Maxim Pharmaceuticals - Blockbuster in Sicht - 500 Beiträge pro Seite
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ISIN: US0534953056 · WKN: 920934 · Symbol: AVXT
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Kurzportrait:
Maxim Pharmaceuticals entwickelt neuartige Medikamente, Therapien und Impfstoffe gegen Krebs und Infektionskrankheiten. Die am weitesten fortgeschrittene Medikamentenserie namens Maxamine wird derzeit in drei Phase III Testreihen in 12 Ländern getestet. Maxamine fördert den Immunsystem-Mechanismus, um volles anti-Tumor und anti-Infektionspotential zu erreichen. Die Markteinführung des ersten Medikaments ist für die USA Anfang 2001, für verschiedene andere Länder Ende 2001 geplant. Eine zweite, von Maxamine abgeleitete Produktserie namens MaxDerm wirkt gegen lokale Krankheiten ist derzeit in der Entwicklungsphase. Die dritte technologische Plattform namens MaxVax ist in der vorklinischen Testphase. Sie soll eine neue, nadelfreie Impfung gegen mehrere Infektionskrankheiten ermöglichen, einschließlich Atemwegsentzündungen, durch Geschlechtsverkehr übertragene Krankheiten sowie Magen- und Darmkrankheiten. Insgesamt befinden sich derzeit ein Medikament in Phase III, zwei in Phase II und zwei in Phase I.
Finanzen:
Für das letzte Quartal 1999 wuchsen die Einkünfte um 59 % auf 140 Tausend Dollar. Der Verlust stieg um 32 % auf 12,4 Millionen Dollar, begründet durch Forschungs- und Entwicklungkosten.
Bewertung:
Eine Marktkapitalisierung von 1,43 Milliarden Dollar (lt. Yahoo! Finance) erscheint bei einem Umsatz von 1,13 Millionen Dollar sehr hoch. Allerdings ist noch kein Maxim-Produkt auf dem Markt. Für 2001 wird ein Umsatz von 70 Millionen Dollar erwartet, für 2002 von 170 Millionen Dollar.
Produkte:
Maxamine - Bei Patienten mit Krebs oder chronischen Infektionskrankheiten ist die Fähigkeit des Immunsystems, erkrankte Zellen zu erkennen und zu zerstören, geschwächt. Maxamine schützt und stimuliert die kritischen Immunzellen. Diese sichere und elegante Methode basiert auf dem natürlichen Abwehrsystem.
Phagocytische Zellen in Tumoren behindern die tumor-tötende Wirkung von NK-Zellen und T-Zellen und können deren Aktivierung durch medikamentös zugeführte Cytokine wie IL-2 oder IFN- verhindern.
Maxamine - Bei Patienten mit Krebs oder chronischen Infektionskrankheiten ist die Fähigkeit des Immunsystems, erkrankte Zellen zu erkennen und zu zerstören, geschwächt. Maxamine schützt und stimuliert die kritischen Immunzellen. Diese sichere und elegante Methode basiert auf dem natürlichen Abwehrsystem.
Phagocytische Zellen in Tumoren behindern die tumor-tötende Wirkung von NK-Zellen und T-Zellen und können deren Aktivierung durch medikamentös zugeführte Cytokine wie IL-2 oder IFN- verhindern.
Phagocytische Zellen in Tumoren behindern die tumor-tötende Wirkung von NK-Zellen und T-Zellen und können deren Aktivierung durch medikamentös zugeführte Cytokine wie IL-2 oder IFN- verhindern.
Maxamine bindet an den Typ-2 Histamin-Rezeptor (H2 Rezeptor) auf der Oberfläche der phagocytischen Zellen, blockiert die Produktion von Reaktiven Sauerstoff Metaboliten (ROMs) wie Wasserstoffperoxid, woraus eine gesteigerte Aktivierung von NK-Zellen und T-Zellen resultiert. Maxamine verbessert die Effektivität der Cytokine, geringere Dosen an Cytokinen müssen eingesetzt werden, wodurch Nebenwirkungen verringert und die Lebensqualität der Patienten aufrechterhalten wird.
Maxamine bindet an den Typ-2 Histamin-Rezeptor (H2 Rezeptor) auf der Oberfläche der phagocytischen Zellen, blockiert die Produktion von Reaktiven Sauerstoff Metaboliten (ROMs) wie Wasserstoffperoxid, woraus eine gesteigerte Aktivierung von NK-Zellen und T-Zellen resultiert. Maxamine verbessert die Effektivität der Cytokine, geringere Dosen an Cytokinen müssen eingesetzt werden, wodurch Nebenwirkungen verringert und die Lebensqualität der Patienten aufrechterhalten wird.
Vorteile von Maxamine sind also: verlängert das Leben, verringert Nebenwirkungen bei der Krebsbehandlung, erhält die Lebensqualität des Patienten während der Therapie, erlaubt die Selbstbehandlung zu hause, ermöglicht eine kosteneffektive Therapie. Die Phase II Testreihen bei der Behandlung Maligner Melanome (Hautkrebs) und Leukämie zeigten eine mehr als Verdopplung der Überlebenszeit. Weitere Tests bei der Behandlung von Nierenkrebs und Hepatitis C verliefen vielversprechend. Das Unternehmen selbst bezeichnet Maxamine als bedeutsame Produkt-Pipeline. Der Markteinführung des Hautkrebs-Medikaments solle jedes Jahr die Einführung eines weiteren Medikaments folgen, gegen Leukämie, Nierenkrebs und Hepatitis C. Weitere Untersuchungen werden derzeit bezüglich der Behandlung von Prostatakrebs durchgeführt. Den Status der klinischen Untersuchungen zeigt folgende Abbildung:
Bei der Vermarktung von Maxamine arbeitet Maxim mit Partnern sowohl aus dem pharmazeutischen als auch klinischen Bereich zusammen. Die globale Markteinführung soll in einer Kombination aus direktem Marketing durch Maxim und einem Partner aus dem Pharmabereich in den Vereinigten Staaten, sowie Allianzen mit Pharmaunternehmen für den internationalen Markt erfolgen. 1999 wurde mit F. H. Faulding & Co., einem führenden Pharmakonzern in Australien und Neuseeland, ein namhafter Partner gewonnen. Verhandlungen mit potentiellen Marketing-Partnern in Europa sind im Gange. Bereits 1998 wurden Abkommen mit Chiron, Amgen und BioNative geschlossen. Diese besitzen Cytokine, deren Wirkung durch Kombination mit Maxamine gesteigert werden sollte.
Bei der Vermarktung von Maxamine arbeitet Maxim mit Partnern sowohl aus dem pharmazeutischen als auch klinischen Bereich zusammen. Die globale Markteinführung soll in einer Kombination aus direktem Marketing durch Maxim und einem Partner aus dem Pharmabereich in den Vereinigten Staaten, sowie Allianzen mit Pharmaunternehmen für den internationalen Markt erfolgen. 1999 wurde mit F. H. Faulding & Co., einem führenden Pharmakonzern in Australien und Neuseeland, ein namhafter Partner gewonnen. Verhandlungen mit potentiellen Marketing-Partnern in Europa sind im Gange. Bereits 1998 wurden Abkommen mit Chiron, Amgen und BioNative geschlossen. Diese besitzen Cytokine, deren Wirkung durch Kombination mit Maxamine gesteigert werden sollte.
MaxDerm - Den aktiven Bestandteil in Maxamine für örtliche Behandlung liefert MaxDerm. Es wurde entwickelt, um Immun- und Wundheilungsprozesse zu modulieren und so bestimmte dermatologische Infektionen zu behandeln. In einer ersten Testreihe wurden 75 Herpes-Patienten mit MaxDerm behandelt. Nach 5 Tagen ergab sich folgendes Ergebnis, abgesichert durch den Einsatz von Placebos.
Trading Spotlight
MaxVax - Dieses Impfsystem hat das Potential, Patienten effektiv, sicher und erschwinglich gegen eine Reihe von Infektionskrankheiten zu schützen. Es stärkt die vorderste Abwehrlinie des Körpers, also Mund, Augen, Ohren, Atemwege, Magen, Verdauungstrakt und urogenitaler Bereich - die Stellen, an denen die meisten Krankheitserreger in der Körper gelangen. Impfungen basierend auf der MaxVax-Technologie könnten eine effektive Immunabwehr des Körpers etablieren, im Kampf gegen zahlreiche Bakterien und Viren eines weiten Spektrums von Krankheiten, von Herpes bis HIV. 1998 wurden erste vorklinische Studien veröffentlicht.
Verwendet wird die Cholera Toxin B (CTB) Technologie. Das Cholera Toxin besteht aus zwei Untereinheiten. Die A-Untereinheit ist der toxische Teil des Moleküls. CTB, der nicht-toxische Teil bindet spezifisch an M-Zellen. Maxim arbeitet daran, Antigene an CTB zu verankern. Das CTB-Antigen Konjugat bindet dann spezifisch an M-Zellen, was die Bildung von Antikörpern initiiert.
Verwendet wird die Cholera Toxin B (CTB) Technologie. Das Cholera Toxin besteht aus zwei Untereinheiten. Die A-Untereinheit ist der toxische Teil des Moleküls. CTB, der nicht-toxische Teil bindet spezifisch an M-Zellen. Maxim arbeitet daran, Antigene an CTB zu verankern. Das CTB-Antigen Konjugat bindet dann spezifisch an M-Zellen, was die Bildung von Antikörpern initiiert.
Analysten-Einstufungen: 3 mal strong buy, 2 mal buy
Maxim Pharmaceuticals befindet sich in der "SmallCaps Online LLC Recommended List"
Deutsche Presse:
"Wir rechnen damit, daß Maxim Pharmaceuticals bereits Anfang 2001 das Medikament Maxamine zur Behandlung bösartiger Gewebewucherungen auf den Markt einführt. 2002 dürften dann Präparate gegen Leukämie und Hepatitis C die internationale Zulassung erhalten. Daher prognostizieren wir für 2002 einen Umsatz von 170 Millionen US-Dollar, nachdem im laufenden Jahr keine nennenswerten Erlöse erzielt werden. Im Vergleich zu anderen Gesellschaften mit Präparaten in ähnlich fortgeschrittenem Stadium ist Maxim mit derzeit 715 Millionen Dollar (vor der Kapitalerhöhung, Anm. d. Verf.) günstig bewertet. Positive Analystenstudien und Nachrichten über Vertriebskooperationen dürften den Kurs unserer Spezialwerte-Empfehlung bereits in den kommenden Monaten in die Nähe von 100 Dollar hieven." (Börse Online 9/00)
"Das Papier profitierte zum einen davon, daß das Medikament zur Behandlung von Hautkrebs Maxamine von der US-Gesundheitsbehörde den "Orphan-Drug-Status" erhielt. Dieser sichert Maxim in den USA für sieben Jahre die exclusiven Marketingrechte und beschleunigt den Zulassungsprozeß. Zudem stufte die US-Investmentbank J.P. Morgan die Aktie mit einem 12-Monats-Kursziel von 91 Dollar als "Kauf" ein. (Börse Online 10/00)
"In der vergangenen Woche hat Maxim die Platzierung von 3,2 Millionen Papieren zu 55 US-Dollar abgeschlossen. Das dürfte der AMEX-Aktie nach der jüngsten Verschnaufpause wieder neuen Schwung verleihen. Das frische Kapital will die im kalifornischen San Diego ansässige Biotechgesellschaft für die Markteinführung des Krebsmedikaments Maxamine sowie zur Finanzierung weiterer klinischer Studien verwenden. Die Aktie bleibt ein klarer Kauf." (Börse Online 11/00)
"Blockbuster ins Sicht. Ein Medikament mit siebenjährigem Alleinvermarktungsrecht kommt Anfang 2001. Es soll gegen Haut- und Blutkrebs sowie Hepatitis C eingesetzt werden - riesige Absatzgebiete. Fazit: Die kürzlich erfolgte Kapitalerhöhung startete mit 55 Dollar je Aktie. Ein gesundes Papier, daher jetzt erwerben und halten - langfristige Anlage. (Chance 3, Risiko 2 von 4)" (Die Telebörse 11/00)
Maxim Pharmaceuticals befindet sich in der "SmallCaps Online LLC Recommended List"
Deutsche Presse:
"Wir rechnen damit, daß Maxim Pharmaceuticals bereits Anfang 2001 das Medikament Maxamine zur Behandlung bösartiger Gewebewucherungen auf den Markt einführt. 2002 dürften dann Präparate gegen Leukämie und Hepatitis C die internationale Zulassung erhalten. Daher prognostizieren wir für 2002 einen Umsatz von 170 Millionen US-Dollar, nachdem im laufenden Jahr keine nennenswerten Erlöse erzielt werden. Im Vergleich zu anderen Gesellschaften mit Präparaten in ähnlich fortgeschrittenem Stadium ist Maxim mit derzeit 715 Millionen Dollar (vor der Kapitalerhöhung, Anm. d. Verf.) günstig bewertet. Positive Analystenstudien und Nachrichten über Vertriebskooperationen dürften den Kurs unserer Spezialwerte-Empfehlung bereits in den kommenden Monaten in die Nähe von 100 Dollar hieven." (Börse Online 9/00)
"Das Papier profitierte zum einen davon, daß das Medikament zur Behandlung von Hautkrebs Maxamine von der US-Gesundheitsbehörde den "Orphan-Drug-Status" erhielt. Dieser sichert Maxim in den USA für sieben Jahre die exclusiven Marketingrechte und beschleunigt den Zulassungsprozeß. Zudem stufte die US-Investmentbank J.P. Morgan die Aktie mit einem 12-Monats-Kursziel von 91 Dollar als "Kauf" ein. (Börse Online 10/00)
"In der vergangenen Woche hat Maxim die Platzierung von 3,2 Millionen Papieren zu 55 US-Dollar abgeschlossen. Das dürfte der AMEX-Aktie nach der jüngsten Verschnaufpause wieder neuen Schwung verleihen. Das frische Kapital will die im kalifornischen San Diego ansässige Biotechgesellschaft für die Markteinführung des Krebsmedikaments Maxamine sowie zur Finanzierung weiterer klinischer Studien verwenden. Die Aktie bleibt ein klarer Kauf." (Börse Online 11/00)
"Blockbuster ins Sicht. Ein Medikament mit siebenjährigem Alleinvermarktungsrecht kommt Anfang 2001. Es soll gegen Haut- und Blutkrebs sowie Hepatitis C eingesetzt werden - riesige Absatzgebiete. Fazit: Die kürzlich erfolgte Kapitalerhöhung startete mit 55 Dollar je Aktie. Ein gesundes Papier, daher jetzt erwerben und halten - langfristige Anlage. (Chance 3, Risiko 2 von 4)" (Die Telebörse 11/00)
Hallo Pitu !
Wirklich eine Aufschlussreiche Analyse von Dir.
Vielen Dank.
Wie siehst Du die Konkurrenz,Ilex Oncology,die ebenfalls
Medikamente(Campath,BLA-Verfahren)gegen Leukämie und
(ILX-295501,Phase II)gegen Nierenkrebs entwickeln, aber
u.U. schneller am Markt sind.
Gruß tomle
Wirklich eine Aufschlussreiche Analyse von Dir.
Vielen Dank.
Wie siehst Du die Konkurrenz,Ilex Oncology,die ebenfalls
Medikamente(Campath,BLA-Verfahren)gegen Leukämie und
(ILX-295501,Phase II)gegen Nierenkrebs entwickeln, aber
u.U. schneller am Markt sind.
Gruß tomle
Hallo Pitu,
ich möchte mich tomle anschliessen und Dir für Deine aussagekräftigen Postings danken.
Bin BioTech Fan und seit ein paar Wochen Besitzer von ein paar Maxim Pharm. (Ist übrigens seuît Februar auch eine Spezialwerteempfehlung im Börse Online).
Es gibt viele gute Stories von BioTech Firmen. Aber langsam fällt mir auf, dass viele dieselbe Story haben:
Krebs, Age-Control, Leukämie und Hepatitis C.
Ist da nicht die Gefahr sehr gross, dass die sich alle Konkurrenz machen und die Preise und Marktanteile der Medikamente enorm drücken ?
Oder dass manche Medikamente gar nicht mehr zu Ende entwickelt werde, da schon andere auf den Markt sind ?
Technostud
ich möchte mich tomle anschliessen und Dir für Deine aussagekräftigen Postings danken.
Bin BioTech Fan und seit ein paar Wochen Besitzer von ein paar Maxim Pharm. (Ist übrigens seuît Februar auch eine Spezialwerteempfehlung im Börse Online).
Es gibt viele gute Stories von BioTech Firmen. Aber langsam fällt mir auf, dass viele dieselbe Story haben:
Krebs, Age-Control, Leukämie und Hepatitis C.
Ist da nicht die Gefahr sehr gross, dass die sich alle Konkurrenz machen und die Preise und Marktanteile der Medikamente enorm drücken ?
Oder dass manche Medikamente gar nicht mehr zu Ende entwickelt werde, da schon andere auf den Markt sind ?
Technostud
natürlich arbeitet eine unmenge von unternehmen und forschungsinstituten an der behandlung von krebs. das fasziniernde an maxamine ist, das es sich hier nicht um ein medikament handelt, daß vielleicht irgendwann eimal eine bestimmte variante von krebs in manchen fällen eventuell heilen könnte. vielmehr wird es in kombination mit bisherigen anwendungsmethoden eingesetzt und stärkt nachweislich die körpereigene immunabwehr, wodurch diese selbst - stimuliert durch in geringerer menge zuzuführende andere medikamente - den kampf gegen den krebs bzw. den krankheitserreger aufnimmt. dabei steigt ausserdem noch die lebensqualität des patienten. und dieses prinzip sollte bei weitem nicht auf krebs und hepatitis beschränkt sein.
zu tomle: ilex oncology scheint ebenfalls sehr aussichtsreich zu sein, und ist vor allem verglichen mit der zahl an medikamenten in den verschiedenen testphasen noch mit einer sehr niedrigen marktkapitalisierung bewertet. "normalen" bewertungskriterien kann es natürlich, wie maxim auch, noch nicht standhalten, da kaum umsatz aber ein verlust von über 40 mio $ erwirtschaftet wurde.
zu tomle: ilex oncology scheint ebenfalls sehr aussichtsreich zu sein, und ist vor allem verglichen mit der zahl an medikamenten in den verschiedenen testphasen noch mit einer sehr niedrigen marktkapitalisierung bewertet. "normalen" bewertungskriterien kann es natürlich, wie maxim auch, noch nicht standhalten, da kaum umsatz aber ein verlust von über 40 mio $ erwirtschaftet wurde.
diese dubiose clinton-blair-aktion betrifft das untenehmen maxim in keinster weise.
nur zwei aspekte können den kurs weiter drücken:
a) gewinnmitnahmen
b) bewertung bei den biotechs nach aktuellen zahlen ohne blick in die zukunft
bei maxim ist du zukunft aber nicht fern. das blockbuster(?)-medikament maxamine wird anfang 2001 auf den markt kommen und maxim hat für 7 jahre das alleinvermarktungsrecht ...
wer denkt, die biotech-korrektur hat das schlimmst hinter sich, kauft heute nach.
pitu
nur zwei aspekte können den kurs weiter drücken:
a) gewinnmitnahmen
b) bewertung bei den biotechs nach aktuellen zahlen ohne blick in die zukunft
bei maxim ist du zukunft aber nicht fern. das blockbuster(?)-medikament maxamine wird anfang 2001 auf den markt kommen und maxim hat für 7 jahre das alleinvermarktungsrecht ...
wer denkt, die biotech-korrektur hat das schlimmst hinter sich, kauft heute nach.
pitu
genau das habe ich heute endlich gemacht - neu gekauft. habe schon lange auf diese gelegenheit gewartet.
das zweite der beiden negativszenarien ist eingetreten:
in usa wird seit zwei tagen von "growth" in "value" umgeschichtet.
kurzfristig kritisch. für langfristanleger eine gelegenheit?
in usa wird seit zwei tagen von "growth" in "value" umgeschichtet.
kurzfristig kritisch. für langfristanleger eine gelegenheit?
Hallo Pitu,
könntest Du diese Aussage bitte etwas näher erläutern ?
- Was bedeutet das für die nächste Zukunft?
- Wann wird voraussichtlich der Rebound kommen ?
- Denkst Du, daß wir bis zum 10.04. warten müssen, bis es wieder bergauf geht ?
Für mich wichtig, da ich natürlich wie alle anderen im richtigen Moment nachkaufen möchte und den steigenden Kursen nicht hinterher schauen möchte ! ;-)
Für die Antworten schon einmal vielen Dank im Voraus.
Gruß
könntest Du diese Aussage bitte etwas näher erläutern ?
- Was bedeutet das für die nächste Zukunft?
- Wann wird voraussichtlich der Rebound kommen ?
- Denkst Du, daß wir bis zum 10.04. warten müssen, bis es wieder bergauf geht ?
Für mich wichtig, da ich natürlich wie alle anderen im richtigen Moment nachkaufen möchte und den steigenden Kursen nicht hinterher schauen möchte ! ;-)
Für die Antworten schon einmal vielen Dank im Voraus.
Gruß
derzeit findet in usa eine branchenrotation statt. von werten der "new economy", also hightech-werten, die vom wachstum (growth) und der zukunftsfantasie leben, wird in die "old economy" umgeschichtet, also in die klassischen unternehmen, hinter denen bereits ein wert (value) steckt. diese rotation wird von "experten" seit langem erwartet, wurde bisher aber jedesmal nach wenigen tagen im kein erstickt. auch ob sie diesmal tatsächlich kommt, ist fraglich. sollten sich allerdings hightech-werte nach klassischen kriterien mit anderen unternehmen messen lassen müssen, sieht es natürlich für unternehmen mit 1 million $ umsatz bei 1 milliarde § marktkapitalisierung schlecht aus. wer allerdings warten will, bis werte wie maxim ihr erstes produkt auf dem markt haben, ist vielleicht zu spät dran. die derzeitige situation ist meiner meinung nach durchaus geeignet, erste positionen in ausgewählten aktien aufzubauen. nun komplett (wieder) in biotech-werte zu gehen, halte ich für gewagt, solange sich keine eindeutige trendumkehr zeigt. diese könnte aber bald erfolgen, denn die großen der branche steigen bereits wieder, zum teil deutlich. die allzu zittrigen anleger sind nun aus dem markt und gehen vorsichtig wieder in konservativere werte rein.
Vielen Dank für die ausführliche und prompte Antwort !!!
Ich werde diesen Thread weiterhin intensiv verfolgen. Würde mich freuen, wenn Du alle Neuigkeiten hier postest ?!
Gruß
Ich werde diesen Thread weiterhin intensiv verfolgen. Würde mich freuen, wenn Du alle Neuigkeiten hier postest ?!
Gruß
wenn sich plötzlich alle besinnen, high-tech-werte nach aktuellen zahlen zu beurteilen, und nicht nach deren zukunftspotential, dann trifft es die besonders hart, die fremdes geld in forschung investieren und noch kein produkt auf dem markt haben. leider aber logischerweise hat es also auch maxim kräftig erwischt. ich würde vorsichtig aufstocken, wenn ich cash hätte.
pitu
pitu
Nach der erfolgreichen Kapitalerhöhung ist es um unsere Biotech-Empfehlung ruhig geworden. Die Aktie verlor zwar in der vergangenen Woche wegen der allgemeinen Schwäche des Biotechsektors zeitweise mehr als 20 %. Wir erwarten jedoch für Anfang April positive Meldungen von den klinischen Prüfungen des Medikaments Maxamine, ein Präparat gegen bösartige Gewebewucherungen. Das sollte dem Titel wieder neuen Schwung verleihen. (Börse Online 13/00)
derzeitiger Kurs in USA: 53,5 $
plus 30 % seit dem tiefststand von vorgestern, aber bis zum ATH ist es noch ein weiter weg.
pitu
derzeitiger Kurs in USA: 53,5 $
plus 30 % seit dem tiefststand von vorgestern, aber bis zum ATH ist es noch ein weiter weg.
pitu
seit vier wochen nichts neues von maxim ...
der kurs schien sich bei 50 $ zu stabilisieren, doch heute gehts wieder kräftig gen süden ...
ergebnisse zu klinischen tests lassen weiter auf sich warten ...
der kurs schien sich bei 50 $ zu stabilisieren, doch heute gehts wieder kräftig gen süden ...
ergebnisse zu klinischen tests lassen weiter auf sich warten ...
Hallo Pitu,
klinische Testphasen dauern eben einige Zeit. Auch wenn sie abgeschlossen sind, ist die Zeit für die eigentliche Zulassung durch die FDA noch hinzuzurechnen. Also mache Dir keine Sorgen.
MfG, Patagonier
klinische Testphasen dauern eben einige Zeit. Auch wenn sie abgeschlossen sind, ist die Zeit für die eigentliche Zulassung durch die FDA noch hinzuzurechnen. Also mache Dir keine Sorgen.
MfG, Patagonier
Halo pitu,
sehr guter Beitrag.
Mal sehen, ob ich noch Kapital locker machen kann.
Gruß
VERTRAUmir
sehr guter Beitrag.
Mal sehen, ob ich noch Kapital locker machen kann.
Gruß
VERTRAUmir
nun kommt wieder bewegung in maxim ...
heute gegen den allgemeinen trend fester ...
Maxim Pharmaceuticals Expands Testing of Maxamine in Hepatitis C
SAN DIEGO--(BW HealthWire)--April 3, 2000--Maxim Pharmaceuticals (AMEX:MMP) (SSE:MAXM) announced the
initiation of a clinical study to evaluate the safety of triple-drug therapy incorporating the company`s lead drug, Maxamine(R), in
patients with chronic hepatitis C infection.
The study will evaluate the safety of treatment with Maxamine in combination with the immunotherapeutic agent interferon-alpha
and the anti-viral drug ribavirin in 15 hepatitis C patients who were nonresponsive to prior therapy. The clinical study is being
conducted at the Kaplan Medical Center, Israel.
Maxim also announced that it expects to commence by mid-year a clinical study to evaluate the safety of Maxamine in
combination with pegylated (sustained release) interferon for the treatment of hepatitis C patients. Moreover, the company
announced that the 24-week results from its 129-patient dose-ranging clinical study of Maxamine and interferon-alpha for the
treatment of hepatitis C have been accepted for presentation on April 12, 2000 at the 10th International Symposium on Viral
Hepatitis and Liver Disease sponsored by the U.S. Center for Disease Control and Prevention to be held in Atlanta. All three
studies are intended to position Maxamine for the commencement of advanced clinical studies in hepatitis C by the end of this
year.
"The interim results reported late last year from our ongoing Phase II hepatitis C trial suggest that Maxamine may substantially
improve the efficacy of interferon-alpha in the treatment of hepatitis C," said Kurt R. Gehlsen, Maxim`s vice president,
development and chief technical officer. "Maxamine may have the potential to benefit a number of existing and proposed
treatments for hepatitis C using immunotherapy, regardless of whether that treatment consists of interferon, pegylated interferon
or any form of interferon administered in combination with anti-viral drugs. These two new trials are designed to facilitate more
advanced testing of Maxamine in combination with a broad range of complementary drugs. We are pleased that as a result of the
growing interest in Maxamine both new safety trials will be funded by our collaborators."
Maxim is currently conducting a 129-patient, dose-ranging clinical study of the combination of Maxamine and interferon-alpha in
the treatment of chronic hepatitis C. This ongoing study is designed to determine the most appropriate dose regimen for
Maxamine, and to evaluate the efficacy of combination immunotherapy using Maxamine in the treatment of chronic hepatitis C.
In late 1999, the company reported that after 12 weeks of treatment, 72% of the patients treated with Maxamine in combination
with interferon-alpha attained a complete biochemical and viral response. Published reports suggest that no more than 20-30%
of patients with similar profiles achieve a complete biochemical and viral response when treated for 12 weeks with interferon
alone. Maxamine, however, is an investigational drug and safety and efficacy have not been established at this time. The
24-week clinical results from the ongoing study have been accepted for presentation April 12, 2000 at the 10th International
Symposium on Viral Hepatitis and Liver Disease.
heute gegen den allgemeinen trend fester ...
Maxim Pharmaceuticals Expands Testing of Maxamine in Hepatitis C
SAN DIEGO--(BW HealthWire)--April 3, 2000--Maxim Pharmaceuticals (AMEX:MMP) (SSE:MAXM) announced the
initiation of a clinical study to evaluate the safety of triple-drug therapy incorporating the company`s lead drug, Maxamine(R), in
patients with chronic hepatitis C infection.
The study will evaluate the safety of treatment with Maxamine in combination with the immunotherapeutic agent interferon-alpha
and the anti-viral drug ribavirin in 15 hepatitis C patients who were nonresponsive to prior therapy. The clinical study is being
conducted at the Kaplan Medical Center, Israel.
Maxim also announced that it expects to commence by mid-year a clinical study to evaluate the safety of Maxamine in
combination with pegylated (sustained release) interferon for the treatment of hepatitis C patients. Moreover, the company
announced that the 24-week results from its 129-patient dose-ranging clinical study of Maxamine and interferon-alpha for the
treatment of hepatitis C have been accepted for presentation on April 12, 2000 at the 10th International Symposium on Viral
Hepatitis and Liver Disease sponsored by the U.S. Center for Disease Control and Prevention to be held in Atlanta. All three
studies are intended to position Maxamine for the commencement of advanced clinical studies in hepatitis C by the end of this
year.
"The interim results reported late last year from our ongoing Phase II hepatitis C trial suggest that Maxamine may substantially
improve the efficacy of interferon-alpha in the treatment of hepatitis C," said Kurt R. Gehlsen, Maxim`s vice president,
development and chief technical officer. "Maxamine may have the potential to benefit a number of existing and proposed
treatments for hepatitis C using immunotherapy, regardless of whether that treatment consists of interferon, pegylated interferon
or any form of interferon administered in combination with anti-viral drugs. These two new trials are designed to facilitate more
advanced testing of Maxamine in combination with a broad range of complementary drugs. We are pleased that as a result of the
growing interest in Maxamine both new safety trials will be funded by our collaborators."
Maxim is currently conducting a 129-patient, dose-ranging clinical study of the combination of Maxamine and interferon-alpha in
the treatment of chronic hepatitis C. This ongoing study is designed to determine the most appropriate dose regimen for
Maxamine, and to evaluate the efficacy of combination immunotherapy using Maxamine in the treatment of chronic hepatitis C.
In late 1999, the company reported that after 12 weeks of treatment, 72% of the patients treated with Maxamine in combination
with interferon-alpha attained a complete biochemical and viral response. Published reports suggest that no more than 20-30%
of patients with similar profiles achieve a complete biochemical and viral response when treated for 12 weeks with interferon
alone. Maxamine, however, is an investigational drug and safety and efficacy have not been established at this time. The
24-week clinical results from the ongoing study have been accepted for presentation April 12, 2000 at the 10th International
Symposium on Viral Hepatitis and Liver Disease.
Hi...
Mein Dad hat mich gefragt was er kaufen soll :o)
Ich hab ihm Maxim empfohlen und er hat sie für 45 Euro gekauft.
Meine Frage: Was habt ihr für ein KZ ?
Sollte man noch bis 12.04.00 warten ?
Bitte mal um ein paar Meinungen.
CU
Lavi (der blutige Anfänger)
Mein Dad hat mich gefragt was er kaufen soll :o)
Ich hab ihm Maxim empfohlen und er hat sie für 45 Euro gekauft.
Meine Frage: Was habt ihr für ein KZ ?
Sollte man noch bis 12.04.00 warten ?
Bitte mal um ein paar Meinungen.
CU
Lavi (der blutige Anfänger)
die von börse online für den 6.4. angekündigte meldung bezüglich der markteinführung von maxamine läßt anscheinend noch auf sich warten, zumindest konnte ich noch keine entsprechende meldung finden.
doch die meldung zu den klinischen studien zur behandlung von hepatitis C hat die aktie wieder in schwung gebracht. auf die ergebnisse der präsentation am 12. april dürfen wir sehr gespannt sein. daß maxim diese präsentation 9 tage zuvor noch einmal explizit ankündigt, deutet darauf hin, daß maxamine die erwartungen mindestens erfüllt hat.
ein langfristiges kursziel anzugeben ist kaum möglich, da abzuwarten ist, inwieweit sich maxamine, das 2001 auf den markt kommen soll, durchsetzen wird. die bisherigen ergebnisse sind allerdings sehr vielversprechend und so halte ich mittelfristig kurse im bereich 80 bis 90 $ für möglich, immer mit der einschränkung "sofern der gesamtmarkt mitspielt".
pitu
doch die meldung zu den klinischen studien zur behandlung von hepatitis C hat die aktie wieder in schwung gebracht. auf die ergebnisse der präsentation am 12. april dürfen wir sehr gespannt sein. daß maxim diese präsentation 9 tage zuvor noch einmal explizit ankündigt, deutet darauf hin, daß maxamine die erwartungen mindestens erfüllt hat.
ein langfristiges kursziel anzugeben ist kaum möglich, da abzuwarten ist, inwieweit sich maxamine, das 2001 auf den markt kommen soll, durchsetzen wird. die bisherigen ergebnisse sind allerdings sehr vielversprechend und so halte ich mittelfristig kurse im bereich 80 bis 90 $ für möglich, immer mit der einschränkung "sofern der gesamtmarkt mitspielt".
pitu
auch der chart von maxim ist sehr aufschlußreich.
die 40 $ - zunächst widerstand, dann unterstützung ende januar/anfang februar - haben gehalten (übrigens börse online stopkurs).
derzeit steht der kurs wieder bei 60 $, also an einem widerstand, der schon mitte februar und mitte märz ein ernstes hindernis dargestellt hat. andererseits könnte dieser widerstand durch eine positive meldung (evtl. auf dem symposium am 12. april) übersprungen werden, was den weg auf über 70 $ freimachen würde.
hier das ergebnis von barchart.com:
Short Term Indicators Average: 40% - Buy
Medium Term Indicators Average: 75% - Buy
Long Term Indicators Average: 67% - Buy
Overall Average: 48% - Buy
die 40 $ - zunächst widerstand, dann unterstützung ende januar/anfang februar - haben gehalten (übrigens börse online stopkurs).
derzeit steht der kurs wieder bei 60 $, also an einem widerstand, der schon mitte februar und mitte märz ein ernstes hindernis dargestellt hat. andererseits könnte dieser widerstand durch eine positive meldung (evtl. auf dem symposium am 12. april) übersprungen werden, was den weg auf über 70 $ freimachen würde.
hier das ergebnis von barchart.com:
Short Term Indicators Average: 40% - Buy
Medium Term Indicators Average: 75% - Buy
Long Term Indicators Average: 67% - Buy
Overall Average: 48% - Buy
moin moin,
jau pitu, hast ne echt gute informationsrecherche.
wollen wir mal hoffen, dass die news am 12.4. gut ausfallen, daraus resultierend den durchbruch durch die 38 tage linie, steigende umsätze und schon sind wir wieder bei den alten hochs um 75 e. gar nicht auszudenken(hoffentlich
) wenn dann in ein paar wochen das komplette menschliche erbgut entschlüsselt ist und die kurse wieder kräftig durchstarten.
Im markt bin ich allgemein für die biotechbranche sehr positiv eingestellt.
im internetbereich siehts schon wesentlich kritischer aus. hier selektiere ich mich eher auf werte wie jafco oder softbank, da hier noch wachstumspotentiale vorhanden sind, der japanische überhaupt freundlich ist, und bestimmt noch ne menge erfolgsstories geboren werden. wenn sich die nasdaq einigermassen hält werden sich die beteiligungen ähnlich entwickeln wie wir es schon an den kursen der nasdaq oder am neuen markt gesehen haben oder nicht? inernet mässig hat der asiatische markt noch gutes nachholpotential.
so sorry, jetzt bin ich vom thema abgekommen, zurück zu maxim pharmaceutical. ich bin mir im anlagehorizont relativ unsicher da ja doch sehr sehr viel vom ersten medikament maxim abhängen wird.
frage: sollte dieses nun später als anfang 2001 auf den markt kommen oder evtl. sogar vorher ein anderer anbieter schneller sein droht doch die pleite und zwar nicht nur fürs unternehmen sondern auch für uns aktinäre. umgekehrt sollte das produkt ein hit/renner werden sind noch mal ordentliche gewinne bzw. kurssprünge drin. hab ich ne andere chance als zu spekulieren, hat jemand vielleicht interessante informationen/theorien diesbezüglich(ich würd mich freuen).
na dann, bis dann dann.
mfg oschi
jau pitu, hast ne echt gute informationsrecherche.
wollen wir mal hoffen, dass die news am 12.4. gut ausfallen, daraus resultierend den durchbruch durch die 38 tage linie, steigende umsätze und schon sind wir wieder bei den alten hochs um 75 e. gar nicht auszudenken(hoffentlich
) wenn dann in ein paar wochen das komplette menschliche erbgut entschlüsselt ist und die kurse wieder kräftig durchstarten. Im markt bin ich allgemein für die biotechbranche sehr positiv eingestellt.
im internetbereich siehts schon wesentlich kritischer aus. hier selektiere ich mich eher auf werte wie jafco oder softbank, da hier noch wachstumspotentiale vorhanden sind, der japanische überhaupt freundlich ist, und bestimmt noch ne menge erfolgsstories geboren werden. wenn sich die nasdaq einigermassen hält werden sich die beteiligungen ähnlich entwickeln wie wir es schon an den kursen der nasdaq oder am neuen markt gesehen haben oder nicht? inernet mässig hat der asiatische markt noch gutes nachholpotential.
so sorry, jetzt bin ich vom thema abgekommen, zurück zu maxim pharmaceutical. ich bin mir im anlagehorizont relativ unsicher da ja doch sehr sehr viel vom ersten medikament maxim abhängen wird.
frage: sollte dieses nun später als anfang 2001 auf den markt kommen oder evtl. sogar vorher ein anderer anbieter schneller sein droht doch die pleite und zwar nicht nur fürs unternehmen sondern auch für uns aktinäre. umgekehrt sollte das produkt ein hit/renner werden sind noch mal ordentliche gewinne bzw. kurssprünge drin. hab ich ne andere chance als zu spekulieren, hat jemand vielleicht interessante informationen/theorien diesbezüglich(ich würd mich freuen).
na dann, bis dann dann.
mfg oschi
Andere anbiter, lieber all-goi, gibt es nicht. MAXAMINE ist konkurrenzlos, ein Zusatzprodukt obendrein und schlußendlich als Amin-Histamin superbillig zu produzieren. Warte mit viel Vorfreude auf die ersten Titelseiten nach der ASCO-Konferenz...
Ss
Ss
danke Ss, hört sich gut an
all-goi
all-goi
Hallo Supersandwich,
was ist die ASCO-Konferenz, wann findet die statt,
und wo gibt es nähere Infos?
MFG
was ist die ASCO-Konferenz, wann findet die statt,
und wo gibt es nähere Infos?
MFG
gestern hat sich maxim hervorragend gehalten, trotz des schlechten marktumfeldes plus 1,36 %.
und trotz der ordentlichen gewinne der letzten tage denkt in usa kaum jemand ans verkaufen.
nur in deutschland wird mit zum teil deutlichem abschlag gehandelt:
60,5625 $ in usa zu 58 € in frankfurt.
pitu
und trotz der ordentlichen gewinne der letzten tage denkt in usa kaum jemand ans verkaufen.
nur in deutschland wird mit zum teil deutlichem abschlag gehandelt:
60,5625 $ in usa zu 58 € in frankfurt.
pitu
Hoi zusammen...
ist ruhig geworden hier.
Wann kommen die news heute ?
Naja der Kurs hält sich gut (62,50) bei wenig Handel.
CU
Lavi
ist ruhig geworden hier.
Wann kommen die news heute ?
Naja der Kurs hält sich gut (62,50) bei wenig Handel.
CU
Lavi
Maxim Reports 69% Complete Response at 24 Weeks in Phase Trial II of Maxamine and Interferon-Alpha
in the Treatment of Hepatitis C
SAN DIEGO--(BW HealthWire)--April 12, 2000--Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) announced today
24-week results from its Phase II dose-ranging study of Maxamine(R) (histamine dihydrochloride) in combination with
interferon-alpha (IFN-alpha) in the treatment of naive, chronically infected hepatitis C patients.
After 24 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and IFN-alpha achieved a complete
viral response in 69 percent of all patients, compared to the 29 percent or less response that is commonly observed in patients
with similar profiles treated with IFN-alpha alone. The results will be presented today at the 10th International Symposium on
Viral Hepatitis and Liver Disease sponsored by the U.S. Center for Disease Control and Prevention in Atlanta by the principal
investigator in the study, Yoav Lurie M.D., Liver Clinic Director, Kaplan Medical Center, Israel.
"These are very promising 24-week results," said Dr. Lurie. "These results are even more impressive due to the high viral loads of
the patients participating in this study, coupled with the significant percentage of patients with the genotype-1 virus, both of which
are factors that would typically lead to a substantially lower response with either IFN-alpha alone or other existing treatments. I
look forward to advancing the testing of Maxamine in hepatitis C, particularly in combination with some of the emerging therapies
such as pegylated interferon and ribavirin."
Study Design
The trial is designed to evaluate the combination of Maxamine and IFN-alpha in the treatment of chronic hepatitis C patients who
had not been previously treated with IFN-alpha. The primary goals of this study are to determine the most appropriate dosing
regimen for Maxamine in the treatment of naive chronic hepatitis C patients, and to provide further evidence that Maxamine may
benefit cytokines such as IFN-alpha in the treatment of this viral infection. The 129-patient trial is based in the United Kingdom,
Belgium, Israel and Russia.
Patients were randomly assigned to one of four treatment groups, and each patient received Maxamine, in one of four dosing
regimens, plus IFN-alpha at the standard dose of 3miu three times per week. The study will evaluate the efficacy and safety of
each of the four dosing regimens. Under the two lower-dose regimens, patients administer one dose of Maxamine each treatment
day, and receive a total of either 3 mg or 5 mg of the drug per week of therapy. Under the two higher-dose regimens, patients
administer two doses of Maxamine each treatment day, and receive a total of either 6 mg or 10 mg of the drug per week of
therapy.
The primary measures of efficacy in the study are a reduction in viral load and a normalization of liver function. A complete viral
response is defined by virus levels that are below the limit of detection using a validated PCR-RNA technique. A complete
biochemical response is defined as normalization of liver enzyme levels, measured by the liver enzyme ALT, a standard measure
of liver function. Patients who responded during the first 12 weeks of treatment will continue treatment through 48 weeks, with
additional evaluations at 24, 48 and 72 weeks.
24-Week Study Results
After 24 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and interferon achieved a complete
biochemical and viral response in 69 percent of all patients. Published reports suggest that 29 percent or less of patients with
similar profiles achieve a complete biochemical and viral response when treated with IFN-alpha therapy alone.
A dose response was observed in the study, and 69 percent of the patients treated with either of the two higher-dose,
twice-per-day regimens achieved complete viral responses after 24 weeks of treatment, while 60 percent of the patients treated
with either of the two lower-dose, once-per-day regimens achieved a complete viral response. The complete viral response for
all patients in the study combined was 64%.
The results also suggest that Maxamine provided a benefit even in the patients expected to have a poor prognosis. Certain
factors can influence the response of a hepatitis C patient to therapy, including the patient`s viral load and the genotype of the
virus with which the patient is infected. Of the variations, or genotypes, of hepatitis C, genotype-1 is the most common type
comprising approximately 70% of the patients in the United States and Asia, and 50% in Europe. Patients infected with
genotype-1 typically have the poorest response to treatment. In the Maxim study, 50% of the patients were infected with the
genotype-1 variant of the virus. Despite the poor prognosis for successful treatment, 79% of the patients with genotype-1 virus
treated with either of the twice-per-day regimens of Maxamine for 24 weeks achieved a complete viral response.
Patients with high viral levels, viral levels greater than two million copies per milliliter of blood, also typically have a poor response
to treatment. In the ongoing Phase II study, the mean viral load of the patients entering the trial was 6.7 million copies per milliliter
of blood, more than three times higher than the 2.0 million copies normally considered to be difficult to treat. However, 64% of
the patients with more than 2 million copies per milliliter of blood treated with either of the twice-per-day regimens of Maxamine
achieved a complete viral response.
Patients in the study were able to treat themselves at home with the Maxamine and IFN-alpha combination therapy. The interim
24-week results suggest that patient compliance and the safety profile of the therapy were consistent with the positive results
shown in other ongoing and completed Maxamine trials.
"We have not seen published reports of 24-week end-of-treatment data better than those obtained in our study with Maxamine,"
said Kurt R. Gehlsen, Ph.D., Maxim`s Vice President, Development and Chief Technical Officer. "The results are also impressive
due to the high percentage of patients in this study that would normally be considered to have a poor prognosis due to a high viral
load and/or an infection with the genotype-1 variant of the virus. The majority of hepatitis C patients in the United States and
Asia are infected with the genotype-1 virus, and existing therapies are largely ineffective in this patient population."
"These results are consistent with the positive results we have seen when using Maxamine in other clinical studies for indications
such as malignant melanoma, acute myelogenous leukemia and renal cell carcinoma," stated Larry G. Stambaugh, Maxim`s
Chairman and CEO. "We believe the discovery underlying Maxamine represents a mechanism for overcoming immune
suppression that may have universal application to a number of cancers and infectious diseases."
Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S.
Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The
World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver
tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts
estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is
the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do
not effectively respond to existing therapies or to therapies known by us to be under development.
The standard treatment for hepatitis C is IFN-alpha, an immunotherapeutic agent often given in combination with the anti-viral
drug ribavirin. The majority of patients do not attain a sustained response with current therapies.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune
system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases.
Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of
therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical
immune cells and is administered in combination with cytokines such as interleukin-2 and IFN-alpha, a class of proteins that
stimulate these same immune cells. More than 1,000 patients have been treated in the Company`s completed and ongoing clinical
trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Clinical trial results to
date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment
that may improve patient survival. Maxamine, however, is an investigational drug and safety and efficacy have not been
established at this time.
in the Treatment of Hepatitis C
SAN DIEGO--(BW HealthWire)--April 12, 2000--Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) announced today
24-week results from its Phase II dose-ranging study of Maxamine(R) (histamine dihydrochloride) in combination with
interferon-alpha (IFN-alpha) in the treatment of naive, chronically infected hepatitis C patients.
After 24 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and IFN-alpha achieved a complete
viral response in 69 percent of all patients, compared to the 29 percent or less response that is commonly observed in patients
with similar profiles treated with IFN-alpha alone. The results will be presented today at the 10th International Symposium on
Viral Hepatitis and Liver Disease sponsored by the U.S. Center for Disease Control and Prevention in Atlanta by the principal
investigator in the study, Yoav Lurie M.D., Liver Clinic Director, Kaplan Medical Center, Israel.
"These are very promising 24-week results," said Dr. Lurie. "These results are even more impressive due to the high viral loads of
the patients participating in this study, coupled with the significant percentage of patients with the genotype-1 virus, both of which
are factors that would typically lead to a substantially lower response with either IFN-alpha alone or other existing treatments. I
look forward to advancing the testing of Maxamine in hepatitis C, particularly in combination with some of the emerging therapies
such as pegylated interferon and ribavirin."
Study Design
The trial is designed to evaluate the combination of Maxamine and IFN-alpha in the treatment of chronic hepatitis C patients who
had not been previously treated with IFN-alpha. The primary goals of this study are to determine the most appropriate dosing
regimen for Maxamine in the treatment of naive chronic hepatitis C patients, and to provide further evidence that Maxamine may
benefit cytokines such as IFN-alpha in the treatment of this viral infection. The 129-patient trial is based in the United Kingdom,
Belgium, Israel and Russia.
Patients were randomly assigned to one of four treatment groups, and each patient received Maxamine, in one of four dosing
regimens, plus IFN-alpha at the standard dose of 3miu three times per week. The study will evaluate the efficacy and safety of
each of the four dosing regimens. Under the two lower-dose regimens, patients administer one dose of Maxamine each treatment
day, and receive a total of either 3 mg or 5 mg of the drug per week of therapy. Under the two higher-dose regimens, patients
administer two doses of Maxamine each treatment day, and receive a total of either 6 mg or 10 mg of the drug per week of
therapy.
The primary measures of efficacy in the study are a reduction in viral load and a normalization of liver function. A complete viral
response is defined by virus levels that are below the limit of detection using a validated PCR-RNA technique. A complete
biochemical response is defined as normalization of liver enzyme levels, measured by the liver enzyme ALT, a standard measure
of liver function. Patients who responded during the first 12 weeks of treatment will continue treatment through 48 weeks, with
additional evaluations at 24, 48 and 72 weeks.
24-Week Study Results
After 24 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and interferon achieved a complete
biochemical and viral response in 69 percent of all patients. Published reports suggest that 29 percent or less of patients with
similar profiles achieve a complete biochemical and viral response when treated with IFN-alpha therapy alone.
A dose response was observed in the study, and 69 percent of the patients treated with either of the two higher-dose,
twice-per-day regimens achieved complete viral responses after 24 weeks of treatment, while 60 percent of the patients treated
with either of the two lower-dose, once-per-day regimens achieved a complete viral response. The complete viral response for
all patients in the study combined was 64%.
The results also suggest that Maxamine provided a benefit even in the patients expected to have a poor prognosis. Certain
factors can influence the response of a hepatitis C patient to therapy, including the patient`s viral load and the genotype of the
virus with which the patient is infected. Of the variations, or genotypes, of hepatitis C, genotype-1 is the most common type
comprising approximately 70% of the patients in the United States and Asia, and 50% in Europe. Patients infected with
genotype-1 typically have the poorest response to treatment. In the Maxim study, 50% of the patients were infected with the
genotype-1 variant of the virus. Despite the poor prognosis for successful treatment, 79% of the patients with genotype-1 virus
treated with either of the twice-per-day regimens of Maxamine for 24 weeks achieved a complete viral response.
Patients with high viral levels, viral levels greater than two million copies per milliliter of blood, also typically have a poor response
to treatment. In the ongoing Phase II study, the mean viral load of the patients entering the trial was 6.7 million copies per milliliter
of blood, more than three times higher than the 2.0 million copies normally considered to be difficult to treat. However, 64% of
the patients with more than 2 million copies per milliliter of blood treated with either of the twice-per-day regimens of Maxamine
achieved a complete viral response.
Patients in the study were able to treat themselves at home with the Maxamine and IFN-alpha combination therapy. The interim
24-week results suggest that patient compliance and the safety profile of the therapy were consistent with the positive results
shown in other ongoing and completed Maxamine trials.
"We have not seen published reports of 24-week end-of-treatment data better than those obtained in our study with Maxamine,"
said Kurt R. Gehlsen, Ph.D., Maxim`s Vice President, Development and Chief Technical Officer. "The results are also impressive
due to the high percentage of patients in this study that would normally be considered to have a poor prognosis due to a high viral
load and/or an infection with the genotype-1 variant of the virus. The majority of hepatitis C patients in the United States and
Asia are infected with the genotype-1 virus, and existing therapies are largely ineffective in this patient population."
"These results are consistent with the positive results we have seen when using Maxamine in other clinical studies for indications
such as malignant melanoma, acute myelogenous leukemia and renal cell carcinoma," stated Larry G. Stambaugh, Maxim`s
Chairman and CEO. "We believe the discovery underlying Maxamine represents a mechanism for overcoming immune
suppression that may have universal application to a number of cancers and infectious diseases."
Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S.
Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The
World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver
tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts
estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is
the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do
not effectively respond to existing therapies or to therapies known by us to be under development.
The standard treatment for hepatitis C is IFN-alpha, an immunotherapeutic agent often given in combination with the anti-viral
drug ribavirin. The majority of patients do not attain a sustained response with current therapies.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune
system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases.
Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of
therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical
immune cells and is administered in combination with cytokines such as interleukin-2 and IFN-alpha, a class of proteins that
stimulate these same immune cells. More than 1,000 patients have been treated in the Company`s completed and ongoing clinical
trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Clinical trial results to
date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment
that may improve patient survival. Maxamine, however, is an investigational drug and safety and efficacy have not been
established at this time.
Naja die Begeisterung hält sich wohl in Grenzen für die Aktie (auch bei den Amis)
CU
Lavi
CU
Lavi
Maxim hat trotz der Biotechkrise eine durchaus ansehnliche Bewertung behalten und das deshalb, weil die Ansaetze wirklich vielversprechend sind.
Interessanter Wert.
Interessanter Wert.
Biotech investors advised that pain could worsen, linger
By Ransdell Pierson
NEW YORK, April 17 (Reuters) - Biotech stocks, which were mauled almost as badly last week as technology stocks, continued their decline on Monday amid caution from some analysts that the sector could feel more pain in days ahead and might not bounce back anytime soon.
The Nasdaq biotech index <.IXB>, comprised of over 200 U.S. and European biotech companies, added another 1.26 percent loss on Monday to its 23.5 percent drop-off last week. Although the decline last week almost equaled a 25 percent fall for the tech-heavy Nasdaq composite index, the techs rallied on Monday to recapture a fourth of their losses.
Just weeks ago, on March 6, the biotech index hit a lifetime high of 1596.53 -- a heady 81 percent rise from its end-of-1999 mark of 881.78. Last week`s decline, however, erased any remaining gains for the year-to-date. In a dramatic reversal of fortune, the sector is now down almost four percent for the year.
"Earlier this year we had a lot of people buying biotech stocks who had not a clue what they were doing. They heard biotech was `hot` and were buying like crazy on pure momentum anything that had the word `gene` in it," said John McCamant, executive editor of the Medical Technology Stock Letter.
He said such investors have now learned that biotechs, research outfits which typically have not yet developed products, can fall like a rock if the overall Nasdaq and its New Economy stocks stumble. Or if interest-rate fears arise, as happened last week with the release of government data indicating a pickup in inflation.
"Most biotechs don`t have earnings and have not yet developed drugs to generate revenues. So when things get dicey, investors aren`t willing to look too far into the future," McCamant said.
Sushant Kumar, a drug analyst at Mehta Partners in New York, said he remained wary about the overall sector. "Despite the magnitude of punishment the biotechs have felt, we don`t think it`s completely over yet. We`re being very cautious."
But Kumar said he is very interested, at the right time, to add to his positions in a group of companies that have profitable drugs on the market, promising products in late-stage clinical trials or compelling business models.
He said they include COR Therapeutics Inc <CORR.O>, Maxim Pharmaceuticals Inc <MMP.A>, Human Genome Sciences Inc <HGSI.O> and Millennium Pharmaceuticals Inc <MLNM.O>.
"Even for the better names, we`ll wait for indications things are improving before we jump in," said Kumar.
Mutual funds that specialize in biotechs were pounded last week. The Fidelity Select Biotechnology Fund, which concentrates on well-established firms such as Amgen Inc. <AMGN.O>, lost 22.4 percent and was down 7 percent for the year.
The Dresdner RCM Biotechnology Fund, which buys stocks in established and newer companies, fell almost 19 percent last week and was up about 18 percent for the year to date.
"Biotech funds are volatile, just as individual biotechs are volatile," said Emily Hall, an analyst for financial information firm Morningstar who recommends that individuals invest no more than five or 10 percent of their portfolios in such funds because of their high risk.
"A lot of people invest in biotech on hype and then get caught in the crossfire when valuations of tech stocks start falling," said Hall, who added she believed the recent downturn in most biotechs was justified "because they were unrealistically high."
While increasing numbers of biotechs are maturing and can stand alone with their money-making drugs, Hall cautioned that the sector as a whole tends to undergo extended downturns when investors turn sour on it.
"In 1996, 1997 and most of 1998, the industry went through a downturn. It`s not out of the realm of possibility that the group could continue to be down significantly for months to come," she added, although an upturn was indeed also possible.
Until bluer skies return, funding for private and publicly traded biotechs will be much harder to come by, said Steve Burrill, chief executive officer of the private investment bank Burrill & Co.
"The biotech industry raised $12 billion during the first quarter of 2000," when investor sentiment was at its highest for the group, Burrill said. "That is more than it raised in all of 1999 and twice the amount it raised in either 1996, 1997 or 1998," he added.
Burrill, whose company is based in San Francisco, said about $3.85 billion of financing raised in the first quarter was from secondary offerings of publicly traded companies, while another $3.8 billion came from issuance of bonds convertible later into shares. Another $1.1 billion was raised through initial public offerings.
The banker said about 50 private companies were preparing to go public when the biotech market began tanking in mid-March. Many, or most of them, will likely now delay their IPOs until investor optimism returns, he predicted.
Moreover, many public companies that had planned to borrow money have realistically pulled back.
"The market is too schizophrenic at the moment. Bankers are sitting on the sidelines, trying to figure out whether it`s worth taking these things to Wall Street," Burrill said.
By Ransdell Pierson
NEW YORK, April 17 (Reuters) - Biotech stocks, which were mauled almost as badly last week as technology stocks, continued their decline on Monday amid caution from some analysts that the sector could feel more pain in days ahead and might not bounce back anytime soon.
The Nasdaq biotech index <.IXB>, comprised of over 200 U.S. and European biotech companies, added another 1.26 percent loss on Monday to its 23.5 percent drop-off last week. Although the decline last week almost equaled a 25 percent fall for the tech-heavy Nasdaq composite index, the techs rallied on Monday to recapture a fourth of their losses.
Just weeks ago, on March 6, the biotech index hit a lifetime high of 1596.53 -- a heady 81 percent rise from its end-of-1999 mark of 881.78. Last week`s decline, however, erased any remaining gains for the year-to-date. In a dramatic reversal of fortune, the sector is now down almost four percent for the year.
"Earlier this year we had a lot of people buying biotech stocks who had not a clue what they were doing. They heard biotech was `hot` and were buying like crazy on pure momentum anything that had the word `gene` in it," said John McCamant, executive editor of the Medical Technology Stock Letter.
He said such investors have now learned that biotechs, research outfits which typically have not yet developed products, can fall like a rock if the overall Nasdaq and its New Economy stocks stumble. Or if interest-rate fears arise, as happened last week with the release of government data indicating a pickup in inflation.
"Most biotechs don`t have earnings and have not yet developed drugs to generate revenues. So when things get dicey, investors aren`t willing to look too far into the future," McCamant said.
Sushant Kumar, a drug analyst at Mehta Partners in New York, said he remained wary about the overall sector. "Despite the magnitude of punishment the biotechs have felt, we don`t think it`s completely over yet. We`re being very cautious."
But Kumar said he is very interested, at the right time, to add to his positions in a group of companies that have profitable drugs on the market, promising products in late-stage clinical trials or compelling business models.
He said they include COR Therapeutics Inc <CORR.O>, Maxim Pharmaceuticals Inc <MMP.A>, Human Genome Sciences Inc <HGSI.O> and Millennium Pharmaceuticals Inc <MLNM.O>.
"Even for the better names, we`ll wait for indications things are improving before we jump in," said Kumar.
Mutual funds that specialize in biotechs were pounded last week. The Fidelity Select Biotechnology Fund, which concentrates on well-established firms such as Amgen Inc. <AMGN.O>, lost 22.4 percent and was down 7 percent for the year.
The Dresdner RCM Biotechnology Fund, which buys stocks in established and newer companies, fell almost 19 percent last week and was up about 18 percent for the year to date.
"Biotech funds are volatile, just as individual biotechs are volatile," said Emily Hall, an analyst for financial information firm Morningstar who recommends that individuals invest no more than five or 10 percent of their portfolios in such funds because of their high risk.
"A lot of people invest in biotech on hype and then get caught in the crossfire when valuations of tech stocks start falling," said Hall, who added she believed the recent downturn in most biotechs was justified "because they were unrealistically high."
While increasing numbers of biotechs are maturing and can stand alone with their money-making drugs, Hall cautioned that the sector as a whole tends to undergo extended downturns when investors turn sour on it.
"In 1996, 1997 and most of 1998, the industry went through a downturn. It`s not out of the realm of possibility that the group could continue to be down significantly for months to come," she added, although an upturn was indeed also possible.
Until bluer skies return, funding for private and publicly traded biotechs will be much harder to come by, said Steve Burrill, chief executive officer of the private investment bank Burrill & Co.
"The biotech industry raised $12 billion during the first quarter of 2000," when investor sentiment was at its highest for the group, Burrill said. "That is more than it raised in all of 1999 and twice the amount it raised in either 1996, 1997 or 1998," he added.
Burrill, whose company is based in San Francisco, said about $3.85 billion of financing raised in the first quarter was from secondary offerings of publicly traded companies, while another $3.8 billion came from issuance of bonds convertible later into shares. Another $1.1 billion was raised through initial public offerings.
The banker said about 50 private companies were preparing to go public when the biotech market began tanking in mid-March. Many, or most of them, will likely now delay their IPOs until investor optimism returns, he predicted.
Moreover, many public companies that had planned to borrow money have realistically pulled back.
"The market is too schizophrenic at the moment. Bankers are sitting on the sidelines, trying to figure out whether it`s worth taking these things to Wall Street," Burrill said.
laut börse-online hat prudential securities maxim als "strong buy" mit kursziel 102 $ eingestuft.
Maxim Pharmaceuticals to Commence Trading On Nasdaq National Market On Thursday, April 27, 2000 Under the Symbol "MAXM"
SAN DIEGO--(BW HealthWire)--April 26, 2000--Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) Wednesday announced that its common stock will commence trading on the Nasdaq National Market under the symbol "MAXM" commencing on Thursday, April 27, 2000.
The company`s redeemable common stock purchase warrants will also commence trading that same day on the Nasdaq National Market under the symbol "MAXMW".
As a result of the commencement of trading on Nasdaq, trading of the company`s common stock and warrant securities on the American Stock Exchange will be suspended after the close of trading on April 26, 2000. The company`s common stock will continue to trade in Europe on the Stockholm Stock Exchange under the symbol "MAXM".
SAN DIEGO--(BW HealthWire)--April 26, 2000--Maxim Pharmaceuticals (AMEX:MMP)(SSE:MAXM) Wednesday announced that its common stock will commence trading on the Nasdaq National Market under the symbol "MAXM" commencing on Thursday, April 27, 2000.
The company`s redeemable common stock purchase warrants will also commence trading that same day on the Nasdaq National Market under the symbol "MAXMW".
As a result of the commencement of trading on Nasdaq, trading of the company`s common stock and warrant securities on the American Stock Exchange will be suspended after the close of trading on April 26, 2000. The company`s common stock will continue to trade in Europe on the Stockholm Stock Exchange under the symbol "MAXM".
Hallo zusammen,
hat jemand eine Erklärung für den momentanen Kursrückgang? Die Nachrichtenlage und die Aussichten sind unverändert gut, und Maxim hat bisher den Rückgang im Biotechsektor auch relativ gut überstanden. Trotzdem nur Marktumfeld, oder gefällt einigen Leuten der Wechsel an die NASDAQ nicht (und warum sollte das so sein)? Wer weiss mehr???
hat jemand eine Erklärung für den momentanen Kursrückgang? Die Nachrichtenlage und die Aussichten sind unverändert gut, und Maxim hat bisher den Rückgang im Biotechsektor auch relativ gut überstanden. Trotzdem nur Marktumfeld, oder gefällt einigen Leuten der Wechsel an die NASDAQ nicht (und warum sollte das so sein)? Wer weiss mehr???
Nur keine Panik; diese täglichen Kurssprünge sind rein zufällig. Wenn mal wieder ein größerer Aktionär Gewinne mitnehmen will oder ein Fond sich umdisponiert, etc.
Langfristig muß das gesehen werden. MMP ist eine Bank aus meiner Sicht. Die Kurse können in 12 Monaten bei 100 $ stehen.
Allerdings sind Biotech-Aktien sehr gefährlich, da in den verschiedenen Forschungsphasen durchaus Rückschläge möglich sind, die bei den Bewertungen schnell zu erheblichen Kursrückgängen führen könnnen. Bestes Beispiel dafür ist Virophara (VPHM).
Pebbles
Langfristig muß das gesehen werden. MMP ist eine Bank aus meiner Sicht. Die Kurse können in 12 Monaten bei 100 $ stehen.
Allerdings sind Biotech-Aktien sehr gefährlich, da in den verschiedenen Forschungsphasen durchaus Rückschläge möglich sind, die bei den Bewertungen schnell zu erheblichen Kursrückgängen führen könnnen. Bestes Beispiel dafür ist Virophara (VPHM).
Pebbles
Panik, wer redet denn von Panik...
Ich war nur verwundert dass es so kontinuierlich abging und dachte, ich hätte vielleicht eine News verpasst. Natürlich ist Maxin langfristig zu sehen, und im Vergleich zu anderen Biotechs, die noch keine Produkte am Markt haben, ist wohl keine mit so VERGLEICHWEISE geringem Risiko wie Maxim (wie gesagt, VERGLEICHSWEISE, nicht absolut), schließlich hat man selten einen so guten Einblick in den Ablauf und die Aussichten (siehe dazu auch Studie von Prudential Securities; wenn ich mal mehr Zeit habe, werde ich die hier mal posten).
Also, scheinbar keine News verpasst, auch gut, so long und viel Spass beim Mai-Urbock
Tores
Ich war nur verwundert dass es so kontinuierlich abging und dachte, ich hätte vielleicht eine News verpasst. Natürlich ist Maxin langfristig zu sehen, und im Vergleich zu anderen Biotechs, die noch keine Produkte am Markt haben, ist wohl keine mit so VERGLEICHWEISE geringem Risiko wie Maxim (wie gesagt, VERGLEICHSWEISE, nicht absolut), schließlich hat man selten einen so guten Einblick in den Ablauf und die Aussichten (siehe dazu auch Studie von Prudential Securities; wenn ich mal mehr Zeit habe, werde ich die hier mal posten).
Also, scheinbar keine News verpasst, auch gut, so long und viel Spass beim Mai-Urbock
Tores
die momentane Kursschwäche ist sogar wahrscheinlich auf die non marginability zurückzuführen, die momentan durch den Wechsel von AMEX an die NASDAQ passiert ist. MAXM wird wie eine Neuemission behandelt: NM = non marginable
Herr Gottschalk, ich biete ihnen folgende Wette an:
Wetten dass, Maxim Pharmaceutical ein Medikament in der Pipeline hat, dass sie nächstes Jahr profitabel macht und ab 2004 Maxamine in der Top 5 der am meist verkauftesten Medikamente steht (potentiell sogar No1).
Und wetten dass, dass das die Wall Street noch nicht erkannt hat.
Und dem nicht genug, ich kenne keine Biotech-Firma, die so niedrige Produktionskosten haben wird (ein einfaches Protein!) = 5% Umsatzkosten. Der restliche Teil kann in die Bottomline gesteckt werden.
Solche Schnäppchenpreise, Ihr schaut hier auf einen weit über 1000$-Stock!!!
ich verkaufe nicht unter 1000
Gruss
Xetra-Max
Herr Gottschalk, ich biete ihnen folgende Wette an:
Wetten dass, Maxim Pharmaceutical ein Medikament in der Pipeline hat, dass sie nächstes Jahr profitabel macht und ab 2004 Maxamine in der Top 5 der am meist verkauftesten Medikamente steht (potentiell sogar No1).
Und wetten dass, dass das die Wall Street noch nicht erkannt hat.
Und dem nicht genug, ich kenne keine Biotech-Firma, die so niedrige Produktionskosten haben wird (ein einfaches Protein!) = 5% Umsatzkosten. Der restliche Teil kann in die Bottomline gesteckt werden.
Solche Schnäppchenpreise, Ihr schaut hier auf einen weit über 1000$-Stock!!!
ich verkaufe nicht unter 1000
Gruss
Xetra-Max
Moinmoin!
Xetra-Max, solche Kursziele zu nennen ist mir einfach zu euphorisch
(auch wenn ich angesichts der Produktpipeline, insbesondere nach den
beeindruckenden HepC-Ergebnissen, auch gigantische Chancen sehe).
Maxim ist mein größter Biotech-Posten im Depot. Man darf jedoch nicht
vergessen, das enttäuschende Maxamine-Ergebnisse und darauf folgende
deutliche Verzögerungen oder gar Abbruch zu einem sofortigen dramatischen
Kurseinbruch führen würden.
Danach sieht es jedoch absolut nicht aus.
Die ASCO-Konferenz findet vom 20.-23. Mai statt und Maxim wird hier
weitere Ergebnisse der Phase3-Studien zur Behandlung von bösartigem
Hautkrebs, bei dem bereits Metastasen gebildet wurden, bekanntgeben.
Bekannt sind seit knapp 2 Wochen die Ergebnisse der University of
Pittsburgh Cancer Institute, wo 40 der gesamten 305 Patienten behandelt
wurden. 20 wurden mit Maxamine und Interleukin-2 behandelt, 20 aus-
schließlich mit IL-2. Die Ergebnisse waren beeindruckend. Am Ende des
Studienzeitraums ergaben sich folgende Ergebnisse:
durchschnittliche Lebensdauer ohne Maxamine: 187 Tage, alle Patienten
waren gestorben.
durchschnittliche Lebensdauer mit Maxamine: 355 Tage, 6 Patienten noch
am Leben.
Die Ergebnisse sämtlicher 305 Patienten werden auf der ASCO präsentiert.
Diese Informationen stammen aus dem
Programm ASCO 2000
http://asco00.agora.com/2000ASCOabstracts/main2.asp
Maxamine unter Melanoma 2252A
sowie aus einer englischen Übersetzung einer aktuellen Kunden-E-Mail
vom schwedischen Brokerhaus Aragon, das u.a. spezialisiert ist auf
Biotechwerte und Maxim seit einiger Zeit auf der Kaufliste hat.
Xetra-Max, solche Kursziele zu nennen ist mir einfach zu euphorisch
(auch wenn ich angesichts der Produktpipeline, insbesondere nach den
beeindruckenden HepC-Ergebnissen, auch gigantische Chancen sehe).
Maxim ist mein größter Biotech-Posten im Depot. Man darf jedoch nicht
vergessen, das enttäuschende Maxamine-Ergebnisse und darauf folgende
deutliche Verzögerungen oder gar Abbruch zu einem sofortigen dramatischen
Kurseinbruch führen würden.
Danach sieht es jedoch absolut nicht aus.
Die ASCO-Konferenz findet vom 20.-23. Mai statt und Maxim wird hier
weitere Ergebnisse der Phase3-Studien zur Behandlung von bösartigem
Hautkrebs, bei dem bereits Metastasen gebildet wurden, bekanntgeben.
Bekannt sind seit knapp 2 Wochen die Ergebnisse der University of
Pittsburgh Cancer Institute, wo 40 der gesamten 305 Patienten behandelt
wurden. 20 wurden mit Maxamine und Interleukin-2 behandelt, 20 aus-
schließlich mit IL-2. Die Ergebnisse waren beeindruckend. Am Ende des
Studienzeitraums ergaben sich folgende Ergebnisse:
durchschnittliche Lebensdauer ohne Maxamine: 187 Tage, alle Patienten
waren gestorben.
durchschnittliche Lebensdauer mit Maxamine: 355 Tage, 6 Patienten noch
am Leben.
Die Ergebnisse sämtlicher 305 Patienten werden auf der ASCO präsentiert.
Diese Informationen stammen aus dem
Programm ASCO 2000
http://asco00.agora.com/2000ASCOabstracts/main2.asp
Maxamine unter Melanoma 2252A
sowie aus einer englischen Übersetzung einer aktuellen Kunden-E-Mail
vom schwedischen Brokerhaus Aragon, das u.a. spezialisiert ist auf
Biotechwerte und Maxim seit einiger Zeit auf der Kaufliste hat.
Jeder soll seine eigenen Kursziele haben,
ich versuche mir vorzustellen, dass es in USA und Europa allein 20 mio Hep C Fälle gibt
bei allen anderen Hepatithis Bereichen, da wurde Maxamine noch gar nicht getestet
und der Mechanismus scheint nicht nur einmalig bei bestimmten Krankheiten/krebsarten zu funktionieren, sondern ganz im Gegenteil, es ist möglich, dass Maxamine so ziemlich bei jeder infektiösen Krankheit oder Krebs hilft.
Seis drun
4,5 mio Hep C in USA
10% Penetration
450.000 Maxamine-Patienten
=4,5 Milliarden $ Umsatz
bei gerade mal 500 mio $ Herstellungskosten
so sieht meine Rechnung aus
und nur für Hep C und nur für USA
Gruss
Xetra-Max
und deswegen verkaufe ich meine Aktie nicht unter 1000$
ich versuche mir vorzustellen, dass es in USA und Europa allein 20 mio Hep C Fälle gibt
bei allen anderen Hepatithis Bereichen, da wurde Maxamine noch gar nicht getestet
und der Mechanismus scheint nicht nur einmalig bei bestimmten Krankheiten/krebsarten zu funktionieren, sondern ganz im Gegenteil, es ist möglich, dass Maxamine so ziemlich bei jeder infektiösen Krankheit oder Krebs hilft.
Seis drun
4,5 mio Hep C in USA
10% Penetration
450.000 Maxamine-Patienten
=4,5 Milliarden $ Umsatz
bei gerade mal 500 mio $ Herstellungskosten
so sieht meine Rechnung aus
und nur für Hep C und nur für USA
Gruss
Xetra-Max
und deswegen verkaufe ich meine Aktie nicht unter 1000$
Maxim Reports Significant Survival Improvement in U.S. Phase III Trial of Maxamine and Interleukin-2 for the Treatment of Stage-IV Malignant Melanoma
SAN DIEGO--(BW HealthWire)--May 2, 2000--Maxim Pharmaceuticals (NasdaqNM:MAXM)(SSE:MAXM) Tuesday announced the first results from its U.S. Phase III clinical trial using Maxamine(R) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of stage-IV malignant melanoma patients.
Treatment with Maxamine plus IL-2 improved survival duration over treatment with IL-2 alone in all six patient populations analyzed in the study. In addition, consistent with the results of earlier Phase II studies, the improvement in survival provided by treatment with Maxamine was most significant in patients having metastases of their melanoma to the liver, a patient population that historically has a very poor prognosis for survival.
Malignant melanoma is the most deadly and serious form of skin cancer and is one of the most rapidly increasing cancers in the world. There are approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment for advanced stage IV melanoma. Treatment with chemotherapy, immunotherapy and combination biochemotherapy has provided varying tumor response rates with little or no improvement in survival duration. Advanced-stage melanoma is a large unmet medical need where more effective treatments are required that can improve survival while maintaining patient quality of life.
Study Design
Maxamine was tested in combination with IL-2 in a randomized, well-controlled, multi-center Phase III trial in the United States. A total of 305 patients were enrolled in the study and were randomized to receive either combination treatment with Maxamine plus IL-2 (n=152 patients) or IL-2 alone (n=153 patients). The purpose of the trial was to demonstrate that Maxamine improves the efficacy of IL-2, an immunotherapeutic agent already approved for the treatment of advanced malignant melanoma.
The patients in the two arms of the study were well matched in terms of demographic characteristics and prognostic factors. Overall, the patients in the study represented a group with factors that are indicative of a poor prognosis for survival, including having an average of three metastatic sites per patient and high LDH levels. Over 40 percent of the patients had liver metastases, a condition normally associated with a poor survival prognosis. "As a group, these patients would have a predicted survival duration of four to five months, substantially less than many historic stage-IV melanoma trials," said Dr. Kurt Gehlsen, Maxim`s vice president, development, and chief technical officer.
The primary endpoint of the Phase III trial was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. Secondary endpoints such as time-to-disease-progression, quality of life and safety were also evaluated. The secondary endpoint of time-to-disease-progression describes the potential benefit for the patient in terms of tumor response and stabilization of disease, and has historically been a primary endpoint for many oncology trials and a basis for FDA approval.
Under the statistical plan for the study the following populations were analyzed:
-- All patients randomized in the study.
-- The "efficacy evaluable" population, the primary group for which
the study was designed and powered. This group consists of all
patients randomized at clinical centers that best adhered to the
study protocol by treating their patients (both Maxamine and
control patients), on average, with two or more cycles of therapy.
-- All patients randomized at clinical centers that developed a
reasonable level of experience with the study drugs under this
protocol, defined as centers that enrolled seven or more patients
in the study. These criteria ensure that a minimum of at least
three Maxamine patients were treated at those centers.
Each of the above populations were comprised of two groups, the first encompassing the patients who entered the study with liver metastases, and the second consisting of all patients who entered the study, resulting in the analysis of a total of six populations. The study called for separate analyses of patients with liver metastases in the various groups due to the historic difficulty in effectively treating this patient population, the high percentage of advanced melanoma patients that have liver metastases, and the apparent benefit provided by Maxamine in this difficult patient group in three completed Phase I/II trials. Separate analysis of the patients with liver metastases was also useful as the expected short survival duration of this population, and the relative homogeneity of this patient group, provide the most relevant basis for comparison between the Maxamine groups and the control groups within the 12-month follow-up period designated in this trial. Approximately 40 percent of stage-IV malignant melanoma patients have detectable liver metastases upon diagnosis, and approximately 80 percent of patients have detectable liver metastases upon death.
The results for each of the six groups reported below represent intent-to-treat populations (the analyses include all patients randomized into the study, with no patients excluded from the study results).
Preliminary Study Results -- All Randomized Patients
Treatment with Maxamine plus IL-2 improved survival duration over treatment with IL-2 alone for all six patient populations analyzed in the study. In addition, consistent with the results of earlier Phase II studies, the improvement in survival provided by treatment with Maxamine was most significant in patients having liver metastases.
For all randomized patients entering the study with liver metastases (n=129), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 212 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 283 days compared to 154 days for control patients treated with IL-2 alone (p=0.004 under the Log-Rank test). Survival, adjusted for quality of life, was also significantly longer for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). A key secondary endpoint, time-to-disease-progression, was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.0033).
For all randomized patients entering the study (n=305), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 273 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 272 days compared to 245 days for control patients treated with IL-2 alone (p greater than 0.05 under the Log-Rank test). Survival, adjusted for quality of life, was significantly improved for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). In addition, time-to-disease-progression was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.01).
"These results represent the first well-controlled, multi-center, Phase III trial to demonstrate a significant survival benefit for patients with advanced metastatic melanoma, especially for those patients having liver metastases," said Dr. John Glaspy, a key investigator in the study from the University of California, Los Angeles. "Based on these results, I expect Maxamine to become a key adjuvant in the treatment of advanced metastatic melanoma patients. The drug has a sound biologic basis for its mechanism of action, and I look forward to participating in additional studies of Maxamine in other cancers."
Preliminary results also demonstrated that treatment with Maxamine and IL-2 was safe and well-tolerated and had substantially less toxicity than standard therapy with high-dose IL-2. The tolerability of the Maxamine/IL-2 treatment allowed these advanced-stage malignant melanoma patients to treat themselves at home.
Preliminary Study Results -- Efficacy Evaluable Population
The statistical plan for this study also called for the evaluation of all patients randomized at clinical centers that best followed the study protocol, defined as those centers that treated all of their randomized patients (in both arms of the study), on average, two or more cycles (the efficacy evaluable population). This analysis is intended to compare the outcomes of patients at centers in which the Maxamine and the control patients were treated in accordance with the study protocol. Such an analysis was deemed to be important as the combined immunotherapy using Maxamine and IL-2 requires a reasonable duration of treatment for it to be effective and beneficial to the patient. The efficacy evaluable population was the primary group for which the study was designed and powered.
For patients entering the study with liver metastases in the efficacy evaluable population (n=93), treatment with Maxamine plus IL-2 resulted in a mean survival of 424 days compared to 210 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 363 days compared to 157 days for control patients treated with IL-2 alone (p=0.0007 under the Log-Rank test).
For all patients in the efficacy evaluable population (n=219), treatment with Maxamine plus IL-2 resulted in a mean survival of 410 days compared to 262 days for patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 326 days compared to 251 days for patients treated with IL-2 alone (p=0.0336 under the Log-Rank test).
"The results are clear, when patients are treated with the combination of Maxamine and IL-2 under the protocol as designed, the improvement in survival is statistically significant over those patients treated with IL-2 alone," said Dr. Gehlsen. "Moreover, for patients having the worst kind of metastatic disease, melanoma that has spread to their liver, the results are unequivocal. We believe that the results of the trial clearly are compelling and will support our applications for registration of the product."
Preliminary Study Results -- Centers with More than Seven Patients
The statistical plan for this study also called for the evaluation of all patients randomized at clinical centers that treated a minimum of seven patients. This analysis is intended to compare the outcome of patients at centers that enrolled a sufficient number of patients to develop a reasonable level of experience with the new combination treatment comprised of Maxamine and IL-2 and with the novel nature of Maxamine and its mechanism of action.
For patients entering the study with liver metastases at clinical centers that enrolled at least seven patients (n=81), treatment with Maxamine plus IL-2 resulted in a mean survival of 360 days compared to 211 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 242 days compared to 152 days for control patients treated with IL-2 alone (p=0.0163 under the Log-Rank test).
For all randomized patients entering the study at clinical centers that enrolled at least seven patients (n=188), treatment with Maxamine plus IL-2 resulted in a mean survival of 391 days compared to 260 days for patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 318 days compared to 204 days for patients treated with IL-2 alone (p=0.0125 under the Log-Rank test).
"We gained valuable experience with this combination treatment during the course of this trial, and we observed that the longer our patients were treated with the combination of Maxamine and IL-2, the more they benefited," said Dr. Sanjiv Agarwala, the lead-enrolling investigator in the study from the University of Pittsburgh. "Based on our experience with this trial, we have been continuing with the Maxamine and IL-2 protocol in a follow-on study at our center along with other U.S. centers from the Phase III study that will encompass approximately 100 patients. An interim analysis of this follow-on study was performed for the upcoming FDA submission being prepared by Maxim and strongly supports the Phase III results."
Safety and Quality of Life
For the first time in any known study, the advanced-stage malignant melanoma patients in this Phase III study were allowed to treat themselves at home. Although the safety and quality of life data are still under analysis, preliminary results suggest that treatment with Maxamine and IL-2 was safe and well-tolerated and had substantially less toxicity than standard therapy with high-dose IL-2.
"The addition of Maxamine improved patient survival without additional toxicity," stated Larry Stambaugh, Maxim`s chairman and chief executive officer. "In fact, it appears that the addition of Maxamine resulted in an improvement in patient quality of life. The combination of survival benefit, safety and quality-of-life results are a major milestone for the treatment of this disease."
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,000 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and safety and efficacy have not been established at this time. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in the summer 2000. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,000 patients have been treated in completed and ongoing clinical trials. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
SAN DIEGO--(BW HealthWire)--May 2, 2000--Maxim Pharmaceuticals (NasdaqNM:MAXM)(SSE:MAXM) Tuesday announced the first results from its U.S. Phase III clinical trial using Maxamine(R) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of stage-IV malignant melanoma patients.
Treatment with Maxamine plus IL-2 improved survival duration over treatment with IL-2 alone in all six patient populations analyzed in the study. In addition, consistent with the results of earlier Phase II studies, the improvement in survival provided by treatment with Maxamine was most significant in patients having metastases of their melanoma to the liver, a patient population that historically has a very poor prognosis for survival.
Malignant melanoma is the most deadly and serious form of skin cancer and is one of the most rapidly increasing cancers in the world. There are approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment for advanced stage IV melanoma. Treatment with chemotherapy, immunotherapy and combination biochemotherapy has provided varying tumor response rates with little or no improvement in survival duration. Advanced-stage melanoma is a large unmet medical need where more effective treatments are required that can improve survival while maintaining patient quality of life.
Study Design
Maxamine was tested in combination with IL-2 in a randomized, well-controlled, multi-center Phase III trial in the United States. A total of 305 patients were enrolled in the study and were randomized to receive either combination treatment with Maxamine plus IL-2 (n=152 patients) or IL-2 alone (n=153 patients). The purpose of the trial was to demonstrate that Maxamine improves the efficacy of IL-2, an immunotherapeutic agent already approved for the treatment of advanced malignant melanoma.
The patients in the two arms of the study were well matched in terms of demographic characteristics and prognostic factors. Overall, the patients in the study represented a group with factors that are indicative of a poor prognosis for survival, including having an average of three metastatic sites per patient and high LDH levels. Over 40 percent of the patients had liver metastases, a condition normally associated with a poor survival prognosis. "As a group, these patients would have a predicted survival duration of four to five months, substantially less than many historic stage-IV melanoma trials," said Dr. Kurt Gehlsen, Maxim`s vice president, development, and chief technical officer.
The primary endpoint of the Phase III trial was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. Secondary endpoints such as time-to-disease-progression, quality of life and safety were also evaluated. The secondary endpoint of time-to-disease-progression describes the potential benefit for the patient in terms of tumor response and stabilization of disease, and has historically been a primary endpoint for many oncology trials and a basis for FDA approval.
Under the statistical plan for the study the following populations were analyzed:
-- All patients randomized in the study.
-- The "efficacy evaluable" population, the primary group for which
the study was designed and powered. This group consists of all
patients randomized at clinical centers that best adhered to the
study protocol by treating their patients (both Maxamine and
control patients), on average, with two or more cycles of therapy.
-- All patients randomized at clinical centers that developed a
reasonable level of experience with the study drugs under this
protocol, defined as centers that enrolled seven or more patients
in the study. These criteria ensure that a minimum of at least
three Maxamine patients were treated at those centers.
Each of the above populations were comprised of two groups, the first encompassing the patients who entered the study with liver metastases, and the second consisting of all patients who entered the study, resulting in the analysis of a total of six populations. The study called for separate analyses of patients with liver metastases in the various groups due to the historic difficulty in effectively treating this patient population, the high percentage of advanced melanoma patients that have liver metastases, and the apparent benefit provided by Maxamine in this difficult patient group in three completed Phase I/II trials. Separate analysis of the patients with liver metastases was also useful as the expected short survival duration of this population, and the relative homogeneity of this patient group, provide the most relevant basis for comparison between the Maxamine groups and the control groups within the 12-month follow-up period designated in this trial. Approximately 40 percent of stage-IV malignant melanoma patients have detectable liver metastases upon diagnosis, and approximately 80 percent of patients have detectable liver metastases upon death.
The results for each of the six groups reported below represent intent-to-treat populations (the analyses include all patients randomized into the study, with no patients excluded from the study results).
Preliminary Study Results -- All Randomized Patients
Treatment with Maxamine plus IL-2 improved survival duration over treatment with IL-2 alone for all six patient populations analyzed in the study. In addition, consistent with the results of earlier Phase II studies, the improvement in survival provided by treatment with Maxamine was most significant in patients having liver metastases.
For all randomized patients entering the study with liver metastases (n=129), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 212 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 283 days compared to 154 days for control patients treated with IL-2 alone (p=0.004 under the Log-Rank test). Survival, adjusted for quality of life, was also significantly longer for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). A key secondary endpoint, time-to-disease-progression, was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.0033).
For all randomized patients entering the study (n=305), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 273 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 272 days compared to 245 days for control patients treated with IL-2 alone (p greater than 0.05 under the Log-Rank test). Survival, adjusted for quality of life, was significantly improved for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). In addition, time-to-disease-progression was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.01).
"These results represent the first well-controlled, multi-center, Phase III trial to demonstrate a significant survival benefit for patients with advanced metastatic melanoma, especially for those patients having liver metastases," said Dr. John Glaspy, a key investigator in the study from the University of California, Los Angeles. "Based on these results, I expect Maxamine to become a key adjuvant in the treatment of advanced metastatic melanoma patients. The drug has a sound biologic basis for its mechanism of action, and I look forward to participating in additional studies of Maxamine in other cancers."
Preliminary results also demonstrated that treatment with Maxamine and IL-2 was safe and well-tolerated and had substantially less toxicity than standard therapy with high-dose IL-2. The tolerability of the Maxamine/IL-2 treatment allowed these advanced-stage malignant melanoma patients to treat themselves at home.
Preliminary Study Results -- Efficacy Evaluable Population
The statistical plan for this study also called for the evaluation of all patients randomized at clinical centers that best followed the study protocol, defined as those centers that treated all of their randomized patients (in both arms of the study), on average, two or more cycles (the efficacy evaluable population). This analysis is intended to compare the outcomes of patients at centers in which the Maxamine and the control patients were treated in accordance with the study protocol. Such an analysis was deemed to be important as the combined immunotherapy using Maxamine and IL-2 requires a reasonable duration of treatment for it to be effective and beneficial to the patient. The efficacy evaluable population was the primary group for which the study was designed and powered.
For patients entering the study with liver metastases in the efficacy evaluable population (n=93), treatment with Maxamine plus IL-2 resulted in a mean survival of 424 days compared to 210 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 363 days compared to 157 days for control patients treated with IL-2 alone (p=0.0007 under the Log-Rank test).
For all patients in the efficacy evaluable population (n=219), treatment with Maxamine plus IL-2 resulted in a mean survival of 410 days compared to 262 days for patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 326 days compared to 251 days for patients treated with IL-2 alone (p=0.0336 under the Log-Rank test).
"The results are clear, when patients are treated with the combination of Maxamine and IL-2 under the protocol as designed, the improvement in survival is statistically significant over those patients treated with IL-2 alone," said Dr. Gehlsen. "Moreover, for patients having the worst kind of metastatic disease, melanoma that has spread to their liver, the results are unequivocal. We believe that the results of the trial clearly are compelling and will support our applications for registration of the product."
Preliminary Study Results -- Centers with More than Seven Patients
The statistical plan for this study also called for the evaluation of all patients randomized at clinical centers that treated a minimum of seven patients. This analysis is intended to compare the outcome of patients at centers that enrolled a sufficient number of patients to develop a reasonable level of experience with the new combination treatment comprised of Maxamine and IL-2 and with the novel nature of Maxamine and its mechanism of action.
For patients entering the study with liver metastases at clinical centers that enrolled at least seven patients (n=81), treatment with Maxamine plus IL-2 resulted in a mean survival of 360 days compared to 211 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 242 days compared to 152 days for control patients treated with IL-2 alone (p=0.0163 under the Log-Rank test).
For all randomized patients entering the study at clinical centers that enrolled at least seven patients (n=188), treatment with Maxamine plus IL-2 resulted in a mean survival of 391 days compared to 260 days for patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 318 days compared to 204 days for patients treated with IL-2 alone (p=0.0125 under the Log-Rank test).
"We gained valuable experience with this combination treatment during the course of this trial, and we observed that the longer our patients were treated with the combination of Maxamine and IL-2, the more they benefited," said Dr. Sanjiv Agarwala, the lead-enrolling investigator in the study from the University of Pittsburgh. "Based on our experience with this trial, we have been continuing with the Maxamine and IL-2 protocol in a follow-on study at our center along with other U.S. centers from the Phase III study that will encompass approximately 100 patients. An interim analysis of this follow-on study was performed for the upcoming FDA submission being prepared by Maxim and strongly supports the Phase III results."
Safety and Quality of Life
For the first time in any known study, the advanced-stage malignant melanoma patients in this Phase III study were allowed to treat themselves at home. Although the safety and quality of life data are still under analysis, preliminary results suggest that treatment with Maxamine and IL-2 was safe and well-tolerated and had substantially less toxicity than standard therapy with high-dose IL-2.
"The addition of Maxamine improved patient survival without additional toxicity," stated Larry Stambaugh, Maxim`s chairman and chief executive officer. "In fact, it appears that the addition of Maxamine resulted in an improvement in patient quality of life. The combination of survival benefit, safety and quality-of-life results are a major milestone for the treatment of this disease."
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,000 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and safety and efficacy have not been established at this time. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in the summer 2000. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,000 patients have been treated in completed and ongoing clinical trials. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
Maxim Pharmaceuticals Announces 2000 Second Quarter Financial Results
SAN DIEGO--(BW HealthWire)--May 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM:MAXM)(SSE:MAXM) Monday announced results for the quarter ended March 31, 2000, the second quarter of its 2000 fiscal year.
The net loss before preferred stock dividends for the second quarter totaled $10,050,000, an increase of 4% over the prior year. The net loss before preferred stock dividends for the six months ended March 31, 2000 totaled $20,079,000, an increase of 5% over the prior year. Consistent with the prior year, current quarter operating activities were comprised primarily of the clinical development and other activities associated with the commercialization of the company`s lead drug candidate, Maxamine(R).
Net loss applicable to common stock for the second quarter totaled $12,649,000 or $0.77 per share, compared with a net loss applicable to common stock of $9,685,000, or $0.97 per share, for the same period of the prior year. The increase in net loss applicable to common stock was primarily the result of $2.6 million in dividends associated with company`s preferred stock that was converted to common stock during the quarter, and the decrease in net loss per share resulted from an increase in the weighted average number of shares outstanding. Net loss applicable to common stock for the six months ended March 31, 2000 totaled $25,092,000 or $1.80 per share, compared with a net loss applicable to common stock of $19,134,000, or $1.92 per share, for the same period of the prior year. The increase in net loss applicable to common stock for the first six months of the current fiscal year was related to $5.0 million in dividends on preferred stock that was converted to common stock during the current fiscal year, and the decrease in per share loss was attributable to an increase in the weighted average number of shares outstanding. As a result of the aforementioned conversion, no preferred stock remained outstanding at March 31, 2000.
"During the second quarter we achieved a significant milestone, the completion of our U.S. Phase III trial of Maxamine for the treatment of advanced malignant melanoma," said Dale A. Sander, Maxim`s vice president, finance and chief financial officer. "Despite the significant effort undertaken during the quarter to complete the trial and the related data preparation within our timeline objectives, our operating expenditures for the quarter were within our expectations and in line with the prior year. The dividends recorded during the quarter related primarily to the conversion of our series B preferred stock into common stock, and the conversion was a non-cash transaction."
In February 2000 the company completed a public offering of common stock that resulted in net proceeds to the company of $165 million after underwriting discounts and expenses. The company had cash, cash equivalents and investments totaling $204.9 million at March 31, 2000, and its net cash used in operations for the six months ended March 31, 2000 was $15.0 million.
SAN DIEGO--(BW HealthWire)--May 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM:MAXM)(SSE:MAXM) Monday announced results for the quarter ended March 31, 2000, the second quarter of its 2000 fiscal year.
The net loss before preferred stock dividends for the second quarter totaled $10,050,000, an increase of 4% over the prior year. The net loss before preferred stock dividends for the six months ended March 31, 2000 totaled $20,079,000, an increase of 5% over the prior year. Consistent with the prior year, current quarter operating activities were comprised primarily of the clinical development and other activities associated with the commercialization of the company`s lead drug candidate, Maxamine(R).
Net loss applicable to common stock for the second quarter totaled $12,649,000 or $0.77 per share, compared with a net loss applicable to common stock of $9,685,000, or $0.97 per share, for the same period of the prior year. The increase in net loss applicable to common stock was primarily the result of $2.6 million in dividends associated with company`s preferred stock that was converted to common stock during the quarter, and the decrease in net loss per share resulted from an increase in the weighted average number of shares outstanding. Net loss applicable to common stock for the six months ended March 31, 2000 totaled $25,092,000 or $1.80 per share, compared with a net loss applicable to common stock of $19,134,000, or $1.92 per share, for the same period of the prior year. The increase in net loss applicable to common stock for the first six months of the current fiscal year was related to $5.0 million in dividends on preferred stock that was converted to common stock during the current fiscal year, and the decrease in per share loss was attributable to an increase in the weighted average number of shares outstanding. As a result of the aforementioned conversion, no preferred stock remained outstanding at March 31, 2000.
"During the second quarter we achieved a significant milestone, the completion of our U.S. Phase III trial of Maxamine for the treatment of advanced malignant melanoma," said Dale A. Sander, Maxim`s vice president, finance and chief financial officer. "Despite the significant effort undertaken during the quarter to complete the trial and the related data preparation within our timeline objectives, our operating expenditures for the quarter were within our expectations and in line with the prior year. The dividends recorded during the quarter related primarily to the conversion of our series B preferred stock into common stock, and the conversion was a non-cash transaction."
In February 2000 the company completed a public offering of common stock that resulted in net proceeds to the company of $165 million after underwriting discounts and expenses. The company had cash, cash equivalents and investments totaling $204.9 million at March 31, 2000, and its net cash used in operations for the six months ended March 31, 2000 was $15.0 million.
Tuesday May 2, 4:19 pm Eastern Time
Maxim says skin cancer drug extends patient survival
----------------------------------------------------
SAN DIEGO, May 2 (Reuters) - Maxim Pharmaceuticals Inc. (NasdaqNM:MAXM - news) released on Tuesday results of a late-stage clinical trial showing that a combination of Maxamine and interleukin-2 extended survival longer than interleukin-2 alone in patients with advanced skin cancer.
The San Diego-based company said patients whose cancer had spread to the liver experienced the most significant improvements.
The treatment extended survival in all six populations of the total 305 patients tested, resulting in a mean survival of 364 days, compared with 273 days for patients treated with just interleukin-2, a chemical that signals the immune system.
There is currently no effective treatment for advanced stage IV melanoma. Chemotherapy, immunotherapy and combination biochemotherapy have had varying effects on tumours, but haven`t extended patient survival.
Maxim said it expects to file an application for the drug as a treatment for malignant melanoma at the U.S. Food and Drug Administration this summer.
Maxamine is designed to reverse a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumour cells or virally infected cells in many patients with cancer and chronic infectious diseases.
The drug is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukaemia. It is also being tested in Phase II as a treatment for hepatitis C and advanced renal cell carcinoma.
Shares of Maxim Pharmaceuticals fell 2-1/8 on Tuesday to close at 38-5/8.
--------------------------------------------------------------------------------
More Quotes and News: Maxim Pharmaceuticals Inc (NasdaqNM:MAXM - news)
Related News Categories: health, US Market News
Maxim says skin cancer drug extends patient survival
----------------------------------------------------
SAN DIEGO, May 2 (Reuters) - Maxim Pharmaceuticals Inc. (NasdaqNM:MAXM - news) released on Tuesday results of a late-stage clinical trial showing that a combination of Maxamine and interleukin-2 extended survival longer than interleukin-2 alone in patients with advanced skin cancer.
The San Diego-based company said patients whose cancer had spread to the liver experienced the most significant improvements.
The treatment extended survival in all six populations of the total 305 patients tested, resulting in a mean survival of 364 days, compared with 273 days for patients treated with just interleukin-2, a chemical that signals the immune system.
There is currently no effective treatment for advanced stage IV melanoma. Chemotherapy, immunotherapy and combination biochemotherapy have had varying effects on tumours, but haven`t extended patient survival.
Maxim said it expects to file an application for the drug as a treatment for malignant melanoma at the U.S. Food and Drug Administration this summer.
Maxamine is designed to reverse a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumour cells or virally infected cells in many patients with cancer and chronic infectious diseases.
The drug is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukaemia. It is also being tested in Phase II as a treatment for hepatitis C and advanced renal cell carcinoma.
Shares of Maxim Pharmaceuticals fell 2-1/8 on Tuesday to close at 38-5/8.
--------------------------------------------------------------------------------
More Quotes and News: Maxim Pharmaceuticals Inc (NasdaqNM:MAXM - news)
Related News Categories: health, US Market News
Hi,
an dieser Stelle einmal ein Dankeschön an Pitu für seine Infos über Maxim. Die Qualität dieses Threads ist wirklich
spitze.
Und vielleicht auch mal ein Zeitpunkt, nach den neuesten Nachrichten ein Resümee zu ziehen ?
Liegen die Ergebnise sowohl der Quartalszahlen als auch der klinischen Tests im Rahmen der Erwartungen ?
Sind die Kursziele und Kaufempfehlungen noch aktuell ?
Ich bin seit 60 Euro dabei mit dem festen Vorsatz, mind. 2 Jahre stehen zu lassen und dann zu schauen wo wir uns vom Kurs
her befinden. Aber mit solchen Infos auf dem Neusten gehalten zu werden, ist natürlich schön.
Gruß
LeNeant
an dieser Stelle einmal ein Dankeschön an Pitu für seine Infos über Maxim. Die Qualität dieses Threads ist wirklich
spitze.
Und vielleicht auch mal ein Zeitpunkt, nach den neuesten Nachrichten ein Resümee zu ziehen ?
Liegen die Ergebnise sowohl der Quartalszahlen als auch der klinischen Tests im Rahmen der Erwartungen ?
Sind die Kursziele und Kaufempfehlungen noch aktuell ?
Ich bin seit 60 Euro dabei mit dem festen Vorsatz, mind. 2 Jahre stehen zu lassen und dann zu schauen wo wir uns vom Kurs
her befinden. Aber mit solchen Infos auf dem Neusten gehalten zu werden, ist natürlich schön.
Gruß
LeNeant
über maxim gibt es auch in usa noch recht wenige analysen.
deshalb konnte ich bisher nicht ausfindig machen, ob die quartalszahlen die erwartungen übertreffen.
von der qualität der testergebnisse scheint zumindest die maxim-führung sehr überzeugt zu sein.
morgen wird die börse online übrigens mitteilen, daß maxim aus der empfehlungsliste gestoppt wurde.
vielleicht sind sie dann morgens mit abschlag zu haben ...
deshalb konnte ich bisher nicht ausfindig machen, ob die quartalszahlen die erwartungen übertreffen.
von der qualität der testergebnisse scheint zumindest die maxim-führung sehr überzeugt zu sein.
morgen wird die börse online übrigens mitteilen, daß maxim aus der empfehlungsliste gestoppt wurde.
vielleicht sind sie dann morgens mit abschlag zu haben ...
Falls Blockbuster noch auf sich warten lässt : bitte bitte , neuen thread aufmachen, dieser wird etwas länglich. Danke.
...und damit wieder ein Wert, der bei BO aus der Empfehlungsliste ausgestoppt wird. Die waren auch schon mal besser.
Wenn ich noch Cash hätte, würde ich mir es ernsthaft überlegen, noch nachzuordern.
Bin gespannt, ob Du noch was zu den Quartalszahlen findest, Pitu ! (ich kuck auch mal nach)
Gruß
LeNeant
Wenn ich noch Cash hätte, würde ich mir es ernsthaft überlegen, noch nachzuordern.
Bin gespannt, ob Du noch was zu den Quartalszahlen findest, Pitu ! (ich kuck auch mal nach)
Gruß
LeNeant
kaum ist BO raus aus maxim, schon kommt wieder schwung in den kurs.
nur begründung für den kursanstieg kann ich keine liefern.
nur begründung für den kursanstieg kann ich keine liefern.
Begründungen braucht es momentan auch gar nicht. Die Biotech Aktien sind so stark Clinton- und Crash-geschädigt, dass bei dem nächsten Hype alle Biotech Aktien wieder aufleben werden. Maxim hat eine gute Story und ist doch nur aufgrund der allgemeinen Konsolidierung mit heruntergezogen worden.
BO hat sie nicht rausgeschmissen, weil sie nichts taugt, sondern nur, weil sie kurzfristig unter den Stoppkurs gefallen war.
Pebbles
BO hat sie nicht rausgeschmissen, weil sie nichts taugt, sondern nur, weil sie kurzfristig unter den Stoppkurs gefallen war.
Pebbles
Moin!
Habe das hier gefunden-ein "Strong Buy"-trotzdem -7,32% !?
Alert: Roth Capital initiates coverage of MAXM at Strong Buy, price target $95
(Headline only) Briefing.com, 05/22/2000 12:20 PM EDT
http://www.quicken.com/investments/quotes/?symbol=maxm
BM
Habe das hier gefunden-ein "Strong Buy"-trotzdem -7,32% !?
Alert: Roth Capital initiates coverage of MAXM at Strong Buy, price target $95
(Headline only) Briefing.com, 05/22/2000 12:20 PM EDT
http://www.quicken.com/investments/quotes/?symbol=maxm
BM
Hallo Pitu,
gefällt mir
Gruss
Trader13
gefällt mir
Gruss
Trader13
Friday May 26, 04:02 AM Eastern time
Company Press Release
Maxim Pharmaceuticals Sells Vaccine Technology
SAN DIEGO--(BW HealthWire)--May 26, 2000--Maxim Pharmaceuticals (Nasdaq/NM:MAXM) (SSE:MAXM) announced today that it has completed an agreement to sell all assets, including patent, license and other intellectual property rights, underlying its MaxVax(R) mucosal vaccine technology, and to settle an arbitration related to the technology, for 3 million. Maxim will record a gain on the transaction of approximately 2.1 million during the quarter ended June 30, 2000.
"During the past several years we have built up significant expertise relating to the treatment of cancer and hepatitis C," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "We believe that we can maximize the creation of shareholder value by accelerating and expanding the commercialization of our existing and future technology platforms primarily in these areas.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the Company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and demonstrated a significant increase in survival for patients treated with Maxamine. Maxim expects to file its NDA for the U.S. Phase III study in the summer 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,000 patients have been treated in completed and ongoing clinical trials. The Company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The Company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine and MaxDerm and the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
BM
Company Press Release
Maxim Pharmaceuticals Sells Vaccine Technology
SAN DIEGO--(BW HealthWire)--May 26, 2000--Maxim Pharmaceuticals (Nasdaq/NM:MAXM) (SSE:MAXM) announced today that it has completed an agreement to sell all assets, including patent, license and other intellectual property rights, underlying its MaxVax(R) mucosal vaccine technology, and to settle an arbitration related to the technology, for 3 million. Maxim will record a gain on the transaction of approximately 2.1 million during the quarter ended June 30, 2000.
"During the past several years we have built up significant expertise relating to the treatment of cancer and hepatitis C," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "We believe that we can maximize the creation of shareholder value by accelerating and expanding the commercialization of our existing and future technology platforms primarily in these areas.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the Company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and demonstrated a significant increase in survival for patients treated with Maxamine. Maxim expects to file its NDA for the U.S. Phase III study in the summer 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,000 patients have been treated in completed and ongoing clinical trials. The Company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The Company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine and MaxDerm and the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
BM
begeistet mich nicht so. aber mal sehen, wie das ankommt.
Hi,könnte mir jemand das ganze in kurzform auf deutsch übersetzen,da mein englisch nicht so überragend ist.Danke in voraus!
Also überzeugend wirkt das auf die Amis nicht besonders, wenn das so toll wäre, würde der Kurs mindestens 10-20% steigen. Tut er aber nicht.
an dakki,
maxim hat dem gesamten bereich maxvax für 3 millionen $ verkauft. neben maxamine und maxderm war maxvax der dritte forschungsbereich.
siehe mein posting vom 11.03. um 23:50:47.
man möchte sich auf die behandlung von krebs und hepatitis spezialisieren.
maxim hat dem gesamten bereich maxvax für 3 millionen $ verkauft. neben maxamine und maxderm war maxvax der dritte forschungsbereich.
siehe mein posting vom 11.03. um 23:50:47.
man möchte sich auf die behandlung von krebs und hepatitis spezialisieren.
The Wall Street Transcript Publishes Biotechnology Issue
NEW YORK, May 30 /PRNewswire/ -- Four leading analysts and top management from thirty-seven sector firms examine the Outlook for Biotechnology in the latest issue of The Wall Street Transcript (212/952-7433) or http://www.twst.com/info/info103.htm
In a vital review of this sector for investors and industry professionals, this valuable 160-page Special Issue features:
1) Outlook for Biotechnology - In an in-depth (9,300 words) Analyst Roundtable, Peter Drake, Managing Director, Robert Toth, Jr., Senior Analyst, and John Sonnier, Senior Biotechnology Analyst, all with Prudential Vector Healthcare Group, examine the outlook for the sector, including merger and acquisition activity, causes of volatility, new products and technology, and share specific stock recommendations.
Drake explains the approach that the Prudential Vector Healthcare Group takes to the biotechnology sector: "Ideally we look for what we call the four P`s: very strong people, so we take a long time looking at managements; a very solid product pipeline; companies need to have a very strong patent position, so we spend a lot of time looking at intellectual property; and then lastly, there has to be some near-term outlook for profits. We have a bias against covering early-stage, venture-oriented companies that have a lot of product risk."
Drake points out Sepracor (Nasdaq: SEPR). "2000 is going to represent a watershed year for the company. Their product portfolio is maturing. They are looking for at least one product approval, perhaps two, in the US and Europe this year. The company is entering the clinic with several new products and is positioned to have what looks to be the largest product pipeline in the biotech industry."
Toth highlights ILEX Oncology (Nasdaq: ILXO). "ILEX Oncology is developing Campath, a monoclonal antibody for the treatment of a deadly cancer called chronic lymphocytic leukemia that has been filed with the FDA, and there is a high probability of approval before the end of this year. Campath is a drug that I think can generate $150-$200 million in worldwide sales at maturity."
Toth continues, "Maxim Pharmaceuticals (Nasdaq: MAXM) has a drug called Maxamine. Maxim has tested it in hepatitis C, which is an area that I`m trying to keep an eye on. Hepatitis C is a four million patient market in the United States. I think Maxamine has a $500 million potential."
Toth questions the valuation of Celera Genomics (NYSE: CRA). "I haven`t quite seen yet how the company plans to make money from all of the work that they are doing in the genetic sequencing game. What Celera has going for it is $800 million in cash, and I believe they will buy their way into that game, but at a $5 billion valuation that`s one that I would call into question."
Speaking about Incyte (Nasdaq: INCY) and Millennium (Nasdaq: MLNM), Toth asserts, "I think they`re both exceptional companies that are going to be around for the long haul and are very well positioned to capitalize on the opportunities that genomics represents in the future. I just haven`t quite figured out how to value them to a degree that would justify a Strong Buy rating in here, that would allow me to tell people that these are stocks that need to be owned today at these prices, and I think that genomics valuation is an issue that the investment community in general is dealing with."
This 160-page Outlook for Biotechnology Issue also features:
2) Biotechnology Stocks - In an in-depth (5,800 words) Analyst Interview, Kurt von Emster, Vice President with Franklin Advisers, examines the outlook for the sector, including the extreme volatility issue in the biotechnology market, new technologies and therapeutics, and shares specific stock recommendations.
3) CEO interviews (average 2,500 words). Top management of thirty-seven sector firms examine the outlook for their firm and the sector. Firms include:
Aastrom Biosciences, AMBI, Atlantic Technologies Ventures, Generex
Biotechnology, Neogen, Nexell Therapeutics, Novavax, Xechem International,
ARIAD Pharmaceuticals, AVAX Technologies, Bioanalytical Systems,
Biomatrix, Boston Life Sciences, CEL-SCI Corporation, Cephalon, Collateral
Therapeutics, Del Global Technologies, Epoch Biosciences, Genetronics
Biomedical Ltd, Genta, Genzyme Molecular Oncology, Human Genome Sciences,
ILEX Oncology, ImmuCell Corporation, Immunomedics, Inamco International,
Integra LifeSciences Holdings, Implant Sciences Corporation, Isis
Pharmaceuticals, Ligand Pharmaceuticals, Lynx Therapeutics, Ortec
International, Polydex Pharmaceuticals, Protein Polymer Technologies,
Ribozyme Pharmaceuticals, Synaptic Pharmaceutical, Trega Biosciences.
To obtain a copy of this 160-page Outlook for Biotechnology issue, call
(212) 952-7433 or see http://www.twst.com/info/info103.htm
The Wall Street Transcript is a premier weekly investment publication interviewing market professionals for serious investors for over 37 years.
The Wall Street Transcript has launched a new free service where investors can ask any of the above companies (or any public company) a question at http://www.qawire.com
The Wall Street Transcript does not endorse the views of any interviewee nor does it make stock recommendations.
NEW YORK, May 30 /PRNewswire/ -- Four leading analysts and top management from thirty-seven sector firms examine the Outlook for Biotechnology in the latest issue of The Wall Street Transcript (212/952-7433) or http://www.twst.com/info/info103.htm
In a vital review of this sector for investors and industry professionals, this valuable 160-page Special Issue features:
1) Outlook for Biotechnology - In an in-depth (9,300 words) Analyst Roundtable, Peter Drake, Managing Director, Robert Toth, Jr., Senior Analyst, and John Sonnier, Senior Biotechnology Analyst, all with Prudential Vector Healthcare Group, examine the outlook for the sector, including merger and acquisition activity, causes of volatility, new products and technology, and share specific stock recommendations.
Drake explains the approach that the Prudential Vector Healthcare Group takes to the biotechnology sector: "Ideally we look for what we call the four P`s: very strong people, so we take a long time looking at managements; a very solid product pipeline; companies need to have a very strong patent position, so we spend a lot of time looking at intellectual property; and then lastly, there has to be some near-term outlook for profits. We have a bias against covering early-stage, venture-oriented companies that have a lot of product risk."
Drake points out Sepracor (Nasdaq: SEPR). "2000 is going to represent a watershed year for the company. Their product portfolio is maturing. They are looking for at least one product approval, perhaps two, in the US and Europe this year. The company is entering the clinic with several new products and is positioned to have what looks to be the largest product pipeline in the biotech industry."
Toth highlights ILEX Oncology (Nasdaq: ILXO). "ILEX Oncology is developing Campath, a monoclonal antibody for the treatment of a deadly cancer called chronic lymphocytic leukemia that has been filed with the FDA, and there is a high probability of approval before the end of this year. Campath is a drug that I think can generate $150-$200 million in worldwide sales at maturity."
Toth continues, "Maxim Pharmaceuticals (Nasdaq: MAXM) has a drug called Maxamine. Maxim has tested it in hepatitis C, which is an area that I`m trying to keep an eye on. Hepatitis C is a four million patient market in the United States. I think Maxamine has a $500 million potential."
Toth questions the valuation of Celera Genomics (NYSE: CRA). "I haven`t quite seen yet how the company plans to make money from all of the work that they are doing in the genetic sequencing game. What Celera has going for it is $800 million in cash, and I believe they will buy their way into that game, but at a $5 billion valuation that`s one that I would call into question."
Speaking about Incyte (Nasdaq: INCY) and Millennium (Nasdaq: MLNM), Toth asserts, "I think they`re both exceptional companies that are going to be around for the long haul and are very well positioned to capitalize on the opportunities that genomics represents in the future. I just haven`t quite figured out how to value them to a degree that would justify a Strong Buy rating in here, that would allow me to tell people that these are stocks that need to be owned today at these prices, and I think that genomics valuation is an issue that the investment community in general is dealing with."
This 160-page Outlook for Biotechnology Issue also features:
2) Biotechnology Stocks - In an in-depth (5,800 words) Analyst Interview, Kurt von Emster, Vice President with Franklin Advisers, examines the outlook for the sector, including the extreme volatility issue in the biotechnology market, new technologies and therapeutics, and shares specific stock recommendations.
3) CEO interviews (average 2,500 words). Top management of thirty-seven sector firms examine the outlook for their firm and the sector. Firms include:
Aastrom Biosciences, AMBI, Atlantic Technologies Ventures, Generex
Biotechnology, Neogen, Nexell Therapeutics, Novavax, Xechem International,
ARIAD Pharmaceuticals, AVAX Technologies, Bioanalytical Systems,
Biomatrix, Boston Life Sciences, CEL-SCI Corporation, Cephalon, Collateral
Therapeutics, Del Global Technologies, Epoch Biosciences, Genetronics
Biomedical Ltd, Genta, Genzyme Molecular Oncology, Human Genome Sciences,
ILEX Oncology, ImmuCell Corporation, Immunomedics, Inamco International,
Integra LifeSciences Holdings, Implant Sciences Corporation, Isis
Pharmaceuticals, Ligand Pharmaceuticals, Lynx Therapeutics, Ortec
International, Polydex Pharmaceuticals, Protein Polymer Technologies,
Ribozyme Pharmaceuticals, Synaptic Pharmaceutical, Trega Biosciences.
To obtain a copy of this 160-page Outlook for Biotechnology issue, call
(212) 952-7433 or see http://www.twst.com/info/info103.htm
The Wall Street Transcript is a premier weekly investment publication interviewing market professionals for serious investors for over 37 years.
The Wall Street Transcript has launched a new free service where investors can ask any of the above companies (or any public company) a question at http://www.qawire.com
The Wall Street Transcript does not endorse the views of any interviewee nor does it make stock recommendations.
Maxim Phase III Malignant Melanoma Data Presented At Clinical Conference; Treatment with Maxamine plus interleukin-2 Improves Two-Year Survival
SAN DIEGO--(BW HealthWire)--June 2, 2000--Maxim Pharmaceuticals (Nasdaq 1/4NM:MAXM)(SSE: MAXM) Friday announced that results from its Phase III trial of Maxamine(R) (histamine dihydrochloride) in Stage-IV malignant melanoma will be presented today at the Perspectives in Melanoma IV conference in Pittsburgh.
The results show that the immunomodulating agent Maxamine used in combination with a lower dose regimen of interleukin-2 (IL-2), improved survival for stage-IV malignant melanoma patients compared with those treated with the same doses of IL-2 alone.
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, and improved time-to-disease-progression over treatment with IL-2 alone. As previously reported, improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis, and in all subgroups analyzed under the approved statistical plan. The results from the 305-patient study will be presented today by Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute.
Included in the new data to be presented at the conference is the fact that 24-month survival occurred in a total of 25% of patients treated with Maxamine and lower-dose IL-2, compared with 17% in those treated with lower-dose IL-2 alone. Published reports indicate that the 24-month survival for patients treated with the approved, high-dose, regimen of IL-2 is 12%. In addition, overall response was achieved in 38% of the patients treated with Maxamine and lower-dose IL-2, compared with 28% in those treated with the same dose of IL-2 alone.
"The patients in this study represented a group with factors that are indicative of a poor prognosis for survival, including a large percentage of patients with liver metastases," explained Dr. Agarwala. "This is the first well-controlled, multi-center Phase III trial to show a significant increase in survival among patients with advanced metastatic melanoma."
Achievement of Primary Endpoint
The company also reported that the study had achieved a primary endpoint required to support global applications for registration. The primary endpoint of the Phase III trial under the prospective statistical plan was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. With the achievement of statistically significant survival improvement in the liver metastases population, and the attainment of survival improvement tending toward significance in the overall population, the study results meet the requirements established in advance for regulatory submissions seeking marketing approval in the United States, Europe and other key markets.
Malignant melanoma is one of the most rapidly increasing cancers in the world, with approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment that increases survival for advanced stage IV melanoma.
Safety and Quality of Life
"Treatment of stage-IV melanoma with chemotherapy, immunotherapy and combination biochemotherapy has provided varying tumor response rates without proof to date that any of these treatments prolong survival," stated John M. Kirkwood, M.D., director of the Melanoma Center at the University of Pittsburgh Cancer Institute. "More effective treatments are required that can improve survival, ideally while maintaining the patient`s quality of life."
As reported previously, preliminary results for the Phase III study indicated that treatment with Maxamine and lower-dose IL-2 was safe and well-tolerated and had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved. The tolerability of the Maxamine and IL-2 combination therapy allowed these advanced-stage malignant melanoma patients to treat themselves at home.
Grade 3 and 4 serious adverse events were substantially less for patients treated with Maxamine and IL-2 than would be expected with high-dose IL-2. For example, one percent of patients treated in this Phase III study with Maxamine and lower-dose IL-2 experienced hypotension, compared with published reports of 45% for patients treated with high-dose IL-2. Gastrointestinal disorders (diarrhea) occurred in one percent of the patients treated with Maxamine and lower-dose IL-2, compared with published reports of 32% for patients treated with high-dose IL-2. None of the patients treated with Maxamine and lower-dose IL-2 experienced renal oliguria, compared with published reports of 39% for patients treated with high-dose IL-2.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,000 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and safety and efficacy have not been established at this time. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in the summer 2000. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Unlike many cancer therapies, Maxamine is designed to be safely administered by patients in their own homes. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
SAN DIEGO--(BW HealthWire)--June 2, 2000--Maxim Pharmaceuticals (Nasdaq 1/4NM:MAXM)(SSE: MAXM) Friday announced that results from its Phase III trial of Maxamine(R) (histamine dihydrochloride) in Stage-IV malignant melanoma will be presented today at the Perspectives in Melanoma IV conference in Pittsburgh.
The results show that the immunomodulating agent Maxamine used in combination with a lower dose regimen of interleukin-2 (IL-2), improved survival for stage-IV malignant melanoma patients compared with those treated with the same doses of IL-2 alone.
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, and improved time-to-disease-progression over treatment with IL-2 alone. As previously reported, improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis, and in all subgroups analyzed under the approved statistical plan. The results from the 305-patient study will be presented today by Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute.
Included in the new data to be presented at the conference is the fact that 24-month survival occurred in a total of 25% of patients treated with Maxamine and lower-dose IL-2, compared with 17% in those treated with lower-dose IL-2 alone. Published reports indicate that the 24-month survival for patients treated with the approved, high-dose, regimen of IL-2 is 12%. In addition, overall response was achieved in 38% of the patients treated with Maxamine and lower-dose IL-2, compared with 28% in those treated with the same dose of IL-2 alone.
"The patients in this study represented a group with factors that are indicative of a poor prognosis for survival, including a large percentage of patients with liver metastases," explained Dr. Agarwala. "This is the first well-controlled, multi-center Phase III trial to show a significant increase in survival among patients with advanced metastatic melanoma."
Achievement of Primary Endpoint
The company also reported that the study had achieved a primary endpoint required to support global applications for registration. The primary endpoint of the Phase III trial under the prospective statistical plan was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. With the achievement of statistically significant survival improvement in the liver metastases population, and the attainment of survival improvement tending toward significance in the overall population, the study results meet the requirements established in advance for regulatory submissions seeking marketing approval in the United States, Europe and other key markets.
Malignant melanoma is one of the most rapidly increasing cancers in the world, with approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment that increases survival for advanced stage IV melanoma.
Safety and Quality of Life
"Treatment of stage-IV melanoma with chemotherapy, immunotherapy and combination biochemotherapy has provided varying tumor response rates without proof to date that any of these treatments prolong survival," stated John M. Kirkwood, M.D., director of the Melanoma Center at the University of Pittsburgh Cancer Institute. "More effective treatments are required that can improve survival, ideally while maintaining the patient`s quality of life."
As reported previously, preliminary results for the Phase III study indicated that treatment with Maxamine and lower-dose IL-2 was safe and well-tolerated and had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved. The tolerability of the Maxamine and IL-2 combination therapy allowed these advanced-stage malignant melanoma patients to treat themselves at home.
Grade 3 and 4 serious adverse events were substantially less for patients treated with Maxamine and IL-2 than would be expected with high-dose IL-2. For example, one percent of patients treated in this Phase III study with Maxamine and lower-dose IL-2 experienced hypotension, compared with published reports of 45% for patients treated with high-dose IL-2. Gastrointestinal disorders (diarrhea) occurred in one percent of the patients treated with Maxamine and lower-dose IL-2, compared with published reports of 32% for patients treated with high-dose IL-2. None of the patients treated with Maxamine and lower-dose IL-2 experienced renal oliguria, compared with published reports of 39% for patients treated with high-dose IL-2.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,000 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and safety and efficacy have not been established at this time. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Maxim Pharmaceuticals is developing advanced drugs and therapies for cancer and infectious diseases. The U.S. Phase III trial of the company`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in the summer 2000. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Unlike many cancer therapies, Maxamine is designed to be safely administered by patients in their own homes. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
Moin Pitu- was sagst du hierzu ? Hört sich gut an -oder-?
Tuesday June 6, 04:01 AM Eastern time
Company Press Release
Maxim Pharmaceuticals Enters Into
Agreement to Acquire Cytovia Inc.
SAN DIEGO--(BW HealthWire)--June 6, 2000--Maxim Pharmaceuticals
(Nasdaq NM:MAXM, SSE: MAXM) announced that it has entered into an
agreement to acquire Cytovia Inc., a privately held biopharmaceutical research
company focused on the discovery and development of apoptosis inhibitors
and activators, novel drugs that modulate programmed cell death.
Cytovia`s technology base includes proprietary drug candidates in the areas of
oncology, oral mucositis and cardiovascular disease, and a proprietary
high-throughput screening process for other apoptosis-targeted drug
candidates.
Upon completion of the acquisition, Maxim will issue 1,585,214 shares of its
common stock, or seven percent of its total post-transaction shares
outstanding, in exchange for all of the capital stock of Cytovia outstanding.
Completion of the acquisition is subject to a vote of Cytovia`s shareholders.
Upon completion of the transaction, Cytovia will be a wholly owned subsidiary
of Maxim.
"We are enthusiastic about combining Cytovia`s exiting drug candidate pipeline
and broad technology platform with our clinical development and
commercialization capabilities," said Larry Stambaugh, Maxim`s chairman and
chief executive officer. "In a short period of time Cytovia has developed a
promising portfolio of drug candidates for cancer, oral mucositis, and
cardiovascular disease, and is screening compound libraries for other
apoptosis-targeted drugs that may be useful in several other therapeutic
indications. We also believe that Cytovia`s highly qualified management group
and associate base will add important capabilities to Maxim that accelerate our
combined drug discovery and development efforts. This is an important
addition to our existing, advanced platform technologies, Maxamine and
MaxDerm."
"We are extremely excited about this merger," said Eckard Weber, M.D.,
Cytovia`s chief executive officer. "The merger of Cytovia into Maxim will allow
us to greatly accelerate the clinical development of our key drug candidates to
the benefit of both shareholder groups. The addition of Cytovia`s drug
candidate pipeline and discovery engine to Maxim`s late-stage clinical
products, and the strength of Maxim`s clinical development and
commercialization capabilities, will make the combined company one of the
more important players in the biotechnology industry."
Cytovia Overview
Cytovia is a San Diego-based biomedical research company focused on the
discovery and development of small-molecule inhibitors and activators of
caspases. Caspases are key enzymes that modulate and carry out the cellular
signaling pathways involved in programmed cell death, also known as
apoptosis. Compounds that can either inhibit caspases or induce caspases may
form the basis for important new drugs for a wide variety of disease targets.
Cytovia has developed a proprietary high-throughput screening system that is
targeted to discovery of both caspase inhibitors and activators. The
high-throughput screening technology has generated a pipeline of new drug
candidates, including several compounds that have undergone in vitro and in
vivo testing. One of the drug candidates is a caspase activator that has shown
favorable results in preclinical models of drug resistant cancers. Two other
drug candidates are caspase inhibitors, one of which has been shown to be
active in preclinical models of oral mucositis. The other caspase inhibitor has
been shown to afford protection of the heart muscle following an ischemic
event such as myocardial infarction, and ischemia/reperfusion injury. This
compound has also been shown to be highly active in preclinical models of
acute liver failure associated with hepatitis, as well as in models of sepsis and
stroke.
Maxim Overview
Maxim Pharmaceuticals is a late-stage pharmaceutical company developing
advanced drugs and therapies for cancer and infectious diseases. The U.S.
Phase III trial of the company`s lead drug candidate Maxamine(R) (histamine
dihydrochloride) for the treatment of malignant melanoma was completed in
March 2000 and the company plans to file its NDA for the Phase III study in
the summer of 2000. Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and
acute myelogenous leukemia. Phase II trials of Maxamine are also underway
for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine
is designed to be safely administered by patients in their own homes, and more
than 1,000 patients have been treated in completed and ongoing clinical trials.
The company is also developing MaxDerm(TM), for the treatment of medical
conditions for which topical therapy is appropriate such as oral mucositis,
herpes, decubitus ulcers, shingles, burns and related conditions. The company
expects to commercialize its technologies through a combination of in-house
development and collaborative agreements with pharmaceutical companies.
This news release contains certain forward-looking statements that involve
risks and uncertainties. Such forward-looking statements include statements
regarding the efficacy and intended utilization of Maxamine, MaxDerm and
Cytovia`s compounds, and regarding the company`s clinical trials. Such
statements are only predictions and the company`s actual results may differ
materially from those anticipated in these forward-looking statements. Factors
that may cause such differences include the risk that products that appeared
promising in early research and clinical trials do not demonstrate safety or
efficacy in larger-scale clinical trials and the risk that the company will not
obtain approval to market its products. Additional factors include uncertainties
related to the integration of Cytovia`s operations and personnel with those of
the company, and the risk that the acquisition of Cytovia may not be
completed, or, if completed, that the company may not realize the anticipated
benefits from such acquisition. These factors and others are more fully
discussed in the company`s periodic reports and other filings with the Securities
and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the
Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at:
http://www.maxim.com.
Tuesday June 6, 04:01 AM Eastern time
Company Press Release
Maxim Pharmaceuticals Enters Into
Agreement to Acquire Cytovia Inc.
SAN DIEGO--(BW HealthWire)--June 6, 2000--Maxim Pharmaceuticals
(Nasdaq NM:MAXM, SSE: MAXM) announced that it has entered into an
agreement to acquire Cytovia Inc., a privately held biopharmaceutical research
company focused on the discovery and development of apoptosis inhibitors
and activators, novel drugs that modulate programmed cell death.
Cytovia`s technology base includes proprietary drug candidates in the areas of
oncology, oral mucositis and cardiovascular disease, and a proprietary
high-throughput screening process for other apoptosis-targeted drug
candidates.
Upon completion of the acquisition, Maxim will issue 1,585,214 shares of its
common stock, or seven percent of its total post-transaction shares
outstanding, in exchange for all of the capital stock of Cytovia outstanding.
Completion of the acquisition is subject to a vote of Cytovia`s shareholders.
Upon completion of the transaction, Cytovia will be a wholly owned subsidiary
of Maxim.
"We are enthusiastic about combining Cytovia`s exiting drug candidate pipeline
and broad technology platform with our clinical development and
commercialization capabilities," said Larry Stambaugh, Maxim`s chairman and
chief executive officer. "In a short period of time Cytovia has developed a
promising portfolio of drug candidates for cancer, oral mucositis, and
cardiovascular disease, and is screening compound libraries for other
apoptosis-targeted drugs that may be useful in several other therapeutic
indications. We also believe that Cytovia`s highly qualified management group
and associate base will add important capabilities to Maxim that accelerate our
combined drug discovery and development efforts. This is an important
addition to our existing, advanced platform technologies, Maxamine and
MaxDerm."
"We are extremely excited about this merger," said Eckard Weber, M.D.,
Cytovia`s chief executive officer. "The merger of Cytovia into Maxim will allow
us to greatly accelerate the clinical development of our key drug candidates to
the benefit of both shareholder groups. The addition of Cytovia`s drug
candidate pipeline and discovery engine to Maxim`s late-stage clinical
products, and the strength of Maxim`s clinical development and
commercialization capabilities, will make the combined company one of the
more important players in the biotechnology industry."
Cytovia Overview
Cytovia is a San Diego-based biomedical research company focused on the
discovery and development of small-molecule inhibitors and activators of
caspases. Caspases are key enzymes that modulate and carry out the cellular
signaling pathways involved in programmed cell death, also known as
apoptosis. Compounds that can either inhibit caspases or induce caspases may
form the basis for important new drugs for a wide variety of disease targets.
Cytovia has developed a proprietary high-throughput screening system that is
targeted to discovery of both caspase inhibitors and activators. The
high-throughput screening technology has generated a pipeline of new drug
candidates, including several compounds that have undergone in vitro and in
vivo testing. One of the drug candidates is a caspase activator that has shown
favorable results in preclinical models of drug resistant cancers. Two other
drug candidates are caspase inhibitors, one of which has been shown to be
active in preclinical models of oral mucositis. The other caspase inhibitor has
been shown to afford protection of the heart muscle following an ischemic
event such as myocardial infarction, and ischemia/reperfusion injury. This
compound has also been shown to be highly active in preclinical models of
acute liver failure associated with hepatitis, as well as in models of sepsis and
stroke.
Maxim Overview
Maxim Pharmaceuticals is a late-stage pharmaceutical company developing
advanced drugs and therapies for cancer and infectious diseases. The U.S.
Phase III trial of the company`s lead drug candidate Maxamine(R) (histamine
dihydrochloride) for the treatment of malignant melanoma was completed in
March 2000 and the company plans to file its NDA for the Phase III study in
the summer of 2000. Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and
acute myelogenous leukemia. Phase II trials of Maxamine are also underway
for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine
is designed to be safely administered by patients in their own homes, and more
than 1,000 patients have been treated in completed and ongoing clinical trials.
The company is also developing MaxDerm(TM), for the treatment of medical
conditions for which topical therapy is appropriate such as oral mucositis,
herpes, decubitus ulcers, shingles, burns and related conditions. The company
expects to commercialize its technologies through a combination of in-house
development and collaborative agreements with pharmaceutical companies.
This news release contains certain forward-looking statements that involve
risks and uncertainties. Such forward-looking statements include statements
regarding the efficacy and intended utilization of Maxamine, MaxDerm and
Cytovia`s compounds, and regarding the company`s clinical trials. Such
statements are only predictions and the company`s actual results may differ
materially from those anticipated in these forward-looking statements. Factors
that may cause such differences include the risk that products that appeared
promising in early research and clinical trials do not demonstrate safety or
efficacy in larger-scale clinical trials and the risk that the company will not
obtain approval to market its products. Additional factors include uncertainties
related to the integration of Cytovia`s operations and personnel with those of
the company, and the risk that the acquisition of Cytovia may not be
completed, or, if completed, that the company may not realize the anticipated
benefits from such acquisition. These factors and others are more fully
discussed in the company`s periodic reports and other filings with the Securities
and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the
Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at:
http://www.maxim.com.
das hört sich wirklich sehr gut an. scheint eine ideale ergänzung für maxim zu sein.
nun verstehe ich auch den verkauf von MaxVax. ein standbein wurde geopfert, um den kernbereich rasant auszubauen.
für das unternehmen maxim mit sicherheit ein weiterer meilenstein.
bleibt nur noch die frage, wie die börse die übernahme aufnimmt.
etwa 70 millionen dollar in eigenen aktien sind zwar heutzutage nicht sehr viel, die frage ist aber, bei welchem kurs der vertrag ausgehandelt wurde.
schließlich muß das maxim-management diesen kurs als fair angesehen haben, wenn sie ihre eigenen aktien hergeben.
(z.b. entrust: man übernahm einen konkurrenten, als der kurs bei etwa 55 $ stand. der vertrag wurde aber ausgehandelt, als entrust bei 47 $ stand. an diesem tag fiel entrust auf 47 $. allerdings bei sehr schlechtem umfeld.)
nun verstehe ich auch den verkauf von MaxVax. ein standbein wurde geopfert, um den kernbereich rasant auszubauen.
für das unternehmen maxim mit sicherheit ein weiterer meilenstein.
bleibt nur noch die frage, wie die börse die übernahme aufnimmt.
etwa 70 millionen dollar in eigenen aktien sind zwar heutzutage nicht sehr viel, die frage ist aber, bei welchem kurs der vertrag ausgehandelt wurde.
schließlich muß das maxim-management diesen kurs als fair angesehen haben, wenn sie ihre eigenen aktien hergeben.
(z.b. entrust: man übernahm einen konkurrenten, als der kurs bei etwa 55 $ stand. der vertrag wurde aber ausgehandelt, als entrust bei 47 $ stand. an diesem tag fiel entrust auf 47 $. allerdings bei sehr schlechtem umfeld.)
Maxim says to buy Cytovia for about $70 mln in stock
SAN DIEGO, June 6 (Reuters) - Drug company Maxim Pharmaceuticals Inc. <MAXM.O> said on Tuesday it had agreed to buy Cytovia Inc., a privately held drug research company, for over $70 million in stock.
Maxim said it would issue 1.59 million in stock in exchange for the outstanding capital stock of Cytovia. Based on Maxim`s closing stock price of 46-1/8 on the Nasdaq on Monday, the deal would be valued at $73.1 million.
After the deal, San Diego, Calif.-based Cytovia will be a wholly owned subsidiary of Maxim, which develops drug and therapies for cancer and infectious diseases.
Completion of the acquisition is subject to a vote by Cytovia`s shareholders, Maxim said.
SAN DIEGO, June 6 (Reuters) - Drug company Maxim Pharmaceuticals Inc. <MAXM.O> said on Tuesday it had agreed to buy Cytovia Inc., a privately held drug research company, for over $70 million in stock.
Maxim said it would issue 1.59 million in stock in exchange for the outstanding capital stock of Cytovia. Based on Maxim`s closing stock price of 46-1/8 on the Nasdaq on Monday, the deal would be valued at $73.1 million.
After the deal, San Diego, Calif.-based Cytovia will be a wholly owned subsidiary of Maxim, which develops drug and therapies for cancer and infectious diseases.
Completion of the acquisition is subject to a vote by Cytovia`s shareholders, Maxim said.
maxim schützt sich gegen eine feindliche übernahme.
offenbar ist maxim derart von maxamine überzeugt, daß man den aktienkurs als zu niedrig ansieht und nun befürchtet, übernommen zu werden!
Maxim Pharmaceuticals Adopts Shareholder Rights Plan
SAN DIEGO--(BW HealthWire)--June 13, 2000--Maxim Pharmaceuticals (Nasdaq NM:MAXM)(SSE:MAXM) announced today
that its Board of Directors has adopted a Shareholder Rights Plan designed to protect the company`s shareholders in the event of an
unsolicited bid for the company.
Maxim adopted this Rights Plan to protect stockholders from coercive or otherwise unfair takeover tactics. In general terms, the
Rights Plan imposes a significant penalty upon any person or group that acquires 15 percent or more of the company`s outstanding
common stock without the approval of the Maxim Board. The Rights Plan should not interfere with any merger or other business
combination approved by the Board.
"The rights plan is intended to protect the long-term interests of all shareholders and to encourage anyone seeking to acquire Maxim
to negotiate in good faith with our Board of Directors," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer.
"The adoption of the rights plan is not in response to any effort to acquire control of the company, and we are not aware of any
planned takeover attempts."
"The favorable and unprecedented data recently reported from our Phase III trial in advanced malignant melanoma and from our
Phase II trial in hepatitis C both underscore the potential value represented by our lead drug Maxamine(R)," added Stambaugh. "We
believe that implementation of the rights plan is warranted and timely in order to protect Maxim and our shareholders from coercive
takeover attempts that might limit the realization of this future value."
Rights Plan Summary
The Board of Directors of Maxim declared a dividend of one preferred share purchase right for each outstanding share of common
stock to be issued to shareholders of record on June 22, 2000. The rights will initially trade with, and will be inseparable from, the
common stock.
The rights will be exercisable only if a person or group acquires 15 percent or more of Maxim`s outstanding common stock, or
announces a tender offer which, if successful, would result in ownership by a person or group of 15 percent or more of Maxim`s
common stock. Each right will entitle stockholders (other than the 15 percent or more acquirer) to buy one one-hundredth of a share
of Maxim`s series A junior participating preferred stock at an exercise price of $325.
If a person or group acquires 15 percent or more of Maxim`s common stock, each right will entitle its holder (other than such person
or member of such group) to purchase a number of Maxim`s common shares having a market value of $650.
If Maxim were to be acquired in a merger or other business combination transaction after a person has acquired 15 percent or more
of Maxim`s common stock, each right will entitle its holder (other than the acquiring person) to purchase a number of the acquiring
company`s common shares having a market value of $650.
The rights plan also includes an exchange option. In general, after the rights become exercisable, the Maxim Board may, at its
option, effect an exchange of part or all of the rights (other than rights that have become void) for shares of Maxim Common Stock.
Under this option, Maxim would issue one share of common stock for each right, subject to adjustment in certain circumstances.
Prior to a person or group acquiring ownership of 15 percent or more of Maxim`s common stock, the rights will be redeemable for
$0.01 per right at the option of Maxim`s Board. The rights will expire June 22, 2010.
offenbar ist maxim derart von maxamine überzeugt, daß man den aktienkurs als zu niedrig ansieht und nun befürchtet, übernommen zu werden!
Maxim Pharmaceuticals Adopts Shareholder Rights Plan
SAN DIEGO--(BW HealthWire)--June 13, 2000--Maxim Pharmaceuticals (Nasdaq NM:MAXM)(SSE:MAXM) announced today
that its Board of Directors has adopted a Shareholder Rights Plan designed to protect the company`s shareholders in the event of an
unsolicited bid for the company.
Maxim adopted this Rights Plan to protect stockholders from coercive or otherwise unfair takeover tactics. In general terms, the
Rights Plan imposes a significant penalty upon any person or group that acquires 15 percent or more of the company`s outstanding
common stock without the approval of the Maxim Board. The Rights Plan should not interfere with any merger or other business
combination approved by the Board.
"The rights plan is intended to protect the long-term interests of all shareholders and to encourage anyone seeking to acquire Maxim
to negotiate in good faith with our Board of Directors," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer.
"The adoption of the rights plan is not in response to any effort to acquire control of the company, and we are not aware of any
planned takeover attempts."
"The favorable and unprecedented data recently reported from our Phase III trial in advanced malignant melanoma and from our
Phase II trial in hepatitis C both underscore the potential value represented by our lead drug Maxamine(R)," added Stambaugh. "We
believe that implementation of the rights plan is warranted and timely in order to protect Maxim and our shareholders from coercive
takeover attempts that might limit the realization of this future value."
Rights Plan Summary
The Board of Directors of Maxim declared a dividend of one preferred share purchase right for each outstanding share of common
stock to be issued to shareholders of record on June 22, 2000. The rights will initially trade with, and will be inseparable from, the
common stock.
The rights will be exercisable only if a person or group acquires 15 percent or more of Maxim`s outstanding common stock, or
announces a tender offer which, if successful, would result in ownership by a person or group of 15 percent or more of Maxim`s
common stock. Each right will entitle stockholders (other than the 15 percent or more acquirer) to buy one one-hundredth of a share
of Maxim`s series A junior participating preferred stock at an exercise price of $325.
If a person or group acquires 15 percent or more of Maxim`s common stock, each right will entitle its holder (other than such person
or member of such group) to purchase a number of Maxim`s common shares having a market value of $650.
If Maxim were to be acquired in a merger or other business combination transaction after a person has acquired 15 percent or more
of Maxim`s common stock, each right will entitle its holder (other than the acquiring person) to purchase a number of the acquiring
company`s common shares having a market value of $650.
The rights plan also includes an exchange option. In general, after the rights become exercisable, the Maxim Board may, at its
option, effect an exchange of part or all of the rights (other than rights that have become void) for shares of Maxim Common Stock.
Under this option, Maxim would issue one share of common stock for each right, subject to adjustment in certain circumstances.
Prior to a person or group acquiring ownership of 15 percent or more of Maxim`s common stock, the rights will be redeemable for
$0.01 per right at the option of Maxim`s Board. The rights will expire June 22, 2010.
deutschland reagiert mit einem abschlag von etwa 4 % ggü. dem usa-kurs. schließlich erlischt die möglichkeit einer übernhame und den damit verbundenen kursgewinnen.
meiner meinung nach eine zu kurzfristige sichtweise. maxamine hat beste chancen, sich zum blockbuster-medikament zu entwickeln.
vor wenigen tagen sprach ein analyst von 500 millionen dolar umsatz allein in den usa. und maxim ist gerade einmal eine milliarde wert.
hier schlummert ein gewaltiges potential. eine übernahme würde diesen effekt nur verwässern.
meiner meinung nach eine zu kurzfristige sichtweise. maxamine hat beste chancen, sich zum blockbuster-medikament zu entwickeln.
vor wenigen tagen sprach ein analyst von 500 millionen dolar umsatz allein in den usa. und maxim ist gerade einmal eine milliarde wert.
hier schlummert ein gewaltiges potential. eine übernahme würde diesen effekt nur verwässern.
Es brodelt ! liebe Maxim Fans. In den USA war der Umsatz gestern bis eine dreiviertelstunde vor Handelsschluß sehr dünn gesäht (ca. 50 000 Aktien) In der LETZTEN HALBEN Stunde bis Dreiviertel Stunde gingen dann noch knapp 200 000 Aktien über den Tisch mit knapp 10 trades, die größer als 10 000 Aktien waren und 2 trades, die zwischen 30k und 40k Aktien umfaßten. Ich glaube das NDA filing ist nicht mehr weit!!!
Maxim Pharmaceuticals Completes Acquisition of Cytovia Inc.
San Diego--(BW HealthWire)--June 20, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it has
completed its acquisition of Cytovia Inc., a privately held biopharmaceutical research company focused on the discovery and
development of apoptosis inhibitors and activators, novel drugs that modulate programmed cell death.
Cytovia`s technology base includes proprietary drug candidates in the areas of oncology, oral mucositis and cardiovascular
disease, and a proprietary high-throughput screening process for other apoptosis-targeted drug candidates.
Under the terms of the acquisition, Maxim will issue approximately 1.5 million shares of its common stock, or seven percent of its
total post-transaction shares outstanding, to the former shareholders of Cytovia. These common shares are being issued in a
private transaction and may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements.
Maxim is obligated under the terms of the acquisition to file a registration statement within 30 days to allow resale of the common
stock. However, Cytovia`s shareholders have entered into a lock-up agreement that prevents them from currently selling any of
the Maxim common stock received in this acquisition. After three months, 25 percent of these shares are released from the lock
up agreement, and an additional 25 percent are released at the end of each subsequent three-month period.
"Over the last several weeks we have begun integrating Cytovia`s portfolio of drug candidates into our clinical development
strategy, and look forward to adding their product opportunities to our commercial pipeline," said Larry Stambaugh, Maxim`s
chairman and chief executive officer. "The management team from Cytovia, and their highly qualified research personnel, have
both added capabilities to Maxim that will be important as we expand our drug discovery and development efforts."
Cytovia Overview
Cytovia is a San Diego-based biomedical research company focused on the discovery and development of small-molecule
inhibitors and activators of caspases. Caspases are key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases
may form the basis for important new drugs for a wide variety of disease targets.
Cytovia has developed a proprietary high-throughput screening system that is targeted to discovery of both caspase inhibitors
and activators. The high-throughput screening technology has generated a pipeline of new drug candidates, including several
compounds that have undergone in vitro and in vivo testing. One of the drug candidates is a caspase activator that has shown
favorable results in preclinical models of drug resistant cancers.
Two other drug candidates are caspase inhibitors, one of which has been shown to be active in preclinical models of oral
mucositis. The other caspase inhibitor has been shown to afford protection of the heart muscle following an ischemic event such
as myocardial infarction, and ischemia/reperfusion injury. This compound has also been shown to be highly active in preclinical
models of acute liver failure associated with hepatitis, as well as in models of sepsis and stroke.
San Diego--(BW HealthWire)--June 20, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it has
completed its acquisition of Cytovia Inc., a privately held biopharmaceutical research company focused on the discovery and
development of apoptosis inhibitors and activators, novel drugs that modulate programmed cell death.
Cytovia`s technology base includes proprietary drug candidates in the areas of oncology, oral mucositis and cardiovascular
disease, and a proprietary high-throughput screening process for other apoptosis-targeted drug candidates.
Under the terms of the acquisition, Maxim will issue approximately 1.5 million shares of its common stock, or seven percent of its
total post-transaction shares outstanding, to the former shareholders of Cytovia. These common shares are being issued in a
private transaction and may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements.
Maxim is obligated under the terms of the acquisition to file a registration statement within 30 days to allow resale of the common
stock. However, Cytovia`s shareholders have entered into a lock-up agreement that prevents them from currently selling any of
the Maxim common stock received in this acquisition. After three months, 25 percent of these shares are released from the lock
up agreement, and an additional 25 percent are released at the end of each subsequent three-month period.
"Over the last several weeks we have begun integrating Cytovia`s portfolio of drug candidates into our clinical development
strategy, and look forward to adding their product opportunities to our commercial pipeline," said Larry Stambaugh, Maxim`s
chairman and chief executive officer. "The management team from Cytovia, and their highly qualified research personnel, have
both added capabilities to Maxim that will be important as we expand our drug discovery and development efforts."
Cytovia Overview
Cytovia is a San Diego-based biomedical research company focused on the discovery and development of small-molecule
inhibitors and activators of caspases. Caspases are key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases
may form the basis for important new drugs for a wide variety of disease targets.
Cytovia has developed a proprietary high-throughput screening system that is targeted to discovery of both caspase inhibitors
and activators. The high-throughput screening technology has generated a pipeline of new drug candidates, including several
compounds that have undergone in vitro and in vivo testing. One of the drug candidates is a caspase activator that has shown
favorable results in preclinical models of drug resistant cancers.
Two other drug candidates are caspase inhibitors, one of which has been shown to be active in preclinical models of oral
mucositis. The other caspase inhibitor has been shown to afford protection of the heart muscle following an ischemic event such
as myocardial infarction, and ischemia/reperfusion injury. This compound has also been shown to be highly active in preclinical
models of acute liver failure associated with hepatitis, as well as in models of sepsis and stroke.
hier noch Finanzdaten, die beweisen, dass das Unternehmen grundsolide dasteht:
SUMMARY FINANCIAL INFORMATION
March 31, 2000
(in US$ Millions)
Cash and Investments $204.8
Total Assets 212.5
Long-Term Liabilities 0.1
Stockholders` Equity 195.1
aktuelle Marktkapitalisierung: 522 Mio $
Schaut euch mal obige Infos von pitu an.
MAXM könnte durchaus bei dem hier spekulierten Anstieg der kleineren Bios ganz vorne mit dabei sein.
Lobenswert ist auch die Homepage http://www.maxim.com, die sehr detaillierte Infos bietet.
SUMMARY FINANCIAL INFORMATION
March 31, 2000
(in US$ Millions)
Cash and Investments $204.8
Total Assets 212.5
Long-Term Liabilities 0.1
Stockholders` Equity 195.1
aktuelle Marktkapitalisierung: 522 Mio $
Schaut euch mal obige Infos von pitu an.
MAXM könnte durchaus bei dem hier spekulierten Anstieg der kleineren Bios ganz vorne mit dabei sein.
Lobenswert ist auch die Homepage http://www.maxim.com, die sehr detaillierte Infos bietet.
kurze zusammenfassung des börse online artikels (26/2000, S. 96).
- für 1,6 mio eigene aktien (80 mio $) cytovia übernommen
- produktpalette dadurch um viele aussichtsreiche präparate erweitert
- zudem mit cytovia ein technologisches verfahren zugekauft, das die entwicklungszeit vom medikamenten erheblich verkürzt
- jüngste klinische tests von maxamine erfreulich
- zulassung durch die amerikanische gesundheitsbehörde FDA eventuell noch dieses jahr
- aktie wegen der hohen volatilität nur für risikobereite investoren geeignet
- kursziel auf 12 bis 18 monate: 100 $
- einstufung: chance 3, risiko 3
- für 1,6 mio eigene aktien (80 mio $) cytovia übernommen
- produktpalette dadurch um viele aussichtsreiche präparate erweitert
- zudem mit cytovia ein technologisches verfahren zugekauft, das die entwicklungszeit vom medikamenten erheblich verkürzt
- jüngste klinische tests von maxamine erfreulich
- zulassung durch die amerikanische gesundheitsbehörde FDA eventuell noch dieses jahr
- aktie wegen der hohen volatilität nur für risikobereite investoren geeignet
- kursziel auf 12 bis 18 monate: 100 $
- einstufung: chance 3, risiko 3
CEO Larry Stambaugh of Maxim Pharmaceuticals
by Todd V. Jerles of Team StreetSideInvestor back
Good morning, this is Todd Jerles with StreetSideInvestor’s Executive’s Corner. Today we’re speaking with Mr. Larry Stambaugh, President and Chief Executive Officer of Maxim Pharmaceuticals. Maxim Pharmaceuticals is a leading biotechnological company that is developing a new generation of drugs, therapies, and vaccines for cancer, infectious diseases, and topical disorders. Maxim’s lead drug candidate, Maxamine, is currently undergoing Phase III clinical trials and other product platforms under development include MaxDerm and caspases, small molecules for modulation of cell death.
StreetSideInvestor: Please describe the most innovative technologies currently being developed at Maxim?
Mr. Stambaugh: I think the most innovative technology is Maxamine, which is a “first in class” drug to prevent immune suppression in several cancer and infectious disease indications. We’ve seen clinical data in different cancers and viral infections, like hepatitis C, that suggest that this discovery may be able to improve survival, while providing a quality of life in these treatments, when used in combination with existing drugs such as interleukin 2 and alpha interferon.
StreetSideInvestor: What is the current status of your anti-cancer therapy Maxamine, and when do you expect FDA approval?
Mr. Stambaugh: The company has three Phase III trials underway. The first of those Phase III trials finished this spring, and the results have recently been announced. That reported trial is in late-stage malignant melanoma, for which there is no effective treatment today. We reported first-time survival improvements in these patients. The NDA for that trial, as a result of the outcome, will be filed this summer, and we know that it’s a priority review at the FDA so we would hope to have an answer on this first indication around year-end.
StreetSideInvestor: Will Maxim be a forerunner in the quest for a cancer cure, and how far away are we from this milestone?
Mr. Stambaugh: Well we don’t like to use “the c word.” We think a cure is a ways off but we do believe that this discovery may allow us to have more long-term survivors than ever before. In combination with other drugs in development for earlier stage patients, we may be able to affect many more long-term survivors and due to the new therapy with a quality of life better than ever before.
StreetSideInvestor: How has the recent $70 million acquisition of Cytovia created a better synergy within Maxim?
Mr. Stambaugh: We’re very excited about the Cytovia acquisition. It adds drug discovery and several identified targets in the field of caspases, which are small molecules that either cause or prevent programmed cell death, known as apoptosis. This adds several additional product opportunities for Maxim. It allows us to bring their discovery and chemistry team to our Maxamine technology to also improve upon it. We think this is a really significant synergy between Cytovia and Maxim.
StreetSideInvestor: How and when do you expect Maxim to become profitable?
Mr. Stambaugh: Being a public company we don’t predict profitability. However, you can get the analyst reports from investment banks that follow the company such as JP Morgan and Prudential. I think they would tell you that they would expect the company to start to approach profitability in our first full year of sales.
StreetSideInvestor: What would you like our readers to think about when Maxim Pharmaceuticals comes to mind?
Mr. Stambaugh: I think that Maxim is an innovative company that, based on a Swedish discovery some 18 years ago, expects to develop drugs that allow our immune system to get back in the fight against cancer and hepatitis C. This discovery about immune suppression that’s been taking place all along can now be reversed. Once we take out the immune suppression, the possibilities in immunotherapy are much greater than they’ve ever been before. And, our quality of life during treatments can be better also.
Todd V. Jerles is a member of Team StreetSide. As a full-time StreetSideInvestor employee, he does not own or short individual stocks. The information in this column under no circumstances serves as a recommendation to buy or sell stocks.
by Todd V. Jerles of Team StreetSideInvestor back
Good morning, this is Todd Jerles with StreetSideInvestor’s Executive’s Corner. Today we’re speaking with Mr. Larry Stambaugh, President and Chief Executive Officer of Maxim Pharmaceuticals. Maxim Pharmaceuticals is a leading biotechnological company that is developing a new generation of drugs, therapies, and vaccines for cancer, infectious diseases, and topical disorders. Maxim’s lead drug candidate, Maxamine, is currently undergoing Phase III clinical trials and other product platforms under development include MaxDerm and caspases, small molecules for modulation of cell death.
StreetSideInvestor: Please describe the most innovative technologies currently being developed at Maxim?
Mr. Stambaugh: I think the most innovative technology is Maxamine, which is a “first in class” drug to prevent immune suppression in several cancer and infectious disease indications. We’ve seen clinical data in different cancers and viral infections, like hepatitis C, that suggest that this discovery may be able to improve survival, while providing a quality of life in these treatments, when used in combination with existing drugs such as interleukin 2 and alpha interferon.
StreetSideInvestor: What is the current status of your anti-cancer therapy Maxamine, and when do you expect FDA approval?
Mr. Stambaugh: The company has three Phase III trials underway. The first of those Phase III trials finished this spring, and the results have recently been announced. That reported trial is in late-stage malignant melanoma, for which there is no effective treatment today. We reported first-time survival improvements in these patients. The NDA for that trial, as a result of the outcome, will be filed this summer, and we know that it’s a priority review at the FDA so we would hope to have an answer on this first indication around year-end.
StreetSideInvestor: Will Maxim be a forerunner in the quest for a cancer cure, and how far away are we from this milestone?
Mr. Stambaugh: Well we don’t like to use “the c word.” We think a cure is a ways off but we do believe that this discovery may allow us to have more long-term survivors than ever before. In combination with other drugs in development for earlier stage patients, we may be able to affect many more long-term survivors and due to the new therapy with a quality of life better than ever before.
StreetSideInvestor: How has the recent $70 million acquisition of Cytovia created a better synergy within Maxim?
Mr. Stambaugh: We’re very excited about the Cytovia acquisition. It adds drug discovery and several identified targets in the field of caspases, which are small molecules that either cause or prevent programmed cell death, known as apoptosis. This adds several additional product opportunities for Maxim. It allows us to bring their discovery and chemistry team to our Maxamine technology to also improve upon it. We think this is a really significant synergy between Cytovia and Maxim.
StreetSideInvestor: How and when do you expect Maxim to become profitable?
Mr. Stambaugh: Being a public company we don’t predict profitability. However, you can get the analyst reports from investment banks that follow the company such as JP Morgan and Prudential. I think they would tell you that they would expect the company to start to approach profitability in our first full year of sales.
StreetSideInvestor: What would you like our readers to think about when Maxim Pharmaceuticals comes to mind?
Mr. Stambaugh: I think that Maxim is an innovative company that, based on a Swedish discovery some 18 years ago, expects to develop drugs that allow our immune system to get back in the fight against cancer and hepatitis C. This discovery about immune suppression that’s been taking place all along can now be reversed. Once we take out the immune suppression, the possibilities in immunotherapy are much greater than they’ve ever been before. And, our quality of life during treatments can be better also.
Todd V. Jerles is a member of Team StreetSide. As a full-time StreetSideInvestor employee, he does not own or short individual stocks. The information in this column under no circumstances serves as a recommendation to buy or sell stocks.
Endlich jetzt kommt maxim fett zurück!!!
juhu
mfg all-goi
juhu mfg all-goi
hier die aktuelle einschätzung der profis:
Number of brokers...............Months Ago
recommending as:............0.....1.....2.....3
Strong Buy......................4.....4.....3.....3
Moderate Buy..................1.....1.....2.....2
Hold................................0.....0.....0.....0
Moderate Sell..................0.....0.....0.....0
Strong Sell......................0.....0.....0.....0
Mean*........................1,10..1,10..1,30..1,30
* (strong buy) 1.00 - 5.00 (strong sell)
zum vergleich: amgen 1,79 - biogen 2,06 - ilex 1,50 - medarex 1,77 - millennium 1,67 - PDLI 2,19
Number of brokers...............Months Ago
recommending as:............0.....1.....2.....3
Strong Buy......................4.....4.....3.....3
Moderate Buy..................1.....1.....2.....2
Hold................................0.....0.....0.....0
Moderate Sell..................0.....0.....0.....0
Strong Sell......................0.....0.....0.....0
Mean*........................1,10..1,10..1,30..1,30
* (strong buy) 1.00 - 5.00 (strong sell)
zum vergleich: amgen 1,79 - biogen 2,06 - ilex 1,50 - medarex 1,77 - millennium 1,67 - PDLI 2,19
An dieser Stelle möchte ich mal Pitu ein großes Kompliment aussprechen. Seine Infos sind immer außergewöhlich gut und aktuell. Auch seine Mühe Texte aus dem Englischen ins Deutsche zu übersetzen verdient ein großes Lob.
Nun aber mein Beitrag zu Maxim:
Diesen Artikel findet Ihr, wenn Ihr bei WO unter unter Analystenschätzungen Maxim eingebt:
"Analystin Fariba F.Ghodsian von Roth Capital Partners stufte die Aktie der Maxim Pharmaceuticals in einer erstmaligen Einschätzung mit Strong Buy ein, Kursziel: 95 US-Dollar."
Außerdem habe ich gehört, (jedoch noch nichts darüber im Internet gelesen) daß die Bank von Norwegen Maxim das Rating Strong buy gegeben hat. Kursziel soll angeblich 150 US-Dollar sein. Hat jemand hierzu vielleicht nähere Infos?
Nun aber mein Beitrag zu Maxim:
Diesen Artikel findet Ihr, wenn Ihr bei WO unter unter Analystenschätzungen Maxim eingebt:
"Analystin Fariba F.Ghodsian von Roth Capital Partners stufte die Aktie der Maxim Pharmaceuticals in einer erstmaligen Einschätzung mit Strong Buy ein, Kursziel: 95 US-Dollar."
Außerdem habe ich gehört, (jedoch noch nichts darüber im Internet gelesen) daß die Bank von Norwegen Maxim das Rating Strong buy gegeben hat. Kursziel soll angeblich 150 US-Dollar sein. Hat jemand hierzu vielleicht nähere Infos?
Stand 9.7.00:
Bewertung MAXIM laut OnVista: 1 Analyst:Halten
Bewertung laut YahooDeutschland: 3 mal strong buy (Hinweis: sucht mit Kürzel MAXM.ST)
laut YahooUSA: 4 mal strong buy, 1 mal buy
mig48 ist guter Hoffnung
Bewertung MAXIM laut OnVista: 1 Analyst:Halten
Bewertung laut YahooDeutschland: 3 mal strong buy (Hinweis: sucht mit Kürzel MAXM.ST)
laut YahooUSA: 4 mal strong buy, 1 mal buy
mig48 ist guter Hoffnung
Maxim Pharmaceuticals Licenses Caspase Activator Cancer Compound to BioChem Pharma
SAN DIEGO--(BW HealthWire)--July 11, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it
has licensed its CV2105 series of anti-cancer compounds to BioChem Pharma Inc.
The agreement requires that BioChem make licensing, research and milestone payments to Maxim totaling up to U.S. $55
million, as well as pay a royalty on product sales resulting from this collaboration.
CV2105 is one of 25 anti-cancer product candidates identified to date by Maxim`s wholly owned subsidiary, Cytovia, Inc,
through its proprietary high-throughput screening technology. The CV2105 series of compounds are cytotoxic agents that have
shown promise in preclinical testing in lung and prostate adenocarcinoma models. Early research has suggested that CV2105 can
induce apoptosis, also known as programmed cell death, in certain cancer cells by activating specific caspase enzymes.
Importantly, this research also suggests that this anti-cancer activity may be attained in cancer cells that are resistant to current
chemotherapeutic agents such as taxol, vinblastine and doxorubicin.
"Our recently acquired screening technology has generated a substantial pipeline of potential anti-cancer product candidates, and
we are pleased to be collaborating with BioChem Pharma to accelerate the development of CV2105," said Larry G. Stambaugh,
Maxim`s chairman and chief executive officer. "We recognize that we cannot develop every high-potential drug candidate
ourselves, and look forward to seeing BioChem move these compounds into clinical trials. We hope that CV2105 will provide a
benefit to patients, including patients whose cancer therapy is currently impaired by drug resistance."
Commenting on the agreement, Jacques Lapointe, president and COO of BioChem Pharma, said, "Today`s agreement is
consistent with our previously announced plans to strengthen our pipeline through such licensing agreements and other strategic
initiatives. We believe that the combination of BioChem`s research and development expertise and the novel anti-cancer
compounds discovered by Cytovia offer exciting potential in the battle against cancer."
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer,
infectious diseases, degenerative diseases and topical disorders. The U.S. Phase III trial of Maxim`s lead drug candidate
Maxamine(R) (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and Maxim
plans to file its NDA for the Phase III study in the summer of 2000.
Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma
and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced
renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,200
patients have been treated in completed and ongoing clinical trials.
Product candidates based on Maxim`s MaxDerm(TM) technology are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Maxim is
also developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular
signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or
induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular
disease and other degenerative diseases.
BioChem Pharma is an innovative and fast-growing biopharmaceutical company focused on infectious diseases and cancer.
SAN DIEGO--(BW HealthWire)--July 11, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it
has licensed its CV2105 series of anti-cancer compounds to BioChem Pharma Inc.
The agreement requires that BioChem make licensing, research and milestone payments to Maxim totaling up to U.S. $55
million, as well as pay a royalty on product sales resulting from this collaboration.
CV2105 is one of 25 anti-cancer product candidates identified to date by Maxim`s wholly owned subsidiary, Cytovia, Inc,
through its proprietary high-throughput screening technology. The CV2105 series of compounds are cytotoxic agents that have
shown promise in preclinical testing in lung and prostate adenocarcinoma models. Early research has suggested that CV2105 can
induce apoptosis, also known as programmed cell death, in certain cancer cells by activating specific caspase enzymes.
Importantly, this research also suggests that this anti-cancer activity may be attained in cancer cells that are resistant to current
chemotherapeutic agents such as taxol, vinblastine and doxorubicin.
"Our recently acquired screening technology has generated a substantial pipeline of potential anti-cancer product candidates, and
we are pleased to be collaborating with BioChem Pharma to accelerate the development of CV2105," said Larry G. Stambaugh,
Maxim`s chairman and chief executive officer. "We recognize that we cannot develop every high-potential drug candidate
ourselves, and look forward to seeing BioChem move these compounds into clinical trials. We hope that CV2105 will provide a
benefit to patients, including patients whose cancer therapy is currently impaired by drug resistance."
Commenting on the agreement, Jacques Lapointe, president and COO of BioChem Pharma, said, "Today`s agreement is
consistent with our previously announced plans to strengthen our pipeline through such licensing agreements and other strategic
initiatives. We believe that the combination of BioChem`s research and development expertise and the novel anti-cancer
compounds discovered by Cytovia offer exciting potential in the battle against cancer."
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer,
infectious diseases, degenerative diseases and topical disorders. The U.S. Phase III trial of Maxim`s lead drug candidate
Maxamine(R) (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and Maxim
plans to file its NDA for the Phase III study in the summer of 2000.
Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma
and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced
renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,200
patients have been treated in completed and ongoing clinical trials.
Product candidates based on Maxim`s MaxDerm(TM) technology are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Maxim is
also developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular
signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or
induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular
disease and other degenerative diseases.
BioChem Pharma is an innovative and fast-growing biopharmaceutical company focused on infectious diseases and cancer.
die übernahme von cytovia scheint sich bald - und damit unglaublich schnell - zu rechnen:
am 20.6. wurde cytovia für 80 mio $ übernommen.
das erste der 25 krebs-präparate von cytovia bringt durch den heutigen deal 55 mio $ liznezeinnahmen für maxim.
dies zeigt mir erneut, daß bei maxim nicht nur ein potentielles blockbuster-medikament kurz vor der markteinführung steht,
sondern auch im management absolute profis am werk sind.
am 20.6. wurde cytovia für 80 mio $ übernommen.
das erste der 25 krebs-präparate von cytovia bringt durch den heutigen deal 55 mio $ liznezeinnahmen für maxim.
dies zeigt mir erneut, daß bei maxim nicht nur ein potentielles blockbuster-medikament kurz vor der markteinführung steht,
sondern auch im management absolute profis am werk sind.
Bei Maxim ist für mich entscheidend, daß das Unternehmen nach der Kapitalerhöhung (zu damals höheren Kursen) dick Geld in der Kasse hat. Der Börsenwert ist also zu rd. 30% mit Substanz unterlegt, während bei den meisten anderen Biotechs der Wert aus 95% Zukunftshoffnung besteht.
Diese Fantasie hat Maxim natürlich auch, so daß der Wert im Branchenvergleich eines der attraktivsten Investments ist. Nur bei Maxim wird die Fantasie gerade realisiert. Die Gewinne stehen vor der Tür.
Dank an alle, die mich hier auf diesen Wert aufmerksam gemacht haben.
Gruß
VERTRAUmir
Diese Fantasie hat Maxim natürlich auch, so daß der Wert im Branchenvergleich eines der attraktivsten Investments ist. Nur bei Maxim wird die Fantasie gerade realisiert. Die Gewinne stehen vor der Tür.
Dank an alle, die mich hier auf diesen Wert aufmerksam gemacht haben.
Gruß
VERTRAUmir
Maxim Pharma hat eine Reihe von Anti-Krebs-Verbindungen an die Biotechnologie-Firma
"BioChem Pharma" (gelistet an Nasdaq und in Toronto) lizensiert.
Als Lizenzeinnahmen werden bis zu 55 Millionen US$ erwartet.
Zusätzlich werden noch Tantiemen für Produkte bezahlt, die aus der Zusammenarbeit
entstehen.
Das Original: http://biz.yahoo.com/rf/000711/n1131460.html
Die Pressemeldung von Maxim pharm: http://biz.yahoo.com/bw/000711/ca_maxim_p_2.html
mig48
"BioChem Pharma" (gelistet an Nasdaq und in Toronto) lizensiert.
Als Lizenzeinnahmen werden bis zu 55 Millionen US$ erwartet.
Zusätzlich werden noch Tantiemen für Produkte bezahlt, die aus der Zusammenarbeit
entstehen.
Das Original: http://biz.yahoo.com/rf/000711/n1131460.html
Die Pressemeldung von Maxim pharm: http://biz.yahoo.com/bw/000711/ca_maxim_p_2.html
mig48
Im BO-Board gefunden:
News July 19, 03:21 Eastern Time
Maxim Pharmaceuticals Submits New Drug Application for Maxamine With FDA
SAN DIEGO, Jul 19, 2000 (BW HealthWire) -- Maxim Pharmaceuticals (Nasdaq
NM:MAXM)(SSE:MAXM) announced that it has submitted a New Drug Application with
the U.S. Food and Drug Administration seeking approval to market its proprietary
histamine dihydrochloride (Maxamine) drug in the United States as an adjuvant to
interleukin-2 (IL-2) for the treatment of stage-IV malignant melanoma.
Malignant melanoma, the most serious form of skin cancer, is one of the most
rapidly increasing cancers in the world, with approximately 90,000 new cases and
15,000 deaths from the disease each year in the United States, Europe and
Australia. At present, there is no effective treatment that increases survival
for advanced stage IV melanoma, and current treatments often involve substantial
toxicity and side effects and may require hospitalization.
"We are pleased to have reached this significant milestone in the development of
Maxamine and in the progress of our company," said Larry G. Stambaugh, Maxim`s
chairman and chief executive officer. "Our clinical and regulatory groups were
successful in expeditiously completing this important application following the
conclusion of the trial in March."
In March 2000 the company completed its U.S. Phase III clinical trial in
stage-IV malignant melanoma patients. The results showed that Maxamine, used in
combination with the cytokine IL-2, improved survival for stage-IV malignant
melanoma patients compared with those treated with the same doses of IL-2 alone.
Improvement in survival was statistically significant in patients having
metastases of their melanoma to the liver (p=0.004), a patient population that
historically has had a very poor prognosis and no effective treatment options.
The Phase III study also indicated that treatment with Maxamine and IL-2 was
safe and well-tolerated and had substantially less toxicity than the high-dose
regimens under which IL-2 was originally approved.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism
that suppresses the capacity of the immune system to detect and destroy tumor
cells or virally infected cells in many patients with cancer and chronic
infectious diseases. Maxamine is designed to reverse this immune suppression,
thereby enhancing the effectiveness of immunotherapy, a class of therapies that
employ the body`s immune system to fight cancer and certain infectious diseases.
Maxamine protects critical immune cells and is administered in combination with
cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate
these same immune cells. More than 1,200 patients have been treated in the
company`s completed and ongoing clinical trials in advanced malignant melanoma,
acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an
investigational drug and safety and efficacy have not been established at this
time. However, clinical trial results to date suggest that Maxamine Therapy, the
administration of Maxamine in combination with cytokines, is a safe, at-home
treatment that may improve patient survival.
Maxim Pharmaceuticals is a late-stage pharmaceutical company developing advanced
drugs and therapies for cancer and infectious diseases. In addition to the
recently completed Phase III trial in stage-IV malignant melanoma, Maxamine is
also currently being tested in two additional Phase III cancer clinical trials
in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II
trials of Maxamine are also underway for the treatment of hepatitis C and
advanced renal cell carcinoma. The company has also developed product candidates
based on its MaxDerm(TM) technology that are designed for the treatment of
medical conditions for which topical therapy is appropriate such as oral
mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Lastly, Maxim is developing small-molecule inhibitors and activators of
caspases, key enzymes that modulate and carry out the cellular signaling
pathways involved in programmed cell death, also known as apoptosis. Compounds
that can either inhibit caspases or induce caspases may form the basis for
important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks
and uncertainties. Such forward-looking statements include statements regarding
the efficacy and intended utilization of Maxamine, MaxDerm and the caspase
modulator compounds, and regarding the company`s clinical trials. Such
statements are only predictions and the company`s actual results may differ
materially from those anticipated in these forward-looking statements. Factors
that may cause such differences include the risk that products that appeared
promising in early research and clinical trials do not demonstrate safety or
efficacy in larger-scale clinical trials and the risk that the company will not
obtain approval to market its products. These factors and others are more fully
discussed in the company`s periodic reports and other filings with the
Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of the company.
Editor`s Note: This release is also available on the Internet at:
http://www.maxim.com.
Gruß !
LeNeant
News July 19, 03:21 Eastern Time
Maxim Pharmaceuticals Submits New Drug Application for Maxamine With FDA
SAN DIEGO, Jul 19, 2000 (BW HealthWire) -- Maxim Pharmaceuticals (Nasdaq
NM:MAXM)(SSE:MAXM) announced that it has submitted a New Drug Application with
the U.S. Food and Drug Administration seeking approval to market its proprietary
histamine dihydrochloride (Maxamine) drug in the United States as an adjuvant to
interleukin-2 (IL-2) for the treatment of stage-IV malignant melanoma.
Malignant melanoma, the most serious form of skin cancer, is one of the most
rapidly increasing cancers in the world, with approximately 90,000 new cases and
15,000 deaths from the disease each year in the United States, Europe and
Australia. At present, there is no effective treatment that increases survival
for advanced stage IV melanoma, and current treatments often involve substantial
toxicity and side effects and may require hospitalization.
"We are pleased to have reached this significant milestone in the development of
Maxamine and in the progress of our company," said Larry G. Stambaugh, Maxim`s
chairman and chief executive officer. "Our clinical and regulatory groups were
successful in expeditiously completing this important application following the
conclusion of the trial in March."
In March 2000 the company completed its U.S. Phase III clinical trial in
stage-IV malignant melanoma patients. The results showed that Maxamine, used in
combination with the cytokine IL-2, improved survival for stage-IV malignant
melanoma patients compared with those treated with the same doses of IL-2 alone.
Improvement in survival was statistically significant in patients having
metastases of their melanoma to the liver (p=0.004), a patient population that
historically has had a very poor prognosis and no effective treatment options.
The Phase III study also indicated that treatment with Maxamine and IL-2 was
safe and well-tolerated and had substantially less toxicity than the high-dose
regimens under which IL-2 was originally approved.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism
that suppresses the capacity of the immune system to detect and destroy tumor
cells or virally infected cells in many patients with cancer and chronic
infectious diseases. Maxamine is designed to reverse this immune suppression,
thereby enhancing the effectiveness of immunotherapy, a class of therapies that
employ the body`s immune system to fight cancer and certain infectious diseases.
Maxamine protects critical immune cells and is administered in combination with
cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate
these same immune cells. More than 1,200 patients have been treated in the
company`s completed and ongoing clinical trials in advanced malignant melanoma,
acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an
investigational drug and safety and efficacy have not been established at this
time. However, clinical trial results to date suggest that Maxamine Therapy, the
administration of Maxamine in combination with cytokines, is a safe, at-home
treatment that may improve patient survival.
Maxim Pharmaceuticals is a late-stage pharmaceutical company developing advanced
drugs and therapies for cancer and infectious diseases. In addition to the
recently completed Phase III trial in stage-IV malignant melanoma, Maxamine is
also currently being tested in two additional Phase III cancer clinical trials
in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II
trials of Maxamine are also underway for the treatment of hepatitis C and
advanced renal cell carcinoma. The company has also developed product candidates
based on its MaxDerm(TM) technology that are designed for the treatment of
medical conditions for which topical therapy is appropriate such as oral
mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Lastly, Maxim is developing small-molecule inhibitors and activators of
caspases, key enzymes that modulate and carry out the cellular signaling
pathways involved in programmed cell death, also known as apoptosis. Compounds
that can either inhibit caspases or induce caspases may form the basis for
important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks
and uncertainties. Such forward-looking statements include statements regarding
the efficacy and intended utilization of Maxamine, MaxDerm and the caspase
modulator compounds, and regarding the company`s clinical trials. Such
statements are only predictions and the company`s actual results may differ
materially from those anticipated in these forward-looking statements. Factors
that may cause such differences include the risk that products that appeared
promising in early research and clinical trials do not demonstrate safety or
efficacy in larger-scale clinical trials and the risk that the company will not
obtain approval to market its products. These factors and others are more fully
discussed in the company`s periodic reports and other filings with the
Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of the company.
Editor`s Note: This release is also available on the Internet at:
http://www.maxim.com.
Gruß !
LeNeant
Maxim seeks malignant melanoma treatment approval
SAN DIEGO, Calif., July 19 (Reuters) - Maxim Pharmaceuticals <MAXM.O> said Wednesday that it filed a new drug application with federal regulators for approval to market a drug to treat malignant melanoma.
The company filed with the U.S. Food and Drug Administration to market histamine dihydrochloride, or Maxamine, in the United States.
Maxim said there is no effective treatment for malignant melanoma, the most serious form of skin cancer, that increases survival after advanced stage IV melanoma. Current treatments often involve substantial toxicity and side effects, the company said.
Maxim said Phase III clinical trial results of its drug showed that when used in combination with cytokine IL-2, improved survival in patients compared with patients treated with the same dose of IL-2 alone.
The trial results also showed that Maxamine treatment had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved, Maxim said.
Cytokines are hormone-like proteins, secreted by many cell types, which regulate the intensity and duration of immune responses and are involved in cell-to-cell communication.
Maxamine was granted orphan drug status by the FDA in February as an adjunct to cytokine therapy. Orphan drug status provides for U.S. marketing exclusivity for seven years upon marketing approval by the administration.
((New York Newsdesk 212-859-1700))
REUTERS
SAN DIEGO, Calif., July 19 (Reuters) - Maxim Pharmaceuticals <MAXM.O> said Wednesday that it filed a new drug application with federal regulators for approval to market a drug to treat malignant melanoma.
The company filed with the U.S. Food and Drug Administration to market histamine dihydrochloride, or Maxamine, in the United States.
Maxim said there is no effective treatment for malignant melanoma, the most serious form of skin cancer, that increases survival after advanced stage IV melanoma. Current treatments often involve substantial toxicity and side effects, the company said.
Maxim said Phase III clinical trial results of its drug showed that when used in combination with cytokine IL-2, improved survival in patients compared with patients treated with the same dose of IL-2 alone.
The trial results also showed that Maxamine treatment had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved, Maxim said.
Cytokines are hormone-like proteins, secreted by many cell types, which regulate the intensity and duration of immune responses and are involved in cell-to-cell communication.
Maxamine was granted orphan drug status by the FDA in February as an adjunct to cytokine therapy. Orphan drug status provides for U.S. marketing exclusivity for seven years upon marketing approval by the administration.
((New York Newsdesk 212-859-1700))
REUTERS
Aurora Biosciences gets $1.7 million in Cytovia sale
SAN DIEGO, July 20 (Reuters) - Biopharmaceutical research company Aurora
Biosciences Corp. <ABSC.O> on Thursday said it had recognized a $1.7 million gain
during the second quarter from the sale of its equity stake in Cytovia Inc. to Maxim
Pharmaceuticals <MAXM.O>.
In June Maxim closed its acquisition of Cytovia in an all-stock transaction valued at more
then $80 million, Aurora said.
Aurora made a strategic investment in Cytovia and began collaborating with the company
in 1998 to conduct screening programs to identity new drug leads for cancer and
degenerative diseases.
Aurora designs, develops and commercializes advanced drug-discovery technologies,
services and systems to hasten the discovery of new medicines.
Cytovia is a San Diego-based biopharmaceutical research company focused on the
discovery and development of new drugs that modulate so-called "death cells."
((--F. Brinley Bruton, New York Newsdesk (212) 859-1711))
REUTERS
Rtr 07:12 07-20-00
Gruß
LeNeant
SAN DIEGO, July 20 (Reuters) - Biopharmaceutical research company Aurora
Biosciences Corp. <ABSC.O> on Thursday said it had recognized a $1.7 million gain
during the second quarter from the sale of its equity stake in Cytovia Inc. to Maxim
Pharmaceuticals <MAXM.O>.
In June Maxim closed its acquisition of Cytovia in an all-stock transaction valued at more
then $80 million, Aurora said.
Aurora made a strategic investment in Cytovia and began collaborating with the company
in 1998 to conduct screening programs to identity new drug leads for cancer and
degenerative diseases.
Aurora designs, develops and commercializes advanced drug-discovery technologies,
services and systems to hasten the discovery of new medicines.
Cytovia is a San Diego-based biopharmaceutical research company focused on the
discovery and development of new drugs that modulate so-called "death cells."
((--F. Brinley Bruton, New York Newsdesk (212) 859-1711))
REUTERS
Rtr 07:12 07-20-00
Gruß
LeNeant
die welt ist klein ...
GPC Biotech forms alliance with Cytovia <MAXM.O>
FRANKFURT, July 25 (Reuters) - German biotechnology firm GPC Biotech AG <GPCG.DE> said on Tuesday it had formed a strategic alliance with Cytovia Inc. of the United States, a unit of Maxim Pharmaceuticals Inc. <MAXM.O>.
GPC said that under the agreement Cytovia would license to GPC certain mammalian cell-based assay technologies which GPC would use in its drug discovery programmes and its pharmaceutical partnerships.
By 0910 GMT, GPC shares were 1.91 percent higher at 58.29 euros. The benchmark Neuer Markt index was 0.3 percent lower.
GPC Biotech forms alliance with Cytovia <MAXM.O>
FRANKFURT, July 25 (Reuters) - German biotechnology firm GPC Biotech AG <GPCG.DE> said on Tuesday it had formed a strategic alliance with Cytovia Inc. of the United States, a unit of Maxim Pharmaceuticals Inc. <MAXM.O>.
GPC said that under the agreement Cytovia would license to GPC certain mammalian cell-based assay technologies which GPC would use in its drug discovery programmes and its pharmaceutical partnerships.
By 0910 GMT, GPC shares were 1.91 percent higher at 58.29 euros. The benchmark Neuer Markt index was 0.3 percent lower.
Maxim Pharmaceuticals Announces 2000 Third Quarter Financial Results
( BW)(CA-MAXIM-PHARM)(MAXM) Maxim Pharmaceuticals Announces 2000 Third Quarter Financial Results
Business Editors & Health/Medical Writers
SAN DIEGO--(BW HeathWire)--Aug. 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM: MAXM)(SSE: MAXM) today announced results for the quarter ended June 30, 2000, the third quarter of its 2000 fiscal year. The net loss applicable to common stock for the third quarter totaled $48.2 million or $2.26 per share compared to a net loss applicable to common stock of $9.9 million, or $0.97 per share, for the same period of the prior year. The increase in net loss for the current quarter results from a non-cash, one-time expense in the amount of $42.3 million related to the acquisition of Cytovia, Inc. The current year`s quarterly results also include a $2.1 million gain related to the sale of a vaccine-carrier technology.
"Excluding the two nonrecurring events that occurred during the quarter, specifically the non-cash expense related to the acquisition of Cytovia and the gain related to the sale of the vaccine technology, the net loss for the quarter was $8.1 million, or $0.38 per share, a decrease compared to the prior year and well within our expectations," said Dale A. Sander, Maxim`s Chief Financial Officer. "Our current cash burn is reasonable based on the significant progress being made, and our cash resources will allow us to prepare for the commercial launch of Maxamine(R), as well as capitalize on our other high-potential opportunities."
The Company had cash, cash equivalents and investments totaling $197.8 million at June 30, 2000, and used net cash of $25.1 million in its operations during the nine months ended June 30, 2000.
"We achieved a number of key success milestones in the last several months, culminating with the timely filing of our New Drug Application with the FDA for Maxamine earlier this month," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Other recent key accomplishments include the broadening of our product pipeline with the acquisition of Cytovia and its caspase modulator product candidates, the release of positive 24-week data from our Phase II hepatitis C trial, and the significant licensing agreement with BioChem Pharma."
The net loss applicable to common stock for the nine months ended June 30, 2000 totaled $73.3 million, or $4.48 per share, compared to a net loss applicable to common stock of $29.1 million, or $2.90 per share, for the same period of the prior year. The net loss for the current year includes three non-recurring events, the $42.3 million non-cash expense related to the acquisition of Cytovia, Inc., the $2.1 million gain related to the sale of a vaccine-carrier technology, and $5.0 million in dividends related to preferred stock that is no longer outstanding. Excluding the effect of these three nonrecurring events, the net loss for the nine months ended June 30, 2000 was $28.2 million, or $1.72 per share, a decrease from the loss incurred during the same period of the prior year.
In June 2000 the Company acquired all of the outstanding capital stock of Cytovia, Inc., a privately held biopharmaceutical research company focused on the discovery and development of caspase inhibitors and activators, novel drugs that modulate programmed cell death. The transaction was accounted for as a purchase. The total purchase price was approximately $77.6 million, representing the value of the shares of stock of the Company issued to effect the purchase, the value of the vested and unvested options and warrants assumed at the closing date and estimated transaction costs. Under the provisions of the purchase accounting requirements, the Company recorded an expense during the third quarter ended June 30, 2000 in the amount of $42.3 million related to purchased in-process technology, and recorded the $36.8 million in goodwill and other intangible assets.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. The U.S. Phase III trial of Maxim`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and the related New Drug Application was filed with the U.S. Food and Drug Administration in July 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,200 patients have been treated in completed and ongoing clinical trials.
The Company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
( BW)(CA-MAXIM-PHARM)(MAXM) Maxim Pharmaceuticals Announces 2000 Third Quarter Financial Results
Business Editors & Health/Medical Writers
SAN DIEGO--(BW HeathWire)--Aug. 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM: MAXM)(SSE: MAXM) today announced results for the quarter ended June 30, 2000, the third quarter of its 2000 fiscal year. The net loss applicable to common stock for the third quarter totaled $48.2 million or $2.26 per share compared to a net loss applicable to common stock of $9.9 million, or $0.97 per share, for the same period of the prior year. The increase in net loss for the current quarter results from a non-cash, one-time expense in the amount of $42.3 million related to the acquisition of Cytovia, Inc. The current year`s quarterly results also include a $2.1 million gain related to the sale of a vaccine-carrier technology.
"Excluding the two nonrecurring events that occurred during the quarter, specifically the non-cash expense related to the acquisition of Cytovia and the gain related to the sale of the vaccine technology, the net loss for the quarter was $8.1 million, or $0.38 per share, a decrease compared to the prior year and well within our expectations," said Dale A. Sander, Maxim`s Chief Financial Officer. "Our current cash burn is reasonable based on the significant progress being made, and our cash resources will allow us to prepare for the commercial launch of Maxamine(R), as well as capitalize on our other high-potential opportunities."
The Company had cash, cash equivalents and investments totaling $197.8 million at June 30, 2000, and used net cash of $25.1 million in its operations during the nine months ended June 30, 2000.
"We achieved a number of key success milestones in the last several months, culminating with the timely filing of our New Drug Application with the FDA for Maxamine earlier this month," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Other recent key accomplishments include the broadening of our product pipeline with the acquisition of Cytovia and its caspase modulator product candidates, the release of positive 24-week data from our Phase II hepatitis C trial, and the significant licensing agreement with BioChem Pharma."
The net loss applicable to common stock for the nine months ended June 30, 2000 totaled $73.3 million, or $4.48 per share, compared to a net loss applicable to common stock of $29.1 million, or $2.90 per share, for the same period of the prior year. The net loss for the current year includes three non-recurring events, the $42.3 million non-cash expense related to the acquisition of Cytovia, Inc., the $2.1 million gain related to the sale of a vaccine-carrier technology, and $5.0 million in dividends related to preferred stock that is no longer outstanding. Excluding the effect of these three nonrecurring events, the net loss for the nine months ended June 30, 2000 was $28.2 million, or $1.72 per share, a decrease from the loss incurred during the same period of the prior year.
In June 2000 the Company acquired all of the outstanding capital stock of Cytovia, Inc., a privately held biopharmaceutical research company focused on the discovery and development of caspase inhibitors and activators, novel drugs that modulate programmed cell death. The transaction was accounted for as a purchase. The total purchase price was approximately $77.6 million, representing the value of the shares of stock of the Company issued to effect the purchase, the value of the vested and unvested options and warrants assumed at the closing date and estimated transaction costs. Under the provisions of the purchase accounting requirements, the Company recorded an expense during the third quarter ended June 30, 2000 in the amount of $42.3 million related to purchased in-process technology, and recorded the $36.8 million in goodwill and other intangible assets.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. The U.S. Phase III trial of Maxim`s lead drug candidate Maxamine (histamine dihydrochloride) for the treatment of malignant melanoma was completed in March 2000 and the related New Drug Application was filed with the U.S. Food and Drug Administration in July 2000. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,200 patients have been treated in completed and ongoing clinical trials.
The Company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
"Excluding the two nonrecurring events that occurred during the quarter, specifically the non-cash expense related to the acquisition of Cytovia and the gain related to the sale of the vaccine technology, the net loss for the quarter was $8.1 million, or $0.38 per share, a decrease compared to the prior year and well within our expectations,"
es gab zwei analysten-erwartungen: - 0,5 $ und - 0,84 $
tatsächliches ergebnis ohne "außergewöhnliche aufwendungen": - 0,38 $
es gab zwei analysten-erwartungen: - 0,5 $ und - 0,84 $
tatsächliches ergebnis ohne "außergewöhnliche aufwendungen": - 0,38 $
SAN DIEGO--(BW HealthWire)--Aug. 10, 2000--
Maxim and Roche Expect Collaboration to Lead to Important Advances
in the Treatment of Cancer and Hepatitis C
Maxim Pharmaceuticals (Nasdaq:MAXM, news, msgs)(SSE:MAXM) announced that it has entered into
a comprehensive development collaboration with F. Hoffmann -- La Roche Ltd, Switzerland and its U.S.
branch Hoffmann -- La Roche Inc. for the development of Maxim`s lead drug Maxamine(R) (histamine
dihydrochloride) in combination with the investigational compound Pegasys(R), Roche`s pegylated
interferon-alpha agent.
Both parties expect that the combination of Maxamine and Pegasys will lead to important advances in
the treatment of cancer and hepatitis C.
"Roche clearly represents a great development partner for Maxim due to the success they have had
with the clinical development of Pegasys, and the fact that they share our commitment to advancing
the treatment of hepatitis C and cancer," said Larry G. Stambaugh, Maxim`s chairman and chief
executive officer. "This collaboration not only produces a substantial strategic and economic benefit to
us, it allows us to accelerate and expand the clinical development of Maxamine."
"We are excited about the potential contribution that the combination of Maxamine and Pegasys may
make to the treatment of hepatitis C and the targeted cancers," said Simon Pedder, Ph.D.,
Pharmaceutical Business Director for Pegasys. "Hepatitis C in particular is a substantial unmet need.
Our hope is that the addition of Maxamine to Pegasys, an agent that has produced promising clinical
data in hepatitis C as a monotherapy, will result in a combination therapy that represents a further
improvement in patient care. In addition, the data from the Phase III trial of Maxamine in advanced
malignant melanoma encouraged us to move aggressively forward with the development of the
Pegasys/Maxamine combination treatment in cancer."
Under the agreement, Maxim and Roche will undertake clinical trials and other activities designed to
seek regulatory approval of the combination of Maxamine and Pegasys for the treatment of hepatitis C
and certain cancers. Specifically, the collaboration program will include two Phase III trials of the
Maxamine and Pegasys combination for the treatment of hepatitis C, one Phase III trial of Maxamine
and Pegasys for the treatment of advanced-stage renal cell carcinoma, and an additional Phase III trial
in another cancer to be selected by the two companies.
Roche will perform the management, monitoring and data management of the trials at its own cost and
Roche and Maxim will share equally the third party costs of the trials. Each company will retain
marketing responsibilities and revenues for their respective drugs, although under the collaboration
agreement they will cooperate in the training of their respective sales forces.
The U.S. Phase III trial of Maxamine for the treatment of malignant melanoma was completed in March
2000 and the related New Drug Application was filed by Maxim with the U.S. Food and Drug
Administration in July 2000. In addition, interim 24-week results from a Phase II dose-ranging hepatitis
C study showed that the combination of the optimal dosing regimen of Maxamine and interferon-alpha
achieved a complete viral response in 69 percent of all patients, compared to the 29 percent or less
response that is commonly observed in patients treated with interferon-alpha alone.
Maxamine Mode of Action
Research suggests that a universal mechanism in the human body suppresses the capacity of the
immune system to detect and destroy tumor cells or virally infected cells in patients with cancer and
chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby
enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune
system to fight these diseases. Maxamine protects critical immune cells and is administered in
combination with stimulators of these same immune cells (cytokines such as interferon-alpha and
IL-2). More than 1,200 patients have been treated in the Maxim`s completed and ongoing clinical trials.
In addition to the U.S. Phase III trial for the treatment of malignant melanoma completed in March
2000, Maxamine is currently being tested in two additional Phase III cancer clinical trials in 12
countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are
also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is an
investigational drug and safety and efficacy have not been established at this time. However, clinical
trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination
with cytokines, is a safe, at-home treatment that may improve patient survival.
Ein ganz großer Partner für Maxim oder wie seht ihr das ??
Gruß
LeNeant
Maxim and Roche Expect Collaboration to Lead to Important Advances
in the Treatment of Cancer and Hepatitis C
Maxim Pharmaceuticals (Nasdaq:MAXM, news, msgs)(SSE:MAXM) announced that it has entered into
a comprehensive development collaboration with F. Hoffmann -- La Roche Ltd, Switzerland and its U.S.
branch Hoffmann -- La Roche Inc. for the development of Maxim`s lead drug Maxamine(R) (histamine
dihydrochloride) in combination with the investigational compound Pegasys(R), Roche`s pegylated
interferon-alpha agent.
Both parties expect that the combination of Maxamine and Pegasys will lead to important advances in
the treatment of cancer and hepatitis C.
"Roche clearly represents a great development partner for Maxim due to the success they have had
with the clinical development of Pegasys, and the fact that they share our commitment to advancing
the treatment of hepatitis C and cancer," said Larry G. Stambaugh, Maxim`s chairman and chief
executive officer. "This collaboration not only produces a substantial strategic and economic benefit to
us, it allows us to accelerate and expand the clinical development of Maxamine."
"We are excited about the potential contribution that the combination of Maxamine and Pegasys may
make to the treatment of hepatitis C and the targeted cancers," said Simon Pedder, Ph.D.,
Pharmaceutical Business Director for Pegasys. "Hepatitis C in particular is a substantial unmet need.
Our hope is that the addition of Maxamine to Pegasys, an agent that has produced promising clinical
data in hepatitis C as a monotherapy, will result in a combination therapy that represents a further
improvement in patient care. In addition, the data from the Phase III trial of Maxamine in advanced
malignant melanoma encouraged us to move aggressively forward with the development of the
Pegasys/Maxamine combination treatment in cancer."
Under the agreement, Maxim and Roche will undertake clinical trials and other activities designed to
seek regulatory approval of the combination of Maxamine and Pegasys for the treatment of hepatitis C
and certain cancers. Specifically, the collaboration program will include two Phase III trials of the
Maxamine and Pegasys combination for the treatment of hepatitis C, one Phase III trial of Maxamine
and Pegasys for the treatment of advanced-stage renal cell carcinoma, and an additional Phase III trial
in another cancer to be selected by the two companies.
Roche will perform the management, monitoring and data management of the trials at its own cost and
Roche and Maxim will share equally the third party costs of the trials. Each company will retain
marketing responsibilities and revenues for their respective drugs, although under the collaboration
agreement they will cooperate in the training of their respective sales forces.
The U.S. Phase III trial of Maxamine for the treatment of malignant melanoma was completed in March
2000 and the related New Drug Application was filed by Maxim with the U.S. Food and Drug
Administration in July 2000. In addition, interim 24-week results from a Phase II dose-ranging hepatitis
C study showed that the combination of the optimal dosing regimen of Maxamine and interferon-alpha
achieved a complete viral response in 69 percent of all patients, compared to the 29 percent or less
response that is commonly observed in patients treated with interferon-alpha alone.
Maxamine Mode of Action
Research suggests that a universal mechanism in the human body suppresses the capacity of the
immune system to detect and destroy tumor cells or virally infected cells in patients with cancer and
chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby
enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune
system to fight these diseases. Maxamine protects critical immune cells and is administered in
combination with stimulators of these same immune cells (cytokines such as interferon-alpha and
IL-2). More than 1,200 patients have been treated in the Maxim`s completed and ongoing clinical trials.
In addition to the U.S. Phase III trial for the treatment of malignant melanoma completed in March
2000, Maxamine is currently being tested in two additional Phase III cancer clinical trials in 12
countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are
also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is an
investigational drug and safety and efficacy have not been established at this time. However, clinical
trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination
with cytokines, is a safe, at-home treatment that may improve patient survival.
Ein ganz großer Partner für Maxim oder wie seht ihr das ??
Gruß
LeNeant
sehe ich ähnlich. schön, wie zielstrebig diese firma und ihr produkt ihren weg gehen.
schließe mich euch ebenso an
MAXM verbessert seine Situation stetig
MAXM verbessert seine Situation stetig
schließe mich euch ebenso an
MAXM verbessert seine Situation stetig
MAXM verbessert seine Situation stetig
hallo IWA
ich hab ja schon gesagt, daß ich meine MAXM nicht verkauft habe
ich hab ja schon gesagt, daß ich meine MAXM nicht verkauft habe
jetzt mal den Inhalt auf Deutsch
Maxim kooperiert mit La Roche
Maxim Pharmaceuticals (Nasdaq: MAXM; WKN 909400) hat heute eine Kooperation mit Hoffmann La Roche bekanntgegeben.
Die Unternehmen planen gemeinsam die weitere Entwicklung von Maxims Medikament Maxamine® in Kombination mit La Roches Pegasys® zur Behandlung von Krebs und Hepatitis C. Finanzielle Einzelheiten wurden nicht veröffentlicht. „Roche stellt einen großartigen Entwicklungspartner für Maxim dar,“ sagte der CEO von Maxim Larry G. Stambaugh.
Maxim kooperiert mit La Roche
Maxim Pharmaceuticals (Nasdaq: MAXM; WKN 909400) hat heute eine Kooperation mit Hoffmann La Roche bekanntgegeben.
Die Unternehmen planen gemeinsam die weitere Entwicklung von Maxims Medikament Maxamine® in Kombination mit La Roches Pegasys® zur Behandlung von Krebs und Hepatitis C. Finanzielle Einzelheiten wurden nicht veröffentlicht. „Roche stellt einen großartigen Entwicklungspartner für Maxim dar,“ sagte der CEO von Maxim Larry G. Stambaugh.
MAXIM PHARMACEUTICALS INC files Form 10-Q, Quarterly Report of Financial Condition
http://www.nasdaq.com/asp/quotes_news.asp?symbol=MAXM%60&sel…
http://www.nasdaq.com/asp/quotes_news.asp?symbol=MAXM%60&sel…
soeben hat maxim in usa die hürde 60 $ genommen.
Moin!
Frisch vom Ticker:
Wednesday September 6, 2000 04:01 AM
Company Press Release
Maxim Reports Caspase Inhibitor Preclinical Data for
Myocardial Infarction and Stroke At Scientific Conference
SAN DIEGO--(BW HealthWire)--Sept. 6, 2000--Maxim Pharmaceuticals (Nasdaq NM:
MAXM)(SSE: MAXM) announced that preclinical data regarding its caspase inhibitor CV1013
was presented at the 220th American Chemical Society National Meeting in Washington, D.C.
The results of the study suggested that CV1013 was effective in preventing apoptosis
(programmed cell death) in animal models of myocardial infarction, stroke and hepatitis,
including a greater than 50 reduction in infarct size (heart damage) in two myocardial infarction
models.
Caspases are key enzymes that modulate and carry out the cellular signaling pathways involved
in programmed cell death, also known as apoptosis. Compounds such as CV1013 that can
inhibit caspases may form the basis for new drugs for cardiovascular and other degenerative
diseases. CV1013 is one in a family of caspase inhibitors identified to date by Maxim through its
proprietary apoptosis drug discovery program. The Company plans to initiate a Phase I
cardiovascular disease study in 2001.
Study Results
Preclinical study results were reported for two myocardial infarction models. In a study using a
mouse cardiac ischemia/reperfusion model conducted at the Baylor College of Medicine, a one
hour occlusion of the left anterior descending artery was followed by reperfusion. A single IV
bolus of CV1013 administered at the time of reperfusion resulted in a mean myocardial infarct
size in the treatment group that was 53 smaller than the mean infarct size in the control group
(p less than 0.001). In a rat myocardial infarction model, CV1013 administered by IV bolus
followed by an infusion resulted in a mean myocardial infarct size in the treatment group that
was 52 smaller than the mean size in the control group (p less than 0.001).
In addition, in a rat middle cerebral artery occlusion reperfusion brain ischemia model, IV bolus
of CV1013 followed by infusion after occlusion resulted in a 50 reduction of mean brain infarct
volume. CV1013 was also shown to reduce the incidence of death in a mouse liver failure model.
"In addition to the preliminary evidence of protection shown by CV1013 in these models, animal
studies have indicated that the compound is selective and has a high therapeutic index,
suggesting a low potential for toxicity issues," said Kurt R. Gehlsen, Vice President, Development
and Chief Technical Officer. "Our analysis of the results to date encourages us to undertake
efforts to prepare one of the compounds from this family of caspase inhibitors for human
clinical trials in cardiovascular disease."
CV1013, and its related compounds, are investigational drug candidates and safety and efficacy
have not been established at this time.
Company Overview
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs
and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. A
New Drug Application for its lead drug Maxamine(R) (histamine dihydrochloride) for the
treatment of stage-IV malignant melanoma was submitted to the U.S. Food and Drug
Administration in July 2000. In addition, Maxamine is also currently being tested in two
additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute
myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of
hepatitis C and advanced renal cell carcinoma. More than 1,200 patients have been treated in
the Company`s completed and ongoing clinical trials in advanced malignant melanoma, acute
myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug
and has not been approved by the FDA or any international regulatory agency. However, clinical
trial results to date suggest that Maxamine Therapy, the administration of Maxamine in
combination with cytokines, is a safe, at-home treatment that may improve patient survival.
The Company has also developed product candidates based on its MaxDerm(TM) technology
that are designed for the treatment of medical conditions for which topical therapy is
appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related
conditions. Furthermore, in addition to the caspase inhibitors described above, Maxim is also
developing small-molecule activators of caspases that may form the basis for new drugs to treat
cancer. "Maxim" and the "Company" refer to Maxim Pharmaceuticals, Inc. and its subsidiaries.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking statements include statements regarding the efficacy and
intended utilization of Maxamine, MaxDerm and the caspase compounds, and regarding
Maxim`s clinical trials and preclinical development efforts. Such statements are only predictions
and Maxim`s actual results may differ materially from those anticipated in these forward-looking
statements. Factors that may cause such differences include the risk that products that
appeared promising in early research and clinical trials do not demonstrate safety or efficacy in
larger-scale clinical trials, the risk that clinical trials may not commence when planned, if at all,
and the risk that Maxim will not obtain approval to market its products. These factors and
others are more fully discussed in Maxim`s periodic reports and other filings with the Securities
and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of Maxim Pharmaceuticals.
BM
Frisch vom Ticker:
Wednesday September 6, 2000 04:01 AM
Company Press Release
Maxim Reports Caspase Inhibitor Preclinical Data for
Myocardial Infarction and Stroke At Scientific Conference
SAN DIEGO--(BW HealthWire)--Sept. 6, 2000--Maxim Pharmaceuticals (Nasdaq NM:
MAXM)(SSE: MAXM) announced that preclinical data regarding its caspase inhibitor CV1013
was presented at the 220th American Chemical Society National Meeting in Washington, D.C.
The results of the study suggested that CV1013 was effective in preventing apoptosis
(programmed cell death) in animal models of myocardial infarction, stroke and hepatitis,
including a greater than 50 reduction in infarct size (heart damage) in two myocardial infarction
models.
Caspases are key enzymes that modulate and carry out the cellular signaling pathways involved
in programmed cell death, also known as apoptosis. Compounds such as CV1013 that can
inhibit caspases may form the basis for new drugs for cardiovascular and other degenerative
diseases. CV1013 is one in a family of caspase inhibitors identified to date by Maxim through its
proprietary apoptosis drug discovery program. The Company plans to initiate a Phase I
cardiovascular disease study in 2001.
Study Results
Preclinical study results were reported for two myocardial infarction models. In a study using a
mouse cardiac ischemia/reperfusion model conducted at the Baylor College of Medicine, a one
hour occlusion of the left anterior descending artery was followed by reperfusion. A single IV
bolus of CV1013 administered at the time of reperfusion resulted in a mean myocardial infarct
size in the treatment group that was 53 smaller than the mean infarct size in the control group
(p less than 0.001). In a rat myocardial infarction model, CV1013 administered by IV bolus
followed by an infusion resulted in a mean myocardial infarct size in the treatment group that
was 52 smaller than the mean size in the control group (p less than 0.001).
In addition, in a rat middle cerebral artery occlusion reperfusion brain ischemia model, IV bolus
of CV1013 followed by infusion after occlusion resulted in a 50 reduction of mean brain infarct
volume. CV1013 was also shown to reduce the incidence of death in a mouse liver failure model.
"In addition to the preliminary evidence of protection shown by CV1013 in these models, animal
studies have indicated that the compound is selective and has a high therapeutic index,
suggesting a low potential for toxicity issues," said Kurt R. Gehlsen, Vice President, Development
and Chief Technical Officer. "Our analysis of the results to date encourages us to undertake
efforts to prepare one of the compounds from this family of caspase inhibitors for human
clinical trials in cardiovascular disease."
CV1013, and its related compounds, are investigational drug candidates and safety and efficacy
have not been established at this time.
Company Overview
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs
and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. A
New Drug Application for its lead drug Maxamine(R) (histamine dihydrochloride) for the
treatment of stage-IV malignant melanoma was submitted to the U.S. Food and Drug
Administration in July 2000. In addition, Maxamine is also currently being tested in two
additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute
myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of
hepatitis C and advanced renal cell carcinoma. More than 1,200 patients have been treated in
the Company`s completed and ongoing clinical trials in advanced malignant melanoma, acute
myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug
and has not been approved by the FDA or any international regulatory agency. However, clinical
trial results to date suggest that Maxamine Therapy, the administration of Maxamine in
combination with cytokines, is a safe, at-home treatment that may improve patient survival.
The Company has also developed product candidates based on its MaxDerm(TM) technology
that are designed for the treatment of medical conditions for which topical therapy is
appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related
conditions. Furthermore, in addition to the caspase inhibitors described above, Maxim is also
developing small-molecule activators of caspases that may form the basis for new drugs to treat
cancer. "Maxim" and the "Company" refer to Maxim Pharmaceuticals, Inc. and its subsidiaries.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking statements include statements regarding the efficacy and
intended utilization of Maxamine, MaxDerm and the caspase compounds, and regarding
Maxim`s clinical trials and preclinical development efforts. Such statements are only predictions
and Maxim`s actual results may differ materially from those anticipated in these forward-looking
statements. Factors that may cause such differences include the risk that products that
appeared promising in early research and clinical trials do not demonstrate safety or efficacy in
larger-scale clinical trials, the risk that clinical trials may not commence when planned, if at all,
and the risk that Maxim will not obtain approval to market its products. These factors and
others are more fully discussed in Maxim`s periodic reports and other filings with the Securities
and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of Maxim Pharmaceuticals.
BM
und die meldungen überschlagen sich ...
Maxim says FDA grants Maxamine priority status
STOCKHOLM, Sept 7 (Reuters) - Maxim Pharmaceuticals Inc <MAXM.ST> <MAXM.O> said on Thursday the U.S. Food and Drug Administration (FDA) had granted its Maxamine skin cancer drug priority review status.
That means the FDA sees Maxamine, which counteracts a drop in melanoma patients` immune systems, as a potential therapeutic advance over existing therapies for the deadly disease, Maxim said in a statement.
The FDA usually takes action on drugs given a priority review within six months of acceptance of a new drug application (NDA), which Maxim submitted for Maxamine in July, it added.
"We are extremely pleased that the FDA has designated Maxamine for priority review and has accepted the NDA for review as filed" Maxim Chief Executive Larry Stambaugh said in the statement.
Maxamine is designed to enhance the effectiveness of immunotherapy, which uses the body`s own defences to fight cancer and certain infections.
Maxim says FDA grants Maxamine priority status
STOCKHOLM, Sept 7 (Reuters) - Maxim Pharmaceuticals Inc <MAXM.ST> <MAXM.O> said on Thursday the U.S. Food and Drug Administration (FDA) had granted its Maxamine skin cancer drug priority review status.
That means the FDA sees Maxamine, which counteracts a drop in melanoma patients` immune systems, as a potential therapeutic advance over existing therapies for the deadly disease, Maxim said in a statement.
The FDA usually takes action on drugs given a priority review within six months of acceptance of a new drug application (NDA), which Maxim submitted for Maxamine in July, it added.
"We are extremely pleased that the FDA has designated Maxamine for priority review and has accepted the NDA for review as filed" Maxim Chief Executive Larry Stambaugh said in the statement.
Maxamine is designed to enhance the effectiveness of immunotherapy, which uses the body`s own defences to fight cancer and certain infections.
Warum dieser Sturz auf unter 70? Weiß jemand was, oder sind das nur Gewinnmitnahmen?
Danke für Antwort.
Mursik
Danke für Antwort.
Mursik
Maxim Reports Preclinical Study of Maxamine in Chronic Myelogenous Leukemia Published in Leading Scientific Journal
SAN DIEGO--(BW HealthWire)--Sept. 13, 2000--
Results Also Presented at Society of Biological Therapy Meeting
Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced the publication of a preclinical study demonstrating that its lead drug candidate Maxamine(R) (histamine dihydrochloride) protected critical cells of the immune system from inhibition by cancer cells recovered from patients with chronic myelogenous leukemia (CML).
The study was published in the September issue of Blood (volume 96, no. 5, pp 1961-68), which is the official journal of The American Society of Hematology (ASH). The results were also presented at the Society of Biological Therapy (SBT) conference in Berlin, Germany.
"We are pleased by these preclinical data as they further support the benefit that Maxamine may provide in cancer therapy by preventing suppression of key elements of the immune system," said Dr. Kurt R. Gehlsen, Maxim`s vice president. "Cancer cells can sometimes escape the immune system by suppressing natural killer cells and cytotoxic T-cells, and it is encouraging that Maxamine was found to protect these cells against inhibition in this CML study, consistent with the results of our research in other cancers."
In the Blood paper, Dr. Ulf-Henrik Mellqvist and co-workers at the University of Goteborg, Sweden, reported that cancer cells recovered from patients with CML, a common form of leukemia, inhibit two type of cells, natural killer (NK) cells and T cells, both of which are key in the defense against cancer cells. NK cells and T cells normally attack and destroy cancer cells, but the authors found that this anti-tumor function was strongly compromised by CML cells. The study concluded, however, that the addition of Maxamine completely restored the anti-tumor functions of NK cells and T cells.
"We are pleased with the rapidly growing awareness and acceptance of the important advancement that Maxamine may represent in the treatment of cancer and infectious diseases," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer. "During the SBT conference this week, results are being presented from our U.S. Phase III study in advanced metastatic melanoma, our Phase II dose-ranging study in hepatitis C, and the recently published preclinical study in CML. The results from these three studies further highlight Maxamine`s potential broad applicability to immunotherapy and biotherapy."
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
SAN DIEGO--(BW HealthWire)--Sept. 13, 2000--
Results Also Presented at Society of Biological Therapy Meeting
Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced the publication of a preclinical study demonstrating that its lead drug candidate Maxamine(R) (histamine dihydrochloride) protected critical cells of the immune system from inhibition by cancer cells recovered from patients with chronic myelogenous leukemia (CML).
The study was published in the September issue of Blood (volume 96, no. 5, pp 1961-68), which is the official journal of The American Society of Hematology (ASH). The results were also presented at the Society of Biological Therapy (SBT) conference in Berlin, Germany.
"We are pleased by these preclinical data as they further support the benefit that Maxamine may provide in cancer therapy by preventing suppression of key elements of the immune system," said Dr. Kurt R. Gehlsen, Maxim`s vice president. "Cancer cells can sometimes escape the immune system by suppressing natural killer cells and cytotoxic T-cells, and it is encouraging that Maxamine was found to protect these cells against inhibition in this CML study, consistent with the results of our research in other cancers."
In the Blood paper, Dr. Ulf-Henrik Mellqvist and co-workers at the University of Goteborg, Sweden, reported that cancer cells recovered from patients with CML, a common form of leukemia, inhibit two type of cells, natural killer (NK) cells and T cells, both of which are key in the defense against cancer cells. NK cells and T cells normally attack and destroy cancer cells, but the authors found that this anti-tumor function was strongly compromised by CML cells. The study concluded, however, that the addition of Maxamine completely restored the anti-tumor functions of NK cells and T cells.
"We are pleased with the rapidly growing awareness and acceptance of the important advancement that Maxamine may represent in the treatment of cancer and infectious diseases," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer. "During the SBT conference this week, results are being presented from our U.S. Phase III study in advanced metastatic melanoma, our Phase II dose-ranging study in hepatitis C, and the recently published preclinical study in CML. The results from these three studies further highlight Maxamine`s potential broad applicability to immunotherapy and biotherapy."
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Mein Englisch ist nicht so gut was tut sich bei Maxim?
Halten oder verkaufen?
Halten oder verkaufen?
kaufen natürlich
wer denkt denn derzeit an einen verkauf?
hier das ergebnis nächsten studie:
Maxim Reports 48-Week Results From Phase II Hepatitis C Study Demonstrating Benefit of Treatment With Maxamine; Results Presented Today At Society of Biological Therapy Meeting
SAN DIEGO--(BW HealthWire)--Sept. 14, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced the 48-week results from its Phase II dose-ranging study of Maxamine(R) (histamine dihydrochloride) in combination with interferon-alpha (IFN-(alpha)) in the treatment of naive, chronically infected hepatitis C patients.
After 48 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and IFN-(alpha) achieved a complete viral response in 61 percent of all patients, compared to the 29 percent or less response that is commonly observed in patients treated with IFN-(alpha) alone. The results are being presented at the Society of Biological Therapy conference in Berlin by the principal investigator in the study, Yoav Lurie, M.D., liver clinic director, Kaplan Medical Center, Israel.
"These are very strong 48-week results for the combination therapy using Maxamine with standard IFN-(alpha)," said Dr. Lurie. "This study had a significant percentage of patients with high viral loads and the genotype-1 virus, both of which are factors that would typically lead to a substantially lower response with either IFN-(alpha) alone or other existing treatments. These end-of-treatment results clearly suggest that Maxamine is providing a benefit not only to the overall study population but to these high-risk groups as well."
In addition to the favorable results in the overall study, response rates achieved for the higher-risk patients treated with the Maxamine/IFN-(alpha) combination were substantially better than those typically expected for treatment with IFN-(alpha) alone:
-- Despite the poor prognosis for successful treatment, 55 percent of
the patients with the genotype-1 variant of the hepatitis C virus
treated with the optimal dose regimen of Maxamine and IFN-(alpha)
achieved a complete viral response at 48-weeks, compared to the
less than 20 percent reported for IFN-(alpha) alone. Patients
infected with the genotype-1 virus typically have the poorest
response to treatment and comprise 70 percent of patients in the
United States and Asia.
-- Patients with high viral levels, viral levels greater than 2
million copies per milliliter of blood, also typically have a poor
response to treatment. However, 54 percent of the patients with
more than 2 million copies per milliliter of blood treated with
the optimal regimen of Maxamine and IFN-(alpha) achieved a
complete viral response at 48-weeks, compared to the less than 20
percent reported for IFN-(alpha) alone.
"Based upon the clinical results achieved to date, we are currently planning two Phase III clinical trials in hepatitis C in collaboration with F. Hoffmann - La Roche using the combination of Maxamine with pegylated interferon and ribavirin," stated Kurt Gehlsen, Ph.D., Maxim vice president, development and chief technical officer. "We believe that Maxamine in combination with emerging new treatments based on the pegylated form of interferon may be synergistic and substantially improve outcomes for naive patients as well as for patients who are previously nonresponsive to therapy."
Phase II Study Design
The Phase II dose-ranging trial is designed to evaluate the combination of Maxamine and IFN-(alpha) in the treatment of chronic hepatitis C patients who had not been previously treated with IFN-(alpha). The primary goals of this study are to determine the most appropriate dosing regimen for Maxamine in the treatment of naive chronic hepatitis C patients, and to provide further evidence that Maxamine may benefit cytokines such as IFN-(alpha) in the treatment of this viral infection. The 129-patient trial is based in the United Kingdom, Belgium, Israel and Russia.
Patients were randomly assigned to one of four treatment groups, and each patient received Maxamine, in one of four dosing regimens, plus IFN-(alpha) at the standard dose of 3miu three times per week. Under the two lower-dose regimens, patients administered one dose of Maxamine each treatment day, and receive a total of either 3 mg or 5 mg of the drug per week of therapy. Under the two higher-dose regimens, patients administered two doses of Maxamine each treatment day, and receive a total of either 6 mg or 10 mg of the drug per week of therapy.
After 48 weeks of treatment, 61 percent of the patients treated with either of the two higher-dose, twice-per-day regimens of Maxamine achieved complete viral responses, compared to a 55 percent complete viral response for the patients treated with either of the two lower-dose, once-per-day regimens of Maxamine. The complete viral response for all patients in the study for all four treatment arms combined was 58 percent. Published reports suggest that only 29 percent or less of patients attain a complete viral response after 48 weeks of treatment with IFN-(alpha) alone.
The primary measures of efficacy in the study are a reduction in viral load and a normalization of liver function. A complete viral response is defined by virus levels that are below the limit of detection using a validated PCR-RNA technique. A complete biochemical response is defined as normalization of liver enzyme levels, measured by the liver enzyme ALT, a standard measure of liver function. Patients who responded during the first 12 weeks of treatment continued treatment through 48 weeks, with the 48-week, end-of-treatment, results summarized above. An additional evaluation will be made at the 72-week point (24 weeks after end of treatment).
Patients in the study were able to treat themselves at home with the Maxamine and IFN-(alpha) combination therapy. The 48-week results suggest that patient compliance and the safety profile of the therapy were consistent with the positive results shown in other ongoing and completed Maxamine trials.
Hepatitis C Overview
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do not effectively respond to existing therapies or to therapies known by us to be under development.
In addition to the Phase II dose-ranging study, the company also has a clinical study underway to evaluate the safety of triple-drug therapy incorporating Maxamine in combination with IFN-(alpha) and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy. The company expects to conduct its Phase III studies under the umbrella of a comprehensive development collaboration with F. Hoffmann - La Roche for the clinical development and approval of Maxamine in combination with Pegasys(R), Roche`s pegylated interferon-alpha agent. The collaboration program will include two Phase III trials of the Maxamine and Pegasys combination for the treatment of hepatitis C, one in naive patients, and one in patients who were nonresponsive to prior therapy.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and IFN-(alpha), a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
hier das ergebnis nächsten studie:
Maxim Reports 48-Week Results From Phase II Hepatitis C Study Demonstrating Benefit of Treatment With Maxamine; Results Presented Today At Society of Biological Therapy Meeting
SAN DIEGO--(BW HealthWire)--Sept. 14, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced the 48-week results from its Phase II dose-ranging study of Maxamine(R) (histamine dihydrochloride) in combination with interferon-alpha (IFN-(alpha)) in the treatment of naive, chronically infected hepatitis C patients.
After 48 weeks of therapy, the combination of the optimal dosing regimen of Maxamine and IFN-(alpha) achieved a complete viral response in 61 percent of all patients, compared to the 29 percent or less response that is commonly observed in patients treated with IFN-(alpha) alone. The results are being presented at the Society of Biological Therapy conference in Berlin by the principal investigator in the study, Yoav Lurie, M.D., liver clinic director, Kaplan Medical Center, Israel.
"These are very strong 48-week results for the combination therapy using Maxamine with standard IFN-(alpha)," said Dr. Lurie. "This study had a significant percentage of patients with high viral loads and the genotype-1 virus, both of which are factors that would typically lead to a substantially lower response with either IFN-(alpha) alone or other existing treatments. These end-of-treatment results clearly suggest that Maxamine is providing a benefit not only to the overall study population but to these high-risk groups as well."
In addition to the favorable results in the overall study, response rates achieved for the higher-risk patients treated with the Maxamine/IFN-(alpha) combination were substantially better than those typically expected for treatment with IFN-(alpha) alone:
-- Despite the poor prognosis for successful treatment, 55 percent of
the patients with the genotype-1 variant of the hepatitis C virus
treated with the optimal dose regimen of Maxamine and IFN-(alpha)
achieved a complete viral response at 48-weeks, compared to the
less than 20 percent reported for IFN-(alpha) alone. Patients
infected with the genotype-1 virus typically have the poorest
response to treatment and comprise 70 percent of patients in the
United States and Asia.
-- Patients with high viral levels, viral levels greater than 2
million copies per milliliter of blood, also typically have a poor
response to treatment. However, 54 percent of the patients with
more than 2 million copies per milliliter of blood treated with
the optimal regimen of Maxamine and IFN-(alpha) achieved a
complete viral response at 48-weeks, compared to the less than 20
percent reported for IFN-(alpha) alone.
"Based upon the clinical results achieved to date, we are currently planning two Phase III clinical trials in hepatitis C in collaboration with F. Hoffmann - La Roche using the combination of Maxamine with pegylated interferon and ribavirin," stated Kurt Gehlsen, Ph.D., Maxim vice president, development and chief technical officer. "We believe that Maxamine in combination with emerging new treatments based on the pegylated form of interferon may be synergistic and substantially improve outcomes for naive patients as well as for patients who are previously nonresponsive to therapy."
Phase II Study Design
The Phase II dose-ranging trial is designed to evaluate the combination of Maxamine and IFN-(alpha) in the treatment of chronic hepatitis C patients who had not been previously treated with IFN-(alpha). The primary goals of this study are to determine the most appropriate dosing regimen for Maxamine in the treatment of naive chronic hepatitis C patients, and to provide further evidence that Maxamine may benefit cytokines such as IFN-(alpha) in the treatment of this viral infection. The 129-patient trial is based in the United Kingdom, Belgium, Israel and Russia.
Patients were randomly assigned to one of four treatment groups, and each patient received Maxamine, in one of four dosing regimens, plus IFN-(alpha) at the standard dose of 3miu three times per week. Under the two lower-dose regimens, patients administered one dose of Maxamine each treatment day, and receive a total of either 3 mg or 5 mg of the drug per week of therapy. Under the two higher-dose regimens, patients administered two doses of Maxamine each treatment day, and receive a total of either 6 mg or 10 mg of the drug per week of therapy.
After 48 weeks of treatment, 61 percent of the patients treated with either of the two higher-dose, twice-per-day regimens of Maxamine achieved complete viral responses, compared to a 55 percent complete viral response for the patients treated with either of the two lower-dose, once-per-day regimens of Maxamine. The complete viral response for all patients in the study for all four treatment arms combined was 58 percent. Published reports suggest that only 29 percent or less of patients attain a complete viral response after 48 weeks of treatment with IFN-(alpha) alone.
The primary measures of efficacy in the study are a reduction in viral load and a normalization of liver function. A complete viral response is defined by virus levels that are below the limit of detection using a validated PCR-RNA technique. A complete biochemical response is defined as normalization of liver enzyme levels, measured by the liver enzyme ALT, a standard measure of liver function. Patients who responded during the first 12 weeks of treatment continued treatment through 48 weeks, with the 48-week, end-of-treatment, results summarized above. An additional evaluation will be made at the 72-week point (24 weeks after end of treatment).
Patients in the study were able to treat themselves at home with the Maxamine and IFN-(alpha) combination therapy. The 48-week results suggest that patient compliance and the safety profile of the therapy were consistent with the positive results shown in other ongoing and completed Maxamine trials.
Hepatitis C Overview
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do not effectively respond to existing therapies or to therapies known by us to be under development.
In addition to the Phase II dose-ranging study, the company also has a clinical study underway to evaluate the safety of triple-drug therapy incorporating Maxamine in combination with IFN-(alpha) and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy. The company expects to conduct its Phase III studies under the umbrella of a comprehensive development collaboration with F. Hoffmann - La Roche for the clinical development and approval of Maxamine in combination with Pegasys(R), Roche`s pegylated interferon-alpha agent. The collaboration program will include two Phase III trials of the Maxamine and Pegasys combination for the treatment of hepatitis C, one in naive patients, and one in patients who were nonresponsive to prior therapy.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and IFN-(alpha), a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company`s completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.
Hi, verfolge den Thread schon lange, bin ziemlich investiert.
Weiß jemand warum Maxim auf einmal wie ein Stein fällt in den USA? Positive Berichte überall und sehr hohe Umsätze an der Nasdaq. Gabs eine schlechte Meldung? Heute war Maxim als Tip einem Bericht der FAZ über einen Biofond erwähnt. Hat jemand den Text?
Danke für die Infos
Weiß jemand warum Maxim auf einmal wie ein Stein fällt in den USA? Positive Berichte überall und sehr hohe Umsätze an der Nasdaq. Gabs eine schlechte Meldung? Heute war Maxim als Tip einem Bericht der FAZ über einen Biofond erwähnt. Hat jemand den Text?
Danke für die Infos
Im BO Auslandsboard gab es eine lange Diskussion zu deiner Frage, warum MAXM heute fiel:
Antwort: Unmengen an Shorties
Antwort: Unmengen an Shorties
Vielen Dank The Red, welche Auswirkungen kann das haben?. Kenne Beispiele wo Shorties den Kurs richtig haben einbrechen lassen und das auf lange Zeit?
Hast Du den Bericht in der FAZ gelesen?
Hast Du den Bericht in der FAZ gelesen?
hmmmmm, klar ist der Kurssturz der letzten Tage durch shorties und Gewinnmitnahmen zu erklären, aber ich persönlich mache auch die Ergebnisse der Hepatitis-C Phase II Studie, die @PITU vor 3 Tagen veröffentlicht hat, hauptsächlich dafür verantwortlich. Ich persönlich finde, daß die Daten sehr enttäuschend ausgefallen sind. Es wird von einem Therapieansprechen nach 48 Wochen Behandlung (after 48 weeks of therapy) von 61% gesprochen und nur mit den Ergebnissen der Interferon-Monotherapie verglichen (Ansprechrate nach 48 Wochen Behandlung von 29%). Fakt ist leider nur, daß der golden standard der Hepatitis-C Therapie längst nicht mehr die Interferon-Monotherapie ist, sondern längst die Kombinationstherapie Interferon/ Ribavirin. Und hier schaut die Ansprechrate und vor allem die complete response im 24 Wochen follow-up viel besser aus. Diese daten wurden bereits 1998 im LANCET veröffentlicht, den ich als -abstract- im Anhang kopieren werde. Nur kurz zum Vergleich: Nach 48 Wochen Behandlung lag hier die Ansprechrate bei 57%, die Heilungsrate im 24w follow-up (dieses Ergebnis ist übrigens viel wichtiger, da der Virus eine hohe Rezidivfreudigkeit hat) von 30%. Zur Info: erst wenn der Patient im 24w follow-up wirklich virusfrei geblieben ist, kann der Patient wirklich als geheilt angesehen werden. Was mich nur wundert ist, daß MAXIM Pharmaceuticals keine Daten über die complete response im 24w follow-up veröffentlicht hat! Man muß also hier vom schlimmsten ausgehen........., wahrscheinlich kam es also bei der Mehrzahl der Patienten zu einem relapse, sprich der Virus kam wieder! Übrigens wird die in der jetzigen klinischen Routine eingesetzte Interferon/ Ribavirin-therapie in den nächsten Monaten von PEG-Interferon/Ribavirin abgelöst werden. PEG-Interferon wird von ENZON vertrieben, hier ist die Aktie dementsprechend auch in den letzten Wochen verdammt gut gelaufen, da die daten der FDA-Zulassungsstudie (Phase III) kurz vor der Veröffentlichung stehen. Es wird übrigens gemunkelt, daß unter PEG-Interferon/Ribavirin Ansprechraten von 70% zu beobachten sind, die complete response soll bei 40-45% liegen. Das bedeutet auch, daß MAXAMIN demnächst mit diesen Zahlen konkurieren muss..... Ich persönlich glaube, daß MAXAMIN -wenn überhaupt- nur eine Chance in der Therapie von Non-responder/ oder relapse Patienten haben wird, doch hier fehlen noch jegliche Daten! Dafür sind zunächst einmal neue teure Phase II Studien von nöten!
OK......... hier noch der versprochene Artikel vom LANCET, ansonsten ein schönes Wochenende und ein Hoffen, daß die chattechnische wichtige Linie bei 60$ gehalten wird!
Lancet 1998 Oct 31;352(9138):1426-32
Related Articles, Books,
LinkOut
Randomised trial of interferon alpha2b plus ribavirin
for 48 weeks or for 24 weeks versus interferon alpha2b
plus placebo for 48 weeks for treatment of chronic
infection with hepatitis C virus. International Hepatitis
Interventional Therapy Group.
Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G,
Bain V, Heathcote J, Zeuzem S, Trepo C, Albrecht J
Groupe Hospitalier, Faculte Pitie-Salpetriere, Universite Paris VI, URA
CNRS 1484, France. tpoynard@teaser.fr
BACKGROUND: Only 15-20% of patients with chronic hepatitis C
achieve a sustained virological response with interferon therapy. The aim
of this study was to compare the efficacy and safety of interferon alpha2b
in combination with oral ribavirin with interferon alone, for treatment of
chronic infection with hepatitis C virus (HCV). METHODS: 832 patients
aged 18 years or more with chronic HCV who had not been treated with
interferon or ribavirin, were enrolled and randomly allocated one of three
regimens: 3 mega units (MU) interferon alpha2b three times a week plus
1000-1200 mg ribavirin per day for 48 weeks; 3 MU interferon alpha2b
three times a week plus 1000-1200 mg ribavirin per day for 24 weeks;
or 3 MU interferon alpha2b three times a week and placebo for 48
weeks. All patients were assessed for safety, tolerance, and efficacy at
the end of weeks 1, 2, 4, 6, and 8, and every 4 weeks during treatment.
After treatment was completed patients were followed up on weeks 4, 8,
12, and 24. The primary endpoint was loss of detectable HCV-RNA
(serum HCV-RNA <100 copies/mL) at week 24 after treatment.
FINDINGS: Sustained virological response at 24 weeks after treatment,
was found in 119 (43%) of the 277 patients treated for 48 weeks with
the combination regimen, 97 (35%) of the 277 patients treated for 24
weeks with the combination regimen (p=O.055), and 53 (19%) of the
278 patients treated for 48 weeks with interferon alone (p<0.001 vs both
combination regimens, intention-to-treat analysis). Logistic regression
identified five independent factors significantly associated with response:
genotype 2 or 3, viral load less than 2 million copies/mL, age 40 years or
less, minimal fibrosis stage, and female sex. Among patients with fewer
than three of these factors the odds ratio of sustained response was 2.6
(95% Cl 1.4-4.8; p=0.002) for the 48 week combination regimen
compared with 24 weeks of the combination regimen. Discontinuation of
therapy for adverse events was more frequent with combination (19%)
and monotherapy (13%) given for 48 weeks than combination therapy
given for 24 weeks (8%). INTERPRETATION: An interferon alpha2b
plus ribavirin combination is more effective than 48 weeks of interferon
alpha2b monotherapy and has an acceptable safety profile. Patients with
few favourable factors benefit more from extending the duration of
combination therapy to 48 weeks.
OK......... hier noch der versprochene Artikel vom LANCET, ansonsten ein schönes Wochenende und ein Hoffen, daß die chattechnische wichtige Linie bei 60$ gehalten wird!
Lancet 1998 Oct 31;352(9138):1426-32
Related Articles, Books,
LinkOut
Randomised trial of interferon alpha2b plus ribavirin
for 48 weeks or for 24 weeks versus interferon alpha2b
plus placebo for 48 weeks for treatment of chronic
infection with hepatitis C virus. International Hepatitis
Interventional Therapy Group.
Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G,
Bain V, Heathcote J, Zeuzem S, Trepo C, Albrecht J
Groupe Hospitalier, Faculte Pitie-Salpetriere, Universite Paris VI, URA
CNRS 1484, France. tpoynard@teaser.fr
BACKGROUND: Only 15-20% of patients with chronic hepatitis C
achieve a sustained virological response with interferon therapy. The aim
of this study was to compare the efficacy and safety of interferon alpha2b
in combination with oral ribavirin with interferon alone, for treatment of
chronic infection with hepatitis C virus (HCV). METHODS: 832 patients
aged 18 years or more with chronic HCV who had not been treated with
interferon or ribavirin, were enrolled and randomly allocated one of three
regimens: 3 mega units (MU) interferon alpha2b three times a week plus
1000-1200 mg ribavirin per day for 48 weeks; 3 MU interferon alpha2b
three times a week plus 1000-1200 mg ribavirin per day for 24 weeks;
or 3 MU interferon alpha2b three times a week and placebo for 48
weeks. All patients were assessed for safety, tolerance, and efficacy at
the end of weeks 1, 2, 4, 6, and 8, and every 4 weeks during treatment.
After treatment was completed patients were followed up on weeks 4, 8,
12, and 24. The primary endpoint was loss of detectable HCV-RNA
(serum HCV-RNA <100 copies/mL) at week 24 after treatment.
FINDINGS: Sustained virological response at 24 weeks after treatment,
was found in 119 (43%) of the 277 patients treated for 48 weeks with
the combination regimen, 97 (35%) of the 277 patients treated for 24
weeks with the combination regimen (p=O.055), and 53 (19%) of the
278 patients treated for 48 weeks with interferon alone (p<0.001 vs both
combination regimens, intention-to-treat analysis). Logistic regression
identified five independent factors significantly associated with response:
genotype 2 or 3, viral load less than 2 million copies/mL, age 40 years or
less, minimal fibrosis stage, and female sex. Among patients with fewer
than three of these factors the odds ratio of sustained response was 2.6
(95% Cl 1.4-4.8; p=0.002) for the 48 week combination regimen
compared with 24 weeks of the combination regimen. Discontinuation of
therapy for adverse events was more frequent with combination (19%)
and monotherapy (13%) given for 48 weeks than combination therapy
given for 24 weeks (8%). INTERPRETATION: An interferon alpha2b
plus ribavirin combination is more effective than 48 weeks of interferon
alpha2b monotherapy and has an acceptable safety profile. Patients with
few favourable factors benefit more from extending the duration of
combination therapy to 48 weeks.
die Daten aus dem 24w-follow-up wurden nicht veröffentlicht, da es sich erst um den -48 week results- report gehandelt hat,.... die Daten über dem 24w-follow-up dürfen wir also in 6 Monaten erwarten. Wenn die Ergebnisse gut ausfallen, dann schaut es nach meiner Meinung sehr gut aus, da es dann endlich eine Alternative zum PEG-Interferon/Ribavirin Schema gibt,...... sprich man kann in der Klinik den non-responder oder relapse Patienten noch eine neue weitere Therapieoption anbieten. Insgesamt muss ich also meine eher düstere Interpretation von gestern relativieren...........! Kennt eigentlich jemand Studienergegnisse über den 24w follow-up aus preclinical studies?
Monday September 18, 3:00 am Eastern Time
Press Release
Maxim Scheduled to Present Maxamine At December 2000 ODAC
Panel Meeting
SAN DIEGO--(BW HealthWire)--Sept. 18, 2000--Maxim Pharmaceuticals (Nasdaq NM:
MAXM - news; SSE: MAXM) announced that its lead drug candidate Maxamine®
(histamine
dihydrochloride) will be reviewed by the Oncology Drugs Advisory Committee (ODAC)
panel at
its December 13-14, 2000 meeting. The ODAC panel advises the U.S. Food and Drug
Administration (FDA) as part of its evaluation of New Drug Applications (NDAs).
In July 2000 Maxim submitted an NDA to the FDA seeking approval to market Maxamine
in the United States as an adjuvant to
interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma. In September the
FDA informed the Company that the
NDA had been assigned priority review status and that the NDA would be reviewed under
accelerated approval statutes.
Priority review status is granted by the FDA to products that are considered to be a
potential therapeutic advance over existing
therapies for a life-threatening illness. Generally, the FDA takes action on drugs given a
priority review within six months of
acceptance of an NDA.
``We are pleased that the review of our NDA appears to be proceeding at an expedited
pace,`` said Larry G. Stambaugh, Maxim`s
Chairman and Chief Executive Officer.
In March 2000 the Company completed its U.S. Phase III trial of Maxamine in Stage-IV
malignant melanoma. The results show that
treatment with the combination of Maxamine and the cytokine IL-2 dramatically improved
survival for advanced metastatic
melanoma patients with liver metastases compared with those treated with the same
doses of IL-2 alone (adjusted p value of 0.008).
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at
12, 18 and 24 months, improved
time-to-disease-progression, and improved quality of life over treatment with IL-2 alone in
all patients.
Results for the Phase III study indicated that treatment with Maxamine and lower-dose
IL-2 was safe and well-tolerated and had
substantially less toxicity than the high-dose regimens under which IL-2 was originally
approved. The tolerability of the Maxamine
and IL-2 combination therapy allowed these advanced-stage malignant melanoma
patients to treat themselves at home.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that
suppresses the capacity of the immune system
to detect and destroy tumor cells or virally infected cells in many patients with cancer
and chronic infectious diseases. Maxamine is
designed to reverse this immune suppression, thereby enhancing the effectiveness of
immunotherapy, a class of therapies that employ
the body`s immune system to fight cancer and certain infectious diseases. Maxamine
protects critical immune cells and is
administered in combination with cytokines such as IL-2 and interferon-alpha, a class of
proteins that stimulate these same immune
cells. More than 1,200 patients have been treated in the Company`s completed and
ongoing clinical trials in advanced malignant
melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma.
Maxamine is an investigational drug and has not been
approved by the FDA or any international regulatory agency. However, clinical trial results
to date suggest that Maxamine Therapy,
the administration of Maxamine in combination with cytokines, is a safe, at-home
treatment that may improve patient survival.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced
drugs and therapies for cancer, infectious
diseases, degenerative diseases and topical disorders. In addition to the recently
completed Phase III trial in stage-IV malignant
melanoma, Maxamine is also currently being tested in two additional Phase III cancer
clinical trials in 12 countries for malignant
melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also
underway for the treatment of hepatitis C and
advanced renal cell carcinoma. The Company has also developed product candidates
based on its MaxDerm(TM) technology that
are designed for the treatment of medical conditions for which topical therapy is
appropriate such as oral mucositis, herpes, decubitus
ulcers, shingles, burns and related conditions. Furthermore, Maxim is developing
small-molecule inhibitors and activators of
caspases, key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as
apoptosis. Compounds that can either inhibit caspases or induce caspases may form
the basis for important new drugs for a wide
variety of disease targets, such as cancer, cardiovascular disease and other degenerative
diseases.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking
statements include statements regarding the efficacy and intended utilization of
Maxamine, MaxDerm and the Company`s caspase
modulator technologies, and regarding Maxim`s clinical trials and preclinical development
efforts. Such statements are only
predictions and the Company`s actual results may differ materially from those anticipated
in these forward-looking statements.
Factors that may cause such differences include the risk that the Company will not
obtain approval to market its products and the risk
that products that appeared promising in early research and clinical trials do not
demonstrate efficacy in larger-scale clinical trials.
These factors and others are more fully discussed in the Company`s periodic reports and
other filings with the Securities and
Exchange Commission.
Press Release
Maxim Scheduled to Present Maxamine At December 2000 ODAC
Panel Meeting
SAN DIEGO--(BW HealthWire)--Sept. 18, 2000--Maxim Pharmaceuticals (Nasdaq NM:
MAXM - news; SSE: MAXM) announced that its lead drug candidate Maxamine®
(histamine
dihydrochloride) will be reviewed by the Oncology Drugs Advisory Committee (ODAC)
panel at
its December 13-14, 2000 meeting. The ODAC panel advises the U.S. Food and Drug
Administration (FDA) as part of its evaluation of New Drug Applications (NDAs).
In July 2000 Maxim submitted an NDA to the FDA seeking approval to market Maxamine
in the United States as an adjuvant to
interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma. In September the
FDA informed the Company that the
NDA had been assigned priority review status and that the NDA would be reviewed under
accelerated approval statutes.
Priority review status is granted by the FDA to products that are considered to be a
potential therapeutic advance over existing
therapies for a life-threatening illness. Generally, the FDA takes action on drugs given a
priority review within six months of
acceptance of an NDA.
``We are pleased that the review of our NDA appears to be proceeding at an expedited
pace,`` said Larry G. Stambaugh, Maxim`s
Chairman and Chief Executive Officer.
In March 2000 the Company completed its U.S. Phase III trial of Maxamine in Stage-IV
malignant melanoma. The results show that
treatment with the combination of Maxamine and the cytokine IL-2 dramatically improved
survival for advanced metastatic
melanoma patients with liver metastases compared with those treated with the same
doses of IL-2 alone (adjusted p value of 0.008).
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at
12, 18 and 24 months, improved
time-to-disease-progression, and improved quality of life over treatment with IL-2 alone in
all patients.
Results for the Phase III study indicated that treatment with Maxamine and lower-dose
IL-2 was safe and well-tolerated and had
substantially less toxicity than the high-dose regimens under which IL-2 was originally
approved. The tolerability of the Maxamine
and IL-2 combination therapy allowed these advanced-stage malignant melanoma
patients to treat themselves at home.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that
suppresses the capacity of the immune system
to detect and destroy tumor cells or virally infected cells in many patients with cancer
and chronic infectious diseases. Maxamine is
designed to reverse this immune suppression, thereby enhancing the effectiveness of
immunotherapy, a class of therapies that employ
the body`s immune system to fight cancer and certain infectious diseases. Maxamine
protects critical immune cells and is
administered in combination with cytokines such as IL-2 and interferon-alpha, a class of
proteins that stimulate these same immune
cells. More than 1,200 patients have been treated in the Company`s completed and
ongoing clinical trials in advanced malignant
melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma.
Maxamine is an investigational drug and has not been
approved by the FDA or any international regulatory agency. However, clinical trial results
to date suggest that Maxamine Therapy,
the administration of Maxamine in combination with cytokines, is a safe, at-home
treatment that may improve patient survival.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced
drugs and therapies for cancer, infectious
diseases, degenerative diseases and topical disorders. In addition to the recently
completed Phase III trial in stage-IV malignant
melanoma, Maxamine is also currently being tested in two additional Phase III cancer
clinical trials in 12 countries for malignant
melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also
underway for the treatment of hepatitis C and
advanced renal cell carcinoma. The Company has also developed product candidates
based on its MaxDerm(TM) technology that
are designed for the treatment of medical conditions for which topical therapy is
appropriate such as oral mucositis, herpes, decubitus
ulcers, shingles, burns and related conditions. Furthermore, Maxim is developing
small-molecule inhibitors and activators of
caspases, key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as
apoptosis. Compounds that can either inhibit caspases or induce caspases may form
the basis for important new drugs for a wide
variety of disease targets, such as cancer, cardiovascular disease and other degenerative
diseases.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking
statements include statements regarding the efficacy and intended utilization of
Maxamine, MaxDerm and the Company`s caspase
modulator technologies, and regarding Maxim`s clinical trials and preclinical development
efforts. Such statements are only
predictions and the Company`s actual results may differ materially from those anticipated
in these forward-looking statements.
Factors that may cause such differences include the risk that the Company will not
obtain approval to market its products and the risk
that products that appeared promising in early research and clinical trials do not
demonstrate efficacy in larger-scale clinical trials.
These factors and others are more fully discussed in the Company`s periodic reports and
other filings with the Securities and
Exchange Commission.
Sehr schöner Beitrag pulsrasen!
Der hat mir sehr weitergeholfen. ich fing nämlich gerade an, mich für Maxim zu interessieren.
So wie ich Dich verstehe, ist aber Enzon noch in den klinischen Studien, oder?
Von einem Goldstandard kann man aber mM. erst dann reden, wenn er in der klinischen Alltag eingezogen ist . Das dauert erst noch ein Weilchen.
Daher schätze ich, dass Maxamine in der Phase 3 erst mal nur gegen die Interferon-Monotherapie antreten muss.
Auf dem Markt müssen die sich dann natürlich erst mal gegen Ribavirin/Interferon-Kombitherapie durchsetzen.
Eine Frage noch, da Du Dich offenbar gut in die Thematik eingearbeitet hast:
Sind die untersuchten Patientengruppen (ENZN,MAXM) tatsächlich vergleichbar? Bei HEPC Patienten gibt es meiner Erinnerung nach auch verschiedene Krankheitsgrade/-bilder, die das Ergebnis maßgeblich beeinflussen. Phase 2-Experimente dienen ja generelll eher der Bestimmung der optimalen Dosis.
Vielen Dank im voraus!
Der Puhvogel
Der hat mir sehr weitergeholfen. ich fing nämlich gerade an, mich für Maxim zu interessieren.
So wie ich Dich verstehe, ist aber Enzon noch in den klinischen Studien, oder?
Von einem Goldstandard kann man aber mM. erst dann reden, wenn er in der klinischen Alltag eingezogen ist . Das dauert erst noch ein Weilchen.
Daher schätze ich, dass Maxamine in der Phase 3 erst mal nur gegen die Interferon-Monotherapie antreten muss.
Auf dem Markt müssen die sich dann natürlich erst mal gegen Ribavirin/Interferon-Kombitherapie durchsetzen.
Eine Frage noch, da Du Dich offenbar gut in die Thematik eingearbeitet hast:
Sind die untersuchten Patientengruppen (ENZN,MAXM) tatsächlich vergleichbar? Bei HEPC Patienten gibt es meiner Erinnerung nach auch verschiedene Krankheitsgrade/-bilder, die das Ergebnis maßgeblich beeinflussen. Phase 2-Experimente dienen ja generelll eher der Bestimmung der optimalen Dosis.
Vielen Dank im voraus!
Der Puhvogel
Hallo @puhvogel,
doch wirklich, inzwischen hat sich schon seit Jahren in der Klinik die Kombinationstherapie Interferon/ Ribavirin durchgesetzt, hoffentlich wird in Deutschland kein Patient mehr mit einer Interferon-Monotherapie behandelt.
Das neue von ENZON ist nur eine neue Anreicherungsform von Interferon, das sogenannte PEG-Interferon. Der Wirkstoff ist der selbe (Interferon), neu ist nur die galenische Form, die ein langsameres Freiwerden der Wirksubstanz ermöglicht. Dementsprechend muß man PEG-Interferon nur noch 1mal/ Woche injizieren (anstatt 3mal pro Woche), außerdem verspricht man sich über den jetzt konstanten Wirkstoffspiegel im Blut eine bessere Ansprechrate. Richtig ist, daß ENZON mit PEG-Interferon noch in der klinischen Studie steckt, die aber wie gesagt kurz vor der erfolgreichen Fertigstellung ist. PEG-Interferon wird übrigens ganz sicher das herkömmliche Interferon ablösen, weil es insgesamt nur Vorteile besitzt!
Wie schon in meinem letzten Beitrag erwähnt habe, glaube ich, daß MAXAMIN niemals die Interferon/Ribaverin-Therapie ablösen wird (dafür unterscheiden sich auch die Ansprechraten zu wenig). Aber wie gesagt, mit MAXAMIN würde eine weitere alternative Therapiesubstanz zur Verfügung stehen. Zur Zeit hat man für die Patienten, die auf Interfreon/Riabaverin nicht ansprechen, keine weitere Therapieoption. Und das ist schlimm, da diese Patienten weiterhin ein hohes Risiko besitzen, schwere Komplikationen (Leberzirrhose, Leberkrebs) zu bekommen. Mit MAXAMIN könnte erstmals auch diesen Patienten geholfen werden......... und der Patientenpool wäre sehr groß, da ja nur etwa 40% der Patienten mit PEG-Interferon/Ribavirin geheilt werden können. Beide Therapieschemata konkurrieren also nicht miteinander, nein im Gegenteil, sie ergänzen sich.
Ein weiteres Standbein von MAXAMIN ist ja die das fortgeschr. Melanom. Hier befindet man sich ja schon im Vorfeld der Phase IV-Studie, in diesem thread wurde schon oft darüber berichtet. Einmal grundsätzlich: In der Krebstherapie ist die Etablierung neuer Therapieschemata äußerst schwierig,.....insbesondere wird eine sehr hohe Anzahl von Patienten verlangt. Besonders für das maligne Melanom ist das sehr wichtig, da hier der spontane Verlauf sehr variabel sein kann. Die 305 Patienten aus der Phase III Studie sind da viel zu wenig......! Dennoch sind die Daten aus dieser Studie sehr zuversichtlich. Bemerkenswert ist, daß man vor allem Patineten mit Lebermetastasen sehr helfen kann. Wichtig zu erwähnen ist jedoch (und hier sehe ich noch die größte Gefahr für MAXAMIN), daß Metastasen in anderen Organen kaum beeinflußt werden können. Schaut man sich die study results (siehe Anhang) von der Phase-III Studie an, sieht man, daß sich der Median bei Kontroll- und Therapiegruppe bei allen Patienten nur unwesentlich unterscheidet (272 days (MAXAMIN-Patienten) 245 days (Kontrollgruppe)). Wie gesagt, bemerkenswert ist jedoch der Unterschied bei Patienten mit Lebermetastasen (283days gegen 154 days). Normalerweise sprechen gerade Patienten mit Lebermetastasen schlecht auf eine Antitumor-Behandlung an, so daß MAXAMIN vielleicht tatsächlich bei dieser Indikation (fortgeschrittenes Melanom mit Lebermetastasen) die Standardtherapie werden könnte......
Hoffe, daß ich Dir ein bißchen helfen konnte, noch einen schönen abend!
Pulsrasen
von @PITU (02.05.00):
For all randomized patients entering the study with liver metastases (n=129), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days
compared to 212 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 283 days
compared to 154 days for control patients treated with IL-2 alone (p=0.004 under the Log-Rank test). Survival, adjusted for quality of life, was also
significantly longer for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival
improvement). A key secondary endpoint, time-to-disease-progression, was also significantly improved for those patients receiving Maxamine and IL-2
(p=0.0033).
For all randomized patients entering the study (n=305), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 273
days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 272 days compared to 245 days
for control patients treated with IL-2 alone (p greater than 0.05 under the Log-Rank test). Survival, adjusted for quality of life, was significantly improved
for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). In
addition, time-to-disease-progression was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.01).
doch wirklich, inzwischen hat sich schon seit Jahren in der Klinik die Kombinationstherapie Interferon/ Ribavirin durchgesetzt, hoffentlich wird in Deutschland kein Patient mehr mit einer Interferon-Monotherapie behandelt.
Das neue von ENZON ist nur eine neue Anreicherungsform von Interferon, das sogenannte PEG-Interferon. Der Wirkstoff ist der selbe (Interferon), neu ist nur die galenische Form, die ein langsameres Freiwerden der Wirksubstanz ermöglicht. Dementsprechend muß man PEG-Interferon nur noch 1mal/ Woche injizieren (anstatt 3mal pro Woche), außerdem verspricht man sich über den jetzt konstanten Wirkstoffspiegel im Blut eine bessere Ansprechrate. Richtig ist, daß ENZON mit PEG-Interferon noch in der klinischen Studie steckt, die aber wie gesagt kurz vor der erfolgreichen Fertigstellung ist. PEG-Interferon wird übrigens ganz sicher das herkömmliche Interferon ablösen, weil es insgesamt nur Vorteile besitzt!
Wie schon in meinem letzten Beitrag erwähnt habe, glaube ich, daß MAXAMIN niemals die Interferon/Ribaverin-Therapie ablösen wird (dafür unterscheiden sich auch die Ansprechraten zu wenig). Aber wie gesagt, mit MAXAMIN würde eine weitere alternative Therapiesubstanz zur Verfügung stehen. Zur Zeit hat man für die Patienten, die auf Interfreon/Riabaverin nicht ansprechen, keine weitere Therapieoption. Und das ist schlimm, da diese Patienten weiterhin ein hohes Risiko besitzen, schwere Komplikationen (Leberzirrhose, Leberkrebs) zu bekommen. Mit MAXAMIN könnte erstmals auch diesen Patienten geholfen werden......... und der Patientenpool wäre sehr groß, da ja nur etwa 40% der Patienten mit PEG-Interferon/Ribavirin geheilt werden können. Beide Therapieschemata konkurrieren also nicht miteinander, nein im Gegenteil, sie ergänzen sich.
Ein weiteres Standbein von MAXAMIN ist ja die das fortgeschr. Melanom. Hier befindet man sich ja schon im Vorfeld der Phase IV-Studie, in diesem thread wurde schon oft darüber berichtet. Einmal grundsätzlich: In der Krebstherapie ist die Etablierung neuer Therapieschemata äußerst schwierig,.....insbesondere wird eine sehr hohe Anzahl von Patienten verlangt. Besonders für das maligne Melanom ist das sehr wichtig, da hier der spontane Verlauf sehr variabel sein kann. Die 305 Patienten aus der Phase III Studie sind da viel zu wenig......! Dennoch sind die Daten aus dieser Studie sehr zuversichtlich. Bemerkenswert ist, daß man vor allem Patineten mit Lebermetastasen sehr helfen kann. Wichtig zu erwähnen ist jedoch (und hier sehe ich noch die größte Gefahr für MAXAMIN), daß Metastasen in anderen Organen kaum beeinflußt werden können. Schaut man sich die study results (siehe Anhang) von der Phase-III Studie an, sieht man, daß sich der Median bei Kontroll- und Therapiegruppe bei allen Patienten nur unwesentlich unterscheidet (272 days (MAXAMIN-Patienten) 245 days (Kontrollgruppe)). Wie gesagt, bemerkenswert ist jedoch der Unterschied bei Patienten mit Lebermetastasen (283days gegen 154 days). Normalerweise sprechen gerade Patienten mit Lebermetastasen schlecht auf eine Antitumor-Behandlung an, so daß MAXAMIN vielleicht tatsächlich bei dieser Indikation (fortgeschrittenes Melanom mit Lebermetastasen) die Standardtherapie werden könnte......
Hoffe, daß ich Dir ein bißchen helfen konnte, noch einen schönen abend!
Pulsrasen
von @PITU (02.05.00):
For all randomized patients entering the study with liver metastases (n=129), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days
compared to 212 days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 283 days
compared to 154 days for control patients treated with IL-2 alone (p=0.004 under the Log-Rank test). Survival, adjusted for quality of life, was also
significantly longer for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival
improvement). A key secondary endpoint, time-to-disease-progression, was also significantly improved for those patients receiving Maxamine and IL-2
(p=0.0033).
For all randomized patients entering the study (n=305), treatment with Maxamine plus IL-2 resulted in a mean survival of 364 days compared to 273
days for control patients treated with IL-2 alone. Treatment with Maxamine plus IL-2 resulted in a median survival of 272 days compared to 245 days
for control patients treated with IL-2 alone (p greater than 0.05 under the Log-Rank test). Survival, adjusted for quality of life, was significantly improved
for patients treated with Maxamine and IL-2 compared to IL-2 alone (p less than 0.0001 for the median quality-adjusted survival improvement). In
addition, time-to-disease-progression was also significantly improved for those patients receiving Maxamine and IL-2 (p=0.01).
Auf jeden Fall hast Du mir weitergeholfen und viel Zeit erspart!! Vielen Dank nochmal!
Speziell das Maxim als historischen Vergleich eine veraltetete Technik präsentiert , stößt mir sauer auf.
a) Was mir noch den Kopf geistert sind die Kosten. Sind Zweitbehandlungen tatsächlich so ohne weiteres finanzierbar?
Interferon kostet ja extrem viel (ich denke da an MS oder Hochdosis-Interferon-Therapie bei MM), und wenn die eine Interferontherapie scheitert, wird dann einfach die nächte angesetzt?
Auf dieser Seite wird ürigens noch Monotherapie als Standardtherapie angegeben, insofern würde ich mir nicht sicher sein, dass Ribavarin wirklich überall eingesetzt wird.
http://hepatitis-c.de/rki_hep.htm
Die Durchsetzung neuer Therapien dauert halt oft. Das man Schlaganfallpatienten bei rechtzeitiger Einliefern prinzipiell lysieren kann, ist auch noch nicht auf jede Notfallambulanz erfaßt worden.
b) Was die MM-Studien angeht, ist mir auch die Diskrepanz zwichen Median und Mittelwert aufgefallen. Erinnert mich stark an die Interferon-Studien bei MS, bei denen die Behandlungserfolge stark individuell sind. Für die Zulassung dürfte es ausreichen.
Was eventuell nötige größere Studien von Maxamine angeht: Wenn ich mir die bisherigen Behandlungsaussichten bei stage 4 -Patienten so betrachte, dann sollte die Onkologen nicht die Erbsenzähler spielen.
Meinesachtens fokussierten sich in der Vergangenheit die Onkologen bei MM eh zu sehr auf die Chemotherapien. Einmal Cancernet aufschlagen, dann purzeln einem die ganzen Chemo-Phase3 -Trials entgegen. Der Erfolg ist bisher sehr dürftig.
Es wird meinesachtens Zeit, neue Therapieansätze zu etablieren.
c) Mit meinem Hinweis auf die Vergleichbarkeit der Patientengruppen zielte ich auf die verschiedeen Genotypen bei HEPC. Der Behandlungserfolg von Interferon ist doch scheinbar stark von dem Genotyp abhängig. Wenn sich nun Maxim vielleicht die schwierigeren Fälle (zb Genoty 1b) selektiert hat, um vielleicht in diesem Teilbereich der Goldstandard zu werden, dann wären die Studien nicht direkt miteinander vergleichbar.
Aber wie gesagt, ich weiß nichts genaues. Ich kenne allerdings jemanden aus der Pharmaindustrie, der ist von Maxim enorm begeistert. Irgendwie konnte ich bisher seine Begeisterung nicht ganz teilen, bei der HEPC-Studie wurde ich aber doch aufmerksam.
Der Puhvogel
Speziell das Maxim als historischen Vergleich eine veraltetete Technik präsentiert , stößt mir sauer auf.
a) Was mir noch den Kopf geistert sind die Kosten. Sind Zweitbehandlungen tatsächlich so ohne weiteres finanzierbar?
Interferon kostet ja extrem viel (ich denke da an MS oder Hochdosis-Interferon-Therapie bei MM), und wenn die eine Interferontherapie scheitert, wird dann einfach die nächte angesetzt?
Auf dieser Seite wird ürigens noch Monotherapie als Standardtherapie angegeben, insofern würde ich mir nicht sicher sein, dass Ribavarin wirklich überall eingesetzt wird.
http://hepatitis-c.de/rki_hep.htm
Die Durchsetzung neuer Therapien dauert halt oft. Das man Schlaganfallpatienten bei rechtzeitiger Einliefern prinzipiell lysieren kann, ist auch noch nicht auf jede Notfallambulanz erfaßt worden.
b) Was die MM-Studien angeht, ist mir auch die Diskrepanz zwichen Median und Mittelwert aufgefallen. Erinnert mich stark an die Interferon-Studien bei MS, bei denen die Behandlungserfolge stark individuell sind. Für die Zulassung dürfte es ausreichen.
Was eventuell nötige größere Studien von Maxamine angeht: Wenn ich mir die bisherigen Behandlungsaussichten bei stage 4 -Patienten so betrachte, dann sollte die Onkologen nicht die Erbsenzähler spielen.
Meinesachtens fokussierten sich in der Vergangenheit die Onkologen bei MM eh zu sehr auf die Chemotherapien. Einmal Cancernet aufschlagen, dann purzeln einem die ganzen Chemo-Phase3 -Trials entgegen. Der Erfolg ist bisher sehr dürftig.
Es wird meinesachtens Zeit, neue Therapieansätze zu etablieren.
c) Mit meinem Hinweis auf die Vergleichbarkeit der Patientengruppen zielte ich auf die verschiedeen Genotypen bei HEPC. Der Behandlungserfolg von Interferon ist doch scheinbar stark von dem Genotyp abhängig. Wenn sich nun Maxim vielleicht die schwierigeren Fälle (zb Genoty 1b) selektiert hat, um vielleicht in diesem Teilbereich der Goldstandard zu werden, dann wären die Studien nicht direkt miteinander vergleichbar.
Aber wie gesagt, ich weiß nichts genaues. Ich kenne allerdings jemanden aus der Pharmaindustrie, der ist von Maxim enorm begeistert. Irgendwie konnte ich bisher seine Begeisterung nicht ganz teilen, bei der HEPC-Studie wurde ich aber doch aufmerksam.
Der Puhvogel
Hallo @PUHVOGEL,
es freut mich, Dir ein bißchen helfen zu können. Dank Dir, habe ich mich jetzt auch schon viel ausführlicher mit MAXAMIN pharmaceuticals beschäftigt. Noch weiß ich nicht sicher, ob ich einsteigen werde! Insgesamt sehe ich zwar jede Menge Potential, doch die Risiken habe ich für mich abschließend noch nicht sicher beurteilt. Welche Werte hast Du eigentlich noch auf Deiner whatch-list? Deine Fragen zeigen einen, daß Du Dich sehr genau und ausführlich damit auseinander setzt und nicht gleich mit jeder Euphoriewelle mitschwimmst!
Zu Deinen Fragen:
zu a:
Wahrlich ist es beschämend, daß das Robert-Koch-Institut noch die Interferon-Monotherapie als Standardtherapie bei Hepatitis-C hält? Naja,........diese page befindet sich nicht auf dem aktuellen Stand (Stand Oktober 1999), trotzdem....... vor 1 Jahr wurden die Patienten auch schon mit der Kombinationstherapie behandelt! Hier eine aktuelle web-side von der Universitätsklinik Düsseldorf
http://www.uni-duesseldorf.de/WWW/gahepinf/hepatitis/hep_c/t…
Übrigens hast Du recht, daß die Interferontherapie sehr teuer ist, kostet doch eine einjährige Therapie fast einen sechsstelligenBetrag. Doch bedenke die Folgekosten, die man spart. So entwickeln fast 30% der Patienten eine Leberzirrhose, und 10 % von denen ein Leberkarzinom. Inzwischen gibt es zahlreiche cost-effectiveness Studien, die alle einstimmig bejahen, daß man unbedingt non-responder oder relapse Patienten eine second-line Therapie zuführen sollte. Im Anhang kopiere ich Dir einen abstract, aber wie gesagt, es gibt noch viele mehr! Was ich aber auch schon kritisch anmerkte, daß man zunächst in Studien zeigen müßte, daß diese Patienten mit MAXAMIN wirkungsvoll behandelt werden könnte!
zu b.
Ja, komisch, daß über diese Diskrepanz in diesem thread noch keiner gesprochen hat! Ich halte den Mittelwert in diesen Studien nicht für verwertbar, da sie ohne Standardabweichung angegeben wurden. Bei Krankheiten, die in Ihrem Verlauf sowieso sehr variabel sind, ist der Median sowieso viel aussagekräftiger! Und betrachtet man diesen, scheint es tatsächlich nur einen Überlebensvorteil bei Patienten mit Lebermetastasen zu geben. Ich freue dennoch sehr über die Daten von der Phase-IV Studie! Da sollen übrigens 1200 Patienten (steht auch irgendwo in diesem thread) eingeschlossen werden.......... ob sich letztendlich MAXAMIN aber durchsetzten wird, entscheidet jedoch nur die Klinik......... und die Konkurrenz ist besonders auf diesem Gebiet sehr hoch! Aber auch das Potential, weil dringend neue Therapiemodelle benötigt werden. Zum Beispiel strukturiert BAYER seine ganze Forschung in Richtung onkologischer Therapien um, da sie mit Herz-Kreislauf kein Potential mehr zum Geldverdienen sehen (bei 20-30 Hypertensiva wäre der Markt für ein neues Hypertonikum extrem eng!). Ich bin jedoch -wie schon gestern gesagt- zuversichtlich, daß MAXAMIN eine Indikation isoliert bei Patienten mit Lebermetasen erhalten könnte!
zu C.
Auch hier hast Du recht, daß der Therapieerfolg von Interferon von zahlreichen Faktoren abhängt. Unter anderem ist der Genotyp entscheidend. Der in Amerika und in Deutschland am häufigsten vertretenene Genoty I läßt sich sehr schlecht behandeln! In der Unternehmungsmeldung vom 14.09.00 wird berichtet, daß die antivirale Therapie bei folgenden Faktoren besser anspricht:
1. genotype 2 or 3
2. viral load less than 2 million copies/mL
3. age 40 years or less
4. minimal fibrosis stage
5. and female sex.
Es bringt also gar nichts, isoliert nur den Genotyp I zu betrachten, wurde übrigens in anderen Studien auch nur peripher gemacht. In dem Artikel, den ich als -abstract- schon vor 2 Tagen kopiert habe, werden ebenfalls die Ansprechraten abhängig von all diesen Faktoren aufgeschlüsselt (z.B. Ansprechraten bei allen 5 Faktoren, oder 4 von 5 u.s.w.). Leider wurde eine solche Aufschlüsslung von MAXAMIN pharmaceuticals nur bedingt gemacht (response was 2,6 (????)), so daß Vergleiche nach meiner Meinung noch nicht möglich sind! Im übrigen werden letztendlich nur die Zahlen vom 24w-follow-up entscheident zu sein....., und die gibt es leider auch noch nicht!
@Pulsrasen!
Anhang:
Am J Med 2000 Apr 1;108(5):366-73
Books, LinkOut
Cost effectiveness of ribavirin/interferon alfa-2b after
interferon relapse in chronic hepatitis C.
Wong JB, Davis GL, Pauker SG
Department of Medicine, Tupper Research Institute, New England
Medical Center, Tufts University School of Medicine, Boston,
Massachusetts 02111, USA.
PURPOSE: Many patients with chronic hepatitis C who are treated with
interferon suffer a relapse after an initial response. About half of these
patients have a sustained virological response to retreatment with the
combination of ribavirin and interferon alfa-2b. The aim of this study was
to estimate the cost effectiveness of retreatment with combination therapy
versus interferon alone for patients who have previously relapsed after
interferon. SUBJECTS AND METHODS: Data from a randomized trial
among 345 relapsed patients that compared combination therapy with
interferon alone were used to project lifelong clinical and economic
outcomes. Natural history and economic estimates (discounted at 3% per
year) were based upon published literature, expert panel estimates, and
cost and reimbursement data. RESULTS: Compared with retreatment
with interferon alone, combination therapy should prolong life expectancy
by about 2 discounted quality-adjusted life years (3 life years,
undiscounted) while increasing costs modestly. The results were robust,
maintaining an advantage to combination therapy in sensitivity analysis for
all subgroups and with reasonable variations in all model parameters.
CONCLUSION: For patients with chronic hepatitis C who relapse after
an initial response to interferon alone, retreatment with the combination of
ribavirin and interferon alfa-2b should prolong life and be cost effective.
es freut mich, Dir ein bißchen helfen zu können. Dank Dir, habe ich mich jetzt auch schon viel ausführlicher mit MAXAMIN pharmaceuticals beschäftigt. Noch weiß ich nicht sicher, ob ich einsteigen werde! Insgesamt sehe ich zwar jede Menge Potential, doch die Risiken habe ich für mich abschließend noch nicht sicher beurteilt. Welche Werte hast Du eigentlich noch auf Deiner whatch-list? Deine Fragen zeigen einen, daß Du Dich sehr genau und ausführlich damit auseinander setzt und nicht gleich mit jeder Euphoriewelle mitschwimmst!
Zu Deinen Fragen:
zu a:
Wahrlich ist es beschämend, daß das Robert-Koch-Institut noch die Interferon-Monotherapie als Standardtherapie bei Hepatitis-C hält? Naja,........diese page befindet sich nicht auf dem aktuellen Stand (Stand Oktober 1999), trotzdem....... vor 1 Jahr wurden die Patienten auch schon mit der Kombinationstherapie behandelt! Hier eine aktuelle web-side von der Universitätsklinik Düsseldorf
http://www.uni-duesseldorf.de/WWW/gahepinf/hepatitis/hep_c/t…
Übrigens hast Du recht, daß die Interferontherapie sehr teuer ist, kostet doch eine einjährige Therapie fast einen sechsstelligenBetrag. Doch bedenke die Folgekosten, die man spart. So entwickeln fast 30% der Patienten eine Leberzirrhose, und 10 % von denen ein Leberkarzinom. Inzwischen gibt es zahlreiche cost-effectiveness Studien, die alle einstimmig bejahen, daß man unbedingt non-responder oder relapse Patienten eine second-line Therapie zuführen sollte. Im Anhang kopiere ich Dir einen abstract, aber wie gesagt, es gibt noch viele mehr! Was ich aber auch schon kritisch anmerkte, daß man zunächst in Studien zeigen müßte, daß diese Patienten mit MAXAMIN wirkungsvoll behandelt werden könnte!
zu b.
Ja, komisch, daß über diese Diskrepanz in diesem thread noch keiner gesprochen hat! Ich halte den Mittelwert in diesen Studien nicht für verwertbar, da sie ohne Standardabweichung angegeben wurden. Bei Krankheiten, die in Ihrem Verlauf sowieso sehr variabel sind, ist der Median sowieso viel aussagekräftiger! Und betrachtet man diesen, scheint es tatsächlich nur einen Überlebensvorteil bei Patienten mit Lebermetastasen zu geben. Ich freue dennoch sehr über die Daten von der Phase-IV Studie! Da sollen übrigens 1200 Patienten (steht auch irgendwo in diesem thread) eingeschlossen werden.......... ob sich letztendlich MAXAMIN aber durchsetzten wird, entscheidet jedoch nur die Klinik......... und die Konkurrenz ist besonders auf diesem Gebiet sehr hoch! Aber auch das Potential, weil dringend neue Therapiemodelle benötigt werden. Zum Beispiel strukturiert BAYER seine ganze Forschung in Richtung onkologischer Therapien um, da sie mit Herz-Kreislauf kein Potential mehr zum Geldverdienen sehen (bei 20-30 Hypertensiva wäre der Markt für ein neues Hypertonikum extrem eng!). Ich bin jedoch -wie schon gestern gesagt- zuversichtlich, daß MAXAMIN eine Indikation isoliert bei Patienten mit Lebermetasen erhalten könnte!
zu C.
Auch hier hast Du recht, daß der Therapieerfolg von Interferon von zahlreichen Faktoren abhängt. Unter anderem ist der Genotyp entscheidend. Der in Amerika und in Deutschland am häufigsten vertretenene Genoty I läßt sich sehr schlecht behandeln! In der Unternehmungsmeldung vom 14.09.00 wird berichtet, daß die antivirale Therapie bei folgenden Faktoren besser anspricht:
1. genotype 2 or 3
2. viral load less than 2 million copies/mL
3. age 40 years or less
4. minimal fibrosis stage
5. and female sex.
Es bringt also gar nichts, isoliert nur den Genotyp I zu betrachten, wurde übrigens in anderen Studien auch nur peripher gemacht. In dem Artikel, den ich als -abstract- schon vor 2 Tagen kopiert habe, werden ebenfalls die Ansprechraten abhängig von all diesen Faktoren aufgeschlüsselt (z.B. Ansprechraten bei allen 5 Faktoren, oder 4 von 5 u.s.w.). Leider wurde eine solche Aufschlüsslung von MAXAMIN pharmaceuticals nur bedingt gemacht (response was 2,6 (????)), so daß Vergleiche nach meiner Meinung noch nicht möglich sind! Im übrigen werden letztendlich nur die Zahlen vom 24w-follow-up entscheident zu sein....., und die gibt es leider auch noch nicht!
@Pulsrasen!
Anhang:
Am J Med 2000 Apr 1;108(5):366-73
Books, LinkOut
Cost effectiveness of ribavirin/interferon alfa-2b after
interferon relapse in chronic hepatitis C.
Wong JB, Davis GL, Pauker SG
Department of Medicine, Tupper Research Institute, New England
Medical Center, Tufts University School of Medicine, Boston,
Massachusetts 02111, USA.
PURPOSE: Many patients with chronic hepatitis C who are treated with
interferon suffer a relapse after an initial response. About half of these
patients have a sustained virological response to retreatment with the
combination of ribavirin and interferon alfa-2b. The aim of this study was
to estimate the cost effectiveness of retreatment with combination therapy
versus interferon alone for patients who have previously relapsed after
interferon. SUBJECTS AND METHODS: Data from a randomized trial
among 345 relapsed patients that compared combination therapy with
interferon alone were used to project lifelong clinical and economic
outcomes. Natural history and economic estimates (discounted at 3% per
year) were based upon published literature, expert panel estimates, and
cost and reimbursement data. RESULTS: Compared with retreatment
with interferon alone, combination therapy should prolong life expectancy
by about 2 discounted quality-adjusted life years (3 life years,
undiscounted) while increasing costs modestly. The results were robust,
maintaining an advantage to combination therapy in sensitivity analysis for
all subgroups and with reasonable variations in all model parameters.
CONCLUSION: For patients with chronic hepatitis C who relapse after
an initial response to interferon alone, retreatment with the combination of
ribavirin and interferon alfa-2b should prolong life and be cost effective.
"Deine Fragen zeigen, daß Du Dich sehr genau und ausführlich damit auseinander setzt und nicht gleich mit jeder Euphoriewelle mitschwimmst!"
Findest Du???? :o
Virophama habe ich eigentlich nur gekauft, weil die Quersumme von VPHM (ersetzt durch die Positionen der Buchstaben im Alphabet) 23 ergibt. Und da die 23 die Geheimzahl der Illuminaten ist, die, wie wir spätestens seit dem Film "23" wissen, die Welt unterwandern wollen, kann eine Investition in einen solche mächtigen Geheimbund nicht falsch sein. MAXM ergibt in der Quersumme leider nur 15, aber immerhin ist eine 13 am Anfang und am Ende. Klingt sehr mystisch/dämonisch und hat bestimmt auch was wichtiges zu bedeuten.
Boston Life habe ich gekauft, weil ich schon mal eine Superaktie namens Boston Chicken besessen habe. Irgendwann habe ich die aber komischerweise nicht mehr in meinem Depot gefunden. Da habe ich halt die nächste im Alphabet gekauft. Amylin züchten angeblich Gilamonster. Da ich Monsterfilme wie Godzilla sehr gerne mag, denke ich mir, dass die bestimmt Monstergewinne haben werden. Supergen muss ja sowiso super sein, wenn das schon im Namen steht! Ich habe noch ein paar andere, aber deren Namen habe ich irgendwie vergessen.
Erstmal noch mal vielen Dank für den guten, informativen Link.
Sechstellige Kosten sind aber natürlich der Hammer, gerade weil es keine seltene Erkrankung wie SCID oder so ist. Ich zerbreche mir ja schon die ganze Zeit den Kopf, ob die Krankenkassen autologe Krebsvakzine, wenn sie denn einst mal akzeptiert werden sollten, bezahlen werden. Und die aktuelle heftige Diskussion über den Einsatz von Interferon zur Behandlung von MS-Kranken in Großbritannien ist Dir vielleicht auch geläufig.
Aber solche Summen hauen ganz schön ins Kontor der Krankenkassen. Umgekehrt ist das natürlich auch eine Riesenchance selbst für einen Nischenanbieter im Bereich HEPC. Und dann muss man richtigerweise die Folgekosten von unbehandelten HEPC mit einberechnen.
Ganz neutral ist der Autor des Papers (Davis) vielleicht nicht, denn er war auch an folgendem Paper beteiligt:
Hepatology 1997 Aug;26(2):473-7
Tolerance and efficacy of oral ribavirin treatment of chronic hepatitis C: a multicenter trial.
Bodenheimer HC Jr, Lindsay KL, Davis GL, Lewis JH, Thung SN, Seeff LB
Department of Medicine, Mount Sinai School of Medicine, New York, NY 10029-6504, USA.
In dem Zusammenhang finde ich auch nicht die zugehörige Phase 3-Studie von Ribavirin in der Medline nicht (muss ja wohl auch so 96/97 gewesen sein), um deren Autoren zu bestimmen..
Aber was soll`s. Ich kann das sicher noch weniger beurteilen und Du hast ja bereits erwähnt, dass es dazu noch mehr Studien dazu gebt.
Was die Statistik der MM-Studie angeht, interpretieren wir die wohl gleich. Mein bereits erwähnter Bekannter, daraufhin angesprochen, war der Meinung, dass Maxamine generell für Stage 4 Patienten zugelassen werden würde (schmerzlindernd, signalisierte Änderung der Zulassungsschemata der FDA etc.). Ich werde mal seine Begründung hier nachreichen, wenn ich sie noch finde. Letztendlich geht es jetzt für MAXM um die Feinabstimmung der Behandlungsschematas. Da traue ich denen noch ein gewisses Potential zur Verbesserung der Ergebnisse zu.
Bzgl der Konkurrenz: Konkurriert denn Maxamine denn direkt mit einem anderen Behandlungsschemata? Ich hatte Maxamine eher als begleitende Behandlung angesehen, so dass es nicht grundsätzlich auf Interleukin beschränkt wäre.. Wäre das der Fall, dann wäre die Zukunft ja nicht so ungewiß.
Deine Bayer-Story ist sehr spannend. Mir ist auch aufgefallen, dass die im letzten Jahr sehr viel im Biotech-Bereich "herumstrampelten": Kooperation hier, Kauf da. Die waren aktiv wie keine andere Pharmafirma. Na ja, irgendwo müssen die AGFA-Gelder ja hin.
Bzgl der Watchlist: Da habe ich eine ganz, ganz grosse. Generell interessiere ich mich für Biotechs mit einer relativ geringen Marktkapitalisierung, die gerade vergessen werden oder wegen einer kurzfristigen Sache downgegradet werden, noch recht viel Cash besitzen , ein oder mehrere Medikamente in der Pipeline haben, bei denen ich eine echte Notwendigkeit für Neuentwicklungen sehe uswusf.
In der Regel keine strahlenden Medienhelden a la Viagra &Co. Da war der Einsturz von IPIC (die haben einen Teil des Appetitzüglers fen-phen produziert) zu prägend.
In der engeren Biotech-Beobachtungsliste habe ich so Werte wie Biomira, Cellegy, Cortex, Antisense(GNTA, ISIP), CEGE, GLIA, PARS, QSC(Hochrisikopapier!), Neurosearch und ganz aktuell CVTX! Meine Beweggründe zum Kauf sind aber nicht immer medizinischer Natur! Aber bevor ich welche kaufe, muß ich erst einen Teil meiner nun steuerfrei gewordenen Amylin wieder losschlagen. Aber nicht zu dem Preis.
Werte wie Immunex, bei denen alles Gute schon eingepreist ist, sind nix für mich. Für Anregungen wäre ich übrigens auch sehr dankbar, denn 300 Biotechs zu screenen ist mir auch nicht möglich.
Das in einem Wallstreet-online board über die Feinheiten des Studiendesigns und der Biostatistik diskutiert wird, ist auch eher die Seltenheit. Ist ja auch nicht ganz so einfach und auch nicht so spannend wie "dausend %" oder "isch mach euch roiiich!!".
Der Thread hier gehört nicht zuletzt dank Pitu auch zu den informativsten und konstruktivsten überhaupt, oder?
Bis die Tage!
Der Puhvogel
Findest Du???? :o
Virophama habe ich eigentlich nur gekauft, weil die Quersumme von VPHM (ersetzt durch die Positionen der Buchstaben im Alphabet) 23 ergibt. Und da die 23 die Geheimzahl der Illuminaten ist, die, wie wir spätestens seit dem Film "23" wissen, die Welt unterwandern wollen, kann eine Investition in einen solche mächtigen Geheimbund nicht falsch sein. MAXM ergibt in der Quersumme leider nur 15, aber immerhin ist eine 13 am Anfang und am Ende. Klingt sehr mystisch/dämonisch und hat bestimmt auch was wichtiges zu bedeuten.
Boston Life habe ich gekauft, weil ich schon mal eine Superaktie namens Boston Chicken besessen habe. Irgendwann habe ich die aber komischerweise nicht mehr in meinem Depot gefunden. Da habe ich halt die nächste im Alphabet gekauft. Amylin züchten angeblich Gilamonster. Da ich Monsterfilme wie Godzilla sehr gerne mag, denke ich mir, dass die bestimmt Monstergewinne haben werden. Supergen muss ja sowiso super sein, wenn das schon im Namen steht! Ich habe noch ein paar andere, aber deren Namen habe ich irgendwie vergessen.
Erstmal noch mal vielen Dank für den guten, informativen Link.
Sechstellige Kosten sind aber natürlich der Hammer, gerade weil es keine seltene Erkrankung wie SCID oder so ist. Ich zerbreche mir ja schon die ganze Zeit den Kopf, ob die Krankenkassen autologe Krebsvakzine, wenn sie denn einst mal akzeptiert werden sollten, bezahlen werden. Und die aktuelle heftige Diskussion über den Einsatz von Interferon zur Behandlung von MS-Kranken in Großbritannien ist Dir vielleicht auch geläufig.
Aber solche Summen hauen ganz schön ins Kontor der Krankenkassen. Umgekehrt ist das natürlich auch eine Riesenchance selbst für einen Nischenanbieter im Bereich HEPC. Und dann muss man richtigerweise die Folgekosten von unbehandelten HEPC mit einberechnen.
Ganz neutral ist der Autor des Papers (Davis) vielleicht nicht, denn er war auch an folgendem Paper beteiligt:
Hepatology 1997 Aug;26(2):473-7
Tolerance and efficacy of oral ribavirin treatment of chronic hepatitis C: a multicenter trial.
Bodenheimer HC Jr, Lindsay KL, Davis GL, Lewis JH, Thung SN, Seeff LB
Department of Medicine, Mount Sinai School of Medicine, New York, NY 10029-6504, USA.
In dem Zusammenhang finde ich auch nicht die zugehörige Phase 3-Studie von Ribavirin in der Medline nicht (muss ja wohl auch so 96/97 gewesen sein), um deren Autoren zu bestimmen..
Aber was soll`s. Ich kann das sicher noch weniger beurteilen und Du hast ja bereits erwähnt, dass es dazu noch mehr Studien dazu gebt.
Was die Statistik der MM-Studie angeht, interpretieren wir die wohl gleich. Mein bereits erwähnter Bekannter, daraufhin angesprochen, war der Meinung, dass Maxamine generell für Stage 4 Patienten zugelassen werden würde (schmerzlindernd, signalisierte Änderung der Zulassungsschemata der FDA etc.). Ich werde mal seine Begründung hier nachreichen, wenn ich sie noch finde. Letztendlich geht es jetzt für MAXM um die Feinabstimmung der Behandlungsschematas. Da traue ich denen noch ein gewisses Potential zur Verbesserung der Ergebnisse zu.
Bzgl der Konkurrenz: Konkurriert denn Maxamine denn direkt mit einem anderen Behandlungsschemata? Ich hatte Maxamine eher als begleitende Behandlung angesehen, so dass es nicht grundsätzlich auf Interleukin beschränkt wäre.. Wäre das der Fall, dann wäre die Zukunft ja nicht so ungewiß.
Deine Bayer-Story ist sehr spannend. Mir ist auch aufgefallen, dass die im letzten Jahr sehr viel im Biotech-Bereich "herumstrampelten": Kooperation hier, Kauf da. Die waren aktiv wie keine andere Pharmafirma. Na ja, irgendwo müssen die AGFA-Gelder ja hin.
Bzgl der Watchlist: Da habe ich eine ganz, ganz grosse. Generell interessiere ich mich für Biotechs mit einer relativ geringen Marktkapitalisierung, die gerade vergessen werden oder wegen einer kurzfristigen Sache downgegradet werden, noch recht viel Cash besitzen , ein oder mehrere Medikamente in der Pipeline haben, bei denen ich eine echte Notwendigkeit für Neuentwicklungen sehe uswusf.
In der Regel keine strahlenden Medienhelden a la Viagra &Co. Da war der Einsturz von IPIC (die haben einen Teil des Appetitzüglers fen-phen produziert) zu prägend.
In der engeren Biotech-Beobachtungsliste habe ich so Werte wie Biomira, Cellegy, Cortex, Antisense(GNTA, ISIP), CEGE, GLIA, PARS, QSC(Hochrisikopapier!), Neurosearch und ganz aktuell CVTX! Meine Beweggründe zum Kauf sind aber nicht immer medizinischer Natur! Aber bevor ich welche kaufe, muß ich erst einen Teil meiner nun steuerfrei gewordenen Amylin wieder losschlagen. Aber nicht zu dem Preis.
Werte wie Immunex, bei denen alles Gute schon eingepreist ist, sind nix für mich. Für Anregungen wäre ich übrigens auch sehr dankbar, denn 300 Biotechs zu screenen ist mir auch nicht möglich.
Das in einem Wallstreet-online board über die Feinheiten des Studiendesigns und der Biostatistik diskutiert wird, ist auch eher die Seltenheit. Ist ja auch nicht ganz so einfach und auch nicht so spannend wie "dausend %" oder "isch mach euch roiiich!!".
Der Thread hier gehört nicht zuletzt dank Pitu auch zu den informativsten und konstruktivsten überhaupt, oder?
Bis die Tage!
Der Puhvogel
Ja, stimmt, @PITU wirklich guter thread! Habe jede Menge Informationen rausgeholt! Ich freue mich auf weitere Beiträge......
Deine Anlagestragie ist wahrlich interessant,.............. nur das mir Rechnerei ist zu anstrengend! Aber werde es mir zu Herzen nehmen und morgen den 23. Titel aus dem DAX in mein Depot legen! Habe gerade nachgeschaut, es ist die Münchner Rückversicherung.! Mit´n SL bei 23E, damit ich auch richtig lange Spass daran haben werde!
Pulsrasen!
Deine Anlagestragie ist wahrlich interessant,.............. nur das mir Rechnerei ist zu anstrengend! Aber werde es mir zu Herzen nehmen und morgen den 23. Titel aus dem DAX in mein Depot legen! Habe gerade nachgeschaut, es ist die Münchner Rückversicherung.! Mit´n SL bei 23E, damit ich auch richtig lange Spass daran haben werde!
Pulsrasen!
Maxim Builds Experienced Marketing and Sales Management Team
SAN DIEGO--(BW HealthWire)--Sept. 25, 2000--Maxim Pharmaceuticals (Nasdaq NM:MAXM) (SSE:MAXM) announced that
William Poncy has joined the company as senior director, U.S. Sales, and that Dennis Takasugi has joined as senior director,
Marketing. Poncy will be responsible for the establishment and management of the U.S. sales forces related to the company`s lead drug
Maxamine(R)(histamine dihydrochloride), and Takasugi will be responsible for the marketing strategy associated with the anticipated
launch of the drug. Both Poncy and Takasugi report to Geoff Altman, Maxim`s vice president, Marketing and Sales.
"With the submission of our New Drug Application and designation of the application as a priority review by the FDA, preparation for
the potential market launch of Maxamine has become one of the major focuses among our corporate activities," said Larry G.
Stambaugh, Maxim`s chairman and chief executive officer. "We are very pleased to attract these two highly experienced marketing and
sales executives with a proven track record of success to the Maxim team.
Prior to joining Maxim, Poncy spent 16 years with DuPont Pharmaceuticals where he played a key leadership role in the development
of new sales divisions and the commercialization of DuPont products, included the HIV drug Sustiva(R). His responsibilities during his
tenure with DuPont included roles as national director Integrated Healthcare, director, Managed Care and director National Accounts.
Takasugi has spent his entire career in healthcare, pharmaceutical sales and marketing. Trained as a pharmacist, Takasugi spent 14
years with Eli Lilly & Company in pharmaceutical sales, market research, product management, hospital sales management,
pricing/national accounts and global product management with responsibilities for drugs including Prozac(R) and Insulin. Prior to
Maxim, Dennis spent 2 years at Ligand Pharmaceuticals as a Senior Product Manager launching ONTAK(R), their first product, and
Targretin(R) capsules, both in cutaneous T-cell lymphoma.
"We have also successfully recruited other key professionals comprising the core of our marketing and sales team, including our regional
sales management and corporate account managers, our medical science liaisons, and our reimbursement specialists," said Geoff B.
Altman, vice president, Marketing and Sales. "I am particularly pleased with the experience level of this team as each of these
professional have a proven track record of success in pharmaceutical sales and marketing, and each brings more than a decade of
average experience to Maxim. I believe that this team forms a nucleus that, combined with the field sales representatives we expect to
bring on board in early 2001, will give us a highly capable team for our planned market launch of Maxamine next year."
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious
diseases, degenerative diseases and topical disorders. In July 2000 Maxim submitted a New Drug Application (NDA) to the FDA
seeking approval to market its lead drug Maxamine in the United States as an adjuvant to interleukin-2 for the treatment of advanced
metastatic melanoma. In September the FDA informed the Company that the NDA had been assigned priority review status and that
the NDA would be reviewed under accelerated approval statutes. In addition, Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are
also underway for the treatment of hepatitis C and advanced renal cell carcinoma.
The company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of
medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related
conditions. Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and
carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit
caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
SAN DIEGO--(BW HealthWire)--Sept. 25, 2000--Maxim Pharmaceuticals (Nasdaq NM:MAXM) (SSE:MAXM) announced that
William Poncy has joined the company as senior director, U.S. Sales, and that Dennis Takasugi has joined as senior director,
Marketing. Poncy will be responsible for the establishment and management of the U.S. sales forces related to the company`s lead drug
Maxamine(R)(histamine dihydrochloride), and Takasugi will be responsible for the marketing strategy associated with the anticipated
launch of the drug. Both Poncy and Takasugi report to Geoff Altman, Maxim`s vice president, Marketing and Sales.
"With the submission of our New Drug Application and designation of the application as a priority review by the FDA, preparation for
the potential market launch of Maxamine has become one of the major focuses among our corporate activities," said Larry G.
Stambaugh, Maxim`s chairman and chief executive officer. "We are very pleased to attract these two highly experienced marketing and
sales executives with a proven track record of success to the Maxim team.
Prior to joining Maxim, Poncy spent 16 years with DuPont Pharmaceuticals where he played a key leadership role in the development
of new sales divisions and the commercialization of DuPont products, included the HIV drug Sustiva(R). His responsibilities during his
tenure with DuPont included roles as national director Integrated Healthcare, director, Managed Care and director National Accounts.
Takasugi has spent his entire career in healthcare, pharmaceutical sales and marketing. Trained as a pharmacist, Takasugi spent 14
years with Eli Lilly & Company in pharmaceutical sales, market research, product management, hospital sales management,
pricing/national accounts and global product management with responsibilities for drugs including Prozac(R) and Insulin. Prior to
Maxim, Dennis spent 2 years at Ligand Pharmaceuticals as a Senior Product Manager launching ONTAK(R), their first product, and
Targretin(R) capsules, both in cutaneous T-cell lymphoma.
"We have also successfully recruited other key professionals comprising the core of our marketing and sales team, including our regional
sales management and corporate account managers, our medical science liaisons, and our reimbursement specialists," said Geoff B.
Altman, vice president, Marketing and Sales. "I am particularly pleased with the experience level of this team as each of these
professional have a proven track record of success in pharmaceutical sales and marketing, and each brings more than a decade of
average experience to Maxim. I believe that this team forms a nucleus that, combined with the field sales representatives we expect to
bring on board in early 2001, will give us a highly capable team for our planned market launch of Maxamine next year."
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious
diseases, degenerative diseases and topical disorders. In July 2000 Maxim submitted a New Drug Application (NDA) to the FDA
seeking approval to market its lead drug Maxamine in the United States as an adjuvant to interleukin-2 for the treatment of advanced
metastatic melanoma. In September the FDA informed the Company that the NDA had been assigned priority review status and that
the NDA would be reviewed under accelerated approval statutes. In addition, Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are
also underway for the treatment of hepatitis C and advanced renal cell carcinoma.
The company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of
medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related
conditions. Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and
carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit
caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
CNBC- MARKET WATCH
MEDICAL TECHNOLOGY STOCK LETTER EDITOR JOHN MCCAMANT ON THE MARKET
SEPTEMBER 26, 2000
SUMMARY: McCamant says the fall biotech outlook is positive in the near-term. He likes ONXX, MAXM, CHIR and CRIS. He then comments on stem-cell related stocks.
Ted: Our next guest says investors, even conservative ones should have some money in the biotechs. Joining us is John McCamant, editor with the Medical Technology Stock Letter.
It`s nice to have you with us today. Let`s talk about this run all right. Not a great performance today but it has had a rough go. It seems to have proved of late. What`s the outlook?
Near term, the outlook is generally positive in the fall with a slew of investors and a scientific conference. The scientific conference will have clinical trial results, which can be key catalyst to move specific stocks. Investor`s conferences will provide a nice forum for the companies to tell stories and differentiate themselves and their product.
Ted: All right longer term, how do you want to be positioned and what do you do specifically in terms of positioning within group?
We are fully invested but would not use a lot of leverage. We`ve had some very good moves this year and the overall market we feel has some risk in it. We would stay fully invested and specific names and only half of our stock are buys right now. We would not chase stocks in this environment.
Ted: Let`s talk about the ones that you do like however we start off with Onyx Pharmaceuticals. The ticker is ONXX.
It is in phase three pivotal trials, head and neck cancer. It`s partnered with Pfizer. They own half of the U.S. rights and we think it is a significant undervalued market cap wise compared to other phase three cancer companies and biotech sectors.
Ted: Maxim pharmaceuticals?
They have just received a fast track from the FDA. They`ll be at the panel in December. Their drug will treat malignant melanoma and there is no current treatment for that. That could be a blockbuster drug for Maxim. They could be selling that in first quarter of one.
Ted: Chiron Corporation? Chiron has been a long-term recommendation at the newsletter. We recommended it back in 1984. Specifically going forward I think the catalyst would some of their intellectual property.
We expect a settlement with the German company, Roach who have been infringing on patents for many years. That would make the analyst have to redo numbers and we could see some significant move up.
Ted: Curis is the company, CRIS is the ticker. What`s the deal here?
I would believe their leaders in regenerative medicine. They`re based in Cambridge. It was two private companies that merged with the public. They`re lead product OP1, bone growth protein could be approved in Europe before year end. Would it be approved here in the U.S. next year and they really put together we think a lot of the components necessary to make products out of genomics. They have functional genomic story and they will enter first products to treat cancer in the first quarter of next year. So, I think they`re ahead of the curve on how to create value out of genomics.
Ted: I was going to ask about genome-related issues. Let me go up to question five, which is stem cell related issues. We keep hearing that they have pushing for in Washington. We see these stocks up a day after they push them and talk about them in Washington and then they will pullback again. Are any of them buys as far as you`re concerned? In fact Curis has stem cell intellectual property specifically for the pancreas. That would enable you to re-grow your pancreas, so you would be able to treat Type I Diabetes without insulin.
Ted: Good to have you. Thanks for coming in today. It`s good to have you, thank you for coming in today. That was John McCamant, editor with the Medical Technology Stock Letter.
MEDICAL TECHNOLOGY STOCK LETTER EDITOR JOHN MCCAMANT ON THE MARKET
SEPTEMBER 26, 2000
SUMMARY: McCamant says the fall biotech outlook is positive in the near-term. He likes ONXX, MAXM, CHIR and CRIS. He then comments on stem-cell related stocks.
Ted: Our next guest says investors, even conservative ones should have some money in the biotechs. Joining us is John McCamant, editor with the Medical Technology Stock Letter.
It`s nice to have you with us today. Let`s talk about this run all right. Not a great performance today but it has had a rough go. It seems to have proved of late. What`s the outlook?
Near term, the outlook is generally positive in the fall with a slew of investors and a scientific conference. The scientific conference will have clinical trial results, which can be key catalyst to move specific stocks. Investor`s conferences will provide a nice forum for the companies to tell stories and differentiate themselves and their product.
Ted: All right longer term, how do you want to be positioned and what do you do specifically in terms of positioning within group?
We are fully invested but would not use a lot of leverage. We`ve had some very good moves this year and the overall market we feel has some risk in it. We would stay fully invested and specific names and only half of our stock are buys right now. We would not chase stocks in this environment.
Ted: Let`s talk about the ones that you do like however we start off with Onyx Pharmaceuticals. The ticker is ONXX.
It is in phase three pivotal trials, head and neck cancer. It`s partnered with Pfizer. They own half of the U.S. rights and we think it is a significant undervalued market cap wise compared to other phase three cancer companies and biotech sectors.
Ted: Maxim pharmaceuticals?
They have just received a fast track from the FDA. They`ll be at the panel in December. Their drug will treat malignant melanoma and there is no current treatment for that. That could be a blockbuster drug for Maxim. They could be selling that in first quarter of one.
Ted: Chiron Corporation? Chiron has been a long-term recommendation at the newsletter. We recommended it back in 1984. Specifically going forward I think the catalyst would some of their intellectual property.
We expect a settlement with the German company, Roach who have been infringing on patents for many years. That would make the analyst have to redo numbers and we could see some significant move up.
Ted: Curis is the company, CRIS is the ticker. What`s the deal here?
I would believe their leaders in regenerative medicine. They`re based in Cambridge. It was two private companies that merged with the public. They`re lead product OP1, bone growth protein could be approved in Europe before year end. Would it be approved here in the U.S. next year and they really put together we think a lot of the components necessary to make products out of genomics. They have functional genomic story and they will enter first products to treat cancer in the first quarter of next year. So, I think they`re ahead of the curve on how to create value out of genomics.
Ted: I was going to ask about genome-related issues. Let me go up to question five, which is stem cell related issues. We keep hearing that they have pushing for in Washington. We see these stocks up a day after they push them and talk about them in Washington and then they will pullback again. Are any of them buys as far as you`re concerned? In fact Curis has stem cell intellectual property specifically for the pancreas. That would enable you to re-grow your pancreas, so you would be able to treat Type I Diabetes without insulin.
Ted: Good to have you. Thanks for coming in today. It`s good to have you, thank you for coming in today. That was John McCamant, editor with the Medical Technology Stock Letter.
Im AVAX-Baord haben die sich tierisch über diesen Satz aufgeregt, und das auch zurecht.
Natürlich gibt es Behandlungsalternativen für MM Stage4 !!
Etabliert ist bereits die Hochdosis-Interferon-Therapie und für Coraxas Melacine wird wohl bald auch ein NDA speziell für Frauen beantragt.
Maxamine ist gerade bei der MM-Forschung nicht im luftleeren Raum.
Der Puhvogel
Natürlich gibt es Behandlungsalternativen für MM Stage4 !!
Etabliert ist bereits die Hochdosis-Interferon-Therapie und für Coraxas Melacine wird wohl bald auch ein NDA speziell für Frauen beantragt.
Maxamine ist gerade bei der MM-Forschung nicht im luftleeren Raum.
Der Puhvogel
Wo finde ich denn aktuelles zu AVAX? Mit Stichworteingabe kommen nur olle Kamellen.
Danke
uger
Danke
uger
Wenn Du Englisch kannst, findest Du hier regelmäßig neue Infos, auch inoffizielle:
http://AVXTINVESTORS.homestead.com/VICTORY.html
Einen kurzen Kommentar zu Avax habe ich heute auf dem Yahoo-Board von Avax geschrieben.
In Deutsch wollte ich auch mal eine wirklich umfangreiche Analyse (noch umfangreicher als die von stis-weekly)schreiben, aber die ist leider nur halb fertig und ich bin leider im Streß.
Im übrigen: Maxamine und M-Vax sind keine Konkurrenz sondern dürften vermutlich synergistisch zusammenarbeiten.
Gruß
Fluffy
http://AVXTINVESTORS.homestead.com/VICTORY.html
Einen kurzen Kommentar zu Avax habe ich heute auf dem Yahoo-Board von Avax geschrieben.
In Deutsch wollte ich auch mal eine wirklich umfangreiche Analyse (noch umfangreicher als die von stis-weekly)schreiben, aber die ist leider nur halb fertig und ich bin leider im Streß.
Im übrigen: Maxamine und M-Vax sind keine Konkurrenz sondern dürften vermutlich synergistisch zusammenarbeiten.
Gruß
Fluffy
Maxim Completes Enrollment of Two Additional Phase III Maxamine Clinical Trials
SAN DIEGO--(BW HealthWire)--Oct. 9, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it has
completed the enrollment of its global Phase III clinical trial of Maxamine(R) in acute myelogenous leukemia (AML), the most common
acute adult leukemia, and its international Phase III trial in advanced metastatic melanoma, the most deadly form of skin cancer.
"The advancement of these Phase III trials is another step in our overall program for the broad development of Maxamine," said Larry
G. Stambaugh, Maxim`s chairman and chief executive officer. "We are planning for the potential U.S. market launch of Maxamine in
early 2001 in advanced metastatic melanoma, and our extensive clinical trial program is designed to support additional global market
launches in AML, renal cell carcinoma, hepatitis C and other indications."
Global Phase III AML Trial
The ongoing global Phase III trial is designed to demonstrate that treatment with the combination of Maxamine and interleukin-2 (IL-2)
can prolong leukemia-free remission time and prevent relapse in AML patients. More than 300 patients were enrolled in 12 countries,
with clinical sites in the United States, Europe, Canada, Australia and Israel. In the study, AML patients in complete remission were
randomized to receive either the combination of Maxamine and IL-2 or the current standard of care, which is no treatment during
remission. Patients will be evaluated for up to 24 months, and trial completion is expected in the second half of 2002.
There are approximately 10,000 new cases of AML and 7,300 deaths caused by this cancer each year in the United States, and
prospects for long-term survival are poor for the majority of patients. Once diagnosed with AML, patients are typically treated with
chemotherapy, and the majority achieve complete remission. Unfortunately, 75-80% of patients who achieve their first complete
remission will relapse, and few survive long term. There are currently no effective remission therapies for AML patients.
Phase II trials in AML patients suggested that therapy with the combination of Maxamine and IL-2 prevented relapse and more than
doubled the number of patients achieving greater than two years of leukemia-free remission, while maintaining patient quality of life
during treatment. Also notable in the studies was the fact that the patients safely self-administered the Maxamine combination at home.
International Phase III Advanced Metastatic Melanoma Trial
The international Phase III trial of Maxamine for the treatment of advanced metastatic melanoma includes 240 patients in Europe,
Australia, Canada and Israel. Patients in the Maxamine group receive a co-administration of Maxamine plus low-dose IL-2 and
interferon-alpha, while patients in the control group receive dacarbazine (DTIC), the most commonly used chemotherapeutic agent for
the treatment of advanced metastatic melanoma, particularly in Europe and Australia. The primary endpoint of this study is survival.
Malignant melanoma is the most serious form of skin cancer and is one of the most rapidly increasing cancers in the world. There are
more than 44,000 new cases of melanoma and 7,300 deaths from the disease each year in the United States.
In July 2000, Maxim submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to
market its lead drug Maxamine in the United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In
September, the FDA informed the Company that the NDA had been assigned priority review status and that the NDA would be
reviewed under accelerated approval statutes.
The NDA application, as well as European and Australian applications expected to be filed late this year, are based on a U.S. Phase III
trial in advanced metastatic melanoma completed in March 2000. The results of the U.S. study showed that treatment with the
combination of Maxamine and the cytokine IL-2 dramatically improved survival for advanced metastatic melanoma patients with liver
metastases compared with those treated with the same doses of IL-2 alone (adjusted p value of 0.008).
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, improved
time-to-disease-progression, and improved quality of life over treatment with IL-2 alone in all patients. The European trial is designed
to complement the U.S. trial by increasing awareness of the drug outside the United States, thus preparing the international markets for
the planned market launch, and to provide data regarding the use of the combination of Maxamine, interferon-alpha and IL-2 for the
treatment of advanced metastatic melanoma.
SAN DIEGO--(BW HealthWire)--Oct. 9, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it has
completed the enrollment of its global Phase III clinical trial of Maxamine(R) in acute myelogenous leukemia (AML), the most common
acute adult leukemia, and its international Phase III trial in advanced metastatic melanoma, the most deadly form of skin cancer.
"The advancement of these Phase III trials is another step in our overall program for the broad development of Maxamine," said Larry
G. Stambaugh, Maxim`s chairman and chief executive officer. "We are planning for the potential U.S. market launch of Maxamine in
early 2001 in advanced metastatic melanoma, and our extensive clinical trial program is designed to support additional global market
launches in AML, renal cell carcinoma, hepatitis C and other indications."
Global Phase III AML Trial
The ongoing global Phase III trial is designed to demonstrate that treatment with the combination of Maxamine and interleukin-2 (IL-2)
can prolong leukemia-free remission time and prevent relapse in AML patients. More than 300 patients were enrolled in 12 countries,
with clinical sites in the United States, Europe, Canada, Australia and Israel. In the study, AML patients in complete remission were
randomized to receive either the combination of Maxamine and IL-2 or the current standard of care, which is no treatment during
remission. Patients will be evaluated for up to 24 months, and trial completion is expected in the second half of 2002.
There are approximately 10,000 new cases of AML and 7,300 deaths caused by this cancer each year in the United States, and
prospects for long-term survival are poor for the majority of patients. Once diagnosed with AML, patients are typically treated with
chemotherapy, and the majority achieve complete remission. Unfortunately, 75-80% of patients who achieve their first complete
remission will relapse, and few survive long term. There are currently no effective remission therapies for AML patients.
Phase II trials in AML patients suggested that therapy with the combination of Maxamine and IL-2 prevented relapse and more than
doubled the number of patients achieving greater than two years of leukemia-free remission, while maintaining patient quality of life
during treatment. Also notable in the studies was the fact that the patients safely self-administered the Maxamine combination at home.
International Phase III Advanced Metastatic Melanoma Trial
The international Phase III trial of Maxamine for the treatment of advanced metastatic melanoma includes 240 patients in Europe,
Australia, Canada and Israel. Patients in the Maxamine group receive a co-administration of Maxamine plus low-dose IL-2 and
interferon-alpha, while patients in the control group receive dacarbazine (DTIC), the most commonly used chemotherapeutic agent for
the treatment of advanced metastatic melanoma, particularly in Europe and Australia. The primary endpoint of this study is survival.
Malignant melanoma is the most serious form of skin cancer and is one of the most rapidly increasing cancers in the world. There are
more than 44,000 new cases of melanoma and 7,300 deaths from the disease each year in the United States.
In July 2000, Maxim submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to
market its lead drug Maxamine in the United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In
September, the FDA informed the Company that the NDA had been assigned priority review status and that the NDA would be
reviewed under accelerated approval statutes.
The NDA application, as well as European and Australian applications expected to be filed late this year, are based on a U.S. Phase III
trial in advanced metastatic melanoma completed in March 2000. The results of the U.S. study showed that treatment with the
combination of Maxamine and the cytokine IL-2 dramatically improved survival for advanced metastatic melanoma patients with liver
metastases compared with those treated with the same doses of IL-2 alone (adjusted p value of 0.008).
Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, improved
time-to-disease-progression, and improved quality of life over treatment with IL-2 alone in all patients. The European trial is designed
to complement the U.S. trial by increasing awareness of the drug outside the United States, thus preparing the international markets for
the planned market launch, and to provide data regarding the use of the combination of Maxamine, interferon-alpha and IL-2 for the
treatment of advanced metastatic melanoma.
Hallo Ihr !!
Habe heute diese Meldung gefunden. Leider hört sich das ja nicht grade sehr positiv an. Hat jemand weitere Informationen, wie die Aussichten für die Zulassung sind ?
**********************************************************************
Maxim cancer drug: moon-shot . . .
...or a train-wreck waiting to happen
By Jesse Schulman, FTMarketWatch 9:03:00 AM BST Oct 6, 2000
LONDON (FTMW) - Swedish-American firm Maxim Pharmaceuticals is nearing a rendezvous with destiny. It`s anticipating a December meeting of the U.S. Food and Drug Administration, where panelists will weigh approval of the company`s experimental drug against cancer.
For would-be investors, it`s a tough call. The potential rewards are mouth-watering if the drug is approved. The risk level for the California company, whose shares trade on Nasdaq and the Stockholm stock exchange, is high enough to make your ears pop.
Maxim [US:MAXM] is seeking marketing approval for its Maxamine drug in the treatment of skin cancer. Maxamine is the company`s trade name for a form of histamine, the immune system chemical messenger well known to allergy-sufferers. Maxim`s research indicates histamine may turn out to help the immune system fight cancer and viral infections.
"No one would have guessed this was a therapeutic drug," CEO Larry Stambaugh, who was in London at a biotechnology conference, told FTMarketWatch.com.
Just the facts
Maxim has carried out clinical trials of Maxamine as part of a drug combination in the treatment of advanced malignant melanoma -- a disease so deadly, Stambaugh says, "it gives cancer a bad name."
The current best available treatment for malignant melanoma is Interleukin-2 (IL-2), which acts as an immune system booster. Maxim compared the survival of patients given Interleukin-2 alone with a group treated with IL-2 and Maxamine.
In patients whose cancer had already spread to the liver, Stambaugh says there was a clear improvement in survival.
In addition to skin cancer, Maxim has also been testing Maxamine in combination therapy against Hepatitis C, a sometimes-lethal virus that infects hundreds of millions of people worldwide.
Hepatitis C often remains undetected for years, and is capable of causing liver disease, cirrhosis and cancer. Current treatments help only a minority of patients. Stamaugh says addition of Maxamine to a standard therapy raised to 61 percent the number of patients whose levels of virus dropped to undetectable levels from 23 percent with standard therapy alone.
The company has struck a deal with pharmaceuticals giant Roche, to test Maxamine as an adjunct to a Roche hepatitis-C drug.
The potential pay-off
Regional market
coverage
MarketPulse
News Alerts
Europe
Asia/Pacific
Americas
Currencies
Stambaugh says Maxamine should help fight a wide range of cancers and viral diseases because it appears to work by helping help the immune system attack and destroy malignant and infected cells. "We`re beginning to think it`s a universal mechanism," Stambaugh says.
Maxamine may also allow doctors to use lower doses of chemotherapy drugs, and thus improve the quality of life for cancer patients.
The biggest potential financial pay-off, though, is the possibility of using Maxamine against hepatitis C. Estimates of the numbers of people infected worldwide run to a half a billion. The disease develops slowly, and in some patients remains dormant for decades. In most, though, it causes chronic liver disease, and some five percent of patients die from cirrhosis or cancer.
Maxim executives say a panel of experts advising the FDA will review the skin cancer data in December. At the end of such meetings, the committee votes whether to recommend approval, and the FDA generally follows the panel`s advice. If Maxamine is approved for skin cancer, physicians are likely to prescribe it for other conditions as well. So-called off-label sales are often greater than for the officially approved use.
The billion-dollar question
Some observers are predicting Maxamine won`t make it. One such is Mike Maroglies, head of Florida-based Avalon Research.
"We have a lot of doubts about the data," Margolies told FTMarketWatch by telephone from his Boca Raton headquarters. Margolies thinks Maxim is heading for a fall.
Margolies is advising his firm`s clients to sell Maxim - - in other words, to short the stock. Shorting is when an investor sells shares he doesn`t own, in hopes of buying them cheaper at a later date.
Avalon is famous in the world of biotech for its short recommendations - - often angering shareholders of small firms, for whom Margolies` short recommendations can be a powerful depressant on share price, not to mention on dreams of early retirement.
"We do fundamental, science-based research, looking for firms trading on misinformation and uninformed opinion," Margolies said. Laughing, he added, "Which right now is probably most of the biotech universe."
Biotechnology shares as a group are among the few technology sectors that continue to thrive amid worldwide selling of tech stocks.
Yet not all biotechs are immune. Last month, shares in the U.K.`s Scotia Holdings [UK:SOH] nose-dived when the FDA rejected its Foscan anti-cancer therapy. Like Scotia, Maxim`s prospects are heavily dependent on a single product.
Stambaugh is understandably upbeat about the prospects for FDA approval. In addition, one of Maxim`s key executives is an industry veteran hired specifically for his strong track record of successfully guiding drugs in development through the regulatory obstacle course.
What`s an investor to do?
Other industry observers are more sanguine than Margolies on Maxim`s chances of winning approval. But the risk is undeniable.
Share prices in biotech firms often rise as crucial dates approach, such as the release of test data, or the results of FDA deliberations- - only to fall when the news is released, even if the news is good. (See "Scotia falls after FDA rejection" and "Bane of biotechs.")
Clever biotech traders often adapt their strategy to the calendar, either by hedging their positions with share options as crunch day approaches, or simply bailing out of the stock altogether.
One industry professional told FTMarketWatch privately he was confident Maxim would win FDA approval for Maxamine against skin cancer and believes the firm has a bright future. Despite his optimism, he still wasn`t going to take any chances.
"I`m not planning to be holding any Maxim shares on Dec. 13 and 14," the dates of the FDA advisory committee meeting, he said.
See related story: "What makes biotechs jump."
Other biotech news: ReNeuron aims at brain, spine repair
Jesse Schulman is a reporter for FTMarketWatch in London
**********************************************************************
Bis dann
Chris
Habe heute diese Meldung gefunden. Leider hört sich das ja nicht grade sehr positiv an. Hat jemand weitere Informationen, wie die Aussichten für die Zulassung sind ?
**********************************************************************
Maxim cancer drug: moon-shot . . .
...or a train-wreck waiting to happen
By Jesse Schulman, FTMarketWatch 9:03:00 AM BST Oct 6, 2000
LONDON (FTMW) - Swedish-American firm Maxim Pharmaceuticals is nearing a rendezvous with destiny. It`s anticipating a December meeting of the U.S. Food and Drug Administration, where panelists will weigh approval of the company`s experimental drug against cancer.
For would-be investors, it`s a tough call. The potential rewards are mouth-watering if the drug is approved. The risk level for the California company, whose shares trade on Nasdaq and the Stockholm stock exchange, is high enough to make your ears pop.
Maxim [US:MAXM] is seeking marketing approval for its Maxamine drug in the treatment of skin cancer. Maxamine is the company`s trade name for a form of histamine, the immune system chemical messenger well known to allergy-sufferers. Maxim`s research indicates histamine may turn out to help the immune system fight cancer and viral infections.
"No one would have guessed this was a therapeutic drug," CEO Larry Stambaugh, who was in London at a biotechnology conference, told FTMarketWatch.com.
Just the facts
Maxim has carried out clinical trials of Maxamine as part of a drug combination in the treatment of advanced malignant melanoma -- a disease so deadly, Stambaugh says, "it gives cancer a bad name."
The current best available treatment for malignant melanoma is Interleukin-2 (IL-2), which acts as an immune system booster. Maxim compared the survival of patients given Interleukin-2 alone with a group treated with IL-2 and Maxamine.
In patients whose cancer had already spread to the liver, Stambaugh says there was a clear improvement in survival.
In addition to skin cancer, Maxim has also been testing Maxamine in combination therapy against Hepatitis C, a sometimes-lethal virus that infects hundreds of millions of people worldwide.
Hepatitis C often remains undetected for years, and is capable of causing liver disease, cirrhosis and cancer. Current treatments help only a minority of patients. Stamaugh says addition of Maxamine to a standard therapy raised to 61 percent the number of patients whose levels of virus dropped to undetectable levels from 23 percent with standard therapy alone.
The company has struck a deal with pharmaceuticals giant Roche, to test Maxamine as an adjunct to a Roche hepatitis-C drug.
The potential pay-off
Regional market
coverage
MarketPulse
News Alerts
Europe
Asia/Pacific
Americas
Currencies
Stambaugh says Maxamine should help fight a wide range of cancers and viral diseases because it appears to work by helping help the immune system attack and destroy malignant and infected cells. "We`re beginning to think it`s a universal mechanism," Stambaugh says.
Maxamine may also allow doctors to use lower doses of chemotherapy drugs, and thus improve the quality of life for cancer patients.
The biggest potential financial pay-off, though, is the possibility of using Maxamine against hepatitis C. Estimates of the numbers of people infected worldwide run to a half a billion. The disease develops slowly, and in some patients remains dormant for decades. In most, though, it causes chronic liver disease, and some five percent of patients die from cirrhosis or cancer.
Maxim executives say a panel of experts advising the FDA will review the skin cancer data in December. At the end of such meetings, the committee votes whether to recommend approval, and the FDA generally follows the panel`s advice. If Maxamine is approved for skin cancer, physicians are likely to prescribe it for other conditions as well. So-called off-label sales are often greater than for the officially approved use.
The billion-dollar question
Some observers are predicting Maxamine won`t make it. One such is Mike Maroglies, head of Florida-based Avalon Research.
"We have a lot of doubts about the data," Margolies told FTMarketWatch by telephone from his Boca Raton headquarters. Margolies thinks Maxim is heading for a fall.
Margolies is advising his firm`s clients to sell Maxim - - in other words, to short the stock. Shorting is when an investor sells shares he doesn`t own, in hopes of buying them cheaper at a later date.
Avalon is famous in the world of biotech for its short recommendations - - often angering shareholders of small firms, for whom Margolies` short recommendations can be a powerful depressant on share price, not to mention on dreams of early retirement.
"We do fundamental, science-based research, looking for firms trading on misinformation and uninformed opinion," Margolies said. Laughing, he added, "Which right now is probably most of the biotech universe."
Biotechnology shares as a group are among the few technology sectors that continue to thrive amid worldwide selling of tech stocks.
Yet not all biotechs are immune. Last month, shares in the U.K.`s Scotia Holdings [UK:SOH] nose-dived when the FDA rejected its Foscan anti-cancer therapy. Like Scotia, Maxim`s prospects are heavily dependent on a single product.
Stambaugh is understandably upbeat about the prospects for FDA approval. In addition, one of Maxim`s key executives is an industry veteran hired specifically for his strong track record of successfully guiding drugs in development through the regulatory obstacle course.
What`s an investor to do?
Other industry observers are more sanguine than Margolies on Maxim`s chances of winning approval. But the risk is undeniable.
Share prices in biotech firms often rise as crucial dates approach, such as the release of test data, or the results of FDA deliberations- - only to fall when the news is released, even if the news is good. (See "Scotia falls after FDA rejection" and "Bane of biotechs.")
Clever biotech traders often adapt their strategy to the calendar, either by hedging their positions with share options as crunch day approaches, or simply bailing out of the stock altogether.
One industry professional told FTMarketWatch privately he was confident Maxim would win FDA approval for Maxamine against skin cancer and believes the firm has a bright future. Despite his optimism, he still wasn`t going to take any chances.
"I`m not planning to be holding any Maxim shares on Dec. 13 and 14," the dates of the FDA advisory committee meeting, he said.
See related story: "What makes biotechs jump."
Other biotech news: ReNeuron aims at brain, spine repair
Jesse Schulman is a reporter for FTMarketWatch in London
**********************************************************************
Bis dann
Chris
Diese Nachrichten hören sich wirklich nicht so gut an.
Die Milliarden-Frage
Einige Beobachter sagen voraus, daß Maxamine es nicht schaffen wird, diese Zulassung zu erhalten. (!!!!!) Einer davon ist Mike Maroglies,Chef der in Florida beheimateten Avalon Research. "Wir haben große Zweifel bezüglich der Daten," erzählt Margolies FTMarketWatch via Telefon aus seinem Hauptquartier Boca Raton. Margolies denkt, daß Maxim`s Abstieg bevorsteht. (!!!!!).
Margolies rät seinen Firmenkunden Maxim zu verkaufen- -in anderen Worten, die Aktie leer zu verkaufen. Leerverkauf bedeutet, daß ein Anleger Aktien verkauft, die er nicht besitzt, und darauf hofft, sie zu einem späteren Zeitpunkt billiger kaufen zu können.
Avalon ist in der Welt der Biotechnologie bekannt für seine Leerverkauf-Empfehlungen-- dabei werden oft die Aktionäre kleiner Unternehmen verärgert,für die Margolies` Leerverkauf-Empfehlungen einen gewaltigen Druckauf den Aktienkurs bedeuten kann, und insbesondere die Träume auf einen frühen Ruhestand zu nichte macht.
"Wir betreiben einen fundamentalen, wissenschaftsbasierten Research,und halten Ausschau nach Unternehmen, die gehandelt werden in dem Zustand der Fehlinformation sowie blindwütiger Gutachten," sagte Margolies. Lachend fügte er hinzu, "Das ist gerade heutzutage vielleicht dasgrößte Problem des Biotech Universums."
Maxim`s prospects are heavily dependent on a single product.
Maxim`s Aussichten sind stark abhängig von einem einzigen Produkt.
What`s an investor to do?
Was soll der Anleger nun machen?
Other industry observers are more sanguine than Margolies on Maxim`schances of winning approval. But the risk is undeniable.
Andere Beobachter der Branche sind zuversichtlicher als Margolies,daß Maxim Chancen hat, die Genehmigung zu erhalten. Aber das Risiko ist unbestreitbar.
Share prices in biotech firms often rise as crucial dates approach,such as the release of test data, or the results of FDA deliberations-- only to fall when the news is released, even if the news is good. (See"Scotia falls after FDA rejection" and "Bane of biotechs.")
Aktienkurse der Biotech-Unternehmen steigen oft, wenn kritische Daten näher kommen, wie zum Beispiel die Veröffentlichung Testergebnissen,oder die Ergebnisse von FDA Überlegungen- - sie fallen nur, wenn die Nachrichten freigegeben werden, selbst wenn die Nachrichten gut sind.(Siehe "Scotia`s Absturz nach FDA Ablehnung" und "Der Fluch von Biotechs.")
Clever biotech traders often adapt their strategy to the calendar, eitherby hedging their positions with share options as crunch day approaches,or simply bailing out of the stock altogether.
Raffinierte Biotech Händler passen oft ihre Strategie dem Kalender an, entweder durch Absichern ihrer Positionen mit Aktien-Optionen, wenn sich der Tag "der schlechten Situation" nähert, oder einfach von der Aktie ganz und gar abspringen.
One industry professional told FTMarketWatch privately he was confidentMaxim would win
FDA approval for Maxamine against skin cancer and believes the firmhas a bright future.
Despite his optimism, he still wasn`t going to take any chances.
Ein Branchen-Fachmann hat FTMarketWatch vertraulich erzählt,daß er überzeugt ist, daß Maxim die FDA Genehmigung für Maxamine gegen Hautkrebs erhalten wird und glaubt, daß das Unternehmen eine glänzende Zukunft hat. Trotz seines Optimismus wollte er noch nicht irgendwelche Chancen wahrnehmen.
"I`m not planning to be holding any Maxim shares on Dec. 13 and 14,"the dates of the FDA advisory committee meeting, he said.
"Ich plane nicht, auch nur eine Aktie Maxim am 13. und 14. Dezember zu halten." Er sagte, das sind die Termine, an dem sich das Komitee, welches die FDA berät, trifft.
Quelle: ftmarketwatch
Wie sind Eure (Pitu,...) Meinungen dazu?
Die Milliarden-Frage
Einige Beobachter sagen voraus, daß Maxamine es nicht schaffen wird, diese Zulassung zu erhalten. (!!!!!) Einer davon ist Mike Maroglies,Chef der in Florida beheimateten Avalon Research. "Wir haben große Zweifel bezüglich der Daten," erzählt Margolies FTMarketWatch via Telefon aus seinem Hauptquartier Boca Raton. Margolies denkt, daß Maxim`s Abstieg bevorsteht. (!!!!!).
Margolies rät seinen Firmenkunden Maxim zu verkaufen- -in anderen Worten, die Aktie leer zu verkaufen. Leerverkauf bedeutet, daß ein Anleger Aktien verkauft, die er nicht besitzt, und darauf hofft, sie zu einem späteren Zeitpunkt billiger kaufen zu können.
Avalon ist in der Welt der Biotechnologie bekannt für seine Leerverkauf-Empfehlungen-- dabei werden oft die Aktionäre kleiner Unternehmen verärgert,für die Margolies` Leerverkauf-Empfehlungen einen gewaltigen Druckauf den Aktienkurs bedeuten kann, und insbesondere die Träume auf einen frühen Ruhestand zu nichte macht.
"Wir betreiben einen fundamentalen, wissenschaftsbasierten Research,und halten Ausschau nach Unternehmen, die gehandelt werden in dem Zustand der Fehlinformation sowie blindwütiger Gutachten," sagte Margolies. Lachend fügte er hinzu, "Das ist gerade heutzutage vielleicht dasgrößte Problem des Biotech Universums."
Maxim`s prospects are heavily dependent on a single product.
Maxim`s Aussichten sind stark abhängig von einem einzigen Produkt.
What`s an investor to do?
Was soll der Anleger nun machen?
Other industry observers are more sanguine than Margolies on Maxim`schances of winning approval. But the risk is undeniable.
Andere Beobachter der Branche sind zuversichtlicher als Margolies,daß Maxim Chancen hat, die Genehmigung zu erhalten. Aber das Risiko ist unbestreitbar.
Share prices in biotech firms often rise as crucial dates approach,such as the release of test data, or the results of FDA deliberations-- only to fall when the news is released, even if the news is good. (See"Scotia falls after FDA rejection" and "Bane of biotechs.")
Aktienkurse der Biotech-Unternehmen steigen oft, wenn kritische Daten näher kommen, wie zum Beispiel die Veröffentlichung Testergebnissen,oder die Ergebnisse von FDA Überlegungen- - sie fallen nur, wenn die Nachrichten freigegeben werden, selbst wenn die Nachrichten gut sind.(Siehe "Scotia`s Absturz nach FDA Ablehnung" und "Der Fluch von Biotechs.")
Clever biotech traders often adapt their strategy to the calendar, eitherby hedging their positions with share options as crunch day approaches,or simply bailing out of the stock altogether.
Raffinierte Biotech Händler passen oft ihre Strategie dem Kalender an, entweder durch Absichern ihrer Positionen mit Aktien-Optionen, wenn sich der Tag "der schlechten Situation" nähert, oder einfach von der Aktie ganz und gar abspringen.
One industry professional told FTMarketWatch privately he was confidentMaxim would win
FDA approval for Maxamine against skin cancer and believes the firmhas a bright future.
Despite his optimism, he still wasn`t going to take any chances.
Ein Branchen-Fachmann hat FTMarketWatch vertraulich erzählt,daß er überzeugt ist, daß Maxim die FDA Genehmigung für Maxamine gegen Hautkrebs erhalten wird und glaubt, daß das Unternehmen eine glänzende Zukunft hat. Trotz seines Optimismus wollte er noch nicht irgendwelche Chancen wahrnehmen.
"I`m not planning to be holding any Maxim shares on Dec. 13 and 14,"the dates of the FDA advisory committee meeting, he said.
"Ich plane nicht, auch nur eine Aktie Maxim am 13. und 14. Dezember zu halten." Er sagte, das sind die Termine, an dem sich das Komitee, welches die FDA berät, trifft.
Quelle: ftmarketwatch
Wie sind Eure (Pitu,...) Meinungen dazu?
Neue Meldung: Da es eine Rattenstudie ist, ist sie klinisch gesehen nicht so relevant, uns ollte auf den Kurs wenig Einfluß haben
Maxamine Reduces Tumor Growth in Preclinical Sarcoma Study
SAN DIEGO--(BW HealthWire)--Oct. 13, 2000--Maxim Pharmaceuticals Friday announced that treatment with Maxamine®
(histamine dihydrochloride) as a single-agent therapy resulted in a significant reduction of
the growth of Leydig cell sarcoma tumors in rats.
The results are being presented by Dr. Peter Naredi, Umea University, Department of Surgery,
at the European Society of Medical Oncology (ESMO) conference in Hamburg, Germany on Sunday, Oct. 15, 2000.
Researchers at the University of Umea, Department of Surgery, and Sahlgrenska University Hospital, Departments of
Surgery and Virology, studied the effects of Maxamine in a rat model for sarcoma. In this model, fast-growing Leydig cell
sarcoma cells are implanted either in the liver or subcutaneously in rats. Animals were treated either with Maxamine
administered as a bolus subcutaneous injection, or a control. Tumor weight was recorded after 10 days of treatment. In
animals treated with bolus injections of Maxamine, liver tumors weighed 54% less (p less than 0.001) and subcutaneous
tumors weighed 37% less (p less than 0.01) than corresponding tumors in the control-treated animals.
``These results are particularly significant as they involved treatment with Maxamine as a single-agent therapy,`` said Kurt
R. Gehlsen, Maxim`s Senior Vice President, Development and Chief Technical Officer. ``In future clinical trials we may
consider expanding the testing of Maxamine beyond the Maxamine/cytokine combination upon which our current clinical
trials are based. We were also pleased to see strong results again in the liver, consistent with our experience to date with
advanced metastatic melanoma and hepatitis C.``
Sarcomas are cancerous tumors that can develop from fat, muscle, nerve, joint, blood vessel, or deep skin tissues. They can
develop in any part of the body. Half of sarcoma tumors develop in the arms or legs, and the rest arise in the trunk, head
and neck area, internal organs, or the back of the abdominal cavity. There are approximately 20,000 new cases of sarcomas
each year in the United States, Europe and Australia, and approximately 50 percent of these patients will die from these
cancers. .
Der Puhvogel
Maxamine Reduces Tumor Growth in Preclinical Sarcoma Study
SAN DIEGO--(BW HealthWire)--Oct. 13, 2000--Maxim Pharmaceuticals Friday announced that treatment with Maxamine®
(histamine dihydrochloride) as a single-agent therapy resulted in a significant reduction of
the growth of Leydig cell sarcoma tumors in rats.
The results are being presented by Dr. Peter Naredi, Umea University, Department of Surgery,
at the European Society of Medical Oncology (ESMO) conference in Hamburg, Germany on Sunday, Oct. 15, 2000.
Researchers at the University of Umea, Department of Surgery, and Sahlgrenska University Hospital, Departments of
Surgery and Virology, studied the effects of Maxamine in a rat model for sarcoma. In this model, fast-growing Leydig cell
sarcoma cells are implanted either in the liver or subcutaneously in rats. Animals were treated either with Maxamine
administered as a bolus subcutaneous injection, or a control. Tumor weight was recorded after 10 days of treatment. In
animals treated with bolus injections of Maxamine, liver tumors weighed 54% less (p less than 0.001) and subcutaneous
tumors weighed 37% less (p less than 0.01) than corresponding tumors in the control-treated animals.
``These results are particularly significant as they involved treatment with Maxamine as a single-agent therapy,`` said Kurt
R. Gehlsen, Maxim`s Senior Vice President, Development and Chief Technical Officer. ``In future clinical trials we may
consider expanding the testing of Maxamine beyond the Maxamine/cytokine combination upon which our current clinical
trials are based. We were also pleased to see strong results again in the liver, consistent with our experience to date with
advanced metastatic melanoma and hepatitis C.``
Sarcomas are cancerous tumors that can develop from fat, muscle, nerve, joint, blood vessel, or deep skin tissues. They can
develop in any part of the body. Half of sarcoma tumors develop in the arms or legs, and the rest arise in the trunk, head
and neck area, internal organs, or the back of the abdominal cavity. There are approximately 20,000 new cases of sarcomas
each year in the United States, Europe and Australia, and approximately 50 percent of these patients will die from these
cancers. .
Der Puhvogel
Hallo Puhvogel!
Schoen Dich hier zu sehen.
Ich muss sagen, dass die Lektuere der differenzierten Diskussion ueber Maxim und Avax Spass macht.
Windward
Live slow, sail fast
Schoen Dich hier zu sehen.
Ich muss sagen, dass die Lektuere der differenzierten Diskussion ueber Maxim und Avax Spass macht.
Windward
Live slow, sail fast
Additional Analysis of Maxim Phase III Advanced Metastatic Melanoma Data Presented at Oncology Conference
SAN DIEGO--(BW HealthWire)--Oct. 16, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that results from its U.S. Phase III trial of Maxamine(R) (histamine dihydrochloride) in advanced metastatic melanoma were presented at the European Society of Medical Oncology (ESMO) conference in Hamburg, Germany on Sunday, October 15, 2000. As previously reported in May 2000, the results show that the immunomodulating agent Maxamine used in combination with the cytokine interleukin-2 (IL-2) significantly improved survival for advanced metastatic melanoma patients with liver metastases compared with those treated with the same doses of IL-2 alone, and demonstrated a strong trend toward increased survival in all patients treated. The results were presented by Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute.
Included in the data presented at the conference were results of multivariate analyses using the Cox Proportional Hazard Models to assess the influence of various demographic and other prognostic characteristics on the survival benefit observed for advanced melanoma patients treated with Maxamine. The results of these analyses further confirm the significance of the survival benefit provided by Maxamine to patients with liver metastases (p=0.0017), and strengthened the trend toward improved survival in all melanoma patients treated (p=0.0612).
Under the approved protocol and statistical analysis plan for the Phase III study, the Cox Proportional Hazard test was used to evaluate demographic characteristics and other known prognostic factors for advanced melanoma patients enrolled in the trial to determine if any such factors impacted the survival benefit observed with Maxamine. As would be expected for advanced metastatic melanoma patients, these analyses demonstrated that significant predictors of survival in the study were elevated lactate dehydrogenase (LDH) levels, baseline performance status, and metastatic sites in the bone, lung, liver or central nervous system. The overall results were then tested against these and other factors in a multivariate analysis to determine if the survival benefits attributable to Maxamine were in any way influenced by differences in the baseline characteristics or prognostic factors within the two randomized arms of the study. These analyses demonstrated that there were no factors that significantly influenced one treatment group over the other, and that the two groups were well balanced with regards to risk factors.
In the primary population within the Phase III study consisting of all patients randomized into the trial with metastasis of the melanoma to their liver, multivariate analysis using the Cox`s Proportionate Hazard Model adjusted for all significant prognostic variables or baseline characteristics demonstrated that treatment with the Maxamine combination significantly improved survival over the control arm (p=0.0017). The highly significant results of the multivariate analyses demonstrate that the significant improvement in survival reported for the Phase III trial did not result from differences in demographic or prognostic characteristics between the Maxamine and control arms of the study. In the primary population consisting of all patients randomized into the trial, the multivariate analysis again demonstrated that the Maxamine survival benefit was attributable to the treatment effect of the drug, and resulted in improved survival over the control arm with a strong trend toward significance (p=0.0612). The results of the multivariate analyses demonstrate that adjusting the survival data from the trial for the prognostic or demographic factors within the patient populations provides further confirmation that the Maxamine survival benefit observed in the study did not result from any differences in such factors. Moreover, these same tests were used to determine if any one particular center or region had an influence on these results. These analyses demonstrated that no single center or geographic region had any significant influence on the trial results.
"The multivariate analyses were part of our approved statistical plan, and these results are included in the recently filed New Drug Application," said Kurt R. Gehlsen, Maxim`s Senior Vice President, Development and Chief Technical Officer. "These analyses are important as they help us ensure that the strong results from our Phase III trial are related to the effect of Maxamine as an adjuvant, as opposed to resulting from any differences in geographic region, demographics or known prognostic factors within the treatment arms. These multivariate analyses further strengthen our assessment of the Phase III study results and the benefits of Maxamine demonstrated in the study. It is notable that this Phase III study is the only large, randomized, multi-center, well-controlled trial ever conducted to demonstrate a significant survival benefit in advanced metastatic melanoma."
The Company further reported that a confirmatory and supportive U.S. Phase II trial in advanced metastatic melanoma has enrolled more than 120 patients. This study was commenced subsequent to completion of enrollment of the U.S. Phase III study to provide the top-enrolling centers in the Phase III study a vehicle to allow them to continue to treat new patients with the Maxamine combination. All patients enrolled in this study have similar inclusion criteria and are treated with the Maxamine/IL-2 combination using the same protocol as the U.S. Phase III trial. Also, included in the Phase II study is additional research regarding the biologic activity underlying the mechanism of action for the Maxamine combination therapy.
"Not only do the interim results from this Phase II study confirm the Phase III results, but the survival results for these patients that had reached the evaluable stage at last analysis was even greater than in the Phase III trial," added Dr. Gehlsen. "These data provide further support for the Phase III results and strengthen our NDA submission."
Phase III Study Overview
In March 2000 the Company completed a 305-patient Phase III clinical study in which Maxamine was tested in combination with a lower-dose regimen of IL-2 for the treatment of advanced metastatic melanoma in a randomized, well-controlled, multi-center trial in the United States. Patients were randomized by a centralized procedure to receive either combination treatment with Maxamine plus IL-2, or the same dose of IL-2 alone.
"The purpose of this study was to demonstrate that Maxamine improves patient survival when used with IL-2, not to optimize the IL-2 dose and regimen," said Dr. Gehlsen. "There has not been a randomized trial demonstrating that high-dose I.V. bolus IL-2, the original labeling for IL-2, is superior to other lower-dose off-label regimens. High-dose I.V. bolus IL-2 is not tolerable by most patients, and under the current practice today the majority of patients receive intermediate dose regimens and subcutaneous administration. The dose and regimens of both drugs used in our Phase III study were accepted under the protocol included in our U.S. investigational new drug (IND) application, and were also accepted by non-U.S. regulatory authorities."
As previously reported, treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, improved time-to-disease-progression, and improved median-quality adjusted survival over treatment with IL-2 alone. Also, as previously reported, improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis, and in all subgroups analyzed under the approved statistical plan.
The primary endpoint of the Phase III trial under the prospective statistical plan was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. With the achievement of statistically significant survival improvement in the liver metastases population (adjusted p=0.008 under the Log-Rank test), and the attainment of survival improvement tending toward significance in the overall population, the study results meet the requirements established in advance for submission of the NDA.
In July 2000, Maxim submitted an NDA to the U.S. Food and Drug Administration (FDA) seeking approval to market its lead drug Maxamine in the United States as an adjuvant to interleukin-2 for the treatment of advanced metastatic melanoma. In September, the FDA informed the Company that the NDA had been assigned priority review status and that the NDA would be reviewed under accelerated approval statutes.
Malignant melanoma is one of the most rapidly increasing cancers in the world, with approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment that increases survival for advanced stage IV melanoma.
SAN DIEGO--(BW HealthWire)--Oct. 16, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that results from its U.S. Phase III trial of Maxamine(R) (histamine dihydrochloride) in advanced metastatic melanoma were presented at the European Society of Medical Oncology (ESMO) conference in Hamburg, Germany on Sunday, October 15, 2000. As previously reported in May 2000, the results show that the immunomodulating agent Maxamine used in combination with the cytokine interleukin-2 (IL-2) significantly improved survival for advanced metastatic melanoma patients with liver metastases compared with those treated with the same doses of IL-2 alone, and demonstrated a strong trend toward increased survival in all patients treated. The results were presented by Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute.
Included in the data presented at the conference were results of multivariate analyses using the Cox Proportional Hazard Models to assess the influence of various demographic and other prognostic characteristics on the survival benefit observed for advanced melanoma patients treated with Maxamine. The results of these analyses further confirm the significance of the survival benefit provided by Maxamine to patients with liver metastases (p=0.0017), and strengthened the trend toward improved survival in all melanoma patients treated (p=0.0612).
Under the approved protocol and statistical analysis plan for the Phase III study, the Cox Proportional Hazard test was used to evaluate demographic characteristics and other known prognostic factors for advanced melanoma patients enrolled in the trial to determine if any such factors impacted the survival benefit observed with Maxamine. As would be expected for advanced metastatic melanoma patients, these analyses demonstrated that significant predictors of survival in the study were elevated lactate dehydrogenase (LDH) levels, baseline performance status, and metastatic sites in the bone, lung, liver or central nervous system. The overall results were then tested against these and other factors in a multivariate analysis to determine if the survival benefits attributable to Maxamine were in any way influenced by differences in the baseline characteristics or prognostic factors within the two randomized arms of the study. These analyses demonstrated that there were no factors that significantly influenced one treatment group over the other, and that the two groups were well balanced with regards to risk factors.
In the primary population within the Phase III study consisting of all patients randomized into the trial with metastasis of the melanoma to their liver, multivariate analysis using the Cox`s Proportionate Hazard Model adjusted for all significant prognostic variables or baseline characteristics demonstrated that treatment with the Maxamine combination significantly improved survival over the control arm (p=0.0017). The highly significant results of the multivariate analyses demonstrate that the significant improvement in survival reported for the Phase III trial did not result from differences in demographic or prognostic characteristics between the Maxamine and control arms of the study. In the primary population consisting of all patients randomized into the trial, the multivariate analysis again demonstrated that the Maxamine survival benefit was attributable to the treatment effect of the drug, and resulted in improved survival over the control arm with a strong trend toward significance (p=0.0612). The results of the multivariate analyses demonstrate that adjusting the survival data from the trial for the prognostic or demographic factors within the patient populations provides further confirmation that the Maxamine survival benefit observed in the study did not result from any differences in such factors. Moreover, these same tests were used to determine if any one particular center or region had an influence on these results. These analyses demonstrated that no single center or geographic region had any significant influence on the trial results.
"The multivariate analyses were part of our approved statistical plan, and these results are included in the recently filed New Drug Application," said Kurt R. Gehlsen, Maxim`s Senior Vice President, Development and Chief Technical Officer. "These analyses are important as they help us ensure that the strong results from our Phase III trial are related to the effect of Maxamine as an adjuvant, as opposed to resulting from any differences in geographic region, demographics or known prognostic factors within the treatment arms. These multivariate analyses further strengthen our assessment of the Phase III study results and the benefits of Maxamine demonstrated in the study. It is notable that this Phase III study is the only large, randomized, multi-center, well-controlled trial ever conducted to demonstrate a significant survival benefit in advanced metastatic melanoma."
The Company further reported that a confirmatory and supportive U.S. Phase II trial in advanced metastatic melanoma has enrolled more than 120 patients. This study was commenced subsequent to completion of enrollment of the U.S. Phase III study to provide the top-enrolling centers in the Phase III study a vehicle to allow them to continue to treat new patients with the Maxamine combination. All patients enrolled in this study have similar inclusion criteria and are treated with the Maxamine/IL-2 combination using the same protocol as the U.S. Phase III trial. Also, included in the Phase II study is additional research regarding the biologic activity underlying the mechanism of action for the Maxamine combination therapy.
"Not only do the interim results from this Phase II study confirm the Phase III results, but the survival results for these patients that had reached the evaluable stage at last analysis was even greater than in the Phase III trial," added Dr. Gehlsen. "These data provide further support for the Phase III results and strengthen our NDA submission."
Phase III Study Overview
In March 2000 the Company completed a 305-patient Phase III clinical study in which Maxamine was tested in combination with a lower-dose regimen of IL-2 for the treatment of advanced metastatic melanoma in a randomized, well-controlled, multi-center trial in the United States. Patients were randomized by a centralized procedure to receive either combination treatment with Maxamine plus IL-2, or the same dose of IL-2 alone.
"The purpose of this study was to demonstrate that Maxamine improves patient survival when used with IL-2, not to optimize the IL-2 dose and regimen," said Dr. Gehlsen. "There has not been a randomized trial demonstrating that high-dose I.V. bolus IL-2, the original labeling for IL-2, is superior to other lower-dose off-label regimens. High-dose I.V. bolus IL-2 is not tolerable by most patients, and under the current practice today the majority of patients receive intermediate dose regimens and subcutaneous administration. The dose and regimens of both drugs used in our Phase III study were accepted under the protocol included in our U.S. investigational new drug (IND) application, and were also accepted by non-U.S. regulatory authorities."
As previously reported, treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, improved time-to-disease-progression, and improved median-quality adjusted survival over treatment with IL-2 alone. Also, as previously reported, improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis, and in all subgroups analyzed under the approved statistical plan.
The primary endpoint of the Phase III trial under the prospective statistical plan was survival duration evaluated by comparing Kaplan-Meier survival curves using the Log-Rank statistical method. With the achievement of statistically significant survival improvement in the liver metastases population (adjusted p=0.008 under the Log-Rank test), and the attainment of survival improvement tending toward significance in the overall population, the study results meet the requirements established in advance for submission of the NDA.
In July 2000, Maxim submitted an NDA to the U.S. Food and Drug Administration (FDA) seeking approval to market its lead drug Maxamine in the United States as an adjuvant to interleukin-2 for the treatment of advanced metastatic melanoma. In September, the FDA informed the Company that the NDA had been assigned priority review status and that the NDA would be reviewed under accelerated approval statutes.
Malignant melanoma is one of the most rapidly increasing cancers in the world, with approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia. At present, there is no effective treatment that increases survival for advanced stage IV melanoma.
Ist das die Antwort von Maxim auf den kritischen Bericht von Avalon Research ?
hallo,
ein beitrag zu Interleukin II kann unter der unten stehenden adresse gelesen werde.
http://www.lifescience.de/news/news_frame.html
mfg
chester
ein beitrag zu Interleukin II kann unter der unten stehenden adresse gelesen werde.
http://www.lifescience.de/news/news_frame.html
mfg
chester
Noch eine Mäusetudie, die ich aber für durchaus sehr interessant halte.
http://biz.yahoo.com/bw/001027/ca_maxim_p.html
Maxamine Provides Protection From Toxicity Induced by Interleukin-2 in Preclinical Study
SAN DIEGO--(BW HealthWire)--Oct. 27, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM - news;
SSE:MAXM) announced that the addition of Maxamine® (histamine dihydrochloride) to interleukin-2
(IL-2) reduced the toxicity and mortality associated with vascular leak syndrome induced by IL-2 in a
preclinical mouse model.
The results will be presented by Dr. Diana M. Orentas, Maxim researcher, at the Society of Biological Therapy meeting in Seattle, on
October 28 and 29.
Vascular leak syndrome is a potentially deadly side effect associated with the very high dose regimens of IL-2. The company`s lead
drug candidate Maxamine has been studied in an extensive series of clinical studies as an adjuvant to IL-2 in the treatment of
advanced metastatic melanoma, acute myelogenous leukemia and renal cell carcinoma patients. The purpose of the preclinical study
was to test the hypothesis that the addition of Maxamine would not worsen IL-2-induced vascular leak syndrome in mice.
In the study, Maxamine administration prior to, or after, the administration of IL-2 demonstrated a dose-dependent protective effect
with regards to IL-2-induced toxicity and protection from death of the animals. For all three doses of IL-2 studied, the administration
of Maxamine resulted in a more than doubling in the rate of survival compared to the group administered IL-2 alone. In addition, the
data indicate that the protective benefit from IL-2-induced toxicity demonstrated by the administration of Maxamine is due to a
reduction in vascular leak syndrome-associated pulmonary edema.
``A surprisingly positive finding from this study was that the addition of Maxamine actually reduced mortality in this model,`` said
Kurt R. Gehlsen, Maxim`s senior vice president, development and chief technical officer. ``Furthermore, this study complements the
safety results from our Phase III trial in advanced metastatic melanoma that demonstrated that treatment with the combination of
Maxamine and IL-2 was safe and could be administered by patients in their own homes. These preclinical data may also provide
further insight into our Phase III trial results that demonstrated that median quality-adjusted survival was significantly improved, and
that quality of life scores tended to be higher, for patients administered the Maxamine/IL-2 combination compared to patients treated
with IL-2 alone.``
Reduktion von Nebenwirkungen von Standardtherapien ist ein netter Nebeneffekt. Nee, short sein mchte ich bei Maxim gewiß nicht.
http://biz.yahoo.com/bw/001027/ca_maxim_p.html
Maxamine Provides Protection From Toxicity Induced by Interleukin-2 in Preclinical Study
SAN DIEGO--(BW HealthWire)--Oct. 27, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM - news;
SSE:MAXM) announced that the addition of Maxamine® (histamine dihydrochloride) to interleukin-2
(IL-2) reduced the toxicity and mortality associated with vascular leak syndrome induced by IL-2 in a
preclinical mouse model.
The results will be presented by Dr. Diana M. Orentas, Maxim researcher, at the Society of Biological Therapy meeting in Seattle, on
October 28 and 29.
Vascular leak syndrome is a potentially deadly side effect associated with the very high dose regimens of IL-2. The company`s lead
drug candidate Maxamine has been studied in an extensive series of clinical studies as an adjuvant to IL-2 in the treatment of
advanced metastatic melanoma, acute myelogenous leukemia and renal cell carcinoma patients. The purpose of the preclinical study
was to test the hypothesis that the addition of Maxamine would not worsen IL-2-induced vascular leak syndrome in mice.
In the study, Maxamine administration prior to, or after, the administration of IL-2 demonstrated a dose-dependent protective effect
with regards to IL-2-induced toxicity and protection from death of the animals. For all three doses of IL-2 studied, the administration
of Maxamine resulted in a more than doubling in the rate of survival compared to the group administered IL-2 alone. In addition, the
data indicate that the protective benefit from IL-2-induced toxicity demonstrated by the administration of Maxamine is due to a
reduction in vascular leak syndrome-associated pulmonary edema.
``A surprisingly positive finding from this study was that the addition of Maxamine actually reduced mortality in this model,`` said
Kurt R. Gehlsen, Maxim`s senior vice president, development and chief technical officer. ``Furthermore, this study complements the
safety results from our Phase III trial in advanced metastatic melanoma that demonstrated that treatment with the combination of
Maxamine and IL-2 was safe and could be administered by patients in their own homes. These preclinical data may also provide
further insight into our Phase III trial results that demonstrated that median quality-adjusted survival was significantly improved, and
that quality of life scores tended to be higher, for patients administered the Maxamine/IL-2 combination compared to patients treated
with IL-2 alone.``
Reduktion von Nebenwirkungen von Standardtherapien ist ein netter Nebeneffekt. Nee, short sein mchte ich bei Maxim gewiß nicht.
Moin!
Süßes oder Saures???
Tuesday October 31, 3:41 am Eastern Time
Press Release
Maxim Reports 12-Week Results From Hepatitis C Study in
Nonresponder Patients
Interim Results from First Study with Maxamine® Triple-Drug Combination Reported at
Liver Disease Conference
SAN DIEGO--(BW HealthWire)--Oct. 31, 2000-- Maxim Pharmaceuticals (Nasdaq NM: MAXM - news; SSE: MAXM) announced the
12-week results from its clinical study to evaluate the safety of triple-drug therapy incorporating the Company`s lead drug
Maxamine (histamine dihydrochloride) in patients with chronic hepatitis C infection. The study is designed to evaluate the
feasibility and safety of treatment with Maxamine in combination with the immunotherapeutic agent interferon-alpha (IFN-alpha)
and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy or relapsed after prior therapy.
After 12 weeks of therapy, the triple-drug Maxamine combination achieved a complete biochemical response, defined as
normalization of liver enzyme levels, in 100 percent of the 13 evaluable patients included in the study, and 62 percent of the
evaluable patients had a greater than two-log decrease in viral load or were complete responders. The results will be presented
today at the American Association for the Study of Liver Diseases (AASLD) conference in Dallas by the principal investigator of
the study, Yoav Lurie M.D., Liver Clinic Director, Kaplan Medical Center, Israel.
``These interim results are very encouraging as they suggest that triple-drug therapy with the combination of Maxamine,
interferon and ribavirin in hepatitis C patients is safe and is not associated with any unexpected or irreversible side effects,`` said
Dr. Lurie. ``These results demonstrate that triple-drug therapy with Maxamine may be safely advanced into pivotal, large-scale
trials in hepatitis C.``
The patients enrolled in the study had failed to respond to prior treatment for hepatitis C or had relapsed. Patients in the study
were able to treat themselves at home with the Maxamine combination, and no safety concerns have been raised to date in the
study. The majority of the patients had extremely unfavorable baseline characteristics, and 83 percent had the genotype-1
variant of the virus. Furthermore, 89 percent of the patients had viral levels greater than two million copies per milliliter of blood.
In addition to the achievement of a complete biochemical response in 100 percent of the evaluable patients after 12 weeks of
treatment, 62 percent (8/13) of the evaluable patients achieved greater than a two-log reduction in viral load, characterized as
``rapid responses``. Of these rapid responders, 31 percent (4/13) of the patients achieved a complete viral response at 12 weeks.
Two additional patients have achieved a complete viral response subsequent to 12 weeks of therapy, therefore a total of 46
percent (6/13) of the patients have achieved a complete viral response to date in the study. Five patients enrolled in the study
were unevaluable as they did not complete 12 weeks of therapy.
``Typically, a rapid response to hepatitis C treatment, or a complete response by week 12, is a strong indicator of longer-term
sustained response,`` said Dr. Yoav Lurie. ``As the majority of hepatitis C patients do not attain a sustained response with the
therapies available today, the nonresponder group is a growing and significant population in great need of more effective
therapies.``
Maxamine in Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S.
Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The
World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver
tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts
estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is
the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do
not effectively respond to existing therapies.
In addition to the triple-drug non-responder trial, Maxamine is also being tested in a Phase II dose-ranging study in combination
with IFN-alpha in the treatment of naive, chronically infected hepatitis C patients. After 48 weeks of therapy, the combination of
the optimal dosing regimen of Maxamine and IFN-alpha achieved a complete viral response in 61 percent of all patients,
compared to the 29 percent or less response that is commonly observed in patients treated with IFN-alpha alone.
``Based upon the clinical results achieved to date, we are currently planning two Phase III clinical trials in hepatitis C in
collaboration with F. Hoffmann - La Roche using the combination of Maxamine with pegylated interferon and ribavirin,`` stated
Kurt Gehlsen, Ph.D., Maxim`s Senior Vice President, Development and Chief Technical Officer. ``We believe that Maxamine in
combination with emerging new treatments based on the pegylated form of interferon may be synergistic and substantially
improve outcomes for naive patients as well as for patients who were previously nonresponsive to therapy or relapsed.``
The Company expects to conduct its Phase III studies under the umbrella of a comprehensive development collaboration with F.
Hoffmann - La Roche for the clinical development and approval of Maxamine in combination with Pegasys®, Roche`s pegylated
(sustained release) IFN-alpha agent. The collaboration program will include two Phase III trials of the Maxamine, Pegasys and
ribavirin combination for the treatment of hepatitis C, one in naive patients, and one in patients who were nonresponsive to prior
therapy.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune
system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases.
Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of
therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical
immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and IFN-alpha, a class of proteins that
stimulate these same immune cells. More than 1,300 patients have been treated in the Company`s completed and ongoing
clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is
an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international
regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in
combination with cytokines, is a safe, at-home treatment that may improve patient survival.
In July 2000 the Company submitted a New Drug Application (NDA) to the FDA seeking approval to market Maxamine in the
United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In September 2000 the FDA informed
the Company that the NDA had been accepted for review as filed, and that the NDA had been granted priority review status and
would be reviewed under the accelerated approval statutes. In addition, Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of
Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer,
infectious diseases, degenerative diseases and topical disorders. In addition to Maxamine, the Company is also developing
product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out
the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit
caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking
statements include statements regarding the efficacy and intended utilization of Maxamine, MaxDerm and the Company`s
caspase modulator technologies, and regarding Maxim`s clinical trials. Such statements are only predictions and the Company`s
actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such
differences include the risk that the Company will not obtain approval to market its products, the risk that products that
appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials, and the risk that
clinical trials may not commence when planned. These factors and others are more fully discussed in the Company`s periodic
reports and other filings with the Securities and Exchange Commission.
Note: Maxamine®, Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com.
BM
Süßes oder Saures???
Tuesday October 31, 3:41 am Eastern Time
Press Release
Maxim Reports 12-Week Results From Hepatitis C Study in
Nonresponder Patients
Interim Results from First Study with Maxamine® Triple-Drug Combination Reported at
Liver Disease Conference
SAN DIEGO--(BW HealthWire)--Oct. 31, 2000-- Maxim Pharmaceuticals (Nasdaq NM: MAXM - news; SSE: MAXM) announced the
12-week results from its clinical study to evaluate the safety of triple-drug therapy incorporating the Company`s lead drug
Maxamine (histamine dihydrochloride) in patients with chronic hepatitis C infection. The study is designed to evaluate the
feasibility and safety of treatment with Maxamine in combination with the immunotherapeutic agent interferon-alpha (IFN-alpha)
and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy or relapsed after prior therapy.
After 12 weeks of therapy, the triple-drug Maxamine combination achieved a complete biochemical response, defined as
normalization of liver enzyme levels, in 100 percent of the 13 evaluable patients included in the study, and 62 percent of the
evaluable patients had a greater than two-log decrease in viral load or were complete responders. The results will be presented
today at the American Association for the Study of Liver Diseases (AASLD) conference in Dallas by the principal investigator of
the study, Yoav Lurie M.D., Liver Clinic Director, Kaplan Medical Center, Israel.
``These interim results are very encouraging as they suggest that triple-drug therapy with the combination of Maxamine,
interferon and ribavirin in hepatitis C patients is safe and is not associated with any unexpected or irreversible side effects,`` said
Dr. Lurie. ``These results demonstrate that triple-drug therapy with Maxamine may be safely advanced into pivotal, large-scale
trials in hepatitis C.``
The patients enrolled in the study had failed to respond to prior treatment for hepatitis C or had relapsed. Patients in the study
were able to treat themselves at home with the Maxamine combination, and no safety concerns have been raised to date in the
study. The majority of the patients had extremely unfavorable baseline characteristics, and 83 percent had the genotype-1
variant of the virus. Furthermore, 89 percent of the patients had viral levels greater than two million copies per milliliter of blood.
In addition to the achievement of a complete biochemical response in 100 percent of the evaluable patients after 12 weeks of
treatment, 62 percent (8/13) of the evaluable patients achieved greater than a two-log reduction in viral load, characterized as
``rapid responses``. Of these rapid responders, 31 percent (4/13) of the patients achieved a complete viral response at 12 weeks.
Two additional patients have achieved a complete viral response subsequent to 12 weeks of therapy, therefore a total of 46
percent (6/13) of the patients have achieved a complete viral response to date in the study. Five patients enrolled in the study
were unevaluable as they did not complete 12 weeks of therapy.
``Typically, a rapid response to hepatitis C treatment, or a complete response by week 12, is a strong indicator of longer-term
sustained response,`` said Dr. Yoav Lurie. ``As the majority of hepatitis C patients do not attain a sustained response with the
therapies available today, the nonresponder group is a growing and significant population in great need of more effective
therapies.``
Maxamine in Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S.
Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The
World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver
tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts
estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is
the leading cause of liver cancer and the primary reason for liver transplantation in many countries. The majority of patients do
not effectively respond to existing therapies.
In addition to the triple-drug non-responder trial, Maxamine is also being tested in a Phase II dose-ranging study in combination
with IFN-alpha in the treatment of naive, chronically infected hepatitis C patients. After 48 weeks of therapy, the combination of
the optimal dosing regimen of Maxamine and IFN-alpha achieved a complete viral response in 61 percent of all patients,
compared to the 29 percent or less response that is commonly observed in patients treated with IFN-alpha alone.
``Based upon the clinical results achieved to date, we are currently planning two Phase III clinical trials in hepatitis C in
collaboration with F. Hoffmann - La Roche using the combination of Maxamine with pegylated interferon and ribavirin,`` stated
Kurt Gehlsen, Ph.D., Maxim`s Senior Vice President, Development and Chief Technical Officer. ``We believe that Maxamine in
combination with emerging new treatments based on the pegylated form of interferon may be synergistic and substantially
improve outcomes for naive patients as well as for patients who were previously nonresponsive to therapy or relapsed.``
The Company expects to conduct its Phase III studies under the umbrella of a comprehensive development collaboration with F.
Hoffmann - La Roche for the clinical development and approval of Maxamine in combination with Pegasys®, Roche`s pegylated
(sustained release) IFN-alpha agent. The collaboration program will include two Phase III trials of the Maxamine, Pegasys and
ribavirin combination for the treatment of hepatitis C, one in naive patients, and one in patients who were nonresponsive to prior
therapy.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune
system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases.
Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of
therapies that employ the body`s immune system to fight cancer and certain infectious diseases. Maxamine protects critical
immune cells and is administered in combination with cytokines such as interleukin-2 (IL-2) and IFN-alpha, a class of proteins that
stimulate these same immune cells. More than 1,300 patients have been treated in the Company`s completed and ongoing
clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is
an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international
regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in
combination with cytokines, is a safe, at-home treatment that may improve patient survival.
In July 2000 the Company submitted a New Drug Application (NDA) to the FDA seeking approval to market Maxamine in the
United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In September 2000 the FDA informed
the Company that the NDA had been accepted for review as filed, and that the NDA had been granted priority review status and
would be reviewed under the accelerated approval statutes. In addition, Maxamine is also currently being tested in two additional
Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of
Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer,
infectious diseases, degenerative diseases and topical disorders. In addition to Maxamine, the Company is also developing
product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out
the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit
caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer,
cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking
statements include statements regarding the efficacy and intended utilization of Maxamine, MaxDerm and the Company`s
caspase modulator technologies, and regarding Maxim`s clinical trials. Such statements are only predictions and the Company`s
actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such
differences include the risk that the Company will not obtain approval to market its products, the risk that products that
appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials, and the risk that
clinical trials may not commence when planned. These factors and others are more fully discussed in the Company`s periodic
reports and other filings with the Securities and Exchange Commission.
Note: Maxamine®, Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com.
BM
Süß.
BTW: Ich besitze keine
BTW: Ich besitze keine
Habe gerade den Rechenschaftsbericht der Nordinvest durchgesehen.
In deren Biotech-Fond NordGenetics befindet sich zwischen Namen wie Amgen, Biogen, Genentech, IDEC und Millennium auch zu 0,67 % Maxim.
In deren Biotech-Fond NordGenetics befindet sich zwischen Namen wie Amgen, Biogen, Genentech, IDEC und Millennium auch zu 0,67 % Maxim.
Cell Genesys, EntreMed, Maxim Among Companies Presenting at BioEurope 2000 Webcast by InformedInvestors.com Nov. 14-15
BERLIN, Nov. 13 /PRNewswire/ -- Biotechnology is not exclusive to U.S. companies, to be sure. For instance, BioEurope 2000, now underway, is a partnering conference designed to introduce biotechnology companies to European financiers, pharmaceutical companies, and service providers.
And while the conference may take place in Berlin, investors worldwide need not understand German, climb a wall or have plane tickets to attend. That`s because Informed Investors will be webcasting the event live at www.InformedInvestors.com (Click on the Bio-Europe 2000 link.) beginning at 2 p.m. EST Tuesday until 7 p.m. Presentations will also be carried on Wednesday. All will also be archived for later review.
Nearly 60 companies will have presentations webcast, including Cell Genesys (Nasdaq: CEGE), EntreMed, (Nasdaq: ENMD) and Maxim Pharmaceuticals (Nasdaq: MAXM).
Cell Genesys` CEO, Stephen Sherwin, M.D., will discuss his company`s research and product development efforts on human disease therapies that are based on gene modification technologies. Cell Genesys recently agreed to sell 750,000 of its shares of Abgenix, Inc., effectively increasing its cash position.
Joanna Horobin, MD, executive vice president of EntreMed, will update investors on the company`s progress developing anti-angiogenesis drugs. The discovery that angiogenesis, or the creation of new blood vessels, is vital to a tumor`s survival has been the basis for the hottest area in cancer research. EntreMed is currently testing a new cancer drug that cuts off blood supply to cancerous tumor to stop growth.
Larry Stambaugh, president and CEO of Maxim Pharmaceuticals, will present his company`s prospects as a development-stage company acquiring a new generation of drugs, therapies and vaccines for cancer, infectious diseases and topical disorders. The company`s lead drug candidate, MAXAMINE, is currently being tested in three Phase III cancer clinical trials in 12 countries around the world.
The conference runs for three days beginning today, but today`s schedule will not be webcast. For more information regarding BioEurope 2000 go to: http://www.ebdgroup.com/bio2000/index.htm .
InformedInvestors.com is the conduit for unfiltered communication between individual investors and the executives of technology and biotechnology companies. Live virtual and onsite Forums, special webcasts, original editorial pieces and widely followed weekly radio shows, "BioTalk" and "Tech Check," put individual investors in the analyst`s chair.
BERLIN, Nov. 13 /PRNewswire/ -- Biotechnology is not exclusive to U.S. companies, to be sure. For instance, BioEurope 2000, now underway, is a partnering conference designed to introduce biotechnology companies to European financiers, pharmaceutical companies, and service providers.
And while the conference may take place in Berlin, investors worldwide need not understand German, climb a wall or have plane tickets to attend. That`s because Informed Investors will be webcasting the event live at www.InformedInvestors.com (Click on the Bio-Europe 2000 link.) beginning at 2 p.m. EST Tuesday until 7 p.m. Presentations will also be carried on Wednesday. All will also be archived for later review.
Nearly 60 companies will have presentations webcast, including Cell Genesys (Nasdaq: CEGE), EntreMed, (Nasdaq: ENMD) and Maxim Pharmaceuticals (Nasdaq: MAXM).
Cell Genesys` CEO, Stephen Sherwin, M.D., will discuss his company`s research and product development efforts on human disease therapies that are based on gene modification technologies. Cell Genesys recently agreed to sell 750,000 of its shares of Abgenix, Inc., effectively increasing its cash position.
Joanna Horobin, MD, executive vice president of EntreMed, will update investors on the company`s progress developing anti-angiogenesis drugs. The discovery that angiogenesis, or the creation of new blood vessels, is vital to a tumor`s survival has been the basis for the hottest area in cancer research. EntreMed is currently testing a new cancer drug that cuts off blood supply to cancerous tumor to stop growth.
Larry Stambaugh, president and CEO of Maxim Pharmaceuticals, will present his company`s prospects as a development-stage company acquiring a new generation of drugs, therapies and vaccines for cancer, infectious diseases and topical disorders. The company`s lead drug candidate, MAXAMINE, is currently being tested in three Phase III cancer clinical trials in 12 countries around the world.
The conference runs for three days beginning today, but today`s schedule will not be webcast. For more information regarding BioEurope 2000 go to: http://www.ebdgroup.com/bio2000/index.htm .
InformedInvestors.com is the conduit for unfiltered communication between individual investors and the executives of technology and biotechnology companies. Live virtual and onsite Forums, special webcasts, original editorial pieces and widely followed weekly radio shows, "BioTalk" and "Tech Check," put individual investors in the analyst`s chair.
maxim heute gegen den trend bei den biotechs deutlich fester. ist doch auch mal etwas.
Neues zu Maxim aus dem BO-Board
Maxim Receives SBIR Grant From National Cancer Institute for Testing of
Caspase Inducer Compound as Anti-Cancer Agent
SAN DIEGO--(BW HealthWire)--Nov. 29, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM
- news; SSE:MAXM) announced
that it has received a $100,000 Phase 1 Small Business Innovation and Research (SBIR)
grant from the National Cancer Institute
(NCI) for testing of its MX2060 compound as a potential anti-cancer agent.
Under the grant program, Maxim will evaluate the efficacy of MX2060 in a number of
preclinical human cancer xenograft animal models, and will determine the
compound`s molecular target and mechanism of action.
MX2060 is designed to induce the death of certain cancer cells by inducing caspases,
key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as apoptosis. MX2060 was discovered
using Maxim`s proprietary high-throughput screening technology that the
company is using to identify compounds that either inhibit or induce caspases. Early
research suggests that MX2060 may induce caspases in tumor cells derived from
a number of difficult to treat human cancers, including breast and prostate cancers. In
addition to MX2060, the company has identified a number of additional
caspase-inducing compounds that are currently being evaluated to select drug
candidates for clinical testing as anti-cancer agents.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced
drugs and therapies for cancer, infectious diseases, degenerative diseases
and topical disorders. In July 2000 the company submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to
market Maxamine® in the United States as an adjuvant to IL-2 for the treatment of
advanced metastatic melanoma. In September 2000 the FDA informed the
company that the NDA had been accepted for review as filed, and that the NDA had been
granted priority review status and would be reviewed under the
accelerated approval statutes. In addition, Maxamine is also currently being tested in two
additional Phase III cancer clinical trials in 12 countries for malignant
melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also
underway for the treatment of hepatitis C and advanced renal cell carcinoma.
The company has also developed product candidates based on its MaxDerm(TM)
technology that are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles,
burns and related conditions. Furthermore, Maxim is also developing
small-molecule inhibitors and inducers of caspases, key enzymes that modulate and
carry out the cellular signaling pathways involved in programmed cell death, also
known as apoptosis. Compounds that can either inhibit caspases or induce caspases
may form the basis for important new drugs for a wide variety of disease
targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Maxamine, MaxDerm and the caspase compounds,
and regarding Maxim`s clinical trials and preclinical development efforts. Such
statements are only predictions and Maxim`s actual results may differ materially from
those anticipated in these forward-looking statements. Factors that may cause
such differences include the risk that products that appeared promising in early research
and clinical trials do not demonstrate safety or efficacy in larger-scale clinical
trials, the risk that clinical trials may not commence when planned, if at all, and the risk
that Maxim will not obtain approval to market its products. These factors and
others are more fully discussed in Maxim`s periodic reports and other filings with the
Securities and Exchange Commission.
Note: Maxamine®, Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of Maxim Pharmaceuticals.
Grüße, insbesondere an Pitu
LeNeant
Maxim Receives SBIR Grant From National Cancer Institute for Testing of
Caspase Inducer Compound as Anti-Cancer Agent
SAN DIEGO--(BW HealthWire)--Nov. 29, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM
- news; SSE:MAXM) announced
that it has received a $100,000 Phase 1 Small Business Innovation and Research (SBIR)
grant from the National Cancer Institute
(NCI) for testing of its MX2060 compound as a potential anti-cancer agent.
Under the grant program, Maxim will evaluate the efficacy of MX2060 in a number of
preclinical human cancer xenograft animal models, and will determine the
compound`s molecular target and mechanism of action.
MX2060 is designed to induce the death of certain cancer cells by inducing caspases,
key enzymes that modulate and carry out the cellular signaling pathways
involved in programmed cell death, also known as apoptosis. MX2060 was discovered
using Maxim`s proprietary high-throughput screening technology that the
company is using to identify compounds that either inhibit or induce caspases. Early
research suggests that MX2060 may induce caspases in tumor cells derived from
a number of difficult to treat human cancers, including breast and prostate cancers. In
addition to MX2060, the company has identified a number of additional
caspase-inducing compounds that are currently being evaluated to select drug
candidates for clinical testing as anti-cancer agents.
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced
drugs and therapies for cancer, infectious diseases, degenerative diseases
and topical disorders. In July 2000 the company submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to
market Maxamine® in the United States as an adjuvant to IL-2 for the treatment of
advanced metastatic melanoma. In September 2000 the FDA informed the
company that the NDA had been accepted for review as filed, and that the NDA had been
granted priority review status and would be reviewed under the
accelerated approval statutes. In addition, Maxamine is also currently being tested in two
additional Phase III cancer clinical trials in 12 countries for malignant
melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also
underway for the treatment of hepatitis C and advanced renal cell carcinoma.
The company has also developed product candidates based on its MaxDerm(TM)
technology that are designed for the treatment of medical conditions for which
topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles,
burns and related conditions. Furthermore, Maxim is also developing
small-molecule inhibitors and inducers of caspases, key enzymes that modulate and
carry out the cellular signaling pathways involved in programmed cell death, also
known as apoptosis. Compounds that can either inhibit caspases or induce caspases
may form the basis for important new drugs for a wide variety of disease
targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and
uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Maxamine, MaxDerm and the caspase compounds,
and regarding Maxim`s clinical trials and preclinical development efforts. Such
statements are only predictions and Maxim`s actual results may differ materially from
those anticipated in these forward-looking statements. Factors that may cause
such differences include the risk that products that appeared promising in early research
and clinical trials do not demonstrate safety or efficacy in larger-scale clinical
trials, the risk that clinical trials may not commence when planned, if at all, and the risk
that Maxim will not obtain approval to market its products. These factors and
others are more fully discussed in Maxim`s periodic reports and other filings with the
Securities and Exchange Commission.
Note: Maxamine®, Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are
trademarks of Maxim Pharmaceuticals.
Grüße, insbesondere an Pitu
LeNeant
Maxim Pharmaceuticals Announces Fiscal 2000 Financial Results
SAN DIEGO--(BW HealthWire)--Dec. 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM: MAXM)(SSE: MAXM) today announced financial results for the fourth quarter and the year ended September 30, 2000. The net loss applicable to common stock for the fourth quarter totaled $9.2 million, or $0.40 per share, compared to a net loss applicable to common stock of $10.6 million, or $1.04 per share, for the same period of the prior year. Revenue from collaborations was $1.0 million in the fourth quarter of fiscal 2000, compared to $0.2 million for the same period of the prior year.
The net loss applicable to common stock for the year ended September 30, 2000 totaled $82.5 million, or $4.58 per share, compared to a net loss applicable to common stock of $39.7 million, or $3.94 per share, for the prior year. The net loss for fiscal 2000 includes three non-recurring events, the $42.3 million non-cash write off of in-process technology related to the acquisition of Cytovia, Inc., the $2.1 million gain related to the sale of a vaccine-carrier technology, and $5.0 million in dividends related to preferred stock that was converted to common stock during the year. Excluding the effect of these three nonrecurring events, the net loss for the year ended September 30, 2000 was $37.3 million, or $2.07 per share, a decrease from the loss incurred during the prior year.
The Company had cash, cash equivalents and investments totaling $190.4 million at September 30, 2000, and used net cash of $37.4 million in its operations during the year ended September 30, 2000.
"Our cash burn for fiscal 2000 was well within our expectations, and we enter fiscal 2001 with a strong cash position that will allow us to undertake the planned commercial launch of Maxamine(R) and to pursue the development of our other high-potential opportunities," said Dale A. Sander, Maxim`s Senior Vice President, Finance and Chief Financial Officer. "The planned U.S. launch of Maxamine, including the build up of our sales force and the related promotional activities, may result in fiscal 2001 sales and marketing expenses of approximately $25 million if the product candidate receives approval during the first six months of the fiscal year. In addition, our current product development plans, including the expanded clinical development of Maxamine and the integration of Cytovia into our operations, may increase our research and development expenses by approximately 40 percent."
The Company invites interested parties to participate in a conference call today, December 1, 2000, at 10:00 a.m. Eastern Standard Time (4:00 p.m. European Continent Time) to discuss the fiscal 2000 financial results and milestones. Interested persons should call 800-777-4086 in the United States and +1-212-896-6112 outside the United States. To hear a replay of this call for 24 hours starting one hour after the conference call is completed, please call 800-633-8284 or 858-812-6440 and ask to be connected to call number 17080164. To access the live call or an archive of the call for seven days online, please log onto http://www.maxim.com.
Company Overview
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. In July 2000 the Company submitted a New Drug Application (NDA) to the FDA seeking approval to market its lead drug Maxamine (histamine dihydrochloride) in the United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In September 2000 the FDA informed the Company that the NDA had been accepted for review as filed, and that the NDA had been granted priority review status and would be reviewed under the accelerated approval statutes. Maxamine will be reviewed by the Oncology Drugs Advisory Committee (ODAC) panel at its next meeting on Wednesday, December 13, 2000 at 1:30 p.m. Eastern Standard Time. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,300 patients have been treated in completed and ongoing clinical trials.
The Company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine, MaxDerm and the caspase modulator technologies and the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products and the risks associated with dependence upon collaborative partners. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com.
MAXIM PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS (unaudited)
Three Months Ended Year Ended
Sept. 30, Sept. 30,
2000 1999 2000 1999
Collaboration and
research revenue $ 956,867 $ 187,500 $1,384,617 $1,077,800
Operating expenses:
Research and
development 8,679,490 9,591,525 36,387,151 36,637,714
Marketing and business
development 2,706,922 354,837 5,126,930 1,682,664
General and
administrative 1,314,709 557,408 4,478,665 2,880,647
Amortization of
goodwill and other
acquisition-related
intangible assets 638,203 -- 744,570 --
Purchased in-process
technology -- -- 42,300,000 --
Total operating
expenses 13,339,324 10,503,770 89,037,316 41,201,025
Other income (expense):
Investment income 3,235,563 188,544 8,085,836 1,023,013
Gain on sale of assets -- -- 2,146,502 --
Interest expense (40,112) (33,511) (91,615) (146,056)
Other income (expense) 12,667 -- 22,930 19,918
Total other income
(expense) 3,208,118 155,033 10,163,653 896,875
Net loss before preferred
stock dividends (9,174,339) (10,161,237)(77,489,046)(39,226,350)
Dividends on preferred
stock -- 482,844 5,012,839 482,844
Net loss applicable to
common stock (9,174,339) (10,644,081)(82,501,885)(39,709,194)
$ (0.40) $ (1.04) $ (4.58) $ (3.94)
Weighted average shares
outstanding 22,886,802 10,203,850 18,018,317 10,078,765
BALANCE SHEET INFORMATION
Sept. 30, 2000 Sept. 30, 1999
(Unaudited)
ASSETS
Cash, cash equivalents and
investments $ 190,364,829 $ 17,942,340
Total assets 237,418,824 24,515,341
Long-term liabilities 1,541,968 908,380
Stockholders` equity 220,524,249 10,843,210
CONTACT: Maxim Pharmaceuticals
Larry G. Stambaugh or Dale A. Sander, 858/453-4040
or
Burns McClellan
Ethan Denkensohn (investors) or Justin Jackson (media)
212/213-0006
SAN DIEGO--(BW HealthWire)--Dec. 1, 2000--Maxim Pharmaceuticals, Inc. (Nasdaq NM: MAXM)(SSE: MAXM) today announced financial results for the fourth quarter and the year ended September 30, 2000. The net loss applicable to common stock for the fourth quarter totaled $9.2 million, or $0.40 per share, compared to a net loss applicable to common stock of $10.6 million, or $1.04 per share, for the same period of the prior year. Revenue from collaborations was $1.0 million in the fourth quarter of fiscal 2000, compared to $0.2 million for the same period of the prior year.
The net loss applicable to common stock for the year ended September 30, 2000 totaled $82.5 million, or $4.58 per share, compared to a net loss applicable to common stock of $39.7 million, or $3.94 per share, for the prior year. The net loss for fiscal 2000 includes three non-recurring events, the $42.3 million non-cash write off of in-process technology related to the acquisition of Cytovia, Inc., the $2.1 million gain related to the sale of a vaccine-carrier technology, and $5.0 million in dividends related to preferred stock that was converted to common stock during the year. Excluding the effect of these three nonrecurring events, the net loss for the year ended September 30, 2000 was $37.3 million, or $2.07 per share, a decrease from the loss incurred during the prior year.
The Company had cash, cash equivalents and investments totaling $190.4 million at September 30, 2000, and used net cash of $37.4 million in its operations during the year ended September 30, 2000.
"Our cash burn for fiscal 2000 was well within our expectations, and we enter fiscal 2001 with a strong cash position that will allow us to undertake the planned commercial launch of Maxamine(R) and to pursue the development of our other high-potential opportunities," said Dale A. Sander, Maxim`s Senior Vice President, Finance and Chief Financial Officer. "The planned U.S. launch of Maxamine, including the build up of our sales force and the related promotional activities, may result in fiscal 2001 sales and marketing expenses of approximately $25 million if the product candidate receives approval during the first six months of the fiscal year. In addition, our current product development plans, including the expanded clinical development of Maxamine and the integration of Cytovia into our operations, may increase our research and development expenses by approximately 40 percent."
The Company invites interested parties to participate in a conference call today, December 1, 2000, at 10:00 a.m. Eastern Standard Time (4:00 p.m. European Continent Time) to discuss the fiscal 2000 financial results and milestones. Interested persons should call 800-777-4086 in the United States and +1-212-896-6112 outside the United States. To hear a replay of this call for 24 hours starting one hour after the conference call is completed, please call 800-633-8284 or 858-812-6440 and ask to be connected to call number 17080164. To access the live call or an archive of the call for seven days online, please log onto http://www.maxim.com.
Company Overview
Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. In July 2000 the Company submitted a New Drug Application (NDA) to the FDA seeking approval to market its lead drug Maxamine (histamine dihydrochloride) in the United States as an adjuvant to IL-2 for the treatment of advanced metastatic melanoma. In September 2000 the FDA informed the Company that the NDA had been accepted for review as filed, and that the NDA had been granted priority review status and would be reviewed under the accelerated approval statutes. Maxamine will be reviewed by the Oncology Drugs Advisory Committee (ODAC) panel at its next meeting on Wednesday, December 13, 2000 at 1:30 p.m. Eastern Standard Time. Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,300 patients have been treated in completed and ongoing clinical trials.
The Company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine, MaxDerm and the caspase modulator technologies and the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products and the risks associated with dependence upon collaborative partners. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com.
MAXIM PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS (unaudited)
Three Months Ended Year Ended
Sept. 30, Sept. 30,
2000 1999 2000 1999
Collaboration and
research revenue $ 956,867 $ 187,500 $1,384,617 $1,077,800
Operating expenses:
Research and
development 8,679,490 9,591,525 36,387,151 36,637,714
Marketing and business
development 2,706,922 354,837 5,126,930 1,682,664
General and
administrative 1,314,709 557,408 4,478,665 2,880,647
Amortization of
goodwill and other
acquisition-related
intangible assets 638,203 -- 744,570 --
Purchased in-process
technology -- -- 42,300,000 --
Total operating
expenses 13,339,324 10,503,770 89,037,316 41,201,025
Other income (expense):
Investment income 3,235,563 188,544 8,085,836 1,023,013
Gain on sale of assets -- -- 2,146,502 --
Interest expense (40,112) (33,511) (91,615) (146,056)
Other income (expense) 12,667 -- 22,930 19,918
Total other income
(expense) 3,208,118 155,033 10,163,653 896,875
Net loss before preferred
stock dividends (9,174,339) (10,161,237)(77,489,046)(39,226,350)
Dividends on preferred
stock -- 482,844 5,012,839 482,844
Net loss applicable to
common stock (9,174,339) (10,644,081)(82,501,885)(39,709,194)
$ (0.40) $ (1.04) $ (4.58) $ (3.94)
Weighted average shares
outstanding 22,886,802 10,203,850 18,018,317 10,078,765
BALANCE SHEET INFORMATION
Sept. 30, 2000 Sept. 30, 1999
(Unaudited)
ASSETS
Cash, cash equivalents and
investments $ 190,364,829 $ 17,942,340
Total assets 237,418,824 24,515,341
Long-term liabilities 1,541,968 908,380
Stockholders` equity 220,524,249 10,843,210
CONTACT: Maxim Pharmaceuticals
Larry G. Stambaugh or Dale A. Sander, 858/453-4040
or
Burns McClellan
Ethan Denkensohn (investors) or Justin Jackson (media)
212/213-0006
kennt jemand gründe für die kursverluste?
nichts gefunden. habe meinen bestand gestern verdoppelt.
Im Börse-Online-Board wird behauptet, ein Fonds habe vor
dem Panel nächste Woche seine Position komplett abgebaut.
Ich kann das allerdings nicht nachprüfen...
Grüße
LeNeant
dem Panel nächste Woche seine Position komplett abgebaut.
Ich kann das allerdings nicht nachprüfen...
Grüße
LeNeant
Vermutlich Short-Verkäufe wegen der anstehenden ODAC-Entscheidung.
06.12.2000
Maxim Kaufsignale
Bluebull
Maxim Pharmaceuticals (WKN 909400) ist ein Biotechunternehmen, welches Medikamente und Impfstoffe gegen Krebs und andere ansteckende Krankheiten entdeckt und entwickelt, berichten die Analysten von Bluebull.
Das Gardeexemplar des Unternehmens, Maxamine, werde aktuell in drei klinischen Versuchsphasen der Phase III in 12 Ländern der Welt geprüft. Der früheste Zulassungszeitraum liege bei diesem Medikament im Frühjahr 2001 in den USA und im Herbst 2001 in weiteren Staaten des Globus. Insbesondere mit Hilfe dieses Medikamentes solle es gelingen, das Immunsystem der infizierten Personen wesentlich zu stärken, Krebs bekämpfen zu können. Mehr als 1000 Personen würden sich bis dato in der Versuchsphase von Maxim befinden. Eine zweite Produktplattform, die sich in der Entwicklung befinde nenne sich MaxDerm, eine mit Maxamine in Verbindung stehende Medikamentenserie für die Behandlung unter anderem von Herpeslabialis, Bindehautentzündungen.
Die dritte Technologieplattform des Unternehmens nenne sich Maxvax und befinde sich aktuell in der preklinickalen Entwicklung. Dieses Medikament stelle eine Art Schleimhautimpfstoff dar, welcher ein injektional zu verabreichendes Medikament ersetze. Insbesondere würden für die Anwendung sexuell übertragbare Krankheiten und Atemwegserkrankungen eine Rolle spielen. Behandlungsschwerpunkte bei Maxim seien Leukämie, Nierenkrebs und Hepatitis C. (Das Projekt "MaxVax" wurde meines Wissens verkauft. Pitu)
Momentan sei das Unternehmen mit einer Marktkapitalisierung von 746 Mio. US$ bewertet und besitze einen Shortanteil von knapp 16% der ausstehenden Aktien. Mckinley Capital Management, Brinson Partners, Wall Street Associates und die wohl bei Biotechfirmen wohlbekannte Barclays Bank seien unter anderem institutionelle Investoren in dem Wert. Maxim Pharmaceuticals habe das Ergebnis des 4.Quartals bekannt gegeben. Man habe das Quartal mit einem Nettoverlust von 9,2 Mio. US$ oder -0,40 US$ je Aktie beendet. Im gleichen Zeitraum des Vorjahres habe man noch einen Verlust von 10,6 Mio. US$ oder -1,04 US$ pro Aktie erreicht.
Einkommen hätten sich auf 1,0 Mio. US$ im 4.Quartal verglichen mit 0,2 Mio. US$ während der gleichen Periode des vorherigen Jahres belaufen. Der Nettoverlust habe 82,5 Mio. US$ oder -4,58 US$ je Aktie verglichen mit einem Nettoverlust von 39,7 Mio. US$ oder -3,94 US$ pro Anteil für das vorherige Jahr betragen. Das Unternehmen besitze ein Cashflow von 190,4 Mio. US$.
Kurzfristig habe man die Tage schon die EMA20 deutlich überschreiten können, notiere jedoch unterhalb selbiger. Die technischen Indikatoren 10er WLR und 14er RSI würden allesamt gen Norden streben und Kaufsignale in dem Wert generieren. Erstes Kursziel würden die Analysten auf mittelfristige Sicht bei 50 US$ sehen. Der Wert solle jedoch schnellst möglich die Marke von 36 US$ hinter sich lassen. Einziger Wehrmutstropfen stelle die Tatsache dar, dass bis zum 18.10. einige Insiderkäufe den Wert an sich und das Image des Unternehmens leicht belastet hätten.
Maxim Kaufsignale
Bluebull
Maxim Pharmaceuticals (WKN 909400) ist ein Biotechunternehmen, welches Medikamente und Impfstoffe gegen Krebs und andere ansteckende Krankheiten entdeckt und entwickelt, berichten die Analysten von Bluebull.
Das Gardeexemplar des Unternehmens, Maxamine, werde aktuell in drei klinischen Versuchsphasen der Phase III in 12 Ländern der Welt geprüft. Der früheste Zulassungszeitraum liege bei diesem Medikament im Frühjahr 2001 in den USA und im Herbst 2001 in weiteren Staaten des Globus. Insbesondere mit Hilfe dieses Medikamentes solle es gelingen, das Immunsystem der infizierten Personen wesentlich zu stärken, Krebs bekämpfen zu können. Mehr als 1000 Personen würden sich bis dato in der Versuchsphase von Maxim befinden. Eine zweite Produktplattform, die sich in der Entwicklung befinde nenne sich MaxDerm, eine mit Maxamine in Verbindung stehende Medikamentenserie für die Behandlung unter anderem von Herpeslabialis, Bindehautentzündungen.
Die dritte Technologieplattform des Unternehmens nenne sich Maxvax und befinde sich aktuell in der preklinickalen Entwicklung. Dieses Medikament stelle eine Art Schleimhautimpfstoff dar, welcher ein injektional zu verabreichendes Medikament ersetze. Insbesondere würden für die Anwendung sexuell übertragbare Krankheiten und Atemwegserkrankungen eine Rolle spielen. Behandlungsschwerpunkte bei Maxim seien Leukämie, Nierenkrebs und Hepatitis C. (Das Projekt "MaxVax" wurde meines Wissens verkauft. Pitu)
Momentan sei das Unternehmen mit einer Marktkapitalisierung von 746 Mio. US$ bewertet und besitze einen Shortanteil von knapp 16% der ausstehenden Aktien. Mckinley Capital Management, Brinson Partners, Wall Street Associates und die wohl bei Biotechfirmen wohlbekannte Barclays Bank seien unter anderem institutionelle Investoren in dem Wert. Maxim Pharmaceuticals habe das Ergebnis des 4.Quartals bekannt gegeben. Man habe das Quartal mit einem Nettoverlust von 9,2 Mio. US$ oder -0,40 US$ je Aktie beendet. Im gleichen Zeitraum des Vorjahres habe man noch einen Verlust von 10,6 Mio. US$ oder -1,04 US$ pro Aktie erreicht.
Einkommen hätten sich auf 1,0 Mio. US$ im 4.Quartal verglichen mit 0,2 Mio. US$ während der gleichen Periode des vorherigen Jahres belaufen. Der Nettoverlust habe 82,5 Mio. US$ oder -4,58 US$ je Aktie verglichen mit einem Nettoverlust von 39,7 Mio. US$ oder -3,94 US$ pro Anteil für das vorherige Jahr betragen. Das Unternehmen besitze ein Cashflow von 190,4 Mio. US$.
Kurzfristig habe man die Tage schon die EMA20 deutlich überschreiten können, notiere jedoch unterhalb selbiger. Die technischen Indikatoren 10er WLR und 14er RSI würden allesamt gen Norden streben und Kaufsignale in dem Wert generieren. Erstes Kursziel würden die Analysten auf mittelfristige Sicht bei 50 US$ sehen. Der Wert solle jedoch schnellst möglich die Marke von 36 US$ hinter sich lassen. Einziger Wehrmutstropfen stelle die Tatsache dar, dass bis zum 18.10. einige Insiderkäufe den Wert an sich und das Image des Unternehmens leicht belastet hätten.
vorbörslich werden für 1000 stück 29,125 $ geboten. (schlusskurs 28 $)
Prudential Securities Reports 12/11/00
By: Prudential Securities
12/11/00 7:04:54 AM
Maxim Pharmaceuticals STRONG BUY
MAXM: PREVIEW OF DECEMBER 13TH ODAC PANEL MEETING
MAXM | $26.25 | NASD
Maxim`s lead drug candidate, Maxamine for metastatic melanoma, is expected to be reviewed at the upcoming FDA Oncologic Drugs Advisory Committee (ODAC) panel meeting on December 13th.
Maxamine is the first agent ever to demonstrate a statistically significant survival benefit in a pivotal, controlled study for the treatment of melanoma.
By: Prudential Securities
12/11/00 7:04:54 AM
Maxim Pharmaceuticals STRONG BUY
MAXM: PREVIEW OF DECEMBER 13TH ODAC PANEL MEETING
MAXM | $26.25 | NASD
Maxim`s lead drug candidate, Maxamine for metastatic melanoma, is expected to be reviewed at the upcoming FDA Oncologic Drugs Advisory Committee (ODAC) panel meeting on December 13th.
Maxamine is the first agent ever to demonstrate a statistically significant survival benefit in a pivotal, controlled study for the treatment of melanoma.
Das ist aber sehr mutig von Prudential, zwei Tage vor dem
Panel mit sowas rauszukommen !
Was könnte da denn dahinterstecken ???
Panel mit sowas rauszukommen !
Was könnte da denn dahinterstecken ???
Top Institutional Holders of MAXM Shares Value
Mckinley Capital Management, Inc. 1,514,830 $53,397,758
Brinson Partners, Inc. 540,300 $19,045,575
Wall Street Associates 437,400 $15,418,350
Montgomery Asset Management, LLC 350,600 $12,358,650
Blackrock Inc. 344,600 $12,147,150
Barclays Bank Plc 307,388 $10,835,427
Scudder Kemper Investments, Inc. 287,300 $10,127,325
Duncan-Hurst Capital Management 255,310 $8,999,678
Putnam Investment Management, Inc. 250,160 $8,818,140
Blue Ridge Capital, L.L.C. 250,000 $8,812,500
Mckinley Capital Management, Inc. 1,514,830 $53,397,758
Brinson Partners, Inc. 540,300 $19,045,575
Wall Street Associates 437,400 $15,418,350
Montgomery Asset Management, LLC 350,600 $12,358,650
Blackrock Inc. 344,600 $12,147,150
Barclays Bank Plc 307,388 $10,835,427
Scudder Kemper Investments, Inc. 287,300 $10,127,325
Duncan-Hurst Capital Management 255,310 $8,999,678
Putnam Investment Management, Inc. 250,160 $8,818,140
Blue Ridge Capital, L.L.C. 250,000 $8,812,500
mann, mann, mann ... MAXM bei island 24 $ ...
Three cancer drugs to face U.S. panel review
By Lisa Richwine
WASHINGTON, Dec 12 (Reuters) - U.S. science advisers meet this week to review three cancer drugs, including one product looking to make gains against leading breast cancer treatment tamoxifen.
Swiss drug maker Novartis AG (NYSE:NVS - news) is asking a Food and Drug Administration (FDA) panel to endorse its drug Femara, which has been on the U.S. market since 1997, as a first-choice treatment for post-menopausal women with advanced breast cancer.
Femara, known generically as letrozole, already holds FDA clearance for second-line breast cancer treatment.
But Novartis wants doctors to consider Femara as the first weapon against breast cancer that has spread.
Company studies, to be presented to the FDA panel Wednesday, showed Femara did better than tamoxifen at delaying progression of the disease in women past menopause. Femara also was more effective at reducing tumor size before surgery, Novartis said.
The FDA usually follows its panels` advice. The company needs the agency`s permission in order to promote Femara as a first-line treatment to oncologists.
``You really have to show good data`` to convince oncologists to switch from tamoxifen, said ING Barings analyst Sergio Traversa, adding that he thought Novartis would make a convincing case to the panel.
Femara is part of a class of drugs known as aromatase inhibitors that includes AstraZeneca Plc`s Arimidex, already approved for first-line treatment. AstraZeneca also sells tamoxifen under the brand name Nolvadex.
Later Wednesday, the FDA panel will review experimental drug Maxamine by San Diego-based Maxim Pharmaceuticals (NasdaqNM:MAXM - news). The company hopes to market Maxamine, which would be its first marketed product, as part of a treatment for advanced skin cancer.
On Thursday, two biotech firms, ILEX Oncology Inc. (NasdaqNM:ILXO - news) and Millennium Pharmaceuticals Inc. (NasdaqNM:MLNM - news), will seek a favorable vote on their drug Campath for treating a rare cancer called chronic lymphocytic leukemia.
Both companies are hoping Campath will become their first product approved for sale, and analysts said they expected the drug would win the panel`s support.
``We think it`s a very effective drug, and it should reach the market,`` said U.S. Bancorp Piper Jaffray analyst Peter Ginsberg, who has a ``buy`` rating on ILEX stock.
San Antonio-based Ilex and Millennium, based in Cambridge, Mass., will share revenues from Campath sales with Germany`s Schering AG (quote from Yahoo! UK & Ireland: SCHG.F), which has U.S. marketing rights to the drug.
Three cancer drugs to face U.S. panel review
By Lisa Richwine
WASHINGTON, Dec 12 (Reuters) - U.S. science advisers meet this week to review three cancer drugs, including one product looking to make gains against leading breast cancer treatment tamoxifen.
Swiss drug maker Novartis AG (NYSE:NVS - news) is asking a Food and Drug Administration (FDA) panel to endorse its drug Femara, which has been on the U.S. market since 1997, as a first-choice treatment for post-menopausal women with advanced breast cancer.
Femara, known generically as letrozole, already holds FDA clearance for second-line breast cancer treatment.
But Novartis wants doctors to consider Femara as the first weapon against breast cancer that has spread.
Company studies, to be presented to the FDA panel Wednesday, showed Femara did better than tamoxifen at delaying progression of the disease in women past menopause. Femara also was more effective at reducing tumor size before surgery, Novartis said.
The FDA usually follows its panels` advice. The company needs the agency`s permission in order to promote Femara as a first-line treatment to oncologists.
``You really have to show good data`` to convince oncologists to switch from tamoxifen, said ING Barings analyst Sergio Traversa, adding that he thought Novartis would make a convincing case to the panel.
Femara is part of a class of drugs known as aromatase inhibitors that includes AstraZeneca Plc`s Arimidex, already approved for first-line treatment. AstraZeneca also sells tamoxifen under the brand name Nolvadex.
Later Wednesday, the FDA panel will review experimental drug Maxamine by San Diego-based Maxim Pharmaceuticals (NasdaqNM:MAXM - news). The company hopes to market Maxamine, which would be its first marketed product, as part of a treatment for advanced skin cancer.
On Thursday, two biotech firms, ILEX Oncology Inc. (NasdaqNM:ILXO - news) and Millennium Pharmaceuticals Inc. (NasdaqNM:MLNM - news), will seek a favorable vote on their drug Campath for treating a rare cancer called chronic lymphocytic leukemia.
Both companies are hoping Campath will become their first product approved for sale, and analysts said they expected the drug would win the panel`s support.
``We think it`s a very effective drug, and it should reach the market,`` said U.S. Bancorp Piper Jaffray analyst Peter Ginsberg, who has a ``buy`` rating on ILEX stock.
San Antonio-based Ilex and Millennium, based in Cambridge, Mass., will share revenues from Campath sales with Germany`s Schering AG (quote from Yahoo! UK & Ireland: SCHG.F), which has U.S. marketing rights to the drug.
Das riecht nach Skandal! Ablehenung nach Raten
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3671b1.htm
Unter statistic reviews zu finden
------------
Major Statistical Problems with the Study
1. Only one randomized open-label study conducted in patients with metastatic malignant
melanoma, which failed to demonstrate efficacy as per the design of the study, in the intent-to-
treat population (log-rank test, P-value = 0.1255).
2. When the overall result fails to show efficacy, usually subgroup findings are not acceptable
and subgroup analyses at best can be exploratory or hypothesis generating analyses (ICH E-3
guidelines, section 11.4.2.8: These analyses are not intended to "salvage" an otherwise non-supportive
study but may suggest hypotheses worth examining in other studies or be helpful
in refining labelling information, patient selection, dose selection etc.). When one starts to
do multiple subgroup testing, one can easily make a false positive claim based on such
subgroup analysis. We do not know how to interpret the P-values based on such post-hoc
analysis. Furthermore, without replication of the results in a second well-controlled study,
the subgroup analysis can not be ruled out for a false positive result.
3. The sponsor wishes to claim approval based on a subgroup of non-randomized patients with
liver metastasis. This subgroup hypothesis corresponding to liver metastasis was not stated
as a hypothesis of interest to be tested in the original protocol. Any subgroup hypothesis
needs to be stated in the protocol and accordingly proper allocation of a has to be specified.
Otherwise, such post-hoc subgroup claim will inflate Type I error and it is difficult to
interpret such P-values.
4. Some of the important issues not addressed by the sponsor are: lack of stratification prior to
randomization and imbalance between the treatment arms with respect to baseline prognostic
factors in this subgroup.
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3671b1.htm
Unter statistic reviews zu finden
------------
Major Statistical Problems with the Study
1. Only one randomized open-label study conducted in patients with metastatic malignant
melanoma, which failed to demonstrate efficacy as per the design of the study, in the intent-to-
treat population (log-rank test, P-value = 0.1255).
2. When the overall result fails to show efficacy, usually subgroup findings are not acceptable
and subgroup analyses at best can be exploratory or hypothesis generating analyses (ICH E-3
guidelines, section 11.4.2.8: These analyses are not intended to "salvage" an otherwise non-supportive
study but may suggest hypotheses worth examining in other studies or be helpful
in refining labelling information, patient selection, dose selection etc.). When one starts to
do multiple subgroup testing, one can easily make a false positive claim based on such
subgroup analysis. We do not know how to interpret the P-values based on such post-hoc
analysis. Furthermore, without replication of the results in a second well-controlled study,
the subgroup analysis can not be ruled out for a false positive result.
3. The sponsor wishes to claim approval based on a subgroup of non-randomized patients with
liver metastasis. This subgroup hypothesis corresponding to liver metastasis was not stated
as a hypothesis of interest to be tested in the original protocol. Any subgroup hypothesis
needs to be stated in the protocol and accordingly proper allocation of a has to be specified.
Otherwise, such post-hoc subgroup claim will inflate Type I error and it is difficult to
interpret such P-values.
4. Some of the important issues not addressed by the sponsor are: lack of stratification prior to
randomization and imbalance between the treatment arms with respect to baseline prognostic
factors in this subgroup.
Maxim slides ahead of FDA review of skin cancer drug
LOS ANGELES, Dec 12 (Reuters) - Shares of Maxim Pharmaceuticals <MAXM.O> sank more than 45 percent on Tuesday, a day ahead of a key U.S. regulatory review of the company`s experimental treatment for the most serious form of skin cancer.
The San Diego company`s stock slumped $13-9/16 to $16-1/2 on Nasdaq.
Maxim is slated to present data on the effectiveness of its drug, Maxamine, to an advisory panel of the U.S. Food and Drug Administration (FDA) on Wednesday. The FDA usually follows the advice of its panels.
The company, which does not yet have a commercial product, needs the agency`s permission to sell the drug as part of a combination treatment for advanced malignant melanoma.
"We will present already public results of Phase III clinical trials to the FDA panel," Maxim Chief Executive Officer Larry Stambaugh told Reuters.
He declined to comment on the company`s discussions with the FDA prior to tomorrow`s panel hearing.
On the topic of the company`s share price, Stambaugh said, "The market is trying to handicap the outcome of the meeting, as it usually does with these things."
If approved, Maxamine would be the only meaningful treatment for in-stage melanoma, a condition that has a life expectancy of weeks.
"I believe this is overreaction big time," said Steve Brozak, an analyst at Vanguard Capital regarding the sharp drop in the stock.
In a worst case scenario, Brozak said he expects the FDA to ask for more statistical evidence.
"If they get FDA approval tomorrow, the stock will be at $40 a share," he said.
Maxim said late-stage clinical trials showed that Maxamine improved survival rates for patients when used in combination with cytokine IL-2 compared with those treated with IL-2 alone.
The trial results also showed that Maxamine treatment had substantially less toxic side effects than the high-dose regimens under which IL-2 was originally approved, the company said.
Cytokines are hormone-like proteins, secreted by many cell types, which regulate the intensity and duration of immune responses and are involved in cell-to-cell communication.
Maxamine was granted orphan drug status by the FDA in February as an adjunct to cytokine therapy. Orphan drug status provides for U.S. marketing exclusivity for 7 years upon approval by the FDA.
"There is no cure for in-stage melanoma," Brozak said. "The FDA says there is nothing there that is going to treat it. If you could extend longevity by months, it is statistically significant."
((--Deena Beasley, Los Angeles bureau + 1 213 380 2014))
REUTERS
LOS ANGELES, Dec 12 (Reuters) - Shares of Maxim Pharmaceuticals <MAXM.O> sank more than 45 percent on Tuesday, a day ahead of a key U.S. regulatory review of the company`s experimental treatment for the most serious form of skin cancer.
The San Diego company`s stock slumped $13-9/16 to $16-1/2 on Nasdaq.
Maxim is slated to present data on the effectiveness of its drug, Maxamine, to an advisory panel of the U.S. Food and Drug Administration (FDA) on Wednesday. The FDA usually follows the advice of its panels.
The company, which does not yet have a commercial product, needs the agency`s permission to sell the drug as part of a combination treatment for advanced malignant melanoma.
"We will present already public results of Phase III clinical trials to the FDA panel," Maxim Chief Executive Officer Larry Stambaugh told Reuters.
He declined to comment on the company`s discussions with the FDA prior to tomorrow`s panel hearing.
On the topic of the company`s share price, Stambaugh said, "The market is trying to handicap the outcome of the meeting, as it usually does with these things."
If approved, Maxamine would be the only meaningful treatment for in-stage melanoma, a condition that has a life expectancy of weeks.
"I believe this is overreaction big time," said Steve Brozak, an analyst at Vanguard Capital regarding the sharp drop in the stock.
In a worst case scenario, Brozak said he expects the FDA to ask for more statistical evidence.
"If they get FDA approval tomorrow, the stock will be at $40 a share," he said.
Maxim said late-stage clinical trials showed that Maxamine improved survival rates for patients when used in combination with cytokine IL-2 compared with those treated with IL-2 alone.
The trial results also showed that Maxamine treatment had substantially less toxic side effects than the high-dose regimens under which IL-2 was originally approved, the company said.
Cytokines are hormone-like proteins, secreted by many cell types, which regulate the intensity and duration of immune responses and are involved in cell-to-cell communication.
Maxamine was granted orphan drug status by the FDA in February as an adjunct to cytokine therapy. Orphan drug status provides for U.S. marketing exclusivity for 7 years upon approval by the FDA.
"There is no cure for in-stage melanoma," Brozak said. "The FDA says there is nothing there that is going to treat it. If you could extend longevity by months, it is statistically significant."
((--Deena Beasley, Los Angeles bureau + 1 213 380 2014))
REUTERS
Wednesday December 13, 6:08 am Eastern Time
Maxim dives on fears of FDA thumbs down
(UPDATE: adds fund manager comment, details)
STOCKHOLM, Dec 13 (Reuters) - Shares in U.S.-Swedish biotech company Maxim Pharmaceuticals dived 39 percent on Wednesday as the market interpreted a preliminary U.S. Food and Drug Administration report as a sign the FDA would reject its Maxamine cancer drug.
Maxim, which has no commercial product yet, is due to present data on the effectiveness of its immune-boosting cancer drug to an advisory panel of the FDA on Wednesday. The FDA usually follows the advice of its panels.
Analysts and fund managers said a document released on the FDA`s website (www.fda.gov) raised concerns over the methodology of key Phase III clinical trials of Maxamine, which needs the FDA`s approval to be used as part of a combination treatment for advanced malignant melanoma, or skin cancer.
``What happened was that the FDA`s investigators went out and called into question the result,`` an analyst said.
The document, setting the agenda for the FDA meeting, addresses issues concerning the medical background of the patients in the study, triggering concerns among analysts that the results might not be meaningful enough for the FDA.
``What they have written is really negative, so I find it very hard to believe that the outcome can be anything but negative,`` said Erik Kinnman, a fund manager at brokerage house Aragon.
The FDA is due to announce the decision on Maxamine on its website at 1830 GMT. Maxim`s U.S.-listed stock fell 44 percent on the Nasdaq overnight.
The company`s Stockholm-listed share hit a one-year low of 155 Swedish crowns in early trade before clawing back slightly to last trade down 30 percent at 179 crowns.
The stock has underperformed the Stoxx pharmaceuticals index (^SXDP - news) by 84 percent since peaking at 689 Swedish crowns on February 25.
Maxamine counteracts immune suppression in cancer and chronic infectious diseases.
Maxim dives on fears of FDA thumbs down
(UPDATE: adds fund manager comment, details)
STOCKHOLM, Dec 13 (Reuters) - Shares in U.S.-Swedish biotech company Maxim Pharmaceuticals dived 39 percent on Wednesday as the market interpreted a preliminary U.S. Food and Drug Administration report as a sign the FDA would reject its Maxamine cancer drug.
Maxim, which has no commercial product yet, is due to present data on the effectiveness of its immune-boosting cancer drug to an advisory panel of the FDA on Wednesday. The FDA usually follows the advice of its panels.
Analysts and fund managers said a document released on the FDA`s website (www.fda.gov) raised concerns over the methodology of key Phase III clinical trials of Maxamine, which needs the FDA`s approval to be used as part of a combination treatment for advanced malignant melanoma, or skin cancer.
``What happened was that the FDA`s investigators went out and called into question the result,`` an analyst said.
The document, setting the agenda for the FDA meeting, addresses issues concerning the medical background of the patients in the study, triggering concerns among analysts that the results might not be meaningful enough for the FDA.
``What they have written is really negative, so I find it very hard to believe that the outcome can be anything but negative,`` said Erik Kinnman, a fund manager at brokerage house Aragon.
The FDA is due to announce the decision on Maxamine on its website at 1830 GMT. Maxim`s U.S.-listed stock fell 44 percent on the Nasdaq overnight.
The company`s Stockholm-listed share hit a one-year low of 155 Swedish crowns in early trade before clawing back slightly to last trade down 30 percent at 179 crowns.
The stock has underperformed the Stoxx pharmaceuticals index (^SXDP - news) by 84 percent since peaking at 689 Swedish crowns on February 25.
Maxamine counteracts immune suppression in cancer and chronic infectious diseases.
Hi Pitu
hast Du irgendwann irgendwo mal was von den 0.1255 gelesen?
So wie die Statistiker das beschreiben, ist die Kritik nicht ganz unbegründet, sorry
Nicht übersehen sollte man aber auch, dass die Patienten schemrzloser den Rest ihres Lebens weiterleben können, die Frage ist bloß, inwieweit das den Bürokraten und Ärzten was wert ist.
Sollten die die "0.1255" nirgendwo veröffentlicht haben, und das primäre Endziel war unklar gestellt , könnte das Klagen nach sich ziehen (vgl GLIA.)
Seit vorsichtig!
Der Puhvogel
hast Du irgendwann irgendwo mal was von den 0.1255 gelesen?
So wie die Statistiker das beschreiben, ist die Kritik nicht ganz unbegründet, sorry
Nicht übersehen sollte man aber auch, dass die Patienten schemrzloser den Rest ihres Lebens weiterleben können, die Frage ist bloß, inwieweit das den Bürokraten und Ärzten was wert ist.
Sollten die die "0.1255" nirgendwo veröffentlicht haben, und das primäre Endziel war unklar gestellt , könnte das Klagen nach sich ziehen (vgl GLIA.)
Seit vorsichtig!
Der Puhvogel
Das Problem dürfte wohl sein, dass die FDA in der Phase III nicht nur festgestellt hat, dass ein Maxim Medikament unwirksam bei fortgeschrittenem Hautkrebs ist, sondern insbesondere zum Tod von Patienten geführt haben könnte.
siehe dazu Biotech - News in BoerseGo.de
siehe dazu Biotech - News in BoerseGo.de
Maxim Pharmaceuticals stürzt 44%
--------------------------------------------------------------------------------
Die US Arzneimittelbehörde stellte in einer erneuten Untersuchung fest, dass Maxim`s Mediakament Maxamine nicht gegen eine fortgeschrittene Form des Hautkrebs helfe und lt. eingereichter Unterlagen sogar zum Tod einiger Patienten beigetragen haben könnte. Daraufhin stürzte Maxim`s Aktienkurs um über 44% ab.
© BörseGo.de
komme mir reichlich veralbert vor.
--------------------------------------------------------------------------------
Die US Arzneimittelbehörde stellte in einer erneuten Untersuchung fest, dass Maxim`s Mediakament Maxamine nicht gegen eine fortgeschrittene Form des Hautkrebs helfe und lt. eingereichter Unterlagen sogar zum Tod einiger Patienten beigetragen haben könnte. Daraufhin stürzte Maxim`s Aktienkurs um über 44% ab.
© BörseGo.de
komme mir reichlich veralbert vor.
Vielleicht sollte man einiges geraderücken:
Stage 4 MM Patienten sind todgeweiht, da gibt es eigentlich nichts zu "töten"
In der Subgruppe der Patienten mit Lebermetastasen betrug die "mittlere" Überlebensdauer der mit Maxamine behandelten Patienten (gemessen am Median) 283 Tage,
der ohne Maxamine 154 Tage. Diese Feststellung steht nicht zur Debatte.
Unmittelbar während der Behandlung mit Maxamine kam es zu zwei Fällen von Leberversagen, was dann als zum Behauptung führte "insbesondere zum Tod von Patienten geführt haben könnte."
Ähnliches sollte auch bei der Interferontherapie vorkommen, trotzdem wird es bisher als Standardtherapie verwendet, zurecht!
Das eigentliche Problem ist die retrospektive Subgruppenanalyse, die wohl vorher nicht mit der FDA abgesprochen wurde (-> Klagen drohen !).
Kritisch für mich persönlich ist, dass ich nicht recht nachvollziehen kann, warum Lebermetastasen eher auf Maxamine reagieren als alle andere Stage4-Patienten (zB Lunge).
"The overall survival of patients who did not have liver metastasis at study entry (ITT-NO LMET) was longer in the IL-2 group (median: 10.3 months) than in the histamine/IL-2 group (median: 8.7 months), although the difference did not reach statistical significance (p=0.4493)."
Das ist so gut wie kein Fortschritt. Dagegen wenn ich selber Lebermetastasen hätte, würde ich schon gerne Maxamine verwendet wissen.
Jedenfalls ist es interessant, mal so eine statistische Analyse der FDA zu lesen.
Der Puhvogel
Stage 4 MM Patienten sind todgeweiht, da gibt es eigentlich nichts zu "töten"
In der Subgruppe der Patienten mit Lebermetastasen betrug die "mittlere" Überlebensdauer der mit Maxamine behandelten Patienten (gemessen am Median) 283 Tage,
der ohne Maxamine 154 Tage. Diese Feststellung steht nicht zur Debatte.
Unmittelbar während der Behandlung mit Maxamine kam es zu zwei Fällen von Leberversagen, was dann als zum Behauptung führte "insbesondere zum Tod von Patienten geführt haben könnte."
Ähnliches sollte auch bei der Interferontherapie vorkommen, trotzdem wird es bisher als Standardtherapie verwendet, zurecht!
Das eigentliche Problem ist die retrospektive Subgruppenanalyse, die wohl vorher nicht mit der FDA abgesprochen wurde (-> Klagen drohen !).
Kritisch für mich persönlich ist, dass ich nicht recht nachvollziehen kann, warum Lebermetastasen eher auf Maxamine reagieren als alle andere Stage4-Patienten (zB Lunge).
"The overall survival of patients who did not have liver metastasis at study entry (ITT-NO LMET) was longer in the IL-2 group (median: 10.3 months) than in the histamine/IL-2 group (median: 8.7 months), although the difference did not reach statistical significance (p=0.4493)."
Das ist so gut wie kein Fortschritt. Dagegen wenn ich selber Lebermetastasen hätte, würde ich schon gerne Maxamine verwendet wissen.
Jedenfalls ist es interessant, mal so eine statistische Analyse der FDA zu lesen.
Der Puhvogel
ein Artikel von gestern, der noch weiter geht: Maxim habe die Aufteilung der Versuchsteilnehmer dahingehend manipuliert, daß hoffnungslose Patienten der Kontrollgruppe (Placebo) zugeteilt wurden, während die gesünderen mit Maxamine behandelt wurden. Wenn dann trotzdem kein signifikantes Ergebnis herauskommt, läßt das tief blicken...
Maxim Plunges as FDA Posting Suggests Approval`s
Not at Hand
By Dane Hamilton
Staff Reporter
12/12/00 4:25 PM ET
Maxim Pharmaceuticals (MAXM:Nasdaq - news) shares nosedived Tuesday
after investors got a hint of how a Food and Drug Administration hearing
tomorrow is likely to unfold.
Maxim`s lead developmental drug, Maxamine, is slated to be discussed
Wednesday before the FDA`s Oncology Drugs Advisory Committee. The San
Diego biotech company is hoping the cancer drug will win a recommendation
from the panel that could push it toward full agency approval. But Maxim shares
plunged $13.38, or 44%, to $16.69 Tuesday after a posting on the FDA`s Web
site suggested the company`s case isn`t likely to win the day.
What`s Valid?
Maxim is seeking approval for Maxamine as a
treatment for advanced skin cancer, or
melanoma, that has spread to the liver. While its
yearlong studies in 300 patients failed to
demonstrate that Maxamine benefited all
patients with melanoma, the company claims
that a subset of 129 patients with liver
metastases did meet the FDA criteria of
statistical significance to support approval.
However, in briefing papers that the FDA posted
Tuesday on its Web site, the agency basically
said subgroup analysis isn`t a valid approach to seeking approval.
"When the overall result fails to show efficacy, usually subgroup findings are not
acceptable," the FDA said in the briefing papers. "Subgroup analyses at best can
be exploratory or hypothesis generating analyses. These analyses are not
intended to `salvage` an otherwise nonsupportive study."
The Takeaway
Avalon Research, a Boca Raton investment research house that last summer
put a sell recommendation on Maxim, Tuesday said the FDA`s briefing papers all
but showed that Maxamine won`t win panel support Wednesday.
"This reads like a Wall Street sell recommendation," says David Hines, president
and head of research at Avalon, which does no corporate finance work for any
company. "This is as close to saying that the company will not get approval as I
have ever seen. The document clearly states that efficacy within a subgroup will
not support approval."
The FDA also raised questions about the objectivity of the study with regards to
how patients were "randomized," a major point of contention between supporters
and critics of the company. To demonstrate that a drug works, in most cases the
FDA will require patients to be randomly assigned to either get the drug or get a
placebo. In the briefing paper, the FDA maintained that the trial wasn`t
randomized at all, a serious criticism of the study.
"The FDA analysis of the data was worse than we thought," says Hines. "It
appears that most ill patients were put in the [placebo-taking group] while the
healthier patients went into the treated group."
Maxim Plunges as FDA Posting Suggests Approval`s
Not at Hand
By Dane Hamilton
Staff Reporter
12/12/00 4:25 PM ET
Maxim Pharmaceuticals (MAXM:Nasdaq - news) shares nosedived Tuesday
after investors got a hint of how a Food and Drug Administration hearing
tomorrow is likely to unfold.
Maxim`s lead developmental drug, Maxamine, is slated to be discussed
Wednesday before the FDA`s Oncology Drugs Advisory Committee. The San
Diego biotech company is hoping the cancer drug will win a recommendation
from the panel that could push it toward full agency approval. But Maxim shares
plunged $13.38, or 44%, to $16.69 Tuesday after a posting on the FDA`s Web
site suggested the company`s case isn`t likely to win the day.
What`s Valid?
Maxim is seeking approval for Maxamine as a
treatment for advanced skin cancer, or
melanoma, that has spread to the liver. While its
yearlong studies in 300 patients failed to
demonstrate that Maxamine benefited all
patients with melanoma, the company claims
that a subset of 129 patients with liver
metastases did meet the FDA criteria of
statistical significance to support approval.
However, in briefing papers that the FDA posted
Tuesday on its Web site, the agency basically
said subgroup analysis isn`t a valid approach to seeking approval.
"When the overall result fails to show efficacy, usually subgroup findings are not
acceptable," the FDA said in the briefing papers. "Subgroup analyses at best can
be exploratory or hypothesis generating analyses. These analyses are not
intended to `salvage` an otherwise nonsupportive study."
The Takeaway
Avalon Research, a Boca Raton investment research house that last summer
put a sell recommendation on Maxim, Tuesday said the FDA`s briefing papers all
but showed that Maxamine won`t win panel support Wednesday.
"This reads like a Wall Street sell recommendation," says David Hines, president
and head of research at Avalon, which does no corporate finance work for any
company. "This is as close to saying that the company will not get approval as I
have ever seen. The document clearly states that efficacy within a subgroup will
not support approval."
The FDA also raised questions about the objectivity of the study with regards to
how patients were "randomized," a major point of contention between supporters
and critics of the company. To demonstrate that a drug works, in most cases the
FDA will require patients to be randomly assigned to either get the drug or get a
placebo. In the briefing paper, the FDA maintained that the trial wasn`t
randomized at all, a serious criticism of the study.
"The FDA analysis of the data was worse than we thought," says Hines. "It
appears that most ill patients were put in the [placebo-taking group] while the
healthier patients went into the treated group."
das ist der hohn schlechthin:
Prudential Securities Reports 12/11/00
Maxim Pharmaceuticals STRONG BUY
13-Dec-00
Prudential downgrade: from Strong Buy to Hold
handel mit maxim seit knapp einer stunde angehalten.
Prudential Securities Reports 12/11/00
Maxim Pharmaceuticals STRONG BUY
13-Dec-00
Prudential downgrade: from Strong Buy to Hold
handel mit maxim seit knapp einer stunde angehalten.
Prudential senkt seine Umsatz- und Gewinnerwartung für Maxim Pharm (MAXM).
Bewertung wird von STRONG BUY auf HOLD reduziert.
Bewertung wird von STRONG BUY auf HOLD reduziert.
Article: MAXM is down 3.69 to 13.06 and was halted at 1 p.m. EST because the FDA Advisory Panel meets at 1:30 p.m. EST to discuss whether or not to give the recommendation for the approval for one of the company`s key drug in treating advanced malignant skin cancer. There is a 50-50 chance that the FDA will give a positive recommendation on the drug, according to Prudential. Prudential said it is downgrading its investment opinion on MAXM to a hold from a strong buy based on a FDA medical review, published Tuesday, which was extremely negative and virtually eliminated all prospects that the drug could be approved. Prudential added that MAXM might have misled investors about the drug, which could lead to legal actions against the company.
Da haben wir es schon. Dann werden bald die Jeckel&Hydes-Kanzleien kommen.
@Pitu: Was würdest an Stelle von Prudential denn jetzt machen? Ich kann es nachvollziehen.
Zur Randomization meinte der Reviewer:
"No stratification for important prognostic factors in metastatic melanoma was performed" S.28
Das wäre aber kein "Betrug", allenfalls ein Formfehler, falls anders mit deer FDA abgesprochen, die zufällige Verteilung der Patienten in beide Behandlungsgruppen ist dadurch nicht in Frage gestellt. Ich habe aber keine Lust, dass ganze Papier durchzulesen.
Die Kardinalfrage wäre, warum haben die die NDA nicht nach dem ersten Durchblick wieder zurückgewiesen, sondern haben ein halbes Jahr dafür gebraucht?
Irgendwie skurril das Ganze.
Der Puhvogel
Da haben wir es schon. Dann werden bald die Jeckel&Hydes-Kanzleien kommen.
@Pitu: Was würdest an Stelle von Prudential denn jetzt machen? Ich kann es nachvollziehen.
Zur Randomization meinte der Reviewer:
"No stratification for important prognostic factors in metastatic melanoma was performed" S.28
Das wäre aber kein "Betrug", allenfalls ein Formfehler, falls anders mit deer FDA abgesprochen, die zufällige Verteilung der Patienten in beide Behandlungsgruppen ist dadurch nicht in Frage gestellt. Ich habe aber keine Lust, dass ganze Papier durchzulesen.
Die Kardinalfrage wäre, warum haben die die NDA nicht nach dem ersten Durchblick wieder zurückgewiesen, sondern haben ein halbes Jahr dafür gebraucht?
Irgendwie skurril das Ganze.
Der Puhvogel
Schaut doch einfach rein: www.brokerstalk.de.vu
CBS MarketWatch
Last Update: 3:46 PM ET Dec 13, 2000:
MAXM in freefall
--3:46 pm - By Michael Baron
Maxim Pharmaceuticals (MAXM: news, msgs) is continuing its descent Wednesday with the shares losing $3.62, or 21.6 percent, to $13.12 before being halted. The weakness is related to growing apprehension about the company`s chances of receiving an approval recommendation for its Maxamine melanoma treatment from an FDA advisory board. Prudential Securities cut its rating on the stock to "hold" from "strong buy" due to these concerns, which prompted a plus 40 percent drop in the shares Tuesday. The company is making its presentation to the FDA`s Oncology Drugs Advisory committee today. In its note, Prudential said that the FDA review published on the agency`s site Tuesday was "extremely negative and in our view virtually eliminated all prospects for this drug to be recommended for approval." In addition, the firm believes Maxim may have misled investors about key aspects of Maxamine`s clinical data, which could lead to investor lawsuits.
Last Update: 3:46 PM ET Dec 13, 2000:
MAXM in freefall
--3:46 pm - By Michael Baron
Maxim Pharmaceuticals (MAXM: news, msgs) is continuing its descent Wednesday with the shares losing $3.62, or 21.6 percent, to $13.12 before being halted. The weakness is related to growing apprehension about the company`s chances of receiving an approval recommendation for its Maxamine melanoma treatment from an FDA advisory board. Prudential Securities cut its rating on the stock to "hold" from "strong buy" due to these concerns, which prompted a plus 40 percent drop in the shares Tuesday. The company is making its presentation to the FDA`s Oncology Drugs Advisory committee today. In its note, Prudential said that the FDA review published on the agency`s site Tuesday was "extremely negative and in our view virtually eliminated all prospects for this drug to be recommended for approval." In addition, the firm believes Maxim may have misled investors about key aspects of Maxamine`s clinical data, which could lead to investor lawsuits.
Na dann gute Nacht!
December 13, 2000 17:04
US FDA panel rejects Maxim drug for skin cancer
BETHESDA, Md., Dec 13 (Reuters) - A U.S. advisory panel on Wednesday rejected Maxim Pharmaceuticals Inc.`s experimental drug Maxamine for treating advanced skin cancer.
The Food and Drug Administration advisory committee said it was not convinced that Maxamine was effective for use as part of a regimen to treat a deadly form of the disease.
Maxim is hoping to bring Maxamine to the U.S. market, giving the company its first commercial product. The FDA usually follows its panels` advice.
December 13, 2000 17:04
US FDA panel rejects Maxim drug for skin cancer
BETHESDA, Md., Dec 13 (Reuters) - A U.S. advisory panel on Wednesday rejected Maxim Pharmaceuticals Inc.`s experimental drug Maxamine for treating advanced skin cancer.
The Food and Drug Administration advisory committee said it was not convinced that Maxamine was effective for use as part of a regimen to treat a deadly form of the disease.
Maxim is hoping to bring Maxamine to the U.S. market, giving the company its first commercial product. The FDA usually follows its panels` advice.
UPDATE 2-US FDA panel rejects Maxim drug for skin cancer
(adds company comments para 6-7, background para 8) By Lisa Richwine
BETHESDA, Md., Dec 13 (Reuters) - Maxim Pharmaceuticals Inc. <MAXM.O>, a company looking to bring its first product to the market, suffered a setback on Wednesday as a U.S. panel rejected the company`s experimental drug Maxamine for treating advanced skin cancer.
A Food and Drug Administration (FDA) advisory committee said the study results presented by the company did not persuade them that Maxamine extended the lives of patients with a deadly form of skin cancer.
"I certainly don`t find this even approaches convincing evidence," said panel member Richard Simon of the National Cancer Institute, after an FDA review raised several questions about the way the study was designed and executed.
The unanimous vote against recommending approval was a blow to Maxim because the FDA usually follows its panels` advice. The company needs the FDA`s approval to sell Maxamine in the United States, and its company`s stock price was hammered a day ahead of the meeting after the FDA posted its critique of the company`s data on the agency Web site.
Maxim is asking the FDA to clear Maxamine as part of a regimen to treat malignant melanoma that has spread to the liver. Patients with skin cancer at that stage have a life expectancy of only months, and no treatment has offered much benefit.
While the panel vote was "disappointing," Maxim was still confident of Maxamine`s value, Chairman and Chief Executive Officer Larry Stambaugh said in a statement.
"We will now work with the FDA to develop a strategy to support the approvability of this drug in this patient population. Fortunately, Maxim has a sound financial position to weather a delay in the approval process," Stambaugh said.
DRUG ENHANCES IMMUNE-BOOSTING DRUG
Maxamine, known generically as histamine dihydrochloride, is designed to enhance the ability of immune-boosting drugs to fight tumors and infections. A clinical trial of 305 patients evaluated Maxamine in addition to interleukin-2 (IL-2), a treatment approved in 1998 for advanced melanoma.
Maxim argued that adding Maxamine to low doses of IL-2, injected by patients or their caregivers at home, could extend survival with few serious side effects.
Even though the clinical trial showed no significant survival benefit for patients overall, the treatment combination did extend the life of a group whose disease had spread, or metastasized, to the liver, Maxim chief technical officer Kurt Gehlson said.
"We believe (the treatment combination) in the liver metastases population does in fact provide a compelling result," Gehlson told the panel.
But an FDA review said that benefit might have been explained by other factors. For example, more patients treated with Maxamine had only one site where cancer had spread, meaning they already were more likely to live longer than patients with several tumor sites.
"The efficacy of the regimen ... is not known," said FDA medical reviewer Judy Chiao.
Chiao also said Maxim did not sufficiently track whether patients took the proper doses on schedule. Although the panel`s action dealt a punishing blow to Maxim, editor John McCamant of the Medical Technology Stock Letter said he believes Maxim and Maxamine both still have a future.
"We believe the product still has legs because its method of action has potential in treating hepatitis C and several other types of cancer, including renal cell carcinoma (kidney cancer) and acute myelogenous leukemia." McCamant said Roche Holding <ROCZg.S> AG agreed in August to finance clinical trials for all three of those indications.
Moreover, he said Maxim was sitting on $180 million in cash, which McCamant said represented at least two years of "cash burn."
It is extremely difficult to set up trials testing the efficacy of treatments for Stage IV metastatic melanoma, said McCamant, whose newsletter is based in California. "There are no good treatments now," he added. (With additional reporting by Ransdell Pierson in New York)
((Lisa Richwine, +1 202 310-5691, fax +1 202 898-8383, washington.equities.newsroom@reuters.com))
REUTERS
nach dem momentanen kurs hat maxim nur noch den wert des cashbestandes.
(adds company comments para 6-7, background para 8) By Lisa Richwine
BETHESDA, Md., Dec 13 (Reuters) - Maxim Pharmaceuticals Inc. <MAXM.O>, a company looking to bring its first product to the market, suffered a setback on Wednesday as a U.S. panel rejected the company`s experimental drug Maxamine for treating advanced skin cancer.
A Food and Drug Administration (FDA) advisory committee said the study results presented by the company did not persuade them that Maxamine extended the lives of patients with a deadly form of skin cancer.
"I certainly don`t find this even approaches convincing evidence," said panel member Richard Simon of the National Cancer Institute, after an FDA review raised several questions about the way the study was designed and executed.
The unanimous vote against recommending approval was a blow to Maxim because the FDA usually follows its panels` advice. The company needs the FDA`s approval to sell Maxamine in the United States, and its company`s stock price was hammered a day ahead of the meeting after the FDA posted its critique of the company`s data on the agency Web site.
Maxim is asking the FDA to clear Maxamine as part of a regimen to treat malignant melanoma that has spread to the liver. Patients with skin cancer at that stage have a life expectancy of only months, and no treatment has offered much benefit.
While the panel vote was "disappointing," Maxim was still confident of Maxamine`s value, Chairman and Chief Executive Officer Larry Stambaugh said in a statement.
"We will now work with the FDA to develop a strategy to support the approvability of this drug in this patient population. Fortunately, Maxim has a sound financial position to weather a delay in the approval process," Stambaugh said.
DRUG ENHANCES IMMUNE-BOOSTING DRUG
Maxamine, known generically as histamine dihydrochloride, is designed to enhance the ability of immune-boosting drugs to fight tumors and infections. A clinical trial of 305 patients evaluated Maxamine in addition to interleukin-2 (IL-2), a treatment approved in 1998 for advanced melanoma.
Maxim argued that adding Maxamine to low doses of IL-2, injected by patients or their caregivers at home, could extend survival with few serious side effects.
Even though the clinical trial showed no significant survival benefit for patients overall, the treatment combination did extend the life of a group whose disease had spread, or metastasized, to the liver, Maxim chief technical officer Kurt Gehlson said.
"We believe (the treatment combination) in the liver metastases population does in fact provide a compelling result," Gehlson told the panel.
But an FDA review said that benefit might have been explained by other factors. For example, more patients treated with Maxamine had only one site where cancer had spread, meaning they already were more likely to live longer than patients with several tumor sites.
"The efficacy of the regimen ... is not known," said FDA medical reviewer Judy Chiao.
Chiao also said Maxim did not sufficiently track whether patients took the proper doses on schedule. Although the panel`s action dealt a punishing blow to Maxim, editor John McCamant of the Medical Technology Stock Letter said he believes Maxim and Maxamine both still have a future.
"We believe the product still has legs because its method of action has potential in treating hepatitis C and several other types of cancer, including renal cell carcinoma (kidney cancer) and acute myelogenous leukemia." McCamant said Roche Holding <ROCZg.S> AG agreed in August to finance clinical trials for all three of those indications.
Moreover, he said Maxim was sitting on $180 million in cash, which McCamant said represented at least two years of "cash burn."
It is extremely difficult to set up trials testing the efficacy of treatments for Stage IV metastatic melanoma, said McCamant, whose newsletter is based in California. "There are no good treatments now," he added. (With additional reporting by Ransdell Pierson in New York)
((Lisa Richwine, +1 202 310-5691, fax +1 202 898-8383, washington.equities.newsroom@reuters.com))
REUTERS
nach dem momentanen kurs hat maxim nur noch den wert des cashbestandes.
SOrry, ich bin schlecht in Englisch! Aber kann mir bitte einer erklären was mit Maxim los ist. Sind das Kaufkurse?
Das Beratergremium der amerikanischen Gesundheitsbehörde FDA hat das Medikament Maxamine abgelehnt.
Es gab offenbar grobe Fehler bei der Antragstellung, Zweifel an der Wirksamkeit von Maxamine und sogar indirekte Manipulationsvorwürfe bzgl. der durchgeführten Studien.
Es gab offenbar grobe Fehler bei der Antragstellung, Zweifel an der Wirksamkeit von Maxamine und sogar indirekte Manipulationsvorwürfe bzgl. der durchgeführten Studien.
Stockholder suit filed against Maxim Pharmaceuticals
SAN DIEGO, Dec 14 (Reuters) - The law firm of Milberg Weiss on Thursday said it has filed a lawsuit seeking class action status on behalf of stockholders of Maxim Pharmaceuticals Inc. <MAXM.O>, a developer of drugs, therapies and vaccines for cancer and infectious diseases.
The suit, filed in U.S. District Court for the Southern District of California, seeks to represents Maxim common stockholders who bought their shares between Jan. 5 and Dec. 13 this year.
The complaint accuses Maxim and certain of its officers and directors with violations of the Securities Exchange Act of 1934 by issuing false and misleading statements about the effectiveness of its Maxamine drug and the company`s adherence to Food and Drug Administration protocol. As such, the complaint accuses the company of allowing Maxim to complete a follow-on public offering on Feb. 28 at $55 and artificially inflate its stock to a Class Period high of $79.50.
Maxim sold 3.2 million shares of its stock at as high as $55 for $165 million in proceeds so as to provide it with ample monies to make a large acquisition and fund its operations.
However this week, the Food and Drug Administration rejected the company`s new skin cancer drug Maxamine.
A representative from the company was not available for immediate comment.
((New York Newsdesk, 212-859-1700))
REUTERS
SAN DIEGO, Dec 14 (Reuters) - The law firm of Milberg Weiss on Thursday said it has filed a lawsuit seeking class action status on behalf of stockholders of Maxim Pharmaceuticals Inc. <MAXM.O>, a developer of drugs, therapies and vaccines for cancer and infectious diseases.
The suit, filed in U.S. District Court for the Southern District of California, seeks to represents Maxim common stockholders who bought their shares between Jan. 5 and Dec. 13 this year.
The complaint accuses Maxim and certain of its officers and directors with violations of the Securities Exchange Act of 1934 by issuing false and misleading statements about the effectiveness of its Maxamine drug and the company`s adherence to Food and Drug Administration protocol. As such, the complaint accuses the company of allowing Maxim to complete a follow-on public offering on Feb. 28 at $55 and artificially inflate its stock to a Class Period high of $79.50.
Maxim sold 3.2 million shares of its stock at as high as $55 for $165 million in proceeds so as to provide it with ample monies to make a large acquisition and fund its operations.
However this week, the Food and Drug Administration rejected the company`s new skin cancer drug Maxamine.
A representative from the company was not available for immediate comment.
((New York Newsdesk, 212-859-1700))
REUTERS
Market Capitalization $187.2M
Total Cash (mrq) $197.8M
Total Cash (mrq) $197.8M
Gibt es inzwischen Stellungnahmen der Firma ??
Ist die Pleite besiegelt oder gibt es noch Hoffnung auf eine Korrektur? Was sagen mir die neusten Zahlen? Danke für Infos Suisa
Ist die Pleite besiegelt oder gibt es noch Hoffnung auf eine Korrektur? Was sagen mir die neusten Zahlen? Danke für Infos Suisa
Auch für mich stellt sich die Frage, ist eine
Erholung noch mal in Sicht oder wars das mit Maxim.
Dann so schnell als möglich den Verlust realisieren. Was meint Ihr dazu?
Erholung noch mal in Sicht oder wars das mit Maxim.
Dann so schnell als möglich den Verlust realisieren. Was meint Ihr dazu?
Schauen sie rein: www.brokerstalk.de.vu
Also pleite sind die gewiß nicht, auch nicht bald, dafür sorgen schon die hohen Barreserven. Bloß der Ausblick für die beiden nächsten zwei Jahre ist nicht so prickelnd.
Es ist gar nicht so unwahrscheinlich, dass Roche wieder aus dem Vertrag austritt (geht über eine Klausel), so dass zunächst nur langwierige und langweilige Studien anstehen (wobei MM-Behandlung u.U tot sein wird; sehr bedauerlich für die Patienten), und erstmal kaum neue positive Phantasie aufkommen kann. Nicht zuletzt ist in zwei Jahren einiges vom Geld wieder aufgebraucht.
Vielleicht sehe ich selber schon zu schwarz und MAXM ist eventuell sogar ein Kauf. Das Management hat aber sträflich leichtsinnig gehandelt , mit solchen Daten und einer retrospektiven Analyse vorm ODAC Kommitee anzutreten.
Vielleicht solltet ihr aber auch darüber nachdenken, die Verluste noch vor Sylvester mitzunehmen, denn steuerlich werden die nur bis dahin zu 100 % angerechnet, danach nur noch zur Hälfte.
Der Puhvogel
Es ist gar nicht so unwahrscheinlich, dass Roche wieder aus dem Vertrag austritt (geht über eine Klausel), so dass zunächst nur langwierige und langweilige Studien anstehen (wobei MM-Behandlung u.U tot sein wird; sehr bedauerlich für die Patienten), und erstmal kaum neue positive Phantasie aufkommen kann. Nicht zuletzt ist in zwei Jahren einiges vom Geld wieder aufgebraucht.
Vielleicht sehe ich selber schon zu schwarz und MAXM ist eventuell sogar ein Kauf. Das Management hat aber sträflich leichtsinnig gehandelt , mit solchen Daten und einer retrospektiven Analyse vorm ODAC Kommitee anzutreten.
Vielleicht solltet ihr aber auch darüber nachdenken, die Verluste noch vor Sylvester mitzunehmen, denn steuerlich werden die nur bis dahin zu 100 % angerechnet, danach nur noch zur Hälfte.
Der Puhvogel
nach aussage des managements reichen die barreserven noch 2 jahre.
maxamine wird noch auf wirkung gegen andere krankheiten - v.a. hepatitis c - getestet.
auch im krebsbereich wird weiter geforscht:
Maxamine Reduces Tumor Growth in Preclinical Sarcoma Study
SAN DIEGO--(BW HealthWire)--Oct. 13, 2000--Maxim Pharmaceuticals Friday announced that treatment with Maxamine® (histamine dihydrochloride) as a single-agent therapy resulted in a significant reduction of the growth of Leydig cell sarcoma tumors in rats.
...
maxamine ist also noch nicht ganz tot. desweiteren ist da noch das projekt maxderm und das im juni für 80 mio $ übernommene unternehmen "cytovia" mit einige vielversprechenden präparaten.
Maxim Pharmaceuticals Licenses Caspase Activator Cancer Compound to BioChem Pharma
SAN DIEGO--(BW HealthWire)--July 11, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it
has licensed its CV2105 series of anti-cancer compounds to BioChem Pharma Inc.
The agreement requires that BioChem make licensing, research and milestone payments to Maxim totaling up to U.S. $55
million, as well as pay a royalty on product sales resulting from this collaboration.
...
maxamine wird noch auf wirkung gegen andere krankheiten - v.a. hepatitis c - getestet.
auch im krebsbereich wird weiter geforscht:
Maxamine Reduces Tumor Growth in Preclinical Sarcoma Study
SAN DIEGO--(BW HealthWire)--Oct. 13, 2000--Maxim Pharmaceuticals Friday announced that treatment with Maxamine® (histamine dihydrochloride) as a single-agent therapy resulted in a significant reduction of the growth of Leydig cell sarcoma tumors in rats.
...
maxamine ist also noch nicht ganz tot. desweiteren ist da noch das projekt maxderm und das im juni für 80 mio $ übernommene unternehmen "cytovia" mit einige vielversprechenden präparaten.
Maxim Pharmaceuticals Licenses Caspase Activator Cancer Compound to BioChem Pharma
SAN DIEGO--(BW HealthWire)--July 11, 2000--Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that it
has licensed its CV2105 series of anti-cancer compounds to BioChem Pharma Inc.
The agreement requires that BioChem make licensing, research and milestone payments to Maxim totaling up to U.S. $55
million, as well as pay a royalty on product sales resulting from this collaboration.
...
Hallo Pitu,
wie Du richtig schreibst:
"Nach Aussage des Managements...". Die Frage ist nur, was kann man "diesem" Management noch glauben. Ich erinnere nur an die Worte des Vorstandsvorsitzenden "es wird ein goldener Dezember" und "wir werden die Erwartungen im Jahr 2001 weit übertreffen". Quelle Pressekonferenz Maxim Anfang Dezember 2000.
Na ja, vielleicht wendet sich ja doch noch alles zum Guten und in ein paar Jahren sehe ich meinen Einstandskurs wieder.
wie Du richtig schreibst:
"Nach Aussage des Managements...". Die Frage ist nur, was kann man "diesem" Management noch glauben. Ich erinnere nur an die Worte des Vorstandsvorsitzenden "es wird ein goldener Dezember" und "wir werden die Erwartungen im Jahr 2001 weit übertreffen". Quelle Pressekonferenz Maxim Anfang Dezember 2000.
Na ja, vielleicht wendet sich ja doch noch alles zum Guten und in ein paar Jahren sehe ich meinen Einstandskurs wieder.
PERFORMAXX-BIOTECH-KOLUMNE: Maxim Pharmaceuticals - Ein Engel ist abgestürzt
WOLFRATSHAUSEN (GoingPublic) - Negative Neuigkeiten gab es in dieser Woche bei Maxim Pharmaceuticals . Kurz vor Weihnachten beendete die FDA, die für Arzneimittelzulassungen zuständige US-Behörde, die Höhenflugambitionen dieses "Börsenengels". Noch im März konnte die Aktie des auf den Bereich Onkologie fokussierten Unternehmens einen Höchststand von 80 USD erreichen. Am Donnerstag nach Börsenschluß war sie in New York auf den Jahrestiefststand von 9,25 USD gefallen. In einer Zeit, in der die Märkte besonders sensibel auf negative Meldungen reagieren, passierte das denkbar schlechteste, was einem Biotechunternehmen zustoßen kann. Die FDA meldete Bedenken bei dem Hauptprodukt von Maxim an. Maxamine, so dessen Name, sollte das erste zugelassene Produkt des Unternehmens sein, das gegen diverse Krebsarten zumeist in Kombination mit anderen Wirkstoffen eingesetzt werden soll. So auch gegen das maligne Melanom, eine gefährliche Hautkrebsart, wo es in der Anwendung zusammen mit Interleukin getestet wurde. Am 12. Dezember meldete die FDA Bedenken bezüglich der von Maxim durchgeführten Studie an. Nach einer ersten Betrachtung der Studienergebnisse durch die FDA wurde angeführt, daß die Ergebnisse auch deshalb angezweifelt werden müssen, weil Patienten mit unterschiedlichem Krankheitsfortschritt in die Untersuchungen miteinbezogen wurden und so diejenigen, die mit Maxamine behandelt wurden, ein bessere Heilungschance gehabt hätten. Auch grundsätzlich Bedenken hinsichtlich des Sicherheitsprofils wurden angemeldet. Zwar stellte dies nur ein vorläufiges Ergebnis dar, da eine erneute Erörterung für den Folgetag angesetzt war, doch brach der Kurs der Aktie aufgrund dieser negativen Nachrichten um bis zu 40 Prozent ein. Auf ein doch noch positives Ergebnis brauchte man in dieser Situation nicht mehr hoffen. So brachte der 13. Dezember Maxim auch nicht mehr Glück, denn die FDA bestätigte ihre Einschätzung und lehnte die Zulassung des Produkts ab. Obwohl sich das Unternehmen weiterhin betont optimistisch gibt und die positive Wirkung des Medikaments in der Phase-III-Studie, die an 305 Patienten durchgeführt wurde, bestätigt sieht, straft die Börse die Aktie weiter ab. Die Reaktion ist verständlich, wenn man sich die Auswirkungen auf das Unternehmen betrachtet. Dieses sieht sich selbst als Biotechnologieunternehmen in fortgeschrittenem Stadium, was sicherlich stimmt, vor allem hinsichtlich der Zahl der klinischen Studien, die Maxim Pharmaceuticals durchführt. Mit aktuell elf Phase-II und drei Phase-III Studien weist man ein breites "Studienportfolio" auf. Doch baut dieses auf das Produkt Maxamine auf und eben jene Studie, die den Weg Maxamines auf den Markt ebnen sollte, erreichte genau dies nicht. Verständlich, daß die Börse daraufhin den Wert des Unternehmens deutlich reduziert hat. Von ehemals rund 1,8 Mrd. USD sind heute nur noch 200 Mio. USD bzw. 11 Prozent verblieben. Die Entwicklung von Maxim Pharmaceuticals zeigt exemplarisch die Gefahr so manchen Biotechnologieunternehmens. Zwar wurde nach außen hin der Anschein erweckt, als handele es sich um ein breit positioniertes Unternehmen. Doch wurde bei Analysen häufig übersehen, daß die Breite der Pipeline auf einem Produkt basiert, das in vielen Bereichen - und dabei vor allem in Kombination mit anderen Wirkstoffen - Anwendung finden soll. Das Reizwort Krebstherapie trug ein übriges dazu bei, um die Favorisierung des Titels zu rechtfertigen, wobei übersehen wurde, daß es sich bei Maxim um ein One-product-Unternehmen handelt, das vom Erfolg Maxamines abhängig ist. Die Ereignisse der letzten Tage haben gezeigt, daß nicht nur kleine Unternehmen durch Rückschläge in der Entwicklungsarbeit schwer getroffen werden können. So war Maxim Pharmaceuticals, gemessen an der Marktkapitalisierung, bis vor kurzem eines der größeren Unternehmen. Durch die FDA-Entscheidung wurde jedoch ein wesentlicher Teil der Strategie zunichte gemacht. So sollte mit Maxamine gegen das maligne Melanom der Markt für das Produkt geöffnet werden und die Anwendung gegen weitere Indikationen hätte auf der Basis guter Erfahrungen mit der Anwendung des Produkts erfolgen können. Da Maxim auf den Erfolg eines Wirkstoffes gesetzt hat, stellt sich die Zukunft entsprechend ungewiß dar.
Tobias Haff, Leiter Biotech-Research bei Performaxx, München
WOLFRATSHAUSEN (GoingPublic) - Negative Neuigkeiten gab es in dieser Woche bei Maxim Pharmaceuticals . Kurz vor Weihnachten beendete die FDA, die für Arzneimittelzulassungen zuständige US-Behörde, die Höhenflugambitionen dieses "Börsenengels". Noch im März konnte die Aktie des auf den Bereich Onkologie fokussierten Unternehmens einen Höchststand von 80 USD erreichen. Am Donnerstag nach Börsenschluß war sie in New York auf den Jahrestiefststand von 9,25 USD gefallen. In einer Zeit, in der die Märkte besonders sensibel auf negative Meldungen reagieren, passierte das denkbar schlechteste, was einem Biotechunternehmen zustoßen kann. Die FDA meldete Bedenken bei dem Hauptprodukt von Maxim an. Maxamine, so dessen Name, sollte das erste zugelassene Produkt des Unternehmens sein, das gegen diverse Krebsarten zumeist in Kombination mit anderen Wirkstoffen eingesetzt werden soll. So auch gegen das maligne Melanom, eine gefährliche Hautkrebsart, wo es in der Anwendung zusammen mit Interleukin getestet wurde. Am 12. Dezember meldete die FDA Bedenken bezüglich der von Maxim durchgeführten Studie an. Nach einer ersten Betrachtung der Studienergebnisse durch die FDA wurde angeführt, daß die Ergebnisse auch deshalb angezweifelt werden müssen, weil Patienten mit unterschiedlichem Krankheitsfortschritt in die Untersuchungen miteinbezogen wurden und so diejenigen, die mit Maxamine behandelt wurden, ein bessere Heilungschance gehabt hätten. Auch grundsätzlich Bedenken hinsichtlich des Sicherheitsprofils wurden angemeldet. Zwar stellte dies nur ein vorläufiges Ergebnis dar, da eine erneute Erörterung für den Folgetag angesetzt war, doch brach der Kurs der Aktie aufgrund dieser negativen Nachrichten um bis zu 40 Prozent ein. Auf ein doch noch positives Ergebnis brauchte man in dieser Situation nicht mehr hoffen. So brachte der 13. Dezember Maxim auch nicht mehr Glück, denn die FDA bestätigte ihre Einschätzung und lehnte die Zulassung des Produkts ab. Obwohl sich das Unternehmen weiterhin betont optimistisch gibt und die positive Wirkung des Medikaments in der Phase-III-Studie, die an 305 Patienten durchgeführt wurde, bestätigt sieht, straft die Börse die Aktie weiter ab. Die Reaktion ist verständlich, wenn man sich die Auswirkungen auf das Unternehmen betrachtet. Dieses sieht sich selbst als Biotechnologieunternehmen in fortgeschrittenem Stadium, was sicherlich stimmt, vor allem hinsichtlich der Zahl der klinischen Studien, die Maxim Pharmaceuticals durchführt. Mit aktuell elf Phase-II und drei Phase-III Studien weist man ein breites "Studienportfolio" auf. Doch baut dieses auf das Produkt Maxamine auf und eben jene Studie, die den Weg Maxamines auf den Markt ebnen sollte, erreichte genau dies nicht. Verständlich, daß die Börse daraufhin den Wert des Unternehmens deutlich reduziert hat. Von ehemals rund 1,8 Mrd. USD sind heute nur noch 200 Mio. USD bzw. 11 Prozent verblieben. Die Entwicklung von Maxim Pharmaceuticals zeigt exemplarisch die Gefahr so manchen Biotechnologieunternehmens. Zwar wurde nach außen hin der Anschein erweckt, als handele es sich um ein breit positioniertes Unternehmen. Doch wurde bei Analysen häufig übersehen, daß die Breite der Pipeline auf einem Produkt basiert, das in vielen Bereichen - und dabei vor allem in Kombination mit anderen Wirkstoffen - Anwendung finden soll. Das Reizwort Krebstherapie trug ein übriges dazu bei, um die Favorisierung des Titels zu rechtfertigen, wobei übersehen wurde, daß es sich bei Maxim um ein One-product-Unternehmen handelt, das vom Erfolg Maxamines abhängig ist. Die Ereignisse der letzten Tage haben gezeigt, daß nicht nur kleine Unternehmen durch Rückschläge in der Entwicklungsarbeit schwer getroffen werden können. So war Maxim Pharmaceuticals, gemessen an der Marktkapitalisierung, bis vor kurzem eines der größeren Unternehmen. Durch die FDA-Entscheidung wurde jedoch ein wesentlicher Teil der Strategie zunichte gemacht. So sollte mit Maxamine gegen das maligne Melanom der Markt für das Produkt geöffnet werden und die Anwendung gegen weitere Indikationen hätte auf der Basis guter Erfahrungen mit der Anwendung des Produkts erfolgen können. Da Maxim auf den Erfolg eines Wirkstoffes gesetzt hat, stellt sich die Zukunft entsprechend ungewiß dar.
Tobias Haff, Leiter Biotech-Research bei Performaxx, München
habe einen schlußstrich unter dieses traurige kapitel meiner börsenaktivitäten gezogen.
kauf zu 77 euro, 39,5 euro, 35 euro und 21 euro - verkauf zu 40 euro und 7,80 euro
es tut mir leid für alle, die diesen kurssturz ebenfalls mitgemacht haben
und vielleicht sogar durch diesen thread zum kauf animiert wurden.
kauf zu 77 euro, 39,5 euro, 35 euro und 21 euro - verkauf zu 40 euro und 7,80 euro
es tut mir leid für alle, die diesen kurssturz ebenfalls mitgemacht haben
und vielleicht sogar durch diesen thread zum kauf animiert wurden.
Cauley & Geller, LLP kündigt Gruppenklageprozeß gegen Maxim-pharmazeutische Produkte, Inc. an.
SAN DIEGO--(BUSINESS WIRE)--Dec. 20, 2000--
Die Rechtsanwaltsfirma Cauley & Geller, LLP, kündigte heute an, daß sie eine Gruppenklage im United States District Court für den Southern District of California im Namen aller Einzelpersonen und Institutionsgeldanleger eingereicht hat, die die Stammaktien von Maxim Pharmaceuticals zwischen 5.Januar 2000 und 13.Dezember 2000 gekauft haben.
Quelle http://biz.yahoo.com/bw/001220/ca_cauley_.html
Weiß jemand, ob wir als Deutsche uns da auch mit anschließen können? Ich jedenfalls möchte mein Geld zurück, wenn MAXM gelogen hat.
mig
SAN DIEGO--(BUSINESS WIRE)--Dec. 20, 2000--
Die Rechtsanwaltsfirma Cauley & Geller, LLP, kündigte heute an, daß sie eine Gruppenklage im United States District Court für den Southern District of California im Namen aller Einzelpersonen und Institutionsgeldanleger eingereicht hat, die die Stammaktien von Maxim Pharmaceuticals zwischen 5.Januar 2000 und 13.Dezember 2000 gekauft haben.
Quelle http://biz.yahoo.com/bw/001220/ca_cauley_.html
Weiß jemand, ob wir als Deutsche uns da auch mit anschließen können? Ich jedenfalls möchte mein Geld zurück, wenn MAXM gelogen hat.
mig
@ pitu + alle !!!!
eine frage !!
ist es möglich aktien - diese für € zu kaufen ( in dt.) und
in den usa zu ferkaufen-für $ !!!!
danke
--->lohnt jetzt noch ein invest, marktkapitalisierung und umsatz, das ist doch ****
--->vergiß es, nix los, wann kommt der umsatz von 10mrd $ - zu 1,4mrd eigenkapital !!!!!!
-meine meinung !!!
danke
eine frage !!
ist es möglich aktien - diese für € zu kaufen ( in dt.) und
in den usa zu ferkaufen-für $ !!!!
danke
--->lohnt jetzt noch ein invest, marktkapitalisierung und umsatz, das ist doch ****
--->vergiß es, nix los, wann kommt der umsatz von 10mrd $ - zu 1,4mrd eigenkapital !!!!!!
-meine meinung !!!
danke
Maxim Caspase Inhibitor Protects Against Liver Apoptosis in Preclinical Study
SAN DIEGO--(BW HealthWire)--Feb. 26, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) announced the publication of a preclinical study demonstrating that its investigational caspase inhibitor CV1013 protected critical cells of the liver from programmed cell death in a mouse model, providing further insight into the mode of action of this family of compounds.
The publication, ``Protection Against TNF-Induced Parenchymal Cell Apoptosis during Endotoxemia by a Novel Caspase Inhibitor in Mice,`` appeared in the November 15, 2000 issue of Toxicology and Applied Pharmacology (volume 169, pp. 77-83).
Caspases are key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as failure due to cell death. Compounds such as CV1013 that can inhibit caspases may potentially form the basis for new drugs for endotoxic shock and other degenerative diseases. CV1013 is a member of one of several novel families of caspase inhibitors identified to date by Maxim through its proprietary apoptosis drug discovery program.
In this study, mice were administered galactosamine and endotoxin (Gal/ET), chemical agents that are used to induce endotoxemia resulting in liver failure due to cell death. Doses of 10 or 1 mg/kg of CV1013 administered 3, 4.5, and 5.5 hours after Gal/ET greatly reduced the amount of liver cell apoptosis in treated animals relative to animals not receiving CV1013. All mice treated with CV1013 survived with little or no liver injury after Gal/ET administration. In contrast, all control animals died within 12 hours of Gal/ET administration due to shock and liver failure. Biochemical data are consistent with the hypothesis that CV1013 inhibited primarily caspase 8, thereby blocking the initial intracellular signal that would be expected to lead to apoptotic cell death and liver failure.
``Maxim`s live-cell, high-throughput screening technology forms the basis for our caspase modulator program that is generating a rapidly growing portfolio of compounds,`` said Larry G. Stambaugh, CEO and president of Maxim Pharmaceuticals. ``Studies such as these highlight the potential of this program, and we are continuing our efforts directed toward preparing our most promising compounds for clinical development and/or corporate collaborations.``
Maxim Researchers Present At 5th World Conference On Melanoma
Three Presentations Focus on Quality of Life and Survival Results for U.S. Phase 3 Trial of Ceplene in Advanced Metastatic Melanoma
VENICE, Italy--(BW HealthWire)--Feb. 28, 2001-- Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) announced that researchers will present three abstracts at the World Health Organization 5th World Conference on Melanoma commencing today in Venice, Italy, describing the results from its U.S. Phase 3 trial of Ceplene(TM) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma patients.
Included in the presentations are additional data regarding quality of life that further support the feasibility of the Ceplene/IL-2 combination treatment.
Overview of Presentations
A total of 305 patients participated in an open-label, controlled, multi-center U.S. Phase 3 trial sponsored by Maxim to evaluate the effectiveness of treatment with the combination of Ceplene and IL-2 versus IL-2 alone in patients with advanced metastatic melanoma. This trial of the Ceplene/IL-2 combination was designed to allow these advanced-stage malignant melanoma patients to be treated at home. A total of 129 patients participating in the study had melanoma that had metastasized to the liver at the time of enrollment in the trial, a population of patients with a particularly poor prognosis for survival.
``Quality of life is an aspect of treatment of paramount importance for patients and their families that live with the daily realities of cancer and other chronic diseases,`` said Kurt R. Gehlsen, Ph.D., Maxim`s senior vice president, development and chief technical officer. ``When survival benefit is sufficiently established, quality-of-life data provide an additional perspective by which we may assess the potential value to patients of proposed treatments like the combination of Ceplene and IL-2. The data from the trial suggested that the addition of Ceplene may improve survival in advanced melanoma patients with liver metastases without adversely affecting patient quality of life, compared to treatment with IL-2 alone.``
Patients participating in the Phase 3 study were asked to complete a validated ``Quality of Well Being`` questionnaire to facilitate a comparison of the effects of the two treatment arms on patient quality of life. The quality-of-life results from the Phase 3 study are summarized in an abstract authored by Dr. John Glaspy, Bower Oncology Center, University of California at Los Angeles, a principal investigator in the study. The results suggest that there was no degradation of quality of life resulting from the addition of Ceplene to low-dose subcutaneous IL-2 therapy. In addition, median quality-adjusted survival was significantly increased for patients receiving treatment with the Ceplene/IL-2 combination compared to treatment with IL-2 alone (p = 0.010 for all patients, adjusted p = 0.014 for patients with liver metastases).
Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute, will present survival results from the Phase 3 study at the conference. Advanced metastatic melanoma patients with liver metastases treated with the combination of Ceplene and the IL-2 had a median survival of nine months (adjusted p = 0.008), compared to a median survival of five months for those patients treated with IL-2 alone. An even greater survival benefit was observed for individuals treated at centers that treated their patients for an average of at least two cycles.
``Although these results are not currently considered adequate on a stand-alone basis by the FDA to support approval of Ceplene in the treatment of advanced metastatic melanoma with liver metastases, we believe that they provide strong evidence of the potential of Ceplene in this disease,`` said Dr. Gehlsen. ``We will work with the FDA to develop a strategy to support the approvability of Ceplene in this important patient population.``
Ceplene Overview
Treatment with Ceplene (formerly Maxamine®) is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Ceplene, based on the naturally occurring molecule histamine, is designed to reverse this immune suppression and protect critical immune cells. Ceplene is administered in combination with cytokines such as IL-2 or interferon-alpha, a class of proteins that stimulate these same immune cells. This combination of actions provided by the Ceplene/cytokine treatment is designed to improve the immune system`s ability to identify, disable and destroy malignant or infected cells, thereby improving patient care.
Ceplene is currently being tested in two additional Phase 3 cancer clinical trials in 12 countries for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
SAN DIEGO--(BW HealthWire)--Feb. 26, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) announced the publication of a preclinical study demonstrating that its investigational caspase inhibitor CV1013 protected critical cells of the liver from programmed cell death in a mouse model, providing further insight into the mode of action of this family of compounds.
The publication, ``Protection Against TNF-Induced Parenchymal Cell Apoptosis during Endotoxemia by a Novel Caspase Inhibitor in Mice,`` appeared in the November 15, 2000 issue of Toxicology and Applied Pharmacology (volume 169, pp. 77-83).
Caspases are key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as failure due to cell death. Compounds such as CV1013 that can inhibit caspases may potentially form the basis for new drugs for endotoxic shock and other degenerative diseases. CV1013 is a member of one of several novel families of caspase inhibitors identified to date by Maxim through its proprietary apoptosis drug discovery program.
In this study, mice were administered galactosamine and endotoxin (Gal/ET), chemical agents that are used to induce endotoxemia resulting in liver failure due to cell death. Doses of 10 or 1 mg/kg of CV1013 administered 3, 4.5, and 5.5 hours after Gal/ET greatly reduced the amount of liver cell apoptosis in treated animals relative to animals not receiving CV1013. All mice treated with CV1013 survived with little or no liver injury after Gal/ET administration. In contrast, all control animals died within 12 hours of Gal/ET administration due to shock and liver failure. Biochemical data are consistent with the hypothesis that CV1013 inhibited primarily caspase 8, thereby blocking the initial intracellular signal that would be expected to lead to apoptotic cell death and liver failure.
``Maxim`s live-cell, high-throughput screening technology forms the basis for our caspase modulator program that is generating a rapidly growing portfolio of compounds,`` said Larry G. Stambaugh, CEO and president of Maxim Pharmaceuticals. ``Studies such as these highlight the potential of this program, and we are continuing our efforts directed toward preparing our most promising compounds for clinical development and/or corporate collaborations.``
Maxim Researchers Present At 5th World Conference On Melanoma
Three Presentations Focus on Quality of Life and Survival Results for U.S. Phase 3 Trial of Ceplene in Advanced Metastatic Melanoma
VENICE, Italy--(BW HealthWire)--Feb. 28, 2001-- Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) announced that researchers will present three abstracts at the World Health Organization 5th World Conference on Melanoma commencing today in Venice, Italy, describing the results from its U.S. Phase 3 trial of Ceplene(TM) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma patients.
Included in the presentations are additional data regarding quality of life that further support the feasibility of the Ceplene/IL-2 combination treatment.
Overview of Presentations
A total of 305 patients participated in an open-label, controlled, multi-center U.S. Phase 3 trial sponsored by Maxim to evaluate the effectiveness of treatment with the combination of Ceplene and IL-2 versus IL-2 alone in patients with advanced metastatic melanoma. This trial of the Ceplene/IL-2 combination was designed to allow these advanced-stage malignant melanoma patients to be treated at home. A total of 129 patients participating in the study had melanoma that had metastasized to the liver at the time of enrollment in the trial, a population of patients with a particularly poor prognosis for survival.
``Quality of life is an aspect of treatment of paramount importance for patients and their families that live with the daily realities of cancer and other chronic diseases,`` said Kurt R. Gehlsen, Ph.D., Maxim`s senior vice president, development and chief technical officer. ``When survival benefit is sufficiently established, quality-of-life data provide an additional perspective by which we may assess the potential value to patients of proposed treatments like the combination of Ceplene and IL-2. The data from the trial suggested that the addition of Ceplene may improve survival in advanced melanoma patients with liver metastases without adversely affecting patient quality of life, compared to treatment with IL-2 alone.``
Patients participating in the Phase 3 study were asked to complete a validated ``Quality of Well Being`` questionnaire to facilitate a comparison of the effects of the two treatment arms on patient quality of life. The quality-of-life results from the Phase 3 study are summarized in an abstract authored by Dr. John Glaspy, Bower Oncology Center, University of California at Los Angeles, a principal investigator in the study. The results suggest that there was no degradation of quality of life resulting from the addition of Ceplene to low-dose subcutaneous IL-2 therapy. In addition, median quality-adjusted survival was significantly increased for patients receiving treatment with the Ceplene/IL-2 combination compared to treatment with IL-2 alone (p = 0.010 for all patients, adjusted p = 0.014 for patients with liver metastases).
Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute, will present survival results from the Phase 3 study at the conference. Advanced metastatic melanoma patients with liver metastases treated with the combination of Ceplene and the IL-2 had a median survival of nine months (adjusted p = 0.008), compared to a median survival of five months for those patients treated with IL-2 alone. An even greater survival benefit was observed for individuals treated at centers that treated their patients for an average of at least two cycles.
``Although these results are not currently considered adequate on a stand-alone basis by the FDA to support approval of Ceplene in the treatment of advanced metastatic melanoma with liver metastases, we believe that they provide strong evidence of the potential of Ceplene in this disease,`` said Dr. Gehlsen. ``We will work with the FDA to develop a strategy to support the approvability of Ceplene in this important patient population.``
Ceplene Overview
Treatment with Ceplene (formerly Maxamine®) is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Ceplene, based on the naturally occurring molecule histamine, is designed to reverse this immune suppression and protect critical immune cells. Ceplene is administered in combination with cytokines such as IL-2 or interferon-alpha, a class of proteins that stimulate these same immune cells. This combination of actions provided by the Ceplene/cytokine treatment is designed to improve the immune system`s ability to identify, disable and destroy malignant or infected cells, thereby improving patient care.
Ceplene is currently being tested in two additional Phase 3 cancer clinical trials in 12 countries for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
Monday March 5, 3:01 am Eastern Time
Press Release
Maxim Announces New U.S. Patent Issued Supporting the MaxDerm
Technology
SAN DIEGO--(BW HealthWire)--March 5, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) today announced that the United States
Patent and Trademark Office has issued a key patent supporting the company`s MaxDerm(TM) technology for the treatment of topical maladies such as oral
mucositis and herpes.
The patent, U.S. Patent Number 6,080,395, is entitled ``Method and Composition for Topical Treatment of Damaged Tissue Using Histamine as Active Ingredient.``
This patent encompasses a pharmaceutical formulation underlying the company`s MaxDerm technology, as well as the use of that formulation in the treatment of
topical maladies such as oral mucositis, herpes labialis (cold sores), herpes genitalis, chicken pox, allergic conjunctivitis, aphthous stomatitis, thermal burns, sunburn,
decubitus ulcers and shingles.
``Our research has suggested that MaxDerm`s active agent, histamine, is an important molecule in the healing process for certain topical maladies, and we are pleased
with the additional protection provided by this most recent patent,`` said Dr. Kurt Gehlsen, Maxim`s senior vice president, development and chief technical officer.
``Our preclinical work, and the results of pilot human studies, have shown promise in a number of indications, including oral mucositis and oral herpes. We are
currently undertaking activities associated with the preparation of this drug candidate for human studies in oral mucositis.``
Maxim now owns or has the rights to six issued U.S. patents and one U.S. patent application relating to MaxDerm. Corresponding international patents or patent
applications have been issued or are pending.
Press Release
Maxim Announces New U.S. Patent Issued Supporting the MaxDerm
Technology
SAN DIEGO--(BW HealthWire)--March 5, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM) today announced that the United States
Patent and Trademark Office has issued a key patent supporting the company`s MaxDerm(TM) technology for the treatment of topical maladies such as oral
mucositis and herpes.
The patent, U.S. Patent Number 6,080,395, is entitled ``Method and Composition for Topical Treatment of Damaged Tissue Using Histamine as Active Ingredient.``
This patent encompasses a pharmaceutical formulation underlying the company`s MaxDerm technology, as well as the use of that formulation in the treatment of
topical maladies such as oral mucositis, herpes labialis (cold sores), herpes genitalis, chicken pox, allergic conjunctivitis, aphthous stomatitis, thermal burns, sunburn,
decubitus ulcers and shingles.
``Our research has suggested that MaxDerm`s active agent, histamine, is an important molecule in the healing process for certain topical maladies, and we are pleased
with the additional protection provided by this most recent patent,`` said Dr. Kurt Gehlsen, Maxim`s senior vice president, development and chief technical officer.
``Our preclinical work, and the results of pilot human studies, have shown promise in a number of indications, including oral mucositis and oral herpes. We are
currently undertaking activities associated with the preparation of this drug candidate for human studies in oral mucositis.``
Maxim now owns or has the rights to six issued U.S. patents and one U.S. patent application relating to MaxDerm. Corresponding international patents or patent
applications have been issued or are pending.
Maxim Announces That Ceplene Will be Included in Multi-National Study of Individualized Treatment for Hepatitis C
SAN DIEGO--(BW HealthWire)--April 16, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) today announced that Ceplene(TM) (histamine dihydrochloride) will be tested in a new multi-national clinical study, the "Dynamically Individualized Treatment of Hepatitis C Infection and Correlates of Viral/Host Dynamics" study ("DITTO-HCV"), expected to commence this month.
The overall objective of the study is to develop a new treatment strategy for chronic hepatitis C that can increase the sustained viral response to therapy, while minimizing impairment of quality of life and socio-economic burden. Sponsors of the study include the European Union Commission and F. Hoffmann -- La Roche Ltd.
The DITTO-HCV study is expected to include up to 300 patients in nine clinical centers based in France, Germany, Greece, Italy, Israel, The Netherlands, Spain, Sweden and Switzerland. The objective of the study is to develop and evaluate treatment strategies tailored to the individual patient`s response to initial therapy. The drugs to be evaluated in the study include pegylated interferon, ribavirin and Ceplene, in various doses and combinations. One of the arms of the study will test a triple-drug regimen of Ceplene in combination with pegylated interferon and ribavirin.
Maxim also announced that it expects that the 72-week data from its recently completed Phase 2 study of Ceplene in combination with interferon-alpha will be presented at the European Association for the Study of Liver (EASL) conference in Prague, Czech Republic on Friday, April 20, 2001.
Hepatitis C Overview
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
In early 2001 Maxim completed a 129-patient Phase 2 dose-ranging study of Ceplene in combination with IFN-(alpha) in the treatment of previously untreated hepatitis C-infected patients. The ongoing study was designed to evaluate the safety and activity of four different dose regimens of Ceplene in combination with interferon-alpha. In addition, the company is conducting a pilot safety study to evaluate the feasibility and safety of triple-drug treatment with Ceplene in combination with IFN-(alpha) and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy or relapsed after prior therapy.
Maxim Overview
Maxim Pharmaceuticals is a biopharmaceutical company developing advanced drugs and therapies for cancer and infectious diseases. The company`s lead drug candidate Ceplene (formerly, Maxamine(R)) is currently being tested in two Phase 3 cancer clinical trials in 12 countries for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
In addition to Ceplene, the company has developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate, such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, MaxDerm and the caspase modulator compounds, and regarding the company`s clinical trials. Such statements are only predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that planned clinical trials may not start when anticipated, the risk that the company will not obtain approval to market its products, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM), Maxamine(R), and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com
CONTACT: Maxim Pharmaceuticals
Larry G. Stambaugh, 858/453-4040
or
Dale A. Sander, 858/453-4040
or
Burns McClellan
Ethan Denkensohn, investors, 212/213-0006
or
Kathy Jones, Ph.D., media, 212/213-0006
Copyright 2001, Business Wire. All of the releases provided by Business Wire are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire`s members, who are solely responsible for their content, accuracy and originality. All reproduction, other than for an individual user`s reference, is prohibited without prior written permission.
Home | About Nasdaq | Feedback | Help & Reference
Equity & Index Options | Site Map, Index, Search
SAN DIEGO--(BW HealthWire)--April 16, 2001--Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) today announced that Ceplene(TM) (histamine dihydrochloride) will be tested in a new multi-national clinical study, the "Dynamically Individualized Treatment of Hepatitis C Infection and Correlates of Viral/Host Dynamics" study ("DITTO-HCV"), expected to commence this month.
The overall objective of the study is to develop a new treatment strategy for chronic hepatitis C that can increase the sustained viral response to therapy, while minimizing impairment of quality of life and socio-economic burden. Sponsors of the study include the European Union Commission and F. Hoffmann -- La Roche Ltd.
The DITTO-HCV study is expected to include up to 300 patients in nine clinical centers based in France, Germany, Greece, Italy, Israel, The Netherlands, Spain, Sweden and Switzerland. The objective of the study is to develop and evaluate treatment strategies tailored to the individual patient`s response to initial therapy. The drugs to be evaluated in the study include pegylated interferon, ribavirin and Ceplene, in various doses and combinations. One of the arms of the study will test a triple-drug regimen of Ceplene in combination with pegylated interferon and ribavirin.
Maxim also announced that it expects that the 72-week data from its recently completed Phase 2 study of Ceplene in combination with interferon-alpha will be presented at the European Association for the Study of Liver (EASL) conference in Prague, Czech Republic on Friday, April 20, 2001.
Hepatitis C Overview
Hepatitis C is more easily transmitted than HIV and is now the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that more than 200 million people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. The progress of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
In early 2001 Maxim completed a 129-patient Phase 2 dose-ranging study of Ceplene in combination with IFN-(alpha) in the treatment of previously untreated hepatitis C-infected patients. The ongoing study was designed to evaluate the safety and activity of four different dose regimens of Ceplene in combination with interferon-alpha. In addition, the company is conducting a pilot safety study to evaluate the feasibility and safety of triple-drug treatment with Ceplene in combination with IFN-(alpha) and the anti-viral drug ribavirin in hepatitis C patients who were nonresponsive to prior therapy or relapsed after prior therapy.
Maxim Overview
Maxim Pharmaceuticals is a biopharmaceutical company developing advanced drugs and therapies for cancer and infectious diseases. The company`s lead drug candidate Ceplene (formerly, Maxamine(R)) is currently being tested in two Phase 3 cancer clinical trials in 12 countries for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
In addition to Ceplene, the company has developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate, such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Lastly, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, MaxDerm and the caspase modulator compounds, and regarding the company`s clinical trials. Such statements are only predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that planned clinical trials may not start when anticipated, the risk that the company will not obtain approval to market its products, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM), Maxamine(R), and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at: http://www.maxim.com
CONTACT: Maxim Pharmaceuticals
Larry G. Stambaugh, 858/453-4040
or
Dale A. Sander, 858/453-4040
or
Burns McClellan
Ethan Denkensohn, investors, 212/213-0006
or
Kathy Jones, Ph.D., media, 212/213-0006
Copyright 2001, Business Wire. All of the releases provided by Business Wire are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire`s members, who are solely responsible for their content, accuracy and originality. All reproduction, other than for an individual user`s reference, is prohibited without prior written permission.
Home | About Nasdaq | Feedback | Help & Reference
Equity & Index Options | Site Map, Index, Search
05.03.2002
Warum so bescheiden, Maxim?
Der medizinische Fortschritt ist nicht aufzuhalten: Die neueste Sensationsnachricht erreicht uns aus Stockholm, wo die Biotech-Firma Maxim ganz bescheiden mitteilt, sie habe mal eben eine der großen Zivilisationskrankheiten besiegt.
Maxim will ein Medikament entdeckt haben, das von Akohol verusachte Leberschäden heilt. Zwar hat es bisher erst bei bei Ratten funktioniert und vor dem Wirkstoff liegen auch noch mehrjährige Testphasen, aber Maxim gibt sich schon mal siegessicher und spricht von Milliardeneinnahmen. Die Börse belohnt die fleißigen Forscher prompt mit knapp vier Prozent Kursaufschlag.
Vor gut einem Jahr hatte Maxim dasselbe Mittel unter einem anderen Namen schon einmal vorgestellt, damals sollte es Hautkrebs heilen. Die US-Zulassungsbehörden verweigerten dem Mittel damals die Zustimmung, die Maxim-Aktie brach um 90 Prozent ein. So richtig erholt hat sich der Kurs bis heute nicht.
Keine Angst vor Hautkrebs. Alkoholmißbrauch ohne Reue. Das Unternehmen hat sich ja wirklich interessante Themen vorgenommen. Aber warum so bescheiden, Maxim ? Wenn ihr Euren Aktienkurs wieder nach oben bringen wollt, müsst ihr schon etwas höher einsteigen. Die Weltformel, der Stein der Weisen, das ewige Leben - drunter würd ich`s an Eurer Stelle nicht machen. Dann erholt sich auch der Kurs wieder.
sharper.de
Warum so bescheiden, Maxim?
Der medizinische Fortschritt ist nicht aufzuhalten: Die neueste Sensationsnachricht erreicht uns aus Stockholm, wo die Biotech-Firma Maxim ganz bescheiden mitteilt, sie habe mal eben eine der großen Zivilisationskrankheiten besiegt.
Maxim will ein Medikament entdeckt haben, das von Akohol verusachte Leberschäden heilt. Zwar hat es bisher erst bei bei Ratten funktioniert und vor dem Wirkstoff liegen auch noch mehrjährige Testphasen, aber Maxim gibt sich schon mal siegessicher und spricht von Milliardeneinnahmen. Die Börse belohnt die fleißigen Forscher prompt mit knapp vier Prozent Kursaufschlag.
Vor gut einem Jahr hatte Maxim dasselbe Mittel unter einem anderen Namen schon einmal vorgestellt, damals sollte es Hautkrebs heilen. Die US-Zulassungsbehörden verweigerten dem Mittel damals die Zustimmung, die Maxim-Aktie brach um 90 Prozent ein. So richtig erholt hat sich der Kurs bis heute nicht.
Keine Angst vor Hautkrebs. Alkoholmißbrauch ohne Reue. Das Unternehmen hat sich ja wirklich interessante Themen vorgenommen. Aber warum so bescheiden, Maxim ? Wenn ihr Euren Aktienkurs wieder nach oben bringen wollt, müsst ihr schon etwas höher einsteigen. Die Weltformel, der Stein der Weisen, das ewige Leben - drunter würd ich`s an Eurer Stelle nicht machen. Dann erholt sich auch der Kurs wieder.
sharper.de
wenn die mal den Mund nicht sehr voll genommen haben.
Wie hoch die Schwundrate bis zur überstandendenen Phase III Studie und damit zur Zulassung eines Medikamentes ist, dürfte bekannt sein. Und auf die Daten zu Nebenwirkungen und möglicherweise Langzeitschäden schauen die Zulassungsstellen bei Medikamenten, die nicht Krebs oder AIDS betreffen, wesetnlich genauer. Ich würde wetten, daß ich man sich schneller eine Leberzirrhose ansaufen kann, wenn man heute anfängt, als daß die Substabz von Maxim auf dem Markt ist.
Grüße
Wie hoch die Schwundrate bis zur überstandendenen Phase III Studie und damit zur Zulassung eines Medikamentes ist, dürfte bekannt sein. Und auf die Daten zu Nebenwirkungen und möglicherweise Langzeitschäden schauen die Zulassungsstellen bei Medikamenten, die nicht Krebs oder AIDS betreffen, wesetnlich genauer. Ich würde wetten, daß ich man sich schneller eine Leberzirrhose ansaufen kann, wenn man heute anfängt, als daß die Substabz von Maxim auf dem Markt ist.
Grüße
Monday March 18, 3:00 am Eastern Time
Press Release
SOURCE: Maxim Pharmaceuticals
Maxim Pharmaceuticals and Celera Genomics Expand Collaborative
Agreement
SAN DIEGO--(BW HealthWire)--March 18, 2002--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM)
announced today that it has expanded the scope of its Collaborative Research and License Agreement with Celera Genomics
(NYSE:CRA - news), an Applera Corp. business.
The objective of the collaboration is to identify and develop novel small-molecule compounds that have the potential to be
commercialized as new therapies for certain cancers.
As part of the expanded collaboration, Maxim will use its proprietary screening assay to evaluate 300,000 additional compounds
from Celera`s proprietary libraries for the purpose of identifying compounds that can induce programmed cell death, or apoptosis,
in certain cancer cells. Under the terms of the original agreement initiated in March 2000, Maxim completed screening of
approximately 400,000 compounds from Celera`s proprietary libraries. Selected compounds from these libraries that exhibited
pro-apoptotic activity when screened by Maxim are currently under preclinical development by Celera. The agreement provides
Maxim the option of electing to jointly participate with Celera in the clinical development and commercialization of compounds
identified through the collaboration.
``We are pleased with the progress of the first phase of this collaboration, and we look forward to combining our unique screening
assay with Celera`s portfolio of proprietary compounds through this expanded joint research effort,`` said Larry G. Stambaugh,
Maxim`s Chairman and Chief Executive Officer. ``There is a substantial medical need for new cancer therapies that can selectively
induce apoptosis in tumor cells, and we believe that a combination of collaborative relationships and our internal development
efforts may provide the best opportunity for accelerating the identification and development of new drug candidates.``
``We look forward to building upon the success of the first stage of this collaboration, which identified compounds currently under
preclinical evaluation by Celera,`` said Michael Venuti, Ph.D., Senior Vice President, Research and General Manager, Celera
South San Francisco. ``Maxim`s novel assay system complements other high throughput technology platforms, such as proteomics
and genomics, utilized by Celera in its effort to discover and develop novel small-molecule therapies against cancer.``
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of product candidates for life-threatening
cancers and hepatitis. Ceplene(TM), based on the naturally occurring molecule histamine, prevents the production and release of
oxygen free radicals. Research suggests that treatment with Ceplene has the potential to protect critical immune cells and to prevent
damage associated with oxygen free radicals. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced
metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell
carcinoma. More than 1,300 patients have participated in the Company`s completed and ongoing clinical trials. Maxim is also developing small-molecule inhibitors
and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative
diseases. Lastly, the Company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral
mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding Maxim`s clinical trials. Such statements are only
predictions and Maxim`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences
include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk
that Maxim will not obtain approval to market its products, the risk that clinical trials may not commence when planned, the risks associated with the dependence
upon collaborative partners, and the fact that Maxim will likely need to raise additional funds in the future, and if Maxim is unable to obtain the funds necessary to
continue its operations, it may be required to delay, scale back or eliminate one or more or its product commercialization programs. These factors and others are
more fully discussed in Maxim`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Press Release
SOURCE: Maxim Pharmaceuticals
Maxim Pharmaceuticals and Celera Genomics Expand Collaborative
Agreement
SAN DIEGO--(BW HealthWire)--March 18, 2002--Maxim Pharmaceuticals (Nasdaq:MAXM - news; SSE:MAXM)
announced today that it has expanded the scope of its Collaborative Research and License Agreement with Celera Genomics
(NYSE:CRA - news), an Applera Corp. business.
The objective of the collaboration is to identify and develop novel small-molecule compounds that have the potential to be
commercialized as new therapies for certain cancers.
As part of the expanded collaboration, Maxim will use its proprietary screening assay to evaluate 300,000 additional compounds
from Celera`s proprietary libraries for the purpose of identifying compounds that can induce programmed cell death, or apoptosis,
in certain cancer cells. Under the terms of the original agreement initiated in March 2000, Maxim completed screening of
approximately 400,000 compounds from Celera`s proprietary libraries. Selected compounds from these libraries that exhibited
pro-apoptotic activity when screened by Maxim are currently under preclinical development by Celera. The agreement provides
Maxim the option of electing to jointly participate with Celera in the clinical development and commercialization of compounds
identified through the collaboration.
``We are pleased with the progress of the first phase of this collaboration, and we look forward to combining our unique screening
assay with Celera`s portfolio of proprietary compounds through this expanded joint research effort,`` said Larry G. Stambaugh,
Maxim`s Chairman and Chief Executive Officer. ``There is a substantial medical need for new cancer therapies that can selectively
induce apoptosis in tumor cells, and we believe that a combination of collaborative relationships and our internal development
efforts may provide the best opportunity for accelerating the identification and development of new drug candidates.``
``We look forward to building upon the success of the first stage of this collaboration, which identified compounds currently under
preclinical evaluation by Celera,`` said Michael Venuti, Ph.D., Senior Vice President, Research and General Manager, Celera
South San Francisco. ``Maxim`s novel assay system complements other high throughput technology platforms, such as proteomics
and genomics, utilized by Celera in its effort to discover and develop novel small-molecule therapies against cancer.``
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of product candidates for life-threatening
cancers and hepatitis. Ceplene(TM), based on the naturally occurring molecule histamine, prevents the production and release of
oxygen free radicals. Research suggests that treatment with Ceplene has the potential to protect critical immune cells and to prevent
damage associated with oxygen free radicals. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced
metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell
carcinoma. More than 1,300 patients have participated in the Company`s completed and ongoing clinical trials. Maxim is also developing small-molecule inhibitors
and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative
diseases. Lastly, the Company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral
mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding Maxim`s clinical trials. Such statements are only
predictions and Maxim`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences
include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk
that Maxim will not obtain approval to market its products, the risk that clinical trials may not commence when planned, the risks associated with the dependence
upon collaborative partners, and the fact that Maxim will likely need to raise additional funds in the future, and if Maxim is unable to obtain the funds necessary to
continue its operations, it may be required to delay, scale back or eliminate one or more or its product commercialization programs. These factors and others are
more fully discussed in Maxim`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
19.03.2002 - Maxim und Celera weiten Kollaboration aus
Die beiden Biotechunternehmen Maxim Pharmaceuticals
(Nasdaq:MAXM) und Celera Genomics (NYSE:CRA) werden ihre
Forschungs- und Lizenzvereinbarungen weiter ausdehnen. Ziel der
erweiterten Zusammenarbeit ist eine Identifizierung neuer kleiner
Moleküleverbindungen sowie deren anschließende Weiterentwicklung zu
vermarktungsfähigen Medikamenten. Dabei will man bevorzugt solche
Verbindungen identifizieren, die das Potenzial zur Bekämpfung
verschiedener Krebserkrankungen besitzen. Im Rahmen der
ausgedehnten Vereinbarung wird Maxim sein proprietäres Testverfahren
nutzen, um damit 300.000 zusätzliche Verbindungen aus Celeras
Wirkstoffbibliotheken einer entsprechenden Überprüfung zu unterziehen.
Dabei soll vor allem auf Substanzen geachtet werden, welche in
unterschiedlichsten Krebszellen eine Apoptose, also den programmierten
Zelltod, induzieren können. Die erste Vereinbarung dieser Art, die bereits
im März 2000 vereinbart worden war, sah das Screening von etwa
400.000 Substanzen vor und wurde kürzlich abgeschlossen. Die während
dieser Testphase selektierten apoptotisch wirkenden Substanzen
werden gerade bei Celera der präklinischen Überprüfung unterzogen. Die
Vereinbarung gewährt Maxim die Option gemeinsam mit Celera an der
weiteren klinischen Entwicklung sowie der anschließenden Vermarktung
der aus dieser Zusammenarbeit hervorgegangenen Wirkstoffe
teilzuhaben.
Die beiden Biotechunternehmen Maxim Pharmaceuticals
(Nasdaq:MAXM) und Celera Genomics (NYSE:CRA) werden ihre
Forschungs- und Lizenzvereinbarungen weiter ausdehnen. Ziel der
erweiterten Zusammenarbeit ist eine Identifizierung neuer kleiner
Moleküleverbindungen sowie deren anschließende Weiterentwicklung zu
vermarktungsfähigen Medikamenten. Dabei will man bevorzugt solche
Verbindungen identifizieren, die das Potenzial zur Bekämpfung
verschiedener Krebserkrankungen besitzen. Im Rahmen der
ausgedehnten Vereinbarung wird Maxim sein proprietäres Testverfahren
nutzen, um damit 300.000 zusätzliche Verbindungen aus Celeras
Wirkstoffbibliotheken einer entsprechenden Überprüfung zu unterziehen.
Dabei soll vor allem auf Substanzen geachtet werden, welche in
unterschiedlichsten Krebszellen eine Apoptose, also den programmierten
Zelltod, induzieren können. Die erste Vereinbarung dieser Art, die bereits
im März 2000 vereinbart worden war, sah das Screening von etwa
400.000 Substanzen vor und wurde kürzlich abgeschlossen. Die während
dieser Testphase selektierten apoptotisch wirkenden Substanzen
werden gerade bei Celera der präklinischen Überprüfung unterzogen. Die
Vereinbarung gewährt Maxim die Option gemeinsam mit Celera an der
weiteren klinischen Entwicklung sowie der anschließenden Vermarktung
der aus dieser Zusammenarbeit hervorgegangenen Wirkstoffe
teilzuhaben.
Press Release
SOURCE: Maxim Pharmaceuticals
Maxim Announces Two Additional U.S. Patents for Apoptosis Screening
Technology
SAN DIEGO--(BW HealthWire)--April 8, 2002--Maxim Pharmaceuticals (NasdaqNM:MAXM)(SSE:MAXM) today announced that
the United States Patent Office has issued two new key patents underlying the proprietary assay that the company is using to identify
compounds that can modulate programmed cell death, or apoptosis.
Multiple compounds identified by Maxim with this assay are currently advancing toward human clinical trials as potential anti-cancer
agents as part of the company`s internal development efforts and as a result of the research being performed under existing
pharmaceutical collaborations.
Overview of Screening Technology and New Patents
Maxim has developed a proprietary assay that is targeted to the identification of compounds that can modulate apoptosis. Promising
compounds are identified from large compound libraries using cell-based assays that monitor the activity of caspases, key enzymes
that modulate and carry out the cellular signaling pathways involved in apoptosis. These assays are able to monitor activation of the
caspase cascade inside a wide variety of living cells or cell lines derived from any organ system in the body. Compounds that are
pro-apoptotic (induce apoptosis) may serve as new drug candidates for the treatment of certain cancers.
The United States Patent Office has issued U.S. Patents 6,335,429 and 6,342,611, both entitled ``Fluorogenic or Fluorescent Reporter
Molecules and their Applications for Whole-Cell Fluorescence Screening Assays for Caspases and other Enzymes and the Use
Thereof.`` These patents encompass the composition of matter and use of the novel fluorescent dyes, novel fluorogenic and
fluorescent reporter molecules and new enzyme assay processes including caspase. They also encompass the novel substrate used in
the screening assay.
Maxim researchers have completed screening libraries comprising more than one-half million compounds, and more than 50 validated
lead compounds have entered the company`s development pipeline. These potential drug candidates are members of newly discovered
pro-apoptotic compound families that specifically target certain cancer cells through a variety of novel or validated mechanisms
depending upon the compound, with targets including certain key kinases and other enzymes, and certain receptors.
``We are pleased to broaden our potential proprietary protection surrounding this core technology platform as the anti-cancer arm of
the discovery program has already identified a series of small-molecule compounds that are pro-apoptotic against specific cancer
types and a number of compounds that exhibit activity against chemo-resistant cancer lines,`` said Kurt R. Gehlsen, Ph.D., Maxim`s
senior vice president, development and chief technical officer. ``With the capacity to screen hundreds of thousands of compounds per
year, we hope to produce multiple additional drug candidates from our research program in the future.``
In February 2002, at the American Association for Cancer Research (AACR) Apoptosis in Cancer Meeting in Kona, Hawaii,
researchers presented this week data highlighting the scope of Maxim`s apoptosis drug discovery program. As described in the
AACR presentation, the anti-cancer arm of the discovery program has identified a series of small-molecule compounds that induce
apoptosis (cell death) against specific cancer types and a number of compounds that exhibit activity against chemo-resistant cancer lines. The company`s apoptosis
inducer compounds represent early stage, investigational drug candidates, and none have been approved by the U.S. Food and Drug Administration or any international
regulatory agency.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s
research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend
survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing
life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development
partners.
Maxim`s lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune
suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute
myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have
participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug
Administration or any international regulatory agency.
The company`s third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy
is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Ceplene, MaxDerm and the apoptosis modulator compounds, and regarding the company`s clinical trials. Such statements are only
predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences
include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that
the company will not obtain approval to market its products, and the risk that if the company fails to secure adequate protection of its intellectual property or the right to
use certain intellectual property of others, it may not be able to protect its products and technologies from competitors. These factors and others are more fully discussed
in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
SOURCE: Maxim Pharmaceuticals
Maxim Announces Two Additional U.S. Patents for Apoptosis Screening
Technology
SAN DIEGO--(BW HealthWire)--April 8, 2002--Maxim Pharmaceuticals (NasdaqNM:MAXM)(SSE:MAXM) today announced that
the United States Patent Office has issued two new key patents underlying the proprietary assay that the company is using to identify
compounds that can modulate programmed cell death, or apoptosis.
Multiple compounds identified by Maxim with this assay are currently advancing toward human clinical trials as potential anti-cancer
agents as part of the company`s internal development efforts and as a result of the research being performed under existing
pharmaceutical collaborations.
Overview of Screening Technology and New Patents
Maxim has developed a proprietary assay that is targeted to the identification of compounds that can modulate apoptosis. Promising
compounds are identified from large compound libraries using cell-based assays that monitor the activity of caspases, key enzymes
that modulate and carry out the cellular signaling pathways involved in apoptosis. These assays are able to monitor activation of the
caspase cascade inside a wide variety of living cells or cell lines derived from any organ system in the body. Compounds that are
pro-apoptotic (induce apoptosis) may serve as new drug candidates for the treatment of certain cancers.
The United States Patent Office has issued U.S. Patents 6,335,429 and 6,342,611, both entitled ``Fluorogenic or Fluorescent Reporter
Molecules and their Applications for Whole-Cell Fluorescence Screening Assays for Caspases and other Enzymes and the Use
Thereof.`` These patents encompass the composition of matter and use of the novel fluorescent dyes, novel fluorogenic and
fluorescent reporter molecules and new enzyme assay processes including caspase. They also encompass the novel substrate used in
the screening assay.
Maxim researchers have completed screening libraries comprising more than one-half million compounds, and more than 50 validated
lead compounds have entered the company`s development pipeline. These potential drug candidates are members of newly discovered
pro-apoptotic compound families that specifically target certain cancer cells through a variety of novel or validated mechanisms
depending upon the compound, with targets including certain key kinases and other enzymes, and certain receptors.
``We are pleased to broaden our potential proprietary protection surrounding this core technology platform as the anti-cancer arm of
the discovery program has already identified a series of small-molecule compounds that are pro-apoptotic against specific cancer
types and a number of compounds that exhibit activity against chemo-resistant cancer lines,`` said Kurt R. Gehlsen, Ph.D., Maxim`s
senior vice president, development and chief technical officer. ``With the capacity to screen hundreds of thousands of compounds per
year, we hope to produce multiple additional drug candidates from our research program in the future.``
In February 2002, at the American Association for Cancer Research (AACR) Apoptosis in Cancer Meeting in Kona, Hawaii,
researchers presented this week data highlighting the scope of Maxim`s apoptosis drug discovery program. As described in the
AACR presentation, the anti-cancer arm of the discovery program has identified a series of small-molecule compounds that induce
apoptosis (cell death) against specific cancer types and a number of compounds that exhibit activity against chemo-resistant cancer lines. The company`s apoptosis
inducer compounds represent early stage, investigational drug candidates, and none have been approved by the U.S. Food and Drug Administration or any international
regulatory agency.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s
research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend
survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing
life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development
partners.
Maxim`s lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune
suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute
myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have
participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug
Administration or any international regulatory agency.
The company`s third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy
is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the
efficacy and intended utilization of Ceplene, MaxDerm and the apoptosis modulator compounds, and regarding the company`s clinical trials. Such statements are only
predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences
include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that
the company will not obtain approval to market its products, and the risk that if the company fails to secure adequate protection of its intellectual property or the right to
use certain intellectual property of others, it may not be able to protect its products and technologies from competitors. These factors and others are more fully discussed
in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Eine neue Meldung von MAXM!
Maxim Scientists Present Preclinical Research Highlighting Ceplene Protection Against Alcohol-Induced Liver Injury
SAN DIEGO--(BW HealthWire)--April 18, 2002--
Results Presented at the European Association for the Study of the Liver Conference
Maxim Pharmaceuticals Inc. (Nasdaq:MAXM)(SSE:MAXM) announced that researchers will present today the first results from a series of preclinical studies showing that Ceplene(TM) (histamine dihydrochloride) protected against alcohol induced liver injury in an animal model.
The results are being presented today at the European Association for the Study of the Liver (EASL) conference in Madrid, Spain.
These studies are among the body of research underway designed to support the human clinical testing of Ceplene in chronic liver diseases such as alcoholic liver disease (ALD) and nonalcoholic steatohepatitis (NASH) planned to commence in 2002. In the United States alone, approximately 25 million people -- one in every ten -- have been afflicted with chronic liver, bile duct or gallbladder diseases. More specifically, liver cirrhosis resulting from alcohol abuse is one of the ten leading causes of death in the United States.
"These data represent the first evaluation of the use of Ceplene as a single-agent therapy in chronic liver disease, and we are pleased with the results in this alcohol protection model," said Dr. Kurt Gehlsen, senior vice president, research and chief technical officer. "A series of follow-on preclinical studies are ongoing to evaluate the potential of Ceplene to reverse the tissue damage caused by alcohol damage. Preclinical studies are also underway to assess the potential of Ceplene in animal models related to NASH, another widespread liver disease impacting many adults. Results from these studies are expected to be available for presentation at upcoming scientific presentations."
Alcohol Liver Injury Research
To examine the potential role of Ceplene in preventing oxidative damage in chronic liver diseases, Ceplene was studied in an alcohol-induced liver injury hepatitis model in rats. Animals were divided into three groups:
-- Control Group: Administered no alcohol and received no
Ceplene.
-- Untreated Group: Administered a single dose of ethanol (5
g/kg) once per day for six weeks, but received no treatment
with Ceplene.
-- Treatment Group: Administered the same dose of ethanol and
also received treatment with Ceplene twice daily for six
weeks.
Animals receiving ethanol but not treated with Ceplene developed steatosis (fatty degeneration of liver tissue), and inflammation and necrosis of liver tissue. The animals in the untreated group also had elevated levels of the liver enzymes ALT and AST, two standard measures of liver function. Animals that were administered the same dose of ethanol but were treated with Ceplene had livers that were comparable in appearance to the control group, and had normal ALT and AST levels (statistically significant at p less than 0.05). The animals treated with Ceplene also had statistically significant better scores (p less than 0.05) for inflammation, necrosis and total pathology score compared to the untreated group. These results suggest that Ceplene protected against early alcohol-induced liver injury in this animal model.
"The expansion of the clinical testing of Ceplene into chronic liver diseases represents a natural evolution of the scientific understanding and the clinical development of this drug candidate resulting from the extensive body of research and clinical testing completed to date," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Our discussions with doctors and patients emphasize the need for a successful therapy for certain diseases of the liver like alcoholic liver disease and NASH, and we are committed to the commencement of human clinical trials in this area. With nearly one in ten Americans afflicted with some form of chronic liver disease, this area represents one of the largest unmet medical needs and may ultimately represent the most important advancement in the development of Ceplene."
Ceplene Overview
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the Company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
A human clinical study of Ceplene in NASH patients is expected to commence in the first half of 2002. A human clinical study of Ceplene in alcoholic liver disease patients is expected to commence in late 2002. Presentation of additional preclinical research is planned for the Digestive Disease Week meeting in May 2002 in San Francisco.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Lastly, the Company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Happy trading
The Red
Maxim Scientists Present Preclinical Research Highlighting Ceplene Protection Against Alcohol-Induced Liver Injury
SAN DIEGO--(BW HealthWire)--April 18, 2002--
Results Presented at the European Association for the Study of the Liver Conference
Maxim Pharmaceuticals Inc. (Nasdaq:MAXM)(SSE:MAXM) announced that researchers will present today the first results from a series of preclinical studies showing that Ceplene(TM) (histamine dihydrochloride) protected against alcohol induced liver injury in an animal model.
The results are being presented today at the European Association for the Study of the Liver (EASL) conference in Madrid, Spain.
These studies are among the body of research underway designed to support the human clinical testing of Ceplene in chronic liver diseases such as alcoholic liver disease (ALD) and nonalcoholic steatohepatitis (NASH) planned to commence in 2002. In the United States alone, approximately 25 million people -- one in every ten -- have been afflicted with chronic liver, bile duct or gallbladder diseases. More specifically, liver cirrhosis resulting from alcohol abuse is one of the ten leading causes of death in the United States.
"These data represent the first evaluation of the use of Ceplene as a single-agent therapy in chronic liver disease, and we are pleased with the results in this alcohol protection model," said Dr. Kurt Gehlsen, senior vice president, research and chief technical officer. "A series of follow-on preclinical studies are ongoing to evaluate the potential of Ceplene to reverse the tissue damage caused by alcohol damage. Preclinical studies are also underway to assess the potential of Ceplene in animal models related to NASH, another widespread liver disease impacting many adults. Results from these studies are expected to be available for presentation at upcoming scientific presentations."
Alcohol Liver Injury Research
To examine the potential role of Ceplene in preventing oxidative damage in chronic liver diseases, Ceplene was studied in an alcohol-induced liver injury hepatitis model in rats. Animals were divided into three groups:
-- Control Group: Administered no alcohol and received no
Ceplene.
-- Untreated Group: Administered a single dose of ethanol (5
g/kg) once per day for six weeks, but received no treatment
with Ceplene.
-- Treatment Group: Administered the same dose of ethanol and
also received treatment with Ceplene twice daily for six
weeks.
Animals receiving ethanol but not treated with Ceplene developed steatosis (fatty degeneration of liver tissue), and inflammation and necrosis of liver tissue. The animals in the untreated group also had elevated levels of the liver enzymes ALT and AST, two standard measures of liver function. Animals that were administered the same dose of ethanol but were treated with Ceplene had livers that were comparable in appearance to the control group, and had normal ALT and AST levels (statistically significant at p less than 0.05). The animals treated with Ceplene also had statistically significant better scores (p less than 0.05) for inflammation, necrosis and total pathology score compared to the untreated group. These results suggest that Ceplene protected against early alcohol-induced liver injury in this animal model.
"The expansion of the clinical testing of Ceplene into chronic liver diseases represents a natural evolution of the scientific understanding and the clinical development of this drug candidate resulting from the extensive body of research and clinical testing completed to date," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Our discussions with doctors and patients emphasize the need for a successful therapy for certain diseases of the liver like alcoholic liver disease and NASH, and we are committed to the commencement of human clinical trials in this area. With nearly one in ten Americans afflicted with some form of chronic liver disease, this area represents one of the largest unmet medical needs and may ultimately represent the most important advancement in the development of Ceplene."
Ceplene Overview
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,300 patients have participated in the Company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
A human clinical study of Ceplene in NASH patients is expected to commence in the first half of 2002. A human clinical study of Ceplene in alcoholic liver disease patients is expected to commence in late 2002. Presentation of additional preclinical research is planned for the Digestive Disease Week meeting in May 2002 in San Francisco.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Lastly, the Company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
Happy trading
The Red
Maxim bastelt an neuem Prozac
Ein Unternehmen, das von der Hoffnung auf bessere Zeiten lebt. Das US-Biotech-Unternehmen Maxim Pharmaceuticals hat Zahlen vorgelegt, was aber kaum interessieren wird. Das Unternehmen hat nicht den besten Ruf, es ist schon mit der US-Gesundheiotsbehörde FDA zusammengestoßen. Maxim setzt voll auf den Wirkstoff Ceplene, der gegen zahlreiche Indikationen eingesetzt werden soll. Unter anderem auch bei Leberschäden, die durch Alkohol verursacht wurden. Eli Lillys Antidepressivum Prozac hat als Partydroge Karriere gemacht, vielleicht gelingt das auch Ceplene, als Neutralisator von Alkoholexzessen. Doch das ist Science Fiction, die Gegenwart sieht trist aus, was die Aktie am Boden halten wird.
sharper.de
Ein Unternehmen, das von der Hoffnung auf bessere Zeiten lebt. Das US-Biotech-Unternehmen Maxim Pharmaceuticals hat Zahlen vorgelegt, was aber kaum interessieren wird. Das Unternehmen hat nicht den besten Ruf, es ist schon mit der US-Gesundheiotsbehörde FDA zusammengestoßen. Maxim setzt voll auf den Wirkstoff Ceplene, der gegen zahlreiche Indikationen eingesetzt werden soll. Unter anderem auch bei Leberschäden, die durch Alkohol verursacht wurden. Eli Lillys Antidepressivum Prozac hat als Partydroge Karriere gemacht, vielleicht gelingt das auch Ceplene, als Neutralisator von Alkoholexzessen. Doch das ist Science Fiction, die Gegenwart sieht trist aus, was die Aktie am Boden halten wird.
sharper.de
Maxim Pharmaceuticals Announces 2002 Third Quarter Financial Results
SAN DIEGO--(BW HealthWire)--Aug. 1, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM) (SSE:MAXM) today announced results for the quarter ended June 30, 2002, the third quarter of its 2002 fiscal year.
The net loss for the third quarter totaled $8,156,000, or $0.35 per share, compared to a net loss of $6,429,000, or $0.28 per share, for the same period of the prior year. The current year increase in net loss related to accelerated clinical development of the company`s lead drug candidate Ceplene(TM), including the ramping up of a confirming Phase 3 clinical trial for the treatment of advanced metastatic melanoma, and a Phase 2 clinical trial in nonresponder hepatitis C patients.
The net loss for the nine months ended June 30, 2002 totaled $53,223,000, or $2.29 per share, compared to a net loss of $29,154,000, or $1.26 per share, for the same period of the prior year. The increase in net loss for the nine months ended June 30, 2002 is largely the result of a non-cash $28,179,000 charge recorded during the quarter ended Dec. 31, 2001 reflecting the write down of the carrying value of goodwill as a result of the adoption, effective Oct. 1, 2001, of Statement of Financial Accounting Standard ("SFAS") No. 142, "Accounting for Goodwill and Other Intangible Assets."
The company had cash, cash equivalents and investments totaling $119.9 million at June 30, 2002. Maxim used net cash of $8.5 million in its operations during the quarter ended June 30, 2002, compared to $6.4 million used in operations for the same period of the prior year.
"Our cash investment required in the third quarter was below our expectations and we remain well positioned to continue the development of our product pipeline, including our three Phase 3 clinical trials currently underway," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer. "A major effort during the quarter was the ramping up of the second Phase 3 clinical trial of Ceplene in advanced metastatic melanoma with liver metastases, designed to support U.S. approval of this drug candidate in this deadly form of skin cancer. We also completed the initial phase of our Phase 2 clinical trial of Ceplene triple-drug therapy in hepatitis C nonresponder patients, a large market with a critical need for more effective therapies."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
Maxim`s lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. The company`s third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding the company`s clinical trials. Such statements are only predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, the risks associated with the dependence upon collaborative partners, and the fact that the company will likely need to raise additional funds in the future, and if the company is unable to obtain the funds necessary to continue its operations, it may be required to delay, scale back or eliminate one or more of its product commercialization programs. These factors and others are more fully discussed in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Maxim Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations (unaudited)
Three Months Ended Nine Months Ended
June 30, June 30,
------------------------ ------------------------
2002 2001 2002 2001
----------- ----------- ----------- -----------
Collaboration
and research
revenue $ 776,296 $ 826,715 $ 1,817,831 $ 2,527,643
Operating expenses:
Research and
development 7,631,218 6,129,592 23,501,071 25,430,092
Marketing and
business
development 885,792 1,357,574 2,268,222 7,198,125
General and
administrative 1,501,805 1,383,058 4,980,825 5,204,177
Amortization of
goodwill and
other
acquisition-
related
intangible
assets -- 550,929 -- 1,667,419
----------- ----------- ----------- -----------
Total operating
expenses 10,018,815 9,421,153 30,750,118 39,499,813
----------- ----------- ----------- -----------
Loss from
operations (9,242,519) (8,594,438) (28,932,287) (36,972,170)
Other income
(expense):
Investment income 1,131,731 2,195,013 4,014,672 7,914,143
Interest expense (44,898) (27,631) (135,832) (95,469)
Other income
(expense) (521) (2,182) 9,685 (897)
----------- ----------- ----------- -----------
Total other
income 1,086,312 2,165,200 3,888,525 7,817,777
----------- ----------- ----------- -----------
Loss before
cumulative effect
of accounting
change (8,156,207) (6,429,238) (25,043,762) (29,154,393)
Cumulative effect
of accounting
change -- -- (28,179,466) --
----------- ----------- ----------- -----------
Net loss applicable
to common stock $(8,156,207) $(6,429,238)$(53,223,228)$(29,154,393)
=========== =========== =========== ===========
Basic and diluted
net loss per share
of common stock:
Before cumulative
effect of
accounting
change $ (0.35) $ (0.28) $ (1.08) $ (1.26)
Cumulative effect
of accounting
change -- -- (1.21) --
----------- ----------- ----------- -----------
Basic and diluted
net loss per share
of common stock $ (0.35) $ (0.28) $ (2.29) $ (1.26)
=========== =========== =========== ===========
Weighted average
shares outstanding 23,280,137 23,235,198 23,266,487 23,211,857
=========== =========== =========== ===========
Selected Balance Sheet Information
June 30, Sept. 30,
2002 2001
------------ ------------
(unaudited)
Assets
Cash, cash equivalents and investments $119,866,770 $146,560,006
Total assets 134,352,114 190,756,338
Long-term liabilities 1,468,520 1,759,667
Stockholders` equity 127,130,408 180,646,601
SAN DIEGO--(BW HealthWire)--Aug. 1, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM) (SSE:MAXM) today announced results for the quarter ended June 30, 2002, the third quarter of its 2002 fiscal year.
The net loss for the third quarter totaled $8,156,000, or $0.35 per share, compared to a net loss of $6,429,000, or $0.28 per share, for the same period of the prior year. The current year increase in net loss related to accelerated clinical development of the company`s lead drug candidate Ceplene(TM), including the ramping up of a confirming Phase 3 clinical trial for the treatment of advanced metastatic melanoma, and a Phase 2 clinical trial in nonresponder hepatitis C patients.
The net loss for the nine months ended June 30, 2002 totaled $53,223,000, or $2.29 per share, compared to a net loss of $29,154,000, or $1.26 per share, for the same period of the prior year. The increase in net loss for the nine months ended June 30, 2002 is largely the result of a non-cash $28,179,000 charge recorded during the quarter ended Dec. 31, 2001 reflecting the write down of the carrying value of goodwill as a result of the adoption, effective Oct. 1, 2001, of Statement of Financial Accounting Standard ("SFAS") No. 142, "Accounting for Goodwill and Other Intangible Assets."
The company had cash, cash equivalents and investments totaling $119.9 million at June 30, 2002. Maxim used net cash of $8.5 million in its operations during the quarter ended June 30, 2002, compared to $6.4 million used in operations for the same period of the prior year.
"Our cash investment required in the third quarter was below our expectations and we remain well positioned to continue the development of our product pipeline, including our three Phase 3 clinical trials currently underway," said Larry G. Stambaugh, Maxim`s chairman and chief executive officer. "A major effort during the quarter was the ramping up of the second Phase 3 clinical trial of Ceplene in advanced metastatic melanoma with liver metastases, designed to support U.S. approval of this drug candidate in this deadly form of skin cancer. We also completed the initial phase of our Phase 2 clinical trial of Ceplene triple-drug therapy in hepatitis C nonresponder patients, a large market with a critical need for more effective therapies."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
Maxim`s lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. The company`s third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding the company`s clinical trials. Such statements are only predictions and the company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, the risks associated with the dependence upon collaborative partners, and the fact that the company will likely need to raise additional funds in the future, and if the company is unable to obtain the funds necessary to continue its operations, it may be required to delay, scale back or eliminate one or more of its product commercialization programs. These factors and others are more fully discussed in the company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Maxim Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations (unaudited)
Three Months Ended Nine Months Ended
June 30, June 30,
------------------------ ------------------------
2002 2001 2002 2001
----------- ----------- ----------- -----------
Collaboration
and research
revenue $ 776,296 $ 826,715 $ 1,817,831 $ 2,527,643
Operating expenses:
Research and
development 7,631,218 6,129,592 23,501,071 25,430,092
Marketing and
business
development 885,792 1,357,574 2,268,222 7,198,125
General and
administrative 1,501,805 1,383,058 4,980,825 5,204,177
Amortization of
goodwill and
other
acquisition-
related
intangible
assets -- 550,929 -- 1,667,419
----------- ----------- ----------- -----------
Total operating
expenses 10,018,815 9,421,153 30,750,118 39,499,813
----------- ----------- ----------- -----------
Loss from
operations (9,242,519) (8,594,438) (28,932,287) (36,972,170)
Other income
(expense):
Investment income 1,131,731 2,195,013 4,014,672 7,914,143
Interest expense (44,898) (27,631) (135,832) (95,469)
Other income
(expense) (521) (2,182) 9,685 (897)
----------- ----------- ----------- -----------
Total other
income 1,086,312 2,165,200 3,888,525 7,817,777
----------- ----------- ----------- -----------
Loss before
cumulative effect
of accounting
change (8,156,207) (6,429,238) (25,043,762) (29,154,393)
Cumulative effect
of accounting
change -- -- (28,179,466) --
----------- ----------- ----------- -----------
Net loss applicable
to common stock $(8,156,207) $(6,429,238)$(53,223,228)$(29,154,393)
=========== =========== =========== ===========
Basic and diluted
net loss per share
of common stock:
Before cumulative
effect of
accounting
change $ (0.35) $ (0.28) $ (1.08) $ (1.26)
Cumulative effect
of accounting
change -- -- (1.21) --
----------- ----------- ----------- -----------
Basic and diluted
net loss per share
of common stock $ (0.35) $ (0.28) $ (2.29) $ (1.26)
=========== =========== =========== ===========
Weighted average
shares outstanding 23,280,137 23,235,198 23,266,487 23,211,857
=========== =========== =========== ===========
Selected Balance Sheet Information
June 30, Sept. 30,
2002 2001
------------ ------------
(unaudited)
Assets
Cash, cash equivalents and investments $119,866,770 $146,560,006
Total assets 134,352,114 190,756,338
Long-term liabilities 1,468,520 1,759,667
Stockholders` equity 127,130,408 180,646,601
Meldung von MAXM:
Maxim Advances Enrollment of Ceplene Phase 2 Clinical Trial in Hepatitis C Nonresponder Patients
SAN DIEGO--(BUSINESS WIRE)--Sept. 10, 2002--
Data Safety Monitoring Board Reports Interim Safety Review and Recommends that Maxim Complete Phase 2 Clinical Trial of Ceplene(TM) Triple-Drug Combination Therapy
Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) today announced that the Data Safety Monitoring Board (DSMB) responsible for reviewing its Phase 2 trial of Ceplene (histamine dihydrochloride) for the treatment of hepatitis C nonresponder patients has concluded that there have been no safety concerns associated with the triple-drug combination of Ceplene, Peg-Intron(R) (peginterferon alfa-2b) and Rebetol(R) (ribavirin, USP).
The randomized, controlled Phase 2 study is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron and Rebetol versus treatment with Peg-Intron and Rebetol combination therapy alone. The study will include up to 282 patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin. The DSMB reported to Maxim that it has reviewed the safety data through 12 weeks of treatment for the first 41 patients enrolled in the trial, and has concluded that there have been no safety concerns and that the trial should proceed under its approved protocol.
"This report from the DSMB is an important step in the development of Ceplene as this study represents the first time that Ceplene has been administered in humans in combination with Peg-Intron and Rebetol for the treatment of hepatitis C," said Philippe Prokocimer, M.D., Maxim`s Vice President of Drug Development. "As with any new drug combination, patient safety is a primary concern. We are pleased that initial results from this large Phase 2 study support the feasibility of adding Ceplene to the current standard of care in an attempt to improve the treatment of hepatitis C patients who have failed prior treatments."
The DSMB includes world-leading clinicians experienced in the treatment of hepatitis C who review the safety data from this Phase 2 clinical trial on an ongoing basis. Maxim is conducting the Phase 2 trial under an agreement whereby Schering Corp., a division of Schering-Plough Corp., is contributing two of its products, Peg-Intron and Rebetol, and performing the viral testing for the study.
The Maxim Phase 2 trial is designed to evaluate the Ceplene triple-drug combination therapy for the treatment of nonresponder patients infected with hepatitis C who failed to respond to prior therapy. Patients will be treated for up to 48 weeks and followed for an additional 24 weeks after completion of treatment. The primary measures of efficacy in the study are sustained complete viral response and sustained biochemical response (normalization of the liver enzyme ALT, a standard measure of liver function) at 72 weeks. The trial is being conducted in Western Europe and Israel.
Hepatitis C
Hepatitis C is the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that at least 200 million people are infected worldwide. Hepatitis C is a viral infection in which oxidative stress causes inflammation and tissue damage in the liver and, in many cases, permanent cirrhosis (scarring). The cycle of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
The standard treatment for hepatitis C is interferon-alpha, an immunotherapeutic agent given in combination with the anti-viral drug ribavirin. The most recent advance in hepatitis C therapy approved for sale is a pegylated, or sustained release, formulation of interferon-alpha given in combination with ribavirin. Even with recent advances, approximately half of patients still do not attain a sustained response with current therapies.
"While we need to continue to improve the treatment available to all hepatitis C patients, the largest unmet need today is patients who have failed prior therapy," stated Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "The steady accumulation of patients over the past several years who have failed existing therapies has resulted in a large population of patients in need of the next generation of treatment, and this group is the focus of our current Phase 2 trial."
Overview of Ceplene and Maxim Pharmaceuticals
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
In addition to hepatitis C, Ceplene is currently being tested in Phase 3 clinical trials for advanced metastatic melanoma and acute myelogenous leukemia, and Phase 2 trials of Ceplene have been completed in advanced renal cell carcinoma (kidney cancer). Clinical trials are also planned in chronic liver diseases such as nonalcoholic steatohepatitis (NASH) and alcoholic liver disease (ALD). More than 1,400 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers, hepatitis C and other chronic liver diseases. Maxim`s research and development programs are designed to provide hope to patients most in need by developing safe and effective product candidates that extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Furthermore, the company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator compounds and MaxDerm, and regarding the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Happy trading
The Red
Maxim Advances Enrollment of Ceplene Phase 2 Clinical Trial in Hepatitis C Nonresponder Patients
SAN DIEGO--(BUSINESS WIRE)--Sept. 10, 2002--
Data Safety Monitoring Board Reports Interim Safety Review and Recommends that Maxim Complete Phase 2 Clinical Trial of Ceplene(TM) Triple-Drug Combination Therapy
Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) today announced that the Data Safety Monitoring Board (DSMB) responsible for reviewing its Phase 2 trial of Ceplene (histamine dihydrochloride) for the treatment of hepatitis C nonresponder patients has concluded that there have been no safety concerns associated with the triple-drug combination of Ceplene, Peg-Intron(R) (peginterferon alfa-2b) and Rebetol(R) (ribavirin, USP).
The randomized, controlled Phase 2 study is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron and Rebetol versus treatment with Peg-Intron and Rebetol combination therapy alone. The study will include up to 282 patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin. The DSMB reported to Maxim that it has reviewed the safety data through 12 weeks of treatment for the first 41 patients enrolled in the trial, and has concluded that there have been no safety concerns and that the trial should proceed under its approved protocol.
"This report from the DSMB is an important step in the development of Ceplene as this study represents the first time that Ceplene has been administered in humans in combination with Peg-Intron and Rebetol for the treatment of hepatitis C," said Philippe Prokocimer, M.D., Maxim`s Vice President of Drug Development. "As with any new drug combination, patient safety is a primary concern. We are pleased that initial results from this large Phase 2 study support the feasibility of adding Ceplene to the current standard of care in an attempt to improve the treatment of hepatitis C patients who have failed prior treatments."
The DSMB includes world-leading clinicians experienced in the treatment of hepatitis C who review the safety data from this Phase 2 clinical trial on an ongoing basis. Maxim is conducting the Phase 2 trial under an agreement whereby Schering Corp., a division of Schering-Plough Corp., is contributing two of its products, Peg-Intron and Rebetol, and performing the viral testing for the study.
The Maxim Phase 2 trial is designed to evaluate the Ceplene triple-drug combination therapy for the treatment of nonresponder patients infected with hepatitis C who failed to respond to prior therapy. Patients will be treated for up to 48 weeks and followed for an additional 24 weeks after completion of treatment. The primary measures of efficacy in the study are sustained complete viral response and sustained biochemical response (normalization of the liver enzyme ALT, a standard measure of liver function) at 72 weeks. The trial is being conducted in Western Europe and Israel.
Hepatitis C
Hepatitis C is the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that at least 200 million people are infected worldwide. Hepatitis C is a viral infection in which oxidative stress causes inflammation and tissue damage in the liver and, in many cases, permanent cirrhosis (scarring). The cycle of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
The standard treatment for hepatitis C is interferon-alpha, an immunotherapeutic agent given in combination with the anti-viral drug ribavirin. The most recent advance in hepatitis C therapy approved for sale is a pegylated, or sustained release, formulation of interferon-alpha given in combination with ribavirin. Even with recent advances, approximately half of patients still do not attain a sustained response with current therapies.
"While we need to continue to improve the treatment available to all hepatitis C patients, the largest unmet need today is patients who have failed prior therapy," stated Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "The steady accumulation of patients over the past several years who have failed existing therapies has resulted in a large population of patients in need of the next generation of treatment, and this group is the focus of our current Phase 2 trial."
Overview of Ceplene and Maxim Pharmaceuticals
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
In addition to hepatitis C, Ceplene is currently being tested in Phase 3 clinical trials for advanced metastatic melanoma and acute myelogenous leukemia, and Phase 2 trials of Ceplene have been completed in advanced renal cell carcinoma (kidney cancer). Clinical trials are also planned in chronic liver diseases such as nonalcoholic steatohepatitis (NASH) and alcoholic liver disease (ALD). More than 1,400 patients have participated in the company`s completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers, hepatitis C and other chronic liver diseases. Maxim`s research and development programs are designed to provide hope to patients most in need by developing safe and effective product candidates that extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Furthermore, the company`s MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator compounds and MaxDerm, and regarding the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
Happy trading
The Red
Dies ist eine positive und WICHTIGE Meldung, vor allem da Wohl und Wehe von MAXM von dieser Studie abhängt.
Wäre die Entscheidung negativ gewesen, hätte dies das ENDE von MAXM einläuten können.
Und MAXM fällt bis 16.20 um über 5 %.
Das verstehe wer will!!!!
Happy trading
The Red
Wäre die Entscheidung negativ gewesen, hätte dies das ENDE von MAXM einläuten können.
Und MAXM fällt bis 16.20 um über 5 %.
Das verstehe wer will!!!!
Happy trading
The Red
Hie geht es wieder um Ceplene, allerdings ind der 2. Produktgruppe, als Salbe.
Maxim Announces Initiation of Enrollment in Radiation Dermatitis Clinical Study
SAN DIEGO--(BUSINESS WIRE)--Sept. 18, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM) (SSE:MAXM) announced the commencement of a randomized, blinded clinical study of its MX8899 topical gel for the treatment of radiation-induced dermatitis, a serious side effect of head and neck radiation therapy used in the treatment of various cancers.
In addition to causing patient discomfort, the burns and severe irritation associated with radiation dermatitis are sometimes severe enough that patients are forced to take breaks in their radiation treatment. Currently, there are no standard preventative or therapeutic treatments for radiation-induced dermatitis.
The investigator clinical study is being conducted by Dr. J. Simon Stewart, of the Department of Radiotherapy, Charing Cross Hospital in the United Kingdom. Up to 30 patients will be enrolled in the trial, each receiving bilateral neck radiotherapy for head and neck squamous cell carcinoma. The objectives of this study are to evaluate the safety, tolerability and biological activity of the MX8899 gel for the treatment of radiation-induced dermatitis in patients with squamous cell carcinoma of the head and neck. Efficacy will be measured using an accepted measure of skin damage, the "RTOG Acute Radiation Morbidity Scoring Criteria."
Patients in the study will apply the MX8899 gel to one side of the neck and a placebo comprised of the vehicle control gel to the other. The trial medication will be pre-packaged in patient kits that are labeled "right" and "left". The study will be blinded in that neither the investigator nor the patient will be aware which kit contains the active drug. The treatment with the MX8899 gel will start with the first series of radiotherapy and continue until seven days after radiotherapy ends.
"This new clinical study in radiation dermatitis complements our study commenced last month in oral mucositis, another serious toxic side effect associated with certain cancer treatments," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Both of these cancer supportive care studies fit strategically with our emphasis on oncology, and we look forward to evaluating whether treatment with the MX8899 gel will alleviate the painful side effects these patients suffer while undergoing treatment for their cancer."
Overview of Radiation Dermatitis and Topical Gel
Radiation-induced dermatitis is a common toxicity associated with skin exposure to ionizing radiation in the treatment of various cancers, such as head and neck squamous cell carcinoma, breast cancer and prostate cancer. The extent of tissue damage can range from erythema to necrosis (tissue death) depending on the amount of area affected and the dose of radiation used. Radiation-induced toxicity is primarily a consequence of ionizing radiation interacting with cellular DNA. Ionization in tissue leads to the formation of oxygen free radicals, which induces breaks in chromosomal DNA. If there is sufficient DNA damage, the irradiated cells are no longer able to replicate and undergo mitotic death.
Histamine dihydrochloride, the active agent in the MX8899 gel, has been shown in preclinical work to reduce inflammation by preventing the production and release of oxygen free radicals and proinflamatory cytokines such TNF-alpha and IL-1b, thereby reducing oxidative stress. In addition, it has been reported that histamine may improve blood circulation and assist in wound healing. Accordingly, histamine-related gels have the potential to be useful in situations where free-radical damage and excessive inflammation are involved and to facilitate the repair processes.
Maxim`s topical gel has been tested by investigators in small pilot, randomized, blinded, placebo-controlled trials conducted by independent researchers in more than 75 patients with oral mucositis, herpes labialis (cold sores), burns (thermal and sun), decubitus ulcers, shingles and conjunctivitis. Patients experienced improved healing times when treated with topical histamine gels compared to placebo controls. The intellectual property protection surrounding Maxim`s topical gel technology includes seven U.S. patents and one pending U.S. patent application, with corresponding patents issued or pending in major international markets. The topical histamine gel is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Happy trading
The Red
Maxim Announces Initiation of Enrollment in Radiation Dermatitis Clinical Study
SAN DIEGO--(BUSINESS WIRE)--Sept. 18, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM) (SSE:MAXM) announced the commencement of a randomized, blinded clinical study of its MX8899 topical gel for the treatment of radiation-induced dermatitis, a serious side effect of head and neck radiation therapy used in the treatment of various cancers.
In addition to causing patient discomfort, the burns and severe irritation associated with radiation dermatitis are sometimes severe enough that patients are forced to take breaks in their radiation treatment. Currently, there are no standard preventative or therapeutic treatments for radiation-induced dermatitis.
The investigator clinical study is being conducted by Dr. J. Simon Stewart, of the Department of Radiotherapy, Charing Cross Hospital in the United Kingdom. Up to 30 patients will be enrolled in the trial, each receiving bilateral neck radiotherapy for head and neck squamous cell carcinoma. The objectives of this study are to evaluate the safety, tolerability and biological activity of the MX8899 gel for the treatment of radiation-induced dermatitis in patients with squamous cell carcinoma of the head and neck. Efficacy will be measured using an accepted measure of skin damage, the "RTOG Acute Radiation Morbidity Scoring Criteria."
Patients in the study will apply the MX8899 gel to one side of the neck and a placebo comprised of the vehicle control gel to the other. The trial medication will be pre-packaged in patient kits that are labeled "right" and "left". The study will be blinded in that neither the investigator nor the patient will be aware which kit contains the active drug. The treatment with the MX8899 gel will start with the first series of radiotherapy and continue until seven days after radiotherapy ends.
"This new clinical study in radiation dermatitis complements our study commenced last month in oral mucositis, another serious toxic side effect associated with certain cancer treatments," said Larry G. Stambaugh, Maxim`s Chairman and Chief Executive Officer. "Both of these cancer supportive care studies fit strategically with our emphasis on oncology, and we look forward to evaluating whether treatment with the MX8899 gel will alleviate the painful side effects these patients suffer while undergoing treatment for their cancer."
Overview of Radiation Dermatitis and Topical Gel
Radiation-induced dermatitis is a common toxicity associated with skin exposure to ionizing radiation in the treatment of various cancers, such as head and neck squamous cell carcinoma, breast cancer and prostate cancer. The extent of tissue damage can range from erythema to necrosis (tissue death) depending on the amount of area affected and the dose of radiation used. Radiation-induced toxicity is primarily a consequence of ionizing radiation interacting with cellular DNA. Ionization in tissue leads to the formation of oxygen free radicals, which induces breaks in chromosomal DNA. If there is sufficient DNA damage, the irradiated cells are no longer able to replicate and undergo mitotic death.
Histamine dihydrochloride, the active agent in the MX8899 gel, has been shown in preclinical work to reduce inflammation by preventing the production and release of oxygen free radicals and proinflamatory cytokines such TNF-alpha and IL-1b, thereby reducing oxidative stress. In addition, it has been reported that histamine may improve blood circulation and assist in wound healing. Accordingly, histamine-related gels have the potential to be useful in situations where free-radical damage and excessive inflammation are involved and to facilitate the repair processes.
Maxim`s topical gel has been tested by investigators in small pilot, randomized, blinded, placebo-controlled trials conducted by independent researchers in more than 75 patients with oral mucositis, herpes labialis (cold sores), burns (thermal and sun), decubitus ulcers, shingles and conjunctivitis. Patients experienced improved healing times when treated with topical histamine gels compared to placebo controls. The intellectual property protection surrounding Maxim`s topical gel technology includes seven U.S. patents and one pending U.S. patent application, with corresponding patents issued or pending in major international markets. The topical histamine gel is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
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The Red
Maxim Researchers Present Three-Year Survival Update for Phase 3 Malignant Melanoma Trial
SAN DIEGO--(BUSINESS WIRE)--Oct. 21, 2002--
Updated Phase 3 Data Published this Month in
Journal of Clinical Oncology Classic Papers
Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM)(SSE:MAXM) announced that clinical researchers presented yesterday during the 27th European Society of Clinical Oncology (ESMO) conference in Nice, France updated results from Maxim`s U.S. Phase 3 trial of Ceplene(TM) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma patients. Advanced metastatic melanoma is the most deadly form of skin cancer and the fastest-growing cancer in the developed world, and there is no established or proven standard of care for the treatment of this life-threatening disease. Ceplene has been tested in seven completed or ongoing clinical trials for melanoma in more than 1,000 patients, and is currently being tested in the final Phase 3 trial designed to support registration for marketing approval.
Sanjiv S. Agarwala, M.D., Associate Medical Director of the Melanoma Center at the University of Pittsburgh Cancer Institute, presented the 36-month data for the largest study of Ceplene completed to date, the U.S.-based Phase 3 trial (the "M01" trial) for the treatment of advanced metastatic melanoma. The 36-month results demonstrated that the intent-to-treat population of all 305 advanced metastatic melanoma patients randomized into the trial demonstrated a statistically significant improvement in survival for patients treated with the combination of Ceplene and IL-2 (p=0.037, evaluated by comparing Kaplan-Meier survival curves using the unadjusted Log-Rank statistical method) compared to patients treated with IL-2 alone. The rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately two times the rate of survival for the control patients. The 36-month data also demonstrated that the Ceplene/IL-2 combination significantly increased survival in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.003). For the liver metastases subpopulation, the rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately six times the rate of survival for the control patients. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
"The improvements in longer-term survival seen in the Ceplene trial, particularly in the poor-prognosis group with liver metastases, represent a significant potential benefit to a patient population that has few therapeutic options available," said Dr. Agarwala. "The combination of Ceplene and IL-2 is safe and well-tolerated by patients, and I look forward to the results of the confirming Phase 3 clinical study."
Regulatory and Clinical Trial Update
Leading clinical researchers from the United States and Europe participated with Maxim researchers in a presentation of clinical results and an overview of the planned regulatory approval process for Ceplene. Among areas highlighted at the session was the status of the U.S. Food and Drug Administration (FDA) approval process for Ceplene for the treatment of advanced metastatic melanoma. In 2000 the Company submitted a New Drug Application (NDA) with the FDA requesting approval to market Ceplene based on the 12-month results of the M01 Phase 3 study. In January 2001 the FDA communicated to the Company that the single M01 study would not support approval on its own and that an additional Phase 3 trial would be required. The combination of Ceplene and IL-2 is currently being tested in a confirming Phase 3 trial (the "M0104" trial) designed to support, in combination with the results of the M01 trial, approval in the U.S. and other countries. The FDA reviewed and accepted the protocol for the M0104 Phase 3 trial under its "Special Protocol Assessment" procedures and has confirmed that it will consider the trial to be an adequate and well-controlled study if conducted in accordance with the protocol. A web cast of this presentation is available at www.maxim.com.
"The approval process for our NDA is now well defined, and we are pleased that we are progressing with the final Phase 3 trial expected to support approval of Ceplene for the treatment of melanoma," said Philippe K. Prokocimer, M.D., Maxim`s Vice President, Drug Development. "The delay experienced in the NDA approval process has generated a certain amount of confusion and misconceptions in the public regarding the strength of the evidence from the M01 Phase 3 trial and the remaining path for approval. The NDA approval process comes down to the need for a second trial to confirm the results from our first trial, and we expect to complete the second trial in early 2005 and amend our existing NDA at that time. The ongoing evaluation of the Phase 3 data from the M01 study continues to highlight the potential benefit of Ceplene, and we are honored that the data from this trial has been selected for publication in the Journal of Clinical Oncology. We will consider the possibility of filing for approval of Ceplene for the treatment of melanoma in Europe in 2003 based upon the results of our six completed clinical trials."
Ceplene research and clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles. The 12-month data from the M01 trial was published in the January 2002 edition of the Journal of Clinical Oncology (JCO). These results, and an update of the 24-month results, were published this month in the JCO "Classic Papers and Current Comments." The Classic Papers and Current Comments publication represents the major articles related to melanoma research published in the JCO over the last 20 years.
Other Ceplene ESMO Presentations
Ceplene has been tested in 17 completed or ongoing clinical trials in 19 countries around the world. In addition to melanoma, Ceplene has been tested in a Phase 3 trial in acute myelogenous leukemia and Phase 2 trials in renal cell carcinoma and hepatitis C. Additional clinical results presented at the ESMO conference included:
-- "The Health-Related Quality-of-Life Impact of Histamine
Dihydrochloride plus Interleukin-2 Compared to Interleukin-2
Alone in Patients with Metastatic Melanoma," by Dr. Sanjiv S.
Agarwala, et al. The presentation described an assessment of
the quality of life that was performed as part of the M01
Phase 3 trial. The researchers concluded the addition of
Ceplene to IL-2 treatment improved median quality-adjusted
survival duration and did not adversely affect quality of life
of patients participating in the study.
-- "Safety and efficacy of combined immunotherapy with
subcutaneous interleukin-2 (IL-2) and histamine
dihydrochloride (HDC) in patients (pts) with stage IV renal
cell carcinoma (RCC): A randomized phase II study," by Dr.
Mark Middleton, et al. The presentation describes a 41-patient
Phase 2 study in which advanced metastatic renal cell
carcinoma patients were treated with a combination of Ceplene
and IL-2, while patients in the control group were treated
with the same dose of IL-2 alone. For the group of patients
treated with the Ceplene/IL-2 combination, 42 percent achieved
a partial response or disease stabilization compared to 26
percent for the group treated with IL-2 alone.
Melanoma Overview and Ongoing Phase 3 Trial
Melanoma is the fastest-growing cancer in the developed world with an estimated prevalence of 230,000 in the United States and 150,000 in Europe. The incidence of melanoma has more than tripled among Caucasians between 1980 and 2002. Malignant melanoma will spread to most organs, and patients with melanoma that has metastasized to their livers have an extremely poor prognosis with a life expectancy of less than five months.
The M0104 Phase 3 trial is being conducted at approximately 40 clinical sites in the United States, Europe and Canada and will include 224 patients with advanced metastatic melanoma with liver metastases (the patient population in which Ceplene demonstrated the strongest statistically significant survival benefit in the M01 Phase 3 trial). The M0104 Phase 3 trial will be conducted under the same treatment protocol as the M01 study, and will evaluate whether Ceplene improves the efficacy of IL-2, an immunotherapeutic agent already approved for the treatment of advanced metastatic melanoma. Patients enrolled in the trial will be randomized and treated with either the combination of Ceplene and IL-2 or the same dose of IL-2 alone. The primary endpoint in the trial is duration of patient survival. The Company currently estimates that the timeline for the M0104 Phase 3 trial will include approximately 18 months for patient enrollment and 18 months of patient follow up, resulting in an expected completion date for the trial in early 2005.
Happy trading
The Red
SAN DIEGO--(BUSINESS WIRE)--Oct. 21, 2002--
Updated Phase 3 Data Published this Month in
Journal of Clinical Oncology Classic Papers
Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM)(SSE:MAXM) announced that clinical researchers presented yesterday during the 27th European Society of Clinical Oncology (ESMO) conference in Nice, France updated results from Maxim`s U.S. Phase 3 trial of Ceplene(TM) (histamine dihydrochloride) in combination with interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma patients. Advanced metastatic melanoma is the most deadly form of skin cancer and the fastest-growing cancer in the developed world, and there is no established or proven standard of care for the treatment of this life-threatening disease. Ceplene has been tested in seven completed or ongoing clinical trials for melanoma in more than 1,000 patients, and is currently being tested in the final Phase 3 trial designed to support registration for marketing approval.
Sanjiv S. Agarwala, M.D., Associate Medical Director of the Melanoma Center at the University of Pittsburgh Cancer Institute, presented the 36-month data for the largest study of Ceplene completed to date, the U.S.-based Phase 3 trial (the "M01" trial) for the treatment of advanced metastatic melanoma. The 36-month results demonstrated that the intent-to-treat population of all 305 advanced metastatic melanoma patients randomized into the trial demonstrated a statistically significant improvement in survival for patients treated with the combination of Ceplene and IL-2 (p=0.037, evaluated by comparing Kaplan-Meier survival curves using the unadjusted Log-Rank statistical method) compared to patients treated with IL-2 alone. The rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately two times the rate of survival for the control patients. The 36-month data also demonstrated that the Ceplene/IL-2 combination significantly increased survival in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.003). For the liver metastases subpopulation, the rate of three-year survival for patients treated with the Ceplene/IL-2 combination was approximately six times the rate of survival for the control patients. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
"The improvements in longer-term survival seen in the Ceplene trial, particularly in the poor-prognosis group with liver metastases, represent a significant potential benefit to a patient population that has few therapeutic options available," said Dr. Agarwala. "The combination of Ceplene and IL-2 is safe and well-tolerated by patients, and I look forward to the results of the confirming Phase 3 clinical study."
Regulatory and Clinical Trial Update
Leading clinical researchers from the United States and Europe participated with Maxim researchers in a presentation of clinical results and an overview of the planned regulatory approval process for Ceplene. Among areas highlighted at the session was the status of the U.S. Food and Drug Administration (FDA) approval process for Ceplene for the treatment of advanced metastatic melanoma. In 2000 the Company submitted a New Drug Application (NDA) with the FDA requesting approval to market Ceplene based on the 12-month results of the M01 Phase 3 study. In January 2001 the FDA communicated to the Company that the single M01 study would not support approval on its own and that an additional Phase 3 trial would be required. The combination of Ceplene and IL-2 is currently being tested in a confirming Phase 3 trial (the "M0104" trial) designed to support, in combination with the results of the M01 trial, approval in the U.S. and other countries. The FDA reviewed and accepted the protocol for the M0104 Phase 3 trial under its "Special Protocol Assessment" procedures and has confirmed that it will consider the trial to be an adequate and well-controlled study if conducted in accordance with the protocol. A web cast of this presentation is available at www.maxim.com.
"The approval process for our NDA is now well defined, and we are pleased that we are progressing with the final Phase 3 trial expected to support approval of Ceplene for the treatment of melanoma," said Philippe K. Prokocimer, M.D., Maxim`s Vice President, Drug Development. "The delay experienced in the NDA approval process has generated a certain amount of confusion and misconceptions in the public regarding the strength of the evidence from the M01 Phase 3 trial and the remaining path for approval. The NDA approval process comes down to the need for a second trial to confirm the results from our first trial, and we expect to complete the second trial in early 2005 and amend our existing NDA at that time. The ongoing evaluation of the Phase 3 data from the M01 study continues to highlight the potential benefit of Ceplene, and we are honored that the data from this trial has been selected for publication in the Journal of Clinical Oncology. We will consider the possibility of filing for approval of Ceplene for the treatment of melanoma in Europe in 2003 based upon the results of our six completed clinical trials."
Ceplene research and clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles. The 12-month data from the M01 trial was published in the January 2002 edition of the Journal of Clinical Oncology (JCO). These results, and an update of the 24-month results, were published this month in the JCO "Classic Papers and Current Comments." The Classic Papers and Current Comments publication represents the major articles related to melanoma research published in the JCO over the last 20 years.
Other Ceplene ESMO Presentations
Ceplene has been tested in 17 completed or ongoing clinical trials in 19 countries around the world. In addition to melanoma, Ceplene has been tested in a Phase 3 trial in acute myelogenous leukemia and Phase 2 trials in renal cell carcinoma and hepatitis C. Additional clinical results presented at the ESMO conference included:
-- "The Health-Related Quality-of-Life Impact of Histamine
Dihydrochloride plus Interleukin-2 Compared to Interleukin-2
Alone in Patients with Metastatic Melanoma," by Dr. Sanjiv S.
Agarwala, et al. The presentation described an assessment of
the quality of life that was performed as part of the M01
Phase 3 trial. The researchers concluded the addition of
Ceplene to IL-2 treatment improved median quality-adjusted
survival duration and did not adversely affect quality of life
of patients participating in the study.
-- "Safety and efficacy of combined immunotherapy with
subcutaneous interleukin-2 (IL-2) and histamine
dihydrochloride (HDC) in patients (pts) with stage IV renal
cell carcinoma (RCC): A randomized phase II study," by Dr.
Mark Middleton, et al. The presentation describes a 41-patient
Phase 2 study in which advanced metastatic renal cell
carcinoma patients were treated with a combination of Ceplene
and IL-2, while patients in the control group were treated
with the same dose of IL-2 alone. For the group of patients
treated with the Ceplene/IL-2 combination, 42 percent achieved
a partial response or disease stabilization compared to 26
percent for the group treated with IL-2 alone.
Melanoma Overview and Ongoing Phase 3 Trial
Melanoma is the fastest-growing cancer in the developed world with an estimated prevalence of 230,000 in the United States and 150,000 in Europe. The incidence of melanoma has more than tripled among Caucasians between 1980 and 2002. Malignant melanoma will spread to most organs, and patients with melanoma that has metastasized to their livers have an extremely poor prognosis with a life expectancy of less than five months.
The M0104 Phase 3 trial is being conducted at approximately 40 clinical sites in the United States, Europe and Canada and will include 224 patients with advanced metastatic melanoma with liver metastases (the patient population in which Ceplene demonstrated the strongest statistically significant survival benefit in the M01 Phase 3 trial). The M0104 Phase 3 trial will be conducted under the same treatment protocol as the M01 study, and will evaluate whether Ceplene improves the efficacy of IL-2, an immunotherapeutic agent already approved for the treatment of advanced metastatic melanoma. Patients enrolled in the trial will be randomized and treated with either the combination of Ceplene and IL-2 or the same dose of IL-2 alone. The primary endpoint in the trial is duration of patient survival. The Company currently estimates that the timeline for the M0104 Phase 3 trial will include approximately 18 months for patient enrollment and 18 months of patient follow up, resulting in an expected completion date for the trial in early 2005.
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The Red
Maxim Announces Results of Preclinical Research Suggesting Ceplene Accelerates Recovery in Liver Damage Model
SAN DIEGO--(BUSINESS WIRE)--Nov. 4, 2002--Maxim Pharmaceuticals, Inc. (Nasdaq: MAXM)(SSE: MAXM) today announced the results from preclinical studies suggesting that Ceplene(TM) (histamine dihydrochloride) accelerated recovery from alcohol-induced liver damage in an animal model of alcoholic liver disease (ALD). In the study, animals treated with Ceplene recovered from alcohol-induced liver injury more rapidly than the untreated control animals.
In the United States alone, approximately 25 million people -- one in every ten -- have been afflicted with chronic liver, bile duct or gallbladder diseases. More specifically, liver cirrhosis resulting from alcohol abuse is one of the ten leading causes of death in the United States. Earlier this year the Company presented the results of the first studies suggesting that Ceplene may protect against alcohol-induced liver injury in an animal model.
In the study reported today, liver injury was induced through the administration of a single dose of ethanol once per day for four weeks in rats. After four weeks, alcohol administration was discontinued and animals were treated with either histamine (0.5 mg/kg) or a vehicle control by subcutaneous injection twice a day for one week. Liver damage was assessed through measurement of the liver enzymes ALT and AST, markers that are elevated when there is damage to the liver. Animals that were treated with histamine achieved normalization of ALT and AST levels in approximately one-half of the time experienced by the control animals. The results are described by Hornyak, Little, Radi, Gehlsen and Haaparanta in "Histamine Accelerates Recovery Time of Early Alcohol-induced Liver Injury in the Intragastric Gavage Rat Model" (American Association for the Study of Liver Diseases).
A second alcohol-damage study demonstrated that histamine treatment also prevented the decrease of IL-1 receptor antagonist (IL-1Ra) mRNA levels, maintaining normal levels of this anti-inflammatory cytokine that blocks the pro-inflammatory IL-1 cytokine family. Histamine also increased the sustained mRNA levels of interferon-gamma, a cytokine known to promote T cell and Natural Killer cell proliferation and thought to be a direct inhibitor of viral hepatitis replication. Based on these results, the researchers concluded that histamine`s combined effect of reducing oxidative stress and balancing the cytokine profile during a diseased condition may help accelerate healing of the liver while promoting the recovery of key immune cells in the liver. In addition, the finding that histamine can increase the levels of interferon-gamma may be one of the mechanisms contributing to the benefits observed in clinical studies of Ceplene combination therapy for the treatment of hepatitis C.
"The active agent in Ceplene reduces oxidative stress as well as modulating several key cytokines like TNF-alpha, IL-12, IL-18 and IFN-gamma, each of which have been shown to be involved in regulating the severity of liver disease," said Dr. Kurt Gehlsen, Maxim`s Chief Scientific Officer. "These results suggest that we should consider investigating the protective mechanism of Ceplene as a potential therapy for certain non-viral chronic liver diseases such as nonalcoholic steatohepatitis (NASH) and ALD."
Ceplene and Maxim Overview
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the Company`s 17 completed and ongoing clinical trials. Ceplene research and clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
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The Red
SAN DIEGO--(BUSINESS WIRE)--Nov. 4, 2002--Maxim Pharmaceuticals, Inc. (Nasdaq: MAXM)(SSE: MAXM) today announced the results from preclinical studies suggesting that Ceplene(TM) (histamine dihydrochloride) accelerated recovery from alcohol-induced liver damage in an animal model of alcoholic liver disease (ALD). In the study, animals treated with Ceplene recovered from alcohol-induced liver injury more rapidly than the untreated control animals.
In the United States alone, approximately 25 million people -- one in every ten -- have been afflicted with chronic liver, bile duct or gallbladder diseases. More specifically, liver cirrhosis resulting from alcohol abuse is one of the ten leading causes of death in the United States. Earlier this year the Company presented the results of the first studies suggesting that Ceplene may protect against alcohol-induced liver injury in an animal model.
In the study reported today, liver injury was induced through the administration of a single dose of ethanol once per day for four weeks in rats. After four weeks, alcohol administration was discontinued and animals were treated with either histamine (0.5 mg/kg) or a vehicle control by subcutaneous injection twice a day for one week. Liver damage was assessed through measurement of the liver enzymes ALT and AST, markers that are elevated when there is damage to the liver. Animals that were treated with histamine achieved normalization of ALT and AST levels in approximately one-half of the time experienced by the control animals. The results are described by Hornyak, Little, Radi, Gehlsen and Haaparanta in "Histamine Accelerates Recovery Time of Early Alcohol-induced Liver Injury in the Intragastric Gavage Rat Model" (American Association for the Study of Liver Diseases).
A second alcohol-damage study demonstrated that histamine treatment also prevented the decrease of IL-1 receptor antagonist (IL-1Ra) mRNA levels, maintaining normal levels of this anti-inflammatory cytokine that blocks the pro-inflammatory IL-1 cytokine family. Histamine also increased the sustained mRNA levels of interferon-gamma, a cytokine known to promote T cell and Natural Killer cell proliferation and thought to be a direct inhibitor of viral hepatitis replication. Based on these results, the researchers concluded that histamine`s combined effect of reducing oxidative stress and balancing the cytokine profile during a diseased condition may help accelerate healing of the liver while promoting the recovery of key immune cells in the liver. In addition, the finding that histamine can increase the levels of interferon-gamma may be one of the mechanisms contributing to the benefits observed in clinical studies of Ceplene combination therapy for the treatment of hepatitis C.
"The active agent in Ceplene reduces oxidative stress as well as modulating several key cytokines like TNF-alpha, IL-12, IL-18 and IFN-gamma, each of which have been shown to be involved in regulating the severity of liver disease," said Dr. Kurt Gehlsen, Maxim`s Chief Scientific Officer. "These results suggest that we should consider investigating the protective mechanism of Ceplene as a potential therapy for certain non-viral chronic liver diseases such as nonalcoholic steatohepatitis (NASH) and ALD."
Ceplene and Maxim Overview
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the Company`s 17 completed and ongoing clinical trials. Ceplene research and clinical results has been the subject of more than 80 presentations at major scientific and clinical meetings, and have been published in more than 300 scientific and clinical articles. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
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Last Trade 9.60 Dollar gestern Abend.
News :
Press Release Source: Maxim Pharmaceuticals
Maxim Pharmaceuticals Discovers Potential Therapeutic Against the SARS Coronavirus
Thursday January 22, 3:05 am ET
Compound Tested by National Institute of Allergy and Infectious Diseases (NIAID)
SAN DIEGO--(BUSINESS WIRE)--Jan. 22, 2004-- Maxim Pharmaceuticals (Nasdaq: MAXM - News; SSE: MAXM) today announced that its scientists have discovered a series of small molecules as inhibitors of the SARS coronavirus (SARS-CoV). These compounds, designated the MX128533 series, have been tested for antimicrobial activity by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, at the Institute for Antiviral Research, Utah State University, by Dr. Dale Barnard and Dr. Robert Sidwell.
The lead compound within Maxim`s MX128533 series has demonstrated inhibition of the SARS-CoV in cell culture at very low concentrations (0.02 (mu)g/mL). In-vitro studies with the compound has demonstrated no toxic effect on uninfected cells even at the highest concentration tested, resulting in a selectivity index (SI) greater than 500. An (SI) of greater than 10 is considered significant by NIAID criteria. Dr. Dale Barnard at the Utah State University has informed the Company that MX128533 is a highly potent inhibitor of SARS-CoV. The MX128533 series of compounds will be further evaluated in-vitro and in preclinical animal models under the agreement with NIAID to select a potential development candidate.
"We are pleased by the potency and selectivity of the MX128533 series of compounds as they may be more potent and selective than other reported compounds," said Kurt R. Gehlsen, Maxim`s Senior Vice President, and Chief Scientific Officer. "Discovery of the MX128533 series was the result of a focused effort by our chemistry group to examine the structure of the SARS coronavirus and to design and synthesize a series of novel small molecule inhibitors of the virus."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim`s lead drug candidate Ceplene(TM) (histamine dihydrochloride) is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. In November 2003, Maxim filed an application for market authorization in Europe for approval to market Ceplene for the treatment of advanced malignant melanoma. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced malignant melanoma with liver metastasis and acute myeloid leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxim is also developing an oral formulation of histamine for the potential treatment of chronic liver diseases. More than 2,000 patients have participated in 17 completed and ongoing clinical trials of Ceplene.
In addition to Ceplene, Maxim is developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, which may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Ceplene, the apoptosis inducers, and the MX128533 series are investigational drugs and have not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, the oral histamine formulation, the MX128533 series and the apoptosis inducers, and the conduct, results and timelines associated with the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risks associated with dependence upon key personnel, and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: The Maxim logo is a trademark of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
--------------------------------------------------------------------------------
Contact:
Maxim Pharmaceuticals, San Diego
Larry G. Stambaugh or Anthony E. Altig, 858-453-4040
or
Investor Relations:
Burns McClellan
Aline Schimmel, 212-213-0006
or
CCG Investor Relations
Media Relations:
Sean Collins or Valerie Bent, 818-789-0100
http://biz.yahoo.com/bw/040122/225187_1.html
Last Trade 9.60 Dollar gestern Abend.
News :
Press Release Source: Maxim Pharmaceuticals
Maxim Pharmaceuticals Discovers Potential Therapeutic Against the SARS Coronavirus
Thursday January 22, 3:05 am ET
Compound Tested by National Institute of Allergy and Infectious Diseases (NIAID)
SAN DIEGO--(BUSINESS WIRE)--Jan. 22, 2004-- Maxim Pharmaceuticals (Nasdaq: MAXM - News; SSE: MAXM) today announced that its scientists have discovered a series of small molecules as inhibitors of the SARS coronavirus (SARS-CoV). These compounds, designated the MX128533 series, have been tested for antimicrobial activity by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, at the Institute for Antiviral Research, Utah State University, by Dr. Dale Barnard and Dr. Robert Sidwell.
The lead compound within Maxim`s MX128533 series has demonstrated inhibition of the SARS-CoV in cell culture at very low concentrations (0.02 (mu)g/mL). In-vitro studies with the compound has demonstrated no toxic effect on uninfected cells even at the highest concentration tested, resulting in a selectivity index (SI) greater than 500. An (SI) of greater than 10 is considered significant by NIAID criteria. Dr. Dale Barnard at the Utah State University has informed the Company that MX128533 is a highly potent inhibitor of SARS-CoV. The MX128533 series of compounds will be further evaluated in-vitro and in preclinical animal models under the agreement with NIAID to select a potential development candidate.
"We are pleased by the potency and selectivity of the MX128533 series of compounds as they may be more potent and selective than other reported compounds," said Kurt R. Gehlsen, Maxim`s Senior Vice President, and Chief Scientific Officer. "Discovery of the MX128533 series was the result of a focused effort by our chemistry group to examine the structure of the SARS coronavirus and to design and synthesize a series of novel small molecule inhibitors of the virus."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim`s research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim`s lead drug candidate Ceplene(TM) (histamine dihydrochloride) is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. In November 2003, Maxim filed an application for market authorization in Europe for approval to market Ceplene for the treatment of advanced malignant melanoma. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced malignant melanoma with liver metastasis and acute myeloid leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxim is also developing an oral formulation of histamine for the potential treatment of chronic liver diseases. More than 2,000 patients have participated in 17 completed and ongoing clinical trials of Ceplene.
In addition to Ceplene, Maxim is developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, which may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Ceplene, the apoptosis inducers, and the MX128533 series are investigational drugs and have not been approved by the U.S. Food and Drug Administration (FDA) or any international regulatory agency.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, the oral histamine formulation, the MX128533 series and the apoptosis inducers, and the conduct, results and timelines associated with the Company`s clinical trials. Such statements are only predictions and the Company`s actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risks associated with dependence upon key personnel, and the risk that the Company will not obtain approval to market its products. These factors and others are more fully discussed in the Company`s periodic reports and other filings with the Securities and Exchange Commission.
Note: The Maxim logo is a trademark of the Company.
Editor`s Note: This release is also available on the Internet at http://www.maxim.com.
--------------------------------------------------------------------------------
Contact:
Maxim Pharmaceuticals, San Diego
Larry G. Stambaugh or Anthony E. Altig, 858-453-4040
or
Investor Relations:
Burns McClellan
Aline Schimmel, 212-213-0006
or
CCG Investor Relations
Media Relations:
Sean Collins or Valerie Bent, 818-789-0100
http://biz.yahoo.com/bw/040122/225187_1.html
MAXIM PHARMACEUT. DL-,001 (909400 US57772M1071) Frankfurt
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