeting aggressive tumors like melanoma might have contributed to the Phase III failures of Antigenics Inc.'s Oncophage and Progenics Pharmaceuticals Inc.'s GMK. Ditto for the Phase III failure of Therion Biologics Corp.'s Panvac-VF in pancreatic cancer.
And even if a company manages to design a promising product targeting a potentially receptive patient population, a poorly designed trial could spoil the chances for success. Miller said many cancer vaccine failures have been caused by trial design issues, pointing to Provenge as an example. Time to progression might have been a valid endpoint when Dendreon originally designed its Phase III prostate cancer trials for Provenge, but the emphasis has since shifted to survival, he said.
The administration schedule for the vaccine also can be a thorny issue, as Oxford found when its latest interim analysis indicated that fewer doses actually may be needed to achieve optimal efficacy.
Deciding whether or not to give the drug in combination with chemotherapy, which chemotherapy to pair with and how to manage the administration schedule also can affect a trial's outcome. Although many cancer vaccines are given after chemotherapy, Benjamin noted that "chemotherapeutic regimens are often immunosuppressive and may decrease or delay the immunotherapeutic efficacy."
Into the Backstretch
The good news is that today's cancer vaccine companies seem to have learned from the mistakes of the past and "have designed better mouse traps," Benjamin said, adding that he expects to see the first therapeutic cancer vaccine achieve FDA approval possibly as early as 2009.
Thanks to its recent Phase III data, Biovest's BiovaxID is in the running. The drug met the primary endpoint of significantly improving disease-free survival in the multicenter, randomized, controlled Phase III trial in indolent follicular non-Hodgkin's lymphoma (NHL). Patients receiving the vaccine had a median progression-free survival of 33.8 months compared to 21.2 months in the control arm (p = 0.047).
Yet Miller cautioned that while a "p" value of less than 0.05 normally would be sufficient, the "p" value specified in the trial's statistical analysis plan was 0.01. Add to that the fact that the analysis wasn't quite final and started with treatment rather than randomization, and Miller said BiovaxID is "not likely to get approved," although falling victim to trial design issues "doesn't mean the drug doesn't work."
In Miller's opinion, Dendreon's autologous dendritic cell vaccine Provenge "clearly has a shot to be first across the finish line." Interim data from an ongoing, confirmatory Phase III prostate cancer trial are expected in October, and positive findings could pave the way to approval. Otherwise, investors will have to wait for the final analysis, likely in the second half of 2009.
Also expected in the second half of 2009 are data from Cell Genesys Inc.'s ongoing Phase III trial with prostate cancer vaccine GVAX. Pantginis noted that GVAX's allogeneic, whole-cell design has generated better median survival data than Provenge, but Miller questioned the Phase II trials supporting the drug.
Behind those front runners, several other cancer vaccines are coming down the pipeline. AVAX Technologies Inc. expects data in 2010 from its Phase III melanoma trial with M-Vax, while Bioniche Life Sciences Inc. is enrolling a Phase III bladder cancer trial with Urocidin. Oncothyreon Inc. (formerly Biomira Inc.) is enrolling patients in a Phase III non-small-cell lung cancer (NSCLC) trial with Stimuvax, and GlaxoSmithKline plc is in Phase III for NSCLC with its MAGE-A3 ASCI. Vical Inc. is enrolling a Phase III melanoma trial with Allovectin-7, while Receptor BioLogix Inc. is in Phase III for pancreatic cancer with Insegia and The Vaccine Co.'s Proteinase 3 PR1 peptide vaccine is in Phase III in acute myeloid leukemia.
To Profitability and Beyond
In addition to the 10 cancer vaccines in Phase III, Rodman & Renshaw reports that there are more than 50 other companies with cancer vaccines in development. With so many shots on goal, it's likely that some will eventually gain approval.
But will they make money?
While expensive to make (and most likely expensive to take, as well), Benjamin predicts that cancer vaccines will "represent a paradigm shift in the treatment and chronic management of cancer" thanks to their potential to increase survival with minimal side effects. Although most are being tested in late-stage cancers, Benjamin said their use after approval will shift to earlier-stage patients with healthier immune systems, providing "multibillion dollar opportunities."
Miller also thinks cancer vaccines will find a multi-billion-dollar market, as physicians likely will use them as a first-line option before moving on to chemotherapy, given their relatively benign side-effect profile.
Pantginis agreed that the market potential is significant, drawing a comparison to monoclonal antibodies, another class of biologics that are expensive to make but have proven extremely profitable.
Published July 28, 2008
Bis die Daten nicht vollständig (komplett) veröffentlicht sind, ist dass alles nur Kaffeesatz lesen. Ende August bis September werden diese veröffentlicht, dann wird man weitersehen. In einem Stimme ich Miller zu, ich glaube auch nicht, dass diese Daten ausreichen (geringe Größe des "abgebrochenen" trials) ausreichen, damit die FDA es genehmigt. Trotz allem gute Daten wären natürlich auch für die BIG Pharma interessant...
Grüße
die 3Q Zahlen:
http://www.accentia.net/investors/news.php
Accentia Reports Fiscal Third Quarter Financial Results
Released: 08/14/08 05:40 PM EDT
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its third fiscal quarter ended June 30, 2008.
Accentia is primarily focused on the commercialization of its three late-stage potential blockbuster therapeutics which are in or entering Phase 3 clinical trials including: BiovaxID™, a personalized anti-cancer vaccine initially targeting indolent follicular non-Hodgkin’s lymphoma; Revimmune™ (ultra-high-dose cyclophosphamide) targeting the treatment of up to 80 autoimmune diseases, with an initial indication of multiple sclerosis; and SinuNase™ for the treatment of chronic sinusitis.
Significant recent milestones include:
BiovaxID Phase 3 results demonstrated a clinically and statistically significant improvement of disease-free survival, providing highly encouraging safety and efficacy data which is expected to provide the basis for seeking accelerated and/or conditional approvals in the U.S. and Europe, respectively. Discussions are now planned with the FDA as to the pathway to commercialization of BiovaxID.
Leading researchers at Johns Hopkins University published unprecedented study results in the treatment of multiple sclerosis, showing therapy with Revimmune to be capable of restoring physical and neurological functions with the potential to eliminate autoimmunity. Preparations are now ongoing to file an Investigational New Drug Application (IND) in order to commence a Phase 3 clinical trial.
Based on these key achievements, Accentia and Biovest are currently engaged in discussions and negotiations with regards to securing strategic alliances and licensing agreements for its products.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI), which is consolidated for reporting purposes with Accentia’s product development and market service business.
On a fully consolidated basis, including Biovest, net revenues for the three months ended June 30, 2008 were $3.0 million, compared with $3.8 million for the same period ended June 30, 2007. The decrease in net revenues was attributed to a slight decrease in net sales reported by our subsidiaries Biovest and Analytica and our specialty pharmaceuticals division.
Consolidated research and development costs were $1.6 million for the third fiscal quarter, compared with $5.2 million for the same fiscal quarter in 2007. This 70% decrease was largely due to our Biovest subsidiary reducing research and development expenses as its clinical trial costs have declined considerably, as a result of our decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the FDA and European regulatory authorities. There was also a decrease in SinuNase research and development expenses due to the completion of its Fast-Tracked Phase 3 clinical trial, which demonstrated statistically significant objective evidence based on secondary endpoint analysis measuring the most severe cases of polyposis and inflammation. The Company is continuing to analyze the Phase 3 SinuNase results to determine the optimal course for future clinical development.
Accentia’s second quarter net loss, on a fully consolidated basis, including Biovest, was $11.4 million, compared to $25.0 million reported for the same three month period in fiscal 2007. Of this loss, approximately $6.6 million was due to non-cash charges. The operating loss, on a fully consolidated basis, was $7.3 million as compared to $12.6 million for the comparable quarter in 2007, representing a 42% reduction, as the Company’s developmental pipeline matures.
The fully consolidated loss per share for the quarter was $0.25, of which $0.08 per share was attributed to Biovest, which is consolidated in Accentia’s financial statements. Since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.71 of which $0.34 per share was attributed to Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest’s decision, based on the independent Data Monitoring Committee’s recommendation, to stop enrollment in the BiovaxID Fast-Tracked Phase 3 study and seek accelerated and/or conditional approval with the FDA and European regulatory authorities.
At June 30, 2008, Accentia had approximately $4.5 million in cash. With the recent positive results reported for BiovaxID and Revimmune, Accentia and Biovest are currently evaluating new financing opportunities, including potential partnering and licensing agreements which are expected to be significant commercial events, providing access to additional sources of capital.
Accentia also reported that on August 13, 2008, the Company received notice from Nasdaq that it is not in compliance with Nasdaq Marketplace Rule 4450(a)(5) because shares of its common stock had closed at a per share bid price of less than $1.00 for 30 consecutive business days. Accentia will be provided with 180 calendar days, or until February 9, 2009, to regain compliance, which would be accomplished when Accentia’s common stock closing bid price is $1.00 per share or more for a minimum of ten consecutive business days. If the Company does not regain compliance by February 9, 2009, the Nasdaq staff will notify the Company that its common stock will be delisted. In that event and at that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq Listing Qualifications Panel. This notification has no effect on the listing of Accentia’s common stock at this time.
Accentia expects to regain compliance within this 180 day cure period and will consider alternatives to address compliance with the continued listing standards of The Nasdaq Stock Market.
Dass SinuaNase immer noch aufgeführt wird ist irgendwie seltsam. Bis heute ist ist kein weiteres Statement von ABPI gekommen, wie der weitere Weg aussieht (zweite Phase III; Spray Version...). Umstz der restlichen Produkte ist um knapp 25 % auf 3 Mio $ zurückgegangen. Verluste wurden durch dass Beenden von BiovaxID und SinuNase begrenzt. Es ist zu hoffen, dass nach der vollständigen Entblindung der BiovaxID Ergebnisse dass Interesse mögflicher Partner gewckt wird.
Grüße
http://www.accentia.net/investors/news.php
Accentia Reports Fiscal Third Quarter Financial Results
Released: 08/14/08 05:40 PM EDT
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announced today that the Company has filed its Quarterly Report (Form 10-Q) with the SEC, reporting the results of its operations, including consolidated results with its majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), for its third fiscal quarter ended June 30, 2008.
Accentia is primarily focused on the commercialization of its three late-stage potential blockbuster therapeutics which are in or entering Phase 3 clinical trials including: BiovaxID™, a personalized anti-cancer vaccine initially targeting indolent follicular non-Hodgkin’s lymphoma; Revimmune™ (ultra-high-dose cyclophosphamide) targeting the treatment of up to 80 autoimmune diseases, with an initial indication of multiple sclerosis; and SinuNase™ for the treatment of chronic sinusitis.
Significant recent milestones include:
BiovaxID Phase 3 results demonstrated a clinically and statistically significant improvement of disease-free survival, providing highly encouraging safety and efficacy data which is expected to provide the basis for seeking accelerated and/or conditional approvals in the U.S. and Europe, respectively. Discussions are now planned with the FDA as to the pathway to commercialization of BiovaxID.
Leading researchers at Johns Hopkins University published unprecedented study results in the treatment of multiple sclerosis, showing therapy with Revimmune to be capable of restoring physical and neurological functions with the potential to eliminate autoimmunity. Preparations are now ongoing to file an Investigational New Drug Application (IND) in order to commence a Phase 3 clinical trial.
Based on these key achievements, Accentia and Biovest are currently engaged in discussions and negotiations with regards to securing strategic alliances and licensing agreements for its products.
Financial Review:
Accentia has two operating segments consisting of specialty pharmaceuticals (Accentia Pharmaceuticals) and product development and market services (Analytica International). Accentia also has an approximate 76% interest in Biovest International, Inc. (OTCBB:BVTI), which is consolidated for reporting purposes with Accentia’s product development and market service business.
On a fully consolidated basis, including Biovest, net revenues for the three months ended June 30, 2008 were $3.0 million, compared with $3.8 million for the same period ended June 30, 2007. The decrease in net revenues was attributed to a slight decrease in net sales reported by our subsidiaries Biovest and Analytica and our specialty pharmaceuticals division.
Consolidated research and development costs were $1.6 million for the third fiscal quarter, compared with $5.2 million for the same fiscal quarter in 2007. This 70% decrease was largely due to our Biovest subsidiary reducing research and development expenses as its clinical trial costs have declined considerably, as a result of our decision, based on the independent Data Monitoring Committee’s recommendation, to stop the BiovaxID Fast-Tracked Phase 3 study early, and seek accelerated and/or conditional approval with the FDA and European regulatory authorities. There was also a decrease in SinuNase research and development expenses due to the completion of its Fast-Tracked Phase 3 clinical trial, which demonstrated statistically significant objective evidence based on secondary endpoint analysis measuring the most severe cases of polyposis and inflammation. The Company is continuing to analyze the Phase 3 SinuNase results to determine the optimal course for future clinical development.
Accentia’s second quarter net loss, on a fully consolidated basis, including Biovest, was $11.4 million, compared to $25.0 million reported for the same three month period in fiscal 2007. Of this loss, approximately $6.6 million was due to non-cash charges. The operating loss, on a fully consolidated basis, was $7.3 million as compared to $12.6 million for the comparable quarter in 2007, representing a 42% reduction, as the Company’s developmental pipeline matures.
The fully consolidated loss per share for the quarter was $0.25, of which $0.08 per share was attributed to Biovest, which is consolidated in Accentia’s financial statements. Since February 2007, Biovest has been self-funded. For the comparable 2007 quarter, the fully consolidated loss per share was $0.71 of which $0.34 per share was attributed to Biovest. The Company notes that the operating loss for Biovest has been substantially reduced in part due to Biovest’s decision, based on the independent Data Monitoring Committee’s recommendation, to stop enrollment in the BiovaxID Fast-Tracked Phase 3 study and seek accelerated and/or conditional approval with the FDA and European regulatory authorities.
At June 30, 2008, Accentia had approximately $4.5 million in cash. With the recent positive results reported for BiovaxID and Revimmune, Accentia and Biovest are currently evaluating new financing opportunities, including potential partnering and licensing agreements which are expected to be significant commercial events, providing access to additional sources of capital.
Accentia also reported that on August 13, 2008, the Company received notice from Nasdaq that it is not in compliance with Nasdaq Marketplace Rule 4450(a)(5) because shares of its common stock had closed at a per share bid price of less than $1.00 for 30 consecutive business days. Accentia will be provided with 180 calendar days, or until February 9, 2009, to regain compliance, which would be accomplished when Accentia’s common stock closing bid price is $1.00 per share or more for a minimum of ten consecutive business days. If the Company does not regain compliance by February 9, 2009, the Nasdaq staff will notify the Company that its common stock will be delisted. In that event and at that time, the Company may appeal Nasdaq’s delisting determination to a Nasdaq Listing Qualifications Panel. This notification has no effect on the listing of Accentia’s common stock at this time.
Accentia expects to regain compliance within this 180 day cure period and will consider alternatives to address compliance with the continued listing standards of The Nasdaq Stock Market.
Dass SinuaNase immer noch aufgeführt wird ist irgendwie seltsam. Bis heute ist ist kein weiteres Statement von ABPI gekommen, wie der weitere Weg aussieht (zweite Phase III; Spray Version...). Umstz der restlichen Produkte ist um knapp 25 % auf 3 Mio $ zurückgegangen. Verluste wurden durch dass Beenden von BiovaxID und SinuNase begrenzt. Es ist zu hoffen, dass nach der vollständigen Entblindung der BiovaxID Ergebnisse dass Interesse mögflicher Partner gewckt wird.
Grüße
Antwort auf Beitrag Nr.: 31.924.229 von Ackergaul am 10.10.07 13:30:40Irgendetwas passiert bei Accentia.
Weiss jemand warum?
Weiss jemand warum?
Antwort auf Beitrag Nr.: 35.172.255 von SunnyOst am 18.09.08 17:54:44Ich denke, dass dies eine Reaktion auf die vergangenen Handelstage war. Auf mehr sollte man nicht spekullieren ("Da haben einige schon ein wenig mehr von den Daten gesehen" - halte ich für unwahrscheinlich).
Die Umsätze gestern waren aber erheblich über denen der letzten Tage und es wurden ziemlich viele Stücke um die 80 Cent eingesammelt. Nichtsdestotrotz sollten BiovaxID Daten noch diesen Monat kommen. Ich würde momentan aber mehr David Millers Aussagen beipflichten (nicht signifikant), aber schaun wa mal...
Grüße
Die Umsätze gestern waren aber erheblich über denen der letzten Tage und es wurden ziemlich viele Stücke um die 80 Cent eingesammelt. Nichtsdestotrotz sollten BiovaxID Daten noch diesen Monat kommen. Ich würde momentan aber mehr David Millers Aussagen beipflichten (nicht signifikant), aber schaun wa mal...
Grüße
Dass ist natürlich schon eine Hausnummer... Dennoch denke ich, dass die geäußerten Kritiken (gerade von miller) noch offen sind (zB "von welchen Zeitpunkt an..."). Der 2. Punkt den ich hier ankreide, ist dass diese studie doch nun arg klein geraten ist - aber umso höher zu bewerten noch statistisch signifikant! Schaun wer mal was wir noch in den nächsten Tagen hören:
Biovest Announces BiovaxID(R) Anti-Cancer Vaccine Prolongs Cancer-Free Survival by 44%
Tuesday, October 07, 2008 11:16 AM
Symbols: ABPI
* Company Closes Phase 3 Fast-Tracked Clinical Trial
* Will Petition to Offer All Study Patients Treatment with BiovaxID
* Intends to Seek Approval in the U.S. and Internationally
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today provided an update on its personalized, anti-cancer vaccine, BiovaxID®, including reporting clinically and statistically significant data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial for the treatment of indolent follicular non-Hodgkin’s lymphoma, an often fatal blood cancer. After a recent meeting with the FDA, the Company closed the clinical trial, unblinded the patients, and analyzed the disease-free survival in both arms through June 30, 2008. The Company has committed to provide the FDA with a detailed clinical report based on this end-of-study data, including statistical analysis, prior to the next meeting in order to discuss a petition to treat all patients in the clinical trial with BiovaxID and to seek Accelerated Approval under subpart E. Originally, the study was intended to follow patients in both arms after unblinding for the purpose of determining overall survival, but based on the trial results, the Company now believes that it would be unethical to withhold BiovaxID from control patients, and that the study, therefore, is closed. Beyond the Company’s U.S. strategy, Biovest disclosed plans regarding preparations to seek approvals in Europe (EU and select non-EU countries), Asia and Australia.
BiovaxID Summary Results for End of Study:
Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial are well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).
The time point at which the difference in disease-free survival between the two arms was greatest was approximately 36 months. At 36 months, 61% of BiovaxID patients and 37% of control patients were cancer-free, meaning that BiovaxID patients were 65% more likely to be cancer-free than were the control patients (p-value = 0.023; HR = 1.9). The Company believes that the data suggests that this might be an optimal time for supplemental booster shots, expected to further enhance the maintenance of clinical remissions.
With regards to safety, there was not a single serious adverse event that was definitely ascribed to BiovaxID.
According to study investigator, Dr. Christopher Flowers, these results herald a new era of personalized medicines in targeting cancers: “I am impressed that these results for BiovaxID represent a breakthrough for the treatment of non-Hodgkin's lymphoma and ultimately for many other kinds of B-cell blood cancers." Dr. Flowers serves as Assistant Professor of Hematology and Oncology at Winship Cancer Institute at the Emory University School of Medicine. He also directs the Lymphoma Clinic at Emory and is a past recipient of the clinical and translational research awards that provide grant funding for exciting new research in hematology.
Biovest’s Chairman and CEO, Dr. Steven Arikian, commented on the Company’s plans to seek U.S. and international approvals for BiovaxID: “We believe that these strongly positive clinical results make it unethical to continue the trial as originally designed. In particular, we believe that we should offer BiovaxID to patients in the control arm who have not relapsed yet, and to patients in both arms who have relapsed but who can achieve another complete remission. Accordingly, we will be seeking a petition to treat these patients with BiovaxID and to file for Accelerated Approval in the U.S. Moreover, based on the data at 36 months, we believe that BiovaxID patients in complete remission post-vaccination should be getting booster shots at about this time frame to maximize their chances of maintaining complete remissions. We are preparing to make submissions with the European Medicines Agency (EMEA) related to the approval process for the European Union (EU), as well regulatory agencies in select European nations (non-EU), Australia, and select Asian countries.”
A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers:
B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body.
Grüße
Biovest Announces BiovaxID(R) Anti-Cancer Vaccine Prolongs Cancer-Free Survival by 44%
Tuesday, October 07, 2008 11:16 AM
Symbols: ABPI
* Company Closes Phase 3 Fast-Tracked Clinical Trial
* Will Petition to Offer All Study Patients Treatment with BiovaxID
* Intends to Seek Approval in the U.S. and Internationally
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today provided an update on its personalized, anti-cancer vaccine, BiovaxID®, including reporting clinically and statistically significant data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial for the treatment of indolent follicular non-Hodgkin’s lymphoma, an often fatal blood cancer. After a recent meeting with the FDA, the Company closed the clinical trial, unblinded the patients, and analyzed the disease-free survival in both arms through June 30, 2008. The Company has committed to provide the FDA with a detailed clinical report based on this end-of-study data, including statistical analysis, prior to the next meeting in order to discuss a petition to treat all patients in the clinical trial with BiovaxID and to seek Accelerated Approval under subpart E. Originally, the study was intended to follow patients in both arms after unblinding for the purpose of determining overall survival, but based on the trial results, the Company now believes that it would be unethical to withhold BiovaxID from control patients, and that the study, therefore, is closed. Beyond the Company’s U.S. strategy, Biovest disclosed plans regarding preparations to seek approvals in Europe (EU and select non-EU countries), Asia and Australia.
BiovaxID Summary Results for End of Study:
Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial are well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).
The time point at which the difference in disease-free survival between the two arms was greatest was approximately 36 months. At 36 months, 61% of BiovaxID patients and 37% of control patients were cancer-free, meaning that BiovaxID patients were 65% more likely to be cancer-free than were the control patients (p-value = 0.023; HR = 1.9). The Company believes that the data suggests that this might be an optimal time for supplemental booster shots, expected to further enhance the maintenance of clinical remissions.
With regards to safety, there was not a single serious adverse event that was definitely ascribed to BiovaxID.
According to study investigator, Dr. Christopher Flowers, these results herald a new era of personalized medicines in targeting cancers: “I am impressed that these results for BiovaxID represent a breakthrough for the treatment of non-Hodgkin's lymphoma and ultimately for many other kinds of B-cell blood cancers." Dr. Flowers serves as Assistant Professor of Hematology and Oncology at Winship Cancer Institute at the Emory University School of Medicine. He also directs the Lymphoma Clinic at Emory and is a past recipient of the clinical and translational research awards that provide grant funding for exciting new research in hematology.
Biovest’s Chairman and CEO, Dr. Steven Arikian, commented on the Company’s plans to seek U.S. and international approvals for BiovaxID: “We believe that these strongly positive clinical results make it unethical to continue the trial as originally designed. In particular, we believe that we should offer BiovaxID to patients in the control arm who have not relapsed yet, and to patients in both arms who have relapsed but who can achieve another complete remission. Accordingly, we will be seeking a petition to treat these patients with BiovaxID and to file for Accelerated Approval in the U.S. Moreover, based on the data at 36 months, we believe that BiovaxID patients in complete remission post-vaccination should be getting booster shots at about this time frame to maximize their chances of maintaining complete remissions. We are preparing to make submissions with the European Medicines Agency (EMEA) related to the approval process for the European Union (EU), as well regulatory agencies in select European nations (non-EU), Australia, and select Asian countries.”
A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers:
B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body.
Grüße
Ich kaufte sie für 1 Euro!
was passieren wird, jetzt
wow
was passieren wird, jetzt
wow
Antwort auf Beitrag Nr.: 35.881.975 von gooner1967 am 08.11.08 11:25:46Habe damals eigentlich für noch günstige 1,90 $ zugreifen können (kurz nach dem Insiderkauf O'Donnells). Der Kurs lief dann auch schön über die 3 $ Marke. Folgende optionen gab es dann:
A) SinuNase TOP Daten: Kurs wird um 100 - 200 % steigen
B) SinuNase FLOP Daten (wie geschehen): minus > 50%.
Für Option B hatte ich KEINEN Stopkurs vorgesehen, da ich nicht zu jedem Kurs aussteigen wollte. Im nachhinein ein Eigentor und habe zuletzt bei 0,80 $ verkauft (habe zuletzt so gut wie alles abgegeben - Gut- wie Schlechtlaufende Papiere)...
Meine aktuelle Einschätzung zu ABPI:
* Die Finanzkrise trifft ABPI mit voller Breitseite: Kein Cash und jede Menge Schulden = Geldnot!
* SinuNase so gut wie tot, BiovaxID mit guten aber nicht mit Top Daten die nötig wären sowie Revimmune, dass in meinen Augen zu gefährlich ist um jemals auf MS Patienten losgelassen zu werden.
* Ruft Euch O'Donnells "Outlook for 2008" in Erinnerung: Hier ist eigentlich jeder Milestone gescheitert beziehungsweise noch nicht eingetreten, der vorgesehen war.
Alles in allem schon verständlich, warum ABPI wie die heiße Kartoffel fallen gelassen wurde. Dennoch denke ich, dass momentan alles ein wenig überzogen ist. Dass named patient Programm ist mit Sicherheit positiv zu bewerten (man bekommt zusätzliche Daten + ein wenig Geld), jedoch wäre eine Partnerschaft bei weitem eine bessere nachricht gewesen. Man muss auch noch dazu sagen, dass BiovaxID um Längen bessere Resultate gezeigt hat, als die Konkurenz vaccines (also irgendwas funktioniert auch)!
Grüße
A) SinuNase TOP Daten: Kurs wird um 100 - 200 % steigen
B) SinuNase FLOP Daten (wie geschehen): minus > 50%.
Für Option B hatte ich KEINEN Stopkurs vorgesehen, da ich nicht zu jedem Kurs aussteigen wollte. Im nachhinein ein Eigentor und habe zuletzt bei 0,80 $ verkauft (habe zuletzt so gut wie alles abgegeben - Gut- wie Schlechtlaufende Papiere)...
Meine aktuelle Einschätzung zu ABPI:
* Die Finanzkrise trifft ABPI mit voller Breitseite: Kein Cash und jede Menge Schulden = Geldnot!
* SinuNase so gut wie tot, BiovaxID mit guten aber nicht mit Top Daten die nötig wären sowie Revimmune, dass in meinen Augen zu gefährlich ist um jemals auf MS Patienten losgelassen zu werden.
* Ruft Euch O'Donnells "Outlook for 2008" in Erinnerung: Hier ist eigentlich jeder Milestone gescheitert beziehungsweise noch nicht eingetreten, der vorgesehen war.
Alles in allem schon verständlich, warum ABPI wie die heiße Kartoffel fallen gelassen wurde. Dennoch denke ich, dass momentan alles ein wenig überzogen ist. Dass named patient Programm ist mit Sicherheit positiv zu bewerten (man bekommt zusätzliche Daten + ein wenig Geld), jedoch wäre eine Partnerschaft bei weitem eine bessere nachricht gewesen. Man muss auch noch dazu sagen, dass BiovaxID um Längen bessere Resultate gezeigt hat, als die Konkurenz vaccines (also irgendwas funktioniert auch)!
Grüße
gibt es noch Hoffnung.
das Beste was ich tun kann, ist mehr kaufen...
gooner,
das Beste was ich tun kann, ist mehr kaufen...
gooner,
Antwort auf Beitrag Nr.: 35.907.432 von gooner1967 am 10.11.08 22:40:12Hi Gooner,
spiele mit dem gleichen Gedanken. Wo werden die jetzt eigentlich
in Deutschland gehandelt?
Gruesse
spiele mit dem gleichen Gedanken. Wo werden die jetzt eigentlich
in Deutschland gehandelt?
Gruesse
Antwort auf Beitrag Nr.: 35.900.803 von Ackergaul am 10.11.08 12:14:52Ich finde eigentlich, dass von vielen möglichen Thread-Überschriften die Überschrift "Warum ausgerechnet Accentia" eine sehr passende ist.
Der geneigte Investor stellt sich diese Frage schon eine ganze Zeit und mit der gestrigen Chapter11-Meldung haben die schlechten Nachrichten Ihren vorläufigen Höhepunkt.
Der geneigte Investor stellt sich diese Frage schon eine ganze Zeit und mit der gestrigen Chapter11-Meldung haben die schlechten Nachrichten Ihren vorläufigen Höhepunkt.
Können die aktien Accentia Biopharmaceuticals Inc. immer noch aus die Pink Sheet raus bekommen?
Sölte ich noch aktien beikaufen van Acentia Bio., wehn sie 0.01 stehn um meine position zu verbeseren?
dankeschön fur die reaction
Anja
Sölte ich noch aktien beikaufen van Acentia Bio., wehn sie 0.01 stehn um meine position zu verbeseren?
dankeschön fur die reaction
Anja
Antwort auf Beitrag Nr.: 35.908.883 von gooner1967 am 11.11.08 10:03:36@gooner1967
Warte lieber bis 0,00 € dann kannst Du zuschlagen .
Warte lieber bis 0,00 € dann kannst Du zuschlagen .
gibt es immer noch Möglichkeiten --> Aktiensplit --> oder übernommen werden.
anja,
anja,
Antwort auf Beitrag Nr.: 35.911.428 von gooner1967 am 11.11.08 14:42:11Erst einmal: Ist ja ein Hammer! Insolvenzantrag... Zugegebenermassen habe ich dass nicht ausgeschlossen, aber der Zeitpunkt überrascht mich schon ein wenig.
Sicherlich ist es möglich aus Insolvenzen, als Anleger eine Menge Geld zu schlagen. Allerdings fehlt mir dazu der Durchblick (und der Mut)... Bin mir nicht im klaren, ob die 5 Mil $ MK zu hoch angesetzt sind oder eher zu niedrig. Auf eine Übernahme würde ich nicht setzen, da z.B. O`Donnell Rechte an Revimmune hält und nicht ABPI...
Auch auf die Gefahr hin, dass es noch ein schlechter Ratschlag ist: Ich würde aktuell zumindest nicht nachkaufen. Sorry...
Grüße
Sicherlich ist es möglich aus Insolvenzen, als Anleger eine Menge Geld zu schlagen. Allerdings fehlt mir dazu der Durchblick (und der Mut)... Bin mir nicht im klaren, ob die 5 Mil $ MK zu hoch angesetzt sind oder eher zu niedrig. Auf eine Übernahme würde ich nicht setzen, da z.B. O`Donnell Rechte an Revimmune hält und nicht ABPI...
Auch auf die Gefahr hin, dass es noch ein schlechter Ratschlag ist: Ich würde aktuell zumindest nicht nachkaufen. Sorry...
Grüße
Mal sehen was da heute noch geht.
PS
Den mutigen gehoert die Welt.
PS
Den mutigen gehoert die Welt.
Antwort auf Beitrag Nr.: 35.950.645 von gooner1967 am 14.11.08 19:45:02Hi Anja,
wie es weiter gehen soll weiss ich leider auch nicht. Kann mir
aber schlecht vorstellen, das die Accentia kpl. dichtmachen.
Gruss
wie es weiter gehen soll weiss ich leider auch nicht. Kann mir
aber schlecht vorstellen, das die Accentia kpl. dichtmachen.
Gruss
Kann ich diese aktien besser halten oder Verkaufen?
Ich habe 80% Verlust....
Danke,
Anja
Ich habe 80% Verlust....
Danke,
Anja
Antwort auf Beitrag Nr.: 35.991.827 von gooner1967 am 18.11.08 16:00:03Hi Gooner,
den Verlust hast du erst, wenn du verkaufst.
den Verlust hast du erst, wenn du verkaufst.
Antwort auf Beitrag Nr.: 35.999.847 von SunnyOst am 19.11.08 09:17:32Irgendetwas scheint bei den Amis
im Busch zu sein. Weiss jemand
was?
im Busch zu sein. Weiss jemand
was?
Antwort auf Beitrag Nr.: 36.831.076 von SunnyOst am 24.03.09 07:34:12Ich hab mich nicht mehr mit dem Wert beschäftigt und wundere mich auch über den Kursverlauf.
Nach dem Insolvenzantrag und dem Wechsel des Segmentes entfernt sich Accentia (WKN: B081PF4, ABPIQ.PK) tatsächlich von den Tiefsttänden.
Wir waren im November und Dezember bei niedrigen 10 Cent und seit Mitte März geht es hoch bis derzeit fast 40 Cent.
Wäre schon erstaunlich, wenn die wirklich noch einmal zurückkommen...
.. mal beobachten.
KJ
Nach dem Insolvenzantrag und dem Wechsel des Segmentes entfernt sich Accentia (WKN: B081PF4, ABPIQ.PK) tatsächlich von den Tiefsttänden.
Wir waren im November und Dezember bei niedrigen 10 Cent und seit Mitte März geht es hoch bis derzeit fast 40 Cent.
Wäre schon erstaunlich, wenn die wirklich noch einmal zurückkommen...
.. mal beobachten.
KJ
Scheinen tatsaechlich zurueckzukommen.
Antwort auf Beitrag Nr.: 37.258.868 von SunnyOst am 27.05.09 06:26:36Sunny,
sieht aus als fehlt jetzt jemand, der die monatlichen SEC-Form 8-K Mitteilungen liest und (korrekt) interpretiert. Unser Experte Ackergaul scheint ja, ich muss sagen leider, das Interesse verloren zu haben.
In Nachricht #187 hat sich Ackergaul geoutet, dass er bei 80 US-Cent ausgestiegen ist und in Nachricht #194 empfahl er zumindest nicht nachzukaufen.
Bei 80 US-Cent auszusteigen war eine sehr gute Idee, da wir danach ja noch US-10 Cent gesehen haben.
Den Nachkauf auf ermässigtem Niveau bei einem Chapter11-Antrag hätte ich auch niemals befürwortet.
Aktueller Kurs 0,48 US-Cent.
Interessant ist folgende Mitteilung vom 21.05.09., denn die BiovaxID Ergebnisse werden bei der ASCO-Veranstaltung am Sonntag besprochen.
"Biovest’s personalized anti-cancer vaccine targeting B-cell blood cancers, will be featured in an oral presentation during the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31st, 2009 in Orlando, Florida.
(...) The BiovaxID presentation (is) titled, “Idiotype Vaccine Therapy (BiovaxID®) in Follicular
Lymphoma in First Complete Remission: Phase III Clinical Trial Results.”"
KJ
sieht aus als fehlt jetzt jemand, der die monatlichen SEC-Form 8-K Mitteilungen liest und (korrekt) interpretiert. Unser Experte Ackergaul scheint ja, ich muss sagen leider, das Interesse verloren zu haben.
In Nachricht #187 hat sich Ackergaul geoutet, dass er bei 80 US-Cent ausgestiegen ist und in Nachricht #194 empfahl er zumindest nicht nachzukaufen.
Bei 80 US-Cent auszusteigen war eine sehr gute Idee, da wir danach ja noch US-10 Cent gesehen haben.
Den Nachkauf auf ermässigtem Niveau bei einem Chapter11-Antrag hätte ich auch niemals befürwortet.
Aktueller Kurs 0,48 US-Cent.
Interessant ist folgende Mitteilung vom 21.05.09., denn die BiovaxID Ergebnisse werden bei der ASCO-Veranstaltung am Sonntag besprochen.
"Biovest’s personalized anti-cancer vaccine targeting B-cell blood cancers, will be featured in an oral presentation during the Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31st, 2009 in Orlando, Florida.
(...) The BiovaxID presentation (is) titled, “Idiotype Vaccine Therapy (BiovaxID®) in Follicular
Lymphoma in First Complete Remission: Phase III Clinical Trial Results.”"
KJ
Antwort auf Beitrag Nr.: 37.261.547 von KillingJoke am 27.05.09 13:00:49Hi KJ,
da scheinen div. Insider im Moment richtig
zuzuschlagen.
Hoffentlich irren die nicht.
da scheinen div. Insider im Moment richtig
zuzuschlagen.
Hoffentlich irren die nicht.
Antwort auf Beitrag Nr.: 37.261.547 von KillingJoke am 27.05.09 13:00:49
Noch eine Meinung zum Austragungsort beim ASCO Treffen,
gefunden in einem US-Board. Das ASCO Treffen könnte also schon für die Phantasie im Wert sorgen...
"There are only four cancer drugs being discussed during this year’s ASCO Plenary Session and BiovaxID is one of them. At the Plenary Session you get to present your trial results in the main room before thousands of people. ASCO usually reserves these spots for what it considers the year’s most important trials. Last year the Plenary Session buzz was centered on ImClone’s Erbitux. Given that ASCO’s theme this year is “Personalizing Cancer Care”, if the BiovaxID Phase III results are well received, some interesting things could happen."
Noch eine Meinung zum Austragungsort beim ASCO Treffen,
gefunden in einem US-Board. Das ASCO Treffen könnte also schon für die Phantasie im Wert sorgen...
"There are only four cancer drugs being discussed during this year’s ASCO Plenary Session and BiovaxID is one of them. At the Plenary Session you get to present your trial results in the main room before thousands of people. ASCO usually reserves these spots for what it considers the year’s most important trials. Last year the Plenary Session buzz was centered on ImClone’s Erbitux. Given that ASCO’s theme this year is “Personalizing Cancer Care”, if the BiovaxID Phase III results are well received, some interesting things could happen."
Ich bin natürlich auch neugierig auf die ASCO Präsentation und anscheinend wird ja "wild" spekuliert... Umso spannender ist es, dass das eigentliche abstract noch gar nicht veröffentlicht ist, was bei den anderen Teilnehmern ab dem 14. Mai schon der Fall war.
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2009 ASCO Annual Meeting
Citation: J Clin Oncol 27:15s, 2009 (suppl; abstr 2)
Abstract No: 2
Attend this session at the ASCO Annual Meeting!
Session: Plenary Session including Science of Oncology Award and Lecture
Type: Plenary Presentation
Time: Sunday May 31, 1:00 PM to 4:00 PM
Location: Level 2, West Hall D2
Personalize your Annual Meeting experience with a suggested or customized itinerary!
Author(s): S. J. Schuster, S. S. Neelapu, B. L. Gause, F. M. Muggia, J. P. Gockerman, E. M. Sotomayor, J. N. Winter, C. R. Flowers, A. M. Stergiou, L. W. Kwak, for the BiovaxID Phase III Study Investigators; Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA; M. D. Anderson Cancer Center, Houston, TX; National Cancer Institute, Bethesda, MD; New York University Medical Center, New York, NY; Duke University Medical Center, Durham, NC; Moffitt Cancer Center & Research Institute, Tampa, FL; Northwestern University, Chicago, IL; Emory University, Atlanta, GA; Biovest International, New York, NY
Abstract: The full, final text of this abstract will be available on
Sunday, May 31 at 12:00 PM ET.
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Was ich erwarte ist ein Update der survival Daten, die dann hoffentlich weiterhin einen positiven Trend zu BiovaxID zeigen! Drücke hier auf jeden Fall feste die Daumen...
Grüße
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2009 ASCO Annual Meeting
Citation: J Clin Oncol 27:15s, 2009 (suppl; abstr 2)
Abstract No: 2
Attend this session at the ASCO Annual Meeting!
Session: Plenary Session including Science of Oncology Award and Lecture
Type: Plenary Presentation
Time: Sunday May 31, 1:00 PM to 4:00 PM
Location: Level 2, West Hall D2
Personalize your Annual Meeting experience with a suggested or customized itinerary!
Author(s): S. J. Schuster, S. S. Neelapu, B. L. Gause, F. M. Muggia, J. P. Gockerman, E. M. Sotomayor, J. N. Winter, C. R. Flowers, A. M. Stergiou, L. W. Kwak, for the BiovaxID Phase III Study Investigators; Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA; M. D. Anderson Cancer Center, Houston, TX; National Cancer Institute, Bethesda, MD; New York University Medical Center, New York, NY; Duke University Medical Center, Durham, NC; Moffitt Cancer Center & Research Institute, Tampa, FL; Northwestern University, Chicago, IL; Emory University, Atlanta, GA; Biovest International, New York, NY
Abstract: The full, final text of this abstract will be available on
Sunday, May 31 at 12:00 PM ET.
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Was ich erwarte ist ein Update der survival Daten, die dann hoffentlich weiterhin einen positiven Trend zu BiovaxID zeigen! Drücke hier auf jeden Fall feste die Daumen...
Grüße
Antwort auf Beitrag Nr.: 37.264.328 von Ackergaul am 27.05.09 17:16:31
Hallo Ackergaul,
Du bist zurück, toll!!!
Hallo Ackergaul,
Du bist zurück, toll!!!
Antwort auf Beitrag Nr.: 37.264.328 von Ackergaul am 27.05.09 17:16:31Hi Ackergaul,
danke fuers Daumendruecken.
danke fuers Daumendruecken.
Antwort auf Beitrag Nr.: 37.264.044 von KillingJoke am 27.05.09 16:52:32Anbei noch weiter Infos zur ASCO-Präsentation von BiovaxID:
Der BiovaxID Vortrag ist eingeodnet unter
Developmental Therapeutics: Immunotherapy / Vaccines
Übersicht aller Vorträge:
http://www.abstract.asco.org/CatAbstView_65_13_AA.html
Die 4 Vorträge am Sonntag in der "Plenary Session" sind:
a)
Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial.
Info zum Unternehmen:
BiPar Sciences Inc. (is a wholly-owned subsidiary of Sanofi-Aventis), http://www.biparsciences.com/, BSI-201.
b)
A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08.
Info zum Unternehmen:
Genentech Inc., http://www.gene.com, NSABP Protocol C-08.
c)
A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials).
Infos zur Gruppe (gemeinnützige Organisation für Studien zur Krebstherapie):
EORTC Gynaecological Cancer Group (European Organisation for Research and Treatment of Cancer), http://www.eortc.be, EORTC 55955 trial.
d)
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results.
Info zum Unternehmen:
Biovest International Inc (is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc.), http://www.biovest.com/, BiovaxID
Grüsse,
KJ
Der BiovaxID Vortrag ist eingeodnet unter
Developmental Therapeutics: Immunotherapy / Vaccines
Übersicht aller Vorträge:
http://www.abstract.asco.org/CatAbstView_65_13_AA.html
Die 4 Vorträge am Sonntag in der "Plenary Session" sind:
a)
Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial.
Info zum Unternehmen:
BiPar Sciences Inc. (is a wholly-owned subsidiary of Sanofi-Aventis), http://www.biparsciences.com/, BSI-201.
b)
A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08.
Info zum Unternehmen:
Genentech Inc., http://www.gene.com, NSABP Protocol C-08.
c)
A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials).
Infos zur Gruppe (gemeinnützige Organisation für Studien zur Krebstherapie):
EORTC Gynaecological Cancer Group (European Organisation for Research and Treatment of Cancer), http://www.eortc.be, EORTC 55955 trial.
d)
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results.
Info zum Unternehmen:
Biovest International Inc (is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc.), http://www.biovest.com/, BiovaxID
Grüsse,
KJ
Antwort auf Beitrag Nr.: 37.264.328 von Ackergaul am 27.05.09 17:16:31Das das Abstract bisher nicht veröffentlicht wurde, garantiert die Spannung bis zum 31.05., 12 Uhr Ortszeit.
Es gibt eine ASCO Abstract Embargo-Richtlinie, die dafür sorgt, dass alle Vorträge, die im Plänarsaal gehalten werden, nicht schon seit 2 Wochen veröffentlicht sein dürfen.
Im Pressebericht von Biovest wird kurz zum Embargo Stellung genommen:
http://finance.yahoo.com/news/Personalized-AntiCancer-bw-153…
"Note to editors: Pursuant to ASCO policy, this abstract is embargoed until 10:30 a.m. (EDT) on Sunday, May 31st, when it will be highlighted during ASCO’s official Press Program to the media."
Eine Veröffentlichung der ASCO fasst die Richtlinie wie folgt zusammen:
http://www.asco.org/ASCOv2/Press+Center/Latest+News+Releases…
"The vast majority of the abstracts being presented at the Annual Meeting will be posted publicly on www.abstract.asco.org May 14, at 6:00 PM (EDT), and the embargoes on these abstracts – including abstracts highlighted during the presscast earlier that day – will lift at this time. Abstracts selected as Plenary, Late-breaking and Clinical Review – the most significant research of the Meeting – are embargoed for release at various times on-site."
Der Sinn der Embargo-Richtlinie wird schon mal diskutiert.
Sie bereitet in Ihrer Einhaltung u.U. Probleme mit anderen Richtlinien wie "Director Dealings".
Grüsse
KJ
Es gibt eine ASCO Abstract Embargo-Richtlinie, die dafür sorgt, dass alle Vorträge, die im Plänarsaal gehalten werden, nicht schon seit 2 Wochen veröffentlicht sein dürfen.
Im Pressebericht von Biovest wird kurz zum Embargo Stellung genommen:
http://finance.yahoo.com/news/Personalized-AntiCancer-bw-153…
"Note to editors: Pursuant to ASCO policy, this abstract is embargoed until 10:30 a.m. (EDT) on Sunday, May 31st, when it will be highlighted during ASCO’s official Press Program to the media."
Eine Veröffentlichung der ASCO fasst die Richtlinie wie folgt zusammen:
http://www.asco.org/ASCOv2/Press+Center/Latest+News+Releases…
"The vast majority of the abstracts being presented at the Annual Meeting will be posted publicly on www.abstract.asco.org May 14, at 6:00 PM (EDT), and the embargoes on these abstracts – including abstracts highlighted during the presscast earlier that day – will lift at this time. Abstracts selected as Plenary, Late-breaking and Clinical Review – the most significant research of the Meeting – are embargoed for release at various times on-site."
Der Sinn der Embargo-Richtlinie wird schon mal diskutiert.
Sie bereitet in Ihrer Einhaltung u.U. Probleme mit anderen Richtlinien wie "Director Dealings".
Grüsse
KJ
http://www.abstract.asco.org/AbstView_65_33572.html
Abstract:
Background: In previous trials, tumor-specific purified idiotype (Id) protein conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induced follicular lymphoma (FL)-specific immune responses and molecular remissions (Nat Med. 1999;5:1171-7). Methods: We conducted a prospective randomized double-blind placebo-controlled multicenter phase III study of patient-specific autologous tumor-derived Id vaccine in advanced stage previously untreated FL patients (pts) with a lymph node adequate for vaccine production (≥ 2cm). Pts achieving complete response (CR) or complete response unconfirmed (CRu) after chemotherapy (PACE: prednisone, doxorubicin, cyclophosphamide, etoposide) were stratified by International Prognostic Index risk group and randomized 2:1 to receive either vaccination with Id-KLH/GM-CSF or control (KLH/GM-CSF). The primary endpoint was disease free survival. Results: 234 pts were enrolled; 177 (76%) achieved CR/CRu and were randomized. Of 177 randomized pts, 117 maintained CR/CRu ≥ 6 mo per protocol requirement and then received at least one dose of vaccine, 55 relapsed before vaccination, 4 were vaccine manufacturing failures, and 1 violated protocol. Pts who received ≥ one vaccine dose constituted the modified intent-to-treat population for determination of efficacy. 76 pts received Id-KLH/GM-CSF and 41 pts received the control (KHL/GM-CSF). No serious adverse events were attributed to Id vaccination. At a median follow-up of 56.6 mo (range 12.6 - 89.3 mo), median time to relapse after randomization for the Id-KLH/GM-CSF arm was 44.2 mo, versus 30.6 mo for the control arm (p = 0.045; HR = 1.6). Conclusions: Id vaccination after a chemotherapy-induced remission of ≥ 6 mo prolongs remission duration in pts with FL. Compared to other phase III Id vaccine trials, the positive outcome of this study may reflect application of Id vaccine in pts in CR/CRu or use of hybridomas to produce Id. Genomic and immune response analyses are planned on residual autologous tumor and blood samples. Additional studies of this patient-specific vaccine in FL pts pretreated with anti-CD20 antibody-containing chemotherapy are indicated.
So, wie ich dass sehe keine eigentlich neuen Daten die hier in die ASCO Daten eingebunden wurden. Was ich gut finde, ist dass eine meiner Fragen geklärt wurde "was ist mit den 60 Patienten passiert mit CR/CRu aber nicht behandelt wurden?"
Also 177 wie erwähnt CR/CRu, aber nur 117 letztendlich behandelt, nun kam die Klärung:
* 55 relapsed before vaccination
* 4 were vaccine manufacturing failures (hier wurden mehr vermutet)
* 1 violated protocol
Wie unten unter Coclusions aufgeführt "Additional studies of this patient-specific vaccine in FL pts pretreated with anti-CD20 antibody-containing chemotherapy are indicated."
Wird wohl soviel bedeuten, wie zu wenig Patienten um zugelassen zu werden, aber zu gute Daten um Fallen gelassen zu werden...
Noch der Pressebericht
http://www.businesswire.com/portal/site/google/?ndmViewId=ne…
Grüße
Abstract:
Background: In previous trials, tumor-specific purified idiotype (Id) protein conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) induced follicular lymphoma (FL)-specific immune responses and molecular remissions (Nat Med. 1999;5:1171-7). Methods: We conducted a prospective randomized double-blind placebo-controlled multicenter phase III study of patient-specific autologous tumor-derived Id vaccine in advanced stage previously untreated FL patients (pts) with a lymph node adequate for vaccine production (≥ 2cm). Pts achieving complete response (CR) or complete response unconfirmed (CRu) after chemotherapy (PACE: prednisone, doxorubicin, cyclophosphamide, etoposide) were stratified by International Prognostic Index risk group and randomized 2:1 to receive either vaccination with Id-KLH/GM-CSF or control (KLH/GM-CSF). The primary endpoint was disease free survival. Results: 234 pts were enrolled; 177 (76%) achieved CR/CRu and were randomized. Of 177 randomized pts, 117 maintained CR/CRu ≥ 6 mo per protocol requirement and then received at least one dose of vaccine, 55 relapsed before vaccination, 4 were vaccine manufacturing failures, and 1 violated protocol. Pts who received ≥ one vaccine dose constituted the modified intent-to-treat population for determination of efficacy. 76 pts received Id-KLH/GM-CSF and 41 pts received the control (KHL/GM-CSF). No serious adverse events were attributed to Id vaccination. At a median follow-up of 56.6 mo (range 12.6 - 89.3 mo), median time to relapse after randomization for the Id-KLH/GM-CSF arm was 44.2 mo, versus 30.6 mo for the control arm (p = 0.045; HR = 1.6). Conclusions: Id vaccination after a chemotherapy-induced remission of ≥ 6 mo prolongs remission duration in pts with FL. Compared to other phase III Id vaccine trials, the positive outcome of this study may reflect application of Id vaccine in pts in CR/CRu or use of hybridomas to produce Id. Genomic and immune response analyses are planned on residual autologous tumor and blood samples. Additional studies of this patient-specific vaccine in FL pts pretreated with anti-CD20 antibody-containing chemotherapy are indicated.
So, wie ich dass sehe keine eigentlich neuen Daten die hier in die ASCO Daten eingebunden wurden. Was ich gut finde, ist dass eine meiner Fragen geklärt wurde "was ist mit den 60 Patienten passiert mit CR/CRu aber nicht behandelt wurden?"
Also 177 wie erwähnt CR/CRu, aber nur 117 letztendlich behandelt, nun kam die Klärung:
* 55 relapsed before vaccination
* 4 were vaccine manufacturing failures (hier wurden mehr vermutet)
* 1 violated protocol
Wie unten unter Coclusions aufgeführt "Additional studies of this patient-specific vaccine in FL pts pretreated with anti-CD20 antibody-containing chemotherapy are indicated."
Wird wohl soviel bedeuten, wie zu wenig Patienten um zugelassen zu werden, aber zu gute Daten um Fallen gelassen zu werden...
Noch der Pressebericht
http://www.businesswire.com/portal/site/google/?ndmViewId=ne…
Grüße
Antwort auf Beitrag Nr.: 37.293.267 von Ackergaul am 01.06.09 09:48:28Die ASCO-Präsentation wurde gehalten.
Nach wie vor stehen die alten Daten zur Diskussion und der p-wert von 0.045 ist nah an der Grenze zu 0.05.
After a median follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045).
Erschwerend kommt hinzu, dass weitere Untersuchungen gemacht werden müssten, um eine Zulassung zu erhalten.
"We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways."
Was fehlt ist Geld.
Die ASCO-Konferenz brachte für die "alten" Aktionäre kaum neue Erkenntnisse.
Biovest und Accentia haben mit BiovaxID Blockbuster-Potential.
Die Frage bleibt, ob die Ansicht "zu gut um nicht weiterverfolgt zu werden" im Umkehrschluss heissen kann "gut genug für einen Blockbuster".
Im Aktienmarkt für Krebsmedikamente geht es nicht immer rational zu, es regiert "Glaube, Liebe, Hoffnung", siehe Dendreon.
Ich glaubte mittlerweile, die ASCO-Konferenz könnte tatsächlich noch den Duchbruch für BiovaxID bedeuten. Die ASCO-Plattform darf man nicht unterschätzen. Es ist zumindest ein guter "letzter Strohhalm".
Deshalb wird (meiner Meinung nach) der Kurs von Biovest und Accentia trotz Chapter11-Status steigen. Biovest könnte kurzfristig mehr profitieren bzw. sie haben bereits im Vorfeld der Konferenz mehr profitiert.
Schaut man sich die Royalities-Regelungen an, ist (meiner Meinung nach) langfristig Accentia in der deutlich besseren Position.
Da einfach derzeit nicht genug Geld da ist, kann ich mich unterm Strich nicht zu einem seriösen "Kauf"-Urteil durchringen. Aber es gibt ja auch Leute, die Lotto spielen, um den Jackpot zu knacken oder beim Roulette auf ein Einzelfeld setzen
KJ
Nach wie vor stehen die alten Daten zur Diskussion und der p-wert von 0.045 ist nah an der Grenze zu 0.05.
After a median follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045).
Erschwerend kommt hinzu, dass weitere Untersuchungen gemacht werden müssten, um eine Zulassung zu erhalten.
"We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways."
Was fehlt ist Geld.
Die ASCO-Konferenz brachte für die "alten" Aktionäre kaum neue Erkenntnisse.
Biovest und Accentia haben mit BiovaxID Blockbuster-Potential.
Die Frage bleibt, ob die Ansicht "zu gut um nicht weiterverfolgt zu werden" im Umkehrschluss heissen kann "gut genug für einen Blockbuster".
Im Aktienmarkt für Krebsmedikamente geht es nicht immer rational zu, es regiert "Glaube, Liebe, Hoffnung", siehe Dendreon.
Ich glaubte mittlerweile, die ASCO-Konferenz könnte tatsächlich noch den Duchbruch für BiovaxID bedeuten. Die ASCO-Plattform darf man nicht unterschätzen. Es ist zumindest ein guter "letzter Strohhalm".
Deshalb wird (meiner Meinung nach) der Kurs von Biovest und Accentia trotz Chapter11-Status steigen. Biovest könnte kurzfristig mehr profitieren bzw. sie haben bereits im Vorfeld der Konferenz mehr profitiert.
Schaut man sich die Royalities-Regelungen an, ist (meiner Meinung nach) langfristig Accentia in der deutlich besseren Position.
Da einfach derzeit nicht genug Geld da ist, kann ich mich unterm Strich nicht zu einem seriösen "Kauf"-Urteil durchringen. Aber es gibt ja auch Leute, die Lotto spielen, um den Jackpot zu knacken oder beim Roulette auf ein Einzelfeld setzen
KJ
Mahlzeit die Herren,
war ja ein klasse Umsatz
aber ein bescheidener Verlauf
Ergo, sit and wait
war ja ein klasse Umsatz
aber ein bescheidener Verlauf
Ergo, sit and wait
Antwort auf Beitrag Nr.: 37.301.094 von SunnyOst am 02.06.09 12:08:54Hallo Sunny,
richtig festgestellt. Stark angefangen und stark nachgelassen.
Bei Biovest war unter dem Strich immerhin noch ein 80% Plus.
Biovest
Vor der Insolvenz: 0,34 USD
Tief Jan/März: 0,05 USD
Gestern nach dem ASCO-Meeting 0,88 USD (+80%)
Accentia
Vor der Insolvenz: 0,90 USD
Tief Jan/März: 0,10 USD
Gestern nach dem ASCO-Meeting 0,54 USD (-5%)
Wer den Kursverlauf von Biovest und der Mutter Accentia ansieht, stellt schnell fest, dass Biovest auf Höchstkursen steht, während Accentia noch deutlich unter den Kursen zum Zeitpunkt der Insolvenzmeldung liegt.
Accentia Nachteile:
Accentia hatte weitere Medikamente in Entwicklung wie Sinunase, die sich allesamt nicht wie erhofft entwickelten. Accentia hat ausserdem den höheren Schuldenberg angehäuft.
Biovest Vorteile:
Wird als "Hersteller" von BiovaxID entsprechend öfter in den Medien genannt.
Hat aufgrund des 75%-Anteils von Accentia nur die geringe Menge von 25% der Aktien im Freefloat, d.h. der Kurs der Aktie reagiert stärker auf Schwankungen.
Aber:
Trotz allem klafft mir die Schere von Biovest und Accentia zu weit ausseinender.
Die Schere müsste wieder zugehen.
Accentia profitiert direkt vom Firmenwert von Biovest durch die gehaltenen Aktien (75%).
Accentia profitiert indirekt durch die ausgehandelten Verträge (royalties) mit der "abhängigen" Tochter.
(Ich unterstelle mal, dass einige der neuen Investoren das noch immer nicht durchblicken. Noch nicht.)
Bedeutet c.p.: Entweder wird Accentia auch Richtung 0,90 USD steigen oder
Biovest wird Richtung 0,50 USD zurückfallen.
Dann gilt meiner Meinung nach noch das folgende "globale" Szenario.
Werden Meldungen im weiteren Vorgehen mit BiovaxID vermeldet, werden beide Werte steigen,
da sich die Zukunft konkretisiert.
Ansonsten wird leider der ASCO-Effekt nachlassen und die Kurse bröckeln.
Sollten wider Erwarten (!) die Kurse auch in 2 Wochen, ohne das Fortschritte kommuniziert werden, unter akzeptablem Volumen noch weiter steigen würde ich das als Zeichen von ersten Übernahmekäufen interpretieren wollen.
KJ
richtig festgestellt. Stark angefangen und stark nachgelassen.
Bei Biovest war unter dem Strich immerhin noch ein 80% Plus.
Biovest
Vor der Insolvenz: 0,34 USD
Tief Jan/März: 0,05 USD
Gestern nach dem ASCO-Meeting 0,88 USD (+80%)
Accentia
Vor der Insolvenz: 0,90 USD
Tief Jan/März: 0,10 USD
Gestern nach dem ASCO-Meeting 0,54 USD (-5%)
Wer den Kursverlauf von Biovest und der Mutter Accentia ansieht, stellt schnell fest, dass Biovest auf Höchstkursen steht, während Accentia noch deutlich unter den Kursen zum Zeitpunkt der Insolvenzmeldung liegt.
Accentia Nachteile:
Accentia hatte weitere Medikamente in Entwicklung wie Sinunase, die sich allesamt nicht wie erhofft entwickelten. Accentia hat ausserdem den höheren Schuldenberg angehäuft.
Biovest Vorteile:
Wird als "Hersteller" von BiovaxID entsprechend öfter in den Medien genannt.
Hat aufgrund des 75%-Anteils von Accentia nur die geringe Menge von 25% der Aktien im Freefloat, d.h. der Kurs der Aktie reagiert stärker auf Schwankungen.
Aber:
Trotz allem klafft mir die Schere von Biovest und Accentia zu weit ausseinender.
Die Schere müsste wieder zugehen.
Accentia profitiert direkt vom Firmenwert von Biovest durch die gehaltenen Aktien (75%).
Accentia profitiert indirekt durch die ausgehandelten Verträge (royalties) mit der "abhängigen" Tochter.
(Ich unterstelle mal, dass einige der neuen Investoren das noch immer nicht durchblicken. Noch nicht.)
Bedeutet c.p.: Entweder wird Accentia auch Richtung 0,90 USD steigen oder
Biovest wird Richtung 0,50 USD zurückfallen.
Dann gilt meiner Meinung nach noch das folgende "globale" Szenario.
Werden Meldungen im weiteren Vorgehen mit BiovaxID vermeldet, werden beide Werte steigen,
da sich die Zukunft konkretisiert.
Ansonsten wird leider der ASCO-Effekt nachlassen und die Kurse bröckeln.
Sollten wider Erwarten (!) die Kurse auch in 2 Wochen, ohne das Fortschritte kommuniziert werden, unter akzeptablem Volumen noch weiter steigen würde ich das als Zeichen von ersten Übernahmekäufen interpretieren wollen.
KJ
Antwort auf Beitrag Nr.: 37.301.369 von KillingJoke am 02.06.09 12:41:15Mahlzeit,
Die ASCO war ein Ritterschlag für BiovaxID!!! Folgender Ausschnitt von Adam Feuerstein ("Guru Ober Pessimist" von the street):
ASCO holds its plenary sessions in huge meeting halls that can seat 15,000 people comfortably. Usually, these
highly attended sessions feature cutting-edge research from the top names in the biotech and pharmaceutical
sectors.
Well this year, those big companies shared the stage with a tiny drug firm sporting a penny stock trading on the
pink sheets.
Accentia and its majority-owned subsidiary Biovest International(BVTI.PK Quote) (yes, another bulletin
board stock) presented data on the first cancer vaccine purported to work in patients with non-Hodgkin's
lymphoma.
Da halten also sonst ganz andere Größen Ihre Präsentationen ab... Interesse ist anscheinend vorhanden!
Ob BVTI oder ABPI:
Könnte mir vorstellen, dass die Firmen über kurz oder lang verschmelzen. ABPI besitzt - soweit ich noch weiß - immer noch knapp 70 % an BVTI und Kosten würde dass ganze auch noch sparen.
Zum Thema Geld:
Man wagt es ja kaum zu sagen, aber BiovaxIDs Marktpotential liegt wirklich jenseits der 500.000.000 $. Alleine Indolent Follicular NHL Patienten gibt es in Amerika 16.000 und Europa 11.500. Werden 20 % zukünftig mit BiovaxID behandelt (Kosten möglicherweise um 100.000 $!!!) wären dies alleine über eine halbe Mrd Dollar Umsatz. Zusätzlich kommen natürlich Patienten mir artverwandter Erkrankung ebenfalls für die Behandlung in Frage... Ach ja, jetzt überlegt nochmal: Verhältnis Größe des Sitzungsraums zu behandelnde Patineten.
Dies muss doch Big Pharma aufmerksam machen, aber anscheinend hat noch keiner angebissen (und hier stellt sich die Frage: Wo liegt die Wahrheit?). Falls es zu einem Deal kommt, werden wohl 60 bis 80 Mil $ sofort fliessen, weitere Milestone Zahlungen bei Zulassung und natürlich Royalities bei späteren Verkauf. Wie dass Chapter 11 Thema alles beeinflussen kann/wird???
Grüße
nochmals zu weiter oben...
Ist natürlich nicht in Stein gemeißelt, dass weitere Untersuchungen folgen müssen (ich denke Du meinst - wie auch ich - eine zusätzliche klinische Phase mit mehreren hunderten Patienten). Mit den FDA und EMEA Treffen ist wohl erst einmal dass normale Prozedere gemeint (welche Dokumente und Daten ABPI bzw BVTI bereitstellen müssen) und wann die nächsten Zulassungsschritte erfolgen.
Dass die FDA ab und zu überraschende Schritte tätigt ist nicht erst seit dem positiven Voting zu Iloperidone (siehe VNDA) bekannt, aber ich denke, dass einfach zu wenig Patienten behandelt wurden, damit FDA und EMEA BiovaxID zulassen. Nach dem "statistical analysis plan" hätte BiovaxID sogar die P=0.01 Grenze unterschreiten müssen, dies ist aber mit den 117 Patienten niemals zu erreichen gewesen.
Die ASCO war ein Ritterschlag für BiovaxID!!! Folgender Ausschnitt von Adam Feuerstein ("Guru Ober Pessimist" von the street):
ASCO holds its plenary sessions in huge meeting halls that can seat 15,000 people comfortably. Usually, these
highly attended sessions feature cutting-edge research from the top names in the biotech and pharmaceutical
sectors.
Well this year, those big companies shared the stage with a tiny drug firm sporting a penny stock trading on the
pink sheets.
Accentia and its majority-owned subsidiary Biovest International(BVTI.PK Quote) (yes, another bulletin
board stock) presented data on the first cancer vaccine purported to work in patients with non-Hodgkin's
lymphoma.
Da halten also sonst ganz andere Größen Ihre Präsentationen ab... Interesse ist anscheinend vorhanden!
Ob BVTI oder ABPI:
Könnte mir vorstellen, dass die Firmen über kurz oder lang verschmelzen. ABPI besitzt - soweit ich noch weiß - immer noch knapp 70 % an BVTI und Kosten würde dass ganze auch noch sparen.
Zum Thema Geld:
Man wagt es ja kaum zu sagen, aber BiovaxIDs Marktpotential liegt wirklich jenseits der 500.000.000 $. Alleine Indolent Follicular NHL Patienten gibt es in Amerika 16.000 und Europa 11.500. Werden 20 % zukünftig mit BiovaxID behandelt (Kosten möglicherweise um 100.000 $!!!) wären dies alleine über eine halbe Mrd Dollar Umsatz. Zusätzlich kommen natürlich Patienten mir artverwandter Erkrankung ebenfalls für die Behandlung in Frage... Ach ja, jetzt überlegt nochmal: Verhältnis Größe des Sitzungsraums zu behandelnde Patineten.
Dies muss doch Big Pharma aufmerksam machen, aber anscheinend hat noch keiner angebissen (und hier stellt sich die Frage: Wo liegt die Wahrheit?). Falls es zu einem Deal kommt, werden wohl 60 bis 80 Mil $ sofort fliessen, weitere Milestone Zahlungen bei Zulassung und natürlich Royalities bei späteren Verkauf. Wie dass Chapter 11 Thema alles beeinflussen kann/wird???
Grüße
nochmals zu weiter oben...
Ist natürlich nicht in Stein gemeißelt, dass weitere Untersuchungen folgen müssen (ich denke Du meinst - wie auch ich - eine zusätzliche klinische Phase mit mehreren hunderten Patienten). Mit den FDA und EMEA Treffen ist wohl erst einmal dass normale Prozedere gemeint (welche Dokumente und Daten ABPI bzw BVTI bereitstellen müssen) und wann die nächsten Zulassungsschritte erfolgen.
Dass die FDA ab und zu überraschende Schritte tätigt ist nicht erst seit dem positiven Voting zu Iloperidone (siehe VNDA) bekannt, aber ich denke, dass einfach zu wenig Patienten behandelt wurden, damit FDA und EMEA BiovaxID zulassen. Nach dem "statistical analysis plan" hätte BiovaxID sogar die P=0.01 Grenze unterschreiten müssen, dies ist aber mit den 117 Patienten niemals zu erreichen gewesen.
Antwort auf Beitrag Nr.: 37.301.602 von Ackergaul am 02.06.09 13:15:53Ackergaul,
ich hab wirklich das Gefühl, dass BiovaxID funktioniert. Dann wäre das so ein Durchbruch wie mit Dendreon, eben ein neuer grundlegender Ansatz. Das Marktpotential ist wirklich enorm, da weitere Krankheitsfelder erschlossen werden könnten.
Im Nachhinein betrachtet wurde wohl zuviel Geld für die anderen Projekte verschwendet. Bei Erfolg wäre das Geld für die weiteren Phase III Tests von BiovaxID da gewesen. Nun ist es aber anders gekommen und man braucht den Partner.
Für die Partnersuche war die ASCO-Plattform die bestmögliche Werbung. Was jetzt noch kommt, sagt uns ... der Kurs...
KJ
ich hab wirklich das Gefühl, dass BiovaxID funktioniert. Dann wäre das so ein Durchbruch wie mit Dendreon, eben ein neuer grundlegender Ansatz. Das Marktpotential ist wirklich enorm, da weitere Krankheitsfelder erschlossen werden könnten.
Im Nachhinein betrachtet wurde wohl zuviel Geld für die anderen Projekte verschwendet. Bei Erfolg wäre das Geld für die weiteren Phase III Tests von BiovaxID da gewesen. Nun ist es aber anders gekommen und man braucht den Partner.
Für die Partnersuche war die ASCO-Plattform die bestmögliche Werbung. Was jetzt noch kommt, sagt uns ... der Kurs...
KJ
Antwort auf Beitrag Nr.: 37.301.369 von KillingJoke am 02.06.09 12:41:15Ich sag nur "Schere"...
Biovest
Vor der Insolvenz: 0,34 USD
Vorgestern nach dem ASCO-Meeting 0,88 USD (+80%)
Gestern: 0,65 (-26%)
Accentia
Vor der Insolvenz: 0,90 USD
Vorgestern nach dem ASCO-Meeting 0,54 USD (-5%)
Gestern 0,53 USD (-2%)
Biovest
Vor der Insolvenz: 0,34 USD
Vorgestern nach dem ASCO-Meeting 0,88 USD (+80%)
Gestern: 0,65 (-26%)
Accentia
Vor der Insolvenz: 0,90 USD
Vorgestern nach dem ASCO-Meeting 0,54 USD (-5%)
Gestern 0,53 USD (-2%)
Antwort auf Beitrag Nr.: 37.293.267 von Ackergaul am 01.06.09 09:48:28Ackergaul,
BiovaxID wurde an Patienten nach Chemotherapie mit PACE (prednisone, doxorubicin, cyclophosphamide, etoposide) getestet.
Was wäre wohl, wenn die Chemo auf anderer Basis / unter Zugabe von anderen Medikamenten (z.B. Rituxan von Genentech/Biogen Idec) durchgeführt worden wäre?
Grüsse,
KJ
BiovaxID wurde an Patienten nach Chemotherapie mit PACE (prednisone, doxorubicin, cyclophosphamide, etoposide) getestet.
Was wäre wohl, wenn die Chemo auf anderer Basis / unter Zugabe von anderen Medikamenten (z.B. Rituxan von Genentech/Biogen Idec) durchgeführt worden wäre?
Grüsse,
KJ
Antwort auf Beitrag Nr.: 37.310.059 von KillingJoke am 03.06.09 13:23:01Ich denke vermutlich ähnlich, zumindest wohl nicht schlechter.
BiovaxID ist eigentlich mehr ein Überlebens-Booster. Also Patienten, die auf die Chemo ansprechen und wo der Tumor nachweisbar stark zurückgeht (CR), werden 6 Monate lang beobachtet. Liegt immer noch ein CR vor, wird mit BiovaxID behandelt.
Da denke ich, dass die es vermutlich fast egal ist, ob Rituxan oder PACE oder eine Kombination von beiden. Ich denke mit Rituxan kann wahrscheinlich die Zahl der CR Patienten erhöht werden.
Von den 234 Patienten die in der Studie teilnahmen, erreichten "nur" 177 (76 %) ein CR. Hier hat man eher mit 80 bis 85 % gerechnet. Von den 177 waren es 55 (31 %) bei denen sich der Tumor "wieder vergrößerte" und die deswegen nicht mit BiovaxID behandelt wurden. Ich denke mit Rituxan hätte dass besser aussehen können...
Grüße!!!
BiovaxID ist eigentlich mehr ein Überlebens-Booster. Also Patienten, die auf die Chemo ansprechen und wo der Tumor nachweisbar stark zurückgeht (CR), werden 6 Monate lang beobachtet. Liegt immer noch ein CR vor, wird mit BiovaxID behandelt.
Da denke ich, dass die es vermutlich fast egal ist, ob Rituxan oder PACE oder eine Kombination von beiden. Ich denke mit Rituxan kann wahrscheinlich die Zahl der CR Patienten erhöht werden.
Von den 234 Patienten die in der Studie teilnahmen, erreichten "nur" 177 (76 %) ein CR. Hier hat man eher mit 80 bis 85 % gerechnet. Von den 177 waren es 55 (31 %) bei denen sich der Tumor "wieder vergrößerte" und die deswegen nicht mit BiovaxID behandelt wurden. Ich denke mit Rituxan hätte dass besser aussehen können...
Grüße!!!
Antwort auf Beitrag Nr.: 37.301.369 von KillingJoke am 02.06.09 12:41:15Biovest
Vor der Insolvenz im November 2008: 0,34 USD
Montag nach dem ASCO-Meeting 0,88 USD (+80%)
Mittwoch: 0,67 (+3%)
Accentia
Vor der Insolvenz im November 2008: 0,90 USD
Montag nach dem ASCO-Meeting 0,54 USD (-5%)
Mittwoch 0,58 USD (+9%)
Vor der Insolvenz im November 2008: 0,34 USD
Montag nach dem ASCO-Meeting 0,88 USD (+80%)
Mittwoch: 0,67 (+3%)
Accentia
Vor der Insolvenz im November 2008: 0,90 USD
Montag nach dem ASCO-Meeting 0,54 USD (-5%)
Mittwoch 0,58 USD (+9%)
Antwort auf Beitrag Nr.: 37.315.284 von KillingJoke am 03.06.09 22:29:35Hi KJ
das Rechenbeispiel erschliesst sich mir nicht.
das Rechenbeispiel erschliesst sich mir nicht.
Antwort auf Beitrag Nr.: 37.317.563 von SunnyOst am 04.06.09 11:17:53Hallo Sunny,
vor der Insolvenzmeldung waren ABPI und BVTI auf einem Kursniveau, dass natürlich noch deutlich höher war als nach dem Chapter11-Antrag. Beide Firmen stellten zeitgleich den Antrag im November letzten Jahres. Danach ging der Kurs in die Grütze, weil die Investoren logischerweise das vertrauen verloren. Die Optimisten hofften in 2008 auf irgendeine neue Geldquelle, z.B. Investoren, die eine Kapitalerhöhung zeichneten. Die Finanzkrise kam und im Biotech-Sektor ging so gut wie keine Finanzierung mehr.
Nach Ankündigung, dass BiovaxID in der ASCO Plenary Session vorgestellt werden sollte, gingen die Kurse unter Schwankungen wieder hoch und erreichten ihren vorläufigen Höhepunkt vor der ASCO-Sitzung letzten Sonntag.
Ich vergleiche nur einfach die Kurse vom November mit denen Ende Mai und stelle fest, dass Biovest viel besser performt als Accentia.
Krönung des Ungleichgewichtes war der 01.06. mit einer 80% Kurssteigerung von Biovest und keiner bei Accentia.
Ich meine, dass es nicht sein kann, das Biovest so viel steigt und Accentia nicht, da Accentia Royalties für BiovaxID Verkäufe erhält und auch noch Großaktionär von Biovest ist, also vom Firmenwert von Biovest profitiert.
Im Moment sieht es so aus, als halte sich Accentia und Biovest fällt zurück. Seit dem 02.08 performt Accentia besser als Biovest und ich meine das könnte noch etwas anhalten.
Grüsse,
KJ
vor der Insolvenzmeldung waren ABPI und BVTI auf einem Kursniveau, dass natürlich noch deutlich höher war als nach dem Chapter11-Antrag. Beide Firmen stellten zeitgleich den Antrag im November letzten Jahres. Danach ging der Kurs in die Grütze, weil die Investoren logischerweise das vertrauen verloren. Die Optimisten hofften in 2008 auf irgendeine neue Geldquelle, z.B. Investoren, die eine Kapitalerhöhung zeichneten. Die Finanzkrise kam und im Biotech-Sektor ging so gut wie keine Finanzierung mehr.
Nach Ankündigung, dass BiovaxID in der ASCO Plenary Session vorgestellt werden sollte, gingen die Kurse unter Schwankungen wieder hoch und erreichten ihren vorläufigen Höhepunkt vor der ASCO-Sitzung letzten Sonntag.
Ich vergleiche nur einfach die Kurse vom November mit denen Ende Mai und stelle fest, dass Biovest viel besser performt als Accentia.
Krönung des Ungleichgewichtes war der 01.06. mit einer 80% Kurssteigerung von Biovest und keiner bei Accentia.
Ich meine, dass es nicht sein kann, das Biovest so viel steigt und Accentia nicht, da Accentia Royalties für BiovaxID Verkäufe erhält und auch noch Großaktionär von Biovest ist, also vom Firmenwert von Biovest profitiert.
Im Moment sieht es so aus, als halte sich Accentia und Biovest fällt zurück. Seit dem 02.08 performt Accentia besser als Biovest und ich meine das könnte noch etwas anhalten.
Grüsse,
KJ
Antwort auf Beitrag Nr.: 37.318.603 von KillingJoke am 04.06.09 13:19:25Leider bröckeln die Kurse und der ASCO-Effect lässt wieder nach.
Biovest
liegt mit 0,41 USD wieder unter dem Wert vor der ASCO-Präsentation (war da 0,45-0,50 USD). Nach der ASCO Präsentation wurden in der Spitze (bei Eröffnung) sogar 1,50 USD gezahlt.
Accentia
liegt mit 0,33 USD wieder deutlich unter dem ASCO-Level von 0,55-0,60 USD. Accentia konnte nach der ASCO-Präsentation nicht profitieren.
Das meiste Geld lässt sich nach wie vor bei diesen Werten im kurzfristigen Shorten von Übertreibungen verdienen.
Biovest
liegt mit 0,41 USD wieder unter dem Wert vor der ASCO-Präsentation (war da 0,45-0,50 USD). Nach der ASCO Präsentation wurden in der Spitze (bei Eröffnung) sogar 1,50 USD gezahlt.
Accentia
liegt mit 0,33 USD wieder deutlich unter dem ASCO-Level von 0,55-0,60 USD. Accentia konnte nach der ASCO-Präsentation nicht profitieren.
Das meiste Geld lässt sich nach wie vor bei diesen Werten im kurzfristigen Shorten von Übertreibungen verdienen.
Antwort auf Beitrag Nr.: 37.301.369 von KillingJoke am 02.06.09 12:41:15Es geht wie angekündigt weiter.
Am Sonntag gab es die folgende Veröffentlchung:
Personalized Anti-Cancer Vaccine, BiovaxID®, Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis
http://www.businesswire.com/portal/site/google/?ndmViewId=ne…
"Personalized Anti-Cancer Vaccine, BiovaxID®, Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis
Biovest and idis Partner to Facilitate Patient Access to Lymphoma Vaccine
(...)
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID®, Biovest’s personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin’s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries.
According to world-renowned hematologist and lymphoma research pioneer, Professor Volker Diehl, M.D., Ph.D., Professor of Medicine, University of Cologne, “With the availability of this truly patient-specific vaccine, I believe hematologists now have a new, safe lymphoma treatment option capable of enhancing existing chemotherapeutic and monoclonal antibody treatment options by training the patient’s own immune system to selectively recognize and attack cancer cells, resulting in potentially longer lasting remissions. As follicular lymphoma so far is supposed to be a generally incurable and fatal blood cancer, it is with great hope and expectations that I welcome such a highly personalized therapeutic approach in addressing an urgent unmet need.” Prof. Dr. Diehl founded the German Hodgkin Study Group and is a recipient of the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany), awarded by the German government for his lifetime achievements in the field of lymphoma research.
(...)
Prof. Dr. Diehl also anticipates that the addition of BiovaxID booster shots could substantially bolster patient results, stating, “The recently reported Phase III results, while impressive, did not include a BiovaxID maintenance regimen consisting of periodic booster shots. Such a maintenance booster regimen may be key in continuing to stimulate a robust and enduring immune response, thus further improving results, and perhaps even resulting in durable remissions for some patients.” Biovest intends to include multiple booster vaccines for potential maintenance therapy purposes as part of the vaccine delivery for prescriptions processed under the named-patient program.
As BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor, a patient wishing to participate in the named-patient program must undergo a lymph node biopsy prior to receiving chemotherapy/monoclonal antibody therapy. Those cells collected by biopsy will then undergo a preparation process performed by Biovest with the resulting vaccine material then preserved until manufacture of the final vaccine is prescribed by the patient’s physician through idis. The vaccine is typically administered approximately 6 months following the end of chemotherapy, and consists of five BiovaxID vaccinations, subcutaneously injected, over a 6 month period (months 1,2,3,4 and 6). As an adjuvant therapy, at each vaccination cycle, patients will also receive four daily injections of an immune stimulating agent, GM-CSF. At the physician’s option, a periodic vaccine booster maintenance regimen may also be prescribed.
A named-patient program is a compassionate-use drug supply program under which physicians are permitted to supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs may be administered to patients who are suffering from a serious illness prior to the drug being approved by the European Medicines Evaluation Agency (EMEA). “Named-patient” distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient, assuming compliance with the local regulatory protocols respective to each participating country. In Europe, under the named-patient program, the drug is most often purchased through the national health system.
Contact Information for BiovaxID Named-Patient Program:
Licensed hematologists can learn more regarding BiovaxID and the named-patient program by contacting:
idis Limited (United Kingdom)
Telephone: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323
Email: internationalsales@idispharma.com
(...)
About idis Limited
idis is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. idis supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on idis please visit their website at http://www.idispharma.com."
Am Sonntag gab es die folgende Veröffentlchung:
Personalized Anti-Cancer Vaccine, BiovaxID®, Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis
http://www.businesswire.com/portal/site/google/?ndmViewId=ne…
"Personalized Anti-Cancer Vaccine, BiovaxID®, Targeting B-cell Lymphomas Available in Europe on a Named-Patient Basis
Biovest and idis Partner to Facilitate Patient Access to Lymphoma Vaccine
(...)
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID®, Biovest’s personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe. Following compliance with local regulatory protocols, BiovaxID will be supplied by idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin’s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Physicians in non-European countries may also contact idis to inquire about the potential availability of BiovaxID, as idis manages named-patient programs in more than 100 countries.
According to world-renowned hematologist and lymphoma research pioneer, Professor Volker Diehl, M.D., Ph.D., Professor of Medicine, University of Cologne, “With the availability of this truly patient-specific vaccine, I believe hematologists now have a new, safe lymphoma treatment option capable of enhancing existing chemotherapeutic and monoclonal antibody treatment options by training the patient’s own immune system to selectively recognize and attack cancer cells, resulting in potentially longer lasting remissions. As follicular lymphoma so far is supposed to be a generally incurable and fatal blood cancer, it is with great hope and expectations that I welcome such a highly personalized therapeutic approach in addressing an urgent unmet need.” Prof. Dr. Diehl founded the German Hodgkin Study Group and is a recipient of the Bundesverdienstkreuz (Order of Merit of the Federal Republic of Germany), awarded by the German government for his lifetime achievements in the field of lymphoma research.
(...)
Prof. Dr. Diehl also anticipates that the addition of BiovaxID booster shots could substantially bolster patient results, stating, “The recently reported Phase III results, while impressive, did not include a BiovaxID maintenance regimen consisting of periodic booster shots. Such a maintenance booster regimen may be key in continuing to stimulate a robust and enduring immune response, thus further improving results, and perhaps even resulting in durable remissions for some patients.” Biovest intends to include multiple booster vaccines for potential maintenance therapy purposes as part of the vaccine delivery for prescriptions processed under the named-patient program.
As BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor, a patient wishing to participate in the named-patient program must undergo a lymph node biopsy prior to receiving chemotherapy/monoclonal antibody therapy. Those cells collected by biopsy will then undergo a preparation process performed by Biovest with the resulting vaccine material then preserved until manufacture of the final vaccine is prescribed by the patient’s physician through idis. The vaccine is typically administered approximately 6 months following the end of chemotherapy, and consists of five BiovaxID vaccinations, subcutaneously injected, over a 6 month period (months 1,2,3,4 and 6). As an adjuvant therapy, at each vaccination cycle, patients will also receive four daily injections of an immune stimulating agent, GM-CSF. At the physician’s option, a periodic vaccine booster maintenance regimen may also be prescribed.
A named-patient program is a compassionate-use drug supply program under which physicians are permitted to supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs may be administered to patients who are suffering from a serious illness prior to the drug being approved by the European Medicines Evaluation Agency (EMEA). “Named-patient” distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient, assuming compliance with the local regulatory protocols respective to each participating country. In Europe, under the named-patient program, the drug is most often purchased through the national health system.
Contact Information for BiovaxID Named-Patient Program:
Licensed hematologists can learn more regarding BiovaxID and the named-patient program by contacting:
idis Limited (United Kingdom)
Telephone: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323
Email: internationalsales@idispharma.com
(...)
About idis Limited
idis is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. idis supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on idis please visit their website at http://www.idispharma.com."
Antwort auf Beitrag Nr.: 37.483.826 von KillingJoke am 29.06.09 08:53:12Hi Ackergaul,
ist das gut oder schlecht?
Gruesse
SunnyOst
ist das gut oder schlecht?
Gruesse
SunnyOst
Ich halte nicht viel von diesen "named patient programs". Ob Pixatrone oder Genasense, bei beiden hats zB nichts gebracht (Umsatz). Waren auch über IDIS.
Wenn ein BiovaxID Partner gefunden würde oder ein Investor hier richtig Geld lässt, dann würde der ABPI Kurs wohl explodieren, also über den Dollar... im Moment sehe ich ABPI im Niemandsland.
Den Text lese ich aber positiv. Sehe es ähnlich: BiovaxID als möglicher Survival Booster
Grüße
Wenn ein BiovaxID Partner gefunden würde oder ein Investor hier richtig Geld lässt, dann würde der ABPI Kurs wohl explodieren, also über den Dollar... im Moment sehe ich ABPI im Niemandsland.
Den Text lese ich aber positiv. Sehe es ähnlich: BiovaxID als möglicher Survival Booster
Grüße
http://www.pharmazeutische-zeitung.de/index.php?id=30288
ASCO-Jahrestagung
Vielversprechende Impftstoffe gegen Krebs
Von Bettina Sauer
Das Immunsystem spezifisch gegen Tumorgewebe anstacheln und auf diese Weise Krebserkrankungen gezielt bekämpfen - so lautet das Konzept der therapeutischen Impfung gegen Krebs. Bisher waren die klinischen Ergebnisse diesbezüglich eher enttäuschend. Doch nun wurden beim Kongress der amerikanischen Krebsgesellschaft ASCO zwei vielversprechende Studien vorgestellt.
Das Immunsystem könnte eine mächtige Waffe gegen Krebsgeschwüre sein, doch sie ist normalerweise ziemlich stumpf. Denn Tumorzellen unterscheiden sich in ihren Eigenschaften kaum von gesunden Körperzellen, sodass das Abwehrsystem sie längst nicht so gut erkennt wie Bakterien, Viren und andere körperfremde Krankheitserreger. Doch möglicherweise lässt sich den Immunzellen beibringen, Krebsgewebe noch besser aufzuspüren und anzugreifen als gewöhnlich. Aufgrund dieser Überlegung versuchen Forscher überall auf der Welt, therapeutische Aktivimpfstoffe gegen Krebs zu entwickeln.
Wie schon der Begriff »therapeutisch« verrät, dient die Impfung nicht zur Vorbeugung von Krebs, sondern zur Behandlung bereits gebildeter Tumoren. Ansonsten funktioniert sie aber ähnlich wie eine Impfung gegen Krankheitserreger: die Vakzinen enthalten Antigene, die das Immunsystem so stimulieren, dass es fortan alle Zellen angreift, die entsprechende Antigene tragen, also alle Tumorzellen, nicht aber das gesunde Gewebe. »Seit fast zwei Jahrzehnten bemühen sich Forscher, therapeutische Impfstoffe gegen Krebs zu entwickeln«, schreiben Dr. Philippe Fournier und Professor Dr. Volker Schirrmacher vom Deutschen Krebsforschungszentrum (DKFZ) in Heidelberg in einem Übersichtsartikel, der Anfang 2009 im Fachjournal »Expert Reviews Vaccines« erschienen ist (Doi: 10.1586/14760584.8.1.51).
Der Veröffentlichung zufolge, enthalten viele der bisherigen Präparate Tumor-antigene (Proteine, Glykoproteine, Glykolipide oder Kohlenhydrate), Aminosäureausschnitte davon (Peptide) oder die genetische Vorlage dafür (DNA). Letztere lässt sich mithilfe von Viren oder anderen Vektoren in die Körperzellen des Patienten einschleusen, die fortan das entsprechende Antigen produzieren. Andere therapeutische Impfstoffe enthalten Antikörper, die Tumorantigene nachahmen (anti-idiotypische Antikörper), oder Zubereitungen aus inaktivierten Tumorzellen oder -lysaten, die vom Patienten selbst, von anderen Krebskranken oder aus im Labor gezüchteten Tumorzelllinien stammen.
Viele dieser Forschungsansätze befinden sich inzwischen in der klinischen Prüfung doch mit bislang eher enttäuschenden Ergebnissen. Das schreiben Fournier und Schirrmacher in ihrem Artikel. Dieser umfasst eine Auswertung der randomisierten Phase-II-, beziehungsweise -III-Studien, die bis einschließlich 2008 veröffentlicht wurden und den härtesten möglichen Messwert betrachten: das Überleben der Patienten, also das Gesamtüberleben, beziehungsweise das sogenannte progressionsfreie Überleben ohne Verschlechterung der Krankheitssymptome. »Bezüglich dieser kritischen Endpunkte misslang es führenden Kandidaten, einen statistisch signifikanten Vorteil zu erzielen«, schreiben die Autoren. Dabei hätten diese Impfstoffe zuvor in kleineren Phase-I-Studien vielversprechende Ergebnisse geliefert. Die Gründe für die Misserfolge in Phase III seien noch nicht abschließend geklärt.
Vielversprechende Ergebnisse
Womöglich lohnt sich eine Intensivierung der klinischen Forschung mit autologen Vakzinen, die aus Tumorzellen der Patienten selbst stammen. Denn einige der bislang durchgeführten und von Fournier und Schirrmacher begutachteten Studien deuten darauf hin, dass diese Präparate am ehesten einen therapeutischen Vorteil bringen. Diese Tendenz führen die Autoren darauf zurück, dass autologe Impfstoffe aufgrund ihrer Herkunft individuell einzigartige Tumorantigene enthalten, die eine besonders intensive und lang-anhaltende Immunantwort erzeugen.
Nun scheint es weitere Fortschritte zu geben. Gleich zwei abgeschlossene, randomisierte Phase-III-Studien mit therapeutischen Impfstoffen gegen Krebs und vielversprechenden Ergebnissen wurden Anfang Juni bei der diesjährigen Jahrestagung der Amerikanischen Gesellschaft für klinische Onkologie (ASCO) in Orlando vorgestellt. Die eine stammt von Dr. Douglas Schwartzentruber vom Center for Cancer Care im US-amerikanischen Goshen und umfasst 185 Patienten mit metastasierendem schwarzen Hautkrebs.
Eine Hälfte von ihnen diente als Vergleichsgruppe und erhielt hochdosiertes Interleukin-2, das das Wachstum von weißen Blutkörperchen ankurbelt, auf diese Weise die körpereigene Abwehr stärkt und in den USA zur Therapie des schwarzen Hautkrebses zugelassen ist. Die andere Hälfte der Teilnehmer bekam ebenfalls hochdosiertes IL-2, aber in Kombination mit einem therapeutischen Peptid-Impfstoff namens gp100:209-217(210M). Dieser enthält eine Aminosäuresequenz aus dem Glykoprotein 100 (gp100), einem Antigen auf der Oberfläche von Melanomzellen, und zeigte in der Studie signifikante positive Effekte beim progressionsfreien wie auch beim Gesamtüberleben. Letzteres betrug in der Testgruppe im Median 17,6 Monate, in der Kontrollgruppe dagegen 12,8 Monate. Das progressionsfreie Überleben verlängerte sich von 1,6 Monaten in der Kontrollgruppe auf 2,9 Monate in der Testgruppe. Bezüglich der Nebenwirkungen zeigten sich kaum Unterschiede zwischen den Gruppen. Wie Schwartzentruber in einer Pressemitteilung angab, ist als Nächstes wohl eine Phase-III-Studie mit einer größeren Patientenzahl erforderlich, um die Ergebnisse zu bestätigen.
Die andere bei der ASCO-Jahrestagung vorgestellte Phase-III-Studie stammt von Forschern um Dr. Stephan Schuster vom Abramson Cancer Center der US-amerikanischen University of Pennsylvania. Sie betrachtet die Wirkung von BiovaxID, einer therapeutischen Vakzine zur Behandlung des follikulären B-Zell-Non-Hodgkin-Lymphoms. Die Herstellung dieses Impfstoffs erfolgt für jeden Patienten individuell, nämlich aus den frisch aus den Lymphknoten isolierten B-Zell-Lymphom-Zellen. Die Tumorzellen werden unter speziellen Bedingungen im Brutschrank kultiviert und produzieren dann in großem Maßstab anti-idiotypische Antikörper. Dabei handelt es sich, wie schon erwähnt, um Antikörper, die Tumorantigene nachahmen und als Impfstoffzubereitung eine Immunantwort gegen sich selbst provozieren, also auch gegen das zugehörige Krebsgeschwür.
An der Studie nahmen 117 Patienten mit follikulären B-Zell-Non-Hodgkin-Lymphom (NHL) teil. Sie waren alle zu Beginn der Untersuchung infolge einer Chemotherapie mindestens sechs Monate symptomfrei.
41 dieser Patienten dienten als Kontrollgruppe und erhielten eine Schein-Impfung und ein Zytokin, den Granulozyten-Monozyten-Kolonie-stimulierenden Faktor (GM-CSF), um die Immunabwehr unspezifisch zu stärken. Die übrigen 76 Patienten bekamen GM-CSF in Kombination mit dem Impfstoff. Dadurch ließ sich das Wiederauftreten des Tumors um durchschnittlich 14 Monate verzögern. Damit blieben die Patienten der Testgruppe im Median 44,2 Monate symptomfrei, die in der Kontrollgruppe dagegen nur 30,6 Monate. Der Therapie ließen sich keine unerwarteten schweren Nebenwirkungen zuordnen. Der Impfstoff-Hersteller, das Biotech-Unternehmen Biovest mit Sitz im US-Staat Florida, verhandelt nach eigenen Angaben wegen dieser Ergebnisse mit der europäischen und der amerikanischen Zulassungsbehörde über die Zulassung.
ASCO-Jahrestagung
Vielversprechende Impftstoffe gegen Krebs
Von Bettina Sauer
Das Immunsystem spezifisch gegen Tumorgewebe anstacheln und auf diese Weise Krebserkrankungen gezielt bekämpfen - so lautet das Konzept der therapeutischen Impfung gegen Krebs. Bisher waren die klinischen Ergebnisse diesbezüglich eher enttäuschend. Doch nun wurden beim Kongress der amerikanischen Krebsgesellschaft ASCO zwei vielversprechende Studien vorgestellt.
Das Immunsystem könnte eine mächtige Waffe gegen Krebsgeschwüre sein, doch sie ist normalerweise ziemlich stumpf. Denn Tumorzellen unterscheiden sich in ihren Eigenschaften kaum von gesunden Körperzellen, sodass das Abwehrsystem sie längst nicht so gut erkennt wie Bakterien, Viren und andere körperfremde Krankheitserreger. Doch möglicherweise lässt sich den Immunzellen beibringen, Krebsgewebe noch besser aufzuspüren und anzugreifen als gewöhnlich. Aufgrund dieser Überlegung versuchen Forscher überall auf der Welt, therapeutische Aktivimpfstoffe gegen Krebs zu entwickeln.
Wie schon der Begriff »therapeutisch« verrät, dient die Impfung nicht zur Vorbeugung von Krebs, sondern zur Behandlung bereits gebildeter Tumoren. Ansonsten funktioniert sie aber ähnlich wie eine Impfung gegen Krankheitserreger: die Vakzinen enthalten Antigene, die das Immunsystem so stimulieren, dass es fortan alle Zellen angreift, die entsprechende Antigene tragen, also alle Tumorzellen, nicht aber das gesunde Gewebe. »Seit fast zwei Jahrzehnten bemühen sich Forscher, therapeutische Impfstoffe gegen Krebs zu entwickeln«, schreiben Dr. Philippe Fournier und Professor Dr. Volker Schirrmacher vom Deutschen Krebsforschungszentrum (DKFZ) in Heidelberg in einem Übersichtsartikel, der Anfang 2009 im Fachjournal »Expert Reviews Vaccines« erschienen ist (Doi: 10.1586/14760584.8.1.51).
Der Veröffentlichung zufolge, enthalten viele der bisherigen Präparate Tumor-antigene (Proteine, Glykoproteine, Glykolipide oder Kohlenhydrate), Aminosäureausschnitte davon (Peptide) oder die genetische Vorlage dafür (DNA). Letztere lässt sich mithilfe von Viren oder anderen Vektoren in die Körperzellen des Patienten einschleusen, die fortan das entsprechende Antigen produzieren. Andere therapeutische Impfstoffe enthalten Antikörper, die Tumorantigene nachahmen (anti-idiotypische Antikörper), oder Zubereitungen aus inaktivierten Tumorzellen oder -lysaten, die vom Patienten selbst, von anderen Krebskranken oder aus im Labor gezüchteten Tumorzelllinien stammen.
Viele dieser Forschungsansätze befinden sich inzwischen in der klinischen Prüfung doch mit bislang eher enttäuschenden Ergebnissen. Das schreiben Fournier und Schirrmacher in ihrem Artikel. Dieser umfasst eine Auswertung der randomisierten Phase-II-, beziehungsweise -III-Studien, die bis einschließlich 2008 veröffentlicht wurden und den härtesten möglichen Messwert betrachten: das Überleben der Patienten, also das Gesamtüberleben, beziehungsweise das sogenannte progressionsfreie Überleben ohne Verschlechterung der Krankheitssymptome. »Bezüglich dieser kritischen Endpunkte misslang es führenden Kandidaten, einen statistisch signifikanten Vorteil zu erzielen«, schreiben die Autoren. Dabei hätten diese Impfstoffe zuvor in kleineren Phase-I-Studien vielversprechende Ergebnisse geliefert. Die Gründe für die Misserfolge in Phase III seien noch nicht abschließend geklärt.
Vielversprechende Ergebnisse
Womöglich lohnt sich eine Intensivierung der klinischen Forschung mit autologen Vakzinen, die aus Tumorzellen der Patienten selbst stammen. Denn einige der bislang durchgeführten und von Fournier und Schirrmacher begutachteten Studien deuten darauf hin, dass diese Präparate am ehesten einen therapeutischen Vorteil bringen. Diese Tendenz führen die Autoren darauf zurück, dass autologe Impfstoffe aufgrund ihrer Herkunft individuell einzigartige Tumorantigene enthalten, die eine besonders intensive und lang-anhaltende Immunantwort erzeugen.
Nun scheint es weitere Fortschritte zu geben. Gleich zwei abgeschlossene, randomisierte Phase-III-Studien mit therapeutischen Impfstoffen gegen Krebs und vielversprechenden Ergebnissen wurden Anfang Juni bei der diesjährigen Jahrestagung der Amerikanischen Gesellschaft für klinische Onkologie (ASCO) in Orlando vorgestellt. Die eine stammt von Dr. Douglas Schwartzentruber vom Center for Cancer Care im US-amerikanischen Goshen und umfasst 185 Patienten mit metastasierendem schwarzen Hautkrebs.
Eine Hälfte von ihnen diente als Vergleichsgruppe und erhielt hochdosiertes Interleukin-2, das das Wachstum von weißen Blutkörperchen ankurbelt, auf diese Weise die körpereigene Abwehr stärkt und in den USA zur Therapie des schwarzen Hautkrebses zugelassen ist. Die andere Hälfte der Teilnehmer bekam ebenfalls hochdosiertes IL-2, aber in Kombination mit einem therapeutischen Peptid-Impfstoff namens gp100:209-217(210M). Dieser enthält eine Aminosäuresequenz aus dem Glykoprotein 100 (gp100), einem Antigen auf der Oberfläche von Melanomzellen, und zeigte in der Studie signifikante positive Effekte beim progressionsfreien wie auch beim Gesamtüberleben. Letzteres betrug in der Testgruppe im Median 17,6 Monate, in der Kontrollgruppe dagegen 12,8 Monate. Das progressionsfreie Überleben verlängerte sich von 1,6 Monaten in der Kontrollgruppe auf 2,9 Monate in der Testgruppe. Bezüglich der Nebenwirkungen zeigten sich kaum Unterschiede zwischen den Gruppen. Wie Schwartzentruber in einer Pressemitteilung angab, ist als Nächstes wohl eine Phase-III-Studie mit einer größeren Patientenzahl erforderlich, um die Ergebnisse zu bestätigen.
Die andere bei der ASCO-Jahrestagung vorgestellte Phase-III-Studie stammt von Forschern um Dr. Stephan Schuster vom Abramson Cancer Center der US-amerikanischen University of Pennsylvania. Sie betrachtet die Wirkung von BiovaxID, einer therapeutischen Vakzine zur Behandlung des follikulären B-Zell-Non-Hodgkin-Lymphoms. Die Herstellung dieses Impfstoffs erfolgt für jeden Patienten individuell, nämlich aus den frisch aus den Lymphknoten isolierten B-Zell-Lymphom-Zellen. Die Tumorzellen werden unter speziellen Bedingungen im Brutschrank kultiviert und produzieren dann in großem Maßstab anti-idiotypische Antikörper. Dabei handelt es sich, wie schon erwähnt, um Antikörper, die Tumorantigene nachahmen und als Impfstoffzubereitung eine Immunantwort gegen sich selbst provozieren, also auch gegen das zugehörige Krebsgeschwür.
An der Studie nahmen 117 Patienten mit follikulären B-Zell-Non-Hodgkin-Lymphom (NHL) teil. Sie waren alle zu Beginn der Untersuchung infolge einer Chemotherapie mindestens sechs Monate symptomfrei.
41 dieser Patienten dienten als Kontrollgruppe und erhielten eine Schein-Impfung und ein Zytokin, den Granulozyten-Monozyten-Kolonie-stimulierenden Faktor (GM-CSF), um die Immunabwehr unspezifisch zu stärken. Die übrigen 76 Patienten bekamen GM-CSF in Kombination mit dem Impfstoff. Dadurch ließ sich das Wiederauftreten des Tumors um durchschnittlich 14 Monate verzögern. Damit blieben die Patienten der Testgruppe im Median 44,2 Monate symptomfrei, die in der Kontrollgruppe dagegen nur 30,6 Monate. Der Therapie ließen sich keine unerwarteten schweren Nebenwirkungen zuordnen. Der Impfstoff-Hersteller, das Biotech-Unternehmen Biovest mit Sitz im US-Staat Florida, verhandelt nach eigenen Angaben wegen dieser Ergebnisse mit der europäischen und der amerikanischen Zulassungsbehörde über die Zulassung.
Antwort auf Beitrag Nr.: 37.646.516 von Ackergaul am 25.07.09 18:58:25BVTI.PK (0,74 USD, +120% in 2 Tagen) und ABPIQ.PK (0,30 USD, +50% in 2 Tagen) kommen mal wieder wieder in Bewegung.
Neue Erkenntisse gibt es meines Wissens nicht?
KJ
Neue Erkenntisse gibt es meines Wissens nicht?
KJ
vielleicht war dass der Grund:
http://www.stockshaven.com/biovest-inches-closer-to-cancer-v…
Biovest Inches Closer to Cancer Vaccine
BLA Filing (OTC:BVTI)
September 21, 2009
Biovest International, Inc.
(Public, OTC:BVTI)
As individuals in our respective societies, we all abide by a certain moral standing. However,
regardless of your lifestyle, you will adhere to the notion that there is no greater feeling in the
world than knowing you are helping fund a company which could potentially save millions of
lives, while at the same time fulfilling your needs through growing your pockets as well. So
without further ado, let’s all welcome Biovest International, Inc. (OTC:BVTI) as
StocksHaven Investment’s newest company profile. Recently the company has stricken
interest from the investment community through its product, BiovaxID, which has seen very
positive Phase III results presented at Asco Plenary Session. BiovaxID is truly revolutionary,
the cancer vaccine evokes the power of each patient’s immune system and primes it to
recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. Before
beginning the analysis, lets also keep in mind that with the phase III were presented nearly
four months ago on 05/31/09, meaning an BLA announcement could come at anytime.
Biovest’s President, Samuel Duffey states, ““We have already initiated discussions with the
FDA and EMEA and are preparing for further meetings with those agencies and other
international regulatory authorities in order to share our significant results and determine the
most appropriate approval regulatory pathways.”
About Biovest International Inc.
Biovest International, Inc. (Biovest) is a biotechnology company focusing primarily on the
development of BiovaxID, a patient-specific, anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkins lymphoma, or follicular NHL. BiovaxID is a customized anti-cancer
vaccine that is derived from a patient’s own cancer cells and is designed to utilize the power
of the patient’s immune system to recognize and destroy cancerous lymphoma cells, while
sparing normal cells. The Company produces this vaccine by extracting some of the patient’s
tumor cells and then replicating and purifying the antigen that is present only on the surface of
the patient’s own tumor cells. Biovest is conducting a pivotal Phase 3 clinical trial for
BiovaxID in patients with the indolent, or low-grade, form of B-cell follicular NHL.
In addition, Biovest is in Chapter 11 under bankruptcy protection, and the company is
currently navigating the reorganization process. They are also not compliant with SEC
financial reporting rules at this time.
Products
BiovaxID Cancer Vaccine
The Biovest cancer immunotherapy stems from work begun in 1986 on development of a
patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of
each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma
cells, while sparing normal B-cells. In the vaccine’s cancer target, B-cell lymphoma, the
process is made possible by the presence of a hallmark surface antigen of the cancer cells that
is not present in non-cancerous tissue. By priming the immune system with this antigen in the
form of an autologous vaccine, the vaccine induces a powerful immune response against the
cancerous cells that in many cases results in pronounced, complete cancer clearance. Because
each dose of Biovest’s vaccine is derived from individual patient’s cancerous cells, the
vaccine is a true targeted, customized therapy. The vaccine’s powerful anti-tumor effect
vastly exceeds that of non-targeted traditional therapy, as it arises from the immune system’s
defense cells’ innate ability to selectively target foreign antigens. Most importantly, the
immune response triggered by the vaccine against the cancerous tissue is a natural diseasefighting
mechanism and has almost none of the side-effects associated with the broadspectrum
chemotherapy and radiation used to traditionally treat this type of lymphoma.
BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own
tumor, and selectively targets only the cancerous B-cells, while sparing healthy cells.
BiovaxID is highly specific in its anti-lymphoma attack because the vaccine “trains” the
body’s own immune system to recognize as foreign the unique protein (idiotype) expressed
only on the cancerous B-cells, thus stimulating and recruiting the patient’s own immune
system to destroy the cancer cells and potentially prevent recurrence. In contrast, other
existing chemotherapeutic and monoclonal antibody therapies destroy most of the healthy Bcells
in addition to the cancerous cells, and may result in serious adverse side-effects. Because
the BiovaxID vaccine is comprised of the patient’s own cells (autologous), the therapy has
been demonstrated to be safe and well-tolerated.
Futhermore, as the leading manufacturer of hollow fiber technology and with over 2 decades
of cell culture experience, Biovest has pioneered a unique platform to commercialize patientspecific
biologics. What makes this vaccine truly unique is the fact that made from each
patient, for each patient using the AutovaxID.
BiovaxID utilzes a patient specific process to create tailor-made therapeutic cancer vaccines
About Non-Hodgkin’s Lymphoma & Target Market
The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2
billion in 2013 from the current size of $2.2 billion.
There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year
in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy
and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is
almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent
but ultimately fatal clinical course. The median relapse time for FL patients is three years,
with 90% of patients dying of a tumor-related mortality within 7 years of the date of
diagnosis. The clinical course is usually characterized by a series of remissions and relapses.
Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte
transplantation, and monoclonal antibodies. However, following initial response to treatment,
the cancer invariably returns and the majority of patients relapse with resistance to all
available therapy. Related B-cell derived neoplasms include multiple myeloma (approx.
15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in
the US).
Positive Critical Phase III Trials
Biovest International, Inc. announced that an eight year pivotal, randomized, multi-center,
double-blind, controlled Phase III clinical study has shown that BiovaxID® (personalized
therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular
non-Hodgkin’s lymphoma. The study, which was featured at the American Society of Clinical
Oncology (ASCO) Annual Meeting Plenary Session, found that patients who received
BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6
months for those who received a control vaccine – an increase of 47 percent. In the study,
with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower
risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the
first ever vaccine targeting lymphoma to demonstrate such a disease-free survival benefit.
A previous Phase II study demonstrated that patients receiving the BiovaxID vaccine
developed a highly-specific immune response against tumor cells, with 95 percent of patients
showing significant T-cell activity against their lymphoma and 75 percent of patients showing
a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent
of patients remained in continuous first complete remission with a median disease-free
survival of 8 years.
The completed Phase III study achieved its primary endpoint of prolonging disease-free
survival in patients who were vaccinated with at least one injection of BiovaxID as compared
to patients who received control. In the study, 177 patients with follicular lymphoma who had
achieved a complete response to PACE (prednisone, doxorubicin, cyclophosphamide and
etoposide) chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to
the control study arm (KLH/GM-CSF). As prospectively identified, investigators analyzed the
cohort of 117 randomized patients who, as required by the study protocol, maintained a
complete response to chemotherapy for at least six months and who received active (N=76) or
control (N=41) vaccine. After a median follow-up of 4.71 years (56.6 months, range: 12.6 –
89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months
compared with 30.6 months in the control arm, which is a clinically and statistically
significant difference (p=0.045).
FDA Update
In addressing regulatory and commercial plans for BiovaxID, Biovest’s President and General
Counsel, Samuel Duffey, commented, “We have already initiated discussions with the FDA
and EMEA and are preparing for further meetings with those agencies and other international
regulatory authorities in order to share our significant results and determine the most
appropriate approval regulatory pathways. In addition, we plan to make BiovaxID available
throughout most of Europe on a named-patient basis. This compassionate-use drug access
program allows European physicians to prescribe drugs to qualifying patients before
approvals are granted, assuming the protocols for each participating country are followed.”
Biovest also reported that the Company expects to publish the final comprehensive results in a
peer-reviewed scientific publication later this year (Q4 of 2009).
Mentor Capital Cancer Immunotherapy Index
The inclusion of BVTI on the Mentor Capital Immunotherapy Index is a tremendous step for
this company on several fronts. First of all, it was named one of the top 10 under $10
companies that is involved in cancer treatments which are considered ground-breaking.
Among the companies on that list include DNDN, Celldex, and Oncothyreon, to name a few.
All of these companies have either reached great end points in their respective critical phase
trials, or have great potential. BVTI is one that has yet to reach its potential. To project the
estimated price per share, one needs to look no further than the other companies on the list
that have reached their potential. DNDN $23 price per share, Celldex $6 price per share,
Onco $5 price per share, are the three that have so far blossomed the most. With a similar, yet
more advanced treatment study having been completed and implemented in Europe, one
would think BVTI can do a similar run-up, once they file an BLA with the FDA. The second
major point is the funding that is available to them through this arrangement with Mentor
Capital. Perhaps the sole reason for the company’s low price per share has been the fact that
their parent company is in chapter 11. Finally, and possible the most surprising and most
exciting part is the market cap of 50 million dollars, which may not stand for much longer.
Thirteen years of testing and research went into this treatment (phase III lasted 8 years). Does
anyone else see DNDN before them? The use of this treatment in Europe on a named patient
basis is getting noticed and provides even more results, not to mention gives the company a
face.
Technical Chart Analysis ( click image to enlarge )
These past six months have seen impressive gains in both volume and price for BVTI, as it
appears to be gaining momentum for another healthy increase in share price. There are strong
bullish signals such as the daily 100 SMA (Orange line) currently running above the daily 200
SMA (Yellow line) and both moving averages are on the rise. Also, the year-to-date price
action has established an upward trending price channel shown in Blue on the chart. The
channel’s definition was actually expanded back in June when the price gained over 1200% in
just one month and the volume increased over 10,000%. This movement revealed the current
channels the price has been moving within, but also indicates the overall channel is actually
much taller. The top of the conservative price channel is currently at $1.03. Today the price
bounced off the bottom trend-line, closed right at the ¼ trend-line of the Blue channel, and
showed there is pressure to go higher. Once the price exceeds the mid-line (dashed Blue line)
currently around .67 cents, the price should easily find the top trend-line of the price channel.
With the current increase in volume this month reaching over 20,000% so far, it’s good to
keep in the back of your mind that the last time the price made it to the top of the channel it
reached $1.50 and that’s over a 200% gain from today’s close.
Overall Sentiment
Now, we perceive BVTI to be somewhat of an iceberg. It is easy to see the tip, however the
true size of it can’t be seen by the naked eye, or average daily investor without conducting
some thorough due diligence. Spend a couple of minutes researching and you will notice the
52wk high of $1.50, the fact that it is an extremely successful phase III cancer drug with a
billion dollar market potential, and a top 10 under $10 nominee, though one key aspect is
missing: the CEO, Francis O’Donnell’s importance. Not many realize he is also the Chairman
of BioDelivery Sciences — Yes, that same company who gained FDA approval for its cancer
pain drug patch, Onsolis.
An experienced CEO who is well acquainted with what it takes to attain FDA approval,
positive Phase III completed four months ago, being a part of one of the most prestigious
cancer biotech indexes worldwide, and a 52wk high of$1.50 — We shouldn’t even have to
state how undervalued Biovest International Inc. truly is.
http://www.stockshaven.com/biovest-inches-closer-to-cancer-v…
Biovest Inches Closer to Cancer Vaccine
BLA Filing (OTC:BVTI)
September 21, 2009
Biovest International, Inc.
(Public, OTC:BVTI)
As individuals in our respective societies, we all abide by a certain moral standing. However,
regardless of your lifestyle, you will adhere to the notion that there is no greater feeling in the
world than knowing you are helping fund a company which could potentially save millions of
lives, while at the same time fulfilling your needs through growing your pockets as well. So
without further ado, let’s all welcome Biovest International, Inc. (OTC:BVTI) as
StocksHaven Investment’s newest company profile. Recently the company has stricken
interest from the investment community through its product, BiovaxID, which has seen very
positive Phase III results presented at Asco Plenary Session. BiovaxID is truly revolutionary,
the cancer vaccine evokes the power of each patient’s immune system and primes it to
recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. Before
beginning the analysis, lets also keep in mind that with the phase III were presented nearly
four months ago on 05/31/09, meaning an BLA announcement could come at anytime.
Biovest’s President, Samuel Duffey states, ““We have already initiated discussions with the
FDA and EMEA and are preparing for further meetings with those agencies and other
international regulatory authorities in order to share our significant results and determine the
most appropriate approval regulatory pathways.”
About Biovest International Inc.
Biovest International, Inc. (Biovest) is a biotechnology company focusing primarily on the
development of BiovaxID, a patient-specific, anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkins lymphoma, or follicular NHL. BiovaxID is a customized anti-cancer
vaccine that is derived from a patient’s own cancer cells and is designed to utilize the power
of the patient’s immune system to recognize and destroy cancerous lymphoma cells, while
sparing normal cells. The Company produces this vaccine by extracting some of the patient’s
tumor cells and then replicating and purifying the antigen that is present only on the surface of
the patient’s own tumor cells. Biovest is conducting a pivotal Phase 3 clinical trial for
BiovaxID in patients with the indolent, or low-grade, form of B-cell follicular NHL.
In addition, Biovest is in Chapter 11 under bankruptcy protection, and the company is
currently navigating the reorganization process. They are also not compliant with SEC
financial reporting rules at this time.
Products
BiovaxID Cancer Vaccine
The Biovest cancer immunotherapy stems from work begun in 1986 on development of a
patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of
each patient’s immune system and primes it to recognize and eliminate cancerous lymphoma
cells, while sparing normal B-cells. In the vaccine’s cancer target, B-cell lymphoma, the
process is made possible by the presence of a hallmark surface antigen of the cancer cells that
is not present in non-cancerous tissue. By priming the immune system with this antigen in the
form of an autologous vaccine, the vaccine induces a powerful immune response against the
cancerous cells that in many cases results in pronounced, complete cancer clearance. Because
each dose of Biovest’s vaccine is derived from individual patient’s cancerous cells, the
vaccine is a true targeted, customized therapy. The vaccine’s powerful anti-tumor effect
vastly exceeds that of non-targeted traditional therapy, as it arises from the immune system’s
defense cells’ innate ability to selectively target foreign antigens. Most importantly, the
immune response triggered by the vaccine against the cancerous tissue is a natural diseasefighting
mechanism and has almost none of the side-effects associated with the broadspectrum
chemotherapy and radiation used to traditionally treat this type of lymphoma.
BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own
tumor, and selectively targets only the cancerous B-cells, while sparing healthy cells.
BiovaxID is highly specific in its anti-lymphoma attack because the vaccine “trains” the
body’s own immune system to recognize as foreign the unique protein (idiotype) expressed
only on the cancerous B-cells, thus stimulating and recruiting the patient’s own immune
system to destroy the cancer cells and potentially prevent recurrence. In contrast, other
existing chemotherapeutic and monoclonal antibody therapies destroy most of the healthy Bcells
in addition to the cancerous cells, and may result in serious adverse side-effects. Because
the BiovaxID vaccine is comprised of the patient’s own cells (autologous), the therapy has
been demonstrated to be safe and well-tolerated.
Futhermore, as the leading manufacturer of hollow fiber technology and with over 2 decades
of cell culture experience, Biovest has pioneered a unique platform to commercialize patientspecific
biologics. What makes this vaccine truly unique is the fact that made from each
patient, for each patient using the AutovaxID.
BiovaxID utilzes a patient specific process to create tailor-made therapeutic cancer vaccines
About Non-Hodgkin’s Lymphoma & Target Market
The European non-Hodgkin’s lymphoma therapeutics market is estimated to reach $7.2
billion in 2013 from the current size of $2.2 billion.
There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year
in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy
and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is
almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent
but ultimately fatal clinical course. The median relapse time for FL patients is three years,
with 90% of patients dying of a tumor-related mortality within 7 years of the date of
diagnosis. The clinical course is usually characterized by a series of remissions and relapses.
Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte
transplantation, and monoclonal antibodies. However, following initial response to treatment,
the cancer invariably returns and the majority of patients relapse with resistance to all
available therapy. Related B-cell derived neoplasms include multiple myeloma (approx.
15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in
the US).
Positive Critical Phase III Trials
Biovest International, Inc. announced that an eight year pivotal, randomized, multi-center,
double-blind, controlled Phase III clinical study has shown that BiovaxID® (personalized
therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular
non-Hodgkin’s lymphoma. The study, which was featured at the American Society of Clinical
Oncology (ASCO) Annual Meeting Plenary Session, found that patients who received
BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6
months for those who received a control vaccine – an increase of 47 percent. In the study,
with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower
risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the
first ever vaccine targeting lymphoma to demonstrate such a disease-free survival benefit.
A previous Phase II study demonstrated that patients receiving the BiovaxID vaccine
developed a highly-specific immune response against tumor cells, with 95 percent of patients
showing significant T-cell activity against their lymphoma and 75 percent of patients showing
a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent
of patients remained in continuous first complete remission with a median disease-free
survival of 8 years.
The completed Phase III study achieved its primary endpoint of prolonging disease-free
survival in patients who were vaccinated with at least one injection of BiovaxID as compared
to patients who received control. In the study, 177 patients with follicular lymphoma who had
achieved a complete response to PACE (prednisone, doxorubicin, cyclophosphamide and
etoposide) chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to
the control study arm (KLH/GM-CSF). As prospectively identified, investigators analyzed the
cohort of 117 randomized patients who, as required by the study protocol, maintained a
complete response to chemotherapy for at least six months and who received active (N=76) or
control (N=41) vaccine. After a median follow-up of 4.71 years (56.6 months, range: 12.6 –
89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months
compared with 30.6 months in the control arm, which is a clinically and statistically
significant difference (p=0.045).
FDA Update
In addressing regulatory and commercial plans for BiovaxID, Biovest’s President and General
Counsel, Samuel Duffey, commented, “We have already initiated discussions with the FDA
and EMEA and are preparing for further meetings with those agencies and other international
regulatory authorities in order to share our significant results and determine the most
appropriate approval regulatory pathways. In addition, we plan to make BiovaxID available
throughout most of Europe on a named-patient basis. This compassionate-use drug access
program allows European physicians to prescribe drugs to qualifying patients before
approvals are granted, assuming the protocols for each participating country are followed.”
Biovest also reported that the Company expects to publish the final comprehensive results in a
peer-reviewed scientific publication later this year (Q4 of 2009).
Mentor Capital Cancer Immunotherapy Index
The inclusion of BVTI on the Mentor Capital Immunotherapy Index is a tremendous step for
this company on several fronts. First of all, it was named one of the top 10 under $10
companies that is involved in cancer treatments which are considered ground-breaking.
Among the companies on that list include DNDN, Celldex, and Oncothyreon, to name a few.
All of these companies have either reached great end points in their respective critical phase
trials, or have great potential. BVTI is one that has yet to reach its potential. To project the
estimated price per share, one needs to look no further than the other companies on the list
that have reached their potential. DNDN $23 price per share, Celldex $6 price per share,
Onco $5 price per share, are the three that have so far blossomed the most. With a similar, yet
more advanced treatment study having been completed and implemented in Europe, one
would think BVTI can do a similar run-up, once they file an BLA with the FDA. The second
major point is the funding that is available to them through this arrangement with Mentor
Capital. Perhaps the sole reason for the company’s low price per share has been the fact that
their parent company is in chapter 11. Finally, and possible the most surprising and most
exciting part is the market cap of 50 million dollars, which may not stand for much longer.
Thirteen years of testing and research went into this treatment (phase III lasted 8 years). Does
anyone else see DNDN before them? The use of this treatment in Europe on a named patient
basis is getting noticed and provides even more results, not to mention gives the company a
face.
Technical Chart Analysis ( click image to enlarge )
These past six months have seen impressive gains in both volume and price for BVTI, as it
appears to be gaining momentum for another healthy increase in share price. There are strong
bullish signals such as the daily 100 SMA (Orange line) currently running above the daily 200
SMA (Yellow line) and both moving averages are on the rise. Also, the year-to-date price
action has established an upward trending price channel shown in Blue on the chart. The
channel’s definition was actually expanded back in June when the price gained over 1200% in
just one month and the volume increased over 10,000%. This movement revealed the current
channels the price has been moving within, but also indicates the overall channel is actually
much taller. The top of the conservative price channel is currently at $1.03. Today the price
bounced off the bottom trend-line, closed right at the ¼ trend-line of the Blue channel, and
showed there is pressure to go higher. Once the price exceeds the mid-line (dashed Blue line)
currently around .67 cents, the price should easily find the top trend-line of the price channel.
With the current increase in volume this month reaching over 20,000% so far, it’s good to
keep in the back of your mind that the last time the price made it to the top of the channel it
reached $1.50 and that’s over a 200% gain from today’s close.
Overall Sentiment
Now, we perceive BVTI to be somewhat of an iceberg. It is easy to see the tip, however the
true size of it can’t be seen by the naked eye, or average daily investor without conducting
some thorough due diligence. Spend a couple of minutes researching and you will notice the
52wk high of $1.50, the fact that it is an extremely successful phase III cancer drug with a
billion dollar market potential, and a top 10 under $10 nominee, though one key aspect is
missing: the CEO, Francis O’Donnell’s importance. Not many realize he is also the Chairman
of BioDelivery Sciences — Yes, that same company who gained FDA approval for its cancer
pain drug patch, Onsolis.
An experienced CEO who is well acquainted with what it takes to attain FDA approval,
positive Phase III completed four months ago, being a part of one of the most prestigious
cancer biotech indexes worldwide, and a 52wk high of$1.50 — We shouldn’t even have to
state how undervalued Biovest International Inc. truly is.
Antwort auf Beitrag Nr.: 38.076.003 von Ackergaul am 29.09.09 12:59:10ich hatte eigentlich bereits gestern ein kurzes Update schreiben wollen. Gestern gabs noch zusätzlich eine schöne Meldung...
Seit November 2008, also knapp 14 Monate, befindet sich ABPI in Insolvenz. In den kommenden Tagen / Wochen muss ABPI wohl einen Plan der SEC vorlegen, wie es denn weiterlaufen soll. Bin mal gespannt, ob ein Zusammenschluss mit Biovest hier auch hereinspielt.
Ende 2009 gab es noch folgende Meldung von BDSI, die wie ABPI und BVTI auch zur Hopkins Capital Group gehören:
http://biz.yahoo.com/e/091231/bdsi8-k.html
Form 8-K for BIODELIVERY SCIENCES INTERNATIONAL INC
--------------------------------------------------------------------------------
31-Dec-2009
Entry into a Material Definitive Agreement, Financial Stat
On December 30, 2009, BioDelivery Sciences International, Inc. (the "Company") and Accentia Biopharmaceuticals, Inc. ("ABPI"), a related party of the Company through common ownership and management, entered into an Emezine Settlement Agreement (the "Agreement") between the Company, Accentia, the Company's wholly-owned subsidiary Arius Pharmaceuticals, Inc. ("Arius") and Accentia Pharmaceuticals, Inc. (f/k/a TEAMM Pharmaceuticals Inc. and referred to herein as "TEAMM", and together with ABPI "Accentia"), a wholly owned subsidiary of ABPI. The Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K.
...
The Agreement provides that the Company and Accentia mutually release all claims that either may have against each other and, in connection therewith, the Company will:
(a) pay $2.5 million to Accentia (the "$2.5 Million Payment"); and
(b) grant the following royalty rights (the "Product Rights") to Accentia with respect to the Company's BEMA Granisetron product candidate ("BEMA Granisetron") (or in the event it is not BEMA Granisetron, the third Company product candidate (excluding BEMA Buprenorphine) as to which the Company files an NDA, which, together with BEMA Granisetron, shall be referred to hereinafter as the "Product"):
(i) 70/30 split (Company/Accentia) of royalty received if a third party sells the Product and 85/15 split on net sales if the Company sells the Product; and
(ii) The Company will, from the sale of the Product, fully recover amounts equal to (1) all internal and external worldwide development costs of the Product ("Costs") plus interest (measured on weighted average prime interest rate from first dollar spent until Product launch) and (2) the $2.5 Million Payment plus interest (measured on weighted average prime interest rate from the time of payment until Product launch) before Accentia begins to receive its split as described in (b) (i) above.
However, should the Company receive any sublicensing or milestone payments associated with the Product up to and including the NDA approval, the Company will apply 30% of such payments toward payback of the Costs of the Product plus interest and the $2.5 Million Payment plus the interest.
The $2.5 Million Payment shall be made upon approval of the Agreement by the Bankruptcy Court and subsequent to a 10 day appeal period, and only if no appeals are received. However, the transfer of Products Rights shall become effective only upon Accentia's exit from Reorganization as evidenced by an effective reorganization plan for Accentia that is confirmed by the Bankruptcy Court, and any conditions to the plan have been satisfied or waived by Accentia. If Accentia does not exit Reorganization by December 31, 2010, the transfer of Product Rights shall be deemed terminated and of no force or effect.
In the event of a proposed sale of the Company or its assets, the Company shall have the right to terminate its Product Right payment obligations and all other obligations to Accentia under the Agreement upon the payment to Accentia of an amount equal to the greater of: (i) Four Million Five Hundred Thousand Dollars ($4,500,000), or (ii) the fair market value of the Product Rights as determined by an independent third party appraiser. Further, if the Product Right is terminated, the Warrant described below will be terminated if not already exercised, and, if exercised, an amount equal to the strike price will, in addition to the amount in (i) or (ii) above, be paid to Accenita. The Company and Accentia have also agreed to negotiate in good faith to determine a payment amount at any time the Company wishes to repurchase the Product Rights.
...
2,5 Mil $ und spätere Royalities... also letztendlich eine erfreuliche Meldung zum Jahresabschluss. Dann gab es gestern aber noch den Orphan Drug Status von der FDA für BiovaxID. Dass ist bei Krebsmedikamenten zwar keine seltene Meldung, ist aber auf jeden Fall positiv zu deuten!
http://finance.yahoo.com/news/FDA-Grants-Orphan-Drug-Status-…
FDA Grants Orphan Drug Status for Personalized Lymphoma Vaccine
Press Release Source: Biovest International, Inc. On Thursday January 7, 2010, 1:45 pm EST
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC: BVTI - News) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.
With FDA Orphan Drug Status, Biovest has a seven-year period of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduced filing fees for marketing applications. Based on statistically significant Phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a Biologic License Application (BLA) with the FDA by approximately mid-year in order to seek U.S. approval of BiovaxID. The Company also expects to file regulatory applications seeking approvals in Europe and Canada.
In other news, Biovest announced that the Company will present at the Biotechnology Showcase to be held in San Francisco next week, running concurrent with the JP Morgan 28th Annual Healthcare Conference.
Event: Biotechnology Showcase™ 2010
Place: Marines’ Memorial Club & Hotel, San Francisco
Biovest Presentation Day/Time: Wednesday, January 13th at 9:00 a.m. (PST)
Conference Website: www.ebdgroup.com/bts/
If qualified investors or corporate partnering candidates are interested in scheduling a meeting with Biovest in San Francisco, please contact Douglas Calder at 813-864-2558 or dwcalder@biovest.com.
According to Biovest’s President, Mr. Samuel S. Duffey, the Biotechnology Showcase kicks off the year with an opportunity to update institutional investors, bankers and analysts as the Company prepares to emerge from reorganization. “We expect to make announcements in the near future that will demonstrate that we have taken full advantage of the reorganization process in restructuring debt and contractual obligations. We anticipate emerging from reorganization in the first part of 2010 with our current shareholder base successfully preserved and with a greatly improved balance sheet, which will enable management to focus on executing our business and drug development plans,” stated, Mr. Duffey.
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, anti-lymphoma cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in patients suffering from indolent follicular non-Hodgkin’s lymphoma. Biovest has developed and markets a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID® which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ - News).
For further information, please visit: http://www.biovest.com
Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Grüße
Seit November 2008, also knapp 14 Monate, befindet sich ABPI in Insolvenz. In den kommenden Tagen / Wochen muss ABPI wohl einen Plan der SEC vorlegen, wie es denn weiterlaufen soll. Bin mal gespannt, ob ein Zusammenschluss mit Biovest hier auch hereinspielt.
Ende 2009 gab es noch folgende Meldung von BDSI, die wie ABPI und BVTI auch zur Hopkins Capital Group gehören:
http://biz.yahoo.com/e/091231/bdsi8-k.html
Form 8-K for BIODELIVERY SCIENCES INTERNATIONAL INC
--------------------------------------------------------------------------------
31-Dec-2009
Entry into a Material Definitive Agreement, Financial Stat
On December 30, 2009, BioDelivery Sciences International, Inc. (the "Company") and Accentia Biopharmaceuticals, Inc. ("ABPI"), a related party of the Company through common ownership and management, entered into an Emezine Settlement Agreement (the "Agreement") between the Company, Accentia, the Company's wholly-owned subsidiary Arius Pharmaceuticals, Inc. ("Arius") and Accentia Pharmaceuticals, Inc. (f/k/a TEAMM Pharmaceuticals Inc. and referred to herein as "TEAMM", and together with ABPI "Accentia"), a wholly owned subsidiary of ABPI. The Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K.
...
The Agreement provides that the Company and Accentia mutually release all claims that either may have against each other and, in connection therewith, the Company will:
(a) pay $2.5 million to Accentia (the "$2.5 Million Payment"); and
(b) grant the following royalty rights (the "Product Rights") to Accentia with respect to the Company's BEMA Granisetron product candidate ("BEMA Granisetron") (or in the event it is not BEMA Granisetron, the third Company product candidate (excluding BEMA Buprenorphine) as to which the Company files an NDA, which, together with BEMA Granisetron, shall be referred to hereinafter as the "Product"):
(i) 70/30 split (Company/Accentia) of royalty received if a third party sells the Product and 85/15 split on net sales if the Company sells the Product; and
(ii) The Company will, from the sale of the Product, fully recover amounts equal to (1) all internal and external worldwide development costs of the Product ("Costs") plus interest (measured on weighted average prime interest rate from first dollar spent until Product launch) and (2) the $2.5 Million Payment plus interest (measured on weighted average prime interest rate from the time of payment until Product launch) before Accentia begins to receive its split as described in (b) (i) above.
However, should the Company receive any sublicensing or milestone payments associated with the Product up to and including the NDA approval, the Company will apply 30% of such payments toward payback of the Costs of the Product plus interest and the $2.5 Million Payment plus the interest.
The $2.5 Million Payment shall be made upon approval of the Agreement by the Bankruptcy Court and subsequent to a 10 day appeal period, and only if no appeals are received. However, the transfer of Products Rights shall become effective only upon Accentia's exit from Reorganization as evidenced by an effective reorganization plan for Accentia that is confirmed by the Bankruptcy Court, and any conditions to the plan have been satisfied or waived by Accentia. If Accentia does not exit Reorganization by December 31, 2010, the transfer of Product Rights shall be deemed terminated and of no force or effect.
In the event of a proposed sale of the Company or its assets, the Company shall have the right to terminate its Product Right payment obligations and all other obligations to Accentia under the Agreement upon the payment to Accentia of an amount equal to the greater of: (i) Four Million Five Hundred Thousand Dollars ($4,500,000), or (ii) the fair market value of the Product Rights as determined by an independent third party appraiser. Further, if the Product Right is terminated, the Warrant described below will be terminated if not already exercised, and, if exercised, an amount equal to the strike price will, in addition to the amount in (i) or (ii) above, be paid to Accenita. The Company and Accentia have also agreed to negotiate in good faith to determine a payment amount at any time the Company wishes to repurchase the Product Rights.
...
2,5 Mil $ und spätere Royalities... also letztendlich eine erfreuliche Meldung zum Jahresabschluss. Dann gab es gestern aber noch den Orphan Drug Status von der FDA für BiovaxID. Dass ist bei Krebsmedikamenten zwar keine seltene Meldung, ist aber auf jeden Fall positiv zu deuten!
http://finance.yahoo.com/news/FDA-Grants-Orphan-Drug-Status-…
FDA Grants Orphan Drug Status for Personalized Lymphoma Vaccine
Press Release Source: Biovest International, Inc. On Thursday January 7, 2010, 1:45 pm EST
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC: BVTI - News) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.
With FDA Orphan Drug Status, Biovest has a seven-year period of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduced filing fees for marketing applications. Based on statistically significant Phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a Biologic License Application (BLA) with the FDA by approximately mid-year in order to seek U.S. approval of BiovaxID. The Company also expects to file regulatory applications seeking approvals in Europe and Canada.
In other news, Biovest announced that the Company will present at the Biotechnology Showcase to be held in San Francisco next week, running concurrent with the JP Morgan 28th Annual Healthcare Conference.
Event: Biotechnology Showcase™ 2010
Place: Marines’ Memorial Club & Hotel, San Francisco
Biovest Presentation Day/Time: Wednesday, January 13th at 9:00 a.m. (PST)
Conference Website: www.ebdgroup.com/bts/
If qualified investors or corporate partnering candidates are interested in scheduling a meeting with Biovest in San Francisco, please contact Douglas Calder at 813-864-2558 or dwcalder@biovest.com.
According to Biovest’s President, Mr. Samuel S. Duffey, the Biotechnology Showcase kicks off the year with an opportunity to update institutional investors, bankers and analysts as the Company prepares to emerge from reorganization. “We expect to make announcements in the near future that will demonstrate that we have taken full advantage of the reorganization process in restructuring debt and contractual obligations. We anticipate emerging from reorganization in the first part of 2010 with our current shareholder base successfully preserved and with a greatly improved balance sheet, which will enable management to focus on executing our business and drug development plans,” stated, Mr. Duffey.
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, anti-lymphoma cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in patients suffering from indolent follicular non-Hodgkin’s lymphoma. Biovest has developed and markets a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID® which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ - News).
For further information, please visit: http://www.biovest.com
Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Grüße
Zum Thema Insolvenz... Im Artikel wird spekuliert, dass ABPIs Pläne und Vorgehensweise möglicherweise noch im 1.Q 2010 umgesetzt werden könnten.
http://tampabay.bizjournals.com/tampabay/stories/2010/01/11/…
Friday, January 8, 2010
Accentia makes post-bankruptcy plans
Tampa Bay Business Journal - by Margie Manning Senior Staff Writer
TAMPA — More than a year after filing a voluntary petition to reorganize its debts, Accentia Biopharmaceuticals Inc. appears set to exit bankruptcy.
When it does, it will have an extra $2.5 million in cash and rights to some of the proceeds from sales of a potential treatment for nausea, a filing with the Securities and Exchange Commission said.
The cash and royalty rights are included in a settlement between drug developer Accentia (Pink Sheets: ABPIQ) and BioDelivery Sciences International Inc. (Nasdaq: BDSI), a Raleigh, N.C., specialty pharma firm with corporate ties to Accentia. The settlement requires approval of the U.S. Bankruptcy Court for the Middle District of Florida and is in part contingent on Accentia emerging from bankruptcy by the end of 2010.
The company is optimistic it will file a plan for reorganization that has the full consent and approval of its creditors soon, spokesman Doug Calder said. It expects the plan will be confirmed and become effective in the first quarter of 2010.
http://tampabay.bizjournals.com/tampabay/stories/2010/01/11/…
Friday, January 8, 2010
Accentia makes post-bankruptcy plans
Tampa Bay Business Journal - by Margie Manning Senior Staff Writer
TAMPA — More than a year after filing a voluntary petition to reorganize its debts, Accentia Biopharmaceuticals Inc. appears set to exit bankruptcy.
When it does, it will have an extra $2.5 million in cash and rights to some of the proceeds from sales of a potential treatment for nausea, a filing with the Securities and Exchange Commission said.
The cash and royalty rights are included in a settlement between drug developer Accentia (Pink Sheets: ABPIQ) and BioDelivery Sciences International Inc. (Nasdaq: BDSI), a Raleigh, N.C., specialty pharma firm with corporate ties to Accentia. The settlement requires approval of the U.S. Bankruptcy Court for the Middle District of Florida and is in part contingent on Accentia emerging from bankruptcy by the end of 2010.
The company is optimistic it will file a plan for reorganization that has the full consent and approval of its creditors soon, spokesman Doug Calder said. It expects the plan will be confirmed and become effective in the first quarter of 2010.
Antwort auf Beitrag Nr.: 38.696.994 von Ackergaul am 08.01.10 19:16:21Die Biotech Showcase Konferenz / Präsentation von BVTI:
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?F…
Ein paar Auszüge
Reorganisation Biovest
- Q1: Plan wird vorgelegt
- 1H: bis dato wahrscheinlich Genehmigung dieses Plans
AutovaxID Contract in Q1 geplant (bedeutet Umsätze für BVTI und demnach auch ABPI)
BiovaxID Lizensierung bzw. Verpartnerung noch nicht zeitlich erwähnt. Wohl nach einer FDA Entscheidung.
Vollständige Phase III Daten BiovaxID in den kommenden Monaten (1H 2010)
Zu ABPI:
Raus aus dem Bankrott: In den letzten Berichten / Meldungen wird hier auf Ende 2010 getippt... Wenn es geschafft werden sollte, wäre eine große Hürde genommen. Denn zukünftig könnte ABPI hierdurch verdienen:
* BVTIs Produkte BiovaxID und AutovaxID
Ungefähr 70%ige Beteiligung an Biovest. Von den Produkten Biovests (zB BiovaxID und AutovaxID) soll es später Royality Zahlungen von knapp 20% geben.
-> Denke dass BiovaxID wohl nicht von der FDA zugelassen wird. Hier wird wohl noch eine zusätzliche Phase III benötigt. Falls BiovaxID von der FDA zugelassen wird, sollte ein Blick auf den Chart von VNDA geworfen werden...
* BDSIs BEMA Granisetron,
pay $2.5 million to Accentia (the "$2.5 Million Payment"); and
70/30 split (Company/Accentia) of royalty received if a third party sells the Product and 85/15 split on net sales if the Company sells the Product;
* dass kerngeschäft von ABPI verlief mehr schlecht als Recht. Da ist nicht viel Umsatz zu erwarten. SinuNase lief nicht erfolgreich; Revimmune sehe ich dass problem vielmehr in Richtung fehlenden Patentschutz... Mit der Tochterfirma Analytica hat man wohl noch etwas an Wert.
bin mal gespannt wie die nächsten Wochen hier verlaufen.
Grüße
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?F…
Ein paar Auszüge
Reorganisation Biovest
- Q1: Plan wird vorgelegt
- 1H: bis dato wahrscheinlich Genehmigung dieses Plans
AutovaxID Contract in Q1 geplant (bedeutet Umsätze für BVTI und demnach auch ABPI)
BiovaxID Lizensierung bzw. Verpartnerung noch nicht zeitlich erwähnt. Wohl nach einer FDA Entscheidung.
Vollständige Phase III Daten BiovaxID in den kommenden Monaten (1H 2010)
Zu ABPI:
Raus aus dem Bankrott: In den letzten Berichten / Meldungen wird hier auf Ende 2010 getippt... Wenn es geschafft werden sollte, wäre eine große Hürde genommen. Denn zukünftig könnte ABPI hierdurch verdienen:
* BVTIs Produkte BiovaxID und AutovaxID
Ungefähr 70%ige Beteiligung an Biovest. Von den Produkten Biovests (zB BiovaxID und AutovaxID) soll es später Royality Zahlungen von knapp 20% geben.
-> Denke dass BiovaxID wohl nicht von der FDA zugelassen wird. Hier wird wohl noch eine zusätzliche Phase III benötigt. Falls BiovaxID von der FDA zugelassen wird, sollte ein Blick auf den Chart von VNDA geworfen werden...
* BDSIs BEMA Granisetron,
pay $2.5 million to Accentia (the "$2.5 Million Payment"); and
70/30 split (Company/Accentia) of royalty received if a third party sells the Product and 85/15 split on net sales if the Company sells the Product;
* dass kerngeschäft von ABPI verlief mehr schlecht als Recht. Da ist nicht viel Umsatz zu erwarten. SinuNase lief nicht erfolgreich; Revimmune sehe ich dass problem vielmehr in Richtung fehlenden Patentschutz... Mit der Tochterfirma Analytica hat man wohl noch etwas an Wert.
bin mal gespannt wie die nächsten Wochen hier verlaufen.
Grüße
der Kurs hat sich zum Dezember gesehen verdoppelt, allerdings fehlen immer noch Neuigkeiten, die den Kursverlauf stützen...
ABPI hat eine Marktkapitalisierung von etwa 30 Mil. US $
hatten etwa 60 Mil. US $ Schulden!
BVTI hat eine Marktkapitalisierung von etwa 85 Mil. US $
hatten etwa 25 Mil. US $ Schulden!
Beide noch unter Chapter 11 und dennoch Stolz bewertet.
In diesem Quartal sollte noch ein AutovaxID Contract möglicherweise gemeldet werden und ein Plan bezüglich der Reorganisation vorgelegt werden.
Schlüsselmeldung werden die vollständigen Phase III Daten zu BiovaxID allerdings sein. Bin gespannt wann diese gemeldet werden. Gut möglich dass dies zur ASCO geschieht. Solange werde ich noch aus"halten"...
Grüße
ABPI hat eine Marktkapitalisierung von etwa 30 Mil. US $
hatten etwa 60 Mil. US $ Schulden!
BVTI hat eine Marktkapitalisierung von etwa 85 Mil. US $
hatten etwa 25 Mil. US $ Schulden!
Beide noch unter Chapter 11 und dennoch Stolz bewertet.
In diesem Quartal sollte noch ein AutovaxID Contract möglicherweise gemeldet werden und ein Plan bezüglich der Reorganisation vorgelegt werden.
Schlüsselmeldung werden die vollständigen Phase III Daten zu BiovaxID allerdings sein. Bin gespannt wann diese gemeldet werden. Gut möglich dass dies zur ASCO geschieht. Solange werde ich noch aus"halten"...
Grüße
Antwort auf Beitrag Nr.: 39.048.085 von Ackergaul am 03.03.10 11:22:30da war ich ja gestern zu voreilig:
heute morgen ist die MK schon > 40 Mil US$
weiterhin keine News und dass Volumen war gestern auch nicht übermässig groß (ungefähr 5 x höher als normal). Ob jemand den Kurs hochpuschen will oder irgendetwas durchgesickert ist kann nur gemutmaßt werden.
Weiterhin abWARTEN.
Grüße
Heute wird wohl ein Teil der Investoren die Kursteigungen der letzten Tage zu Gewinnen machen...
heute morgen ist die MK schon > 40 Mil US$
weiterhin keine News und dass Volumen war gestern auch nicht übermässig groß (ungefähr 5 x höher als normal). Ob jemand den Kurs hochpuschen will oder irgendetwas durchgesickert ist kann nur gemutmaßt werden.
Weiterhin abWARTEN.
Grüße
Heute wird wohl ein Teil der Investoren die Kursteigungen der letzten Tage zu Gewinnen machen...
Antwort auf Beitrag Nr.: 39.055.432 von Ackergaul am 04.03.10 08:29:49Wollen doch mal hoffen, das der Kurs nicht hochgeputscht wurde.
Schoener waeren doch endlich mal gute Neuigkeiten.
Schoener waeren doch endlich mal gute Neuigkeiten.
huiuhuihui, seit gestern ist mir klar geworden wieder auf dass falsche Pferd gesetzt zu haben. BVTI hat gestern die 2 Dollar erreicht (+40 %) = MK von knapp 200 Mil. $!!!
Im 1 Jahres Vergelich ABPI vs BVTI:
Für mich ein Zeichen, dass BVTI und ABPI wohl doch nicht verschmelzen werden, wo drauf ich gesetzt hatte...
Grüße
Im 1 Jahres Vergelich ABPI vs BVTI:
Für mich ein Zeichen, dass BVTI und ABPI wohl doch nicht verschmelzen werden, wo drauf ich gesetzt hatte...
Grüße
Antwort auf Beitrag Nr.: 39.100.407 von Ackergaul am 10.03.10 08:34:32Hi Ackergaul,
nicht die Nerven verlieren. Wart erst mal ab, was die Woche noch
so bringt. Vermute das BVTI und ABPI miteinander so verstrickt sind, das man nur gemeinsam aus dem Chapter 11 herauskommen.
So watch and wait.
nicht die Nerven verlieren. Wart erst mal ab, was die Woche noch
so bringt. Vermute das BVTI und ABPI miteinander so verstrickt sind, das man nur gemeinsam aus dem Chapter 11 herauskommen.
So watch and wait.
Antwort auf Beitrag Nr.: 39.100.407 von Ackergaul am 10.03.10 08:34:32Hallo Ackergaul und Sunny.
Bei mir war es eigentlich schon seit April 2008 so, dass ich ABPI für das intelligentere Investment gehalten habe, um am potentiellen Erfolg von BiovaxID zu partizipieren.
ABPI hält 70% an BVTI und erhält (hohe) 20% Royalty Zahlungen. BVTI würde eine Vertriebspartnerschaft benötigen uns selbst mit weniger (!) Royalties auskommen müssen.
Ich habe hier auch zu verschiedenen Zeitpunkten die Kursverläufe miteinander verglichen und mich gewundert, dass die BVTI Kurssteigerungen ggü. dem ABPI Kurs stärker ausfallen. Durch das Ungleichgewicht hätte ein Investment in ABPI eigentlich gute Arbitragemöglichkeiten bieten müssen, um am Erfolg von BiovaxId zu partizipieren.
Gut, beide Kurse steigen. Da jedoch die Schere immer weiter auseinander klafft, kann das nur folgendes bedeuten.
Entweder:
BVTI wird gepuscht und ist das Geld nicht wert.
Am Markt springen Trader auf fahrende Züge in Richtung des güldenen Horizonts der Hoffnung auf und interessieren sich nicht für die Grundsituation, denn sie springen vorher wieder ab und beabsichtigen gar nicht, auf die gefährliche Entscheidung zu warten.
Oder:
ABPI(Q) kommt aus der Insolvenz nicht unbeschadet heraus, d.h. die Partizipationsmöglichkeiten am potentiellen Erfolg von BiovaxID verschlechtern sich.
KJ
Bei mir war es eigentlich schon seit April 2008 so, dass ich ABPI für das intelligentere Investment gehalten habe, um am potentiellen Erfolg von BiovaxID zu partizipieren.
ABPI hält 70% an BVTI und erhält (hohe) 20% Royalty Zahlungen. BVTI würde eine Vertriebspartnerschaft benötigen uns selbst mit weniger (!) Royalties auskommen müssen.
Ich habe hier auch zu verschiedenen Zeitpunkten die Kursverläufe miteinander verglichen und mich gewundert, dass die BVTI Kurssteigerungen ggü. dem ABPI Kurs stärker ausfallen. Durch das Ungleichgewicht hätte ein Investment in ABPI eigentlich gute Arbitragemöglichkeiten bieten müssen, um am Erfolg von BiovaxId zu partizipieren.
Gut, beide Kurse steigen. Da jedoch die Schere immer weiter auseinander klafft, kann das nur folgendes bedeuten.
Entweder:
BVTI wird gepuscht und ist das Geld nicht wert.
Am Markt springen Trader auf fahrende Züge in Richtung des güldenen Horizonts der Hoffnung auf und interessieren sich nicht für die Grundsituation, denn sie springen vorher wieder ab und beabsichtigen gar nicht, auf die gefährliche Entscheidung zu warten.
Oder:
ABPI(Q) kommt aus der Insolvenz nicht unbeschadet heraus, d.h. die Partizipationsmöglichkeiten am potentiellen Erfolg von BiovaxID verschlechtern sich.
KJ
will ja jetzt nicht sagen, dass es "endlich" mal einen kräftigen Rücksetzer gibt, aber gerade die Bewertung bei BVTI war schon ziemlich aufgeheizt...
Eigentlich sollte der Einbruch bei ABPI um einiges geringer als bei BVTI heute ausfallen, aber was heißt schon eigentlich.
Grüße
Eigentlich sollte der Einbruch bei ABPI um einiges geringer als bei BVTI heute ausfallen, aber was heißt schon eigentlich.
Grüße
Der Monat März neigt sich dem Ende entgegen und damit auch dass 1.Q 2010. Ich bin gespannt ob ABPIs Tochter BVTI den Plan of Reorganization noch vorlegen wird. Befürchte eher Nein...
Nochmals zur Erinnerung Anfang Januar gab es eine SEC Mitteilung seitens BVTI. Einige Punkte darunter:
Reorganization Status
• Filed for Chapter 11 protections in November 2008
• Continued operations with a focus on core projects supported by cash flow and non-dilutive financing (DIP)
• Expect to file Plan of Reorganization with creditor approval and consent in Q1 2010
• Committed to ensuring the preservation of existing shareholder base (common shares NOT canceled)
• Expect a greatly improved balance sheet via restructured debt and contractual obligations
• Opportunity for Plan to be confirmed and declared effective in first half 2010
• Compliance with SEC financial reporting
Building Shareholder Value
• Emergence from reorganization
• BiovaxlD represents an enormous market opportunity and is holds the potential to be among the first therapeutic cancer vaccines to
be granted international approval(s)
• Significant BiovaxlD licensing/partnering opportunity
• Increasing HF instrument revenues with expectation of reporting a significant AutovaxlD contract in Q1 2010
• Increasing contract manufacturing revenues
• Elevate stock exchange listing
• Proactive investor relations program
• Highly-disciplined budget management
Das Thema Reoranisation ist alles andere als einfach. Aus einem Posting aus dem Y! Board habe ich mal folgendes notiert:
Doc # 37 Debt as of 10/31/08
Accentia- $31.3M in secured debt and $30.1M in unsecured, total = $61.4M
Secured- $14.7 to Laurus, $4.085M to Southwest Bank, $8.9M in Convertible Debentures (convertible at $1.10 and secured by IP of Sinunase), to a loong list of funds, and $3.6M to McKesson Corp.
Unsecured- $30.1M to 125 creditors
Biovest- $33.4M in secured debt and $14.2M in unsecured, total = $47.6M
Secured-$20M to Laurus, $1.5M to O'Donnell, Osman and others, and $11.9M to Accentia "secured by a security interest in all of the assets of Biovest".
Unsecured- $14.2M to 170 creditors.
170 creditors die man alleine bei BVTI unter einen Hut bekommen muss... Dass hört sich nicht so einfach an. Ist dass Kapitel BVTI Reoranisation geklärt, wird wohl als nächstes ABPI an der Reihe sein.
Dann gabs auch noch mal eine nette Übersicht der Beteiligung an BVTI:
Re: O'Donnell/Hopkins vs Laurus et. al. (BVTI ownership)
BVTI ownership table per the most recent 10-K filing (1/28/2008):
Steven Arikian - 1,921,211 options (1.97%)
Peter J. Pappas, Sr. - 1,552,545 shares (1.61%)
Francis E. O’Donnell, Jr. - 1,370,454 options + warrants (1.41%)
James A. McNulty - 1,000,000 options (1.03%)
Robert D. Weiss - 255,000 shares (0.27%)
Jeffrey A. Scott - 170,000 shares (0.18%)
Raphael J. Mannino - 135,000 shares (0.14%)
Christopher C. Chapman - 100,000 shares (0.10%)
John Sitilides - 273,636 shares (0.29%)
Ronald E. Osman - 4,667,610 shares (4.65%)
Alan M. Pearce - 501,822 shares (0.52%)
Accentia Biopharmaceuticals, Inc. - 73,115,818 shares (76.38%)
Laurus Master Fund, Ltd. - 18,005,161 shares + warrants (16.50%)
It also notes that holders of greater than 10% of the outstanding stock of Accentia include Hopkins Capital Group, LLC., MOAB Investments LP, Timothy Ryll, and PPD International Holding, Inc.
The percentages add to > 100% because: "In computing the number of shares beneficially owned by a person listed below and the percentage ownership of such person, shares of common stock underlying options, warrants or convertible securities held by each such person that are exercisable or convertible within 60 days of December 31, 2007 are deemed outstanding, but are not deemed outstanding for computing the percentage ownership of any other person."
Grüße
Nochmals zur Erinnerung Anfang Januar gab es eine SEC Mitteilung seitens BVTI. Einige Punkte darunter:
Reorganization Status
• Filed for Chapter 11 protections in November 2008
• Continued operations with a focus on core projects supported by cash flow and non-dilutive financing (DIP)
• Expect to file Plan of Reorganization with creditor approval and consent in Q1 2010
• Committed to ensuring the preservation of existing shareholder base (common shares NOT canceled)
• Expect a greatly improved balance sheet via restructured debt and contractual obligations
• Opportunity for Plan to be confirmed and declared effective in first half 2010
• Compliance with SEC financial reporting
Building Shareholder Value
• Emergence from reorganization
• BiovaxlD represents an enormous market opportunity and is holds the potential to be among the first therapeutic cancer vaccines to
be granted international approval(s)
• Significant BiovaxlD licensing/partnering opportunity
• Increasing HF instrument revenues with expectation of reporting a significant AutovaxlD contract in Q1 2010
• Increasing contract manufacturing revenues
• Elevate stock exchange listing
• Proactive investor relations program
• Highly-disciplined budget management
Das Thema Reoranisation ist alles andere als einfach. Aus einem Posting aus dem Y! Board habe ich mal folgendes notiert:
Doc # 37 Debt as of 10/31/08
Accentia- $31.3M in secured debt and $30.1M in unsecured, total = $61.4M
Secured- $14.7 to Laurus, $4.085M to Southwest Bank, $8.9M in Convertible Debentures (convertible at $1.10 and secured by IP of Sinunase), to a loong list of funds, and $3.6M to McKesson Corp.
Unsecured- $30.1M to 125 creditors
Biovest- $33.4M in secured debt and $14.2M in unsecured, total = $47.6M
Secured-$20M to Laurus, $1.5M to O'Donnell, Osman and others, and $11.9M to Accentia "secured by a security interest in all of the assets of Biovest".
Unsecured- $14.2M to 170 creditors.
170 creditors die man alleine bei BVTI unter einen Hut bekommen muss... Dass hört sich nicht so einfach an. Ist dass Kapitel BVTI Reoranisation geklärt, wird wohl als nächstes ABPI an der Reihe sein.
Dann gabs auch noch mal eine nette Übersicht der Beteiligung an BVTI:
Re: O'Donnell/Hopkins vs Laurus et. al. (BVTI ownership)
BVTI ownership table per the most recent 10-K filing (1/28/2008):
Steven Arikian - 1,921,211 options (1.97%)
Peter J. Pappas, Sr. - 1,552,545 shares (1.61%)
Francis E. O’Donnell, Jr. - 1,370,454 options + warrants (1.41%)
James A. McNulty - 1,000,000 options (1.03%)
Robert D. Weiss - 255,000 shares (0.27%)
Jeffrey A. Scott - 170,000 shares (0.18%)
Raphael J. Mannino - 135,000 shares (0.14%)
Christopher C. Chapman - 100,000 shares (0.10%)
John Sitilides - 273,636 shares (0.29%)
Ronald E. Osman - 4,667,610 shares (4.65%)
Alan M. Pearce - 501,822 shares (0.52%)
Accentia Biopharmaceuticals, Inc. - 73,115,818 shares (76.38%)
Laurus Master Fund, Ltd. - 18,005,161 shares + warrants (16.50%)
It also notes that holders of greater than 10% of the outstanding stock of Accentia include Hopkins Capital Group, LLC., MOAB Investments LP, Timothy Ryll, and PPD International Holding, Inc.
The percentages add to > 100% because: "In computing the number of shares beneficially owned by a person listed below and the percentage ownership of such person, shares of common stock underlying options, warrants or convertible securities held by each such person that are exercisable or convertible within 60 days of December 31, 2007 are deemed outstanding, but are not deemed outstanding for computing the percentage ownership of any other person."
Grüße
Antwort auf Beitrag Nr.: 39.157.469 von Ackergaul am 17.03.10 12:07:20Das Form 10-K/A ist vom 28.01.08 und schon recht alt.
Aber der Ausschnitt aus dem Y!Board stimmt, siehe Link ab Seite 16.
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=56750…
Die folgenden Forms 10-Q enthalten diese Information nicht.
Tja und dann kamen auch schon diese leidlichen monatlichen 8-K Meldungen...
Aber der Ausschnitt aus dem Y!Board stimmt, siehe Link ab Seite 16.
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=56750…
Die folgenden Forms 10-Q enthalten diese Information nicht.
Tja und dann kamen auch schon diese leidlichen monatlichen 8-K Meldungen...
heute kamen übrigends Termine. Bin mir nicht sicher, ob da nicht einige enttäuscht sind, weil der Name ASCO hier fehlt:
Biovest Announces Upcoming Conference Calendar to Present on Personalized Cancer Vaccine Targeting B-cell Lymphomas
March 17, 2010, 12:19 pm EDT
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC:BVTI - News) today announced that the company is confirmed to present its personalized cancer vaccine, BiovaxID®, at the following upcoming conferences:
World Vaccine Congress 2010, April 19-22, Washington D.C.
BIO International Convention, May 3-6, Chicago
Active Immunotherapeutics Forum 2010, June 21-23, Barcelona, Spain
At these events, Biovest plans to review positive Phase II and Phase III data for BiovaxID and discuss the potential market opportunity including regulatory and manufacturing strategies. The company will make further announcements related to the specifics for each presentation prior to each conference.
In addition, Biovest will be attending the American Society of Oncology’s (ASCO) Annual Meeting, June 4-8 in Chicago, intending to meet with corporate partnering candidates, key opinion leaders treating lymphomas and patient advocacy groups.
Biovest’s President, Mr. Samuel S. Duffey, stated, “As Biovest and its parent, Accentia Biopharmaceuticals, Inc., prepare to exit from reorganization, it is a priority for us to attend and present at key industry and investor events to communicate the vital role that we envision for BiovaxID in potentially enhancing existing regimens for the treatment of indolent follicular non-Hodgkin’s lymphoma and other B-cell blood cancers.”
Es sollen ja noch aktuelle Phase III Daten (overall survivall) veröffentlicht werden. Nicht unwahrscheinlich, dass mindestens einer der drei Termine ein Key Event wird - auch für den Kurs!
Grüße
Biovest Announces Upcoming Conference Calendar to Present on Personalized Cancer Vaccine Targeting B-cell Lymphomas
March 17, 2010, 12:19 pm EDT
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (Other OTC:BVTI - News) today announced that the company is confirmed to present its personalized cancer vaccine, BiovaxID®, at the following upcoming conferences:
World Vaccine Congress 2010, April 19-22, Washington D.C.
BIO International Convention, May 3-6, Chicago
Active Immunotherapeutics Forum 2010, June 21-23, Barcelona, Spain
At these events, Biovest plans to review positive Phase II and Phase III data for BiovaxID and discuss the potential market opportunity including regulatory and manufacturing strategies. The company will make further announcements related to the specifics for each presentation prior to each conference.
In addition, Biovest will be attending the American Society of Oncology’s (ASCO) Annual Meeting, June 4-8 in Chicago, intending to meet with corporate partnering candidates, key opinion leaders treating lymphomas and patient advocacy groups.
Biovest’s President, Mr. Samuel S. Duffey, stated, “As Biovest and its parent, Accentia Biopharmaceuticals, Inc., prepare to exit from reorganization, it is a priority for us to attend and present at key industry and investor events to communicate the vital role that we envision for BiovaxID in potentially enhancing existing regimens for the treatment of indolent follicular non-Hodgkin’s lymphoma and other B-cell blood cancers.”
Es sollen ja noch aktuelle Phase III Daten (overall survivall) veröffentlicht werden. Nicht unwahrscheinlich, dass mindestens einer der drei Termine ein Key Event wird - auch für den Kurs!
Grüße
Schlusskurs 1,08 USD, also über einen Dollar.
Das ich das noch erleben darf!
Das ich das noch erleben darf!
Antwort auf Beitrag Nr.: 39.258.821 von KillingJoke am 31.03.10 22:47:56die 1 Dollar Marke geknackt! Damit hätte ich zu diesem Zeitpunkt nicht gerechnet...
* Der Reorg Plan BVTIs steht immer noch nicht. Anscheinend ist in 2-3 Wochen der nächste Anlauf
* Zu AutoxaxID ist noch keine Partnerschaftsmeldung gekommen. Wird wohl erst nach dem Reorg Plan der Fall sein
* wann ABPI an der Reihe ist bezüglich "raus aus Chapter 11"?
Im April wird BiovaxID auf einer Konferenz präsentiert. Möglicherweise bekommen wir hier schon die endgültigen (noch NICHT veröffentlichten) Daten zu sehen. Dass ist natürlich dann ein Ereignis...
Generell denke ich aber dass BiovaxID von der FDA NICHT zugelassen wird. Der Trial war einfach zu klein, es fehlten mehrere Hundert Personen. Hier wird mind. einen weitere Phase III gestartet werden müssen - also ein ähnlicher Fall wie bei Pixantrone!
Grüße
* Der Reorg Plan BVTIs steht immer noch nicht. Anscheinend ist in 2-3 Wochen der nächste Anlauf
* Zu AutoxaxID ist noch keine Partnerschaftsmeldung gekommen. Wird wohl erst nach dem Reorg Plan der Fall sein
* wann ABPI an der Reihe ist bezüglich "raus aus Chapter 11"?
Im April wird BiovaxID auf einer Konferenz präsentiert. Möglicherweise bekommen wir hier schon die endgültigen (noch NICHT veröffentlichten) Daten zu sehen. Dass ist natürlich dann ein Ereignis...
Generell denke ich aber dass BiovaxID von der FDA NICHT zugelassen wird. Der Trial war einfach zu klein, es fehlten mehrere Hundert Personen. Hier wird mind. einen weitere Phase III gestartet werden müssen - also ein ähnlicher Fall wie bei Pixantrone!
Grüße
sapperlot
die Schere zwischen ABPI und BVTI schließt sich heute vielleicht ein wenig zugunsten ABPIs...
die Schere zwischen ABPI und BVTI schließt sich heute vielleicht ein wenig zugunsten ABPIs...
imY! Board wirde auf folgende Story gepostet:
http://www.curetoday.com/index.cfm/fuseaction/article.PrintA…
Getting Personal
BY KATY HUMAN
Using personalized vaccines, researchers enlist the immune system to oust tumors.
In 2003, Stephen Creel, a manager at a software company in Austin, Texas,
suddenly started passing blood in his urine. He had just celebrated his 40th
birthday with friends and his wife, who was pregnant with their daughter, and he
was as fit as he’d been in years.
The diagnosis of kidney cancer—renal cell carcinoma—was “shocking,” Creel says.
His father-in-law, a cancer researcher, directed Creel to M.D. Anderson Cancer
Center in Houston, almost 170 miles away, where oncologists were testing an
experimental vaccine to treat kidney cancer.
They surgically removed patients’ tumors, sent samples away for processing, and
then re-injected cancer-specific proteins back into the patient. They were trying
to activate the patients’ own immune system cells, train them to recognize cancer
as an invader, and fight it off.
“I really liked the idea of that, getting your body to do the work, not just
chemicals,” Creel says.
Preventive vaccination, also referred to as immunization, has become a critical
part of global public health. Since the body has a much easier time developing
immunity against foreign proteins that come from viruses or bacteria, vaccines to
prevent cervical and liver cancers (associated with viral infection) are already
available. But tricking the body into fighting existing cancer has proved more
complicated because most cancer cell proteins are similar to normal proteins,
and the body is “educated” not to develop immunity against its own proteins.
Nonetheless, treatment vaccines for prostate cancer, lymphoma, melanoma, and
other cancer types are undergoing late-phase tests in people, and the results are
inspiring restrained optimism.
Stephen Creel often played tennis the night before receiving a vaccine
to treat his kidney cancer. Photo by Glenn Zamora.
“We’re training the body to reject the tumor,” says Leisha Emens, MD, PhD, a
breast cancer researcher and vaccine developer at Johns Hopkins University in
Baltimore. The immune approach is unlike new types of chemotherapy, radiation,
or hormonal therapy, Emens says. Treatment vaccines target cancer cells more
precisely, have far fewer side effects, and may be less likely to foster drug
resistance. “This works completely differently,” Emens says. “With immune-based
therapy, you’re actually changing how the body responds to cancer.”
Emens and other cancer vaccine researchers caution that it could be years before
clinicians routinely use this immunological approach to treat cancer. Scientists
have been experimenting with the technique for decades, and have tripped over
many obstacles. One of the most fundamental: The immune system discriminates
“self” from “nonself” at a basic level. Viral or bacterial infections are “nonself”
and perceived as a threat, but cancers come from the body’s own tissue, so the
immune system generally develops “tolerance” and recognizes cancer cells as
“self,” and does not respond.
But as scientific understanding of the complex immune system has grown, many
of those obstacles are falling away. Today, the Food and Drug Administration is
considering data from a phase 3 clinical trial of a vaccine against metastatic
prostate cancer called Provenge (sipuleucel-T). The FDA will decide whether to
approve the vaccine by May 1.
“This is such an exciting time to be in the field of cancer vaccine research,” says
James Gulley, MD, PhD, director of the clinical trials group within the Laboratory
of Tumor Immunology and Biology at the National Cancer Institute. “We’re on the
verge of having approved an entirely new approach to cancer treatment.”
View Chart: Vaccines to Treat Cancer
View Chart: Vaccines to Treat Cancer
Bringing the Body into the Fight
In 1891, New York doctor William Coley was frustrated by the deaths of patients
In 1891, New York doctor William Coley was frustrated by the deaths of patients
with metastatic bone sarcomas. He pored over the literature of the time, and
found reports that sarcomas sometimes disappeared in patients who suffered
unrelated bacterial infections.
“Coley began injecting different types of bacteria, anything into tumors, to trigger
an immune response,” Gulley says. Anecdotally, the technique worked on
occasion: “Coley’s toxins” appeared to activate patients’ immune systems against
cancer as well as bacterial invaders (the immune system sometimes
“cross-reacts” with a broader set of proteins than the triggering infection).
But when researchers began conducting carefully controlled clinical trials with
cancer vaccines, many simply didn’t work. Part of the reason may have had to do
with patient selection, Gulley says. “We started testing these therapies in patients
who failed everything else and have no other options. They’ve had every other
poison around. They have very advanced disease. So when vaccines were tried, lo
and behold, there wasn’t a lot of activity.”
Even in the past few years, a few high-profile “failures” diminished some hope for
the technique. A much-discussed vaccine against melanoma known as Canvaxin
showed no benefit, and a phase 3 trial for the vaccine Oncophage (vitespen)
delivered mixed results in kidney cancer: One specific group of patients with
stage 1 or 2 disease saw significant improvement in recurrence-free survival, but
there was no positive effect when all study participants, including later-stage
patients, were evaluated as a group.
Creel, in Austin, was one of the lucky ones. After surgery to remove the kidney
that harbored his cancer, researchers sent a piece of tumor to vaccine maker
Antigenics. There, heat shock proteins—proteins that carry around various
tumor-specific peptides—were extracted from the tumor and formed the basis of
Creel’s personalized vaccine. The theory was that Creel’s immune cells would
“meet” the injected heat shock protein complexes and learn to recognize and
target them—and activated killer T cells, a soldier-like type of white blood cell,
would also then identify and target any metastatic cancer cells still floating
around in Creel’s body.
Every two weeks for a year, Creel drove to Houston for vaccinations. He often
played tennis with old friends the night before treatment. And he drove himself
home.
“I was fortunate,” Creel says. “I saw the treatments that other people there were
going through. They were going through heavy chemo, walking around with
oxygen masks and wearing bandanas … and I had none of that. I got a red spot on
my skin. I’d go in, get my injection and run back down 10 flights of stairs, and get
in my car.” Creel is now cancer-free.
All Eyes on the FDA
Many researchers believe Provenge for prostate cancer will likely be the first
cancer treatment vaccine approved by the FDA.
Dendreon, the maker of Provenge, based its technology on powerful dendritic
cells. These immune cells normally help process molecules called antigens found
uniquely on invaders, such as bacteria or viruses. Dendritic cells present those
antigens on their own surfaces and interact with T cells, priming the T cells to
attack anything bearing those antigens.
For Provenge, the company takes a patient’s blood, finds dendritic cells, and loads
those cells with a recombinant fusion protein composed of an antigen called PAP
(prostatic acid phosphatase, found primarily on normal prostate cells) that is
fused to an immune stimulant called GM-CSF (granulocyte-macrophage
colony-stimulating factor). The antigen-loaded cells are then reinjected into a
patient, a process that is repeated three times in one month.
The immunization appears to stimulate a powerful immune response involving T
cells. Men receiving the vaccine survived, on average, nearly 26 months, compared
with 21.7 months for the placebo group, according to updated phase 3 data
reported in early March. Typical side effects of the vaccine included transient
chills, fever, and sometimes headaches during administration.
View Illustration: Taking a Shot Against Cancer
View Illustration: Taking a Short Against Cancer
Larry Kwak, MD, PhD, of M.D. Anderson Cancer Center, presented similarly
promising results for a patient-specific vaccine against follicular lymphoma
called BiovaxID at last year’s annual meeting of the American Society of Clinical
Oncology. Like Provenge, the lymphoma vaccine also included the immune
stimulant GM-CSF, but Kwak and his colleagues used tumor-specific molecules
called “idiotypes” to trigger an immune response.
The scientists treated patients whose follicular lymphoma had gone into
remission following chemotherapy, and those treated with the vaccine remained
in remission almost 14 months longer than patients on a placebo (44.2 months
versus 30.6 months).
Devil in the Details
Patrick Hwu, MD, also at M.D. Anderson Cancer Center, is taking a different
vaccine approach to treating cancer, his against metastatic melanoma. The
non-customized protein-based vaccine called gp100 had shown a relatively weak
immune response in many patients, so Hwu and his colleagues added the
powerful immune booster interleukin-2. Progression-free survival increased
from about 1.6 months in control patients to 2.9 months in those receiving the
vaccine.
One of his patients was Audhild Stapleton, 53, of south Texas, who had received a
prior experimental vaccine at the University of Virginia in 1999. “It did work for
seven years, I believe,” Stapleton says. When her melanoma recurred in 2006, she
participated in a second trial, this one under Hwu’s care, and with the updated
vaccine/interleukin-2 combination.
“The vaccine injection itself was not a problem, but the interleukin, it was very,
“The vaccine injection itself was not a problem, but the interleukin, it was very,
very hard,” she says. “I was in intensive care for three to four days each time, my
skin dried out, I gained 40 pounds of water weight. … But I believe you need to
take a stand and fight this disease every way possible.”
Armed with a better understanding of the immune system, researchers are now
doing just that. One of the most important next steps, Hwu and Emens say, is to
understand how to best combine vaccine treatments with other therapies. Emens
and others have shown that vaccines can work in synergy with drug therapy or
radiation.
The researchers are also working closely with regulators to figure out how best
to measure outcomes of cancer vaccine trials. In theory, it should take longer to
see an effect of immune therapy, says NCI’s Gulley. “The immune system keeps
knocking off a few cells, so it’s like compounding interest. … Early on, you see
only modest improvement, but many months or years down the road, significant
benefits accrue. And in theory, this can be going on long after the vaccine
treatment.” Considering it may take longer to develop an immune response,
therapeutic vaccines may be particularly impactful against early-stage cancers,
which can sometimes recur years later.
The value of vaccine therapy continues to grow with promising data from
late-phase trials in prostate cancer, metastatic melanoma, and lymphoma. “I
wouldn’t call any of these three results home runs, but they are all base hits,”
Hwu says. “We just need to continue swinging away at the plate.”
Grüße
http://www.curetoday.com/index.cfm/fuseaction/article.PrintA…
Getting Personal
BY KATY HUMAN
Using personalized vaccines, researchers enlist the immune system to oust tumors.
In 2003, Stephen Creel, a manager at a software company in Austin, Texas,
suddenly started passing blood in his urine. He had just celebrated his 40th
birthday with friends and his wife, who was pregnant with their daughter, and he
was as fit as he’d been in years.
The diagnosis of kidney cancer—renal cell carcinoma—was “shocking,” Creel says.
His father-in-law, a cancer researcher, directed Creel to M.D. Anderson Cancer
Center in Houston, almost 170 miles away, where oncologists were testing an
experimental vaccine to treat kidney cancer.
They surgically removed patients’ tumors, sent samples away for processing, and
then re-injected cancer-specific proteins back into the patient. They were trying
to activate the patients’ own immune system cells, train them to recognize cancer
as an invader, and fight it off.
“I really liked the idea of that, getting your body to do the work, not just
chemicals,” Creel says.
Preventive vaccination, also referred to as immunization, has become a critical
part of global public health. Since the body has a much easier time developing
immunity against foreign proteins that come from viruses or bacteria, vaccines to
prevent cervical and liver cancers (associated with viral infection) are already
available. But tricking the body into fighting existing cancer has proved more
complicated because most cancer cell proteins are similar to normal proteins,
and the body is “educated” not to develop immunity against its own proteins.
Nonetheless, treatment vaccines for prostate cancer, lymphoma, melanoma, and
other cancer types are undergoing late-phase tests in people, and the results are
inspiring restrained optimism.
Stephen Creel often played tennis the night before receiving a vaccine
to treat his kidney cancer. Photo by Glenn Zamora.
“We’re training the body to reject the tumor,” says Leisha Emens, MD, PhD, a
breast cancer researcher and vaccine developer at Johns Hopkins University in
Baltimore. The immune approach is unlike new types of chemotherapy, radiation,
or hormonal therapy, Emens says. Treatment vaccines target cancer cells more
precisely, have far fewer side effects, and may be less likely to foster drug
resistance. “This works completely differently,” Emens says. “With immune-based
therapy, you’re actually changing how the body responds to cancer.”
Emens and other cancer vaccine researchers caution that it could be years before
clinicians routinely use this immunological approach to treat cancer. Scientists
have been experimenting with the technique for decades, and have tripped over
many obstacles. One of the most fundamental: The immune system discriminates
“self” from “nonself” at a basic level. Viral or bacterial infections are “nonself”
and perceived as a threat, but cancers come from the body’s own tissue, so the
immune system generally develops “tolerance” and recognizes cancer cells as
“self,” and does not respond.
But as scientific understanding of the complex immune system has grown, many
of those obstacles are falling away. Today, the Food and Drug Administration is
considering data from a phase 3 clinical trial of a vaccine against metastatic
prostate cancer called Provenge (sipuleucel-T). The FDA will decide whether to
approve the vaccine by May 1.
“This is such an exciting time to be in the field of cancer vaccine research,” says
James Gulley, MD, PhD, director of the clinical trials group within the Laboratory
of Tumor Immunology and Biology at the National Cancer Institute. “We’re on the
verge of having approved an entirely new approach to cancer treatment.”
View Chart: Vaccines to Treat Cancer
View Chart: Vaccines to Treat Cancer
Bringing the Body into the Fight
In 1891, New York doctor William Coley was frustrated by the deaths of patients
In 1891, New York doctor William Coley was frustrated by the deaths of patients
with metastatic bone sarcomas. He pored over the literature of the time, and
found reports that sarcomas sometimes disappeared in patients who suffered
unrelated bacterial infections.
“Coley began injecting different types of bacteria, anything into tumors, to trigger
an immune response,” Gulley says. Anecdotally, the technique worked on
occasion: “Coley’s toxins” appeared to activate patients’ immune systems against
cancer as well as bacterial invaders (the immune system sometimes
“cross-reacts” with a broader set of proteins than the triggering infection).
But when researchers began conducting carefully controlled clinical trials with
cancer vaccines, many simply didn’t work. Part of the reason may have had to do
with patient selection, Gulley says. “We started testing these therapies in patients
who failed everything else and have no other options. They’ve had every other
poison around. They have very advanced disease. So when vaccines were tried, lo
and behold, there wasn’t a lot of activity.”
Even in the past few years, a few high-profile “failures” diminished some hope for
the technique. A much-discussed vaccine against melanoma known as Canvaxin
showed no benefit, and a phase 3 trial for the vaccine Oncophage (vitespen)
delivered mixed results in kidney cancer: One specific group of patients with
stage 1 or 2 disease saw significant improvement in recurrence-free survival, but
there was no positive effect when all study participants, including later-stage
patients, were evaluated as a group.
Creel, in Austin, was one of the lucky ones. After surgery to remove the kidney
that harbored his cancer, researchers sent a piece of tumor to vaccine maker
Antigenics. There, heat shock proteins—proteins that carry around various
tumor-specific peptides—were extracted from the tumor and formed the basis of
Creel’s personalized vaccine. The theory was that Creel’s immune cells would
“meet” the injected heat shock protein complexes and learn to recognize and
target them—and activated killer T cells, a soldier-like type of white blood cell,
would also then identify and target any metastatic cancer cells still floating
around in Creel’s body.
Every two weeks for a year, Creel drove to Houston for vaccinations. He often
played tennis with old friends the night before treatment. And he drove himself
home.
“I was fortunate,” Creel says. “I saw the treatments that other people there were
going through. They were going through heavy chemo, walking around with
oxygen masks and wearing bandanas … and I had none of that. I got a red spot on
my skin. I’d go in, get my injection and run back down 10 flights of stairs, and get
in my car.” Creel is now cancer-free.
All Eyes on the FDA
Many researchers believe Provenge for prostate cancer will likely be the first
cancer treatment vaccine approved by the FDA.
Dendreon, the maker of Provenge, based its technology on powerful dendritic
cells. These immune cells normally help process molecules called antigens found
uniquely on invaders, such as bacteria or viruses. Dendritic cells present those
antigens on their own surfaces and interact with T cells, priming the T cells to
attack anything bearing those antigens.
For Provenge, the company takes a patient’s blood, finds dendritic cells, and loads
those cells with a recombinant fusion protein composed of an antigen called PAP
(prostatic acid phosphatase, found primarily on normal prostate cells) that is
fused to an immune stimulant called GM-CSF (granulocyte-macrophage
colony-stimulating factor). The antigen-loaded cells are then reinjected into a
patient, a process that is repeated three times in one month.
The immunization appears to stimulate a powerful immune response involving T
cells. Men receiving the vaccine survived, on average, nearly 26 months, compared
with 21.7 months for the placebo group, according to updated phase 3 data
reported in early March. Typical side effects of the vaccine included transient
chills, fever, and sometimes headaches during administration.
View Illustration: Taking a Shot Against Cancer
View Illustration: Taking a Short Against Cancer
Larry Kwak, MD, PhD, of M.D. Anderson Cancer Center, presented similarly
promising results for a patient-specific vaccine against follicular lymphoma
called BiovaxID at last year’s annual meeting of the American Society of Clinical
Oncology. Like Provenge, the lymphoma vaccine also included the immune
stimulant GM-CSF, but Kwak and his colleagues used tumor-specific molecules
called “idiotypes” to trigger an immune response.
The scientists treated patients whose follicular lymphoma had gone into
remission following chemotherapy, and those treated with the vaccine remained
in remission almost 14 months longer than patients on a placebo (44.2 months
versus 30.6 months).
Devil in the Details
Patrick Hwu, MD, also at M.D. Anderson Cancer Center, is taking a different
vaccine approach to treating cancer, his against metastatic melanoma. The
non-customized protein-based vaccine called gp100 had shown a relatively weak
immune response in many patients, so Hwu and his colleagues added the
powerful immune booster interleukin-2. Progression-free survival increased
from about 1.6 months in control patients to 2.9 months in those receiving the
vaccine.
One of his patients was Audhild Stapleton, 53, of south Texas, who had received a
prior experimental vaccine at the University of Virginia in 1999. “It did work for
seven years, I believe,” Stapleton says. When her melanoma recurred in 2006, she
participated in a second trial, this one under Hwu’s care, and with the updated
vaccine/interleukin-2 combination.
“The vaccine injection itself was not a problem, but the interleukin, it was very,
“The vaccine injection itself was not a problem, but the interleukin, it was very,
very hard,” she says. “I was in intensive care for three to four days each time, my
skin dried out, I gained 40 pounds of water weight. … But I believe you need to
take a stand and fight this disease every way possible.”
Armed with a better understanding of the immune system, researchers are now
doing just that. One of the most important next steps, Hwu and Emens say, is to
understand how to best combine vaccine treatments with other therapies. Emens
and others have shown that vaccines can work in synergy with drug therapy or
radiation.
The researchers are also working closely with regulators to figure out how best
to measure outcomes of cancer vaccine trials. In theory, it should take longer to
see an effect of immune therapy, says NCI’s Gulley. “The immune system keeps
knocking off a few cells, so it’s like compounding interest. … Early on, you see
only modest improvement, but many months or years down the road, significant
benefits accrue. And in theory, this can be going on long after the vaccine
treatment.” Considering it may take longer to develop an immune response,
therapeutic vaccines may be particularly impactful against early-stage cancers,
which can sometimes recur years later.
The value of vaccine therapy continues to grow with promising data from
late-phase trials in prostate cancer, metastatic melanoma, and lymphoma. “I
wouldn’t call any of these three results home runs, but they are all base hits,”
Hwu says. “We just need to continue swinging away at the plate.”
Grüße
Antwort auf Beitrag Nr.: 39.272.610 von Ackergaul am 04.04.10 13:54:44Joo, hochexplosives Möbel!
Der Reorg-Plan steht mutmaßlich immer noch nicht, wenn überhaupt, die Aktien können schlimmstenfalls gelöscht werden, so weit der üble Teil.
Aaaaaaber.....
Wenns mit der Reorganisation hinhaut, dann hat Accentia als ca. 80% (??)-Mutter von BIOVEST gute Aussichten, die Daten der Vakzine, siehe oben, sind, glaube ich, nicht übel.
Ich bin in beiden Papierchen drin, kann also nichts schiefgehn - oder alles -mal schau`n.
Der Reorg-Plan steht mutmaßlich immer noch nicht, wenn überhaupt, die Aktien können schlimmstenfalls gelöscht werden, so weit der üble Teil.
Aaaaaaber.....
Wenns mit der Reorganisation hinhaut, dann hat Accentia als ca. 80% (??)-Mutter von BIOVEST gute Aussichten, die Daten der Vakzine, siehe oben, sind, glaube ich, nicht übel.
Ich bin in beiden Papierchen drin, kann also nichts schiefgehn - oder alles -mal schau`n.
Antwort auf Beitrag Nr.: 39.275.821 von glaubehoffnung am 05.04.10 19:33:52Handelsvolumen gestern 4x höher als normal:
Mehr als 680T Aktien (Durschnitt: 158T) wurden zuletzt Anfang Januar gehandelt (>750T). Damals gabs eine Nachricht: Orphan Drug Status für BiovaxID, gestern war es \"nachrichtenlos\"... ABPI legt gestern gut zu: 8% hoch; BVTI 8% runter. MK von ABPI 72 Mil. $; BVTI 167 Mil. $.
Nochmals zu BiovaxID: Die Daten sind gut bis sehr gut, jedoch sind die Chancen auf eine Zulassung gering, da der Trial einfach zu klein war. Eine zusätzliche Phase III wird wohl benötigt um a) die Daten nochmals zu bestätigen und b) die Nebenwirkungen (bisher auch mit Gut zu bewerten) beurteilen zu können.
Was ich mir vorstellen kann, ist dass nachdem BVTI und ABPI mal iregndwann aus dem Chapter 11 heraus sein sollten \"BIG Pharma\" ankkommt und die Geldbörse öffnet und eine Phase III startet. Dass Problem ist nur, dass diese einige Jährchen laufen wird... Aus dem Stehgreif weiß ich leider nicht wie es sich mit Patentschutz hier verhält.
Bei ABPI hat man eine \"gesundere\" Bewertung (> 50% unter BVTI); mit Revimmune und der SinuNase Neuformulierung vielleicht noch zwei kleine Trümpfe, bekommt noch ein paar Royalities von BDSI und hat bekanntlich einen >70% Anteil an BVTI und 20% Royalities von deren Produkten. Die Tochterfirma von ABPI (Analytica) machte glaube ich sogar noch Gewinne...
Allerdings: wenn dass mit der Reorganisation alles glatt laufen sollte, werden wohl einige neue Aktien damit verbunden auf dem Markt sein!
Abwarten.
Mehr als 680T Aktien (Durschnitt: 158T) wurden zuletzt Anfang Januar gehandelt (>750T). Damals gabs eine Nachricht: Orphan Drug Status für BiovaxID, gestern war es \"nachrichtenlos\"... ABPI legt gestern gut zu: 8% hoch; BVTI 8% runter. MK von ABPI 72 Mil. $; BVTI 167 Mil. $.
Nochmals zu BiovaxID: Die Daten sind gut bis sehr gut, jedoch sind die Chancen auf eine Zulassung gering, da der Trial einfach zu klein war. Eine zusätzliche Phase III wird wohl benötigt um a) die Daten nochmals zu bestätigen und b) die Nebenwirkungen (bisher auch mit Gut zu bewerten) beurteilen zu können.
Was ich mir vorstellen kann, ist dass nachdem BVTI und ABPI mal iregndwann aus dem Chapter 11 heraus sein sollten \"BIG Pharma\" ankkommt und die Geldbörse öffnet und eine Phase III startet. Dass Problem ist nur, dass diese einige Jährchen laufen wird... Aus dem Stehgreif weiß ich leider nicht wie es sich mit Patentschutz hier verhält.
Bei ABPI hat man eine \"gesundere\" Bewertung (> 50% unter BVTI); mit Revimmune und der SinuNase Neuformulierung vielleicht noch zwei kleine Trümpfe, bekommt noch ein paar Royalities von BDSI und hat bekanntlich einen >70% Anteil an BVTI und 20% Royalities von deren Produkten. Die Tochterfirma von ABPI (Analytica) machte glaube ich sogar noch Gewinne...
Allerdings: wenn dass mit der Reorganisation alles glatt laufen sollte, werden wohl einige neue Aktien damit verbunden auf dem Markt sein!
Abwarten.
Hier gibts einen Bericht "Cancer Vaccine Therapies: Failures and Future Opportunities" von meinem Freund, dem früheren Cytogen-CEO Michael Becker. Er benennt auch BiovaxID in seiner Liste von (sagen wir) "zündenden" Ansätzen.
http://seekingalpha.com/article/197683-7-companies-in-the-ra…
Dargestellt werden die FDA-Approvals von "passive immunotherapy / cancer mAbs (monoclonal antibodies)" der letzten Jahre bevor er auf die neuen Ansätze für "active immunotherapies" eingeht.
"Active immunotherapies are therapies that contain a specific antigen or set of antigens that are designed to activate the patient’s own immune system to seek out and destroy cells that carry the same antigen. They have no direct therapeutic action, but rather rely on the patient’s immune system to recognize and destroy the intended target.
(...)
If approved by the FDA, (Dendreon's) Provenge would represent the first active immunotherapy for the treatment of cancer. However (...) Provenge could face competition in a relatively short period of time. Numerous active immunotherapies are in late-stage clinical development for prostate cancer – including a promising off-the-shelf vaccine set to begin a pivotal Phase III trial in 2010. In fact, nine product candidates are in clinical trials for the treatment of prostate cancer, representing the largest therapeutic area within the active immunotherapy market.
Beyond Provenge, there are a number of additional catalysts in 2010 that could ignite further interest in the field of cancer immunotherapy. Nearly 50 clinical programs involving active cancer immunotherapies are currently underway, including nearly a dozen that are in pivotal Phase III development with several BLAs planned in 2010.
For example,
(...)
- Bristol-Myers Squibb Company (BMY) / ipilimumab
- GlaxoSmithKline plc / MAGE-A3 ASCI immunotherapy
- Biovest International, Inc. (BVTI.PK) / BiovaxID
(...)
Lastly, following the presentation of positive Phase III trial results at ASCO 2009, Biovest International, Inc. (BVTI.PK) expects to file a BLA for BiovaxID in NHL in 2010.
"
Grüße
KJ
http://seekingalpha.com/article/197683-7-companies-in-the-ra…
Dargestellt werden die FDA-Approvals von "passive immunotherapy / cancer mAbs (monoclonal antibodies)" der letzten Jahre bevor er auf die neuen Ansätze für "active immunotherapies" eingeht.
"Active immunotherapies are therapies that contain a specific antigen or set of antigens that are designed to activate the patient’s own immune system to seek out and destroy cells that carry the same antigen. They have no direct therapeutic action, but rather rely on the patient’s immune system to recognize and destroy the intended target.
(...)
If approved by the FDA, (Dendreon's) Provenge would represent the first active immunotherapy for the treatment of cancer. However (...) Provenge could face competition in a relatively short period of time. Numerous active immunotherapies are in late-stage clinical development for prostate cancer – including a promising off-the-shelf vaccine set to begin a pivotal Phase III trial in 2010. In fact, nine product candidates are in clinical trials for the treatment of prostate cancer, representing the largest therapeutic area within the active immunotherapy market.
Beyond Provenge, there are a number of additional catalysts in 2010 that could ignite further interest in the field of cancer immunotherapy. Nearly 50 clinical programs involving active cancer immunotherapies are currently underway, including nearly a dozen that are in pivotal Phase III development with several BLAs planned in 2010.
For example,
(...)
- Bristol-Myers Squibb Company (BMY) / ipilimumab
- GlaxoSmithKline plc / MAGE-A3 ASCI immunotherapy
- Biovest International, Inc. (BVTI.PK) / BiovaxID
(...)
Lastly, following the presentation of positive Phase III trial results at ASCO 2009, Biovest International, Inc. (BVTI.PK) expects to file a BLA for BiovaxID in NHL in 2010.
"
Grüße
KJ
hallo,
ich bin neu hier und auf dies forum gestoßen auf der suche nach infos zu dieser aktie:
ACCENTIA BIOPHARMACEUTICALS IN REGISTERED SHARES DL -,01(A0EATH)
die hab ich letztes jahr an der frankfurter börse gekauft. dann wurde der handel dort (und an allen anderen deutschen börsen) leider eingestellt.
kann mir jemand sagen, ob das dasselbe papier ist wie dieses:
ABPIQ — Accentia Biopharmaceuticals, Inc.
die kennungen sind zwar nicht die selben. andererseits gibt es ja keinien grund, warum nach der einstellung des handels in brd die aktie spurlos verschwinden sollte. falls ja, wie kann ich die traden? meiner derzeitigen depotbank cortal ist das nach mehrfacher anfrage nicht möglich
ich habe bisher nur mit deutschen papieren gehandelt. dies ist mein erster internationaler ausflug.
wäre für hilfe ausgesprochen dankbar
grts tobag
ich bin neu hier und auf dies forum gestoßen auf der suche nach infos zu dieser aktie:
ACCENTIA BIOPHARMACEUTICALS IN REGISTERED SHARES DL -,01(A0EATH)
die hab ich letztes jahr an der frankfurter börse gekauft. dann wurde der handel dort (und an allen anderen deutschen börsen) leider eingestellt.
kann mir jemand sagen, ob das dasselbe papier ist wie dieses:
ABPIQ — Accentia Biopharmaceuticals, Inc.
die kennungen sind zwar nicht die selben. andererseits gibt es ja keinien grund, warum nach der einstellung des handels in brd die aktie spurlos verschwinden sollte. falls ja, wie kann ich die traden? meiner derzeitigen depotbank cortal ist das nach mehrfacher anfrage nicht möglich
ich habe bisher nur mit deutschen papieren gehandelt. dies ist mein erster internationaler ausflug.
wäre für hilfe ausgesprochen dankbar
grts tobag
Antwort auf Beitrag Nr.: 39.320.112 von tobag am 13.04.10 01:09:25Hallo tobag.
Cortal Consors muss doch hier Auskunft geben können. Was hat man Dir genn genau gesagt? Hast Du es neben der telefonischen Anfrage auch schon mal schriftlich versucht?
Cortal Consors muss doch hier Auskunft geben können. Was hat man Dir genn genau gesagt? Hast Du es neben der telefonischen Anfrage auch schon mal schriftlich versucht?
Antwort auf Beitrag Nr.: 39.320.707 von KillingJoke am 13.04.10 09:00:13Habe Cortal schon mehrfach tel. und per Fax kontaktiert. Angeblich kann ich wg. einer Arbitragesperre die Aktien nur an dem Börsenplatz verkaufen, wo ich sie auch gekauft habe. Und das ist leider Deutschland, wo sie nicht mehr gehandelt werden.
Weiß jemand, ob es evtl. eine Chance gibt, dass sie in BRD wieder gehandelt werden, wenn Accentia aus Chapter 11 rauskommt?
Weiß jemand, ob es evtl. eine Chance gibt, dass sie in BRD wieder gehandelt werden, wenn Accentia aus Chapter 11 rauskommt?
Die kommende Woche wird interessant. Am Donnerstag gibts ein Update zu BiovaxID mit folgenden Themen:
http://www.terrapinn.com/2010/wvcdc/Programme_5067.stm
CONGRESS DAY 4 – 22nd April - STREAM 2 – CANCER IMMUNOTHERAPIES: REDEFINING A MARKET
--------------------------------------------------------------------------------
...
10.45 Morning coffee
11.15 Personalised biologic therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma
* Phase III study results achieving primary endpoint of prolonging disease-free survival in patients who were vaccinated with BiovaxID®
* Further planned studies examining BiovaxID® in patients with other B-cell lymphomas
* Addressing regulatory and commercial plans and determining the most appropriate approval regulatory pathways with the FDA and EMEA
Dr Carlos Santos,Chief Scientific Officer, Biovest International
...
Der Reorg-Plan läuft weiter voran - den Stand kann ich nicht bewerten. Alleine bis zum 22. Feb 2010 habe ich die letzten Mitteilung gefunden:
http://www.freecourtdockets.com/Dockets/Accentia-Biopharmace…
Grüße
http://www.terrapinn.com/2010/wvcdc/Programme_5067.stm
CONGRESS DAY 4 – 22nd April - STREAM 2 – CANCER IMMUNOTHERAPIES: REDEFINING A MARKET
--------------------------------------------------------------------------------
...
10.45 Morning coffee
11.15 Personalised biologic therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma
* Phase III study results achieving primary endpoint of prolonging disease-free survival in patients who were vaccinated with BiovaxID®
* Further planned studies examining BiovaxID® in patients with other B-cell lymphomas
* Addressing regulatory and commercial plans and determining the most appropriate approval regulatory pathways with the FDA and EMEA
Dr Carlos Santos,Chief Scientific Officer, Biovest International
...
Der Reorg-Plan läuft weiter voran - den Stand kann ich nicht bewerten. Alleine bis zum 22. Feb 2010 habe ich die letzten Mitteilung gefunden:
http://www.freecourtdockets.com/Dockets/Accentia-Biopharmace…
Grüße
Topnews!
...ich sehe gerade... es gibt News zur Restrukturierung von Biovest.
Biovest Announces Settlement with Largest Creditor (Laurus Master Fund, Ltd.)
http://studio-5.financialcontent.com/ir/?Module=MediaViewer&…
Mit dieser Einigung erhält Biovest, laut Biovest President Mr. Samuel S. Duffey, "die wesentliche geschäftlichen Vereinbarung, die erfolderlich ist, um den Weg für die Vermarktung und Lizenzierungs-Potenzial BiovaxID zu ebnen."
So mal das Kleingedruckte lesen...
...ich sehe gerade... es gibt News zur Restrukturierung von Biovest.
Biovest Announces Settlement with Largest Creditor (Laurus Master Fund, Ltd.)
http://studio-5.financialcontent.com/ir/?Module=MediaViewer&…
Mit dieser Einigung erhält Biovest, laut Biovest President Mr. Samuel S. Duffey, "die wesentliche geschäftlichen Vereinbarung, die erfolderlich ist, um den Weg für die Vermarktung und Lizenzierungs-Potenzial BiovaxID zu ebnen."
So mal das Kleingedruckte lesen...
Antwort auf Beitrag Nr.: 39.360.521 von KillingJoke am 19.04.10 13:04:33Ich hab nochmal ein wenig recherhiert und festgestellt, dass Freitagabend noch ein paar nicht-offizielle Informationen im Y! Board veröffentlicht wurden. Die Informationen stammen offensichtlich direkt von der Gerichtsverhandlung. Ein Aktionär fasste Sie wie folgt zusammen.
"So, on Friday we get posted court documents that seem to be legit, information during trading hours and no halt. Somebody very astutely picked it up before the press release.
so, as I understand it from the agreement there are the following points and please correct anything that I misunderstand. I am not trying to mis-represent anything.
1) shares will not be cancelled.
2) All BVTI royalties now go to BVTI (this is huge)
3) There may or may not be some dilution, perhaps as much as 37 million shares depending upon the warrant price. However, if ABPI pays off the debt there will be no new shares created by this agreement. That is not to say there won't be more dilution later.
4) ABPI increases it's ownership to 80%, that mean fewer shares available for retail."
"So, on Friday we get posted court documents that seem to be legit, information during trading hours and no halt. Somebody very astutely picked it up before the press release.
so, as I understand it from the agreement there are the following points and please correct anything that I misunderstand. I am not trying to mis-represent anything.
1) shares will not be cancelled.
2) All BVTI royalties now go to BVTI (this is huge)
3) There may or may not be some dilution, perhaps as much as 37 million shares depending upon the warrant price. However, if ABPI pays off the debt there will be no new shares created by this agreement. That is not to say there won't be more dilution later.
4) ABPI increases it's ownership to 80%, that mean fewer shares available for retail."
Antwort auf Beitrag Nr.: 39.360.806 von KillingJoke am 19.04.10 14:00:42Die durchgesickerte "nicht-offizilelle Zusammenfassung des Gerichtsentscheids" deckt sich nicht 100% mit der heute veröffentlichen Pressemeldung.
Ich vermute aber so könnte es laufen:
Accentia gibt die Royalties-Vereinbarung für BiovaxID auf und erhält sich im Gegenzug die Beteiligung an BiovaxID.
Ich vermute aber so könnte es laufen:
Accentia gibt die Royalties-Vereinbarung für BiovaxID auf und erhält sich im Gegenzug die Beteiligung an BiovaxID.
Antwort auf Beitrag Nr.: 39.360.872 von KillingJoke am 19.04.10 14:11:18schwer momentan einzuschätzen, wie sich dies auf ABPI auswirkt. Ich denke genau diese Art von Mitteilung müsste seitens BVTI zu ABPI auch noch heraus gebracht werden. Dann wird man weitersehen...
BVTI hatte um die 20 Mil $ Schulden an Laurus:
Restructure approximately $30.2 million of pre-petition indebtedness, consisting primarily of short-term obligations, into two notes aggregating to $29.1 million with the commencement of scheduled payments of principal and interest deferred until two years after Biovest emerges from Chapter 11
Reduce royalties to Laurus and other parties based on sales of Biovest’s personalized cancer vaccine, BiovaxID®, from 35.0% to 6.25%
Eliminate all royalties based on the sales of Biovest’s automated bio-manufacturing system for personalized medicines and cell-based products, AutovaxID™, including the remaining $7.5 million balance of a previously guaranteed minimum royalty payment
Cancel all warrants issued to Laurus, including approximately 23.4 million warrants to purchase Biovest common shares at an exercise price of $0.01 per share
Laurus will receive a 9.99% equity stake in Biovest, subject to resale restrictions and will support and vote for acceptance for Biovest’s Plan of Reorganization
Biovest’s President, Mr. Samuel S. Duffey, stated, “This settlement represents an extremely positive development for Biovest, and I am appreciative that Laurus, as our largest senior secured creditor, has placed such a strong vote of confidence in the Company and its management. With this settlement, we have restructured the significant business arrangements necessary to pave the way for the commercialization and licensing potential of BiovaxID. Additionally, by delaying for two years all principal and interest payments, this settlement significantly enhances our financial position and supports our goal of obtaining marketing approval for BiovaxID.”
BVTI hatte um die 20 Mil $ Schulden an Laurus:
Restructure approximately $30.2 million of pre-petition indebtedness, consisting primarily of short-term obligations, into two notes aggregating to $29.1 million with the commencement of scheduled payments of principal and interest deferred until two years after Biovest emerges from Chapter 11
Reduce royalties to Laurus and other parties based on sales of Biovest’s personalized cancer vaccine, BiovaxID®, from 35.0% to 6.25%
Eliminate all royalties based on the sales of Biovest’s automated bio-manufacturing system for personalized medicines and cell-based products, AutovaxID™, including the remaining $7.5 million balance of a previously guaranteed minimum royalty payment
Cancel all warrants issued to Laurus, including approximately 23.4 million warrants to purchase Biovest common shares at an exercise price of $0.01 per share
Laurus will receive a 9.99% equity stake in Biovest, subject to resale restrictions and will support and vote for acceptance for Biovest’s Plan of Reorganization
Biovest’s President, Mr. Samuel S. Duffey, stated, “This settlement represents an extremely positive development for Biovest, and I am appreciative that Laurus, as our largest senior secured creditor, has placed such a strong vote of confidence in the Company and its management. With this settlement, we have restructured the significant business arrangements necessary to pave the way for the commercialization and licensing potential of BiovaxID. Additionally, by delaying for two years all principal and interest payments, this settlement significantly enhances our financial position and supports our goal of obtaining marketing approval for BiovaxID.”
Antwort auf Beitrag Nr.: 39.361.008 von Ackergaul am 19.04.10 14:34:14Sehe ich auch so, Ackergaul.
Eine Mitteilung hinsichtlich ABPI fehlt.
In der Laurus Mitteilung steht, dass Biovest statt 35% Royalties nur noch 6,25% abzugeben hat. Das sind hervoragende News für Biovest, bedeutet aber auch das ABPI diese Zahlungen (evtl. ganz) verliert.
Wenn in der "fehlenden" Mitteilung noch berichtet wird, dass Accentia seine Anteile an Biovest behält (oder sogar erhöht), dann ist sichergestellt, dass Accentia weiterhin als Groß-Aktionär am Erfolg der Tocher partizipiert.
Dann könnte man als ABPI Aktionär eigentlich ganz entspannt sein, da die Marktkapitalisierungen (ABPI 70 Mio, BVTI 180 Mio USD) Luft zur Angleichung haben.
Eine Mitteilung hinsichtlich ABPI fehlt.
In der Laurus Mitteilung steht, dass Biovest statt 35% Royalties nur noch 6,25% abzugeben hat. Das sind hervoragende News für Biovest, bedeutet aber auch das ABPI diese Zahlungen (evtl. ganz) verliert.
Wenn in der "fehlenden" Mitteilung noch berichtet wird, dass Accentia seine Anteile an Biovest behält (oder sogar erhöht), dann ist sichergestellt, dass Accentia weiterhin als Groß-Aktionär am Erfolg der Tocher partizipiert.
Dann könnte man als ABPI Aktionär eigentlich ganz entspannt sein, da die Marktkapitalisierungen (ABPI 70 Mio, BVTI 180 Mio USD) Luft zur Angleichung haben.
Antwort auf Beitrag Nr.: 39.357.184 von Ackergaul am 18.04.10 12:44:33Was Ackergaul schon selbst herausgesucht hatte, wird heute nochmal in einer Pressemeldung bestätigt. Biovest präsentiert am vierten und letzten Tag der Veranstaltung.
Event: World Vaccine Congress 2010
Biovest Presentation Day/Time: Thursday, April 22nd at 11:15 a.m.
Title: “Personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma”
http://studio-5.financialcontent.com/ir/?Module=MediaViewer&…
Event: World Vaccine Congress 2010
Biovest Presentation Day/Time: Thursday, April 22nd at 11:15 a.m.
Title: “Personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma”
http://studio-5.financialcontent.com/ir/?Module=MediaViewer&…
Antwort auf Beitrag Nr.: 39.258.821 von KillingJoke am 31.03.10 22:47:56Wenn ich mir überlege, dass wir am 31.03. erst den ABPI(Q) Sprung über 1,00 USD gefeiert haben, fällt auf, wie rapide es in den letzten Tagen hoch gegangen ist.
Schlusskurs gestern war 1,60 USD (neues Jahreshoch).
Vor 5 Monaten Mitte November standen wir beim Tief 0,155 USD.
Ein Blick auf DNDN, HGSI, TRGT oder meinetwegen auch die nicht nur von mir gescholtene CTIC zeigt, welche Wahnsinnsbewertungen Biotechs mit potentiellen Blockbustern vor Zulassung erreichen können.
Bei diesem Top oder Flop Investment ist theoretisch tatsächlich noch unheimlich viel Luft nach oben. Ist aber noch ein langer Weg und ich glaube auch an die Notwendigkeit weiterer Tests vor Zulassung.
Schlusskurs gestern war 1,60 USD (neues Jahreshoch).
Vor 5 Monaten Mitte November standen wir beim Tief 0,155 USD.
Ein Blick auf DNDN, HGSI, TRGT oder meinetwegen auch die nicht nur von mir gescholtene CTIC zeigt, welche Wahnsinnsbewertungen Biotechs mit potentiellen Blockbustern vor Zulassung erreichen können.
Bei diesem Top oder Flop Investment ist theoretisch tatsächlich noch unheimlich viel Luft nach oben. Ist aber noch ein langer Weg und ich glaube auch an die Notwendigkeit weiterer Tests vor Zulassung.
Antwort auf Beitrag Nr.: 39.366.813 von KillingJoke am 20.04.10 12:54:53hmmmh, irgendwie ärgerlich. Anscheinend sind die Ergebnisse der WVC nicht für die breite Öffentlichkeit gedacht... Ich vermute, dass sich dies bei den nächsten 2 gemeldeten Veranstaltungen genauso verhält.
Schade
Schade
wenig spannend momentan...
Die BiovaxID Konferenzen sind leider nicht für die Öffentlichkeit bestimmt, so dass keine "neuen" Daten herausgegeben wurden. Zur ASCO (Anfang Juni) plant Biovest keine Präsentation, sondern will nur zugegen sein um mit potentiellen Partnern zu verhandeln und mit der Fachwelt zu kommunizieren. Abwarten was da heraus kommt!
Die Reorg-Pläne laufen weiterhin zäh, wie auch nicht anders zu vermuten war. Nachdem BVTI und Laurus sich einigen konnten werden Laurus und ABPI sich noch unterhalten müssen. Im Y! Board war schon von einem Dokument berichtet worden, in dem anscheinend Fortschritte zu vermelden waren. Hoffen wir mal, dass bald eine Pressemitteilung folgt in dem es um die Einigung geht...
Grüße
und weiterschlafen
(ich denke wird noch ein paar Wochen brauchen bis es mal wieder hoch geht, möglicherweise zur ASCO...)
Die BiovaxID Konferenzen sind leider nicht für die Öffentlichkeit bestimmt, so dass keine "neuen" Daten herausgegeben wurden. Zur ASCO (Anfang Juni) plant Biovest keine Präsentation, sondern will nur zugegen sein um mit potentiellen Partnern zu verhandeln und mit der Fachwelt zu kommunizieren. Abwarten was da heraus kommt!
Die Reorg-Pläne laufen weiterhin zäh, wie auch nicht anders zu vermuten war. Nachdem BVTI und Laurus sich einigen konnten werden Laurus und ABPI sich noch unterhalten müssen. Im Y! Board war schon von einem Dokument berichtet worden, in dem anscheinend Fortschritte zu vermelden waren. Hoffen wir mal, dass bald eine Pressemitteilung folgt in dem es um die Einigung geht...
Grüße
und weiterschlafen
(ich denke wird noch ein paar Wochen brauchen bis es mal wieder hoch geht, möglicherweise zur ASCO...)
Antwort auf Beitrag Nr.: 39.525.673 von Ackergaul am 15.05.10 10:55:09BVTI hat anscheinend den Reorg Plan schon vorgelegt!
http://biomedreports.com/articles/most-popular/40418-rxnews-…
RxNews Recap for Friday 05-14-10 PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 14 May 2010 16:43
Below is a list of the companies that made news in the healthcare sector on Friday, May 14, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.
Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the corrective actions put forth by Anika to address the issues raised in the 2008 Warning Letter received by the company, and therefore has removed any restrictions placed upon Anika as a result of that letter.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today reported on its recent developments and financial results for the first quarter, and its cash balance as of March 31, 2010.
Biovest International, Inc. (Pink Sheets: BVTI) today announced that the Company filed its proposed Plan of Reorganization with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division.
...
Grüße
http://biomedreports.com/articles/most-popular/40418-rxnews-…
RxNews Recap for Friday 05-14-10 PDF | Print | E-mail
Written by BioMedReports.com Staff
Friday, 14 May 2010 16:43
Below is a list of the companies that made news in the healthcare sector on Friday, May 14, 2010.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.
Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the corrective actions put forth by Anika to address the issues raised in the 2008 Warning Letter received by the company, and therefore has removed any restrictions placed upon Anika as a result of that letter.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today reported on its recent developments and financial results for the first quarter, and its cash balance as of March 31, 2010.
Biovest International, Inc. (Pink Sheets: BVTI) today announced that the Company filed its proposed Plan of Reorganization with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division.
...
Grüße
schreibe jetzt erst mal nichts zum Reorg Plan... Dies sehr gut gemachte Recherche hat Vorrang:
http://biopharmaceuticalnews.blogspot.com/2010/05/revisiting…
MONDAY, M A Y 1 7 , 2 0 1 0
Revisiting BiovaxID
In the wake of the FDA's approval of Provenge for Prostate Cancer
therapy, several recently published articles have downplayed the
importance of Dendreon’s contribution to immunotherapy or played up
the unlikelihood of another imminent vaccine. Among the cited
examples of failed companies and misguided therapies, some have
erroneously listed Biovest International or by innuendo questioned the
viability of their lead drug candidate BiovaxID.
BiovaxID is a novel and disruptive therapy for the treatment of Non
Hodgkin’s Lymphoma and potentially for other B-cell blood cancers.
Developed by Biovest International, a majority-owned subsidiary of
Accentia Biopharmaceuticals, this patient-specific idiotype vaccine
uses samples from the individual’s tumor to create an immune
system response capable of selectively targeting only the cancerous
B-cells.
The objections stated in the aforementioned articles were not that
BiovaxID was ineffective nor were there questions concerning the
safety of this immunotherapy. Most commonly cited as barriers to
FDA approval were the following:
1) The number of patients projected by the NCI, the designer
of the Phase III trial, necessary to fully statistically power (in
probability terms, the capability of a test to detect a
significant effect) the study was not met. In addition, the
projected p-value (statistical significance) of 0.01, also
established by the NCI, was not met.
The BiovaxID Phase III trial did not enroll all of the patients initially
sought to power a study reaching a p-value of 0.01. However,
enough patients were randomized to treatment and non-treatment
arms to be able to make a plausible decision rendering a Type I error
unlikely within the limits set by the FDA. The demonstrable effects of
the vaccine made a larger enrollment pool necessary to achieve the
low standard beta used to show the avoidance of a Type II error
moot. Had the trial been fully enrolled, there is a high probability an
alpha of 0.01 would have been achieved.
“The probability of Type II error is conventionally set at 10 percent to
20 percent. It is in the sponsor’s interest to keep this figure as low as
feasible, especially in the case of trials that are difficult or impossible
to repeat."
- http://www.bcg-usa.com/regulatory/docs/1998/ICHE9.pdf (pg. 49591
- middle column top)
Please note the phrase - "it is in the sponsor's interest" - as it's not
the FDA's interest as far as its by-law role is concerned: to protect
public health. Low enrollment numbers are not a bar to approval. The
chemotherapeutic agent Taxotere was approved based on a trial with
104 participants."
2) The trial was a modified intent to treat exercise and is
inferior for that reason.
The trial was designed and pursued as an intent-to-treat trial.
However, in the CFR and the Drug Approval Requirement, proof of
efficacy trials “often use intent-to-treat analysis” with the following
parameters: “all randomized patients; limited exclusions may be
permissible (modified intent-to-treat); defined in advance, based on
indication.”
- www.kkblaw.com/publications/DrugApprovalReq.ppt
The BiovaxID Phase III trial protocols clearly stated that patients who
did not achieve complete response(CR) to chemo therapy or who
relapsed prior to the end of the six month waiting period would not be
randomized to receive either the adjuvant+ BiovaxID nor to the
adjuvant alone arms of the study.
3) The trial used PACE, an outmoded chemotherapy, which
has been supplanted by the use of rituximab in conjunction
with chemotherapy.
One misleading point in the PACE comparison is that the trial pitted
BiovaxID against a chemo therapy. It did not. The trial was designed
to compare the effects of BiovaxID vaccine plus an adjuvant versus
the adjuvant alone in patients who had achieved a complete
remission due to the chemotherapy. An amendment to use CHOP-R
as an agent of remission after rituximab became available was
allowed by the FDA.
4) The stringent nature of the FDA, when considering the
statistics for a BLA, was alluded to as an insurmountable
barrier to approval in the case of BiovaxID.
The FDA must be vigilant in its review of substances or devices
purported to be of medical benefit but it is not unaware of the plastic
posture that vigilance must sometimes take. As noted in the linked
document below from 2003, the FDA periodically reaches out to the
scientific and medical communities for guidance in areas without
strictly delineated boundaries. One of the subjects explored in this
meeting was Health Related Quality of Life Issues - hardly an area of
interest for a dispassionate bureaucracy.
The FDA states that Accelerated Approval will not be granted unless
the new therapy has a demonstrable advantage over available
therapy.
“AA, which can only be granted when the new drug provides an
advantage over available therapy, may rely on a less-established
surrogate endpoint, a surrogate that is only reasonably likely to
predict clinical benefit.”
-
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/uc…
0832.pdf
The nature of that advantage does not have to compete directly with
the available therapy. A better quality of life, less toxicity or longer
disease free survival can all bestow an advantage on a new
candidate.
BiovaxID is presenting itself as an adjuvant. This area is
unambiguously defined in the above. “FDA has long stated that for
adjuvant treatment, disease-free survival (DFS) would be an
adequate approval endpoint in disease settings where most patients
are symptomatic or where effects on DFS are a reliable predictor of
effects on survival.”
If BiovaxID demonstrates longer DFS or complete molecular
remission in their secondary endpoints, it would have an advantage
over rituximab.
The Code of Federal Regulations as summarized in the FDA power
point presentation from 2004 below state the FDA must assess a new
applicant on relative efficacy. The FDA may not disapprove a drug on
the ground a more effective option is available.
- www.kkblaw.com/publications/DrugApprovalReq.ppt
Other refutable criticisms of Biovest International in these articles
have cited that Biovest has yet to submit a BLA with the FDA and
that the future of both Biovest and its parent Accentia
Biopharmaceuticals remains uncertain due to their ongoing Chapter
11 bankruptcy case.
While a BLA has yet to be filed, one must take into account the
chapter 11 status and the struggle of Biovest and Accentia to regain
sound fiscal footing. Emergence from bankruptcy will facilitate
completion of their regulatory filings with the FDA.
At this time, the Court has approved the company’s settlement with
its largest senior secured creditor and Biovest has filed a Plan of
Reorganization for approval. Through the terms of the Biovest plan,
they expect to emerge from Chapter 11 protection this summer fully
restructured. The plan also protects current stockholders through the
preservation of common shares. Accentia is in the process of
finalizing their Plan of Reorganization for submission in the very near
future and is expected to emerge from Chapter 11 simultaneously
with Biovest.
In these risk averse times of credit tightening, emerging from
bankruptcy while keeping faith with common shareholders is no mean
feat and speaks to the integrity and competency of the management
and pared down staff of these companies.
Revisiting BiovaxID…
When highlighted as the subject of a plenary presentation at the
ASCO 2009 convention, BiovaxID was reviewed in several online
blogs as an “interesting immunotherapy.” Although many took notice,
the financial precariousness of Biovest and Accentia forestalled any
close examination of BiovaxID.
Upon its renewed revelation as a plausible candidate for inclusion in
the war on cancer, we have seen several passing references made to
what some view as possible weaknesses in the BiovaxID data.
However, the pending extrication of the companies responsible for
the development of BiovaxID from the intricacies of Chapter 11
protection provide an opportunity to more closely examine this data
supporting the treatment and the possibilities it presents.
This article has been collaboratively authored by several
biotechnology investors.
Disclosure: These authors hold positions in Accentia
Biopharmaceuticals, Inc. and/or Biovest International, Inc.
POSTED BY DAVID KAINE AT 12:16 PM
da sind einige meiner Bedenken erwähnt, die er aus seiner Perspektive anderes rübergebracht bzw. entkräftet hat! Klasse!
Grüße
http://biopharmaceuticalnews.blogspot.com/2010/05/revisiting…
MONDAY, M A Y 1 7 , 2 0 1 0
Revisiting BiovaxID
In the wake of the FDA's approval of Provenge for Prostate Cancer
therapy, several recently published articles have downplayed the
importance of Dendreon’s contribution to immunotherapy or played up
the unlikelihood of another imminent vaccine. Among the cited
examples of failed companies and misguided therapies, some have
erroneously listed Biovest International or by innuendo questioned the
viability of their lead drug candidate BiovaxID.
BiovaxID is a novel and disruptive therapy for the treatment of Non
Hodgkin’s Lymphoma and potentially for other B-cell blood cancers.
Developed by Biovest International, a majority-owned subsidiary of
Accentia Biopharmaceuticals, this patient-specific idiotype vaccine
uses samples from the individual’s tumor to create an immune
system response capable of selectively targeting only the cancerous
B-cells.
The objections stated in the aforementioned articles were not that
BiovaxID was ineffective nor were there questions concerning the
safety of this immunotherapy. Most commonly cited as barriers to
FDA approval were the following:
1) The number of patients projected by the NCI, the designer
of the Phase III trial, necessary to fully statistically power (in
probability terms, the capability of a test to detect a
significant effect) the study was not met. In addition, the
projected p-value (statistical significance) of 0.01, also
established by the NCI, was not met.
The BiovaxID Phase III trial did not enroll all of the patients initially
sought to power a study reaching a p-value of 0.01. However,
enough patients were randomized to treatment and non-treatment
arms to be able to make a plausible decision rendering a Type I error
unlikely within the limits set by the FDA. The demonstrable effects of
the vaccine made a larger enrollment pool necessary to achieve the
low standard beta used to show the avoidance of a Type II error
moot. Had the trial been fully enrolled, there is a high probability an
alpha of 0.01 would have been achieved.
“The probability of Type II error is conventionally set at 10 percent to
20 percent. It is in the sponsor’s interest to keep this figure as low as
feasible, especially in the case of trials that are difficult or impossible
to repeat."
- http://www.bcg-usa.com/regulatory/docs/1998/ICHE9.pdf (pg. 49591
- middle column top)
Please note the phrase - "it is in the sponsor's interest" - as it's not
the FDA's interest as far as its by-law role is concerned: to protect
public health. Low enrollment numbers are not a bar to approval. The
chemotherapeutic agent Taxotere was approved based on a trial with
104 participants."
2) The trial was a modified intent to treat exercise and is
inferior for that reason.
The trial was designed and pursued as an intent-to-treat trial.
However, in the CFR and the Drug Approval Requirement, proof of
efficacy trials “often use intent-to-treat analysis” with the following
parameters: “all randomized patients; limited exclusions may be
permissible (modified intent-to-treat); defined in advance, based on
indication.”
- www.kkblaw.com/publications/DrugApprovalReq.ppt
The BiovaxID Phase III trial protocols clearly stated that patients who
did not achieve complete response(CR) to chemo therapy or who
relapsed prior to the end of the six month waiting period would not be
randomized to receive either the adjuvant+ BiovaxID nor to the
adjuvant alone arms of the study.
3) The trial used PACE, an outmoded chemotherapy, which
has been supplanted by the use of rituximab in conjunction
with chemotherapy.
One misleading point in the PACE comparison is that the trial pitted
BiovaxID against a chemo therapy. It did not. The trial was designed
to compare the effects of BiovaxID vaccine plus an adjuvant versus
the adjuvant alone in patients who had achieved a complete
remission due to the chemotherapy. An amendment to use CHOP-R
as an agent of remission after rituximab became available was
allowed by the FDA.
4) The stringent nature of the FDA, when considering the
statistics for a BLA, was alluded to as an insurmountable
barrier to approval in the case of BiovaxID.
The FDA must be vigilant in its review of substances or devices
purported to be of medical benefit but it is not unaware of the plastic
posture that vigilance must sometimes take. As noted in the linked
document below from 2003, the FDA periodically reaches out to the
scientific and medical communities for guidance in areas without
strictly delineated boundaries. One of the subjects explored in this
meeting was Health Related Quality of Life Issues - hardly an area of
interest for a dispassionate bureaucracy.
The FDA states that Accelerated Approval will not be granted unless
the new therapy has a demonstrable advantage over available
therapy.
“AA, which can only be granted when the new drug provides an
advantage over available therapy, may rely on a less-established
surrogate endpoint, a surrogate that is only reasonably likely to
predict clinical benefit.”
-
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/uc…
0832.pdf
The nature of that advantage does not have to compete directly with
the available therapy. A better quality of life, less toxicity or longer
disease free survival can all bestow an advantage on a new
candidate.
BiovaxID is presenting itself as an adjuvant. This area is
unambiguously defined in the above. “FDA has long stated that for
adjuvant treatment, disease-free survival (DFS) would be an
adequate approval endpoint in disease settings where most patients
are symptomatic or where effects on DFS are a reliable predictor of
effects on survival.”
If BiovaxID demonstrates longer DFS or complete molecular
remission in their secondary endpoints, it would have an advantage
over rituximab.
The Code of Federal Regulations as summarized in the FDA power
point presentation from 2004 below state the FDA must assess a new
applicant on relative efficacy. The FDA may not disapprove a drug on
the ground a more effective option is available.
- www.kkblaw.com/publications/DrugApprovalReq.ppt
Other refutable criticisms of Biovest International in these articles
have cited that Biovest has yet to submit a BLA with the FDA and
that the future of both Biovest and its parent Accentia
Biopharmaceuticals remains uncertain due to their ongoing Chapter
11 bankruptcy case.
While a BLA has yet to be filed, one must take into account the
chapter 11 status and the struggle of Biovest and Accentia to regain
sound fiscal footing. Emergence from bankruptcy will facilitate
completion of their regulatory filings with the FDA.
At this time, the Court has approved the company’s settlement with
its largest senior secured creditor and Biovest has filed a Plan of
Reorganization for approval. Through the terms of the Biovest plan,
they expect to emerge from Chapter 11 protection this summer fully
restructured. The plan also protects current stockholders through the
preservation of common shares. Accentia is in the process of
finalizing their Plan of Reorganization for submission in the very near
future and is expected to emerge from Chapter 11 simultaneously
with Biovest.
In these risk averse times of credit tightening, emerging from
bankruptcy while keeping faith with common shareholders is no mean
feat and speaks to the integrity and competency of the management
and pared down staff of these companies.
Revisiting BiovaxID…
When highlighted as the subject of a plenary presentation at the
ASCO 2009 convention, BiovaxID was reviewed in several online
blogs as an “interesting immunotherapy.” Although many took notice,
the financial precariousness of Biovest and Accentia forestalled any
close examination of BiovaxID.
Upon its renewed revelation as a plausible candidate for inclusion in
the war on cancer, we have seen several passing references made to
what some view as possible weaknesses in the BiovaxID data.
However, the pending extrication of the companies responsible for
the development of BiovaxID from the intricacies of Chapter 11
protection provide an opportunity to more closely examine this data
supporting the treatment and the possibilities it presents.
This article has been collaboratively authored by several
biotechnology investors.
Disclosure: These authors hold positions in Accentia
Biopharmaceuticals, Inc. and/or Biovest International, Inc.
POSTED BY DAVID KAINE AT 12:16 PM
da sind einige meiner Bedenken erwähnt, die er aus seiner Perspektive anderes rübergebracht bzw. entkräftet hat! Klasse!
Grüße
Bereits der erste AutovaxID Auftrag und dass gleich von DoD... Vielleicht kann BVTI in den nächsten Wochen schon ein Partner zur Vermarktung für AutovaxID präsentieren.
Biovest Announces U.S. Department of
Defense Contract to Further Develop
Bioreactor Technology for Vaccine Production
Press Release Source: Biovest International, Inc. On Tuesday May 18, 2010, 9:15 am EDT
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (Pink Sheets: BVTI - News)
today announced that it is under contract with the U.S. Department of Defense (“DoD”) to supply
AutovaxID™ bioreactors for the development and application of this platform technology for cell-culturebased
vaccine production. This initial contract, valued at approximately $1.5 million, is part of a DoD
initiative tasked with developing new bio-manufacturing solutions for the cost effective and rapid
production of preventative and therapeutic vaccines for the treatment of infectious diseases and
cancers.
According to Biovest’s Chief Scientific Officer, Dr. Mark Hirschel, “We are working very closely with the
Department of Defense and its leading research facility in San Diego to adapt our automated bioreactor
systems into a novel, rapid viral vaccine production methodology. Together, we are jointly conducting
virus propagation studies designed to confirm the strong potential for AutovaxID as an efficient platform
for the cell-culture based production of viral vaccines, including those targeting multiple strains of
influenza.”
Biovest’s President, Mr. Samuel S. Duffey, stated, “We are proud to be working with the DoD to expand
the capabilities of the AutovaxID which we initially developed as a commercially viable, GMP-compliant
bioreactor for the manufacture of personalized cancer vaccines. Based on the preliminary work
performed under the DoD contract, we are encouraged that the AutovaxID may emerge to play a vital
role in producing many other kinds of vaccines.”
“With the filing of the Biovest Plan of Reorganization last week, I believe that other discussions with
partnering candidates may now accelerate to result in potentially significant new opportunities for the
AutovaxID,” added Mr. Duffey.
This DoD Project is the first to evaluate the AutovaxID’s capabilities in producing anti-viral therapeutics
targeting highly infectious agents; however, the system’s multiple advantages and benefits have been
validated in the production of Biovest’s autologous anti-lymphoma vaccine (BiovaxID®), providing a
robust and dependable commercial process for the manufacture of a personalized cancer vaccine.
Biovest Announces U.S. Department of
Defense Contract to Further Develop
Bioreactor Technology for Vaccine Production
Press Release Source: Biovest International, Inc. On Tuesday May 18, 2010, 9:15 am EDT
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (Pink Sheets: BVTI - News)
today announced that it is under contract with the U.S. Department of Defense (“DoD”) to supply
AutovaxID™ bioreactors for the development and application of this platform technology for cell-culturebased
vaccine production. This initial contract, valued at approximately $1.5 million, is part of a DoD
initiative tasked with developing new bio-manufacturing solutions for the cost effective and rapid
production of preventative and therapeutic vaccines for the treatment of infectious diseases and
cancers.
According to Biovest’s Chief Scientific Officer, Dr. Mark Hirschel, “We are working very closely with the
Department of Defense and its leading research facility in San Diego to adapt our automated bioreactor
systems into a novel, rapid viral vaccine production methodology. Together, we are jointly conducting
virus propagation studies designed to confirm the strong potential for AutovaxID as an efficient platform
for the cell-culture based production of viral vaccines, including those targeting multiple strains of
influenza.”
Biovest’s President, Mr. Samuel S. Duffey, stated, “We are proud to be working with the DoD to expand
the capabilities of the AutovaxID which we initially developed as a commercially viable, GMP-compliant
bioreactor for the manufacture of personalized cancer vaccines. Based on the preliminary work
performed under the DoD contract, we are encouraged that the AutovaxID may emerge to play a vital
role in producing many other kinds of vaccines.”
“With the filing of the Biovest Plan of Reorganization last week, I believe that other discussions with
partnering candidates may now accelerate to result in potentially significant new opportunities for the
AutovaxID,” added Mr. Duffey.
This DoD Project is the first to evaluate the AutovaxID’s capabilities in producing anti-viral therapeutics
targeting highly infectious agents; however, the system’s multiple advantages and benefits have been
validated in the production of Biovest’s autologous anti-lymphoma vaccine (BiovaxID®), providing a
robust and dependable commercial process for the manufacture of a personalized cancer vaccine.
der Reorg Plan ist draussen, das ging jetzt doch schneller als ich erwartet habe... Mal abwarten ob ABPI im Sommer wirklich schon aus Chapter 11 heraus ist.
June 01, 2010 07:00 AM Eastern Daylight Time
Accentia Files Plan of Reorganization
Restructuring Supports Plans to Advance Promising Multiple Sclerosis Therapy into Late-
Stage Clinical Trial While Preserving Common Shares
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (PINK SHEETS: ABPIQ) today
announced that the Company filed its proposed Plan of Reorganization (Plan) with the U.S. Bankruptcy
Court for the Middle District of Florida, Tampa Division. With this filing, Accentia is positioned to emerge
from Chapter 11 protection this summer as a fully restructured company. Upon Court-ordered confirmation,
the Plan is expected to support the regulatory advancement of the autoimmune disease therapy,
Revimmune™, a comprehensive system of care and drug regimen designed to “reboot” the immune
system to potentially eliminate multiple sclerosis and significantly reduce disability. Accentia is preparing to
advance a regulatory strategy in order to proceed with a planned late-stage clinical trial for Revimmune.
“We are very proud to report that the Accentia Plan of Reorganization achieves our priority goal of
preserving the interests of all stakeholders. The Plan will strengthen the Company’s financial position and
balance sheet with favorably restructured terms allowing us to service our long-term debt obligations while
importantly preserving the common shares without significantly increasing the fully diluted share count,”
stated Accentia’s President, Mr. Samuel S. Duffey. “Our foremost priority in emerging from Chapter 11 is to
devote our resources towards the advancement of Revimmune, which offers the unprecedented potential
to change the way multiple sclerosis and other autoimmune diseases are treated. Revimmune has been
shown to eliminate the peripheral immune cells, including the cells perpetuating the autoimmunity, as
opposed to current standard of care treatments that only delay disease progression.”
Through an Accentia-managed Revimmune patient registration program, a Revimmune therapy candidate
would be pre-qualified to determine eligibility to receive a comprehensive system of care which includes an
ultra-high dose, pulsed regimen of cyclophosphamide (HyCy) designed to "reboot" the patient's immune
system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout
the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of
Revimmune, the bone marrow stem cells repopulate the immune system with new cells that lack the traits
of autoimmunity, offering the potential for sustained remissions.
Accentia is also a majority stakeholder in Biovest International, Inc. (Other OTC: “BVTI”), and this
investment may represent significant value as Biovest has completed a Phase III clinical trial and plans to
seek approvals for BiovaxID®, a personalized cancer vaccine to treat certain B-cell lymphomas.
Die Frage ist bei Revimmune: wie sieht ist mit der Patent Situation aus? Und wie will man eine Phase III finanziell stemmen?
Bin da mal gespannt...
Grüße
June 01, 2010 07:00 AM Eastern Daylight Time
Accentia Files Plan of Reorganization
Restructuring Supports Plans to Advance Promising Multiple Sclerosis Therapy into Late-
Stage Clinical Trial While Preserving Common Shares
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (PINK SHEETS: ABPIQ) today
announced that the Company filed its proposed Plan of Reorganization (Plan) with the U.S. Bankruptcy
Court for the Middle District of Florida, Tampa Division. With this filing, Accentia is positioned to emerge
from Chapter 11 protection this summer as a fully restructured company. Upon Court-ordered confirmation,
the Plan is expected to support the regulatory advancement of the autoimmune disease therapy,
Revimmune™, a comprehensive system of care and drug regimen designed to “reboot” the immune
system to potentially eliminate multiple sclerosis and significantly reduce disability. Accentia is preparing to
advance a regulatory strategy in order to proceed with a planned late-stage clinical trial for Revimmune.
“We are very proud to report that the Accentia Plan of Reorganization achieves our priority goal of
preserving the interests of all stakeholders. The Plan will strengthen the Company’s financial position and
balance sheet with favorably restructured terms allowing us to service our long-term debt obligations while
importantly preserving the common shares without significantly increasing the fully diluted share count,”
stated Accentia’s President, Mr. Samuel S. Duffey. “Our foremost priority in emerging from Chapter 11 is to
devote our resources towards the advancement of Revimmune, which offers the unprecedented potential
to change the way multiple sclerosis and other autoimmune diseases are treated. Revimmune has been
shown to eliminate the peripheral immune cells, including the cells perpetuating the autoimmunity, as
opposed to current standard of care treatments that only delay disease progression.”
Through an Accentia-managed Revimmune patient registration program, a Revimmune therapy candidate
would be pre-qualified to determine eligibility to receive a comprehensive system of care which includes an
ultra-high dose, pulsed regimen of cyclophosphamide (HyCy) designed to "reboot" the patient's immune
system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout
the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of
Revimmune, the bone marrow stem cells repopulate the immune system with new cells that lack the traits
of autoimmunity, offering the potential for sustained remissions.
Accentia is also a majority stakeholder in Biovest International, Inc. (Other OTC: “BVTI”), and this
investment may represent significant value as Biovest has completed a Phase III clinical trial and plans to
seek approvals for BiovaxID®, a personalized cancer vaccine to treat certain B-cell lymphomas.
Die Frage ist bei Revimmune: wie sieht ist mit der Patent Situation aus? Und wie will man eine Phase III finanziell stemmen?
Bin da mal gespannt...
Grüße
Quo Vadis ABPI
* BVTI hat bei BiovaxID Orphan DFrug Status in der Indikation Mantle Cell Lymphoma erhalten - positiv zu werten.
* Die ">75 % Tochter" von ABPI hat Roth Capital beauftragt um über das Thema Kapitalaufstockung sich Gedanken zu machen, sprich einige neue Aktien auf den Markt zu werfen - unumgänglich
* in Sachen Chapter 11 gibt es wenig neues. Nicht falsch verstehen, es läuft nach Plan diese Kapitel hinter sich zu lassen. Ich persönlich rechne damit frühestens bei BVTI gegen Anfang des 4.Q und bei ABPI Ende des Jahres.
* zu BiovaxID gibt es keine wesentlichen News. Ohne einen Partner sehe ich BiovaxID als tot an, da ich nicht damit rechne das die FDA die erfolgreiche aber kleine Phase III als zulassungswürdig betrachtet. Also muss hier noch mehr geforscht und investiert werden, mit Geld das ABPI und BVTI nicht hat!
* AutovaxID steht auf einen anderen Blatt. Mit dem U.S. Department of Defense hat BVTI schon einen Contract geschlossen, gehe davon aus das andere noch folgen - allerdings wohl erst nach der Chapter 11 Geschichte...
* auch bei ABPI wird es wohl einige neue Aktien geben, soviel sollte man schon annehmen. An eine Verpartnerung Revimmunes ist nicht mit zu rechnen. In meinen Augen eine High-Risk Sache, jedoch sollte diese im Auge behalten werden. Die Resultate (fast Heilung zu nennen) sind natürlich gut... Allerdings ist die Sache mit dem Lizenzschutz (Patent) hier vollkommen offen.
* Am BDSI Nausea Produkt wird auch ein wenig eingenommen: Royalities!
* Nebenbei erscheinen die Zahlen stark verbessert. Aktuell gibt es ein 10-Q vom 16.8. Obwohl die Zahlen unterm Strich mehr als GRAUSAM aussehen: Derivative loss was $36.5 million for the six months ended March 31, 2010 (dies ist aber noch begründet). Gut allerdings: Umsatz 5,8 Mil; R&D 0,6 Mil; SG&A 2,8 Mil
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
When you read this section of this Quarterly Report on Form 10-Q, it is important that you also read the financial statements and
related notes included elsewhere in this Form 10-Q. This section of this Quarterly Report contains forward-looking statements
that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. We use words such
as "anticipate," "estimate," "plan," "project," "continuing," "ongoing," "expect," "believe," "intend," "may," "will," "should," "could,"
and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in
these forward-looking statements for many reasons, including the matters discussed under the caption "Item 1A. Risk Factors" in
our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and other risks and uncertainties discussed in
our other filings with the Securities and Exchange Commission.
Overview
Headquartered in Tampa, Florida, Accentia Biopharmaceuticals, Inc. (Other OTC:
"ABPIQ") is a biotechnology company that is developing Revimmune? as a comprehensive system of care for the treatment of
multiple sclerosis ("MS") and other human autoimmune diseases and, through our, majority-owned subsidiary, Biovest
International, Inc., BiovaxID? as a therapeutic cancer vaccine for treatment of follicular non-Hodgkin's lymphoma ("FL") and
mantle cell lymphoma ("MCL"). Additionally, through our, wholly-owned subsidiary, Analytica International, Inc., we conduct a
health economics research and consulting business (Analytica International, Inc.) which we market to the pharmaceutical and
biotechnology industries, using our cash flow to support our corporate administration and product development activities.
Revimmune? is being developed as a comprehensive system of care for the treatment of MS and other human autoimmune
diseases. In the treatment of MS, Revimmune seeks to restore neurological and physical functions that have been lost due to
disease progression as well as to delay further disease progression. Revimmune's primary mode of action is to eliminate mature
white blood cells (lymphocytes) that circulate throughout the body, including the white blood cells that are believed to cause the
progressive disability characteristic of autoimmune disease. At the same time, Revimmune selectively seeks to spare immature
immune stem cells in the bone marrow which can repopulate the immune system without the autoimmunity. As part of
Revimmune therapy, an immune "rebooting" process takes place as the marrow stem cells reform the immune system with new
cells lacking autoimmunity. We are currently planning a Phase 3 clinical trial of Revimmune for the treatment of MS. Additionally,
we anticipate potential future studies in other conditions with an underlying autoimmune component.
Through a collaboration with the National Cancer Institute ("NCI"), our majority-owned subsidiary, Biovest International, Inc.
(OTCQB: "BVTI") ("Biovest") has developed a patient-specific cancer vaccine, BiovaxID?, which has demonstrated statistically
significant Phase 3 clinical benefit by prolonging disease-free survival in follicular non-Hodgkin's lymphoma patients treated with
BiovaxID. Based on Phase 2 and Phase 3 clinical trial results, Biovest plans discussions with the U.S. Food and Drug
Administration (the "FDA") and international regulatory agencies regarding marketing approval.
Additionally, through our wholly-owned subsidiary, Analytica International, Inc. ("Analytica"), based in New York City, we conduct
a global research and strategy consulting business that provides professional services to the pharmaceutical and biotechnology
industries. Since 1997, Analytica has expertly directed research studies and projects, including traditional health economic
modeling projects, database studies, structured reviews, health technology assessments, reimbursement analyses, and value
dossiers.
Table of Contents
Results of Operations
Six Months Ended March 31, 2010 Compared to the Six Months Ended March 31, 2009
Consolidated Results of Operations
Net Sales. Our net sales for the six months ended March 31, 2010 were $5.8 million compared to net sales of $6.0 million for
the six months ended March 31, 2009 excluding sales from discontinued operations.
Research and Development Expenses. Our research and development costs were $0.6 million for the six months ended March
31, 2010; a decrease of $0.1 million, or 16%, over the six months ended March 31, 2009.
General and Administrative Expenses. Our general and administrative expenses were $2.8 million for the six months ended
March 31, 2010; a decrease of $1.6 million, or 37%, over the six months ended March 31, 2009. This decrease is primarily due
to a reduction in headcount associated with our Chapter 11 bankruptcy petition filed on November 10, 2008.
Derivative gain/loss. Derivative loss was $36.5 million for the six months ended March 31, 2010 as compared to a gain of $8.6
million for the six months ended March 31, 2009. This change is primarily related to the derivative instruments issued in
conjunction with our various financings, and results primarily from the increase in our common stock price during the period
ended March 31, 2010.
Interest expense. Interest expense increased to $12.1 million for the six months ended March 31, 2010 from $1.4 million for the
six months ended March 31, 2009 primarily due to the difference in the change in fair market value of the September 2006
hybrid debt instrument of $9.7 million which is classified as interest expense.
Impairment of intangible assets. The expense for the six months ended March 31, 2010 relates to the GmbH insolvency. The
expense for the same period in the prior year relates to certain acquired product right.
Non-controlling interest in losses from variable interest entities. Non-controlling interest in losses from variable interest entities for
the six months ended March 31, 2010 and March 31, 2009 was $0.2 million relating to Biovest's interest in the NMTC entities.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have funded our operations primarily through public and private placements of our capital stock, debt
financing, conversions of debt to equity, and financing transactions with our strategic partners. These transactions are described
throughout the following pages.
We have historically had significant losses from operations. On March 31, 2010, we had an accumulated deficit of approximately
$326 million and a working capital deficit of approximately $150 million including those liabilities subject to compromise through
our Chapter 11 proceedings. We filed a voluntary petition for reorganization under Chapter 11 of the United States Bankruptcy
Code (the "Bankruptcy Code") in the United States Bankruptcy Court for the Middle District of Florida (the "Bankruptcy Court")
on November 10, 2008. We will continue to operate as "debtors-in-possession" under the jurisdiction of the Bankruptcy Court
and in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court. The Company's
independent registered certified public accounting firm's report included a "going concern" uncertainty on the financial statements
for the year ended September 30, 2009, citing significant losses and working capital deficits at that date, which raised substantial
doubt about our ability to continue as a going concern. We intend to attempt to meet our cash requirements through proceeds
from our cell culture and instrument manufacturing activities from our Biovest subsidiary and income from our Analytica
subsidiary, the use of cash on hand, trade-vendor credit, and short-term borrowings. Additionally, we may seek public or private
equity investment, short or long term debt financing or strategic relationships such as investments or licensees. Our ability to
continue present operations and to continue our product development efforts are dependent upon our ability to successfully
emerge from Chapter 11 and to obtain significant external funding, which raises substantial doubt about our ability to continue as
a going concern. The need for funds is expected to grow as we continue our efforts to commercialize Revimmune?, BiovaxID?,
and AutovaxID?.
* BVTI hat bei BiovaxID Orphan DFrug Status in der Indikation Mantle Cell Lymphoma erhalten - positiv zu werten.
* Die ">75 % Tochter" von ABPI hat Roth Capital beauftragt um über das Thema Kapitalaufstockung sich Gedanken zu machen, sprich einige neue Aktien auf den Markt zu werfen - unumgänglich
* in Sachen Chapter 11 gibt es wenig neues. Nicht falsch verstehen, es läuft nach Plan diese Kapitel hinter sich zu lassen. Ich persönlich rechne damit frühestens bei BVTI gegen Anfang des 4.Q und bei ABPI Ende des Jahres.
* zu BiovaxID gibt es keine wesentlichen News. Ohne einen Partner sehe ich BiovaxID als tot an, da ich nicht damit rechne das die FDA die erfolgreiche aber kleine Phase III als zulassungswürdig betrachtet. Also muss hier noch mehr geforscht und investiert werden, mit Geld das ABPI und BVTI nicht hat!
* AutovaxID steht auf einen anderen Blatt. Mit dem U.S. Department of Defense hat BVTI schon einen Contract geschlossen, gehe davon aus das andere noch folgen - allerdings wohl erst nach der Chapter 11 Geschichte...
* auch bei ABPI wird es wohl einige neue Aktien geben, soviel sollte man schon annehmen. An eine Verpartnerung Revimmunes ist nicht mit zu rechnen. In meinen Augen eine High-Risk Sache, jedoch sollte diese im Auge behalten werden. Die Resultate (fast Heilung zu nennen) sind natürlich gut... Allerdings ist die Sache mit dem Lizenzschutz (Patent) hier vollkommen offen.
* Am BDSI Nausea Produkt wird auch ein wenig eingenommen: Royalities!
* Nebenbei erscheinen die Zahlen stark verbessert. Aktuell gibt es ein 10-Q vom 16.8. Obwohl die Zahlen unterm Strich mehr als GRAUSAM aussehen: Derivative loss was $36.5 million for the six months ended March 31, 2010 (dies ist aber noch begründet). Gut allerdings: Umsatz 5,8 Mil; R&D 0,6 Mil; SG&A 2,8 Mil
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
When you read this section of this Quarterly Report on Form 10-Q, it is important that you also read the financial statements and
related notes included elsewhere in this Form 10-Q. This section of this Quarterly Report contains forward-looking statements
that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. We use words such
as "anticipate," "estimate," "plan," "project," "continuing," "ongoing," "expect," "believe," "intend," "may," "will," "should," "could,"
and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in
these forward-looking statements for many reasons, including the matters discussed under the caption "Item 1A. Risk Factors" in
our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and other risks and uncertainties discussed in
our other filings with the Securities and Exchange Commission.
Overview
Headquartered in Tampa, Florida, Accentia Biopharmaceuticals, Inc. (Other OTC:
"ABPIQ") is a biotechnology company that is developing Revimmune? as a comprehensive system of care for the treatment of
multiple sclerosis ("MS") and other human autoimmune diseases and, through our, majority-owned subsidiary, Biovest
International, Inc., BiovaxID? as a therapeutic cancer vaccine for treatment of follicular non-Hodgkin's lymphoma ("FL") and
mantle cell lymphoma ("MCL"). Additionally, through our, wholly-owned subsidiary, Analytica International, Inc., we conduct a
health economics research and consulting business (Analytica International, Inc.) which we market to the pharmaceutical and
biotechnology industries, using our cash flow to support our corporate administration and product development activities.
Revimmune? is being developed as a comprehensive system of care for the treatment of MS and other human autoimmune
diseases. In the treatment of MS, Revimmune seeks to restore neurological and physical functions that have been lost due to
disease progression as well as to delay further disease progression. Revimmune's primary mode of action is to eliminate mature
white blood cells (lymphocytes) that circulate throughout the body, including the white blood cells that are believed to cause the
progressive disability characteristic of autoimmune disease. At the same time, Revimmune selectively seeks to spare immature
immune stem cells in the bone marrow which can repopulate the immune system without the autoimmunity. As part of
Revimmune therapy, an immune "rebooting" process takes place as the marrow stem cells reform the immune system with new
cells lacking autoimmunity. We are currently planning a Phase 3 clinical trial of Revimmune for the treatment of MS. Additionally,
we anticipate potential future studies in other conditions with an underlying autoimmune component.
Through a collaboration with the National Cancer Institute ("NCI"), our majority-owned subsidiary, Biovest International, Inc.
(OTCQB: "BVTI") ("Biovest") has developed a patient-specific cancer vaccine, BiovaxID?, which has demonstrated statistically
significant Phase 3 clinical benefit by prolonging disease-free survival in follicular non-Hodgkin's lymphoma patients treated with
BiovaxID. Based on Phase 2 and Phase 3 clinical trial results, Biovest plans discussions with the U.S. Food and Drug
Administration (the "FDA") and international regulatory agencies regarding marketing approval.
Additionally, through our wholly-owned subsidiary, Analytica International, Inc. ("Analytica"), based in New York City, we conduct
a global research and strategy consulting business that provides professional services to the pharmaceutical and biotechnology
industries. Since 1997, Analytica has expertly directed research studies and projects, including traditional health economic
modeling projects, database studies, structured reviews, health technology assessments, reimbursement analyses, and value
dossiers.
Table of Contents
Results of Operations
Six Months Ended March 31, 2010 Compared to the Six Months Ended March 31, 2009
Consolidated Results of Operations
Net Sales. Our net sales for the six months ended March 31, 2010 were $5.8 million compared to net sales of $6.0 million for
the six months ended March 31, 2009 excluding sales from discontinued operations.
Research and Development Expenses. Our research and development costs were $0.6 million for the six months ended March
31, 2010; a decrease of $0.1 million, or 16%, over the six months ended March 31, 2009.
General and Administrative Expenses. Our general and administrative expenses were $2.8 million for the six months ended
March 31, 2010; a decrease of $1.6 million, or 37%, over the six months ended March 31, 2009. This decrease is primarily due
to a reduction in headcount associated with our Chapter 11 bankruptcy petition filed on November 10, 2008.
Derivative gain/loss. Derivative loss was $36.5 million for the six months ended March 31, 2010 as compared to a gain of $8.6
million for the six months ended March 31, 2009. This change is primarily related to the derivative instruments issued in
conjunction with our various financings, and results primarily from the increase in our common stock price during the period
ended March 31, 2010.
Interest expense. Interest expense increased to $12.1 million for the six months ended March 31, 2010 from $1.4 million for the
six months ended March 31, 2009 primarily due to the difference in the change in fair market value of the September 2006
hybrid debt instrument of $9.7 million which is classified as interest expense.
Impairment of intangible assets. The expense for the six months ended March 31, 2010 relates to the GmbH insolvency. The
expense for the same period in the prior year relates to certain acquired product right.
Non-controlling interest in losses from variable interest entities. Non-controlling interest in losses from variable interest entities for
the six months ended March 31, 2010 and March 31, 2009 was $0.2 million relating to Biovest's interest in the NMTC entities.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have funded our operations primarily through public and private placements of our capital stock, debt
financing, conversions of debt to equity, and financing transactions with our strategic partners. These transactions are described
throughout the following pages.
We have historically had significant losses from operations. On March 31, 2010, we had an accumulated deficit of approximately
$326 million and a working capital deficit of approximately $150 million including those liabilities subject to compromise through
our Chapter 11 proceedings. We filed a voluntary petition for reorganization under Chapter 11 of the United States Bankruptcy
Code (the "Bankruptcy Code") in the United States Bankruptcy Court for the Middle District of Florida (the "Bankruptcy Court")
on November 10, 2008. We will continue to operate as "debtors-in-possession" under the jurisdiction of the Bankruptcy Court
and in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court. The Company's
independent registered certified public accounting firm's report included a "going concern" uncertainty on the financial statements
for the year ended September 30, 2009, citing significant losses and working capital deficits at that date, which raised substantial
doubt about our ability to continue as a going concern. We intend to attempt to meet our cash requirements through proceeds
from our cell culture and instrument manufacturing activities from our Biovest subsidiary and income from our Analytica
subsidiary, the use of cash on hand, trade-vendor credit, and short-term borrowings. Additionally, we may seek public or private
equity investment, short or long term debt financing or strategic relationships such as investments or licensees. Our ability to
continue present operations and to continue our product development efforts are dependent upon our ability to successfully
emerge from Chapter 11 and to obtain significant external funding, which raises substantial doubt about our ability to continue as
a going concern. The need for funds is expected to grow as we continue our efforts to commercialize Revimmune?, BiovaxID?,
and AutovaxID?.
gestern gab es endlich mal wieder ein bischen Bewegung im Kurs... Was letztendlich der Auslöser war, ist mir noch ein Rätsel.
Volumen war auch mal wieder höher (> 200T) und der Kurswert hat den von BVTI überschritten - ist aber ja eigentlich belanglos.
Ob es jetzt so langsam ans Eingemachte geht (Plan of Reorganization) oder möglicherweise die Pipeline ABPIs betrifft (BiovaxiD war nicht Auslöser, sonst hätte BVTI den Sprung gestern auch gemacht), bleibt wie erwähnt mir bisher ein Rätsel, dass vielleicht in den nächsten Tagen schon geklärt wird.
Grüße
Volumen war auch mal wieder höher (> 200T) und der Kurswert hat den von BVTI überschritten - ist aber ja eigentlich belanglos.
Ob es jetzt so langsam ans Eingemachte geht (Plan of Reorganization) oder möglicherweise die Pipeline ABPIs betrifft (BiovaxiD war nicht Auslöser, sonst hätte BVTI den Sprung gestern auch gemacht), bleibt wie erwähnt mir bisher ein Rätsel, dass vielleicht in den nächsten Tagen schon geklärt wird.
Grüße
http://www.genengnews.com/keywordsandtools/print/3/20815/
Analysis & insight : Oct 18 2010
What Comes After Dendreon’s Provenge?
Success of prostate cancer vaccine has ushered in a wave of autologous vaccine
development.
Patricia F. Dimond, Ph.D.
Therapeutic cancer vaccines have gained new momentum in the clinic and gotten serious attention
from previously wary investors. While development remains extremely challenging, the April approval
of prostate cancer vaccine Provenge (sipleucel-T) for metastatic prostate cancer effectively changed
the treatment paradigm for patients with hormone-refractory tumors.
Additionally, acceptance of individually prepared therapies like Provenge has increased. And as
clinical successes for one-off therapies accumulate, uncertainty about costs have also diminished as
health insurance providers including Aetna, Humana, Kaiser Permanente, some of the Blues, and
Medicare have stepped up to support them; Provenge costs $93,000 a year. In an October 13 report,
Canaccord Genuity analyst George Farmer, Ph.D., commented, “Reimbursement is happening and
appears consistent with what would be expected during launch of a premium-priced new product.”
The results of Dendreon’s IMPACT study, published in the July 29 issue of The New England Journal
of Medicine, demonstrated that among 512 patients, Provenge extended median survival by 4.1
months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5%.
Provenge is administered as a one-time treatment and has fewer side effects compared to the only
other approved drug, Taxotere (docetaxel), which in clinical trials extended lives by 2–3 months.
A Kalorama report released this year noted, “With a couple prophylactic vaccines for cervical cancer
on the market, a few select therapeutic vaccine approvals, and several therapeutic vaccines on a
promising path to commercialization, the market could see a surge of regulatory activity and an influx
of market opportunities.”
Coming Down the Pike
In late-stage autologous vaccine development is Biovest’s BiovaxID for follicular non-Hodgkin
lymphoma. The company reported preliminary Phase III results at last year’s ASCO and expects to
reveal further analysis later this year. It also plans to report on long-term follow-up studies of a
BiovaxID Phase II trial in patients with mantle cell lymphoma.
Investigators analyzed a group of 117 randomized patients who maintained a complete response to
chemotherapy for at least six months and who received active (n=76) or control (n=41) vaccine. After
a median follow-up of 4.71 years (range: 12.6–89.3 months), the median disease-free survival in the
BiovaxID arm was 44.2 months compared with 30.6 months in the control arm.
Larry Kwak, M.D., Ph.D., professor and chair of the department of lymphoma and myeloma at The
University of Texas MD Anderson Cancer Center and the vaccine’s developer, commented that
several patients from an earlier trial of the vaccine are still in remission after 12 years of follow-up.
“These patients have not needed anything else—not even rituximab, which is often given as
maintenance therapy for lymphoma.”
The BiovaxID vaccine is manufactured through a process known as rescue fusion hybridization in
which individual tumor cells obtained through biopsy are fused with an antibody-secreting cell to form
a heterohybridoma. This cell then secretes the unique idiotype, or immunoglobulin antigen
characteristic of the individual tumor, which is purified for use as the vaccine. The vaccine is
administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating
factor (GM-CSF) and keyhole limpet hemocyanin (KLH) as a carrier protein and adjuvant.
Two other companies, Favrille and Genitope, failed in their attempts to develop an autologous vaccine
for follicular lymphoma. These companies sought to shorten production time from six months to two
months by cloning the patient-specific genes that encoded the tumor-specific idiotype protein and
then expressing that protein in either mouse or insect cell lines. The cloned idiotype was then bound
to KLH and given along with GM-CSF.
Commenting on the Phase III failures of both company’s vaccines, Biovest’s CSO, Carlos Santos,
Ph.D., told GEN, “In both recombinant efforts, the variable region of an antibody was cloned, in effect
capturing only a fragment of the original tumor’s antigen. We believe that rescue hybridization yields a
higher-fidelity idiotype than cloning. The approach employs the tumor cells themselves to produce a
true, full-length idiotype rather than a fragment of the protein. We feel this profound difference in
tumor antigen manufacture translates to treatment benefit in lymphoma.”
In early clinical studies, the BioVaxID prototype vaccine required approximately six months to
manufacture, but Dr. Santos told GEN that mostly as a result of streamlined tumor collection and cell
culture technology, the company has reduced production time to three months.
Dr. Santos further noted that “the patients that are most amenable to active immunotherapy are
probably patients in complete remission who have been treated with chemotherapies. Due to the need
for the immune system to fully recover from the assault produced by chemotherapy, all vaccines
require a waiting period for the immune system to recover. Even if you could manufacture the vaccine
in 24 hours, you still have to wait three to six months before you can vaccinate a patient.”
In other autologous cancer vaccine developments, Geron’s autologous cancer vaccine candidate,
GRNVAC1, is a dendritic cell product. It has been studied in Phase I trials at Duke University and
currently is in a multicenter Phase II study of acute myelogenous leukemia patients in remission.
It is distinct from Dendreon’s Provenge as Geron transfects immature dendritic cells through
electroporation with mRNA encoding the sequences for the human telomerase catalytic subunit
(hTERT), linked to a lysosomal targeting sequence (LAMP). The transfected cells express hTERTLAMP
as protein prior to processing to peptides, which can be presented in the context of each
patient’s specific HLA.
The transfected cells are then matured in medium containing a cytokine mix. Cryopreserved aliquots
of the final mature DC preparations are ultimately supplied to the clinic for intradermal injections.
Lastly, Australian company Prima Biomed is developing an autologous dendritic cell vaccine for
ovarian cancer treatment. CVac™ incorporates the MUC-1 antigen that is overexpressed in some
cancers like epithelial ovarian carcinoma. Phase I and II studies conducted in Australia in heavily
pretreated, advanced-stage patients showed minimal toxicities and prolonged disease stabilization,
according to the company.
Prima Biomed announced in September that it is seeking a listing on NASDAQ. Managing director
Martin Rogers said that the proposed NASDAQ listing is timely, following a number of important
developments. “We have recently commenced patient recruitment for our Phase IIb trial with the FDA,
received orphan drug designation from the FDA, and are well under way with preparations for a Phase
III trial in Europe to commence in 2011.”
Changing Tides for Autologous Vaccines
Investors and potential partners have traditionally favored nonautologous cancer vaccines, which don’t
require one-off manufacturing and are likely to cost less than custom-made vaccines. These vaccines,
however, generally use an antigen or antigen-like molecule characteristic of a specific tumor type, not
a patient’s specific tumor, to provoke an antitumor response.
“If we were to rewind to two years ago I would agree that financing active immunotherapy had its
challenges due to multiple failures reported in the space,” Dr. Santos stated. “But there has been a
renaissance in this therapy based on Provenge.” After presentations at ASCO 2009, Biovest received
multiple expressions of interest from partnering candidates, he added.
As more vaccines go through clinical development, whether the most effective prove to be autologous,
nonautologous, or need to be used with other treatment modalities, patients stand to gain longer
survival times with fewer side effects than those inflicted by conventional chemotherapies.
Patricia F. Dimond, Ph.D. (drpdimond@genengnews.com), is a principal at BioInsight Consulting.
Also zum festhalten:
* Ein Daten Update wirds noch in diesem Jahr geben. Zur Phase II bei MCL wohl ebenfalls noch Daten kommen
* der Versuch der Erklärung warum GTOP und FVRL "gefloppt" waren
* und für mich am wichtigtsten (falls es stimmt): Partnerinteresse!
Gehe nicht davon aus das die FDA und EMEA BiovaxID durchwinken werden. Dafür war die Phase III (n = 117) zu klein. Hier muss eine neue Phase gestartet werden, die einige Jahre benötigt... Mit einem großen Partner wärte dies leicht möglich und mit dem Geld für die BiovaxiD Rechte (Upfront Zahlung) könnte man zur Zeit schöne Sachen anstellen...
Grüße
Analysis & insight : Oct 18 2010
What Comes After Dendreon’s Provenge?
Success of prostate cancer vaccine has ushered in a wave of autologous vaccine
development.
Patricia F. Dimond, Ph.D.
Therapeutic cancer vaccines have gained new momentum in the clinic and gotten serious attention
from previously wary investors. While development remains extremely challenging, the April approval
of prostate cancer vaccine Provenge (sipleucel-T) for metastatic prostate cancer effectively changed
the treatment paradigm for patients with hormone-refractory tumors.
Additionally, acceptance of individually prepared therapies like Provenge has increased. And as
clinical successes for one-off therapies accumulate, uncertainty about costs have also diminished as
health insurance providers including Aetna, Humana, Kaiser Permanente, some of the Blues, and
Medicare have stepped up to support them; Provenge costs $93,000 a year. In an October 13 report,
Canaccord Genuity analyst George Farmer, Ph.D., commented, “Reimbursement is happening and
appears consistent with what would be expected during launch of a premium-priced new product.”
The results of Dendreon’s IMPACT study, published in the July 29 issue of The New England Journal
of Medicine, demonstrated that among 512 patients, Provenge extended median survival by 4.1
months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5%.
Provenge is administered as a one-time treatment and has fewer side effects compared to the only
other approved drug, Taxotere (docetaxel), which in clinical trials extended lives by 2–3 months.
A Kalorama report released this year noted, “With a couple prophylactic vaccines for cervical cancer
on the market, a few select therapeutic vaccine approvals, and several therapeutic vaccines on a
promising path to commercialization, the market could see a surge of regulatory activity and an influx
of market opportunities.”
Coming Down the Pike
In late-stage autologous vaccine development is Biovest’s BiovaxID for follicular non-Hodgkin
lymphoma. The company reported preliminary Phase III results at last year’s ASCO and expects to
reveal further analysis later this year. It also plans to report on long-term follow-up studies of a
BiovaxID Phase II trial in patients with mantle cell lymphoma.
Investigators analyzed a group of 117 randomized patients who maintained a complete response to
chemotherapy for at least six months and who received active (n=76) or control (n=41) vaccine. After
a median follow-up of 4.71 years (range: 12.6–89.3 months), the median disease-free survival in the
BiovaxID arm was 44.2 months compared with 30.6 months in the control arm.
Larry Kwak, M.D., Ph.D., professor and chair of the department of lymphoma and myeloma at The
University of Texas MD Anderson Cancer Center and the vaccine’s developer, commented that
several patients from an earlier trial of the vaccine are still in remission after 12 years of follow-up.
“These patients have not needed anything else—not even rituximab, which is often given as
maintenance therapy for lymphoma.”
The BiovaxID vaccine is manufactured through a process known as rescue fusion hybridization in
which individual tumor cells obtained through biopsy are fused with an antibody-secreting cell to form
a heterohybridoma. This cell then secretes the unique idiotype, or immunoglobulin antigen
characteristic of the individual tumor, which is purified for use as the vaccine. The vaccine is
administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating
factor (GM-CSF) and keyhole limpet hemocyanin (KLH) as a carrier protein and adjuvant.
Two other companies, Favrille and Genitope, failed in their attempts to develop an autologous vaccine
for follicular lymphoma. These companies sought to shorten production time from six months to two
months by cloning the patient-specific genes that encoded the tumor-specific idiotype protein and
then expressing that protein in either mouse or insect cell lines. The cloned idiotype was then bound
to KLH and given along with GM-CSF.
Commenting on the Phase III failures of both company’s vaccines, Biovest’s CSO, Carlos Santos,
Ph.D., told GEN, “In both recombinant efforts, the variable region of an antibody was cloned, in effect
capturing only a fragment of the original tumor’s antigen. We believe that rescue hybridization yields a
higher-fidelity idiotype than cloning. The approach employs the tumor cells themselves to produce a
true, full-length idiotype rather than a fragment of the protein. We feel this profound difference in
tumor antigen manufacture translates to treatment benefit in lymphoma.”
In early clinical studies, the BioVaxID prototype vaccine required approximately six months to
manufacture, but Dr. Santos told GEN that mostly as a result of streamlined tumor collection and cell
culture technology, the company has reduced production time to three months.
Dr. Santos further noted that “the patients that are most amenable to active immunotherapy are
probably patients in complete remission who have been treated with chemotherapies. Due to the need
for the immune system to fully recover from the assault produced by chemotherapy, all vaccines
require a waiting period for the immune system to recover. Even if you could manufacture the vaccine
in 24 hours, you still have to wait three to six months before you can vaccinate a patient.”
In other autologous cancer vaccine developments, Geron’s autologous cancer vaccine candidate,
GRNVAC1, is a dendritic cell product. It has been studied in Phase I trials at Duke University and
currently is in a multicenter Phase II study of acute myelogenous leukemia patients in remission.
It is distinct from Dendreon’s Provenge as Geron transfects immature dendritic cells through
electroporation with mRNA encoding the sequences for the human telomerase catalytic subunit
(hTERT), linked to a lysosomal targeting sequence (LAMP). The transfected cells express hTERTLAMP
as protein prior to processing to peptides, which can be presented in the context of each
patient’s specific HLA.
The transfected cells are then matured in medium containing a cytokine mix. Cryopreserved aliquots
of the final mature DC preparations are ultimately supplied to the clinic for intradermal injections.
Lastly, Australian company Prima Biomed is developing an autologous dendritic cell vaccine for
ovarian cancer treatment. CVac™ incorporates the MUC-1 antigen that is overexpressed in some
cancers like epithelial ovarian carcinoma. Phase I and II studies conducted in Australia in heavily
pretreated, advanced-stage patients showed minimal toxicities and prolonged disease stabilization,
according to the company.
Prima Biomed announced in September that it is seeking a listing on NASDAQ. Managing director
Martin Rogers said that the proposed NASDAQ listing is timely, following a number of important
developments. “We have recently commenced patient recruitment for our Phase IIb trial with the FDA,
received orphan drug designation from the FDA, and are well under way with preparations for a Phase
III trial in Europe to commence in 2011.”
Changing Tides for Autologous Vaccines
Investors and potential partners have traditionally favored nonautologous cancer vaccines, which don’t
require one-off manufacturing and are likely to cost less than custom-made vaccines. These vaccines,
however, generally use an antigen or antigen-like molecule characteristic of a specific tumor type, not
a patient’s specific tumor, to provoke an antitumor response.
“If we were to rewind to two years ago I would agree that financing active immunotherapy had its
challenges due to multiple failures reported in the space,” Dr. Santos stated. “But there has been a
renaissance in this therapy based on Provenge.” After presentations at ASCO 2009, Biovest received
multiple expressions of interest from partnering candidates, he added.
As more vaccines go through clinical development, whether the most effective prove to be autologous,
nonautologous, or need to be used with other treatment modalities, patients stand to gain longer
survival times with fewer side effects than those inflicted by conventional chemotherapies.
Patricia F. Dimond, Ph.D. (drpdimond@genengnews.com), is a principal at BioInsight Consulting.
Also zum festhalten:
* Ein Daten Update wirds noch in diesem Jahr geben. Zur Phase II bei MCL wohl ebenfalls noch Daten kommen
* der Versuch der Erklärung warum GTOP und FVRL "gefloppt" waren
* und für mich am wichtigtsten (falls es stimmt): Partnerinteresse!
Gehe nicht davon aus das die FDA und EMEA BiovaxID durchwinken werden. Dafür war die Phase III (n = 117) zu klein. Hier muss eine neue Phase gestartet werden, die einige Jahre benötigt... Mit einem großen Partner wärte dies leicht möglich und mit dem Geld für die BiovaxiD Rechte (Upfront Zahlung) könnte man zur Zeit schöne Sachen anstellen...
Grüße
Antwort auf Beitrag Nr.: 40.346.491 von Ackergaul am 19.10.10 09:21:33Cool, der Restrukturierungsplan ist durch:
"Accentia Biopharmaceuticals, Inc. (OTCQB: ABPIQ) today announced that at a hearing held on October 27, 2010, the Company’s Plan of Reorganization was confirmed (i.e., approved) by the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division. Accentia is scheduled to emerge from Chapter 11 as a fully restructured company by mid-November 2010. "
Quelle und weitere Details: http://finance.yahoo.com/news/Accentia-Announces-bw-39339262…
"Accentia Biopharmaceuticals, Inc. (OTCQB: ABPIQ) today announced that at a hearing held on October 27, 2010, the Company’s Plan of Reorganization was confirmed (i.e., approved) by the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division. Accentia is scheduled to emerge from Chapter 11 as a fully restructured company by mid-November 2010. "
Quelle und weitere Details: http://finance.yahoo.com/news/Accentia-Announces-bw-39339262…
Antwort auf Beitrag Nr.: 40.408.339 von KillingJoke am 28.10.10 15:32:17mal sehen was der November bringt...
Antwort auf Beitrag Nr.: 40.408.339 von KillingJoke am 28.10.10 15:32:17hallo killing joke,
kenne dich schon länger aus dem CRXX-thread als "wohlbedachten" kopf.
kannst du mir folgende fragen beantworten bzw. punkte bestätigen:
-ist die ch.11 sache jetzt definitiv vom tisch - bis/am 10. nov. nach
2 wochen soll klarheit herrschen - reorg. plan unumstößlich durch?
-ist accentia nun mit 80% an BVTI beteiligt und die royalties aber ganz weg?
- besteht die gefahr einer weiteren dilution? hab irgendetwas von "noch" 37 mio.shares
gelesen
-kann die FDA noch "ein haar in der suppe" finden oder stehen die chancen
auf approval anfang/mitte 2011 (?) wirklich sehr gut...
ansonsten gratulation dir und ackergaul zur langjährigen "threadpflege"...wirklich
fundiert und ausdauernd...
spiele mit dem gedanken jetzt einzusteigen, wobei die aktie ja doch
für ihre "kurslaunen" bekannt ist, bzw. MK schere zu BVTI...würdest du noch warten
bis nov.10 - ich weiss keine kaufempfehlung, aber deiner meinung vertraue ich hier
kenne dich schon länger aus dem CRXX-thread als "wohlbedachten" kopf.
kannst du mir folgende fragen beantworten bzw. punkte bestätigen:
-ist die ch.11 sache jetzt definitiv vom tisch - bis/am 10. nov. nach
2 wochen soll klarheit herrschen - reorg. plan unumstößlich durch?
-ist accentia nun mit 80% an BVTI beteiligt und die royalties aber ganz weg?
- besteht die gefahr einer weiteren dilution? hab irgendetwas von "noch" 37 mio.shares
gelesen
-kann die FDA noch "ein haar in der suppe" finden oder stehen die chancen
auf approval anfang/mitte 2011 (?) wirklich sehr gut...
ansonsten gratulation dir und ackergaul zur langjährigen "threadpflege"...wirklich
fundiert und ausdauernd...
spiele mit dem gedanken jetzt einzusteigen, wobei die aktie ja doch
für ihre "kurslaunen" bekannt ist, bzw. MK schere zu BVTI...würdest du noch warten
bis nov.10 - ich weiss keine kaufempfehlung, aber deiner meinung vertraue ich hier
Antwort auf Beitrag Nr.: 40.415.289 von Gustl24 am 29.10.10 13:26:50natürlich vertraue ich ebenso ackergaul - seine meinung als "long-beobachter"
wäre mir ebenfalls sehr wichtig - danke vorab
wäre mir ebenfalls sehr wichtig - danke vorab
Antwort auf Beitrag Nr.: 40.415.314 von Gustl24 am 29.10.10 13:29:14-ist die ch.11 sache jetzt definitiv vom tisch - bis/am 10. nov. nach
2 wochen soll klarheit herrschen - reorg. plan unumstößlich durch?
sehe ich so, wobei ich seit Ende 2009 schon daran glaube...
-ist accentia nun mit 80% an BVTI beteiligt und die royalties aber ganz weg?
- besteht die gefahr einer weiteren dilution? hab irgendetwas von "noch" 37 mio.shares
gelesen
die beiden Fragen mal zusammen: ABPI hält etwa 75 % wohl zur Zeit, wobei sich der Anteil durch dilution noch verringern wird. Bei ABPI wird dies auch noch Thema werden: cash (für revimmune)
-kann die FDA noch "ein haar in der suppe" finden oder stehen die chancen
auf approval anfang/mitte 2011 (?) wirklich sehr gut...
habe dies letztens gepostet:
Gehe nicht davon aus das die FDA und EMEA BiovaxID durchwinken werden. Dafür war die Phase III (n = 117) zu klein. Hier muss eine neue Phase gestartet werden, die einige Jahre benötigt... Mit einem großen Partner wärte dies leicht möglich und mit dem Geld für die BiovaxiD Rechte (Upfront Zahlung) könnte man zur Zeit schöne Sachen anstellen...
es ist sicher möglich, dass die FDA BiovaxID zulässt, aber die Wahrscheinlichkeit ist wohl < 10 %. Könnte mir auch vorstellen, dass BVTI übernommen wird oder ABPI und BVTI zusammengehen...
Grüße
2 wochen soll klarheit herrschen - reorg. plan unumstößlich durch?
sehe ich so, wobei ich seit Ende 2009 schon daran glaube...
-ist accentia nun mit 80% an BVTI beteiligt und die royalties aber ganz weg?
- besteht die gefahr einer weiteren dilution? hab irgendetwas von "noch" 37 mio.shares
gelesen
die beiden Fragen mal zusammen: ABPI hält etwa 75 % wohl zur Zeit, wobei sich der Anteil durch dilution noch verringern wird. Bei ABPI wird dies auch noch Thema werden: cash (für revimmune)
-kann die FDA noch "ein haar in der suppe" finden oder stehen die chancen
auf approval anfang/mitte 2011 (?) wirklich sehr gut...
habe dies letztens gepostet:
Gehe nicht davon aus das die FDA und EMEA BiovaxID durchwinken werden. Dafür war die Phase III (n = 117) zu klein. Hier muss eine neue Phase gestartet werden, die einige Jahre benötigt... Mit einem großen Partner wärte dies leicht möglich und mit dem Geld für die BiovaxiD Rechte (Upfront Zahlung) könnte man zur Zeit schöne Sachen anstellen...
es ist sicher möglich, dass die FDA BiovaxID zulässt, aber die Wahrscheinlichkeit ist wohl < 10 %. Könnte mir auch vorstellen, dass BVTI übernommen wird oder ABPI und BVTI zusammengehen...
Grüße
Antwort auf Beitrag Nr.: 40.415.289 von Gustl24 am 29.10.10 13:26:50Hallo Gustl,
Danke für Dein Lob mit dem "wohlbedachten" Kopf.
Ich kenne Dich als jemanden, der oft schon im Thema/Thread ist,
wenn ich gerade erst neugierig werde.
Insofern deute ich Dein Interesse für ABPI als gutes Zeichen.
Was ABPI angeht, ist Ackergaul der Allerbeste.
200 der 274 Kommentare in diesem Thread sind vermutlich von ihm,
habe nicht nachgezählt. Ackergaul würde ich mir auch für alle anderen
Threads wünschen.
Ich teile seine Einschätzung.
Chapter 11 ist vom Tisch.
Das der Kurs allein anspringt, wenn das Q noch weg ist, dürfte
normalerweise nicht sein. Das sollte eingepreist sein.
Aber man weiß ja nie, ob es nicht doch Käufer wie Fondsmanager gibt,
die z.B. rechtlich auf die offizielle Aufhebung angewiesen sind.
Wegen den ca. 75% Beteiligung und der unterschiedlichen Aktienanzahl/MCap würde ich
beim derzeitigen Kurs ABPI ggü. BVTI bevorzugen.
Beide Werte sind wegen BiovaxID ein Hop- oder Top-Investment.
Ackergaul hat Recht, wenn er sagt, dass es keine Zulassung im ersten Versuch gibt.
Ich glaube BiovaxID funktioniert.
Es hängt an der Hoffnung der Aktionäre, zu fantastischen Kursen
Kapitalerhöhungen zu tragen oder am Einstieg eines Milestone-Partners,
die neue PIII zu finanzieren.
Falls BiovaxID irgendwann eine Zulassung erhält, haben wir einen DNDN Kursverlauf.
Wahrscheinlichkeiten mag ich nicht angeben.
Eigentlich waren ABPI und BVTI schon weg.
Aus Chapter 11 herauszukommen grenzt für mich bereits an ein Wunder.
Ob es noch ein zweitens gibt...?
Gruss
KJ
Danke für Dein Lob mit dem "wohlbedachten" Kopf.
Ich kenne Dich als jemanden, der oft schon im Thema/Thread ist,
wenn ich gerade erst neugierig werde.
Insofern deute ich Dein Interesse für ABPI als gutes Zeichen.
Was ABPI angeht, ist Ackergaul der Allerbeste.
200 der 274 Kommentare in diesem Thread sind vermutlich von ihm,
habe nicht nachgezählt. Ackergaul würde ich mir auch für alle anderen
Threads wünschen.
Ich teile seine Einschätzung.
Chapter 11 ist vom Tisch.
Das der Kurs allein anspringt, wenn das Q noch weg ist, dürfte
normalerweise nicht sein. Das sollte eingepreist sein.
Aber man weiß ja nie, ob es nicht doch Käufer wie Fondsmanager gibt,
die z.B. rechtlich auf die offizielle Aufhebung angewiesen sind.
Wegen den ca. 75% Beteiligung und der unterschiedlichen Aktienanzahl/MCap würde ich
beim derzeitigen Kurs ABPI ggü. BVTI bevorzugen.
Beide Werte sind wegen BiovaxID ein Hop- oder Top-Investment.
Ackergaul hat Recht, wenn er sagt, dass es keine Zulassung im ersten Versuch gibt.
Ich glaube BiovaxID funktioniert.
Es hängt an der Hoffnung der Aktionäre, zu fantastischen Kursen
Kapitalerhöhungen zu tragen oder am Einstieg eines Milestone-Partners,
die neue PIII zu finanzieren.
Falls BiovaxID irgendwann eine Zulassung erhält, haben wir einen DNDN Kursverlauf.
Wahrscheinlichkeiten mag ich nicht angeben.
Eigentlich waren ABPI und BVTI schon weg.
Aus Chapter 11 herauszukommen grenzt für mich bereits an ein Wunder.
Ob es noch ein zweitens gibt...?
Gruss
KJ
Antwort auf Beitrag Nr.: 40.464.864 von KillingJoke am 05.11.10 17:04:18dank dir für deine antwort!
dann warten wir mal folgenden termin ab:
Form 8-K for ACCENTIA BIOPHARMACEUTICALS INC
--------------------------------------------------------------------------------
2-Nov-2010
Bankruptcy or Receivership, Regulation FD Disclosure, Financial S
Item 1.03. Bankruptcy or Receivership.
On November 10, 2008, Accentia Biopharmaceuticals, Inc. (the "Company") and its subsidiaries (collectively, the "Debtors") filed voluntary petitions for relief under Chapter 11 of the Bankruptcy Code with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). On August 16, 2010, Debtors filed their First Amended Joint Plan of Reorganization, and on October 25, 2010 Debtors filed the First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the "Plan"). On October 27, 2010, the Bankruptcy Court held a Confirmation hearing and confirmed the Plan, and on November 2, 2010 the Bankruptcy Court entered an Order Confirming Debtors' First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the "Confirmation Order"), which approved and confirmed the Plan, as modified by the Confirmation Order. In connection with the confirmation hearing all creditor classes deemed "impaired" pursuant to the Bankruptcy Code voted to support the Plan.
The Debtors anticipate that they will likely emerge from Chapter 11 protection on or about November 17, 2010 (the actual date of emergence, the "Effective Date"). Although Debtors anticipate that all conditions that the Debtors must satisfy before the Effective Date, other than the passage of time, will have been satisfied, the Debtors can make no assurances as to when, or ultimately if, the Plan will become effective. It is also possible that technical amendments could be made to the Plan.
was mir bei diesem wert in meiner jetzigen recherche auffiel ist, dass
es auch in einigen us-boards und foren, durchaus fachkundige und "niveauvolle"
long-anleger gibt - hebt sich von der oft dumpfen biotech-pusherei ab -
welche aber nach "entfernung des Q´s" gewaltig die medien auf diesen umstand
"aufmerksam" machen wollen...dies könnte verbunden mit einem passablen
newsflow durch die company doch beträchtlich interesse hervorrufen...
ich hoffe man entfernt sich bald von dem jetzigen börsensegment in usa als weiteren schritt und wird zur nasdaq wechseln - dies wäre sicherlich ein weiterer meilenstein...
an approval mag ich (vorerst ) nicht denken - dann gäb es natürlich
ein feuerwerk!!
dann warten wir mal folgenden termin ab:
Form 8-K for ACCENTIA BIOPHARMACEUTICALS INC
--------------------------------------------------------------------------------
2-Nov-2010
Bankruptcy or Receivership, Regulation FD Disclosure, Financial S
Item 1.03. Bankruptcy or Receivership.
On November 10, 2008, Accentia Biopharmaceuticals, Inc. (the "Company") and its subsidiaries (collectively, the "Debtors") filed voluntary petitions for relief under Chapter 11 of the Bankruptcy Code with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the "Bankruptcy Court"). On August 16, 2010, Debtors filed their First Amended Joint Plan of Reorganization, and on October 25, 2010 Debtors filed the First Modification to the First Amended Joint Plan of Reorganization (collectively and as amended and supplemented, the "Plan"). On October 27, 2010, the Bankruptcy Court held a Confirmation hearing and confirmed the Plan, and on November 2, 2010 the Bankruptcy Court entered an Order Confirming Debtors' First Amended Joint Plan of Reorganization Under Chapter 11 of the Bankruptcy Code (the "Confirmation Order"), which approved and confirmed the Plan, as modified by the Confirmation Order. In connection with the confirmation hearing all creditor classes deemed "impaired" pursuant to the Bankruptcy Code voted to support the Plan.
The Debtors anticipate that they will likely emerge from Chapter 11 protection on or about November 17, 2010 (the actual date of emergence, the "Effective Date"). Although Debtors anticipate that all conditions that the Debtors must satisfy before the Effective Date, other than the passage of time, will have been satisfied, the Debtors can make no assurances as to when, or ultimately if, the Plan will become effective. It is also possible that technical amendments could be made to the Plan.
was mir bei diesem wert in meiner jetzigen recherche auffiel ist, dass
es auch in einigen us-boards und foren, durchaus fachkundige und "niveauvolle"
long-anleger gibt - hebt sich von der oft dumpfen biotech-pusherei ab -
welche aber nach "entfernung des Q´s" gewaltig die medien auf diesen umstand
"aufmerksam" machen wollen...dies könnte verbunden mit einem passablen
newsflow durch die company doch beträchtlich interesse hervorrufen...
ich hoffe man entfernt sich bald von dem jetzigen börsensegment in usa als weiteren schritt und wird zur nasdaq wechseln - dies wäre sicherlich ein weiterer meilenstein...
an approval mag ich (vorerst ) nicht denken - dann gäb es natürlich
ein feuerwerk!!
Antwort auf Beitrag Nr.: 40.416.510 von Ackergaul am 29.10.10 15:54:06ebenfalls vielen dank - der zusammenschluss von ABPI und BVTI verbunden
mit einer moderaten KE drängt sich mir auch auf - was ich durchaus
als positiv bewerten würde...ich glaube im december diesen jahres wissen wir
schon deutlich mehr!!
mit einer moderaten KE drängt sich mir auch auf - was ich durchaus
als positiv bewerten würde...ich glaube im december diesen jahres wissen wir
schon deutlich mehr!!
dass ASH abstract ist schon abrufbar:
http://ash.confex.com/ash/2010/webprogram/Paper34600.html
429 Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration In Follicular Lymphoma Patients
Oral and Poster Abstracts
Oral Session: Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Immunotherapy for Indolent Lymphoma
Monday, December 6, 2010: 11:00 AM
311 EFGH (Orange County Convention Center)
Stephen J. Schuster1, Carlos F. Santos2*, Sattva S. Neelapu3, Donald A. Berry4*, Mihaela A. Popa2*, Amy M. McCord2*, Elise A. Chong1* and Larry Kwak3
1Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
2Biovest International, Inc., Tampa, FL
3Lymphoma & Myeloma, U.T. M.D. Anderson Cancer Center, Houston, TX
4Division of Quantitative Sciences, Berry Consultants, LLC/M.D. Anderson Cancer Center, College Station, TX
Background: Tumor-derived idiotype (Id) protein conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) can induce follicular lymphoma (FL)-specific immune responses that target tumor-specific antigenic determinants within the tumor cell's unique immunoglobulin (Ig) variable region (Fv). While Fv idiotypic determinants serve as specific tumor antigens, preclinical evidence suggests that the isotype of the Ig constant region (Fc) may independently influence the immunogenicity of hybridoma-derived immunoglobulins. Whereas Ids that have switched to IgG were tolerogenic, Ids of their IgM progenitors were highly immunogenic (Reitan et al. Proc Natl Acad Sci U S A, 2002). Thus, we examined the clinical impact of tumor Ig isotype on disease-free survival (DFS) within a prospective randomized double-blind placebo-controlled multicenter phase III study of patient-specific tumor heterohybridoma-derived Id vaccine in advanced stage previously untreated FL patients with a lymph node adequate for vaccine production (≥ 2cm).
Methods: Patients achieving complete response (CR) or complete response unconfirmed (CRu) after chemotherapy (PACE: prednisone, doxorubicin, cyclophosphamide, etoposide) were stratified by International Prognostic Index risk group and number of cycles of PACE and randomized 2:1 to receive tumor isotype-matched Id vaccine (Id-KLH/GM-CSF) or control (KLH/GM-CSF). The primary endpoint was DFS.
Results: 234 patients were enrolled; 177 (76%) achieved CR/CRu and were randomized. Of 177 randomized patients, 117 maintained CR/CRu ≥ 6 months per protocol requirement and then received at least one dose of vaccine, 55 relapsed before vaccination, 4 were vaccine manufacturing failures, and 1 violated protocol. Patients who received ≥ 1 vaccine dose constituted the modified intent-to-treat population for determination of efficacy. 76 patients received Id vaccine and 41 patients received the control. At a median follow-up of 56.6 months (range 12.6 - 89.3), median DFS after randomization for the Id vaccine arm was 44.2 months versus 30.6 months for the control arm (P = 0.048; HR = 0.62; 95% CI: 0.39-0.99). Among 76 patients receiving Id vaccine, 36 received IgM-Id vaccines and 40 received IgG-Id vaccines corresponding to their tumor Ig isotype. Of 41 patients receiving control, 25 had tumors with IgM isotype and 15 had tumors with IgG isotype; 1 patient had a tumor with mixed IgM/IgG isotypes. Among 36 patients with IgM tumor isotype receiving an IgM-Id vaccine, median time to relapse after randomization was 50.6 months, versus 27.1 months in the IgM tumor isotype control-treated patients (log-rank p=0.002; HR = 0.36 (p=0.003); [95% CI: 0.19-0.71]) [Figure 1]. Among 40 patients with IgG tumor isotype receiving an IgG-Id vaccine, median time to relapse after randomization was 35.1 months, versus 32.4 months in control-treated patients with IgG tumor isotype (log-rank p = 0.807; HR = 1.1 (p=0.807); [95% CI: 0.50-2.44]) [Figure 2]. It must be noted that although this trial was not powered to address such subsetting, the dramatically different results suggest that the treatment effect is different in the two groups, with a surprisingly small p-value of 0.085.
Conclusions: Our results suggest that the isotype of an Id vaccine may influence DFS in FL patients vaccinated in first complete remission. Unexpectedly, we observed that the IgM-Id vaccine significantly prolonged remission duration in comparison to the IgG-Id vaccine. Compared to other phase III Id vaccine trials that used recombinant Id vaccines with IgG constant regions for all patients, the positive outcome of our study may reflect the use of hybridomas to produce Id protein with variable and constant regions identical to patient tumor Ig. Additional studies are expected to further evaluate the effect of Id vaccine isotype on clinical outcome in FL and other B-cell malignancies. If confirmed, our findings will have profound implications on Id vaccine production strategies and clinical development.
Disclosures: Schuster: Biovest International, Inc.: Research Funding. Santos: Biovest International, Inc.: Employment. Neelapu: Biovest International, Inc.: Research Funding. Popa: Biovest International, Inc.: Employment. McCord: Biovest International, Inc.: Employment. Kwak: Biovest International, Inc.: Consultancy.
Was bedeutet dass? Aus meiner Sicht zum einen, das die möglichen peak sales durch diese subset Analyse nahezu halbiert werden, anders herum das man hier eine Gruppe (IgM-Id) gefunden hat, bei der BiovaxID DEUTLICH wirkt. Leider sind die Patientenzahlen sehr klein: IgM-Id 36 Patienten und IgG-Id 40 Patienten. Ob man daraus wirklich diese Rückschlüsse ziehen kann? Bei den IgG-Id Patienten scheint BiovaxID überhaupt keine Verbesserung zu zeigen...
Für eine neue Phase III sind dies natürlich wichtige Erkenntnisse. Diese könnten beim Trial Aufbau mit eingebracht werden. Natürlich ist es immer noch möglich, dass die FDA BiovaxID anhand der jetzigen Phase III zulässt die Wahrscheinlichkeit sehe ich aber bei unter 5%; aber bei der FDA weiß man ja nie!
Grüße
http://ash.confex.com/ash/2010/webprogram/Paper34600.html
429 Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration In Follicular Lymphoma Patients
Oral and Poster Abstracts
Oral Session: Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Immunotherapy for Indolent Lymphoma
Monday, December 6, 2010: 11:00 AM
311 EFGH (Orange County Convention Center)
Stephen J. Schuster1, Carlos F. Santos2*, Sattva S. Neelapu3, Donald A. Berry4*, Mihaela A. Popa2*, Amy M. McCord2*, Elise A. Chong1* and Larry Kwak3
1Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
2Biovest International, Inc., Tampa, FL
3Lymphoma & Myeloma, U.T. M.D. Anderson Cancer Center, Houston, TX
4Division of Quantitative Sciences, Berry Consultants, LLC/M.D. Anderson Cancer Center, College Station, TX
Background: Tumor-derived idiotype (Id) protein conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor (GM-CSF) can induce follicular lymphoma (FL)-specific immune responses that target tumor-specific antigenic determinants within the tumor cell's unique immunoglobulin (Ig) variable region (Fv). While Fv idiotypic determinants serve as specific tumor antigens, preclinical evidence suggests that the isotype of the Ig constant region (Fc) may independently influence the immunogenicity of hybridoma-derived immunoglobulins. Whereas Ids that have switched to IgG were tolerogenic, Ids of their IgM progenitors were highly immunogenic (Reitan et al. Proc Natl Acad Sci U S A, 2002). Thus, we examined the clinical impact of tumor Ig isotype on disease-free survival (DFS) within a prospective randomized double-blind placebo-controlled multicenter phase III study of patient-specific tumor heterohybridoma-derived Id vaccine in advanced stage previously untreated FL patients with a lymph node adequate for vaccine production (≥ 2cm).
Methods: Patients achieving complete response (CR) or complete response unconfirmed (CRu) after chemotherapy (PACE: prednisone, doxorubicin, cyclophosphamide, etoposide) were stratified by International Prognostic Index risk group and number of cycles of PACE and randomized 2:1 to receive tumor isotype-matched Id vaccine (Id-KLH/GM-CSF) or control (KLH/GM-CSF). The primary endpoint was DFS.
Results: 234 patients were enrolled; 177 (76%) achieved CR/CRu and were randomized. Of 177 randomized patients, 117 maintained CR/CRu ≥ 6 months per protocol requirement and then received at least one dose of vaccine, 55 relapsed before vaccination, 4 were vaccine manufacturing failures, and 1 violated protocol. Patients who received ≥ 1 vaccine dose constituted the modified intent-to-treat population for determination of efficacy. 76 patients received Id vaccine and 41 patients received the control. At a median follow-up of 56.6 months (range 12.6 - 89.3), median DFS after randomization for the Id vaccine arm was 44.2 months versus 30.6 months for the control arm (P = 0.048; HR = 0.62; 95% CI: 0.39-0.99). Among 76 patients receiving Id vaccine, 36 received IgM-Id vaccines and 40 received IgG-Id vaccines corresponding to their tumor Ig isotype. Of 41 patients receiving control, 25 had tumors with IgM isotype and 15 had tumors with IgG isotype; 1 patient had a tumor with mixed IgM/IgG isotypes. Among 36 patients with IgM tumor isotype receiving an IgM-Id vaccine, median time to relapse after randomization was 50.6 months, versus 27.1 months in the IgM tumor isotype control-treated patients (log-rank p=0.002; HR = 0.36 (p=0.003); [95% CI: 0.19-0.71]) [Figure 1]. Among 40 patients with IgG tumor isotype receiving an IgG-Id vaccine, median time to relapse after randomization was 35.1 months, versus 32.4 months in control-treated patients with IgG tumor isotype (log-rank p = 0.807; HR = 1.1 (p=0.807); [95% CI: 0.50-2.44]) [Figure 2]. It must be noted that although this trial was not powered to address such subsetting, the dramatically different results suggest that the treatment effect is different in the two groups, with a surprisingly small p-value of 0.085.
Conclusions: Our results suggest that the isotype of an Id vaccine may influence DFS in FL patients vaccinated in first complete remission. Unexpectedly, we observed that the IgM-Id vaccine significantly prolonged remission duration in comparison to the IgG-Id vaccine. Compared to other phase III Id vaccine trials that used recombinant Id vaccines with IgG constant regions for all patients, the positive outcome of our study may reflect the use of hybridomas to produce Id protein with variable and constant regions identical to patient tumor Ig. Additional studies are expected to further evaluate the effect of Id vaccine isotype on clinical outcome in FL and other B-cell malignancies. If confirmed, our findings will have profound implications on Id vaccine production strategies and clinical development.
Disclosures: Schuster: Biovest International, Inc.: Research Funding. Santos: Biovest International, Inc.: Employment. Neelapu: Biovest International, Inc.: Research Funding. Popa: Biovest International, Inc.: Employment. McCord: Biovest International, Inc.: Employment. Kwak: Biovest International, Inc.: Consultancy.
Was bedeutet dass? Aus meiner Sicht zum einen, das die möglichen peak sales durch diese subset Analyse nahezu halbiert werden, anders herum das man hier eine Gruppe (IgM-Id) gefunden hat, bei der BiovaxID DEUTLICH wirkt. Leider sind die Patientenzahlen sehr klein: IgM-Id 36 Patienten und IgG-Id 40 Patienten. Ob man daraus wirklich diese Rückschlüsse ziehen kann? Bei den IgG-Id Patienten scheint BiovaxID überhaupt keine Verbesserung zu zeigen...
Für eine neue Phase III sind dies natürlich wichtige Erkenntnisse. Diese könnten beim Trial Aufbau mit eingebracht werden. Natürlich ist es immer noch möglich, dass die FDA BiovaxID anhand der jetzigen Phase III zulässt die Wahrscheinlichkeit sehe ich aber bei unter 5%; aber bei der FDA weiß man ja nie!
Grüße
Antwort auf Beitrag Nr.: 40.516.396 von Ackergaul am 13.11.10 11:32:42sicherlich den meisten hier bekannt, aber als offizielles ereignis nochmals:
November 17, 2010 08:45 AM Eastern Time
Accentia Biopharmaceuticals Emerges from Chapter 11 Reorganization
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”) announced that, effective today, the Company and its majority-owned subsidiary, Biovest International, Inc. (OTCQB: “BVTI”), have both successfully completed their reorganizations. Pursuant to their respective Plans of Reorganization approved by the bankruptcy court, Accentia and Biovest have now formally exited Chapter 11 as fully restructured organizations. According to Samuel S. Duffey who serves as President & General Counsel for both Accentia and Biovest, “Today marks an exciting new beginning for Accentia and Biovest, as both companies have emerged as much stronger, more financially secure organizations. As such, we are preparing to report significant new milestones that we believe will reflect the enormous growth potential for our companies. Even before yearend, Accentia is striving to report its first key strategic agreement for Revimmune™, its system-of-care therapy for the treatment of autoimmune diseases. And Biovest is planning to present important new Phase III data for BiovaxID®, its personalized lymphoma vaccine, at the ASH Annual Meeting in December and also report new revenue-generating contract manufacturing agreements for biologics production to be performed at its cell culture center. These events should cap off a highly successful year and set the stage for 2011 and beyond.”
November 17, 2010 08:45 AM Eastern Time
Accentia Biopharmaceuticals Emerges from Chapter 11 Reorganization
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”) announced that, effective today, the Company and its majority-owned subsidiary, Biovest International, Inc. (OTCQB: “BVTI”), have both successfully completed their reorganizations. Pursuant to their respective Plans of Reorganization approved by the bankruptcy court, Accentia and Biovest have now formally exited Chapter 11 as fully restructured organizations. According to Samuel S. Duffey who serves as President & General Counsel for both Accentia and Biovest, “Today marks an exciting new beginning for Accentia and Biovest, as both companies have emerged as much stronger, more financially secure organizations. As such, we are preparing to report significant new milestones that we believe will reflect the enormous growth potential for our companies. Even before yearend, Accentia is striving to report its first key strategic agreement for Revimmune™, its system-of-care therapy for the treatment of autoimmune diseases. And Biovest is planning to present important new Phase III data for BiovaxID®, its personalized lymphoma vaccine, at the ASH Annual Meeting in December and also report new revenue-generating contract manufacturing agreements for biologics production to be performed at its cell culture center. These events should cap off a highly successful year and set the stage for 2011 and beyond.”
Antwort auf Beitrag Nr.: 40.539.180 von Gustl24 am 17.11.10 16:33:05jetzt wird der kurs gedrückt und dann fleissig billig eingekauft in usa -
immer das gleiche spiel der MM´s...soll mir recht sein...hab auch nochmal
5k zugekauft...jetzt kann ich warten
immer das gleiche spiel der MM´s...soll mir recht sein...hab auch nochmal
5k zugekauft...jetzt kann ich warten
Antwort auf Beitrag Nr.: 40.539.222 von Gustl24 am 17.11.10 16:36:20Hätte mich auch lieber nur über das freudige "offizielle Ereignis" unterhalten.
Doch dann fällt der Kurs von 1,28 auf 1,00 USD.
http://www.otcmarkets.com/stock/abpiq/quote
Interpretiere das auch als Manipulation.
Nicht unbedingt vom MM aber von anderer Seite.
Herrje, nie kann man sich zurücklehnen. Musste auch kaufen.
KJ
Doch dann fällt der Kurs von 1,28 auf 1,00 USD.
http://www.otcmarkets.com/stock/abpiq/quote
Interpretiere das auch als Manipulation.
Nicht unbedingt vom MM aber von anderer Seite.
Herrje, nie kann man sich zurücklehnen. Musste auch kaufen.
KJ
Antwort auf Beitrag Nr.: 40.539.510 von KillingJoke am 17.11.10 17:05:15die aktie wird heute wahrscheinlich den höchsten tagesumsatz der letzten
jahre in usa haben - festgetackert bei 1.00$ - ein schelm wer glaubt
das dies kein zufall ist...aber ich habe ein sehr gutes gefühl bei diesem
invest...das wird schon
Gustl
jahre in usa haben - festgetackert bei 1.00$ - ein schelm wer glaubt
das dies kein zufall ist...aber ich habe ein sehr gutes gefühl bei diesem
invest...das wird schon
Gustl
Antwort auf Beitrag Nr.: 40.539.898 von Gustl24 am 17.11.10 17:45:40habe jetzt erst von den News gelesen... Persönlich hatte ich mir den Tagesverlauf genau anders herum vorgestellt.
Abwarten was die nächsten tage bringen, vielleicht wollten einige "Alt-Investoren" Kasse machen oder konnten erst nach der "offiziellen Rettung" verkaufen. Wer weiß...
Grüße
Abwarten was die nächsten tage bringen, vielleicht wollten einige "Alt-Investoren" Kasse machen oder konnten erst nach der "offiziellen Rettung" verkaufen. Wer weiß...
Grüße
Antwort auf Beitrag Nr.: 40.542.199 von Ackergaul am 17.11.10 22:15:51Guten Morgen Ackergaul und Gustl,
habe mir noch ein wenig über die Gründe für den Ausverkauf gestern Gedanken gemacht.
Würde das gerne im Laufe des Tages diskutieren, auch wenn wir dem Rätsel vermutlich
nicht auf den Grund gehen werden.
Anbei die grundlegenden Fakten, denn für die Analyse wichtige Faktoren sind
neben Meldung und Kurs auch Volumen, Kursverlauf, Timing.
1)
Meldung
Die Meldung gestern war eine Gute.
Sie lautete für ABPIQ "Accentia Biopharmaceuticals Emerges from Chapter 11 Reorganization" und für BVTI "Biovest International Emerges from Chapter 11 Reorganization".
Die Meldung war knapp verfasst und enthielt auch keine neuen Informationen.
2)
Kurs
BVTI und ABPIQ waren gleichermassen vom Kursverfall betroffen.
Bei beiden Werten ging es unmittelbar nach der Eröffnung nach unten.
Handelsdaten ABPIQ
0.98 -0.30 ( -23.44%)
Previous Close 1.28
Open 1.33
Daily Range 0.93- 1.37
52wk Range 0.155- 1.84
Volume 1,155,411
Handelsdaten BVTI
1.45 -0.33 ( -18.54%)
Previous Close 1.78
Open 1.84
Daily Range 1.40- 1.84
52wk Range 0.32- 2.11
Volume 664,076
3)
Volumen
Gustl hatte es gestern schon beiläufig erwähnt:
"die aktie wird heute wahrscheinlich den höchsten tagesumsatz der letzten
jahre in usa haben"
Man vergleiche das Handelsvolumen mit dem durchschnittlichen Handelsvolumen:
ABPIQ
Volume: 1,155,411
Avg Vol (3m): 81,929
BVTI
Volume: 664,076
Avg Vol (3m): 68,423
4)
Kursverlauf
Auch war die Beobachtung richtig, dass der Kursverlauf nach dem rapiden Abfall
recht stabil blieb. Der Handel lief den Rest des Tages auf niedrigem Niveau stabil.
5)
Timing
Im Vorfeld wurde hier im Diskussionsforum wurde besprochen,
dass wir eigentlich im Falle dieser Meldung mit keiner
Kurssteigerung zu rechnen haben.
Die Information hätte bereits eingepreist sein sollen.
Da Börse nie wirklich vorhersehbar ist (wie gestern gesehen)
gingen Spekulationen im Vorfeld eher in Richtung Kurssteigerung.
Später mehr...
habe mir noch ein wenig über die Gründe für den Ausverkauf gestern Gedanken gemacht.
Würde das gerne im Laufe des Tages diskutieren, auch wenn wir dem Rätsel vermutlich
nicht auf den Grund gehen werden.
Anbei die grundlegenden Fakten, denn für die Analyse wichtige Faktoren sind
neben Meldung und Kurs auch Volumen, Kursverlauf, Timing.
1)
Meldung
Die Meldung gestern war eine Gute.
Sie lautete für ABPIQ "Accentia Biopharmaceuticals Emerges from Chapter 11 Reorganization" und für BVTI "Biovest International Emerges from Chapter 11 Reorganization".
Die Meldung war knapp verfasst und enthielt auch keine neuen Informationen.
2)
Kurs
BVTI und ABPIQ waren gleichermassen vom Kursverfall betroffen.
Bei beiden Werten ging es unmittelbar nach der Eröffnung nach unten.
Handelsdaten ABPIQ
0.98 -0.30 ( -23.44%)
Previous Close 1.28
Open 1.33
Daily Range 0.93- 1.37
52wk Range 0.155- 1.84
Volume 1,155,411
Handelsdaten BVTI
1.45 -0.33 ( -18.54%)
Previous Close 1.78
Open 1.84
Daily Range 1.40- 1.84
52wk Range 0.32- 2.11
Volume 664,076
3)
Volumen
Gustl hatte es gestern schon beiläufig erwähnt:
"die aktie wird heute wahrscheinlich den höchsten tagesumsatz der letzten
jahre in usa haben"
Man vergleiche das Handelsvolumen mit dem durchschnittlichen Handelsvolumen:
ABPIQ
Volume: 1,155,411
Avg Vol (3m): 81,929
BVTI
Volume: 664,076
Avg Vol (3m): 68,423
4)
Kursverlauf
Auch war die Beobachtung richtig, dass der Kursverlauf nach dem rapiden Abfall
recht stabil blieb. Der Handel lief den Rest des Tages auf niedrigem Niveau stabil.
5)
Timing
Im Vorfeld wurde hier im Diskussionsforum wurde besprochen,
dass wir eigentlich im Falle dieser Meldung mit keiner
Kurssteigerung zu rechnen haben.
Die Information hätte bereits eingepreist sein sollen.
Da Börse nie wirklich vorhersehbar ist (wie gestern gesehen)
gingen Spekulationen im Vorfeld eher in Richtung Kurssteigerung.
Später mehr...
Antwort auf Beitrag Nr.: 40.539.222 von Gustl24 am 17.11.10 16:36:20Spekulation Stopp-Loss-Fishing
Gustl schrieb:
"jetzt wird der kurs gedrückt und dann fleissig billig eingekauft in usa -
immer das gleiche spiel der MM´s"
In den frühen Handelsminuten hielt ich klassisches Stopp-Loss-Fishing noch für möglich.
Die Theorie (von der ich wenig halte) besagt, dass ein MM die Stoppkurse sehen kann
und diese mit Downtrades auslöst, um die unlimitierten Stopp-Orders abzufischen.
Auch andere Marktteilnehmer ausser dem MM könnten solche Aktionen versuchen.
Es gibt in der Historie einige populäre Beispiele für solche Attacken.
Da waren gestern tatsächlich mit ein wenig Verkaufsdruck ein paar größere Blöcke
(50k, 68k) zu sehen.
Allerdings hätte sich der Kurs nach eine solchen Attacke meiner Meinung nach
erholen müssen. Erst wäre ein tiefer Krater gerissen worden, dann wäre es wieder mit abnehmender Verunsicherung hochgegangen.
Für mehrere Stunden nahe der 1 Euro zu verharren bei weiter ansteigenden Volumen hat
ja nichts mehr mit Stopps zu tun.
Stopp-Loss-Fishing? Unwahrscheinlich.
Gustl schrieb:
"jetzt wird der kurs gedrückt und dann fleissig billig eingekauft in usa -
immer das gleiche spiel der MM´s"
In den frühen Handelsminuten hielt ich klassisches Stopp-Loss-Fishing noch für möglich.
Die Theorie (von der ich wenig halte) besagt, dass ein MM die Stoppkurse sehen kann
und diese mit Downtrades auslöst, um die unlimitierten Stopp-Orders abzufischen.
Auch andere Marktteilnehmer ausser dem MM könnten solche Aktionen versuchen.
Es gibt in der Historie einige populäre Beispiele für solche Attacken.
Da waren gestern tatsächlich mit ein wenig Verkaufsdruck ein paar größere Blöcke
(50k, 68k) zu sehen.
Allerdings hätte sich der Kurs nach eine solchen Attacke meiner Meinung nach
erholen müssen. Erst wäre ein tiefer Krater gerissen worden, dann wäre es wieder mit abnehmender Verunsicherung hochgegangen.
Für mehrere Stunden nahe der 1 Euro zu verharren bei weiter ansteigenden Volumen hat
ja nichts mehr mit Stopps zu tun.
Stopp-Loss-Fishing? Unwahrscheinlich.
Antwort auf Beitrag Nr.: 40.542.199 von Ackergaul am 17.11.10 22:15:51Spekulation Freigabe von Aktien nach Chapter 11 Reorganization
Ackergaul schrieb: "vielleicht wollten einige "Alt-Investoren" Kasse machen oder konnten erst nach der "offiziellen Rettung" verkaufen"
Da könnte etwas dran sein.
Diese Theorie ist zumindest konform mit Timing und Kursverlauf.
Timing: Durch die offizielle Chapter 11 Reorganization entsteht ein besonderer Zeitpunkt.
Kursverlauf: Niedriger Kurs über den Tag verteilt ohne Erholung zeugt von anhaltendem Verkaufsdruck.
Leider ist mir nicht bekannt, ob eine offizielle Chapter 11 Reorganization
entweder gesetzlich oder im konkreten Fall vertraglich solche Aufhebungen
von zuvor gesperrten Aktien ermöglicht.
Freigabe von Aktien nach Chapter 11 Reorganization? Gut möglich.
Ackergaul schrieb: "vielleicht wollten einige "Alt-Investoren" Kasse machen oder konnten erst nach der "offiziellen Rettung" verkaufen"
Da könnte etwas dran sein.
Diese Theorie ist zumindest konform mit Timing und Kursverlauf.
Timing: Durch die offizielle Chapter 11 Reorganization entsteht ein besonderer Zeitpunkt.
Kursverlauf: Niedriger Kurs über den Tag verteilt ohne Erholung zeugt von anhaltendem Verkaufsdruck.
Leider ist mir nicht bekannt, ob eine offizielle Chapter 11 Reorganization
entweder gesetzlich oder im konkreten Fall vertraglich solche Aufhebungen
von zuvor gesperrten Aktien ermöglicht.
Freigabe von Aktien nach Chapter 11 Reorganization? Gut möglich.
Antwort auf Beitrag Nr.: 40.543.104 von KillingJoke am 18.11.10 08:23:57Spekulation Ausgabe von neuen Aktien durch Chapter 11 Reorganization
Wir haben keine 100% Informationen über die vertragliche Ausgestaltung
bei den Insolvenzverhandlungen.
Satz mit Konjunktiv:
Wenn ich Gläubiger von ABPI wäre und würde im Laufe der Verhandlungen
einem Deal zustimmen, der mir (neue) Aktien des verschuldeten Unternehmens bescheren
würde, dann würde ich schnell (also beim erstmöglichen Termin) versuchen,
diese zu Geld zu machen.
Das sind immer diese etwas blöden Theorien, denn gäbe es so etwas,
dann wüsste man nicht, wann die Verkäufe aufhören.
Man würde es nur am Kurs erkennen.
Ausgabe von neuen Aktien durch Chapter 11 Reorganization? Keine Ahnung.
Glaube ich nicht, wäre vermutlich meldepflichtig.
Wir haben keine 100% Informationen über die vertragliche Ausgestaltung
bei den Insolvenzverhandlungen.
Satz mit Konjunktiv:
Wenn ich Gläubiger von ABPI wäre und würde im Laufe der Verhandlungen
einem Deal zustimmen, der mir (neue) Aktien des verschuldeten Unternehmens bescheren
würde, dann würde ich schnell (also beim erstmöglichen Termin) versuchen,
diese zu Geld zu machen.
Das sind immer diese etwas blöden Theorien, denn gäbe es so etwas,
dann wüsste man nicht, wann die Verkäufe aufhören.
Man würde es nur am Kurs erkennen.
Ausgabe von neuen Aktien durch Chapter 11 Reorganization? Keine Ahnung.
Glaube ich nicht, wäre vermutlich meldepflichtig.
Antwort auf Beitrag Nr.: 40.010.526 von Ackergaul am 19.08.10 09:48:05Spekulation Anstehende Kaptialerhöhung
Ackergaul schrieb "zu BiovaxID gibt es keine wesentlichen News. Ohne einen Partner sehe ich BiovaxID als tot an, da ich nicht damit rechne das die FDA die erfolgreiche aber kleine Phase III als zulassungswürdig betrachtet. Also muss hier noch mehr geforscht und investiert werden, mit Geld das ABPI und BVTI nicht hat!"
Klar ist, dass Geld gebraucht wird, um BiovaxID zur Marktreife zu bringen.
Eindimensional gedacht könnte einigen Marktteilnehmern vielleicht bekannt sein, dass
eine Kapitalerhöhung kommt und sie verkaufen, um später zurückzukaufen.
Diese Theorie passt aber nicht zum Timing.
Wieso bis zu dieser "Emerging" Meldung warten?
Anstehende Kaptialerhöhung?
Sehr Fraglich, ob "plötzliches" Insiderwissen über Zeitpunkt und Konditionen bestehen kann?
Ackergaul schrieb "zu BiovaxID gibt es keine wesentlichen News. Ohne einen Partner sehe ich BiovaxID als tot an, da ich nicht damit rechne das die FDA die erfolgreiche aber kleine Phase III als zulassungswürdig betrachtet. Also muss hier noch mehr geforscht und investiert werden, mit Geld das ABPI und BVTI nicht hat!"
Klar ist, dass Geld gebraucht wird, um BiovaxID zur Marktreife zu bringen.
Eindimensional gedacht könnte einigen Marktteilnehmern vielleicht bekannt sein, dass
eine Kapitalerhöhung kommt und sie verkaufen, um später zurückzukaufen.
Diese Theorie passt aber nicht zum Timing.
Wieso bis zu dieser "Emerging" Meldung warten?
Anstehende Kaptialerhöhung?
Sehr Fraglich, ob "plötzliches" Insiderwissen über Zeitpunkt und Konditionen bestehen kann?
Antwort auf Beitrag Nr.: 40.543.273 von KillingJoke am 18.11.10 08:53:32Spekulation Bedingungen einer anstehenden Kaptialerhöhung verändern
Eindimensional gedacht war "vor einer Kapitalerhöhung zu verkaufen und später zurück kaufen".
Jetzt kommt der interessante Teil: um die Ecke denken.
Man stelle sich vor, ein Investor ist bereit, eine anstehende Kapitalerhöhung
in großem Umfang zu tragen. Sagen wir, er möchte mehrere Mio USD investieren.
Dann könnte es lohnend sein, den Kurs durch Verkäufe so zu manipulieren, dass
der für die Kapitalerhöhung als Referenz wichtige Kurs abtaucht.
Wäre alles eine Frage der Kalkulation.
Man muss Aktien opfern, bevor man neue Aktien bekommt.
Ausgangsfragen:
Wo wäre der Kurs ohne Manipulation?
Wie erfolgreich ist eine Manipulation?
Mit welchen Volumina rechne ich?
Welchen Mitteleinsatz benötige ich?
Welche Strategien fahre ich, um die größtmögliche Wirkung zu erzielen?
Bedingungen einer anstehenden Kaptialerhöhung verändern?
Gern gemachter Gedankengang, weil das Grundszenario zu einen bulischen Ausgang hat.
Ist doch Wunschdenken, oder nicht?
Eindimensional gedacht war "vor einer Kapitalerhöhung zu verkaufen und später zurück kaufen".
Jetzt kommt der interessante Teil: um die Ecke denken.
Man stelle sich vor, ein Investor ist bereit, eine anstehende Kapitalerhöhung
in großem Umfang zu tragen. Sagen wir, er möchte mehrere Mio USD investieren.
Dann könnte es lohnend sein, den Kurs durch Verkäufe so zu manipulieren, dass
der für die Kapitalerhöhung als Referenz wichtige Kurs abtaucht.
Wäre alles eine Frage der Kalkulation.
Man muss Aktien opfern, bevor man neue Aktien bekommt.
Ausgangsfragen:
Wo wäre der Kurs ohne Manipulation?
Wie erfolgreich ist eine Manipulation?
Mit welchen Volumina rechne ich?
Welchen Mitteleinsatz benötige ich?
Welche Strategien fahre ich, um die größtmögliche Wirkung zu erzielen?
Bedingungen einer anstehenden Kaptialerhöhung verändern?
Gern gemachter Gedankengang, weil das Grundszenario zu einen bulischen Ausgang hat.
Ist doch Wunschdenken, oder nicht?
Antwort auf Beitrag Nr.: 40.543.412 von KillingJoke am 18.11.10 09:10:53Fakt Shortselling
Hilfestellung für die Interpretation.
Gestern gab es ein massives Shortselling.
Bei ABPIQ wurden 627K von 1155K ungedeckt verkauft (54%).
Bei BVTI waren es relativ gesehen noch mehr (67%).
Quelle:
http://regsho.finra.org/FORFshvol20101117.txt
Date|Symbol|ShortVolume|TotalVolume|Market
20101117|ABPIQ|627541|1155411|O
20101117|BVTI|411744|662076|O
http://www.otcmarkets.com/stock/ABPI/short-sales
Damit dürfte sich die Menge der bereits zuvor short-gehaltenen Aktien enorm erhöhen.
Hilfestellung für die Interpretation.
Gestern gab es ein massives Shortselling.
Bei ABPIQ wurden 627K von 1155K ungedeckt verkauft (54%).
Bei BVTI waren es relativ gesehen noch mehr (67%).
Quelle:
http://regsho.finra.org/FORFshvol20101117.txt
Date|Symbol|ShortVolume|TotalVolume|Market
20101117|ABPIQ|627541|1155411|O
20101117|BVTI|411744|662076|O
http://www.otcmarkets.com/stock/ABPI/short-sales
Damit dürfte sich die Menge der bereits zuvor short-gehaltenen Aktien enorm erhöhen.
Antwort auf Beitrag Nr.: 40.543.601 von KillingJoke am 18.11.10 09:33:56Ich nutze selbst das Mittel Short-selling.
Ich wäre nie so töricht, das bei einem Biotech Wert mit so geringer Marktkapitalisierung mit den bekannten potentiellen Katalysatoren und ohne die Möglichkeit einer Absicherung durch ein Gegengeschäft anzuwenden.
Ich wäre nie so töricht, das bei einem Biotech Wert mit so geringer Marktkapitalisierung mit den bekannten potentiellen Katalysatoren und ohne die Möglichkeit einer Absicherung durch ein Gegengeschäft anzuwenden.
Antwort auf Beitrag Nr.: 40.542.962 von KillingJoke am 18.11.10 07:56:31Kurz festgehalten das Preis und Volumen von gestern.
Kurs ABPI stabil, BVTI weiter gefallen.
Volumen kommen beide zurück, bei ABPI klarer im Rückgang, beide noch deutlich über dem Durchschnitt.
ABPI
1,00 USD (+2,04%)
Volume: 330.917
(Volume 17.Nov.: 1,155,411)
Avg Vol (3m): 86,471
BVTI
1,32 USD (-8,97%)
Volume: 388.387
(Volume 17.Nov.: 664,076)
Avg Vol (3m): 73,108
Schlussfolgerung der Momentaufnahme ist, das BVTI noch unter
höherem Verkaufsdruck steht als ABPI.
Im Y! Board wird vermehrt über die "Ausgabe von neuen Aktien durch Chapter 11 Reorganization" spekuliert, also über einen Debt-Equity swap.
Sollten Forderungen gegenüber ABPI und BVTI in Aktienbeteiligungen umgewandelt sein,
so könnten diese für den Verkaufsdruck sorgen.
Über die Ausgabe neuer Aktien wurde meines Wissens bisher nicht berichtet.
Die Volumenzunahme und die Auswirkungen auf den Kurs würden sich so erklären lassen.
Offen bleibt die Herleitung des hohen Short-Anteils.
Habe so etwas schon mal beim Combinatorx / Neuromed Merger (ZLCS) vermutet:
Die Bekanntmachung des maßgeblichen Ereignisses (hier "Chapter 11 Emerge") macht den "Dept-Equity swap" wasserdicht und ist der Auslöser, den Verkauf sofort zu tätigen. Das Gegengeschäft ergibt sich durch eine zeitlich verzögerte "effektive" Einbuchung von Aktien.
Man verkauft also die noch nicht eingebuchten Aktien, weil man weiss, dass sie in ein paar Tagen im Depot eintrudeln. Sie sind in diesem Moment Short-Seller.
Sollte die Theorie stimmen, erfolgt (hoffentlich) eine Volumenabnahme bei gleichzeitiger Kurserholung.
Gruss von
KJ
Kurs ABPI stabil, BVTI weiter gefallen.
Volumen kommen beide zurück, bei ABPI klarer im Rückgang, beide noch deutlich über dem Durchschnitt.
ABPI
1,00 USD (+2,04%)
Volume: 330.917
(Volume 17.Nov.: 1,155,411)
Avg Vol (3m): 86,471
BVTI
1,32 USD (-8,97%)
Volume: 388.387
(Volume 17.Nov.: 664,076)
Avg Vol (3m): 73,108
Schlussfolgerung der Momentaufnahme ist, das BVTI noch unter
höherem Verkaufsdruck steht als ABPI.
Im Y! Board wird vermehrt über die "Ausgabe von neuen Aktien durch Chapter 11 Reorganization" spekuliert, also über einen Debt-Equity swap.
Sollten Forderungen gegenüber ABPI und BVTI in Aktienbeteiligungen umgewandelt sein,
so könnten diese für den Verkaufsdruck sorgen.
Über die Ausgabe neuer Aktien wurde meines Wissens bisher nicht berichtet.
Die Volumenzunahme und die Auswirkungen auf den Kurs würden sich so erklären lassen.
Offen bleibt die Herleitung des hohen Short-Anteils.
Habe so etwas schon mal beim Combinatorx / Neuromed Merger (ZLCS) vermutet:
Die Bekanntmachung des maßgeblichen Ereignisses (hier "Chapter 11 Emerge") macht den "Dept-Equity swap" wasserdicht und ist der Auslöser, den Verkauf sofort zu tätigen. Das Gegengeschäft ergibt sich durch eine zeitlich verzögerte "effektive" Einbuchung von Aktien.
Man verkauft also die noch nicht eingebuchten Aktien, weil man weiss, dass sie in ein paar Tagen im Depot eintrudeln. Sie sind in diesem Moment Short-Seller.
Sollte die Theorie stimmen, erfolgt (hoffentlich) eine Volumenabnahme bei gleichzeitiger Kurserholung.
Gruss von
KJ
Antwort auf Beitrag Nr.: 40.553.868 von KillingJoke am 19.11.10 13:42:35konnte dir gestern leider durch zu "hohe arbeitsbelastung" nicht antworten...
finde deinen heutigen schluss sehr naheliegend...unterstützt wird diese
entwicklung leider durch den undurchsichtigen handel an der OTC
in der transparenz leider ein fremdwort ist...
man hat stark den eindruck seit gestern, dass ABPI und BVTI in
ihrem aktienkurs nun auf ein bestimmtes niveau gebracht werden (...sollen).
ein wechsel an einen regulierten handelsplatz würde den sicherlich
bei positivem newsflow nun einsetzenden kursanstieg "unterstützen..."
während CRXX nach dem merger(welcher ja durch die zulassung erst realisiert
wurde) ihr "pulver" vorerst verschossen hatte...sehe ich die
mittelfristige zukunft hier bei ABPI deutlich aussichtsreicher.
finde deinen heutigen schluss sehr naheliegend...unterstützt wird diese
entwicklung leider durch den undurchsichtigen handel an der OTC
in der transparenz leider ein fremdwort ist...
man hat stark den eindruck seit gestern, dass ABPI und BVTI in
ihrem aktienkurs nun auf ein bestimmtes niveau gebracht werden (...sollen).
ein wechsel an einen regulierten handelsplatz würde den sicherlich
bei positivem newsflow nun einsetzenden kursanstieg "unterstützen..."
während CRXX nach dem merger(welcher ja durch die zulassung erst realisiert
wurde) ihr "pulver" vorerst verschossen hatte...sehe ich die
mittelfristige zukunft hier bei ABPI deutlich aussichtsreicher.
Antwort auf Beitrag Nr.: 40.554.289 von Gustl24 am 19.11.10 14:43:06jetzt nachdem diese ganze ch.11 unsicherheit weg ist...
wurde ja hier auch schon diskutiert - aber unter ch.11 zählt dies natürlich
wenig...pleite bleibt pleite - aber jetzt nochmal zum thema:
wie kann es nach reorganization sein, dass MK ABPI ca. 50 mio.usd und
MK BVTI ca. 140 mio. usd, wenn accentia, und dies ist ja fakt (!), 75 % an BVTI hält.
diese schere müsste doch jetzt "nach zeitalter ch.11" geschlossen werden -
oder hängt das mit irgendwelchen loans, weiteren verschuldungen von accentia
zusammen...
da ich auch von steigenden kursen bei BVTI ausgehe ist der kursverlauf hier
immer noch sehr verwunderlich!!
wurde ja hier auch schon diskutiert - aber unter ch.11 zählt dies natürlich
wenig...pleite bleibt pleite - aber jetzt nochmal zum thema:
wie kann es nach reorganization sein, dass MK ABPI ca. 50 mio.usd und
MK BVTI ca. 140 mio. usd, wenn accentia, und dies ist ja fakt (!), 75 % an BVTI hält.
diese schere müsste doch jetzt "nach zeitalter ch.11" geschlossen werden -
oder hängt das mit irgendwelchen loans, weiteren verschuldungen von accentia
zusammen...
da ich auch von steigenden kursen bei BVTI ausgehe ist der kursverlauf hier
immer noch sehr verwunderlich!!
Antwort auf Beitrag Nr.: 40.558.497 von Gustl24 am 20.11.10 09:43:40Hallo Gustl,
ja, ABPI müsste aufgrund der Anteilsstruktur an BVTI einen höheren Kurs aufweisen.
Versuche aber mal meine rosa ABPI-Brille abzulegen.
Wenn man es kritisch sieht, ist man mit ABPI einen Schritt weiter vom spannenden BiovaxID entfernt als mit BVTI.
Ein Zusammenschluss von ABPI mit BVTI wäre natürlich klasse für ABPI, weil Sie ja relativ unterbewertet sind. Aber ich weiß nicht, ob dass nur Wunschdenken von uns Aktionären ist.
Könnte sich ABPI Kapitalerhöhungen für BVTI leisten? Sehr fraglich.
Wenn beide Firmen für sich Kapitalerhöhungen durchführen müssen, dann
verwässern möglicherweise BVTI Kapitalerhöhungen den ABPI-Anteil.
Ich würde jetzt erstmal gemütlich abwarten bis zum nächsten wichtigen Event.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Event: BiovaxID Phase III Study Results Presentation at ASH
Day/Time: Monday, December 6, 2010 at 11:00 a.m. (EST)
Außerdem könnte ich mir vorstellen, dass die lange Zeit bis zum Emerge genutzt wurde, und sich bald irgendwas Entscheidendes tut.
ja, ABPI müsste aufgrund der Anteilsstruktur an BVTI einen höheren Kurs aufweisen.
Versuche aber mal meine rosa ABPI-Brille abzulegen.
Wenn man es kritisch sieht, ist man mit ABPI einen Schritt weiter vom spannenden BiovaxID entfernt als mit BVTI.
Ein Zusammenschluss von ABPI mit BVTI wäre natürlich klasse für ABPI, weil Sie ja relativ unterbewertet sind. Aber ich weiß nicht, ob dass nur Wunschdenken von uns Aktionären ist.
Könnte sich ABPI Kapitalerhöhungen für BVTI leisten? Sehr fraglich.
Wenn beide Firmen für sich Kapitalerhöhungen durchführen müssen, dann
verwässern möglicherweise BVTI Kapitalerhöhungen den ABPI-Anteil.
Ich würde jetzt erstmal gemütlich abwarten bis zum nächsten wichtigen Event.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Event: BiovaxID Phase III Study Results Presentation at ASH
Day/Time: Monday, December 6, 2010 at 11:00 a.m. (EST)
Außerdem könnte ich mir vorstellen, dass die lange Zeit bis zum Emerge genutzt wurde, und sich bald irgendwas Entscheidendes tut.
Antwort auf Beitrag Nr.: 40.567.196 von KillingJoke am 22.11.10 16:08:56Schlusskurs gestern 0,85 USD.
Zwei Möglichkeiten:
1) Irgendwo gibts ein Problem, das keiner erkennt oder
2) es ist ein Trick.
Was ich sehe ist folgendes (basierend auf unveränderter Aktienanzahl nach Emerge):
Marktkapitalisierung ABPI ist 50 Mio USD.
BVTI hat bei 1,38 USD 134,62 Mio USD.
Bei 75% ABPI Anteil an BVTI wäre ABPI allein 100 Mio USD wert und
könnte doppelt so hoch bei 1,70 USD stehen.
Zwei Möglichkeiten:
1) Irgendwo gibts ein Problem, das keiner erkennt oder
2) es ist ein Trick.
Was ich sehe ist folgendes (basierend auf unveränderter Aktienanzahl nach Emerge):
Marktkapitalisierung ABPI ist 50 Mio USD.
BVTI hat bei 1,38 USD 134,62 Mio USD.
Bei 75% ABPI Anteil an BVTI wäre ABPI allein 100 Mio USD wert und
könnte doppelt so hoch bei 1,70 USD stehen.
Antwort auf Beitrag Nr.: 40.571.418 von KillingJoke am 23.11.10 08:55:49ABPI
Ich sehe keine Meldung, dass sich seit der Jahresgeschäftsbericht die Anzahl der ABPI Aktien erhöht hat.
Im Geschäftsbericht vom 16.08. wird die Anzahl ausstehender Aktien mit 58 Mio und die Prozentbeteiligung an BVTI mit 75% angegeben.
http://studio-5.financialcontent.com/edgar?accesscode=119312…
Form 10-K for ACCENTIA BIOPHARMACEUTICALS INC
16-Aug-2010
Annual Report
"As of September 30, 2009, we had approximately 58,048,208 shares of common stock outstanding, which were held by approximately 130 stockholders of record."
"We currently own of record approximately 75% of common stock of Biovest with the minority interest being held by approximately 400 shareholders of record."
BVTI
Ich finde eine Meldung von BVTI vom 25.10. hinsichtlich einer Kapitalerhöhung in Höhe von 7 Mio USD.
Das bedeutet, dass mit Wirksamkeit des Reorganisationsplans (dem "Emerge") die ausgegebenen Schuldverschreibungen in Aktien gewandelt werden können.
Das kann dazu führen, dass der BVTI Kurs unter Druck gerät.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Biovest Announces $7 Million Financing Required to Exit from Reorganization and Advance Key Regulatory and Commercial Strategies for BiovaxID® Cancer Vaccine
Released: 10/25/10 10:39 AM EDT
"Biovest International, Inc. (OTCQB: BVTI) today announced that the Company has entered into definitive loan documents and other agreements for the issuance of $7 million of convertible debtor-in-possession term notes (“DIP Notes”) and common stock purchase warrants to institutional investors. "
"(...) DIP Notes have been issued by Biovest to the lenders for an aggregate principal amount of $7 million. Upon Court confirmation and effectiveness of Biovest’s Plan of Reorganization, the DIP Notes will be exchanged for new notes (the “Exchange Notes”) with a maturity date of 2-years from the Effective Date of Biovest’s Plan of Reorganization and the Exchange Notes will bear interest at a rate of 7% per annum. All or any portion of the outstanding amount of the Exchange Notes is convertible, at the option of the investor, into shares of Biovest common stock at an initial conversion price of $0.91 per share.
(...) The offering includes the issuance of warrants giving the holders the right to purchase approximately 7 million shares of Company common stock, exercisable at $1.45 per share with a 7-year term."
Durch die Kapitalerhöhung bei BVTI ("Exchange Notes") liegt die Prozentbeteiligung von ABPI an BVTI nun (unter 75%) bei ca. 71%.
Gruss
KJ
Ich sehe keine Meldung, dass sich seit der Jahresgeschäftsbericht die Anzahl der ABPI Aktien erhöht hat.
Im Geschäftsbericht vom 16.08. wird die Anzahl ausstehender Aktien mit 58 Mio und die Prozentbeteiligung an BVTI mit 75% angegeben.
http://studio-5.financialcontent.com/edgar?accesscode=119312…
Form 10-K for ACCENTIA BIOPHARMACEUTICALS INC
16-Aug-2010
Annual Report
"As of September 30, 2009, we had approximately 58,048,208 shares of common stock outstanding, which were held by approximately 130 stockholders of record."
"We currently own of record approximately 75% of common stock of Biovest with the minority interest being held by approximately 400 shareholders of record."
BVTI
Ich finde eine Meldung von BVTI vom 25.10. hinsichtlich einer Kapitalerhöhung in Höhe von 7 Mio USD.
Das bedeutet, dass mit Wirksamkeit des Reorganisationsplans (dem "Emerge") die ausgegebenen Schuldverschreibungen in Aktien gewandelt werden können.
Das kann dazu führen, dass der BVTI Kurs unter Druck gerät.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Biovest Announces $7 Million Financing Required to Exit from Reorganization and Advance Key Regulatory and Commercial Strategies for BiovaxID® Cancer Vaccine
Released: 10/25/10 10:39 AM EDT
"Biovest International, Inc. (OTCQB: BVTI) today announced that the Company has entered into definitive loan documents and other agreements for the issuance of $7 million of convertible debtor-in-possession term notes (“DIP Notes”) and common stock purchase warrants to institutional investors. "
"(...) DIP Notes have been issued by Biovest to the lenders for an aggregate principal amount of $7 million. Upon Court confirmation and effectiveness of Biovest’s Plan of Reorganization, the DIP Notes will be exchanged for new notes (the “Exchange Notes”) with a maturity date of 2-years from the Effective Date of Biovest’s Plan of Reorganization and the Exchange Notes will bear interest at a rate of 7% per annum. All or any portion of the outstanding amount of the Exchange Notes is convertible, at the option of the investor, into shares of Biovest common stock at an initial conversion price of $0.91 per share.
(...) The offering includes the issuance of warrants giving the holders the right to purchase approximately 7 million shares of Company common stock, exercisable at $1.45 per share with a 7-year term."
Durch die Kapitalerhöhung bei BVTI ("Exchange Notes") liegt die Prozentbeteiligung von ABPI an BVTI nun (unter 75%) bei ca. 71%.
Gruss
KJ
Antwort auf Beitrag Nr.: 40.573.543 von KillingJoke am 23.11.10 13:34:29die Frage ist was ist mit den Schulden passiert?
http://finance.yahoo.com/q/bs?s=ABPI.PK
zum 30. Juni 2010: Other Liabilities 135,527
Sind (bzw. werden) diese oder Teile in Aktien umgewandelt worden? Ich denke nicht das die Gläubiger auf Ihre Beträge verzichtet haben...
Im übrigen im letzten Q. gabs Dank Umstrukturierung ein Plus:
http://finance.yahoo.com/q/is?s=ABPI.PK
Es sollten die nächsten 4-8 Wochen erst einmal abgewartet werden, wie die nächsten Schritte aussehen bzw. wie das mit Kapitalmaßnahmen ausschaut. Dann muss zusätzlich ein Statement kommen wie die Zukunft ABPIs weitergehen soll: Stichwort Revimmune (Phase III + Finanzierung) und seitens Biovest BiovaxID Fahrplan
Im übrigen glaube ich dass Biovest auch erst jetzt in der Lage ist (nach Chapter 11) einen potentiellen Partner für BiovaxiD zu suchen und finden. Da bin ich persönlich gespannt; könnte mir vorstellen das in der 1.H 2011 möglicherweise jemand präsentiert werden kann (GSK vielleicht?). Für mich ist die Partnerfrage gleich bedeutend mit dem Überlebenschancen von BiovaxID. Möglicherweise wird BVTI versuchen BiovaxID alleine an Hand bisheriger Daten bei der FDA zuzulassen, hier denke ich wirds aber schwierig...
Grüße
http://finance.yahoo.com/q/bs?s=ABPI.PK
zum 30. Juni 2010: Other Liabilities 135,527
Sind (bzw. werden) diese oder Teile in Aktien umgewandelt worden? Ich denke nicht das die Gläubiger auf Ihre Beträge verzichtet haben...
Im übrigen im letzten Q. gabs Dank Umstrukturierung ein Plus:
http://finance.yahoo.com/q/is?s=ABPI.PK
Es sollten die nächsten 4-8 Wochen erst einmal abgewartet werden, wie die nächsten Schritte aussehen bzw. wie das mit Kapitalmaßnahmen ausschaut. Dann muss zusätzlich ein Statement kommen wie die Zukunft ABPIs weitergehen soll: Stichwort Revimmune (Phase III + Finanzierung) und seitens Biovest BiovaxID Fahrplan
Im übrigen glaube ich dass Biovest auch erst jetzt in der Lage ist (nach Chapter 11) einen potentiellen Partner für BiovaxiD zu suchen und finden. Da bin ich persönlich gespannt; könnte mir vorstellen das in der 1.H 2011 möglicherweise jemand präsentiert werden kann (GSK vielleicht?). Für mich ist die Partnerfrage gleich bedeutend mit dem Überlebenschancen von BiovaxID. Möglicherweise wird BVTI versuchen BiovaxID alleine an Hand bisheriger Daten bei der FDA zuzulassen, hier denke ich wirds aber schwierig...
Grüße
Antwort auf Beitrag Nr.: 40.553.868 von KillingJoke am 19.11.10 13:42:35Die Volumenabnahme bewerte ich positiv, da kein großer Verkaufsdruck mehr herrscht.
17.11.: 1,155,500
18.11.: 311,000
19.11.: 191,200
22.11.: 218,400
23.11.: 132,500
24.11.: 77,300
25.11.: Thanksgiving
26.11.: 9,400
Average (3m): 93,543
17.11.: 1,155,500
18.11.: 311,000
19.11.: 191,200
22.11.: 218,400
23.11.: 132,500
24.11.: 77,300
25.11.: Thanksgiving
26.11.: 9,400
Average (3m): 93,543
Antwort auf Beitrag Nr.: 40.574.209 von Ackergaul am 23.11.10 14:58:35Ackergaul, die ABPI Bilanz lässt keine grossen Sprünge zu. Zu wenig Cash.
Aus ABPI ist meiner Meinung nach ein Stillhalter geworden, der versucht, keine Mittel mehr zu verbrennen und auf das BiovaxID der Tochter setzt.
Aus ABPI ist meiner Meinung nach ein Stillhalter geworden, der versucht, keine Mittel mehr zu verbrennen und auf das BiovaxID der Tochter setzt.
Antwort auf Beitrag Nr.: 40.574.209 von Ackergaul am 23.11.10 14:58:35Neues zu Revimmune:
"Accentia Biopharmaceuticals Announces Strategic Agreement with Baxter"
"Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) today announced a strategic agreement with Baxter Healthcare Corporation (NYSE:BAX - News) to provide Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan®, for the treatment of designated autoimmune diseases including multiple sclerosis. Cyclophosphamide is the active drug used in Revimmune™ therapy, Accentia’s proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases."
Komplett hier:
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
"Accentia Biopharmaceuticals Announces Strategic Agreement with Baxter"
"Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) today announced a strategic agreement with Baxter Healthcare Corporation (NYSE:BAX - News) to provide Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan®, for the treatment of designated autoimmune diseases including multiple sclerosis. Cyclophosphamide is the active drug used in Revimmune™ therapy, Accentia’s proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases."
Komplett hier:
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Antwort auf Beitrag Nr.: 40.608.259 von KillingJoke am 29.11.10 13:41:20wohl noch wichtiger das man auch auf alle bisherigen Daten von Baxter zurückgreifen kann
GEN news highlights : Nov 29 2010
Accentia Secures Rights to Baxter’s
Cyclophosphamide for Autoimmune
Candidate
Deal would also give firm rights to historical cyclophosphamide dataset.
Accentia has negotiated exclusive, worldwide rights to acquire Baxter’s cyclophosphamide drug,
which is marketed as Cytoxan®. Cyclophosphamide is the active ingredient in Accentia’s Phase IIIstage
Revimmune™ therapy for the treatment of a broad range of autommune diseases including
multiple sclerosis.
The deal with Baxter also gives Accentia the right to reference Baxter’s cyclophosphamide dataset for
use in the development of Revimmune. The firm will also purchase cyclophosphamide from Baxter.
“We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to
reference Baxter’s data related to cyclophosphamide not only assures that Accentia will have access
to the highest quality supply of cyclophosphamide, but also facilitates Accentia’s regulatory strategy
and reinforces its marketing position,” remarks Samuel S. Duffey, Accentia president. “With this
agreement in place, we are planning a robust clinical and regulatory development strategy to advance
our mission to establish Revimmune as a new standard of care treatment for patients suffering from
autoimmune diseases, including orphan indications with potential accelerated regulatory pathways as
well as major indications such as multiple sclerosis.”
Revimmune exploits cyclophosphamide through ultrahigh-dose, pulsed administration that Accentia
believes is capable of "rebooting" a patient's immune system. The treatment is thought to act by
completely eliminating mature lymphocytes throughout the body while selectively sparing immune
stem cells in the bone marrow, the firm adds. Accentia's majority-owned subsidiary, Biovest
International, is separately developing Revimmune for the treatment and prevention of transplant
rejection including bone marrow transplants for sickle cell anemia.
Accentia has licensed the Revimmune technology from its original developers at Johns Hopkins
University School of Medicine. The Johns Hopkins researchers have previously published
encouraging results from a two-year study evaluating Revimmune in the treatment of aggressive
relapsing-remitting multiple sclerosis, the firm points out. In addition to multiple sclerosis, Johns
Hopkins scientists have successfully treated a range of autoimmune diseases in preliminary case
studies.
Für mich ist aber immer noch das Thema Patentschutz fraglich, also wie ABPI mit Revimmune einen kommerziellen Erfolg verbuchen kann. Zudem denke ich auch, das Revimmune wirklich nur bei extremen Krankheitsverläufen eingesetzt werden kann (zB aggressiverelapsing-remitting multiple sclerosis), da sich das ganze wirklich ein wenig sehr gefährlich anhört...
Aber die bisherigen Daten waren wirklich sehr erfreulich gut bislang. Mal abwarten, was da noch kommt (gibts bald ein SPA mit der FDA?).
Grüße
GEN news highlights : Nov 29 2010
Accentia Secures Rights to Baxter’s
Cyclophosphamide for Autoimmune
Candidate
Deal would also give firm rights to historical cyclophosphamide dataset.
Accentia has negotiated exclusive, worldwide rights to acquire Baxter’s cyclophosphamide drug,
which is marketed as Cytoxan®. Cyclophosphamide is the active ingredient in Accentia’s Phase IIIstage
Revimmune™ therapy for the treatment of a broad range of autommune diseases including
multiple sclerosis.
The deal with Baxter also gives Accentia the right to reference Baxter’s cyclophosphamide dataset for
use in the development of Revimmune. The firm will also purchase cyclophosphamide from Baxter.
“We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to
reference Baxter’s data related to cyclophosphamide not only assures that Accentia will have access
to the highest quality supply of cyclophosphamide, but also facilitates Accentia’s regulatory strategy
and reinforces its marketing position,” remarks Samuel S. Duffey, Accentia president. “With this
agreement in place, we are planning a robust clinical and regulatory development strategy to advance
our mission to establish Revimmune as a new standard of care treatment for patients suffering from
autoimmune diseases, including orphan indications with potential accelerated regulatory pathways as
well as major indications such as multiple sclerosis.”
Revimmune exploits cyclophosphamide through ultrahigh-dose, pulsed administration that Accentia
believes is capable of "rebooting" a patient's immune system. The treatment is thought to act by
completely eliminating mature lymphocytes throughout the body while selectively sparing immune
stem cells in the bone marrow, the firm adds. Accentia's majority-owned subsidiary, Biovest
International, is separately developing Revimmune for the treatment and prevention of transplant
rejection including bone marrow transplants for sickle cell anemia.
Accentia has licensed the Revimmune technology from its original developers at Johns Hopkins
University School of Medicine. The Johns Hopkins researchers have previously published
encouraging results from a two-year study evaluating Revimmune in the treatment of aggressive
relapsing-remitting multiple sclerosis, the firm points out. In addition to multiple sclerosis, Johns
Hopkins scientists have successfully treated a range of autoimmune diseases in preliminary case
studies.
Für mich ist aber immer noch das Thema Patentschutz fraglich, also wie ABPI mit Revimmune einen kommerziellen Erfolg verbuchen kann. Zudem denke ich auch, das Revimmune wirklich nur bei extremen Krankheitsverläufen eingesetzt werden kann (zB aggressiverelapsing-remitting multiple sclerosis), da sich das ganze wirklich ein wenig sehr gefährlich anhört...
Aber die bisherigen Daten waren wirklich sehr erfreulich gut bislang. Mal abwarten, was da noch kommt (gibts bald ein SPA mit der FDA?).
Grüße
Biovest International (BVTI): A New Lease on Life
December 03, 2010 | Comments: 0
Recommended this article (2)
BVTI Print Share Grant Zeng, CFA
Biovest International Inc. (BVTI) (Biovest) is a clinical stage biotech company focused on the research and development of therapeutic cancer vaccines and related business.
The Company operates in three identifiable industry segments. Cell Culture Products and Services segment is engaged in the production and contract manufacturing of biologic drugs and cell production for research institutions worldwide. The Instruments and Disposables segment is engaged in the development, manufacture and marketing of patented cell culture systems, equipment and consumables to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide. The Therapeutic Vaccine segment is focused on developing BiovaxID for non-Hodgkin Lymphomas.
The Company generated revenue of $1.3 million from Instruments and Disposables segment in 2Q10, accounting for about 81% of total revenue. Cell Culture Products and Services segment generated revenue of $0.3 million, accounting for 19% of total revenue in 2Q10. The Company’s Therapeutic Vaccine segment has generated no revenues to date.
Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.
BiovaxID is the Key to the Company’s Success
Since revenue from the other two segments is limited, Biovest’s current focus is apparently its lead therapeutic vaccine BiovaxID. In collaboration with the National Cancer Institute (NCI), Biovest is developing BiovaxID as a personalized therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma (NHL), specifically follicular lymphoma (FL), mantle cell lymphoma (MCL), and potentially other B-cell blood cancers. Both FL and MCL are generally considered to be incurable with currently approved therapies.
BiovaxID belongs to the emerging new class of targeted cancer therapy known as active immunotherapy (therapeutic cancer vaccine) like Dendreon’s Provenge. BiovaxID is the only cancer vaccine in late stage development after Provenge was approved in April 2010 by the FDA. BiovaxID is manufactured through a process known as rescue fusion hybridization in which individual tumor cells obtained through biopsy are fused with an antibody-secreting cell to form a heterohybridoma. This cell then secretes the unique idiotype, or immunoglobulin antigen characteristic of the individual tumor, which is purified for use as the vaccine. The vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet hemocyanin (KLH) as a carrier protein and adjuvant.
Biovest has finished three clinical trials for BiovaxID in NHL so far. These studies include a Phase II clinical trial and a Phase III clinical trial in patients with FL, as well as a Phase II clinical trial in MCL patients. The Company presented the eight year pivotal, randomized, multi-center, double-blind, controlled Phase III clinical study results at 2009 ASCO.
In the Phase III study, investigators analyzed a cohort of 117 randomized FL patients who maintained a complete response to chemotherapy for at least six months and who received BiovaxID (n=76) or control (n=41). After a median follow-up of 4.7 years (range: 12.6–89.3 months), the median disease-free survival (the primary endpoint) in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, an 14 month improvement for the BiovaxID patients, which is a clinically and statistically significant difference (p=0.045). In the study, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID demonstrated a favorable safety profile and was very well-tolerated by patients.
The completed Phase III study achieved its primary endpoint of prolonging disease-free survival in BiovaxID patients. The Phase III study confirmed a previous Phase II study which demonstrated that patients receiving the BiovaxID vaccine developed a highly-specific immune response against tumor cells, with 95 percent of patients showing significant T-cell activity against their lymphoma and 75 percent of patients showing a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent of patients remained in continuous first complete remission with a median disease-free survival of 8 years.
Biovest plans to present new data analysis of the above Phase III study at the ASH meeting on Dec 6, 2010. We expect to see some long term follow up data and subset data for the FL patients.
The data collected so far for BiovaxID for follicular lymphoma are encouraging although the Phase III trial is relatively small. The enrollment number fell short of the original one probably due to the financial difficulty. According to management, the Company plans to meet with the FDA, EMEA and other international health authorities to seek accelerated and conditional approval of BiovaxID for the indication of FL. Accelerated or conditional approval would require the Company to perform additional clinical studies as a condition to continued marketing of BiovaxID.
BiovaxID is already available on a named-patient (compassionate-use) basis in Europe for follicular lymphoma patients. This compassionate-use drug access program allows European physicians to prescribe BiovaxID to qualifying patients before approvals are granted.
Biovest plans to further study the role of BiovaxID in patients with mantle cell lymphoma and other B-cell lymphomas. In addition, new lymphoma studies will evaluate the addition of BiovaxID booster maintenance therapy, which is expected to even further improve survival benefits by maximizing the chance of continuously maintaining complete remissions.
The Chapter 11 Reorganization and Liquidity
Like many other small biotech companies, Biovest has been in a difficult position to get sufficient cash to fund its operations in the past few years. The Company filed voluntary petitions in November of 2008 for reorganization under Chapter 11 of the Bankruptcy Code due to funding shortage.
From November 17, 2010, Biovest has successfully completed its reorganization. The Company has now formally exited Chapter 11 as a fully restructured organization.
The Plan of Reorganization restructured Biovest’s balance sheet by reducing outstanding debt, rescheduling debt payment obligations and reducing operating expenses. Under the Plan, stockholders retained their common shares. An important part of the confirmed restructuring was a $7 million financing (notes and warrants) for which Roth Capital Partners, LLC acted as the exclusive placement agent. Structural changes to certain agreements are now in effect including the reduction of the outstanding royalty on BiovaxID sales from 35% to 6.30%, thus expected to enhance Biovest’s commercial and partnering opportunities.
In early November of 2010, Biovest received a grant of approximately $245,000 from the US Government’s Qualifying Therapeutic Discover Project Program (QTDP). The funds were awarded to support the advancement of BiovaxID for the treatment of non-Hodgkin’s lymphoma. The amount of funds awarded were the maximum allocation allowed under the program. The grant program was very competitive and being selected is a strong validation of the Company’s technology.
As of June, 2010, Biovest held $131,000 in cash, plus the above $7 million notes issued in October and the federal grant of $245,000 awarded in November, the Company should have roughly $7.3 million in cash at hand now which will last for a few quarters.
Obviously, cash position is still a major issue for the Company. Cash burn may be relieved if the Company can find a partner for the commercialization of its lead candidate BiovaxID. Otherwise, the Company may need to tap the capital market again in 2011. Equity financing will dilute current shareholder base, and the share price will suffer.
The Bottom Line……
Increased interest in anti-cancer therapeutic vaccines among investors has been triggered by the approval of Dendreon’s Provenge, the first in class of anti-cancer therapeutic vaccine, for the treatment of advanced prostate cancer. The approval of Provenge is certainly good news for this whole class of new targeted therapy, including BiovaxID.
BiovaxID is the only cancer vaccine after Provenge, which is in late stage clinical trials. There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe, among which about 30% cases are follicular lymphomas. About 195,000 NHL patients died in 2009 in the US alone. Despite the use of aggressive chemotherapy and recent advances in targeted therapy such as Rituxan, the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy.
Current data for BiovaxID are encouraging which could transform the treatment of NHL if approved. With the exit from Chapter II reorganization, Biovest is poised to deliver shareholder value in a new way.
Sehr optimistische Analyse! Ich denke, jetzt nach der Chapter 11-Sache werden vielleicht einige Analysten mal einen Blick riskieren.
Heute ist im übrigen Biovest bei der ASH an der Reihe. Könnte also ein interessanter Tag werden. Wäre schön, wenn es (wie im zacks Beitrag) ein Update zur Survival Kurve gibt.
Grüße
December 03, 2010 | Comments: 0
Recommended this article (2)
BVTI Print Share Grant Zeng, CFA
Biovest International Inc. (BVTI) (Biovest) is a clinical stage biotech company focused on the research and development of therapeutic cancer vaccines and related business.
The Company operates in three identifiable industry segments. Cell Culture Products and Services segment is engaged in the production and contract manufacturing of biologic drugs and cell production for research institutions worldwide. The Instruments and Disposables segment is engaged in the development, manufacture and marketing of patented cell culture systems, equipment and consumables to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide. The Therapeutic Vaccine segment is focused on developing BiovaxID for non-Hodgkin Lymphomas.
The Company generated revenue of $1.3 million from Instruments and Disposables segment in 2Q10, accounting for about 81% of total revenue. Cell Culture Products and Services segment generated revenue of $0.3 million, accounting for 19% of total revenue in 2Q10. The Company’s Therapeutic Vaccine segment has generated no revenues to date.
Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.
BiovaxID is the Key to the Company’s Success
Since revenue from the other two segments is limited, Biovest’s current focus is apparently its lead therapeutic vaccine BiovaxID. In collaboration with the National Cancer Institute (NCI), Biovest is developing BiovaxID as a personalized therapeutic cancer vaccine for the treatment of non-Hodgkin’s lymphoma (NHL), specifically follicular lymphoma (FL), mantle cell lymphoma (MCL), and potentially other B-cell blood cancers. Both FL and MCL are generally considered to be incurable with currently approved therapies.
BiovaxID belongs to the emerging new class of targeted cancer therapy known as active immunotherapy (therapeutic cancer vaccine) like Dendreon’s Provenge. BiovaxID is the only cancer vaccine in late stage development after Provenge was approved in April 2010 by the FDA. BiovaxID is manufactured through a process known as rescue fusion hybridization in which individual tumor cells obtained through biopsy are fused with an antibody-secreting cell to form a heterohybridoma. This cell then secretes the unique idiotype, or immunoglobulin antigen characteristic of the individual tumor, which is purified for use as the vaccine. The vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet hemocyanin (KLH) as a carrier protein and adjuvant.
Biovest has finished three clinical trials for BiovaxID in NHL so far. These studies include a Phase II clinical trial and a Phase III clinical trial in patients with FL, as well as a Phase II clinical trial in MCL patients. The Company presented the eight year pivotal, randomized, multi-center, double-blind, controlled Phase III clinical study results at 2009 ASCO.
In the Phase III study, investigators analyzed a cohort of 117 randomized FL patients who maintained a complete response to chemotherapy for at least six months and who received BiovaxID (n=76) or control (n=41). After a median follow-up of 4.7 years (range: 12.6–89.3 months), the median disease-free survival (the primary endpoint) in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, an 14 month improvement for the BiovaxID patients, which is a clinically and statistically significant difference (p=0.045). In the study, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID demonstrated a favorable safety profile and was very well-tolerated by patients.
The completed Phase III study achieved its primary endpoint of prolonging disease-free survival in BiovaxID patients. The Phase III study confirmed a previous Phase II study which demonstrated that patients receiving the BiovaxID vaccine developed a highly-specific immune response against tumor cells, with 95 percent of patients showing significant T-cell activity against their lymphoma and 75 percent of patients showing a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent of patients remained in continuous first complete remission with a median disease-free survival of 8 years.
Biovest plans to present new data analysis of the above Phase III study at the ASH meeting on Dec 6, 2010. We expect to see some long term follow up data and subset data for the FL patients.
The data collected so far for BiovaxID for follicular lymphoma are encouraging although the Phase III trial is relatively small. The enrollment number fell short of the original one probably due to the financial difficulty. According to management, the Company plans to meet with the FDA, EMEA and other international health authorities to seek accelerated and conditional approval of BiovaxID for the indication of FL. Accelerated or conditional approval would require the Company to perform additional clinical studies as a condition to continued marketing of BiovaxID.
BiovaxID is already available on a named-patient (compassionate-use) basis in Europe for follicular lymphoma patients. This compassionate-use drug access program allows European physicians to prescribe BiovaxID to qualifying patients before approvals are granted.
Biovest plans to further study the role of BiovaxID in patients with mantle cell lymphoma and other B-cell lymphomas. In addition, new lymphoma studies will evaluate the addition of BiovaxID booster maintenance therapy, which is expected to even further improve survival benefits by maximizing the chance of continuously maintaining complete remissions.
The Chapter 11 Reorganization and Liquidity
Like many other small biotech companies, Biovest has been in a difficult position to get sufficient cash to fund its operations in the past few years. The Company filed voluntary petitions in November of 2008 for reorganization under Chapter 11 of the Bankruptcy Code due to funding shortage.
From November 17, 2010, Biovest has successfully completed its reorganization. The Company has now formally exited Chapter 11 as a fully restructured organization.
The Plan of Reorganization restructured Biovest’s balance sheet by reducing outstanding debt, rescheduling debt payment obligations and reducing operating expenses. Under the Plan, stockholders retained their common shares. An important part of the confirmed restructuring was a $7 million financing (notes and warrants) for which Roth Capital Partners, LLC acted as the exclusive placement agent. Structural changes to certain agreements are now in effect including the reduction of the outstanding royalty on BiovaxID sales from 35% to 6.30%, thus expected to enhance Biovest’s commercial and partnering opportunities.
In early November of 2010, Biovest received a grant of approximately $245,000 from the US Government’s Qualifying Therapeutic Discover Project Program (QTDP). The funds were awarded to support the advancement of BiovaxID for the treatment of non-Hodgkin’s lymphoma. The amount of funds awarded were the maximum allocation allowed under the program. The grant program was very competitive and being selected is a strong validation of the Company’s technology.
As of June, 2010, Biovest held $131,000 in cash, plus the above $7 million notes issued in October and the federal grant of $245,000 awarded in November, the Company should have roughly $7.3 million in cash at hand now which will last for a few quarters.
Obviously, cash position is still a major issue for the Company. Cash burn may be relieved if the Company can find a partner for the commercialization of its lead candidate BiovaxID. Otherwise, the Company may need to tap the capital market again in 2011. Equity financing will dilute current shareholder base, and the share price will suffer.
The Bottom Line……
Increased interest in anti-cancer therapeutic vaccines among investors has been triggered by the approval of Dendreon’s Provenge, the first in class of anti-cancer therapeutic vaccine, for the treatment of advanced prostate cancer. The approval of Provenge is certainly good news for this whole class of new targeted therapy, including BiovaxID.
BiovaxID is the only cancer vaccine after Provenge, which is in late stage clinical trials. There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe, among which about 30% cases are follicular lymphomas. About 195,000 NHL patients died in 2009 in the US alone. Despite the use of aggressive chemotherapy and recent advances in targeted therapy such as Rituxan, the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy.
Current data for BiovaxID are encouraging which could transform the treatment of NHL if approved. With the exit from Chapter II reorganization, Biovest is poised to deliver shareholder value in a new way.
Sehr optimistische Analyse! Ich denke, jetzt nach der Chapter 11-Sache werden vielleicht einige Analysten mal einen Blick riskieren.
Heute ist im übrigen Biovest bei der ASH an der Reihe. Könnte also ein interessanter Tag werden. Wäre schön, wenn es (wie im zacks Beitrag) ein Update zur Survival Kurve gibt.
Grüße
Antwort auf Beitrag Nr.: 40.650.721 von Ackergaul am 06.12.10 09:14:07Ich stelle fest, dass der Preis von BVTI (und der von ABPI) nach dem ASH-Meeting gestern nicht dorthin geht, wo ich ihn sehen will.
BVTI
Last Trade: 1.19
Volume: 1,362,100
Avg Vol (3m): 79,921
ABPI
Last Trade: 0.90
Volume: 250,400
Avg Vol (3m): 105,950
Gestern kam Biovest mit einer langen Meldung zu den Phase III Daten.
Eine Zusammenfassung davon ist:
http://www.bizjournals.com/tampabay/news/2010/12/06/biovest-…
"The analysis suggests that the improved disease-free survival following personalized lymphoma vaccine therapy depends on an integral tumor protein fragment administered as part of each patient’s vaccine, a company statement said. In lymphoma, the protein fragment, termed the “isotype,” was previously believed to be unimportant to vaccine response, but the new analysis further suggests that patients receiving a vaccine with a specific isotype experienced a dramatic diseases-free survival benefit."
BiovaxID wirkt nur bei "IgM-positive patients" statistisch signifikant.
BVTI hat nun im Rahmen der Testauswertung nachträglich einen Zusammenhang erkannt und macht nun Aussagen über gebildete Untergruppen.
Die Wirkung
- von BiovaxID ggü Placebo bei "IgM-positive patients" und
- von BiovaxID bei "IgM-positive patients" ggü der Kontrollgruppe (nicht IgM-positive)
wird als statistisch signifikant bzw. (natürlichsprachlich) dramatisch beschrieben.
Wird die Kontrollgruppe (nicht IgM-positive) mit BiovaxID behandelt, ist der Erfolg nicht mehr statistisch signifikant.
Die Erkenntnis dürfte weichreichende Auswirkungen haben und einen Nestart von Phase III Tests bedeuten.
Ackergaul kommt bestimmt mit einer detailierten Analyse des kompletten Textes.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Es stellt sich die Frage, welche (negativen) Auswirkungen die Erkenntnise auf den Zeitplan haben und welche (positive) auf die Förderfähigkeit von BiovaxID.
Meines Erachtens ist jetzt noch klarer, dass BiovaxID funktioniert!
Allerdings, und das ist der springende Punkt, nicht bei allen.
Gruss
KJ
BVTI
Last Trade: 1.19
Volume: 1,362,100
Avg Vol (3m): 79,921
ABPI
Last Trade: 0.90
Volume: 250,400
Avg Vol (3m): 105,950
Gestern kam Biovest mit einer langen Meldung zu den Phase III Daten.
Eine Zusammenfassung davon ist:
http://www.bizjournals.com/tampabay/news/2010/12/06/biovest-…
"The analysis suggests that the improved disease-free survival following personalized lymphoma vaccine therapy depends on an integral tumor protein fragment administered as part of each patient’s vaccine, a company statement said. In lymphoma, the protein fragment, termed the “isotype,” was previously believed to be unimportant to vaccine response, but the new analysis further suggests that patients receiving a vaccine with a specific isotype experienced a dramatic diseases-free survival benefit."
BiovaxID wirkt nur bei "IgM-positive patients" statistisch signifikant.
BVTI hat nun im Rahmen der Testauswertung nachträglich einen Zusammenhang erkannt und macht nun Aussagen über gebildete Untergruppen.
Die Wirkung
- von BiovaxID ggü Placebo bei "IgM-positive patients" und
- von BiovaxID bei "IgM-positive patients" ggü der Kontrollgruppe (nicht IgM-positive)
wird als statistisch signifikant bzw. (natürlichsprachlich) dramatisch beschrieben.
Wird die Kontrollgruppe (nicht IgM-positive) mit BiovaxID behandelt, ist der Erfolg nicht mehr statistisch signifikant.
Die Erkenntnis dürfte weichreichende Auswirkungen haben und einen Nestart von Phase III Tests bedeuten.
Ackergaul kommt bestimmt mit einer detailierten Analyse des kompletten Textes.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
Es stellt sich die Frage, welche (negativen) Auswirkungen die Erkenntnise auf den Zeitplan haben und welche (positive) auf die Förderfähigkeit von BiovaxID.
Meines Erachtens ist jetzt noch klarer, dass BiovaxID funktioniert!
Allerdings, und das ist der springende Punkt, nicht bei allen.
Gruss
KJ
Antwort auf Beitrag Nr.: 40.660.931 von KillingJoke am 07.12.10 11:07:40Mahlzeit,
hatte ja schon mal meinen Senf dazu gegeben (siehe Posting 13.11.). Letztendlich sind keine zusätzlichen weiteren Infos geflossen (zB OS), als zum Zeitpunkt der ASH Veröffentlichung im November. Somit ist auch zu erklären, das der Markt die Meldung nicht honoriert hatte...
noch mal meine kleine Anmerkung vom November:
Was bedeutet dass? Aus meiner Sicht zum einen, das die möglichen peak sales durch diese subset Analyse nahezu halbiert werden, anders herum das man hier eine Gruppe (IgM-Id) gefunden hat, bei der BiovaxID DEUTLICH wirkt. Leider sind die Patientenzahlen sehr klein: IgM-Id 36 Patienten und IgG-Id 40 Patienten. Ob man daraus wirklich diese Rückschlüsse ziehen kann? Bei den IgG-Id Patienten scheint BiovaxID überhaupt keine Verbesserung zu zeigen...
Für eine neue Phase III sind dies natürlich wichtige Erkenntnisse. Diese könnten beim Trial Aufbau mit eingebracht werden. Natürlich ist es immer noch möglich, dass die FDA BiovaxID anhand der jetzigen Phase III zulässt die Wahrscheinlichkeit sehe ich aber bei unter 5%; aber bei der FDA weiß man ja nie!
Grüße
Die Seite der HOPKINS CAPITAL GROUP ist übrigends wieder online. http://www.teammpharma.com/index.php
Schaut man unter PORTFOLIO COMPANIES, wird BVTI (oder besser BiovaxID) im übrigen unter ABPI aufgeführt. Ob dies ein Zeichen ist das diese beiden sich zusammenschließen sollte jeder sich selbst beantworten. Ich persönlich würde es für sinnvoll betrachten...
hatte ja schon mal meinen Senf dazu gegeben (siehe Posting 13.11.). Letztendlich sind keine zusätzlichen weiteren Infos geflossen (zB OS), als zum Zeitpunkt der ASH Veröffentlichung im November. Somit ist auch zu erklären, das der Markt die Meldung nicht honoriert hatte...
noch mal meine kleine Anmerkung vom November:
Was bedeutet dass? Aus meiner Sicht zum einen, das die möglichen peak sales durch diese subset Analyse nahezu halbiert werden, anders herum das man hier eine Gruppe (IgM-Id) gefunden hat, bei der BiovaxID DEUTLICH wirkt. Leider sind die Patientenzahlen sehr klein: IgM-Id 36 Patienten und IgG-Id 40 Patienten. Ob man daraus wirklich diese Rückschlüsse ziehen kann? Bei den IgG-Id Patienten scheint BiovaxID überhaupt keine Verbesserung zu zeigen...
Für eine neue Phase III sind dies natürlich wichtige Erkenntnisse. Diese könnten beim Trial Aufbau mit eingebracht werden. Natürlich ist es immer noch möglich, dass die FDA BiovaxID anhand der jetzigen Phase III zulässt die Wahrscheinlichkeit sehe ich aber bei unter 5%; aber bei der FDA weiß man ja nie!
Grüße
Die Seite der HOPKINS CAPITAL GROUP ist übrigends wieder online. http://www.teammpharma.com/index.php
Schaut man unter PORTFOLIO COMPANIES, wird BVTI (oder besser BiovaxID) im übrigen unter ABPI aufgeführt. Ob dies ein Zeichen ist das diese beiden sich zusammenschließen sollte jeder sich selbst beantworten. Ich persönlich würde es für sinnvoll betrachten...
Antwort auf Beitrag Nr.: 40.661.791 von Ackergaul am 07.12.10 12:30:32Mahlzeit Ackergaul,
stimmt, im ASH Abstract stand schon alles.
Und Du hast am 13.11. direkt richtig zusammengefasst. Quasi noch schneller als durch Verfolgen von Unternehmensmeldungen möglich.
Doch was ist jetzt Ursache und was Wirkung?
Habe nochmal recherchiert, dass BVTI am 15.11. eine Mitteilung mit Verweis auf das Abstract gemacht hat.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
http://ash.confex.com/ash/2010/webprogram/Paper34600.html
Am 17.11. kam die Nachricht mit dem Chapter 11 Emerge.
Vielleicht ist der BVTI Kurs ja seit Mitte November auch unter Druck, weil die Gültigkeit eingeschränkt wurde und sich die Peak sales verringern?
Ist eigentlich klar, wie die protentuale Aufteilung von IgM-Id Patienten zu IgG-Id Patienten (nicht IgM-positive) ist?
Nur weil im Test die Aufteilung 36 zu 40 Patienten ist, muss das ja nicht zwingend allgemeingültig sein.
stimmt, im ASH Abstract stand schon alles.
Und Du hast am 13.11. direkt richtig zusammengefasst. Quasi noch schneller als durch Verfolgen von Unternehmensmeldungen möglich.
Doch was ist jetzt Ursache und was Wirkung?
Habe nochmal recherchiert, dass BVTI am 15.11. eine Mitteilung mit Verweis auf das Abstract gemacht hat.
http://markets.financialcontent.com/ir/?Module=MediaViewer&G…
http://ash.confex.com/ash/2010/webprogram/Paper34600.html
Am 17.11. kam die Nachricht mit dem Chapter 11 Emerge.
Vielleicht ist der BVTI Kurs ja seit Mitte November auch unter Druck, weil die Gültigkeit eingeschränkt wurde und sich die Peak sales verringern?
Ist eigentlich klar, wie die protentuale Aufteilung von IgM-Id Patienten zu IgG-Id Patienten (nicht IgM-positive) ist?
Nur weil im Test die Aufteilung 36 zu 40 Patienten ist, muss das ja nicht zwingend allgemeingültig sein.
Antwort auf Beitrag Nr.: 40.661.791 von Ackergaul am 07.12.10 12:30:32Die Seite von Hopkins Capital ist zwar online, scheint aber alt zu sein.
http://www.teammpharma.com/portfolio.php#Accentia
Ich komme darauf wegen der Angaben zur ABPI Pipeline.
Da würde aus der Nennung von BiovaxID unter Accentia nichts folgern wollen.
Wie war es eigentlich historisch, ist BiovaxID mal an Biovest als (neu gegründete) 100% Tocher ausgelagert worden?
http://www.teammpharma.com/portfolio.php#Accentia
Ich komme darauf wegen der Angaben zur ABPI Pipeline.
Da würde aus der Nennung von BiovaxID unter Accentia nichts folgern wollen.
Wie war es eigentlich historisch, ist BiovaxID mal an Biovest als (neu gegründete) 100% Tocher ausgelagert worden?
Antwort auf Beitrag Nr.: 40.662.291 von KillingJoke am 07.12.10 13:20:09zum Anteil IgM-Id Patienten zu IgG-Id Patienten:
ich denke etwa 50-50
und zur Hopkins Capital Seite:
war jetzt auch nicht sonderlich ernst gemeint, das auf der Homepage der Capital Group (HCG) solch eine Meldung vorangekündigt wird... Aber soweit ich noch im Kopf habe waren diese Angaben wirklich einmal anders strukturiert.
Ich denke das irgendwann ABPI (oder HCG) mal die Rechte an BiovaxID hatte und diese dann irgendwann in BVTI ausgegliedert wurden, ist aber nur eine Vermutung.
Grüße
ich denke etwa 50-50
und zur Hopkins Capital Seite:
war jetzt auch nicht sonderlich ernst gemeint, das auf der Homepage der Capital Group (HCG) solch eine Meldung vorangekündigt wird... Aber soweit ich noch im Kopf habe waren diese Angaben wirklich einmal anders strukturiert.
Ich denke das irgendwann ABPI (oder HCG) mal die Rechte an BiovaxID hatte und diese dann irgendwann in BVTI ausgegliedert wurden, ist aber nur eine Vermutung.
Grüße
seit der offiziellen "Rettung" aus Chapter 11 vor nicht einmal 4 Wochen, stehen 40 % Kursverlust auf dem Zettel. Das ist schon ein wenig merkwürdig aus meiner Sicht...
Jetzt kann darüber spekuliert werden, ob die (IgM-Id - IgG-Id) ASH Schuld am Kursverfall war oder ...?
Grüße
Jetzt kann darüber spekuliert werden, ob die (IgM-Id - IgG-Id) ASH Schuld am Kursverfall war oder ...?
Grüße
noch mal was, O'Donnell hatte am 24. November für fast eine Viertel Mil. $ zugekauft:
http://finance.yahoo.com/q/it?s=ABPI.PK+Insider+Transactions
Nov 24, 2010 ODONNELL FRANCIS E JR
Officer 225,954 Indirect Purchase at $0.99 per share. 223,694
Grüße
http://finance.yahoo.com/q/it?s=ABPI.PK+Insider+Transactions
Nov 24, 2010 ODONNELL FRANCIS E JR
Officer 225,954 Indirect Purchase at $0.99 per share. 223,694
Grüße
Antwort auf Beitrag Nr.: 40.684.089 von Ackergaul am 09.12.10 20:05:04Erfreulich!
http://www.thecleverbull.com/articles/view/article/17/Accent…
Accentia (OTC:ABPI) is advancing potential blockbuster drug candidates
Posted on Dec 2, 2010, 11:23 am Author: The Clever Bull
Accentia is a biopharmaceutical company focused on commercialization of innovative product based on revolutionary discoveries in the field of immunology.
Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin's lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis.
Accentia's interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc., and Accentia also maintains a royalty interest in Biovest's biologic products.
Analytica International, Inc. is a wholly-owned subsidiary of Accentia which provides a broad range of consulting services to pharmaceutical and biotechnology companies. Analytica's team in New York and Germany includes research professionals at the Master's and Doctoral level in the fields of medicine, epidemiology, biochemistry, statistics, engineering, public health, pharmacy, health economics and business administration.
Pipeline:
BiovaxID®
BiovaxID is a personalized, patient–specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B–cells (a specific type of white blood cell or lymphocyte) that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non–Hodgkin's lymphoma, BiovaxID is designed to kill only cancerous B–cells, with the initial indication of indolent follicular non–Hodgkin's lymphoma. Additionally, it is anticipated that BiovaxID could potentially be used to treat other types of blood cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
Originally developed by researchers at the National Cancer Institute and Stanford University, BiovaxID holds the potential to be the very first anti–cancer vaccine to achieve U.S. and/or broad global approvals. Of the 130,000 new cases of non–Hodgkin's lymphoma (NHL) diagnosed every year in the U.S. and Europe, approximately 30% fall into the category of indolent, follicular B–cell NHL, which is the segment that BiovaxID is initially targeting. Although chemotherapy, radiation and certain immunotherapies are routinely used to treat indolent, follicular B–cell NHL, such treatments are by no means considered a cure, are often very difficult to tolerate, with relapse likely if not inevitable. There is an urgent need to improve existing regimens in order to indefinitely sustain remission rates, thus representing an enormous opportunity for BiovaxID.
Completed Phase II Study:
After completing the vaccination protocol (n=20), with a median 9-year following complete response to chemotherapy (PACE):
• 45% of patients remained tumor-free (continuous complete remission) after a median of 8-years.
• 95% of patients were still alive after 9-years.
• 95% had significant T-cell activity and/or 75% B-cell activity against their lymphoma cells
Completed Phase III Study:
Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial were well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The modified intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).
Revimmune™
Accentia holds the worldwide exclusive license to Revimmune for the treatment of autoimmune diseases, such as multiple sclerosis. Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at Johns Hopkins University School of Medicine, Revimmune uses an already-approved active pharmaceutical (cyclophosphamide) in a novel, patent-pending, ultra-high dose, pulsed administration capable of "rebooting" a patient's immune system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of Revimmune, a natural "rebooting" process takes place as bone marrow stem cells repopulate the immune system without memory of the autoimmunity.
Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to the new immune system over 2 to 3 weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune is the world's first therapy to propose the restoration of neurologic and physical functions and offer the potential for the elimination of autoimmunity.
Recently Accentia Biopharmaceuticals announced a strategic agreement with Baxter Healthcare Corp. to provide Accentia with the exclusive, worldwide right to purchase Baxter's cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.
Cyclophosphamide is the active drug used in Revimmune therapy, Accentia's proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases.
The agreement also grants Accentia with the exclusive right for designated indications to reference Baxter's proprietary, historical data related to cyclophosphamide as part of Accentia's planned clinical and regulatory development of Revimmune. The agreement designates Baxter as Accentia's sole source of cyclophosphamide for Revimmune.
According to Accentia's President, Samuel S. Duffey, "We consider our agreement with Baxter to be highly strategic to Accentia's plans for the development and commercialization of Revimmune. We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to reference Baxter's data related to cyclophosphamide not only assures that Accentia will have access to the highest quality supply of cyclophosphamide, but also facilitates Accentia's regulatory strategy and reinforces its market position. With this agreement in place, we are planning a robust clinical and regulatory development strategy to advance our mission to establish Revimmune as a new standard-of-care treatment for patients suffering from autoimmune diseases, including orphan indications with potential accelerated regulatory pathways, as well as major indications such as multiple sclerosis."
Study Results: Revimmune for Multiple Sclerosis
Researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune.
An article titled "Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis" was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient's functional status.
Accentia believes these preliminary results to be unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up.
Other Potential Autoimmune Indications:
In addition to multiple sclerosis, investigators at Johns Hopkins have successfully treated the following autoimmune diseases in preliminary studies and case experiences: Systemic Lupus; Myasthenia Gravis; Aplastic Anemia; Autoimmune Hemolytic Anemia; Refractory Scleroderma; Acquired Pemphigus; Rheumatoid Arthritis and Crohn's Disease.
SinuNase™
Accentia holds the worldwide, exclusive commercial rights to SinuNase (topical amphotericin B 0.01% suspension), an intranasal, low-dose antifungal product, as granted by the Mayo Clinic. SinuNase is especially unique because it is the first product to target what is believed to be the true cause of chronic sinusitis: fungal-induced inflammation. SinuNase is self-administered into a patient's nasal cavity and holds the potential to be the first product approved for treating chronic sinusitis.
Currently, there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMEA) approved treatments for chronic sinusitis, which affects more than 60 million sufferers in the U.S. and Europe. SinuNase is the only intranasal, anti-fungal chronic sinusitis product that has been submitted as an Investigational New Drug (IND) to the FDA, and while SinuNase failed to achieve its primary endpoint in its initial Fast-Track pivotal Phase 3 clinical trial, Accentia found certain encouraging results that warrant further development. Accentia is continuing to analyze these results to determine the optimal course of future clinical development of SinuNase.
More than 60 Million CS Sufferers in U.S. and Europe with Sales Potential > $5B
SinuTest™
Accentia has the exclusive commercial rights in the U.S. to the patented diagnostic, SinuTest™, which is a diagnostic used to measure eMBP (eosinophilic major basic protein) in the nasal mucin of the suspected chronic sinusitis patients. SinuTest is the only confirmatory lab test available for the diagnosis of chronic sinusitis, and it is currently being marketed by Accentia to Ear, Nose and Throat Specialists (ENTs) and Allergy Specialists. SinuTest is expected to provide physicians with a tool to predict those patient candidates best suited to benefit from treatment with SinuNase.
Financial:
On November 17, 2010, Accentia Biopharmaceuticals announced that the Company and its majority-owned subsidiary, Biovest International, have both successfully completed their reorganizations. Pursuant to their respective Plans of Reorganization approved by the bankruptcy court, Accentia and Biovest have now formally exited Chapter 11 as fully restructured organizations.
Conclusion:
Accentia Biopharmaceuticals is now in a better position to achieve significant long-term growth. The pipeline targets multi-billion dollar market opportunities and the recent agreement with Baxter is a great development. Data from Cytoxan will be used in the regulatory process for Revimmune.
Accentia Biopharmaceuticals was trading at $1.50 before the reorganization plan was announced, since then the share price went down to $0.77 and has now stabilized at $0.90. We believe that some debtors sold their shares just after the company has formally exited Chapter 11. We think this is now oversold, the company has many catalysts that should drive the price well over the $1 range again.
It is also actually undervalued by the market based on its majority ownership stake in Biovest International.
Full Disclosure:
-Long position on ABPI, the author owns 30.000 shares at an average price of $1.02
-The Clever bull has NOT been compensated in any way by Accentia to promote or write this article.
The Clever Bull team.
By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, www.thecleverbull.com, for complete risks and disclosures.
Grüße
Accentia (OTC:ABPI) is advancing potential blockbuster drug candidates
Posted on Dec 2, 2010, 11:23 am Author: The Clever Bull
Accentia is a biopharmaceutical company focused on commercialization of innovative product based on revolutionary discoveries in the field of immunology.
Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin's lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis.
Accentia's interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc., and Accentia also maintains a royalty interest in Biovest's biologic products.
Analytica International, Inc. is a wholly-owned subsidiary of Accentia which provides a broad range of consulting services to pharmaceutical and biotechnology companies. Analytica's team in New York and Germany includes research professionals at the Master's and Doctoral level in the fields of medicine, epidemiology, biochemistry, statistics, engineering, public health, pharmacy, health economics and business administration.
Pipeline:
BiovaxID®
BiovaxID is a personalized, patient–specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B–cells (a specific type of white blood cell or lymphocyte) that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non–Hodgkin's lymphoma, BiovaxID is designed to kill only cancerous B–cells, with the initial indication of indolent follicular non–Hodgkin's lymphoma. Additionally, it is anticipated that BiovaxID could potentially be used to treat other types of blood cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.
Originally developed by researchers at the National Cancer Institute and Stanford University, BiovaxID holds the potential to be the very first anti–cancer vaccine to achieve U.S. and/or broad global approvals. Of the 130,000 new cases of non–Hodgkin's lymphoma (NHL) diagnosed every year in the U.S. and Europe, approximately 30% fall into the category of indolent, follicular B–cell NHL, which is the segment that BiovaxID is initially targeting. Although chemotherapy, radiation and certain immunotherapies are routinely used to treat indolent, follicular B–cell NHL, such treatments are by no means considered a cure, are often very difficult to tolerate, with relapse likely if not inevitable. There is an urgent need to improve existing regimens in order to indefinitely sustain remission rates, thus representing an enormous opportunity for BiovaxID.
Completed Phase II Study:
After completing the vaccination protocol (n=20), with a median 9-year following complete response to chemotherapy (PACE):
• 45% of patients remained tumor-free (continuous complete remission) after a median of 8-years.
• 95% of patients were still alive after 9-years.
• 95% had significant T-cell activity and/or 75% B-cell activity against their lymphoma cells
Completed Phase III Study:
Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial were well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The modified intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).
Revimmune™
Accentia holds the worldwide exclusive license to Revimmune for the treatment of autoimmune diseases, such as multiple sclerosis. Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at Johns Hopkins University School of Medicine, Revimmune uses an already-approved active pharmaceutical (cyclophosphamide) in a novel, patent-pending, ultra-high dose, pulsed administration capable of "rebooting" a patient's immune system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of Revimmune, a natural "rebooting" process takes place as bone marrow stem cells repopulate the immune system without memory of the autoimmunity.
Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to the new immune system over 2 to 3 weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune is the world's first therapy to propose the restoration of neurologic and physical functions and offer the potential for the elimination of autoimmunity.
Recently Accentia Biopharmaceuticals announced a strategic agreement with Baxter Healthcare Corp. to provide Accentia with the exclusive, worldwide right to purchase Baxter's cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.
Cyclophosphamide is the active drug used in Revimmune therapy, Accentia's proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases.
The agreement also grants Accentia with the exclusive right for designated indications to reference Baxter's proprietary, historical data related to cyclophosphamide as part of Accentia's planned clinical and regulatory development of Revimmune. The agreement designates Baxter as Accentia's sole source of cyclophosphamide for Revimmune.
According to Accentia's President, Samuel S. Duffey, "We consider our agreement with Baxter to be highly strategic to Accentia's plans for the development and commercialization of Revimmune. We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to reference Baxter's data related to cyclophosphamide not only assures that Accentia will have access to the highest quality supply of cyclophosphamide, but also facilitates Accentia's regulatory strategy and reinforces its market position. With this agreement in place, we are planning a robust clinical and regulatory development strategy to advance our mission to establish Revimmune as a new standard-of-care treatment for patients suffering from autoimmune diseases, including orphan indications with potential accelerated regulatory pathways, as well as major indications such as multiple sclerosis."
Study Results: Revimmune for Multiple Sclerosis
Researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune.
An article titled "Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis" was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient's functional status.
Accentia believes these preliminary results to be unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up.
Other Potential Autoimmune Indications:
In addition to multiple sclerosis, investigators at Johns Hopkins have successfully treated the following autoimmune diseases in preliminary studies and case experiences: Systemic Lupus; Myasthenia Gravis; Aplastic Anemia; Autoimmune Hemolytic Anemia; Refractory Scleroderma; Acquired Pemphigus; Rheumatoid Arthritis and Crohn's Disease.
SinuNase™
Accentia holds the worldwide, exclusive commercial rights to SinuNase (topical amphotericin B 0.01% suspension), an intranasal, low-dose antifungal product, as granted by the Mayo Clinic. SinuNase is especially unique because it is the first product to target what is believed to be the true cause of chronic sinusitis: fungal-induced inflammation. SinuNase is self-administered into a patient's nasal cavity and holds the potential to be the first product approved for treating chronic sinusitis.
Currently, there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMEA) approved treatments for chronic sinusitis, which affects more than 60 million sufferers in the U.S. and Europe. SinuNase is the only intranasal, anti-fungal chronic sinusitis product that has been submitted as an Investigational New Drug (IND) to the FDA, and while SinuNase failed to achieve its primary endpoint in its initial Fast-Track pivotal Phase 3 clinical trial, Accentia found certain encouraging results that warrant further development. Accentia is continuing to analyze these results to determine the optimal course of future clinical development of SinuNase.
More than 60 Million CS Sufferers in U.S. and Europe with Sales Potential > $5B
SinuTest™
Accentia has the exclusive commercial rights in the U.S. to the patented diagnostic, SinuTest™, which is a diagnostic used to measure eMBP (eosinophilic major basic protein) in the nasal mucin of the suspected chronic sinusitis patients. SinuTest is the only confirmatory lab test available for the diagnosis of chronic sinusitis, and it is currently being marketed by Accentia to Ear, Nose and Throat Specialists (ENTs) and Allergy Specialists. SinuTest is expected to provide physicians with a tool to predict those patient candidates best suited to benefit from treatment with SinuNase.
Financial:
On November 17, 2010, Accentia Biopharmaceuticals announced that the Company and its majority-owned subsidiary, Biovest International, have both successfully completed their reorganizations. Pursuant to their respective Plans of Reorganization approved by the bankruptcy court, Accentia and Biovest have now formally exited Chapter 11 as fully restructured organizations.
Conclusion:
Accentia Biopharmaceuticals is now in a better position to achieve significant long-term growth. The pipeline targets multi-billion dollar market opportunities and the recent agreement with Baxter is a great development. Data from Cytoxan will be used in the regulatory process for Revimmune.
Accentia Biopharmaceuticals was trading at $1.50 before the reorganization plan was announced, since then the share price went down to $0.77 and has now stabilized at $0.90. We believe that some debtors sold their shares just after the company has formally exited Chapter 11. We think this is now oversold, the company has many catalysts that should drive the price well over the $1 range again.
It is also actually undervalued by the market based on its majority ownership stake in Biovest International.
Full Disclosure:
-Long position on ABPI, the author owns 30.000 shares at an average price of $1.02
-The Clever bull has NOT been compensated in any way by Accentia to promote or write this article.
The Clever Bull team.
By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.
TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, www.thecleverbull.com, for complete risks and disclosures.
Grüße
mal ein paar Anmerkungen zum 10K:
* zum 30. Sept 2010 hatte ABPI einen 75%igen Anteil an BVTI. Die 7 Mil.$ KE verwässert dies natürlich noch
* zum BiovaxID Trial gab es anscheinend keine Vorgaben seitens der FDA einer subgroup Auswertung. Hier spiele ich speziell IgM und IgG an. DFS bei BiovaxID bei IgM Patienten war 52,9 vs. 28,7 Monaten der Kontrollgruppe. Zum Vergleich DNDNs Provenge ergab hier keinen Vorteil, aber bei OS gab es eine rund 20%ige Verbesserung (24 vs. 20 Monate). BiovaxID DFS Vorteil 44% (44,2 vs. 30,6 Monate). Die Ergebnisse bei MCL (Mantle Cell Lymphoma), sollten auch noch im Hinterkopf behalten werden!
* bei Revimmune werden wohl schwierige Verhandlungen mit der FDA zum Thema Sicherheit (Angst vor Infektionen beim "rebooten"?) erwartet. Die cyclophosphamide Dosis ist in etwa 5 x höher als üblich. Statt MS werden KLEINE Brötchen gebacken: systemic sclerosis und hemolytic anemia heißen die Ziele für Phase III. Finanziell ist MS nicht möglich, stattdessen werden "nur" Patientenzahlen von jährlich 2100 und 2400 anvisiert. Wenn 100 % davon behandelt würden und ein Preis von 50T angesetzt wird, kommt man auf 225 Mil $ Umsatz, was weit entfernt vom potentiellen Blockbuster Umsatz für MS ist.
* SinuNase ist komplett gestorben!
* und zum schlimmsten: Total liabilities 150,262,936!
Naja mal schauen was sich in nächster Zeit so tut... Ich rechne im Anfang Januar mit einem Brief vom CEO an die Investoren, in dem es Klärung und einen Ausblick gibt.
Grüße
* zum 30. Sept 2010 hatte ABPI einen 75%igen Anteil an BVTI. Die 7 Mil.$ KE verwässert dies natürlich noch
* zum BiovaxID Trial gab es anscheinend keine Vorgaben seitens der FDA einer subgroup Auswertung. Hier spiele ich speziell IgM und IgG an. DFS bei BiovaxID bei IgM Patienten war 52,9 vs. 28,7 Monaten der Kontrollgruppe. Zum Vergleich DNDNs Provenge ergab hier keinen Vorteil, aber bei OS gab es eine rund 20%ige Verbesserung (24 vs. 20 Monate). BiovaxID DFS Vorteil 44% (44,2 vs. 30,6 Monate). Die Ergebnisse bei MCL (Mantle Cell Lymphoma), sollten auch noch im Hinterkopf behalten werden!
* bei Revimmune werden wohl schwierige Verhandlungen mit der FDA zum Thema Sicherheit (Angst vor Infektionen beim "rebooten"?) erwartet. Die cyclophosphamide Dosis ist in etwa 5 x höher als üblich. Statt MS werden KLEINE Brötchen gebacken: systemic sclerosis und hemolytic anemia heißen die Ziele für Phase III. Finanziell ist MS nicht möglich, stattdessen werden "nur" Patientenzahlen von jährlich 2100 und 2400 anvisiert. Wenn 100 % davon behandelt würden und ein Preis von 50T angesetzt wird, kommt man auf 225 Mil $ Umsatz, was weit entfernt vom potentiellen Blockbuster Umsatz für MS ist.
* SinuNase ist komplett gestorben!
* und zum schlimmsten: Total liabilities 150,262,936!
Naja mal schauen was sich in nächster Zeit so tut... Ich rechne im Anfang Januar mit einem Brief vom CEO an die Investoren, in dem es Klärung und einen Ausblick gibt.
Grüße
Antwort auf Beitrag Nr.: 40.715.383 von Ackergaul am 15.12.10 15:26:05ich habe jetzt mal meine position bei 0.80$ mit -30% glattgestellt.
der kursverlauf ist nun doch erstaunlich und erscheint mir etwas übertrieben...
sind die ergebnisse bezgl. der unterschiedlichen isotypen-gruppen
doch so viel schlechter als erwartet??
ich sehe es persönlich nicht so, da man sich dem ziel nähert...
aber wie interpretiert ihr folgenden vortrag:
Biovest Reports a Significant Discovery in Cancer Vaccines for Lymphoma: Vaccine Isotype Determines Improvement in Disease-Free Survival Following Vaccine Therapy TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: “BVTI”) today announced at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, an updated Phase III data analysis for BiovaxID®, Biovest’s personalized vaccine for the treatment of non-Hodgkin’s lymphoma. This analysis suggests that the improved disease-free survival following personalized lymphoma vaccine therapy depends on an integral tumor protein fragment administered as part of each patient’s vaccine. In lymphoma, this protein fragment, termed the “isotype”, was previously believed to be unimportant to vaccine response. The new analysis further suggests that patients receiving a vaccine with a specific isotype (IgM) experienced a dramatic disease-free survival benefit.
“Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration in Follicular Lymphoma Patients”
Stephen J. Schuster, M.D., Associate Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania, and BiovaxID study investigator, presented the data at the ASH conference. Dr. Schuster explained, “This significant new data may help shape future cancer vaccine development. Unlike previous vaccine approaches, Biovest manufactures BiovaxID using each patient’s entire tumor protein including both the variable region (idiotype), as well as the heavy-chain isotype. Biovest’s manufacturing process preserves the isotype of the tumor (either IgM or IgG) in each patient’s vaccine. In the study, IgM-positive patients treated with an IgM vaccine and IgG-positive patients treated with IgG vaccine were compared to isotype-matched control patients, and the results were both unanticipated and dramatic. We discovered a fundamental relationship between vaccine isotype and the efficacy of the vaccine.”
According to Carlos F. Santos, Ph.D. Biovest’s Vice President of Scientific Affairs, Product Development & Regulatory Affairs, “This is the ultimate definition of personalized medicine, as we can now screen a patient with a simple diagnostic in advance of vaccine treatment to determine suitability, and then manufacture a vaccine to stimulate each individual’s immune response to target the destruction of their lymphoma. Based on the analysis of our Phase III results reported today, after five-years following vaccination, approximately 42% of the patients treated with IgM-vaccine remained tumor-free as compared to approximately 11% of IgM-positive patients receiving a control vaccine. IgM-positive patients treated with BiovaxID remained tumor-free nearly twice as long (52.9 months median-time-to-relapse) compared to IgM-postive control (28.7 months median-time-to-relapse; p=0.001). In stark contrast, there was no statistically significant difference in disease-free survival observed when comparing the patients treated with IgG-vaccine and IgG-positive control patients. In addition to strengthening the clinical evidence for the efficacy of BiovaxID, these data likely explain why prior lymphoma vaccine clinical trials, such as those by Favrille, Inc. and Genitope Corporation failed; these vaccines universally employed IgG isotype, regardless of the patient’s actual tumor isotype. Notwithstanding the relatively small sample sizes in this analysis, the highly-statistically significant difference in disease-free survival observed makes the isotype-dependent outcome clear and unambiguous. We believe these results expand the industry’s knowledge in the field of cancer vaccines by demonstrating that cancer vaccine isotype profoundly impacts vaccination outcomes.”
Dr. Santos clarified Biovest’s regulatory strategy, “It is important to note that our Phase III study achieved statistical significance for disease-free survival (p=0.045) in the prospectively-identified, modified intent-to-treat population which analyzed all patients who were treated with BiovaxID or control (including IgM and IgG patients). Those previously announced results, which we reported at the ASCO Plenary Session last year, form the foundation for our regulatory strategy. Our discovery of the relationship between isotype and clinical benefit represents a significant discovery for cancer vaccine development, and comprises but one of a number of potentially important analyses which we are currently conducting. Accordingly, we believe that the findings reported today will further cement the efficacy of BiovaxID and will play a significant role in our planned regulatory discussions.”
Dr. Schuster presented the following IgM versus IgG BiovaxID Phase III results at ASH this morning. Among the 75 patients receiving BiovaxID in the study, 35 received BiovaxID manufactured with an IgM isotype and 40 received BiovaxID manufactured with an IgG isotype with each treatment vaccine produced to correspond with the patient’s tumor immunoglobulin isotype. Of 40 patients receiving control, 25 had tumors with IgM isotype and 15 had tumors with IgG isotype. Two of the patients in the vaccinated treatment/control population had a tumor with mixed IgM/IgG isotypes and were excluded from this analysis. Among 35 patients with IgM tumor isotype receiving BiovaxID manufactured with an IgM isotype, median time to relapse after randomization was 52.9 months versus 28.7 months in the IgM tumor isotype control-treated patients (log-rank p=0.001; HR=0.34 (p=0.002); [95% CI: 0.17-0.68]. Among 40 patients with IgG tumor isotype receiving BiovaxiD manufactured with an IgG isotype, median time to relapse after randomization was 35.1 months, versus 32.4 months in control-treated patients with IgG tumor isotype (log-rank p=0.807; HR=1.1 (p=0.807): [95% CI: 0.50-2.44].
Biovest’s President, Mr. Samuel S. Duffey, stated, “It is our sincere hope that this new data and its impact on future cancer vaccine development will be important to patients suffering from lymphoma. There is no other cancer vaccine that we are aware of, either approved or in clinical trials, that has conducted an isotype/idiotype analysis such as that reported today for BiovaxID. We believe that this new data may have potentially paradigm-changing implications to the future of cancer vaccine development and accordingly, we have filed new patent applications in order to add another layer of protection for BiovaxID, as well as potentially covering other new vaccines and products that may be developed based on this technology.”
The abstract, “Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration in Follicular Lymphoma Patients”, reporting on the BiovaxID Phase III results can be accessed at the ASH website by visiting: http://ash.confex.com/ash/2010/webprogram/Paper34600.html
This evening, Biovest and ROTH Capital Partners, LLC will host a reception at the Ritz-Carlton Hotel, Orlando Grande Lakes, to further discuss the data with a panel of key opinion leaders.
warum gerät die aktie derart unter "die räder"...was meint ihr???
der kursverlauf ist nun doch erstaunlich und erscheint mir etwas übertrieben...
sind die ergebnisse bezgl. der unterschiedlichen isotypen-gruppen
doch so viel schlechter als erwartet??
ich sehe es persönlich nicht so, da man sich dem ziel nähert...
aber wie interpretiert ihr folgenden vortrag:
Biovest Reports a Significant Discovery in Cancer Vaccines for Lymphoma: Vaccine Isotype Determines Improvement in Disease-Free Survival Following Vaccine Therapy TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: “BVTI”) today announced at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, an updated Phase III data analysis for BiovaxID®, Biovest’s personalized vaccine for the treatment of non-Hodgkin’s lymphoma. This analysis suggests that the improved disease-free survival following personalized lymphoma vaccine therapy depends on an integral tumor protein fragment administered as part of each patient’s vaccine. In lymphoma, this protein fragment, termed the “isotype”, was previously believed to be unimportant to vaccine response. The new analysis further suggests that patients receiving a vaccine with a specific isotype (IgM) experienced a dramatic disease-free survival benefit.
“Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration in Follicular Lymphoma Patients”
Stephen J. Schuster, M.D., Associate Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania, and BiovaxID study investigator, presented the data at the ASH conference. Dr. Schuster explained, “This significant new data may help shape future cancer vaccine development. Unlike previous vaccine approaches, Biovest manufactures BiovaxID using each patient’s entire tumor protein including both the variable region (idiotype), as well as the heavy-chain isotype. Biovest’s manufacturing process preserves the isotype of the tumor (either IgM or IgG) in each patient’s vaccine. In the study, IgM-positive patients treated with an IgM vaccine and IgG-positive patients treated with IgG vaccine were compared to isotype-matched control patients, and the results were both unanticipated and dramatic. We discovered a fundamental relationship between vaccine isotype and the efficacy of the vaccine.”
According to Carlos F. Santos, Ph.D. Biovest’s Vice President of Scientific Affairs, Product Development & Regulatory Affairs, “This is the ultimate definition of personalized medicine, as we can now screen a patient with a simple diagnostic in advance of vaccine treatment to determine suitability, and then manufacture a vaccine to stimulate each individual’s immune response to target the destruction of their lymphoma. Based on the analysis of our Phase III results reported today, after five-years following vaccination, approximately 42% of the patients treated with IgM-vaccine remained tumor-free as compared to approximately 11% of IgM-positive patients receiving a control vaccine. IgM-positive patients treated with BiovaxID remained tumor-free nearly twice as long (52.9 months median-time-to-relapse) compared to IgM-postive control (28.7 months median-time-to-relapse; p=0.001). In stark contrast, there was no statistically significant difference in disease-free survival observed when comparing the patients treated with IgG-vaccine and IgG-positive control patients. In addition to strengthening the clinical evidence for the efficacy of BiovaxID, these data likely explain why prior lymphoma vaccine clinical trials, such as those by Favrille, Inc. and Genitope Corporation failed; these vaccines universally employed IgG isotype, regardless of the patient’s actual tumor isotype. Notwithstanding the relatively small sample sizes in this analysis, the highly-statistically significant difference in disease-free survival observed makes the isotype-dependent outcome clear and unambiguous. We believe these results expand the industry’s knowledge in the field of cancer vaccines by demonstrating that cancer vaccine isotype profoundly impacts vaccination outcomes.”
Dr. Santos clarified Biovest’s regulatory strategy, “It is important to note that our Phase III study achieved statistical significance for disease-free survival (p=0.045) in the prospectively-identified, modified intent-to-treat population which analyzed all patients who were treated with BiovaxID or control (including IgM and IgG patients). Those previously announced results, which we reported at the ASCO Plenary Session last year, form the foundation for our regulatory strategy. Our discovery of the relationship between isotype and clinical benefit represents a significant discovery for cancer vaccine development, and comprises but one of a number of potentially important analyses which we are currently conducting. Accordingly, we believe that the findings reported today will further cement the efficacy of BiovaxID and will play a significant role in our planned regulatory discussions.”
Dr. Schuster presented the following IgM versus IgG BiovaxID Phase III results at ASH this morning. Among the 75 patients receiving BiovaxID in the study, 35 received BiovaxID manufactured with an IgM isotype and 40 received BiovaxID manufactured with an IgG isotype with each treatment vaccine produced to correspond with the patient’s tumor immunoglobulin isotype. Of 40 patients receiving control, 25 had tumors with IgM isotype and 15 had tumors with IgG isotype. Two of the patients in the vaccinated treatment/control population had a tumor with mixed IgM/IgG isotypes and were excluded from this analysis. Among 35 patients with IgM tumor isotype receiving BiovaxID manufactured with an IgM isotype, median time to relapse after randomization was 52.9 months versus 28.7 months in the IgM tumor isotype control-treated patients (log-rank p=0.001; HR=0.34 (p=0.002); [95% CI: 0.17-0.68]. Among 40 patients with IgG tumor isotype receiving BiovaxiD manufactured with an IgG isotype, median time to relapse after randomization was 35.1 months, versus 32.4 months in control-treated patients with IgG tumor isotype (log-rank p=0.807; HR=1.1 (p=0.807): [95% CI: 0.50-2.44].
Biovest’s President, Mr. Samuel S. Duffey, stated, “It is our sincere hope that this new data and its impact on future cancer vaccine development will be important to patients suffering from lymphoma. There is no other cancer vaccine that we are aware of, either approved or in clinical trials, that has conducted an isotype/idiotype analysis such as that reported today for BiovaxID. We believe that this new data may have potentially paradigm-changing implications to the future of cancer vaccine development and accordingly, we have filed new patent applications in order to add another layer of protection for BiovaxID, as well as potentially covering other new vaccines and products that may be developed based on this technology.”
The abstract, “Vaccination with IgM but Not IgG Idiotype Prolongs Remission Duration in Follicular Lymphoma Patients”, reporting on the BiovaxID Phase III results can be accessed at the ASH website by visiting: http://ash.confex.com/ash/2010/webprogram/Paper34600.html
This evening, Biovest and ROTH Capital Partners, LLC will host a reception at the Ritz-Carlton Hotel, Orlando Grande Lakes, to further discuss the data with a panel of key opinion leaders.
warum gerät die aktie derart unter "die räder"...was meint ihr???
Antwort auf Beitrag Nr.: 40.725.598 von Gustl24 am 17.12.10 06:04:42sind es die liabilities, welche auf der company lasten - gab es hier änderungen
im rahmen der reorganisation...?
oder wird accentia immer mehr zu einem one-trick-pony mit biovaxID,
da revimmune "gestutzt werden musste" und einfach kein geld für weitere und
zu aufwändige studien da ist...
im rahmen der reorganisation...?
oder wird accentia immer mehr zu einem one-trick-pony mit biovaxID,
da revimmune "gestutzt werden musste" und einfach kein geld für weitere und
zu aufwändige studien da ist...
Antwort auf Beitrag Nr.: 40.725.607 von Gustl24 am 17.12.10 06:20:55was hier derzeit abgeht, ist nicht nachzuvollziehen. Zum Zeitpunkt Chapter 11 stand ABPI mehr als 3 x höher da, als Momentan. Die Umsatz Aussichten von BiovaxID (und Revimmune) kristallisieren sich zwar schlechter als erwartet heraus, dennoch???
Habe hier seit längeren aber auch nicht mehr nach der BiovaxID "Konkurenz" gesucht. Mag sein das in den letzten Wochen eine Studie bei FL veröffentlicht wurde die die Chancen von BiovaxID schmälern oder ähnliches...
Bin aüßerst verwundert wie ABPI nach unten geknüppelt wird, mit eigentlich normalen Umsätzen.
Grüße
Habe hier seit längeren aber auch nicht mehr nach der BiovaxID "Konkurenz" gesucht. Mag sein das in den letzten Wochen eine Studie bei FL veröffentlicht wurde die die Chancen von BiovaxID schmälern oder ähnliches...
Bin aüßerst verwundert wie ABPI nach unten geknüppelt wird, mit eigentlich normalen Umsätzen.
Grüße
Antwort auf Beitrag Nr.: 40.726.675 von Ackergaul am 17.12.10 10:30:06das Spielchen soll nun einer verstehen...
Ich nicht.
Grüße
Ich nicht.
Grüße
das Pearce geht ist doch überraschend... Mal sehen ob es am 19. Januar Infos gibt!
Accentia CFO resigns
By: Gulf Coast Business Review
January 07, 2011
TAMPA — Accentia Biopharmaceuticals Chief Financial Officer Alan Pearce resigned from his position with the company at the end of 2010, a filing with the Securities & Exchange Commission shows.
Pearce will remain with the company as a director until its next annual shareholder meeting, scheduled for Jan. 19.
Along with its subsidiary Biovest International Inc., Accentia emerged from Chapter 11 bankruptcy in November of last year. With $10.46 million in revenues, the company lost $47.8 million in the twelve months ended Sept. 30, 2010.
Grüße
Accentia CFO resigns
By: Gulf Coast Business Review
January 07, 2011
TAMPA — Accentia Biopharmaceuticals Chief Financial Officer Alan Pearce resigned from his position with the company at the end of 2010, a filing with the Securities & Exchange Commission shows.
Pearce will remain with the company as a director until its next annual shareholder meeting, scheduled for Jan. 19.
Along with its subsidiary Biovest International Inc., Accentia emerged from Chapter 11 bankruptcy in November of last year. With $10.46 million in revenues, the company lost $47.8 million in the twelve months ended Sept. 30, 2010.
Grüße
aus der 8K Präsentation:
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?F…
Expected Key Milestones: BiovaxID
• Report additional BiovaxID Phase III data to support regulatory filings, including immune response data (a secondary endpoint) with analysis ongoing at MD Anderson Cancer Center
• Accelerate the advancement of BiovaxID through strategic partnership(s)
• Meet with FDA and other international regulatory agencies to determine regulatory pathway in seeking approval(s)
• Obtain Orphan Drug designation from EMA for BiovaxID for mantle cell lymphoma indication (10-years of market exclusivity in EU and other regulatory benefits)
• Announce private/public partnership with non-dilutive funding to expand Minneapolis Cell Culture Center to accommodate production of BiovaxID
• Publish Phase III BiovaxID follicular lymphoma results in leading cancer peer-review journal
ABPI hat nach der Präsentation zufolge 2/3 aller BVTI Aktien.
Grüße
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?F…
Expected Key Milestones: BiovaxID
• Report additional BiovaxID Phase III data to support regulatory filings, including immune response data (a secondary endpoint) with analysis ongoing at MD Anderson Cancer Center
• Accelerate the advancement of BiovaxID through strategic partnership(s)
• Meet with FDA and other international regulatory agencies to determine regulatory pathway in seeking approval(s)
• Obtain Orphan Drug designation from EMA for BiovaxID for mantle cell lymphoma indication (10-years of market exclusivity in EU and other regulatory benefits)
• Announce private/public partnership with non-dilutive funding to expand Minneapolis Cell Culture Center to accommodate production of BiovaxID
• Publish Phase III BiovaxID follicular lymphoma results in leading cancer peer-review journal
ABPI hat nach der Präsentation zufolge 2/3 aller BVTI Aktien.
Grüße
im Biotech Mailbag von Feuerstein gab es am Freitag harsche Kritik:
In a December Mailbag column about BioVest(BVTI.PK) in which I expressed skepticism about the company's lymphoma
vaccine BioVaxID, I wrote:
"Investors and potential partners were clearly skeptical about the BiovaxID data, and rightly so because the results likely
over-stage the vaccine's efficacy. The study, as designed, uses an unconventional accounting of patient responses,
essentially not starting the disease-progression clock until six months after patients are treated initially with a standard
regime of drugs used to put the cancer into remission."
This prompted an email response from Biovest spokesperson Doug Calder:
"I'm not quite sure I understand the point you are trying to make as the data reported as the 2009 ASCO Plenary Session
measured disease-free survival for vaccinated patients (BiovaxID or control) from the time of randomization. And the
patients had to complete chemotherapy and achieve a complete remission in order to be randomized. As the mechanism of
action for active immunotherapy is to prime the immune system, it only makes sense to eliminate the immune-compromised
state of the patient prior to vaccination, thus the trial design. If you are suggesting that the DFS clock starts six months
following randomization, you are entirely incorrect.
"Or perhaps you are questioning why patients were not vaccinated when randomized? The reason for this was related to an
approximate 6-12 month delay to allow patients to have an immune recovery period (post-chemotherapy), again consistent
with a vaccination approach. This delay is immaterial in measuring clinical benefit for the reason I mentioned before being
that the results were measured from time of randomization for both cohorts."
I'm sticking with my bearish thesis: The FDA will not approve BiovaxID based because the phase III study was flawed and
produced biased results that skewed the true efficacy of the vaccine. I'm not the only person who believes this to be true.
So did Dr. Ron Levy, the ASCO 2009 plenary session discussant who reviewed the phase III BiovaxID data. I encourage
anyone conducting due diligence on Biovest to watch the 15-minute video of Levy's presentation that can be found on the
ASCO web site.
The more relevant reason Biovest chose not to randomize patients at the beginning of the study is because manufacturing
the BiovaxID vaccine can take as long as six months. That means there wasn't any vaccine for patients to receive when
they entered the study.
By requiring patients to complete six months of chemotherapy first, then achieve and maintain a complete remission,
Biovest eliminates a wide swath of lymphoma patients who don't respond to initial treatment. In other words, Biovest makes
believe that some really sick patients don't exist when it comes to measuring the efficacy of BiovaxID.
Said Levy, in his ASCO presentation: "The patients who made it to this [BiovaxID] trial are the best of the best -- the ones
who could get a complete response and hold it for as long as a year after being deemed a complete response."
This is why the BiovaxID study was positive (barely so) only using a modified intent-to-treat analysis. The FDA doesn't use
modified-ITT to analyze clinical data. Instead, the agency will look at an intent-to-treat population that includes all patients,
even those who didn't achieve or maintain a complete response to chemo prior to vaccination with BiovaxID.
The more stringent ITT analysis of the BiovaxID phase III study failed:
Again, Levy:
"The analysis by ITT was negative. Of course, this is the most conservative way to analyze the data. It avoids the biases
that can creep in as patients are lost from their respective assigned arms in a long waiting period after the randomization
occurred. So that analysis which we would have liked to see positive was negative."
Ich bin kein Fan von Feuerstein, finde seine Beiträge aber immer hochinteressant vor allem weil er nicht immer rosarot sieht oder sehen will... Dennoch muss man hier jetzt aber relativieren:
Feuerstein und sein werter Kollege David Miller hatten, bevor die BiovaxID Daten damals veröffentlicht wurden, bereits ihre negative Meinung aufgebaut: BiovaxID wirkt nicht. Nachdem dann überraschend(?) die Ergebnisse statistich signifikante Resultate brachten (44.2 Monate vs. 30.6 Monate entspricht hier ein p = 0.045) gab Miller zu bedenken, das der Zeitpunkt der "Randomisierung", also die ungefähren 6 Monate Wartezeit bis die Patienten BiovaxID erhielten, den Ausschlag für den positiven p-Wert gebracht hatten. Feuerstein hielt sich mehr zurück, bekräftigte aber die Meinung von Miller. Diese Einwände wurden geklärt und nach wie vor stehen der wichtige p-Wert und wurde auch so auf der plenary session der ASCO kundgetan. Dies war im übrigen eine Art Adelung für BiovaxID und Biovest denn hier präsentieren sich eignetlich nur die Größen wie Genentech oder ähnliche Kaliber!
Nun wird eine neue Baustelle aufgemacht: ITT. Das bedeutet das Feuerstein und Levy der Ansicht sind das nicht alle Patienten in die Auswertung gerutscht sind und deswegn die Studie positive Ergebnisse vorweist. In meinen Augen ist dies so nicht fair! Biovest hatte die Studie so aufgebaut, das nur Patienten die komplett auf die Chemo angeschlagen hatten mit BiovaxID behandelt werden. Von den 177 Patienten konnten somit nur noch 117 entweder Placebo (41) oder BiovaxID (76) erhalten. Werden die kompletten 177 Patienten mit einberechnet dann ist das Ergebnis nie und nimmer signifikant!
Wie auch immer, wo Feuerstein recht hat ist, das hier natürlich zahlreiche Patienten wegfallen, was natürlich kommerziell auch nicht BVTI und ABPI gut tut. Aber die Kritik lediglich die besten Patienten bahndeln zu wollen, also die Rosinen heraus zu picken kann ich nicht nachvollziehen:
Wenn man diesen Patienten helfen kann die Überlebenschancen deutlich zu steigern, was ist daran falsch?
Trotz allem denke ich aber auch das die FDA BiovaxID so nicht zulassen wird, da die Studie zu klein war und natürlich dadurch die Chance auf falsch positive Ergebnisse vergrößert hat. Aber bei der FDA weiß man auch nie so genau...
Grüße
In a December Mailbag column about BioVest(BVTI.PK) in which I expressed skepticism about the company's lymphoma
vaccine BioVaxID, I wrote:
"Investors and potential partners were clearly skeptical about the BiovaxID data, and rightly so because the results likely
over-stage the vaccine's efficacy. The study, as designed, uses an unconventional accounting of patient responses,
essentially not starting the disease-progression clock until six months after patients are treated initially with a standard
regime of drugs used to put the cancer into remission."
This prompted an email response from Biovest spokesperson Doug Calder:
"I'm not quite sure I understand the point you are trying to make as the data reported as the 2009 ASCO Plenary Session
measured disease-free survival for vaccinated patients (BiovaxID or control) from the time of randomization. And the
patients had to complete chemotherapy and achieve a complete remission in order to be randomized. As the mechanism of
action for active immunotherapy is to prime the immune system, it only makes sense to eliminate the immune-compromised
state of the patient prior to vaccination, thus the trial design. If you are suggesting that the DFS clock starts six months
following randomization, you are entirely incorrect.
"Or perhaps you are questioning why patients were not vaccinated when randomized? The reason for this was related to an
approximate 6-12 month delay to allow patients to have an immune recovery period (post-chemotherapy), again consistent
with a vaccination approach. This delay is immaterial in measuring clinical benefit for the reason I mentioned before being
that the results were measured from time of randomization for both cohorts."
I'm sticking with my bearish thesis: The FDA will not approve BiovaxID based because the phase III study was flawed and
produced biased results that skewed the true efficacy of the vaccine. I'm not the only person who believes this to be true.
So did Dr. Ron Levy, the ASCO 2009 plenary session discussant who reviewed the phase III BiovaxID data. I encourage
anyone conducting due diligence on Biovest to watch the 15-minute video of Levy's presentation that can be found on the
ASCO web site.
The more relevant reason Biovest chose not to randomize patients at the beginning of the study is because manufacturing
the BiovaxID vaccine can take as long as six months. That means there wasn't any vaccine for patients to receive when
they entered the study.
By requiring patients to complete six months of chemotherapy first, then achieve and maintain a complete remission,
Biovest eliminates a wide swath of lymphoma patients who don't respond to initial treatment. In other words, Biovest makes
believe that some really sick patients don't exist when it comes to measuring the efficacy of BiovaxID.
Said Levy, in his ASCO presentation: "The patients who made it to this [BiovaxID] trial are the best of the best -- the ones
who could get a complete response and hold it for as long as a year after being deemed a complete response."
This is why the BiovaxID study was positive (barely so) only using a modified intent-to-treat analysis. The FDA doesn't use
modified-ITT to analyze clinical data. Instead, the agency will look at an intent-to-treat population that includes all patients,
even those who didn't achieve or maintain a complete response to chemo prior to vaccination with BiovaxID.
The more stringent ITT analysis of the BiovaxID phase III study failed:
Again, Levy:
"The analysis by ITT was negative. Of course, this is the most conservative way to analyze the data. It avoids the biases
that can creep in as patients are lost from their respective assigned arms in a long waiting period after the randomization
occurred. So that analysis which we would have liked to see positive was negative."
Ich bin kein Fan von Feuerstein, finde seine Beiträge aber immer hochinteressant vor allem weil er nicht immer rosarot sieht oder sehen will... Dennoch muss man hier jetzt aber relativieren:
Feuerstein und sein werter Kollege David Miller hatten, bevor die BiovaxID Daten damals veröffentlicht wurden, bereits ihre negative Meinung aufgebaut: BiovaxID wirkt nicht. Nachdem dann überraschend(?) die Ergebnisse statistich signifikante Resultate brachten (44.2 Monate vs. 30.6 Monate entspricht hier ein p = 0.045) gab Miller zu bedenken, das der Zeitpunkt der "Randomisierung", also die ungefähren 6 Monate Wartezeit bis die Patienten BiovaxID erhielten, den Ausschlag für den positiven p-Wert gebracht hatten. Feuerstein hielt sich mehr zurück, bekräftigte aber die Meinung von Miller. Diese Einwände wurden geklärt und nach wie vor stehen der wichtige p-Wert und wurde auch so auf der plenary session der ASCO kundgetan. Dies war im übrigen eine Art Adelung für BiovaxID und Biovest denn hier präsentieren sich eignetlich nur die Größen wie Genentech oder ähnliche Kaliber!
Nun wird eine neue Baustelle aufgemacht: ITT. Das bedeutet das Feuerstein und Levy der Ansicht sind das nicht alle Patienten in die Auswertung gerutscht sind und deswegn die Studie positive Ergebnisse vorweist. In meinen Augen ist dies so nicht fair! Biovest hatte die Studie so aufgebaut, das nur Patienten die komplett auf die Chemo angeschlagen hatten mit BiovaxID behandelt werden. Von den 177 Patienten konnten somit nur noch 117 entweder Placebo (41) oder BiovaxID (76) erhalten. Werden die kompletten 177 Patienten mit einberechnet dann ist das Ergebnis nie und nimmer signifikant!
Wie auch immer, wo Feuerstein recht hat ist, das hier natürlich zahlreiche Patienten wegfallen, was natürlich kommerziell auch nicht BVTI und ABPI gut tut. Aber die Kritik lediglich die besten Patienten bahndeln zu wollen, also die Rosinen heraus zu picken kann ich nicht nachvollziehen:
Wenn man diesen Patienten helfen kann die Überlebenschancen deutlich zu steigern, was ist daran falsch?
Trotz allem denke ich aber auch das die FDA BiovaxID so nicht zulassen wird, da die Studie zu klein war und natürlich dadurch die Chance auf falsch positive Ergebnisse vergrößert hat. Aber bei der FDA weiß man auch nie so genau...
Grüße
am 7. Jan. wurde bekanntgegeben das Pearce sich von ABPI zurückzieht. Am 10. hat dieser jedoch noch 66T Aktien geordert...
http://finance.yahoo.com/q/it?s=ABPI.PK+Insider+Transactions
Im übrigen hier noch mal die FAQs auf DE:
http://www.news-medical.net/news/20101221/5150/German.aspx
Biovest Fragen FAQ zu aktualisieren BiovaxID individuell Krebsimpfstoff
21. December 2010 07:49
Biovest International, Inc. (OTCQB: "BVTI") veröffentlichte heute das folgende Update in Form eines "Frequently Asked Questions"-Bericht als Reaktion auf die hohe Volumen der Anfragen, die nach der letzten Präsentation des Unternehmens auf der 2010 American Society of Hematology Annual Meeting (ASH 2010) in Orlando, Florida.
BiovaxID Phase-III-Übersicht
In der BiovaxID Phase III der klinischen Studie wurden Patienten mit follikulärem Lymphom im ersten Remission mit BiovaxID ®, eine personalisierte Krebsimpfstoff ursprünglich am National Cancer Institute entwickelt oder einem Kontroll-Impfstoff behandelt. In der Studie zeigte Patienten, die BiovaxID erhielten durchschnittlich 13,6 Monate zusätzlicher krankheitsfreien Überlebens (Dauer der Remission) im Vergleich zu Patienten, die eine nicht-spezifische Steuerung Impfstoff erhalten hat. BiovaxID stellt die einzige Lymphom Impfstoff, der zweite Impfstoff gegen Krebs insgesamt zu positiven klinischen Nutzen in einem fertigen, randomisierte Phase-III-Studie demonstrieren.
Wegen der Bedeutung dieser Befunde wurden die Ergebnisse der BiovaxID Phase III der klinischen Studie für eine Präsentation auf 31. Mai 2009 bei einer Plenarsitzung der American Society of Clinical Oncology (ASCO) ausgewählt.
ASH 2010 Zusammenfassung
Im Dezember 2010 wurde Biovest ausgewählt, um zusätzliche Daten aus dem Phase-III-Studie beim ASH 2010. Diese Daten erweitern und verfeinern die Phase-III-Studienergebnisse zuvor berichtet auf der ASCO und weiter zu etablieren BiovaxID klinischen Nutzen bei der Behandlung von Lymphomen. Die Daten ergeben sich aus einer detaillierten Analyse der Biovest's Herstellungsprozess in Verbindung mit den klinischen Ergebnissen beobachtet in der klinischen Phase III. Die Ergebnisse zeigen, dass eine grundlegende Protein charakteristisch BiovaxID zutiefst Auswirkungen klinischen Nutzen nach der Impfung in follikulärem Lymphom.
Zusammenfassend berichtete die Daten auf dem ASH 2010 zeigen, dass die verbesserten krankheitsfreien Überlebens in BiovaxID-behandelten Patienten beobachtet, hängt von einer bestimmten Variante des Tumor-Protein Fragment vorhanden auf jeden Patienten BiovaxID Impfstoff. In Lymphom, kann dieses Protein-Variante (oder Isotyp) zum Zeitpunkt der erstmaligen Tumorbiopsie bestimmt werden, der entweder "IgM" oder "IgG"-Typ sein. Aufgrund der einzigartigen Natur der BiovaxID's Herstellungsprozess, Biovest jeden Patienten spezifischen Tumor Isotyp reproduziert bei der Herstellung von BiovaxID, und daher jeder Patient letztendlich erhält ein Impfstoff, der ihren spezifischen Tumor Isotyp Spiele ("IgM" oder "IgG"). (Siehe Abbildung 1)
Etwa die Hälfte der Patienten (46%) in der klinischen Phase-III-Studie hatte Tumorzellen mit dem IgM-Isotyp Protein (und damit mit BiovaxID mit IgM-Isotyp hergestellt vorgesehen ist), und der Rest hatte Tumorzellen Lager IgG-Isotyp Protein (und damit waren behandelt mit BiovaxID hergestellt mit IgG-Isotyp). Der Tumor Isotyp des Impfstoffes wurde bisher angenommen als unwichtig zu klinischen Nutzen.
Die neue Analyse ergab, dass Patienten BiovaxID Empfang hergestellt mit einem IgM-Isotyp erlebt einen dramatischen krankheitsfreien Überlebens profitieren, während Patienten BiovaxID mit dem IgG-Isotyp nicht erlebt einen klinischen Nutzen von Impfungen hergestellt Empfang.
Häufig gestellte Fragen:
F: Was war 2010 berichtet auf der ASH?
A: ASH 2010, Wissenschaftler und Mitarbeiter berichteten, dass die Biovest Isotyp BiovaxID verwendet bei der Herstellung von zutiefst beeinflusst die Dauer der Remission (krankheitsfreie Überleben). Patienten mit IgM-Version von BiovaxID geimpft erlebte eine statistisch hoch signifikante Zunahme der krankheitsfreien Überlebenszeit (Dauer der Remission) von über zwei Jahren zu kontrollieren behandelten Patienten verglichen. Diese Daten gemeldet beim ASH 2010 klar und eindeutig nachweisen, dass BiovaxID einen wesentlichen Vorteil bietet, um Patienten mit follikulärem Lymphom diagnostiziert.
Die Erkenntnisse auf dem ASH 2010 vorgestellt statistisch hoch signifikant sind und klären Sie die Ergebnisse für die klinische Phase-III-Studie vorgestellt.
Q: Muss der ASH 2010 Ergebnisse stellen eine neue wissenschaftliche Entdeckung?
A: Ja, vor, um die Daten von 2010 vorgestellt Biovest bei ASH, haben die Wissenschaftler nicht erkennen, die entscheidenden Einfluss, dass Impfstoff Isotyp Impfung ist über die Verlängerung der Remission nach Idiotyp. Als ein Beispiel in zwei früheren Phase III der klinischen Studien mit Idiotyp Impfstoffe follikulärem Lymphom zu behandeln, Hersteller universell produziert Impfstoff ausschließlich mit IgG-Isotyp. Beide Studien, die von Genitope Corporation und Favrille, Inc., konnte eine statistisch Verbesserung des krankheitsfreien Überlebens nachweisen. Wie auf dem ASH 2010 berichtet, ähneln die Ergebnisse der Genitope und Favrille Studien die Ergebnisse berichtet für BiovaxID, wenn es mit IgG-Isotyp hergestellt wird, aber sie dagegen signifikant mit der robusten klinischen Nutzen für Patienten mit BiovaxID behandelt wurden, wenn sie mit IgM-Isotyp hergestellt . In der Phase-III-Studie, erfahrenen Patienten IgM BiovaxID ein Durchschnittseinkommen von über zwei Jahren von krankheitsfreien Überlebens im Vergleich zu IgM-Kontroll-Patienten>
F: Wie hat sich die IgM-Version von BiovaxID BiovaxID durchführen, wann im Vergleich zu den IgG-Version?
A: Wie 2010 berichtet auf der ASH, behandelt wurden, mit IgM-Isotyp BiovaxID Patienten eine mediane krankheitsfreie Überleben von über zwei Jahren im Vergleich zu IgM Tumor Isotypkontrolle behandelten Patienten>
Q: Muss der ASH 2010 Daten Auswirkungen Biovest die regulatorischen Strategie BiovaxID suchen Marktzulassung für?
A: Ja, wir erwarten, dass die ASH Daten werden BiovaxID stärken die Wirksamkeit Entschlossenheit und Unterstützung unserer regulatorischen Strategie.
Wir sind für Gespräche mit den Regulierungs-Agenturen, die nächsten Schritte von den Regulierungsbehörden, um für Biovest auf Marktzulassung für BiovaxID suchen müssen klären vor. Während wir unsere geplanten Gespräche mit den Zulassungsbehörden als vertraulich betrachten, können wir im Großen und Ganzen einen Überblick über unsere regulatorische Strategie.
Unsere regulatorische Strategie basiert auf unserer klinischen Phase-III-Studie, die wir glauben, klar und eindeutig Basis zeigt, dass BiovaxID beide sehr sicher und wirksam ist. Die BiovaxID Phase III der klinischen Studie, die vom National Cancer Institute (NCI) entwickelt wurde, bestätigt die Ergebnisse unserer Phase-II-Studie, die auch vom NCI entworfen wurde. Dementsprechend unter unserer regulatorischen Strategie planen wir, die Marktzulassung für BiovaxID basiert auf den kumulierten klinischen Studien abgeschlossen aktuell und ohne Durchführung zusätzlicher langwierige vorherige Genehmigung klinischer Studien zu verfolgen. Unsere Strategie beruht auf den gesamten Körper des Beweises aus klinischen Studien BiovaxID's von denen wir glauben wurden in einem adäquaten und gut kontrollierten klinischen Einstellung durchgeführt wurde. Ferner glauben wir, dass die Daten auf dem ASH 2010 berichtet unterstützt und verdeutlicht die Wirksamkeit von BiovaxID und zeigt deutlich, dass BiovaxID einem robusten klinischen Nutzen bietet, die geimpft Patienten.
Als ein Patienten-spezifischer Impfstoff gegen Krebs, stellt BiovaxID eine neue Klasse von Medikamenten entwickelt, um das Immunsystem der natürlichen Krankheit kämpfen Mechanismus in einer sehr persönlichen und gezielt zu entlocken. Die Wirkungsweise und Ziel von BiovaxID ist völlig anders als jede andere Droge, die zugelassen follikulärem Lymphom zu behandeln, die nicht ausgehärteten und häufig tödlich trotz derzeitiger Behandlungsmethoden bleibt. Unsere regulatorische Strategie erkennt an, dass beschleunigte / bedingten Zulassung darf ein geeigneter Rechtsrahmen Weg sein, auch weil BiovaxID hat Orphan-Drug in den USA und der EU für die Behandlung von follikulärem Lymphom erhalten, die Verwendung von BiovaxID durch ein Bündel von Beweisen aus unterstützt wird drei separaten klinischen Studien; follikulärem Lymphom ist eine ungehärtete, tödliche Krankheit und BiovaxID stellt einen neuen Wirkmechanismus mit robusten klinischen Nutzen. Im Rahmen unserer Strategie der bedingten Zulassung, würden wir erwarten, dass weitere Studien erforderlich wären und dementsprechend auch unsere regulatorische Strategie Phase IV-Studien nach der Zulassung, um mit Eingang von der Zulassungsbehörden konzipiert werden.
Während wir glauben, dass unsere regulatorischen Strategien solide sind, sind wir letztendlich unterliegen Entscheidungen der Regulierungsbehörden gerendert.
F: Wie kann die Isotyp Erkenntnisse Auswirkungen präsentierte auf dem ASH 2010 die klinische Phase-III-Studie die Ergebnisse 2009 vorgestellt auf der ASCO?
A: Die Daten ASH präsentiert auf sind sehr unterstützend der klinischen Phase III-Studienergebnisse 2009 berichtet auf der ASCO. In unserer Phase-III-Studie wurden Patienten mit follikulärem Lymphom im ersten Remission mit BiovaxID behandelt und im Vergleich zu Patienten mit einer Kontrollgruppe Behandlung geimpft. Wie auf der ASCO berichtet, demonstrierte Patienten BiovaxID durchschnittlich 13,6 Monate zusätzlicher krankheitsfreien Überlebens im Vergleich zu Patienten, die eine nicht-spezifische Steuerung Impfstoff erhalten hat. Dieses Ergebnis war statistisch signifikant>
Dementsprechend sind die gesamten Phase-III-Ergebnisse für alle geimpften Patienten noch wirkungsvoller jetzt, wo es klar ist, dass der Patienten mit BiovaxID behandelt, nur die mit dem Impfstoff mit IgM-Isotyp hergestellt, was etwa der Hälfte aller behandelten Patienten behandelt, erhielt profitieren .
F: Sind die Ergebnisse zur Wirksamkeit BiovaxID berichtete auf dem ASH 2010 retrospektiv oder prospektiv in der Natur?
A: Die ASH 2010 Isotyp Ergebnisse, obwohl ursprünglich nicht geplant Protokoll in der Studie analysiert Daten, die die Studie erhoben wurden prospektiv als Teil. Das Studienprotokoll prospektiv festgelegten Aufnahmekriterien, dass nur Patienten mit IgM-oder IgG-positiven Tumoren konnte in der Studie anmelden. Darüber hinaus benötigt das individualisierte Art des BiovaxID prospektive Bestimmung jedes Impfstoffes Isotyp vor Impfstoff herzustellen. Die ASH 2010 gewonnenen Erkenntnisse wurden zwar entdeckt, nachdem die Studie zu dem Schluss, nicht als Ergebnis der statistischen "Data Mining" Techniken angekommen, noch sind die Erkenntnisse in der Natur parteiisch, detaillierte statistische Analysen durchgeführt nach der Entdeckung ferner vorschlagen, dass keine anderen Faktoren (z. B. vor Zyklen der Chemotherapie erhalten, IPI Status bei der Einschreibung, etc.) waren verantwortlich für die beobachteten Unterschiede in den Ergebnissen. Letztlich aber sind diese Daten nicht als eine Teilmenge Analyse sollen die insgesamt positiven Ergebnisse bei geimpften Patienten in Phase III der klinischen Prüfung zu ersetzen angeboten, sondern diese Daten unterstützen nachdrücklich die Bestimmung der Wirksamkeit des Impfstoffs.
F: In follikulärem Lymphom, dies IgG-und IgM-positiven Patienten unterscheiden sich erheblich in Bezug auf die Prognose?
A: Frühere Studien scheinen nicht zu empfehlen Patienten eine starke oder signifikanter Unterschied in der Prognose zwischen IgM-und IgG-positiv. In unserer klinischen Phase-III-Studie, erfahrene IgM-positiven Kontrolle Patienten kürzere mediane Dauer der Remission als IgG-positiven Patienten (28,7 Monate versus 32,4 Monate; Log-Rank->
In unserer Phase III-Studie zeigte BiovaxID IgM-Impfstoff behandelten Patienten eine statistisch hoch signifikante Verbesserung des krankheitsfreien Überlebens (52,9 Monate versus 30,6 Monate; Log-Rank->
Dementsprechend glauben wir, dass es keine signifikanten Faktoren in der klinischen Studie, dass der Unterschied in den klinischen Nutzen zwischen den IgM-und IgG-Kohorte mit Ausnahme der Auswirkungen der BiovaxID mit IgM-Isotyp hergestellt Vergleich zu BiovaxID hergestellt mit IgG-Isotyp würde erklären.
F: Wie vor Phase III der klinischen Studienergebnisse berichtet von Genitope und Favrille in follikulärem Lymphom Auswirkungen der Biovest klinischen Phase-III-Studie?
A: Die Phase-III-Studien unter der Leitung von Favrille Genitope und jeder ausgewertet Idiotyp Impfstoffe hergestellt nur mit IgG-Isotyp (unabhängig von der Tumor-Isotyp). Diese Studien leider nicht statistisch signifikanten klinischen Nutzen zu zeigen. Von Anfang an hat Biovest öffentlich behauptet, dass High-Fidelity-Wiedergabe von Lymphomen Idiotyp Proteins könnte von grundlegender Bedeutung für die Wirksamkeit von Impfstoffen gegen Krebs beim follikulären Lymphom. Biovest's Hybridom Fertigungssystem produziert Impfstoffe unterscheiden sich grundlegend von den rekombinanten Methoden in Genitope und Favrille-Impfstoffe, die eine universelle IgG-Isotyp benutzt beschäftigt.
Die BiovaxID klinischen Studien untersucht Impfstoffe mit IgM-Isotyp Impfstoff hergestellt, wenn der Patient an Krebs erkrankte Zellen wurden als IgM und hergestellt Impfstoffe mit IgG-Isotypen, wenn der Patient die Krebszellen als IgG klassifiziert eingestuft wurden. Die Genitope und Favrille Studien jeder gegen klinischen Nutzen Bericht während der BiovaxID-Studie ergab statistisch signifikante klinische Vorteile sowohl für alle geimpften Patienten und insbesondere für die IgM geimpft Patientenpopulation. Interessanterweise sind die Ergebnisse für Genitope und Favrille's IgG-Isotyp Impfstoffe in der Regel entsprechen die beobachteten Ergebnisse für die IgG-Isotyp Impfstoffen in der BiovaxID klinischen Studie (in denen IgG-geimpften Patienten nicht profitieren von Impfungen) untersucht. Diese Ergebnisse unterscheiden sich von dramatisch Ergebnisse mit den Patienten mit BiovaxID mit IgM-Isotyp, die eine statistisch hoch signifikante Verbesserung des krankheitsfreien Überlebens erfahrenen hergestellt behandelt wurden.
Dementsprechend meldete die Daten auf dem ASH 2010 unterstützen als einzige Impfstoff gegen Krebs zu robusten klinischen Nutzen im follikulärem Lymphom bieten BiovaxID. Die ASH 2010 Daten deutlich unterscheiden BiovaxID klinischen Studie aus dem Stand der Untersuchungen von Favrille und Genitope damit endgültig beseitigt jede Andeutung, dass die Studien durch Genitope und Favrille in irgendeiner Weise Einfluss auf die Zuverlässigkeit der BiovaxID klinischen Ergebnissen. (Siehe Abbildung 2)
F: Wie kann die ASH 2010 Daten beeinflussen den potenziellen Markt Chance für BiovaxID?
A: Überzeugende klinische Daten nur erhöht die Wahrscheinlichkeit von Arzt und Patient die Annahme erhöhen Marktdurchdringung nach Genehmigung. Zusätzlich veredeln die ASH 2010 Daten unser Verständnis der Nutzen für den Patienten gewonnenen Impfung, die unsere Kosten auswirken wird / Nutzen-Analyse und die Erstattung möglicherweise Matrix für BiovaxID wenn genehmigt.
Q: Wie viel Prozent der Patienten mit follikulärem Lymphom positiven IgM-?
A: Es wird angenommen, dass mindestens 50% der Patienten mit follikulärem Lymphom positiven IgM-, obwohl einige wichtige Meinungsführer positive Meinung der Prozentsatz könnte näher sein als 70% IgM-. Für Mantelzell-Lymphom und bestimmte andere Arten von Lymphomen, einschließlich aggressive Krankheiten, für die es keine Standardtherapie, sind praktisch alle Patienten IgM-positiv.
F: Wie lange dauert es, bis BiovaxID her?
A: Wir schätzen, dass durchschnittlich 3-Monats erforderlich ist, um Patienten Herstellung des Impfstoffs für jeden. Während des Herstellungsprozesses für den Impfstoff BiovaxID ist stark auf den einzelnen Patienten individuell, halten wir es als sehr kontrolliert und vorhersehbar. Während der klinischen Phase-III-Studie erlebten wir ca. 95% Erfolgsquote bei der Herstellung Impfstoffe. Der häufigste Grund für ein Versagen erfolgreich produzieren eines Patienten Impfstoff war die Anwesenheit von seltenen Idiotyp Varianten als auf das Scheitern der einen Schritt im Herstellungsprozess gegenüber.
Q: Ist der klinische Nutzen bei der ASCO 2009 berichtet Randomisierung gemessen ab?
A: Ja, die Daten auf der ASCO berichtet wurde Randomisierung gemessen vom Zeitpunkt der. Zur Klarstellung gab es nicht eine 6-monatige Verzögerung in einem solchen Messung wie einige Internet-Berichte vor kurzem vorgeschlagen haben. Die BiovaxID gemeldeten Daten auf dem 2009 ASCO Plenarsitzung gemessen krankheitsfreie Überleben für zwei prospektiv definierten Populationen von der Randomisierung: alle randomisierten Patienten, und, alle randomisierten Patienten, die entweder mit BiovaxID oder den Kontroll-Impfstoff geimpft wurden. Die statistisch signifikanten Ergebnisse>
Q: Ist BiovaxID wichtig, da Rituximab-haltigen Chemotherapie ist der aktuelle Standard der Behandlung?
A: Ja, BiovaxID ist ein potenziell sehr wichtige therapeutische Option. Follikulärem Lymphom bleibt fast überall unheilbaren und oft tödlich trotz derzeit zugelassenen Therapien, einschließlich Rituximab. Während es scheint klar, dass Rituximab Überleben verlängert durch Verzögerung der Zeit bis zum Rezidiv, dass viele Patienten nicht zu reagieren oder für Rituximab kontraindiziert, und die meisten Patienten werden schließlich gegen Rituximab. So werden zusätzliche Therapien dringend ungeachtet der derzeitigen Standardtherapie benötigt.
BiovaxID stellt eine völlig neue Klasse von Therapien für follikulärem Lymphom. BiovaxID setzt auf eine völlig neue Wirkungsweise, die den Idiotyp-Protein auf der Oberfläche von Krebszellen B-Zellen exprimiert Ziele, nicht aber auf gesunden B-Zellen exprimiert. So soll mit BiovaxID, um das Immunsystem zu entlocken krebsartige B-Zellen als fremd zu identifizieren, um das Immunsystem der natürlichen Krankheit kämpfen Mechanismus verwenden. Im Gegensatz Ziele Rituximab die "CD20"-Rezeptor auf der Oberfläche fast aller B-Zellen, einschließlich gesunde B-Zellen ist. So soll mit Rituximab die Wirkungsweise auf B-Zellen zerstören wahllos in den Körper als einen Weg zur Tumorprogression zu steuern. Da follikulärem Lymphom Rückfall bleibt sehr häufig und schließlich betrifft fast alle Patienten auch mit aktuellen Therapien, neue therapeutische Optionen mit unterschiedlichen Wirkmechanismen sind sehr wichtig.
F: Sind die Ergebnisse der klinischen Phase-III-Studie zuverlässig, da die Studie aufgelaufenen weniger Patienten als ursprünglich gedacht?
A: Ja; Wir glauben, dass die Ergebnisse 2009 sind sehr zuverlässig, obwohl die Anmeldung, die vor dem ASCO anfallenden so viele Patienten wie ursprünglich erwartet. Am berichteten wir, dass trotz dieser geringen Stichprobenumfangs, unsere klinischen Prüfung> zeigte eine statistisch signifikante Verbesserung
Die geringen Stichprobenumfangs kann jedoch heben einige Überlegungen, die als Ganzes überwunden werden, wenn die endgültige Studie Baseline-Charakteristika sind gut ausgeglichen werden, so kann die Aufteilung verborgen ist, und die Studie ist doppelt verblindet. Am ASCO 2009 berichteten wir über die Ergebnisse von 117 behandelten Patienten in einer randomisierten, doppel-blinde Phase-III-Studie, in der beide Studie Arme waren sehr ausgewogenen in allen relevanten Kriterien.
Q: Ist BiovaxID sicher?
A: Ja, das klinischen Phase-III-Studie gezeigt, dass BiovaxID sicher ist hoch. In unserer klinischen Studie wurden sowohl Idiotyp-Impfstoff-und Kontrollgruppen sicher und gut verträglich. Es gab keine statistisch signifikanten Unterschiede in der Häufigkeit oder der Art der unerwünschten Ereignisse beobachtet zwischen den Gruppen. Wie auf der ASCO 2009 berichtet, waren mild (Grad 1-2) Nebenwirkungen in beiden BiovaxID und Kontrollgruppen verbreitet und die häufigste unerwünschte Ereignisse wurden Reaktionen an der Injektionsstelle mild (> 80% der Patienten an jedem Arm). In unserer Studie wurden Grad 3-4 Nebenwirkungen äußerst selten. Es gab keine Impfung zurückzuführen schweren Nebenwirkungen. Diese Ergebnisse Ergebnisse in allen klinischen Studien mit Idiotyp Impfung beobachtet aktuell und entsprechen dem hoch selektiven und gezielten Art der Immunisierung entsprechen.
Biovest Berichte New Manufacturing Contract
In other news berichtete Biovest dass einer der weltweit führenden Medizintechnik-Unternehmen in Auftrag gegeben hat Biovest an einen monoklonalen Antikörper diagnostisches Produkt auf den Biovest Zellkultur-Center in Minneapolis, Minnesota hergestellt werden produzieren. Der Vertrag wird auf ungefähr 350.000 Dollar geschätzt.
Biovest Chief Scientific Officer, Mark Hirshel, Ph.D., sagte: "Wir freuen uns, als der Vertrag Hersteller wurden für diesen neuen Kunden, eine hundertprozentige Tochtergesellschaft eines 18000000000 $ Dollar globale Organisation gewählt. Die Produktpalette, die eine zugelassene monoklonale Antikörper für diagnostische Anwendung bestimmt sind, unter Verwendung unserer Acusyst Hohlfaser-Bioreaktor Instrumentierung, und es ist erfreulich, wenn die Kunden die vielen wesentlichen Vorteile dieser Technologie zu erkennen. Ferner anderen neuen Kunden haben starkes Interesse an unseren Dienstleistungen zum Ausdruck gebracht und erwarten wir zusätzliche Verträge Anfang nächsten Jahres. "
Biovest auch angekündigt, dass sie ihren jährlichen Bericht auf Formular 10-K bei der Securities and Exchange Commission (SEC) für das Geschäftsjahr 30. September 2010 mit dem Bericht mit einem Going-Concern-Qualifikation aus seiner unabhängigen eingetragenen Wirtschaftsprüfungsgesellschaft, Cherry Bekaert & Holland LLP.
Biovest Präsident, Herr Samuel S. Duffey, erklärte: "Wir empfehlen unseren Aktionären zu unserem Geschäftsbericht schreiben, da es enthält auch eine detaillierte Überprüfung der aktualisierten Phase-III-Ergebnisse für BiovaxID bei der ASH-Konferenz vorgestellt. Aus unserer Sicht diese auffallende Entdeckung zeigt, dass die Isotyp eine maßgebliche Rolle bei der Bestimmung klinischen Nutzen für Idiotyp-basierte Impfung Lymphom verbessert die Value Proposition für BiovaxID spielt. "
SOURCE Biovest International, Inc.
Grüße
http://finance.yahoo.com/q/it?s=ABPI.PK+Insider+Transactions
Im übrigen hier noch mal die FAQs auf DE:
http://www.news-medical.net/news/20101221/5150/German.aspx
Biovest Fragen FAQ zu aktualisieren BiovaxID individuell Krebsimpfstoff
21. December 2010 07:49
Biovest International, Inc. (OTCQB: "BVTI") veröffentlichte heute das folgende Update in Form eines "Frequently Asked Questions"-Bericht als Reaktion auf die hohe Volumen der Anfragen, die nach der letzten Präsentation des Unternehmens auf der 2010 American Society of Hematology Annual Meeting (ASH 2010) in Orlando, Florida.
BiovaxID Phase-III-Übersicht
In der BiovaxID Phase III der klinischen Studie wurden Patienten mit follikulärem Lymphom im ersten Remission mit BiovaxID ®, eine personalisierte Krebsimpfstoff ursprünglich am National Cancer Institute entwickelt oder einem Kontroll-Impfstoff behandelt. In der Studie zeigte Patienten, die BiovaxID erhielten durchschnittlich 13,6 Monate zusätzlicher krankheitsfreien Überlebens (Dauer der Remission) im Vergleich zu Patienten, die eine nicht-spezifische Steuerung Impfstoff erhalten hat. BiovaxID stellt die einzige Lymphom Impfstoff, der zweite Impfstoff gegen Krebs insgesamt zu positiven klinischen Nutzen in einem fertigen, randomisierte Phase-III-Studie demonstrieren.
Wegen der Bedeutung dieser Befunde wurden die Ergebnisse der BiovaxID Phase III der klinischen Studie für eine Präsentation auf 31. Mai 2009 bei einer Plenarsitzung der American Society of Clinical Oncology (ASCO) ausgewählt.
ASH 2010 Zusammenfassung
Im Dezember 2010 wurde Biovest ausgewählt, um zusätzliche Daten aus dem Phase-III-Studie beim ASH 2010. Diese Daten erweitern und verfeinern die Phase-III-Studienergebnisse zuvor berichtet auf der ASCO und weiter zu etablieren BiovaxID klinischen Nutzen bei der Behandlung von Lymphomen. Die Daten ergeben sich aus einer detaillierten Analyse der Biovest's Herstellungsprozess in Verbindung mit den klinischen Ergebnissen beobachtet in der klinischen Phase III. Die Ergebnisse zeigen, dass eine grundlegende Protein charakteristisch BiovaxID zutiefst Auswirkungen klinischen Nutzen nach der Impfung in follikulärem Lymphom.
Zusammenfassend berichtete die Daten auf dem ASH 2010 zeigen, dass die verbesserten krankheitsfreien Überlebens in BiovaxID-behandelten Patienten beobachtet, hängt von einer bestimmten Variante des Tumor-Protein Fragment vorhanden auf jeden Patienten BiovaxID Impfstoff. In Lymphom, kann dieses Protein-Variante (oder Isotyp) zum Zeitpunkt der erstmaligen Tumorbiopsie bestimmt werden, der entweder "IgM" oder "IgG"-Typ sein. Aufgrund der einzigartigen Natur der BiovaxID's Herstellungsprozess, Biovest jeden Patienten spezifischen Tumor Isotyp reproduziert bei der Herstellung von BiovaxID, und daher jeder Patient letztendlich erhält ein Impfstoff, der ihren spezifischen Tumor Isotyp Spiele ("IgM" oder "IgG"). (Siehe Abbildung 1)
Etwa die Hälfte der Patienten (46%) in der klinischen Phase-III-Studie hatte Tumorzellen mit dem IgM-Isotyp Protein (und damit mit BiovaxID mit IgM-Isotyp hergestellt vorgesehen ist), und der Rest hatte Tumorzellen Lager IgG-Isotyp Protein (und damit waren behandelt mit BiovaxID hergestellt mit IgG-Isotyp). Der Tumor Isotyp des Impfstoffes wurde bisher angenommen als unwichtig zu klinischen Nutzen.
Die neue Analyse ergab, dass Patienten BiovaxID Empfang hergestellt mit einem IgM-Isotyp erlebt einen dramatischen krankheitsfreien Überlebens profitieren, während Patienten BiovaxID mit dem IgG-Isotyp nicht erlebt einen klinischen Nutzen von Impfungen hergestellt Empfang.
Häufig gestellte Fragen:
F: Was war 2010 berichtet auf der ASH?
A: ASH 2010, Wissenschaftler und Mitarbeiter berichteten, dass die Biovest Isotyp BiovaxID verwendet bei der Herstellung von zutiefst beeinflusst die Dauer der Remission (krankheitsfreie Überleben). Patienten mit IgM-Version von BiovaxID geimpft erlebte eine statistisch hoch signifikante Zunahme der krankheitsfreien Überlebenszeit (Dauer der Remission) von über zwei Jahren zu kontrollieren behandelten Patienten verglichen. Diese Daten gemeldet beim ASH 2010 klar und eindeutig nachweisen, dass BiovaxID einen wesentlichen Vorteil bietet, um Patienten mit follikulärem Lymphom diagnostiziert.
Die Erkenntnisse auf dem ASH 2010 vorgestellt statistisch hoch signifikant sind und klären Sie die Ergebnisse für die klinische Phase-III-Studie vorgestellt.
Q: Muss der ASH 2010 Ergebnisse stellen eine neue wissenschaftliche Entdeckung?
A: Ja, vor, um die Daten von 2010 vorgestellt Biovest bei ASH, haben die Wissenschaftler nicht erkennen, die entscheidenden Einfluss, dass Impfstoff Isotyp Impfung ist über die Verlängerung der Remission nach Idiotyp. Als ein Beispiel in zwei früheren Phase III der klinischen Studien mit Idiotyp Impfstoffe follikulärem Lymphom zu behandeln, Hersteller universell produziert Impfstoff ausschließlich mit IgG-Isotyp. Beide Studien, die von Genitope Corporation und Favrille, Inc., konnte eine statistisch Verbesserung des krankheitsfreien Überlebens nachweisen. Wie auf dem ASH 2010 berichtet, ähneln die Ergebnisse der Genitope und Favrille Studien die Ergebnisse berichtet für BiovaxID, wenn es mit IgG-Isotyp hergestellt wird, aber sie dagegen signifikant mit der robusten klinischen Nutzen für Patienten mit BiovaxID behandelt wurden, wenn sie mit IgM-Isotyp hergestellt . In der Phase-III-Studie, erfahrenen Patienten IgM BiovaxID ein Durchschnittseinkommen von über zwei Jahren von krankheitsfreien Überlebens im Vergleich zu IgM-Kontroll-Patienten>
F: Wie hat sich die IgM-Version von BiovaxID BiovaxID durchführen, wann im Vergleich zu den IgG-Version?
A: Wie 2010 berichtet auf der ASH, behandelt wurden, mit IgM-Isotyp BiovaxID Patienten eine mediane krankheitsfreie Überleben von über zwei Jahren im Vergleich zu IgM Tumor Isotypkontrolle behandelten Patienten>
Q: Muss der ASH 2010 Daten Auswirkungen Biovest die regulatorischen Strategie BiovaxID suchen Marktzulassung für?
A: Ja, wir erwarten, dass die ASH Daten werden BiovaxID stärken die Wirksamkeit Entschlossenheit und Unterstützung unserer regulatorischen Strategie.
Wir sind für Gespräche mit den Regulierungs-Agenturen, die nächsten Schritte von den Regulierungsbehörden, um für Biovest auf Marktzulassung für BiovaxID suchen müssen klären vor. Während wir unsere geplanten Gespräche mit den Zulassungsbehörden als vertraulich betrachten, können wir im Großen und Ganzen einen Überblick über unsere regulatorische Strategie.
Unsere regulatorische Strategie basiert auf unserer klinischen Phase-III-Studie, die wir glauben, klar und eindeutig Basis zeigt, dass BiovaxID beide sehr sicher und wirksam ist. Die BiovaxID Phase III der klinischen Studie, die vom National Cancer Institute (NCI) entwickelt wurde, bestätigt die Ergebnisse unserer Phase-II-Studie, die auch vom NCI entworfen wurde. Dementsprechend unter unserer regulatorischen Strategie planen wir, die Marktzulassung für BiovaxID basiert auf den kumulierten klinischen Studien abgeschlossen aktuell und ohne Durchführung zusätzlicher langwierige vorherige Genehmigung klinischer Studien zu verfolgen. Unsere Strategie beruht auf den gesamten Körper des Beweises aus klinischen Studien BiovaxID's von denen wir glauben wurden in einem adäquaten und gut kontrollierten klinischen Einstellung durchgeführt wurde. Ferner glauben wir, dass die Daten auf dem ASH 2010 berichtet unterstützt und verdeutlicht die Wirksamkeit von BiovaxID und zeigt deutlich, dass BiovaxID einem robusten klinischen Nutzen bietet, die geimpft Patienten.
Als ein Patienten-spezifischer Impfstoff gegen Krebs, stellt BiovaxID eine neue Klasse von Medikamenten entwickelt, um das Immunsystem der natürlichen Krankheit kämpfen Mechanismus in einer sehr persönlichen und gezielt zu entlocken. Die Wirkungsweise und Ziel von BiovaxID ist völlig anders als jede andere Droge, die zugelassen follikulärem Lymphom zu behandeln, die nicht ausgehärteten und häufig tödlich trotz derzeitiger Behandlungsmethoden bleibt. Unsere regulatorische Strategie erkennt an, dass beschleunigte / bedingten Zulassung darf ein geeigneter Rechtsrahmen Weg sein, auch weil BiovaxID hat Orphan-Drug in den USA und der EU für die Behandlung von follikulärem Lymphom erhalten, die Verwendung von BiovaxID durch ein Bündel von Beweisen aus unterstützt wird drei separaten klinischen Studien; follikulärem Lymphom ist eine ungehärtete, tödliche Krankheit und BiovaxID stellt einen neuen Wirkmechanismus mit robusten klinischen Nutzen. Im Rahmen unserer Strategie der bedingten Zulassung, würden wir erwarten, dass weitere Studien erforderlich wären und dementsprechend auch unsere regulatorische Strategie Phase IV-Studien nach der Zulassung, um mit Eingang von der Zulassungsbehörden konzipiert werden.
Während wir glauben, dass unsere regulatorischen Strategien solide sind, sind wir letztendlich unterliegen Entscheidungen der Regulierungsbehörden gerendert.
F: Wie kann die Isotyp Erkenntnisse Auswirkungen präsentierte auf dem ASH 2010 die klinische Phase-III-Studie die Ergebnisse 2009 vorgestellt auf der ASCO?
A: Die Daten ASH präsentiert auf sind sehr unterstützend der klinischen Phase III-Studienergebnisse 2009 berichtet auf der ASCO. In unserer Phase-III-Studie wurden Patienten mit follikulärem Lymphom im ersten Remission mit BiovaxID behandelt und im Vergleich zu Patienten mit einer Kontrollgruppe Behandlung geimpft. Wie auf der ASCO berichtet, demonstrierte Patienten BiovaxID durchschnittlich 13,6 Monate zusätzlicher krankheitsfreien Überlebens im Vergleich zu Patienten, die eine nicht-spezifische Steuerung Impfstoff erhalten hat. Dieses Ergebnis war statistisch signifikant>
Dementsprechend sind die gesamten Phase-III-Ergebnisse für alle geimpften Patienten noch wirkungsvoller jetzt, wo es klar ist, dass der Patienten mit BiovaxID behandelt, nur die mit dem Impfstoff mit IgM-Isotyp hergestellt, was etwa der Hälfte aller behandelten Patienten behandelt, erhielt profitieren .
F: Sind die Ergebnisse zur Wirksamkeit BiovaxID berichtete auf dem ASH 2010 retrospektiv oder prospektiv in der Natur?
A: Die ASH 2010 Isotyp Ergebnisse, obwohl ursprünglich nicht geplant Protokoll in der Studie analysiert Daten, die die Studie erhoben wurden prospektiv als Teil. Das Studienprotokoll prospektiv festgelegten Aufnahmekriterien, dass nur Patienten mit IgM-oder IgG-positiven Tumoren konnte in der Studie anmelden. Darüber hinaus benötigt das individualisierte Art des BiovaxID prospektive Bestimmung jedes Impfstoffes Isotyp vor Impfstoff herzustellen. Die ASH 2010 gewonnenen Erkenntnisse wurden zwar entdeckt, nachdem die Studie zu dem Schluss, nicht als Ergebnis der statistischen "Data Mining" Techniken angekommen, noch sind die Erkenntnisse in der Natur parteiisch, detaillierte statistische Analysen durchgeführt nach der Entdeckung ferner vorschlagen, dass keine anderen Faktoren (z. B. vor Zyklen der Chemotherapie erhalten, IPI Status bei der Einschreibung, etc.) waren verantwortlich für die beobachteten Unterschiede in den Ergebnissen. Letztlich aber sind diese Daten nicht als eine Teilmenge Analyse sollen die insgesamt positiven Ergebnisse bei geimpften Patienten in Phase III der klinischen Prüfung zu ersetzen angeboten, sondern diese Daten unterstützen nachdrücklich die Bestimmung der Wirksamkeit des Impfstoffs.
F: In follikulärem Lymphom, dies IgG-und IgM-positiven Patienten unterscheiden sich erheblich in Bezug auf die Prognose?
A: Frühere Studien scheinen nicht zu empfehlen Patienten eine starke oder signifikanter Unterschied in der Prognose zwischen IgM-und IgG-positiv. In unserer klinischen Phase-III-Studie, erfahrene IgM-positiven Kontrolle Patienten kürzere mediane Dauer der Remission als IgG-positiven Patienten (28,7 Monate versus 32,4 Monate; Log-Rank->
In unserer Phase III-Studie zeigte BiovaxID IgM-Impfstoff behandelten Patienten eine statistisch hoch signifikante Verbesserung des krankheitsfreien Überlebens (52,9 Monate versus 30,6 Monate; Log-Rank->
Dementsprechend glauben wir, dass es keine signifikanten Faktoren in der klinischen Studie, dass der Unterschied in den klinischen Nutzen zwischen den IgM-und IgG-Kohorte mit Ausnahme der Auswirkungen der BiovaxID mit IgM-Isotyp hergestellt Vergleich zu BiovaxID hergestellt mit IgG-Isotyp würde erklären.
F: Wie vor Phase III der klinischen Studienergebnisse berichtet von Genitope und Favrille in follikulärem Lymphom Auswirkungen der Biovest klinischen Phase-III-Studie?
A: Die Phase-III-Studien unter der Leitung von Favrille Genitope und jeder ausgewertet Idiotyp Impfstoffe hergestellt nur mit IgG-Isotyp (unabhängig von der Tumor-Isotyp). Diese Studien leider nicht statistisch signifikanten klinischen Nutzen zu zeigen. Von Anfang an hat Biovest öffentlich behauptet, dass High-Fidelity-Wiedergabe von Lymphomen Idiotyp Proteins könnte von grundlegender Bedeutung für die Wirksamkeit von Impfstoffen gegen Krebs beim follikulären Lymphom. Biovest's Hybridom Fertigungssystem produziert Impfstoffe unterscheiden sich grundlegend von den rekombinanten Methoden in Genitope und Favrille-Impfstoffe, die eine universelle IgG-Isotyp benutzt beschäftigt.
Die BiovaxID klinischen Studien untersucht Impfstoffe mit IgM-Isotyp Impfstoff hergestellt, wenn der Patient an Krebs erkrankte Zellen wurden als IgM und hergestellt Impfstoffe mit IgG-Isotypen, wenn der Patient die Krebszellen als IgG klassifiziert eingestuft wurden. Die Genitope und Favrille Studien jeder gegen klinischen Nutzen Bericht während der BiovaxID-Studie ergab statistisch signifikante klinische Vorteile sowohl für alle geimpften Patienten und insbesondere für die IgM geimpft Patientenpopulation. Interessanterweise sind die Ergebnisse für Genitope und Favrille's IgG-Isotyp Impfstoffe in der Regel entsprechen die beobachteten Ergebnisse für die IgG-Isotyp Impfstoffen in der BiovaxID klinischen Studie (in denen IgG-geimpften Patienten nicht profitieren von Impfungen) untersucht. Diese Ergebnisse unterscheiden sich von dramatisch Ergebnisse mit den Patienten mit BiovaxID mit IgM-Isotyp, die eine statistisch hoch signifikante Verbesserung des krankheitsfreien Überlebens erfahrenen hergestellt behandelt wurden.
Dementsprechend meldete die Daten auf dem ASH 2010 unterstützen als einzige Impfstoff gegen Krebs zu robusten klinischen Nutzen im follikulärem Lymphom bieten BiovaxID. Die ASH 2010 Daten deutlich unterscheiden BiovaxID klinischen Studie aus dem Stand der Untersuchungen von Favrille und Genitope damit endgültig beseitigt jede Andeutung, dass die Studien durch Genitope und Favrille in irgendeiner Weise Einfluss auf die Zuverlässigkeit der BiovaxID klinischen Ergebnissen. (Siehe Abbildung 2)
F: Wie kann die ASH 2010 Daten beeinflussen den potenziellen Markt Chance für BiovaxID?
A: Überzeugende klinische Daten nur erhöht die Wahrscheinlichkeit von Arzt und Patient die Annahme erhöhen Marktdurchdringung nach Genehmigung. Zusätzlich veredeln die ASH 2010 Daten unser Verständnis der Nutzen für den Patienten gewonnenen Impfung, die unsere Kosten auswirken wird / Nutzen-Analyse und die Erstattung möglicherweise Matrix für BiovaxID wenn genehmigt.
Q: Wie viel Prozent der Patienten mit follikulärem Lymphom positiven IgM-?
A: Es wird angenommen, dass mindestens 50% der Patienten mit follikulärem Lymphom positiven IgM-, obwohl einige wichtige Meinungsführer positive Meinung der Prozentsatz könnte näher sein als 70% IgM-. Für Mantelzell-Lymphom und bestimmte andere Arten von Lymphomen, einschließlich aggressive Krankheiten, für die es keine Standardtherapie, sind praktisch alle Patienten IgM-positiv.
F: Wie lange dauert es, bis BiovaxID her?
A: Wir schätzen, dass durchschnittlich 3-Monats erforderlich ist, um Patienten Herstellung des Impfstoffs für jeden. Während des Herstellungsprozesses für den Impfstoff BiovaxID ist stark auf den einzelnen Patienten individuell, halten wir es als sehr kontrolliert und vorhersehbar. Während der klinischen Phase-III-Studie erlebten wir ca. 95% Erfolgsquote bei der Herstellung Impfstoffe. Der häufigste Grund für ein Versagen erfolgreich produzieren eines Patienten Impfstoff war die Anwesenheit von seltenen Idiotyp Varianten als auf das Scheitern der einen Schritt im Herstellungsprozess gegenüber.
Q: Ist der klinische Nutzen bei der ASCO 2009 berichtet Randomisierung gemessen ab?
A: Ja, die Daten auf der ASCO berichtet wurde Randomisierung gemessen vom Zeitpunkt der. Zur Klarstellung gab es nicht eine 6-monatige Verzögerung in einem solchen Messung wie einige Internet-Berichte vor kurzem vorgeschlagen haben. Die BiovaxID gemeldeten Daten auf dem 2009 ASCO Plenarsitzung gemessen krankheitsfreie Überleben für zwei prospektiv definierten Populationen von der Randomisierung: alle randomisierten Patienten, und, alle randomisierten Patienten, die entweder mit BiovaxID oder den Kontroll-Impfstoff geimpft wurden. Die statistisch signifikanten Ergebnisse>
Q: Ist BiovaxID wichtig, da Rituximab-haltigen Chemotherapie ist der aktuelle Standard der Behandlung?
A: Ja, BiovaxID ist ein potenziell sehr wichtige therapeutische Option. Follikulärem Lymphom bleibt fast überall unheilbaren und oft tödlich trotz derzeit zugelassenen Therapien, einschließlich Rituximab. Während es scheint klar, dass Rituximab Überleben verlängert durch Verzögerung der Zeit bis zum Rezidiv, dass viele Patienten nicht zu reagieren oder für Rituximab kontraindiziert, und die meisten Patienten werden schließlich gegen Rituximab. So werden zusätzliche Therapien dringend ungeachtet der derzeitigen Standardtherapie benötigt.
BiovaxID stellt eine völlig neue Klasse von Therapien für follikulärem Lymphom. BiovaxID setzt auf eine völlig neue Wirkungsweise, die den Idiotyp-Protein auf der Oberfläche von Krebszellen B-Zellen exprimiert Ziele, nicht aber auf gesunden B-Zellen exprimiert. So soll mit BiovaxID, um das Immunsystem zu entlocken krebsartige B-Zellen als fremd zu identifizieren, um das Immunsystem der natürlichen Krankheit kämpfen Mechanismus verwenden. Im Gegensatz Ziele Rituximab die "CD20"-Rezeptor auf der Oberfläche fast aller B-Zellen, einschließlich gesunde B-Zellen ist. So soll mit Rituximab die Wirkungsweise auf B-Zellen zerstören wahllos in den Körper als einen Weg zur Tumorprogression zu steuern. Da follikulärem Lymphom Rückfall bleibt sehr häufig und schließlich betrifft fast alle Patienten auch mit aktuellen Therapien, neue therapeutische Optionen mit unterschiedlichen Wirkmechanismen sind sehr wichtig.
F: Sind die Ergebnisse der klinischen Phase-III-Studie zuverlässig, da die Studie aufgelaufenen weniger Patienten als ursprünglich gedacht?
A: Ja; Wir glauben, dass die Ergebnisse 2009 sind sehr zuverlässig, obwohl die Anmeldung, die vor dem ASCO anfallenden so viele Patienten wie ursprünglich erwartet. Am berichteten wir, dass trotz dieser geringen Stichprobenumfangs, unsere klinischen Prüfung> zeigte eine statistisch signifikante Verbesserung
Die geringen Stichprobenumfangs kann jedoch heben einige Überlegungen, die als Ganzes überwunden werden, wenn die endgültige Studie Baseline-Charakteristika sind gut ausgeglichen werden, so kann die Aufteilung verborgen ist, und die Studie ist doppelt verblindet. Am ASCO 2009 berichteten wir über die Ergebnisse von 117 behandelten Patienten in einer randomisierten, doppel-blinde Phase-III-Studie, in der beide Studie Arme waren sehr ausgewogenen in allen relevanten Kriterien.
Q: Ist BiovaxID sicher?
A: Ja, das klinischen Phase-III-Studie gezeigt, dass BiovaxID sicher ist hoch. In unserer klinischen Studie wurden sowohl Idiotyp-Impfstoff-und Kontrollgruppen sicher und gut verträglich. Es gab keine statistisch signifikanten Unterschiede in der Häufigkeit oder der Art der unerwünschten Ereignisse beobachtet zwischen den Gruppen. Wie auf der ASCO 2009 berichtet, waren mild (Grad 1-2) Nebenwirkungen in beiden BiovaxID und Kontrollgruppen verbreitet und die häufigste unerwünschte Ereignisse wurden Reaktionen an der Injektionsstelle mild (> 80% der Patienten an jedem Arm). In unserer Studie wurden Grad 3-4 Nebenwirkungen äußerst selten. Es gab keine Impfung zurückzuführen schweren Nebenwirkungen. Diese Ergebnisse Ergebnisse in allen klinischen Studien mit Idiotyp Impfung beobachtet aktuell und entsprechen dem hoch selektiven und gezielten Art der Immunisierung entsprechen.
Biovest Berichte New Manufacturing Contract
In other news berichtete Biovest dass einer der weltweit führenden Medizintechnik-Unternehmen in Auftrag gegeben hat Biovest an einen monoklonalen Antikörper diagnostisches Produkt auf den Biovest Zellkultur-Center in Minneapolis, Minnesota hergestellt werden produzieren. Der Vertrag wird auf ungefähr 350.000 Dollar geschätzt.
Biovest Chief Scientific Officer, Mark Hirshel, Ph.D., sagte: "Wir freuen uns, als der Vertrag Hersteller wurden für diesen neuen Kunden, eine hundertprozentige Tochtergesellschaft eines 18000000000 $ Dollar globale Organisation gewählt. Die Produktpalette, die eine zugelassene monoklonale Antikörper für diagnostische Anwendung bestimmt sind, unter Verwendung unserer Acusyst Hohlfaser-Bioreaktor Instrumentierung, und es ist erfreulich, wenn die Kunden die vielen wesentlichen Vorteile dieser Technologie zu erkennen. Ferner anderen neuen Kunden haben starkes Interesse an unseren Dienstleistungen zum Ausdruck gebracht und erwarten wir zusätzliche Verträge Anfang nächsten Jahres. "
Biovest auch angekündigt, dass sie ihren jährlichen Bericht auf Formular 10-K bei der Securities and Exchange Commission (SEC) für das Geschäftsjahr 30. September 2010 mit dem Bericht mit einem Going-Concern-Qualifikation aus seiner unabhängigen eingetragenen Wirtschaftsprüfungsgesellschaft, Cherry Bekaert & Holland LLP.
Biovest Präsident, Herr Samuel S. Duffey, erklärte: "Wir empfehlen unseren Aktionären zu unserem Geschäftsbericht schreiben, da es enthält auch eine detaillierte Überprüfung der aktualisierten Phase-III-Ergebnisse für BiovaxID bei der ASH-Konferenz vorgestellt. Aus unserer Sicht diese auffallende Entdeckung zeigt, dass die Isotyp eine maßgebliche Rolle bei der Bestimmung klinischen Nutzen für Idiotyp-basierte Impfung Lymphom verbessert die Value Proposition für BiovaxID spielt. "
SOURCE Biovest International, Inc.
Grüße
die Q-Zahlen fallen enttäuschend aus... das fette Minus von 12 Mil $ lässt sich aber relativieren, durch die 10,4 Mil die einmalig anfallen.
General and Administrative Expenses. Our general and administrative expenses were approximately $12.4 million for
the three months ended December 31, 2010; an increase of $10.9 million over the three months ended December 31,
2009. This increase is primarily due to an increase in share-based compensation of $10.4 million. This increase is
attributable to the expense related to options granted during our bankruptcy with vesting contingent upon our emergence
from bankruptcy in addition to the market value of 1.5 million shares issued to executives on the Effective Date. The
remainder of the increase is primarily due to an increase in professional fees in conjunction with our resumption of
financial statement audits associated with our filings with the Securities and Exchange Commission (“SEC”).
Dennoch sind die Umsätze von knapp 3,7 auf etwa 2,1 Mil gefallen. Ansonsten ist mir nicht wirklich etwas interessantes zum letzten Q-Bericht aufgefallen. Der Schuldenstand stellt sich im übrigen so dar:
Accounts payable and accrued expenses(1)(2)(3) $ 15,232,863
Hybrid financial instrument 3,608,674
Convertible debentures 28,626,149
Laurus term note 8,800,000
Valens 15% convertible note, Biovest 926,300
Secured promissory notes payable to Laurus and the
Valens Funds, Biovest 28,522,108
Unsecured promissory notes payable to Pulaski Bank
and Trust Company(1) 1,161,900
Unsecured promissory note payable to Southwest Bank
of St. Louis 228,330
Southwest line of credit 4,000,000
Notes payable, related parties 2,313,623
Other notes payable 610,683
Minimum royalty due to Laurus on net sales of
AutovaxID instrumentation 6,318,233
Derivative liabilities 40,532,057
Dividend payable 479,452
Other 2,209,756
$ 143,570,128
Ich denke bis zum Ende des 1H 2011 sollten Fortschritte zu BiovaxID (Stand mit der FDA; evtl. auch Verpartnerung); AutovaxID (neue Kontrakte) und Revimmune (SPA mit der FDA oder Plan wann der Phase III Start geplant ist) gemeldet werden, ansonsten ist es fraglich ob hier jemals wieder etwas auf die Beine gestellt wird...
Roth Capital hat im übrigen die Analyse mit BVTI aufgenommen: Kursziel 2 Dollar
Grüße
General and Administrative Expenses. Our general and administrative expenses were approximately $12.4 million for
the three months ended December 31, 2010; an increase of $10.9 million over the three months ended December 31,
2009. This increase is primarily due to an increase in share-based compensation of $10.4 million. This increase is
attributable to the expense related to options granted during our bankruptcy with vesting contingent upon our emergence
from bankruptcy in addition to the market value of 1.5 million shares issued to executives on the Effective Date. The
remainder of the increase is primarily due to an increase in professional fees in conjunction with our resumption of
financial statement audits associated with our filings with the Securities and Exchange Commission (“SEC”).
Dennoch sind die Umsätze von knapp 3,7 auf etwa 2,1 Mil gefallen. Ansonsten ist mir nicht wirklich etwas interessantes zum letzten Q-Bericht aufgefallen. Der Schuldenstand stellt sich im übrigen so dar:
Accounts payable and accrued expenses(1)(2)(3) $ 15,232,863
Hybrid financial instrument 3,608,674
Convertible debentures 28,626,149
Laurus term note 8,800,000
Valens 15% convertible note, Biovest 926,300
Secured promissory notes payable to Laurus and the
Valens Funds, Biovest 28,522,108
Unsecured promissory notes payable to Pulaski Bank
and Trust Company(1) 1,161,900
Unsecured promissory note payable to Southwest Bank
of St. Louis 228,330
Southwest line of credit 4,000,000
Notes payable, related parties 2,313,623
Other notes payable 610,683
Minimum royalty due to Laurus on net sales of
AutovaxID instrumentation 6,318,233
Derivative liabilities 40,532,057
Dividend payable 479,452
Other 2,209,756
$ 143,570,128
Ich denke bis zum Ende des 1H 2011 sollten Fortschritte zu BiovaxID (Stand mit der FDA; evtl. auch Verpartnerung); AutovaxID (neue Kontrakte) und Revimmune (SPA mit der FDA oder Plan wann der Phase III Start geplant ist) gemeldet werden, ansonsten ist es fraglich ob hier jemals wieder etwas auf die Beine gestellt wird...
Roth Capital hat im übrigen die Analyse mit BVTI aufgenommen: Kursziel 2 Dollar
Grüße
mal abwarten "wann hier noch was kommt"...
http://blogs.wsj.com/bankruptcy/2011/04/05/company-sees-bank…
April 5, 2011, 4:06 PM ET
Company Sees Bankruptcy as Boon to Cancer Vaccine
By Rachel Feintzeig
To hear Sam Duffy tell it, bankruptcy was the best thing that could have happened to Biovest International Inc.
The company, which is edging closer to its goal of bringing a personalized lymphoma vaccine to market, has seen a string of successes recently, from honors at oncology conferences to the announcement of public funding for its Minnesota manufacturing plan (made with Senator Al Franken in tow). But Duffy, the company’s chief executive, claims that those wins might never have materialized if the company hadn’t hit a financial low two years ago.
“Bankruptcy reorganization has been incredibly positive as an experience for us,” he said. “It has allowed us to do things that even if the finance market had not closed and we could have continued going on we would never be where we are today.”
Biovest entered bankruptcy protection alongside parent company Accentia Pharmaceuticals Inc. in November of 2008. Loaded up with debt in the midst of a global credit crunch, the company had trouble tapping into financing. By the end of October 2008, Accentia was carrying $31.3 million in secured debt and $30.1 million in unsecured debt, while Biovest’s secured and unsecured liabilities topped $47 million, according to court papers.
The company launched its bankruptcy proceedings—which would end up lasting two years—with the goal of restructuring all of the nitty-gritty pieces that can drag a company down: contracts, overhead costs, royalty burdens, capital structure. But while the company’s professionals—including attorneys and specialists brought on board to handle the bankruptcy—tackled those intricate issues, the company’s leaders found themselves able to take a bigger-picture approach to the business.
“Along with [bankruptcy] came the opportunity, while we were out of the hustle and bustle of being a public company, to really think about fundamental things that were important to the success of the company,” Duffy said. “I’m not so sure that you can establish a sea change in philosophy in the heat of the battle, but you certainly can do it in reorganization.”
One of the “fundamental things” that the company decided to refocus on was the cancer vaccine itself, which gained “tremendous ground” during the company’s two-year stint in bankruptcy, Duffy said.
The vaccine, known as BiovaxID, harnesses the power of a patient’s immune system to target cancer cells. It’s created from the patient’s own tumor cells, obtained during a biopsy, and then injected back into the patient, where its “sole mission in life is to alert the immune system” that the cancer cells are diseased and need to be attacked, Duffy said.
The vaccine, which has been shown to extend patients’ cancer-free survival period by two years, was originally developed at the National Cancer Institute, which then partnered with the company to bring it to market. Currently, Biovest is in the “very late stages” of seeking regulatory approval for the drug, Duffy said, and hopes to have all its required data into the Federal Drug Administration by the end of this year.
The company’s new reality represents a startling turnaround that continues to surprise the company’s CEO and his management team.
“We still pinch ourselves to say, ‘Look how far we’ve come,’” Duffy said. “We do this on at least a weekly basis.”
Grüße
http://blogs.wsj.com/bankruptcy/2011/04/05/company-sees-bank…
April 5, 2011, 4:06 PM ET
Company Sees Bankruptcy as Boon to Cancer Vaccine
By Rachel Feintzeig
To hear Sam Duffy tell it, bankruptcy was the best thing that could have happened to Biovest International Inc.
The company, which is edging closer to its goal of bringing a personalized lymphoma vaccine to market, has seen a string of successes recently, from honors at oncology conferences to the announcement of public funding for its Minnesota manufacturing plan (made with Senator Al Franken in tow). But Duffy, the company’s chief executive, claims that those wins might never have materialized if the company hadn’t hit a financial low two years ago.
“Bankruptcy reorganization has been incredibly positive as an experience for us,” he said. “It has allowed us to do things that even if the finance market had not closed and we could have continued going on we would never be where we are today.”
Biovest entered bankruptcy protection alongside parent company Accentia Pharmaceuticals Inc. in November of 2008. Loaded up with debt in the midst of a global credit crunch, the company had trouble tapping into financing. By the end of October 2008, Accentia was carrying $31.3 million in secured debt and $30.1 million in unsecured debt, while Biovest’s secured and unsecured liabilities topped $47 million, according to court papers.
The company launched its bankruptcy proceedings—which would end up lasting two years—with the goal of restructuring all of the nitty-gritty pieces that can drag a company down: contracts, overhead costs, royalty burdens, capital structure. But while the company’s professionals—including attorneys and specialists brought on board to handle the bankruptcy—tackled those intricate issues, the company’s leaders found themselves able to take a bigger-picture approach to the business.
“Along with [bankruptcy] came the opportunity, while we were out of the hustle and bustle of being a public company, to really think about fundamental things that were important to the success of the company,” Duffy said. “I’m not so sure that you can establish a sea change in philosophy in the heat of the battle, but you certainly can do it in reorganization.”
One of the “fundamental things” that the company decided to refocus on was the cancer vaccine itself, which gained “tremendous ground” during the company’s two-year stint in bankruptcy, Duffy said.
The vaccine, known as BiovaxID, harnesses the power of a patient’s immune system to target cancer cells. It’s created from the patient’s own tumor cells, obtained during a biopsy, and then injected back into the patient, where its “sole mission in life is to alert the immune system” that the cancer cells are diseased and need to be attacked, Duffy said.
The vaccine, which has been shown to extend patients’ cancer-free survival period by two years, was originally developed at the National Cancer Institute, which then partnered with the company to bring it to market. Currently, Biovest is in the “very late stages” of seeking regulatory approval for the drug, Duffy said, and hopes to have all its required data into the Federal Drug Administration by the end of this year.
The company’s new reality represents a startling turnaround that continues to surprise the company’s CEO and his management team.
“We still pinch ourselves to say, ‘Look how far we’ve come,’” Duffy said. “We do this on at least a weekly basis.”
Grüße
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