Protox Therapeutics Inc. (TSX;PRX) Prostatamedikament - Ergebnisse kommen in wenigen Tagen - 500 Beiträge pro Seite
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Meistdiskutierte Wertpapiere
Platz | vorher | Wertpapier | Kurs | Perf. % | Anzahl | ||
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1. | 1. | 17.697,57 | -0,31 | 198 | |||
2. | 2. | 148,72 | -0,81 | 97 | |||
3. | 7. | 6,6920 | -0,54 | 76 | |||
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7. | 17. | 7,3000 | -0,07 | 46 | |||
8. | 3. | 7,3100 | +4,43 | 34 |
In wenigen Tagen wird Protox Therapeutics die Ergebnisse für PRX302 präsentieren!
http://www.trendaktien.com/EN/553/1563
Protox Therapeutics – Spannung zum Jahreswechsel
In wenigen Tagen wird Protox Therapeutics die Ergebnisse für PRX302 präsentieren, einem Präparat zur Behandlung von BPH. Analysten trauen der Aktie von Protox Therapeutics eine Verdopplung zu.
Pünktlich zum Jahreswechsel wird es bei Protox Therapeutics noch einmal so richtig spannend. Das Biotechnologieunternehmen aus Vancouver wird nämlich in wenigen Tagen – Ende Dezember/Anfang Januar – die Ergebnisse aus einer Versuchsreihe mit dem Präparat PRX302 mitteilen. Dieses Präparat, das zur Behandlung der Benignen Prostatahyperplasie (BPH) eingesetzt wird, einer unter Männern weitverbreiteten krankhaften Vergrößerung der Prostata, hat bereits im Vorfeld seine Wirksamkeit unter Beweis stellen können. Nun sollen die Daten aus der klinischen Forschung der Phase 2b veröffentlicht werden. Die Ergebnisse dazu wurden mit Hilfe von 92 Patienten in einer sogenannten „doppeltblind und placebokontrollierten Studie“ erhoben. Das heißt, die Testgruppe bestand aus an BPH erkrankten Männern, davon wurde aber nur ein Teil mit PRX302 behandelt. Weder Arzt noch Patient wurden darüber jedoch informiert.
BPH ist eine Volkskrankheit
Zur Erinnerung, BPH ist eine Volkskrankheit, deren Behandlung Unsummen verschlingt. So werden allein in den USA jedes Jahr rund 300.000 Operationen zur Beseitigung der BPH durchgeführt. Dafür fallen Kosten in Höhe von zwei Milliarden US-Dollar an. Die Ausgaben für die medikamentöse Behandlung von BPH belaufen sich jährlich auf etwa vier Milliarden US-Dollar. Und obwohl die BPH an sich eine gut erforschte Krankheit ist, gibt es bisher keine Behandlungsmethode, die nicht mit erheblichen Nachteilen verbunden ist. Vor allem die im großen Umfang verschriebenen Alpha-Blocker und 5Alpha-Reduktase-Inhibitoren führen in nicht wenigen Fällen zu Bluthochdruck, zu erektiler Dysfunktion und zu einem Rückgang der Libido. PRX302 könnte hier möglicherweise den Durchbruch bringen.
Sie wollen in Zuk unft frühzeitig über die neusten Megatrends an der Börse informiert werden? Sie wollen brandheiße Informationen von Unternehmen, die kurz davor stehen, Zukunftstechnologien erfolgreich zu vermarkten? Dann melden Sie sich zu unserem kostenlosen VIP-Newsletter an.
Ein Klick, und Sie sind dabei!
Blockbuster-Medikament – mindestens eine Milliarde US-Dollar Umsatz im Jahr!
Mit PRX302 stößt Protox Therapeutics in einen Milliardenmarkt vor. Das Präparat ist ein potenzieller Blockbuster, das heißt, es könnte eines Tages auf einen Jahresumsatz von mindestens eine Milliarde US-Dollar kommen. BPH ist eine Volkskrankheit, unter der rund 50 Prozent aller männlichen Personen leiden, die 60 Jahre oder älter sind. Ab einem Alter von 70 Jahren steigt die Quote der Betroffenen auf sogar 90 Prozent. In den USA wird jeder vierte Mann, der über 80 Jahre ist, an BPH behandelt.
Aktien haben Verdopplungspotenzial
Das Potenzial von Protox Therapeutics wurde nun auch von Dundee Capital Marktes erkannt. Der kanadische Finanzdienstleister hat eine Studie veröffentlicht, die auf die Tragweite der anstehenden Ergebnisse zu PRX302 aufmerksam macht. Falls die Daten gut ausfallen, sehen die Analysten die Aktien von Protox Therapeutics bei 1,30 Kanadischen Dollar bis 1,80 Kanadischen Dollar. Im Vergleich zum aktuellen Kurs bedeutet das eine glatte Verdopplung, und mehr!
Sind Sie neugierig auf Protox Therapeutics geworden? Lesen Sie die aktuelle Studie von Dundee Capital Markets.
Weitere Hintergrundinformationen und ein ausführliches Profil über Protox Therapeutics bekommen Sie auf www.trendaktien.com.
http://www.trendaktien.com/EN/553/1563
Protox Therapeutics – Spannung zum Jahreswechsel
In wenigen Tagen wird Protox Therapeutics die Ergebnisse für PRX302 präsentieren, einem Präparat zur Behandlung von BPH. Analysten trauen der Aktie von Protox Therapeutics eine Verdopplung zu.
Pünktlich zum Jahreswechsel wird es bei Protox Therapeutics noch einmal so richtig spannend. Das Biotechnologieunternehmen aus Vancouver wird nämlich in wenigen Tagen – Ende Dezember/Anfang Januar – die Ergebnisse aus einer Versuchsreihe mit dem Präparat PRX302 mitteilen. Dieses Präparat, das zur Behandlung der Benignen Prostatahyperplasie (BPH) eingesetzt wird, einer unter Männern weitverbreiteten krankhaften Vergrößerung der Prostata, hat bereits im Vorfeld seine Wirksamkeit unter Beweis stellen können. Nun sollen die Daten aus der klinischen Forschung der Phase 2b veröffentlicht werden. Die Ergebnisse dazu wurden mit Hilfe von 92 Patienten in einer sogenannten „doppeltblind und placebokontrollierten Studie“ erhoben. Das heißt, die Testgruppe bestand aus an BPH erkrankten Männern, davon wurde aber nur ein Teil mit PRX302 behandelt. Weder Arzt noch Patient wurden darüber jedoch informiert.
BPH ist eine Volkskrankheit
Zur Erinnerung, BPH ist eine Volkskrankheit, deren Behandlung Unsummen verschlingt. So werden allein in den USA jedes Jahr rund 300.000 Operationen zur Beseitigung der BPH durchgeführt. Dafür fallen Kosten in Höhe von zwei Milliarden US-Dollar an. Die Ausgaben für die medikamentöse Behandlung von BPH belaufen sich jährlich auf etwa vier Milliarden US-Dollar. Und obwohl die BPH an sich eine gut erforschte Krankheit ist, gibt es bisher keine Behandlungsmethode, die nicht mit erheblichen Nachteilen verbunden ist. Vor allem die im großen Umfang verschriebenen Alpha-Blocker und 5Alpha-Reduktase-Inhibitoren führen in nicht wenigen Fällen zu Bluthochdruck, zu erektiler Dysfunktion und zu einem Rückgang der Libido. PRX302 könnte hier möglicherweise den Durchbruch bringen.
Sie wollen in Zuk unft frühzeitig über die neusten Megatrends an der Börse informiert werden? Sie wollen brandheiße Informationen von Unternehmen, die kurz davor stehen, Zukunftstechnologien erfolgreich zu vermarkten? Dann melden Sie sich zu unserem kostenlosen VIP-Newsletter an.
Ein Klick, und Sie sind dabei!
Blockbuster-Medikament – mindestens eine Milliarde US-Dollar Umsatz im Jahr!
Mit PRX302 stößt Protox Therapeutics in einen Milliardenmarkt vor. Das Präparat ist ein potenzieller Blockbuster, das heißt, es könnte eines Tages auf einen Jahresumsatz von mindestens eine Milliarde US-Dollar kommen. BPH ist eine Volkskrankheit, unter der rund 50 Prozent aller männlichen Personen leiden, die 60 Jahre oder älter sind. Ab einem Alter von 70 Jahren steigt die Quote der Betroffenen auf sogar 90 Prozent. In den USA wird jeder vierte Mann, der über 80 Jahre ist, an BPH behandelt.
Aktien haben Verdopplungspotenzial
Das Potenzial von Protox Therapeutics wurde nun auch von Dundee Capital Marktes erkannt. Der kanadische Finanzdienstleister hat eine Studie veröffentlicht, die auf die Tragweite der anstehenden Ergebnisse zu PRX302 aufmerksam macht. Falls die Daten gut ausfallen, sehen die Analysten die Aktien von Protox Therapeutics bei 1,30 Kanadischen Dollar bis 1,80 Kanadischen Dollar. Im Vergleich zum aktuellen Kurs bedeutet das eine glatte Verdopplung, und mehr!
Sind Sie neugierig auf Protox Therapeutics geworden? Lesen Sie die aktuelle Studie von Dundee Capital Markets.
Weitere Hintergrundinformationen und ein ausführliches Profil über Protox Therapeutics bekommen Sie auf www.trendaktien.com.
Das Chart kann sich sehen lassen!
Der Aktienkurs zieht weiter an. Die Volumen sind erstaunlich. Mir wurde gesagt, dass die Ergebnisse Ende dieser Woche oder anfangs nächste Woche kommen werden.
Auf trendaktien.com (http://www.trendaktien.com/EN/553/1563 ist ein Link zur einer kleinen Research-Studie von Dundee Capital. Der Analyst denkt, dass sich die Aktie bei positiven Ergebnissen verdreifachen kann. Ist auf jeden Fall interessant zu lesen.
Auf trendaktien.com (http://www.trendaktien.com/EN/553/1563 ist ein Link zur einer kleinen Research-Studie von Dundee Capital. Der Analyst denkt, dass sich die Aktie bei positiven Ergebnissen verdreifachen kann. Ist auf jeden Fall interessant zu lesen.
Die Volumen sind weiterhin sehr gross. Ich habe mich mit der Firma in Verbindung gesetzt. Die Ergebnisse sind noch nicht bekannt.
Protox Announces Positive Phase 2B BPH Results
Vancouver, British Columbia, January 11, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive top-line results from its double-blinded placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in patients with moderate to severe benign prostatic hyperplasia (BPH), a painful and bothersome urological condition that affects more than 50 million men worldwide. The study achieved its primary clinical endpoint of a statistically significant improvement in International Prostate Symptom Score (IPSS) for patients treated with PRX302 versus subjects receiving placebo (p=0.0238, ANCOVA).
“We are very excited about the results of the TRIUMPH study,” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. “We believe that PRX302 has an immense commercial opportunity and look forward to sharing these impressive data with our potential partners”.
“The future for new drug development is to create molecules that target the organ or cell of interest and affect it as needed with minimal collateral damage. PRX302 is an excellent example of such a designer drug that targets cells producing PSA which is limited to the prostate gland,” commented Dr. Mostafa M. Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator and Stephen Jarislowsky Chair of Urology at McGill University. “The study results from this placebo controlled trial showed that injecting PRX302 in the prostate produced the desired effects with minimal side effects which is quite exciting. Furthermore, improvements in symptoms were also associated with improvements in flow rates and Quality of Life measures”.
Study Design:
TRIUMPH was a double-blinded, placebo-controlled, multi-centre Phase 2b study in subjects with moderate to severe BPH. Enrolment criteria included baseline IPSS scores greater than or equal to 15, a maximum urinary flow rate (Qmax) of less than 12 milliliters per second and prostate volume between 30 and 100 milliliters. Each subject was treated with either PRX302 (3 μg/mL) or placebo at a volume equivalent to 20 percent of the total prostate volume via a single ultrasound guided injection into each lobe of the prostate.
The trial’s primary clinical endpoint of the study was to determine the efficacy of PRX302, as demonstrated at 90 days post-treatment, by a statistically significant improvement in IPSS from baseline when compared to placebo. IPSS is a validated primary clinical endpoint used to assess the treatment benefit in BPH trials. This index is measured on a 0 to 35 scale with 0 being defined as having no problems and 35 defined as the high end of severe symptoms.
Study Results:
Of the 73 per protocol efficacy evaluable subjects, 52 received PRX302 and 21 received placebo. The PRX302 arm showed an average IPSS improvement at 90 days of 9.1 (± 5.9) points versus an average IPSS improvement of 5.8 (± 5.4) points for the placebo arm, a statistically significant improvement of 3.3 points (p=0.0238, ANCOVA). Baseline average IPSS for the PRX302 and placebo groups were 23.5 and 22.9 points, respectively.
A sub-group analysis was performed for subjects with severe BPH (baseline IPSS>22, n=40). Results of this sub-group analysis showed that those treated with PRX302 had an average IPSS improvement at 90 days from baseline of 10.8 (± 6.0) versus an improvement of 5.8 (± 6.2) for those receiving placebo for an overall 5.0 point improvement over placebo.
No significant safety issues were identified in this study. There were no drug related serious adverse events or Grade 3 or greater adverse events reported in the study. PRX302 related adverse events were mild to moderate, transient in nature (resolved within days) and localized to the urinary tract. In addition, no sexual dysfunction was reported in any of the subjects.
A total of 92 subjects were enrolled on a 2-to-1 basis (treatment to placebo) and randomized based on their baseline IPSS and prostate size. At 90 days, the number of per protocol efficacy evaluable subjects was 21 (mean age of 64.5 years) of the 31 that were dosed at baseline in the placebo arm and 52 (mean age of 63.7 years) of the 61 dosed at baseline in the PRX302 arm. The decrease in efficacy evaluable subjects was due to protocol violations, medical interventions, or patient withdrawal and included three subjects that needed surgery to treat BPH (all from the placebo arm).
Detailed results from this study will be presented by Professor Mostafa Elhilali during a podium session at the Annual Meeting of the American Urological Association to be held in San Francisco, May 29 – June 3, 2010.
Conference call
Protox will host a conference call and live webcast today at 8:45 a.m. E.T. to discuss these results. To access the conference call by telephone, dial 647-427-7450 or 1-888-231-8191. Please connect approximately ten minutes prior to the beginning of the call to ensure participation. The conference call will be archived for 30 days. To access the archived conference call, dial 416-849-0833 or 1-800-642-1687 and enter the reservation number 50203392 followed by the number sign.
A live audio webcast of the conference call will be available at www.protoxtherapeutics.com . Please connect at least ten minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived for 30 days.
About PRX302
PRX302 is the lead drug in the company’s PORxin™ technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $4 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. Protox’s lead program, PRX302 (PORxin), has announced positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox’ current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
Vancouver, British Columbia, January 11, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced positive top-line results from its double-blinded placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in patients with moderate to severe benign prostatic hyperplasia (BPH), a painful and bothersome urological condition that affects more than 50 million men worldwide. The study achieved its primary clinical endpoint of a statistically significant improvement in International Prostate Symptom Score (IPSS) for patients treated with PRX302 versus subjects receiving placebo (p=0.0238, ANCOVA).
“We are very excited about the results of the TRIUMPH study,” said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. “We believe that PRX302 has an immense commercial opportunity and look forward to sharing these impressive data with our potential partners”.
“The future for new drug development is to create molecules that target the organ or cell of interest and affect it as needed with minimal collateral damage. PRX302 is an excellent example of such a designer drug that targets cells producing PSA which is limited to the prostate gland,” commented Dr. Mostafa M. Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator and Stephen Jarislowsky Chair of Urology at McGill University. “The study results from this placebo controlled trial showed that injecting PRX302 in the prostate produced the desired effects with minimal side effects which is quite exciting. Furthermore, improvements in symptoms were also associated with improvements in flow rates and Quality of Life measures”.
Study Design:
TRIUMPH was a double-blinded, placebo-controlled, multi-centre Phase 2b study in subjects with moderate to severe BPH. Enrolment criteria included baseline IPSS scores greater than or equal to 15, a maximum urinary flow rate (Qmax) of less than 12 milliliters per second and prostate volume between 30 and 100 milliliters. Each subject was treated with either PRX302 (3 μg/mL) or placebo at a volume equivalent to 20 percent of the total prostate volume via a single ultrasound guided injection into each lobe of the prostate.
The trial’s primary clinical endpoint of the study was to determine the efficacy of PRX302, as demonstrated at 90 days post-treatment, by a statistically significant improvement in IPSS from baseline when compared to placebo. IPSS is a validated primary clinical endpoint used to assess the treatment benefit in BPH trials. This index is measured on a 0 to 35 scale with 0 being defined as having no problems and 35 defined as the high end of severe symptoms.
Study Results:
Of the 73 per protocol efficacy evaluable subjects, 52 received PRX302 and 21 received placebo. The PRX302 arm showed an average IPSS improvement at 90 days of 9.1 (± 5.9) points versus an average IPSS improvement of 5.8 (± 5.4) points for the placebo arm, a statistically significant improvement of 3.3 points (p=0.0238, ANCOVA). Baseline average IPSS for the PRX302 and placebo groups were 23.5 and 22.9 points, respectively.
A sub-group analysis was performed for subjects with severe BPH (baseline IPSS>22, n=40). Results of this sub-group analysis showed that those treated with PRX302 had an average IPSS improvement at 90 days from baseline of 10.8 (± 6.0) versus an improvement of 5.8 (± 6.2) for those receiving placebo for an overall 5.0 point improvement over placebo.
No significant safety issues were identified in this study. There were no drug related serious adverse events or Grade 3 or greater adverse events reported in the study. PRX302 related adverse events were mild to moderate, transient in nature (resolved within days) and localized to the urinary tract. In addition, no sexual dysfunction was reported in any of the subjects.
A total of 92 subjects were enrolled on a 2-to-1 basis (treatment to placebo) and randomized based on their baseline IPSS and prostate size. At 90 days, the number of per protocol efficacy evaluable subjects was 21 (mean age of 64.5 years) of the 31 that were dosed at baseline in the placebo arm and 52 (mean age of 63.7 years) of the 61 dosed at baseline in the PRX302 arm. The decrease in efficacy evaluable subjects was due to protocol violations, medical interventions, or patient withdrawal and included three subjects that needed surgery to treat BPH (all from the placebo arm).
Detailed results from this study will be presented by Professor Mostafa Elhilali during a podium session at the Annual Meeting of the American Urological Association to be held in San Francisco, May 29 – June 3, 2010.
Conference call
Protox will host a conference call and live webcast today at 8:45 a.m. E.T. to discuss these results. To access the conference call by telephone, dial 647-427-7450 or 1-888-231-8191. Please connect approximately ten minutes prior to the beginning of the call to ensure participation. The conference call will be archived for 30 days. To access the archived conference call, dial 416-849-0833 or 1-800-642-1687 and enter the reservation number 50203392 followed by the number sign.
A live audio webcast of the conference call will be available at www.protoxtherapeutics.com . Please connect at least ten minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived for 30 days.
About PRX302
PRX302 is the lead drug in the company’s PORxin™ technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $4 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. Protox’s lead program, PRX302 (PORxin), has announced positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox’ current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
Welches KZ meinst du ist möglich?
Antwort auf Beitrag Nr.: 38.709.102 von Hoizzo am 11.01.10 15:59:30Habe gerade infos von meinem Börsenbrief bekommen! Die meinen Protox wird jetzt mit einem Big Player eine Partnerschaft eingehen oder warscheinlich von einem Großen Konzern übernommen! Ich gehe davon aus das bei diesen Positiven Nachrichten bzw. bei einer Übernahme sich der Kurs mindestens verdoppeln möglicherweise aber auch verdreifachen wird!
Hier nochmals die news übersetzt mit einem einfachen übersetzer Programm!
Protox gibt positive Ergebnisse der Phase 2B BPH
Vancouver, British Columbia, 11. Januar 2010 - Protox Therapeutics Inc. (TSX: PRX), ein Marktführer in der Entwicklung von Rezeptor gezielte Fusionsproteine, gab heute positive top-line Ergebnisse aus der doppelt verblindeten placebokontrollierten Phase-2b-Studie PRX302 (Studie Name: TRIUMPH) bei Patienten mit mittelschwerer bis schwerer benigner Prostatahyperplasie (BPH), eine schmerzhafte und lästige urologischen Bedingung, dass mehr als 50 Millionen Menschen weltweit betrifft. Die Studie erreichte ihren primären klinischen Endpunkt einer statistisch signifikanten Verbesserung der International Prostate Symptom Score (IPSS) für Patienten mit PRX302 gegenüber Patienten unter Placebo (p = 0,0238, ANCOVA).
"Wir sind sehr besorgt über die Ergebnisse der TRIUMPH-Studie sind begeistert", sagte Dr. Fahar Merchant, President und Chief Executive Officer von Protox. "Wir glauben, dass PRX302 ein riesiges Einkaufs-Möglichkeit hat und freuen uns darauf, diesen beeindruckenden Daten mit unserer potenziellen Partner".
"Die Zukunft der Entwicklung neuer Medikamente ist, um Moleküle zu schaffen, die auf das Organ oder Zellen des Interesses und beeinflussen als mit minimalen Kollateralschäden erforderlich. PRX302 ist ein ausgezeichnetes Beispiel für eine solche Designer-Droge, die Ziele PSA-produzierenden Zellen, die auf die Prostata begrenzt ist ", kommentierte Dr. Mostafa M. Elhilali, OC, MD, Ph.D. Chief Co-Principal Investigator und Stephen Jarislowsky Lehrstuhl für Urologie an der McGill University. "Die Ergebnisse der Studie von dieser Placebo-kontrollierten Studie zeigte, dass die Injektion PRX302 in der Prostata die gewünschte Wirkung bei minimalen Nebenwirkungen, die ganz spannend produziert. Darüber hinaus wurden Verbesserungen der Symptome auch mit einer Verbesserung der Flussraten und Quality of Life Maßnahmen verbundenen ".
Studiendesign:
Triumph war eine doppelt verblindete, Plazebo-kontrollierten, multizentrischen Phase-2b-Studie bei Patienten mit mittelschwerer bis schwerer BPH. Einschreibung Kriterien enthalten Baseline IPSS Werte größer oder gleich 15, maximal Harnflussrate (Qmax) von weniger als 12 Milliliter pro Sekunde und Prostata-Volumen zwischen 30 und 100 Milliliter. Jedes Thema wurde entweder mit PRX302 (3, ug / ml) oder Placebo bei einem Volumen in Höhe von 20 Prozent der gesamten Prostata-Volumen über einen einzigen Ultraschall-geführte Injektion in jeder Lappen der Prostata behandelt.
Der Prozess der primäre klinische Endpunkt der Studie war es, die Wirksamkeit von PRX302 bestimmen, wie bei 90 Tage nach der Behandlung gezeigt hat, durch eine statistisch signifikante Verbesserung bei IPSS gegenüber dem Ausgangswert im Vergleich zu Placebo. IPSS ist ein validiertes primäre klinische Endpunkt verwendet, um die Versorgung bei BPH-Studien zu beurteilen. Dieser Index basiert auf einer Skala von 0 bis 35 mit 0 gemessen wird als ohne Probleme und 35 als High-End schwerer Symptome definiert definiert.
Ergebnisse der Studie:
Von den 73 auswertbaren Per-Protokoll-Wirksamkeit Themen, 52 erhielten PRX302 und 21 erhielten Placebo. Die PRX302 Arms wiesen eine durchschnittliche Verbesserung IPSS nach 90 Tagen von 9,1 (± 5,9) Punkten im Vergleich zu einem durchschnittlichen IPSS Verbesserung von 5,8 (± 5,4) Punkte in der Placebo - Arm, eine statistisch signifikante Verbesserung von 3,3 Punkten (p = 0,0238, ANCOVA). Baseline durchschnittlichen IPSS für die PRX302 und Placebo-Gruppe waren 23,5 und 22,9 Punkten, respectively.
Eine Untergruppe Analyse wurde für Patienten mit schwerer BPH durchgeführt (Baseline IPSS> 22, n = 40). Die Ergebnisse dieser Untergruppe Analyse zeigte, dass Personen mit einem durchschnittlichen PRX302 behandelt IPSS Verbesserung war auf 90 Tage gegenüber dem Ausgangswert von 10,8 (± 6,0) im Vergleich zu einer Verbesserung von 5,8 (± 6,2) für die Placebo erhielten für insgesamt 5,0 Punkte Verbesserung gegenüber Placebo.
Keine wesentlichen Fragen der Sicherheit wurden in dieser Studie identifiziert. Es gab kein Medikament schwerwiegenden unerwünschten Ereignissen oder Grad 3 oder höher berichteten unerwünschten Ereignisse waren in der Studie. PRX302 Nebenwirkungen waren mild bis moderat und vorübergehend in der Natur (innerhalb weniger Tage behoben) und lokalisiert, um die Harnwege. Darüber hinaus wurde keine sexuelle Dysfunktion in einem der Fächer gemeldet.
Insgesamt 92 Probanden wurden auf einem 2 eingeschrieben-zu-1-Basis (Behandlung mit Placebo) und randomisierten auf ihren Ausgangswert IPSS-und Prostata-Größe basiert. Nach 90 Tagen ist die Zahl der Per-Protokoll-Wirksamkeit auswertbaren Patienten war 21 (Durchschnittsalter 64,5 Jahre) der 31, die zu Studienbeginn in der Placebo-Arm verabreicht wurden und 52 (Durchschnittsalter 63,7 Jahre) der 61 zu Studienbeginn in der Dosierung PRX302 Arm. Die Abnahme der Wirksamkeit auswertbaren Patienten war aufgrund von Verletzungen des Protokolls, medizinische Eingriffe oder Patienten Rücknahme-und umfasste drei Themen, die erforderlich Chirurgie zur Behandlung von BPH (alle aus der Placebo-Arm).
Ausführliche Ergebnisse dieser Studie wird von Professor Mostafa Elhilali während einer Podiums-Sitzung auf der Jahrestagung der American Urological Association in San Francisco, 29. Mai statt - 3. Juni 2010 vorgelegt werden.
Telefonkonferenz
Protox wird eine Telefonkonferenz und Live-Webcast heute um 8.45 Uhr ET um diese Ergebnisse zu diskutieren. Um die Telefonkonferenz per Telefon, Einwahl 647-427-7450 oder 1-888-231-8191. Bitte verbinden Sie etwa zehn Minuten vor Beginn der Aufforderung zur Teilnahme zu gewährleisten. Die Telefonkonferenz wird für 30 Tage archiviert werden. Für den Zugriff auf die archivierten Telefonkonferenz wählen Sie 416-849-0833 oder 1-800-642-1687 und geben Sie die Reservierungsnummer 50203392 durch die Anzahl Zeichen gefolgt.
Ein Live-Audio-Webcast der Telefonkonferenz wird im Internet unter www.protoxtherapeutics.com . Bitte verbinden Sie mindestens zehn Minuten vor der Telefonkonferenz, um genügend Zeit für einen Software-Download, die erforderlich werden, um den Webcast teilzunehmen, kann zu gewährleisten. Der Webcast wird für 30 Tage archiviert werden.
Über PRX302
PRX302, ist der führende Medikament in PORxin des Unternehmens ™-Technologie-Plattform. PORxin Drogen sind porenbildenden pro-Medikamente, die durch spezifische Proteasen auf hohem Niveau auf der Oberfläche der Zielzellen produziert aktiviert sind. PRX302 wurde von Engineering in der Natur vorkommenden Toxin proaerolysin, so dass es von der Prostata aktiviert-spezifischen Antigens (PSA), erzeugt ein Enzym, das bei Patienten mit Prostatakrebs und BPH überproduziert ist. Einmal aktiviert, Stempel des Medikaments Löcher in die Zellen, wodurch die Inhalte auslaufen und letztlich zum Zelltod.
Über BPH
BPH ist eine häufige urologische Zustand von schmerzhaften und lästigen Symptomen, die Schwierigkeiten bei der Einleitung ein Urinstrahl gekennzeichnet sind, ein Gefühl der Dringlichkeit, Dribbling, unvollständige Entleerung der Blase, Wachen mehrmals in der Nacht zu urinieren und manchmal auch die Anwesenheit von Blut in der Urin. Mehr als die Hälfte aller Menschen, die Symptome der BPH im Alter von 60 haben und nicht weniger als 90% kann von BPH nach dem Alter von 80 Jahren leiden. Aktuelle orale Therapien bieten vor allem Linderung der Symptome und können eine Reihe von Nebenwirkungen einschließlich sexueller Dysfunktion und Hypotonie auslösen. Es wird geschätzt, dass in den sieben größten Märkten weltweit rund 10 Millionen Menschen werden jährlich mit oralen Therapien behandelt werden und diese Produkte umfassen rund 4 Mrd. USD Umsatz pro Jahr. Chirurgische Optionen, einschließlich der minimal-invasiven Verfahren können die sexuelle Dysfunktion, Inkontinenz führen, sowie andere, schwerwiegendere Verfahrens-Effekte. Operative Maßnahmen kann ein Krankenhausaufenthalt notwendig sein, deutliche Erholung Zeit und erfordert Katheterisierung für variable Zeitintervalle. Fast 600.000 Operationen werden jährlich in den sieben größten Märkten durchgeführt.
Über Protox
Protox Therapeutics ist führend in der Förderung neuer, gezielter Rezeptor-Fusionsproteinen. Zwei neuartige Wirkstoffe stammen aus INxin des Unternehmens ™ und PORxin ™ Plattformen werden in drei klinischen Programme entwickelt. Führen Protox Programm, PRX302 (PORxin), hat positive Ergebnisse aus der Phase-2b bekannt, placebo-kontrollierten Studie genannt TRIUMPH, einer gutartigen Prostatavergrößerung behandeln (BPH oder Vergrößerung der Prostata). Zusätzlich zu diesen positiven Ergebnissen werden die Daten aus der Phase-2a-Studie hat gezeigt, Haltbarkeit bei 12 Monaten. PRX302 auch für die Behandlung von lokalisierten Prostatakrebs geprüft. Eine Phase 2a der klinischen Studie zur Evaluierung PRX321 (INxin) für die Behandlung der primären bösartigen Hirntumors abgeschlossen ist und das Medikament Fast-Track-und Orphan-Drug-Status von der US-Zulassungsbehörde FDA und der EMEA erhalten. Protox ist auch die Zusammenarbeit mit den US National Institutes of Health (NIH) im Rahmen eines Forschungsprogramms auf die Entdeckung der nächsten Generation konzentriert vollständig humanen gezielte Therapeutika.
Bestimmte Aussagen in dieser Pressemitteilung können zukunftsbezogene Aussagen in Betracht gezogen werden. Solche Aussagen beinhalten bekannte und unbekannte Risiken, Ungewissheiten und andere Faktoren, die die tatsächlichen Ergebnisse, Leistungen oder Errungenschaften dazu führen können, wesentlich abweichen von den in diesen Aussagen implizit, und deshalb sollten diese Aussagen nicht als Garantien für zukünftige Leistungen oder Ergebnisse, gelesen werden. Alle zukunftsbezogenen Aussagen beruhen auf gegenwärtigen Einschätzungen Protox "basiert, sowie Annahmen und den derzeit verfügbaren Informationen Protox gemacht und betreffen unter anderem erwartete finanzielle Leistungen, Geschäftsaussichten, Strategien, rechtlichen Entwicklungen, die Marktakzeptanz und künftigen Verpflichtungen. Die Leser werden gewarnt, sich nicht unangemessen auf diese zukunftsgerichteten Aussagen, die nur ab dem Datum dieser Pressemitteilung Bestand hat. Auf Grund von Risiken und Ungewissheiten, einschließlich der Risiken und Unsicherheiten, die durch Protox in ihrer Wertpapiere der öffentlichen Hand-Unterlagen, die tatsächlichen Ereignisse können unterscheiden sich erheblich von den derzeitigen Erwartungen. Protox lehnt jede Absicht oder Verpflichtung zur Aktualisierung oder Überprüfung von zukunftsgerichteten Aussagen, ob als Ergebnis neuer Informationen, zukünftiger Ereignisse oder anderweitig.
Hier nochmals die news übersetzt mit einem einfachen übersetzer Programm!
Protox gibt positive Ergebnisse der Phase 2B BPH
Vancouver, British Columbia, 11. Januar 2010 - Protox Therapeutics Inc. (TSX: PRX), ein Marktführer in der Entwicklung von Rezeptor gezielte Fusionsproteine, gab heute positive top-line Ergebnisse aus der doppelt verblindeten placebokontrollierten Phase-2b-Studie PRX302 (Studie Name: TRIUMPH) bei Patienten mit mittelschwerer bis schwerer benigner Prostatahyperplasie (BPH), eine schmerzhafte und lästige urologischen Bedingung, dass mehr als 50 Millionen Menschen weltweit betrifft. Die Studie erreichte ihren primären klinischen Endpunkt einer statistisch signifikanten Verbesserung der International Prostate Symptom Score (IPSS) für Patienten mit PRX302 gegenüber Patienten unter Placebo (p = 0,0238, ANCOVA).
"Wir sind sehr besorgt über die Ergebnisse der TRIUMPH-Studie sind begeistert", sagte Dr. Fahar Merchant, President und Chief Executive Officer von Protox. "Wir glauben, dass PRX302 ein riesiges Einkaufs-Möglichkeit hat und freuen uns darauf, diesen beeindruckenden Daten mit unserer potenziellen Partner".
"Die Zukunft der Entwicklung neuer Medikamente ist, um Moleküle zu schaffen, die auf das Organ oder Zellen des Interesses und beeinflussen als mit minimalen Kollateralschäden erforderlich. PRX302 ist ein ausgezeichnetes Beispiel für eine solche Designer-Droge, die Ziele PSA-produzierenden Zellen, die auf die Prostata begrenzt ist ", kommentierte Dr. Mostafa M. Elhilali, OC, MD, Ph.D. Chief Co-Principal Investigator und Stephen Jarislowsky Lehrstuhl für Urologie an der McGill University. "Die Ergebnisse der Studie von dieser Placebo-kontrollierten Studie zeigte, dass die Injektion PRX302 in der Prostata die gewünschte Wirkung bei minimalen Nebenwirkungen, die ganz spannend produziert. Darüber hinaus wurden Verbesserungen der Symptome auch mit einer Verbesserung der Flussraten und Quality of Life Maßnahmen verbundenen ".
Studiendesign:
Triumph war eine doppelt verblindete, Plazebo-kontrollierten, multizentrischen Phase-2b-Studie bei Patienten mit mittelschwerer bis schwerer BPH. Einschreibung Kriterien enthalten Baseline IPSS Werte größer oder gleich 15, maximal Harnflussrate (Qmax) von weniger als 12 Milliliter pro Sekunde und Prostata-Volumen zwischen 30 und 100 Milliliter. Jedes Thema wurde entweder mit PRX302 (3, ug / ml) oder Placebo bei einem Volumen in Höhe von 20 Prozent der gesamten Prostata-Volumen über einen einzigen Ultraschall-geführte Injektion in jeder Lappen der Prostata behandelt.
Der Prozess der primäre klinische Endpunkt der Studie war es, die Wirksamkeit von PRX302 bestimmen, wie bei 90 Tage nach der Behandlung gezeigt hat, durch eine statistisch signifikante Verbesserung bei IPSS gegenüber dem Ausgangswert im Vergleich zu Placebo. IPSS ist ein validiertes primäre klinische Endpunkt verwendet, um die Versorgung bei BPH-Studien zu beurteilen. Dieser Index basiert auf einer Skala von 0 bis 35 mit 0 gemessen wird als ohne Probleme und 35 als High-End schwerer Symptome definiert definiert.
Ergebnisse der Studie:
Von den 73 auswertbaren Per-Protokoll-Wirksamkeit Themen, 52 erhielten PRX302 und 21 erhielten Placebo. Die PRX302 Arms wiesen eine durchschnittliche Verbesserung IPSS nach 90 Tagen von 9,1 (± 5,9) Punkten im Vergleich zu einem durchschnittlichen IPSS Verbesserung von 5,8 (± 5,4) Punkte in der Placebo - Arm, eine statistisch signifikante Verbesserung von 3,3 Punkten (p = 0,0238, ANCOVA). Baseline durchschnittlichen IPSS für die PRX302 und Placebo-Gruppe waren 23,5 und 22,9 Punkten, respectively.
Eine Untergruppe Analyse wurde für Patienten mit schwerer BPH durchgeführt (Baseline IPSS> 22, n = 40). Die Ergebnisse dieser Untergruppe Analyse zeigte, dass Personen mit einem durchschnittlichen PRX302 behandelt IPSS Verbesserung war auf 90 Tage gegenüber dem Ausgangswert von 10,8 (± 6,0) im Vergleich zu einer Verbesserung von 5,8 (± 6,2) für die Placebo erhielten für insgesamt 5,0 Punkte Verbesserung gegenüber Placebo.
Keine wesentlichen Fragen der Sicherheit wurden in dieser Studie identifiziert. Es gab kein Medikament schwerwiegenden unerwünschten Ereignissen oder Grad 3 oder höher berichteten unerwünschten Ereignisse waren in der Studie. PRX302 Nebenwirkungen waren mild bis moderat und vorübergehend in der Natur (innerhalb weniger Tage behoben) und lokalisiert, um die Harnwege. Darüber hinaus wurde keine sexuelle Dysfunktion in einem der Fächer gemeldet.
Insgesamt 92 Probanden wurden auf einem 2 eingeschrieben-zu-1-Basis (Behandlung mit Placebo) und randomisierten auf ihren Ausgangswert IPSS-und Prostata-Größe basiert. Nach 90 Tagen ist die Zahl der Per-Protokoll-Wirksamkeit auswertbaren Patienten war 21 (Durchschnittsalter 64,5 Jahre) der 31, die zu Studienbeginn in der Placebo-Arm verabreicht wurden und 52 (Durchschnittsalter 63,7 Jahre) der 61 zu Studienbeginn in der Dosierung PRX302 Arm. Die Abnahme der Wirksamkeit auswertbaren Patienten war aufgrund von Verletzungen des Protokolls, medizinische Eingriffe oder Patienten Rücknahme-und umfasste drei Themen, die erforderlich Chirurgie zur Behandlung von BPH (alle aus der Placebo-Arm).
Ausführliche Ergebnisse dieser Studie wird von Professor Mostafa Elhilali während einer Podiums-Sitzung auf der Jahrestagung der American Urological Association in San Francisco, 29. Mai statt - 3. Juni 2010 vorgelegt werden.
Telefonkonferenz
Protox wird eine Telefonkonferenz und Live-Webcast heute um 8.45 Uhr ET um diese Ergebnisse zu diskutieren. Um die Telefonkonferenz per Telefon, Einwahl 647-427-7450 oder 1-888-231-8191. Bitte verbinden Sie etwa zehn Minuten vor Beginn der Aufforderung zur Teilnahme zu gewährleisten. Die Telefonkonferenz wird für 30 Tage archiviert werden. Für den Zugriff auf die archivierten Telefonkonferenz wählen Sie 416-849-0833 oder 1-800-642-1687 und geben Sie die Reservierungsnummer 50203392 durch die Anzahl Zeichen gefolgt.
Ein Live-Audio-Webcast der Telefonkonferenz wird im Internet unter www.protoxtherapeutics.com . Bitte verbinden Sie mindestens zehn Minuten vor der Telefonkonferenz, um genügend Zeit für einen Software-Download, die erforderlich werden, um den Webcast teilzunehmen, kann zu gewährleisten. Der Webcast wird für 30 Tage archiviert werden.
Über PRX302
PRX302, ist der führende Medikament in PORxin des Unternehmens ™-Technologie-Plattform. PORxin Drogen sind porenbildenden pro-Medikamente, die durch spezifische Proteasen auf hohem Niveau auf der Oberfläche der Zielzellen produziert aktiviert sind. PRX302 wurde von Engineering in der Natur vorkommenden Toxin proaerolysin, so dass es von der Prostata aktiviert-spezifischen Antigens (PSA), erzeugt ein Enzym, das bei Patienten mit Prostatakrebs und BPH überproduziert ist. Einmal aktiviert, Stempel des Medikaments Löcher in die Zellen, wodurch die Inhalte auslaufen und letztlich zum Zelltod.
Über BPH
BPH ist eine häufige urologische Zustand von schmerzhaften und lästigen Symptomen, die Schwierigkeiten bei der Einleitung ein Urinstrahl gekennzeichnet sind, ein Gefühl der Dringlichkeit, Dribbling, unvollständige Entleerung der Blase, Wachen mehrmals in der Nacht zu urinieren und manchmal auch die Anwesenheit von Blut in der Urin. Mehr als die Hälfte aller Menschen, die Symptome der BPH im Alter von 60 haben und nicht weniger als 90% kann von BPH nach dem Alter von 80 Jahren leiden. Aktuelle orale Therapien bieten vor allem Linderung der Symptome und können eine Reihe von Nebenwirkungen einschließlich sexueller Dysfunktion und Hypotonie auslösen. Es wird geschätzt, dass in den sieben größten Märkten weltweit rund 10 Millionen Menschen werden jährlich mit oralen Therapien behandelt werden und diese Produkte umfassen rund 4 Mrd. USD Umsatz pro Jahr. Chirurgische Optionen, einschließlich der minimal-invasiven Verfahren können die sexuelle Dysfunktion, Inkontinenz führen, sowie andere, schwerwiegendere Verfahrens-Effekte. Operative Maßnahmen kann ein Krankenhausaufenthalt notwendig sein, deutliche Erholung Zeit und erfordert Katheterisierung für variable Zeitintervalle. Fast 600.000 Operationen werden jährlich in den sieben größten Märkten durchgeführt.
Über Protox
Protox Therapeutics ist führend in der Förderung neuer, gezielter Rezeptor-Fusionsproteinen. Zwei neuartige Wirkstoffe stammen aus INxin des Unternehmens ™ und PORxin ™ Plattformen werden in drei klinischen Programme entwickelt. Führen Protox Programm, PRX302 (PORxin), hat positive Ergebnisse aus der Phase-2b bekannt, placebo-kontrollierten Studie genannt TRIUMPH, einer gutartigen Prostatavergrößerung behandeln (BPH oder Vergrößerung der Prostata). Zusätzlich zu diesen positiven Ergebnissen werden die Daten aus der Phase-2a-Studie hat gezeigt, Haltbarkeit bei 12 Monaten. PRX302 auch für die Behandlung von lokalisierten Prostatakrebs geprüft. Eine Phase 2a der klinischen Studie zur Evaluierung PRX321 (INxin) für die Behandlung der primären bösartigen Hirntumors abgeschlossen ist und das Medikament Fast-Track-und Orphan-Drug-Status von der US-Zulassungsbehörde FDA und der EMEA erhalten. Protox ist auch die Zusammenarbeit mit den US National Institutes of Health (NIH) im Rahmen eines Forschungsprogramms auf die Entdeckung der nächsten Generation konzentriert vollständig humanen gezielte Therapeutika.
Bestimmte Aussagen in dieser Pressemitteilung können zukunftsbezogene Aussagen in Betracht gezogen werden. Solche Aussagen beinhalten bekannte und unbekannte Risiken, Ungewissheiten und andere Faktoren, die die tatsächlichen Ergebnisse, Leistungen oder Errungenschaften dazu führen können, wesentlich abweichen von den in diesen Aussagen implizit, und deshalb sollten diese Aussagen nicht als Garantien für zukünftige Leistungen oder Ergebnisse, gelesen werden. Alle zukunftsbezogenen Aussagen beruhen auf gegenwärtigen Einschätzungen Protox "basiert, sowie Annahmen und den derzeit verfügbaren Informationen Protox gemacht und betreffen unter anderem erwartete finanzielle Leistungen, Geschäftsaussichten, Strategien, rechtlichen Entwicklungen, die Marktakzeptanz und künftigen Verpflichtungen. Die Leser werden gewarnt, sich nicht unangemessen auf diese zukunftsgerichteten Aussagen, die nur ab dem Datum dieser Pressemitteilung Bestand hat. Auf Grund von Risiken und Ungewissheiten, einschließlich der Risiken und Unsicherheiten, die durch Protox in ihrer Wertpapiere der öffentlichen Hand-Unterlagen, die tatsächlichen Ereignisse können unterscheiden sich erheblich von den derzeitigen Erwartungen. Protox lehnt jede Absicht oder Verpflichtung zur Aktualisierung oder Überprüfung von zukunftsgerichteten Aussagen, ob als Ergebnis neuer Informationen, zukünftiger Ereignisse oder anderweitig.
Antwort auf Beitrag Nr.: 38.709.632 von DermitdemBrokertanzt am 11.01.10 16:39:02Wo kommt diese Übersetzung her? Es hat Fehler drin
Antwort auf Beitrag Nr.: 38.709.799 von RogerThat am 11.01.10 16:51:56Hallo aufwachen ich habe doch geschrieben das es mit einem einfachen übersetzer Program übersetzt wurde!
Antwort auf Beitrag Nr.: 38.709.632 von DermitdemBrokertanzt am 11.01.10 16:39:02Welcher BB war das?
moin moin ,hier sinngemäss übersetzt :
IRW-PRESS: Protox Therapeutics Inc.: Protox meldet positive Phase-2b-BPH-Ergebnisse
Protox meldet positive Phase-2b-BPH-Ergebnisse
Vancouver, 11. Januar (CNW). Protox Therapeutics Inc. (TSX: PRX News), ein führendes Unternehmen bei der Entwicklung von rezeptororientierten Fusionsproteinen, meldete heute die positiven Ergebnisse seiner doppelblinden, placebo-kontrollierten Phase-2b-Studie von PRX302 (Studienname: TRIUMPH) bei Patienten mit mäßiger bis schwerer gutartiger Prostatavergrößerung (BPH), einem schmerzhaften und unangenehmen urologischen Zustand, von dem weltweit über 50 Millionen Männer betroffen sind. Die Studie erreichte ihren primären klinischen Endpunkt einer statistisch relevanten Verbesserung des International Prostate Symptom Scores (IPSS) bei Patienten, die mit PRX302 behandelt wurden, im Vergleich zu jenen, die Placebos erhielten (p = 0,0238, ANCOVA).
Wir sind mit den Ergebnissen der Studie TRIUMPH sehr zufrieden, sagte Dr. Fahar Merchant, President und Chief Executive Officer von Protox. Wir glauben, dass PRX302 beträchtliches kommerzielles Potenzial aufweist, und freuen uns bereits darauf, diese beeindruckenden Daten mit unseren potenziellen Partnern zu teilen.
Die Zukunft der neuen Arzneimittelentwicklung besteht darin, Moleküle zu erzeugen, die das betroffene Organ oder die betroffene Zelle anpeilen und mit einem so geringen Kollateralschaden wie möglich behandeln. PRX302 ist ein hervorragendes Beispiel für ein solches Designer-Medikament, das Zellen anpeilt, die PSA produzieren, welches der Prostatadrüse vorbehalten ist, sagten Dr. Mostafa M. Elhilali, OC, M. D., Ph. D., Chief Co-Pricipal Investigator, und Stephen Jarislowsky, Chair of Urology der McGill University. Die Studienergebnisse dieses placebo-kontrollierten Versuchs zeigten, dass die Injektion von PRX302 in die Prostata die gewünschten Wirkungen mit nur geringen Nebenwirkungen erzielte, was äußerst viel versprechend ist. Zudem standen die Besserungen der Symptome auch in Zusammenhang mit Verbesserungen des Harnflusses und der Lebensqualität.
Studien-Design: -------------
TRIUMPH war eine doppelblinde, placebo-kontrollierte, multizentrische Phase-2b-Studie bei Patienten mit moderater bis schwerer BPH. Zu den Aufnahmekriterien zählten IPSS-Werte von mindestens 15, eine Harnflussrate (Qmax) von weniger als 12 Millimeter pro Sekunde und ein Prostatavolumen von 30 bis 100 Millilitern. Jeder Patient wurde entweder mit PRX302 (3 Mikrogramm/ml) oder einem Placebo mit einem Volumenäquivalent von 20 % des gesamten Prostatavolumens mittels einer einzelnen ultraschallgesteuerten Injektion in jeden Lappen der Prostata behandelt.
Der primäre klinische Endpunkt der Studie war die Bestimmung der Effizienz von PRX302 wie bei einer Nachbehandlung nach 90 Tagen gezeigt wurde durch eine statistisch relevante Verbesserung des IPSS im Vergleich zu den Placebos. IPSS ist ein validierter primärer klinischer Endpunkt, der verwendet wird, um die Vorteile einer Behandlung bei BPH-Versuchen zu evaluieren. Dieser Index wird auf einer Skala zwischen 0 und 35 angegeben, wobei 0 bedeutet, dass keine Probleme vorliegen, während 35 als Höchstwert von schweren Symptomen angegeben wird.
Studienergebnisse: --------------
Von den 73 pro Protokolleffizienz auswertbaren Patienten erhielten 52 PRX302 und 21 ein Placebo. Die PRX302-Patienten zeigten nach 90 Tagen eine durchschnittliche Verbesserung des IPSS um 9,1 (+/- 5,9) Punkte, während die Placebo-Patienten eine durchschnittliche Verbesserung von 5,8 (+/- 5,4) Punkte zeigten eine statistisch relevante Verbesserung um 3,3 Punkte (p = 0,0238, ANCOVA). Vor dem Beginn der Behandlung belief sich der durchschnittliche IPSS der PRX302- und Placebo-Gruppen auf 23,5 bzw. 22,9 Punkte.
Eine Untergruppenanalyse wurde bei Patienten mit schwerer BPH (IPSS vor der Behandlung > 22, n = 40) durchgeführt. Die Ergebnisse dieser Untergruppenanalyse zeigten, dass jene, die mit PRX302 behandelt wurden, nach 90 Tagen eine durchschnittliche Verbesserung des IPSS um 10,8 (+/- 6,0) aufwiesen, während jene, die ein Placebo erhielten, eine Verbesserung um 5,8 (+/- 6,2) verzeichneten eine Differenz von 5,0 Punkten im Vergleich zu den Placebo-Patienten.
Bei dieser Studie wurden keine bedeutenden Sicherheitsprobleme festgestellt. In der Studie wurden keine schweren arzneimittelbezogenen unerwünschte Ereignisse der Stufe 3 oder höher gemeldet. Die PRX302-bezogenen unerwünschten Ereignisse waren gering bis moderat und nur vorübergehend (innerhalb weniger Tage gelöst) und wurden im Harntrakt lokalisiert. Zudem wurde bei keinem Patienten eine sexuelle Disfunktion gemeldet.
Insgesamt 92 Patienten, die anhand ihres IPSS und ihrer Prostatagröße vor dem Beginn der Behandlung randomisiert wurden, nahmen in einem Verhältnis von 2:1 (Behandlung zu Placebo) teil. Nach 90 Tagen belief sich die Anzahl der pro Protokolleffizienz auswertbaren Patienten auf 21 (Durchschnittsalter: 64,5 Jahre) von 31, die vor dem Beginn der Behandlung in der Placebo-Gruppe waren. Bei den 61 Patienten, die der PRX302-Gruppe angehörten, waren es 52 (Durchschnittsalter: 63,7 Jahre). Der Rückgang der auswertbaren Patienten waren auf Verstöße gegen das Protokoll, auf medizinische Eingriffe und auf den Ausstieg von Patienten zurückzuführen und beinhaltete drei Patienten, die zur Behandlung der BPH eine Operation benötigten (allesamt aus der Placebo-Gruppe).
Die detaillierten Ergebnisse dieser Studie werden von Professor Mostafa Elhilali im Rahmen einer Podiumsdiskussion bei der Jahreshauptversammlung der American Urological Association präsentiert werden, welche von 29. Mai bis 3. Juni 2010 in San Francisco stattfinden wird.
Telefonkonferenz
Protox wird heute um 8:45 Uhr (Eastern Time) eine Telefonkonferenz und ein Live-Webcast abhalten, um über diese Ergebnisse zu sprechen. Um die Konferenz per Telefon abzurufen, wählen Sie bitte 647-427-7450 oder 1-888-231-8191. Bitte wählen Sie sich etwa zehn Minuten vor dem Beginn der Telefonkonferenz ein, um Ihre Teilnahme zu gewährleisten. Die Telefonkonferenz wird 30 Tage lang archiviert werden. Um die Telefonkonferenz aufzurufen, wählen Sie bitte 416-849-0833 oder 1-800-642-1687 und geben Sie die Reservierungsnummer 50203392, gefolgt von der Rautetaste ein.
Ein Live-Audio-Webcast der Konferenz wird unter www.protoxtherapeutics.com verfügbar sein. Bitte stellen Sie die Verbindung mindestens zehn Minuten vor dem Beginn der Telefonkonferenz her, um sicherzustellen, dass ausreichend Zeit für einen Software-Download, der eventuell für eine Verbindung zum Webcast erforderlich ist, zu haben. Das Webcast wird 30 Tage lang archiviert werden.
Über PRX302 PRX302 ist das führende Arzneimittel der unternehmenseigenen Technologieplattform PORxin. PORxin-Arzneimittel sind Poren bildende Vorläufersubstanzen, die durch spezifische Proteasen aktiviert werden, welche an der Oberfläche der angepeilten Zellen in erhöhten Mengen produziert werden. PRX302 wird erzeugt, indem das natürlich vorkommende Toxin Proaerolysin so manipuliert wird, dass es von einem prostataspezifischen Antigen (PSA) einem Enzym, das bei Patienten, die an Prostatakrebs und BPH leiden, überproduziert wird aktiviert wird. Nach der Aktivierung sorgen die Löcher in den Zellen dafür, dass deren Inhalt ausfließt, was schließlich zum Absterben der Zelle führt.
Über BPH BPH ist ein häufiger urologischer Zustand, der von schmerzhaften und unangenehmen Symptomen geprägt ist, wie etwa Schwierigkeiten beim Beginn des Harnlassens, Harndrang, Tröpfeln, unvollständiges Entleeren der Blase, mehrmaliges harndrangbedingtes Aufwachen in der Nacht und manchmal auch das Vorkommen von Blut im Urin. Mehr als die Hälfte aller Männer werden bis zu ihrem 60. Lebensjahr Symptome von BPH aufweisen und nicht weniger als 90 % könnten nach dem 80. Lebensjahr an BPH erkranken. Die aktuellen oralen Therapien führen vor allem zu einem Rückgang der Symptome und können eine Reihe von Nebenwirkungen auslösen, einschließlich sexueller Disfunktion und Hypotension. Man schätzt, dass in den sieben größten Märkten der Welt jährlich etwa 10 Millionen Männer mit oralen Therapien behandelt werden und dass diese Produkte in den USA einen Jahresumsatz von etwa $ 4 Milliarden einbringen. Chirurgische Alternativen, einschließlich kleinerer invasiver Eingriffe, können eine sexuelle Disfunktion, Inkontinenz und viele andere ernsthafte Nebenwirkungen verursachen, die in Zusammenhang mit diesem Eingriff stehen. Chirurgische Maßnahmen können einen Krankenhausaufenthalt, eine erhebliche Genesungszeit und eine Katheterisierung für eine gewisse Zeit erfordern. Auf den sieben größten Märkten werden jedes Jahr etwa 600.000 chirurgische Eingriffe durchgeführt.
Über Protox Protox Therapeutics ist ein führendes Unternehmen bei der Weiterentwicklung von neuartigen rezeptororientierten Fusionsproteinen. Zwei neuartige Arzneimittelkandidaten, die von den unternehmenseigenen Plattformen INxin und PORxin stammen, werden zurzeit im Rahmen dreier klinischer Programme entwickelt. Protox führendes Programm, PRX302 (PORxin), lieferte bei seinem placebo-kontrollierten Phase-2b-Versuch, genannt TRIUMPH, zur Behandlung der gutartigen Prostatahyperplasie (BPH oder Prostatavergrößerung) äußerst positive Ergebnisse. Abgesehen von diesen positiven Ergebnissen wiesen die Daten der Phase-2a-Studie nach 12 Monaten eine Nachhaltigkeit auf. PRX302 wird auch zur Behandlung von lokalisiertem Prostatakrebs evaluiert. Ein klinischer Phase-2a-Versuch, bei dem PRX221 (INxin) zur Behandlung von primären Gehirntumoren evaluiert wird, wurde bereits abgeschlossen und das Arzneimittel erlangte die Fast Track Designation und den Orphan Drug Status von der US FDA und der EMEA. Protox arbeitet auch mit den U.S. National Institutes of Health (NIH) an einem Forschungsprogramm, dessen Schwerpunkt auf der Entdeckung der nächsten Generation von ausschließlich menschenorientierten Arzneimitteln.
Bestimmte Aussagen in dieser Pressemitteilung könnten als vorausblickend erachtet werden. Solche Aussagen beinhalten bekannte und unbekannte Risiken, Ungewissheiten und andere Faktoren, die dazu führen könnten, dass sich die tatsächlichen Ergebnisse, Leistungen oder Erfolge erheblich von jenen unterscheiden, die in solchen Aussagen zum Ausdruck gebracht wurden, weshalb diese Aussagen keine Garantie für zukünftige Leistungen oder Ergebnisse darstellen. Sämtliche vorausblickenden Aussagen basieren auf den aktuellen Ansichten von Protox sowie auf den Annahmen infolge von Informationen, die Protox im Moment zur Verfügung stehen, und stehen unter anderem in Zusammenhang mit der erwarteten Finanzleistung, Geschäftsprognosen, Strategien, behördlichen Entwicklungen, der Marktakzeptanz und zukünftigen Verbindlichkeiten. Die Leser sollten sich nicht auf diese vorausblickenden Aussagen verlassen, da diese nur zum Zeitpunkt der Veröffentlichung dieser Pressemitteilung gültig sind. Aufgrund der Risiken und Ungewissheiten, einschließlich der Risiken und Ungewissheiten, die Protox in seinen Veröffentlichungen identifiziert, könnten sich die tatsächlichen Ergebnisse erheblich von den aktuellen Erwartungen unterscheiden. Protox schließt eine Verpflichtung zur Aktualisierung oder Überprüfung seiner vorausblickenden Aussagen weder infolge neuer Informationen noch infolge zukünftiger Ereignisse aus.
Für weitere Informationen James Beesley, Senior Director, Investor Relations, Protox Therapeutics, (604) 484-0975, jbeesley@protoxtherapeutics.com
Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 DW 241, mmoore@equicomgroup.com
Für die Richtigkeit der Übersetzung wird keine Haftung übernommen! Bitte englische Originalmeldung beachten
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ISIN CA74373H1064
AXC0160 2010-01-11/17:19
IRW-PRESS: Protox Therapeutics Inc.: Protox meldet positive Phase-2b-BPH-Ergebnisse
Protox meldet positive Phase-2b-BPH-Ergebnisse
Vancouver, 11. Januar (CNW). Protox Therapeutics Inc. (TSX: PRX News), ein führendes Unternehmen bei der Entwicklung von rezeptororientierten Fusionsproteinen, meldete heute die positiven Ergebnisse seiner doppelblinden, placebo-kontrollierten Phase-2b-Studie von PRX302 (Studienname: TRIUMPH) bei Patienten mit mäßiger bis schwerer gutartiger Prostatavergrößerung (BPH), einem schmerzhaften und unangenehmen urologischen Zustand, von dem weltweit über 50 Millionen Männer betroffen sind. Die Studie erreichte ihren primären klinischen Endpunkt einer statistisch relevanten Verbesserung des International Prostate Symptom Scores (IPSS) bei Patienten, die mit PRX302 behandelt wurden, im Vergleich zu jenen, die Placebos erhielten (p = 0,0238, ANCOVA).
Wir sind mit den Ergebnissen der Studie TRIUMPH sehr zufrieden, sagte Dr. Fahar Merchant, President und Chief Executive Officer von Protox. Wir glauben, dass PRX302 beträchtliches kommerzielles Potenzial aufweist, und freuen uns bereits darauf, diese beeindruckenden Daten mit unseren potenziellen Partnern zu teilen.
Die Zukunft der neuen Arzneimittelentwicklung besteht darin, Moleküle zu erzeugen, die das betroffene Organ oder die betroffene Zelle anpeilen und mit einem so geringen Kollateralschaden wie möglich behandeln. PRX302 ist ein hervorragendes Beispiel für ein solches Designer-Medikament, das Zellen anpeilt, die PSA produzieren, welches der Prostatadrüse vorbehalten ist, sagten Dr. Mostafa M. Elhilali, OC, M. D., Ph. D., Chief Co-Pricipal Investigator, und Stephen Jarislowsky, Chair of Urology der McGill University. Die Studienergebnisse dieses placebo-kontrollierten Versuchs zeigten, dass die Injektion von PRX302 in die Prostata die gewünschten Wirkungen mit nur geringen Nebenwirkungen erzielte, was äußerst viel versprechend ist. Zudem standen die Besserungen der Symptome auch in Zusammenhang mit Verbesserungen des Harnflusses und der Lebensqualität.
Studien-Design: -------------
TRIUMPH war eine doppelblinde, placebo-kontrollierte, multizentrische Phase-2b-Studie bei Patienten mit moderater bis schwerer BPH. Zu den Aufnahmekriterien zählten IPSS-Werte von mindestens 15, eine Harnflussrate (Qmax) von weniger als 12 Millimeter pro Sekunde und ein Prostatavolumen von 30 bis 100 Millilitern. Jeder Patient wurde entweder mit PRX302 (3 Mikrogramm/ml) oder einem Placebo mit einem Volumenäquivalent von 20 % des gesamten Prostatavolumens mittels einer einzelnen ultraschallgesteuerten Injektion in jeden Lappen der Prostata behandelt.
Der primäre klinische Endpunkt der Studie war die Bestimmung der Effizienz von PRX302 wie bei einer Nachbehandlung nach 90 Tagen gezeigt wurde durch eine statistisch relevante Verbesserung des IPSS im Vergleich zu den Placebos. IPSS ist ein validierter primärer klinischer Endpunkt, der verwendet wird, um die Vorteile einer Behandlung bei BPH-Versuchen zu evaluieren. Dieser Index wird auf einer Skala zwischen 0 und 35 angegeben, wobei 0 bedeutet, dass keine Probleme vorliegen, während 35 als Höchstwert von schweren Symptomen angegeben wird.
Studienergebnisse: --------------
Von den 73 pro Protokolleffizienz auswertbaren Patienten erhielten 52 PRX302 und 21 ein Placebo. Die PRX302-Patienten zeigten nach 90 Tagen eine durchschnittliche Verbesserung des IPSS um 9,1 (+/- 5,9) Punkte, während die Placebo-Patienten eine durchschnittliche Verbesserung von 5,8 (+/- 5,4) Punkte zeigten eine statistisch relevante Verbesserung um 3,3 Punkte (p = 0,0238, ANCOVA). Vor dem Beginn der Behandlung belief sich der durchschnittliche IPSS der PRX302- und Placebo-Gruppen auf 23,5 bzw. 22,9 Punkte.
Eine Untergruppenanalyse wurde bei Patienten mit schwerer BPH (IPSS vor der Behandlung > 22, n = 40) durchgeführt. Die Ergebnisse dieser Untergruppenanalyse zeigten, dass jene, die mit PRX302 behandelt wurden, nach 90 Tagen eine durchschnittliche Verbesserung des IPSS um 10,8 (+/- 6,0) aufwiesen, während jene, die ein Placebo erhielten, eine Verbesserung um 5,8 (+/- 6,2) verzeichneten eine Differenz von 5,0 Punkten im Vergleich zu den Placebo-Patienten.
Bei dieser Studie wurden keine bedeutenden Sicherheitsprobleme festgestellt. In der Studie wurden keine schweren arzneimittelbezogenen unerwünschte Ereignisse der Stufe 3 oder höher gemeldet. Die PRX302-bezogenen unerwünschten Ereignisse waren gering bis moderat und nur vorübergehend (innerhalb weniger Tage gelöst) und wurden im Harntrakt lokalisiert. Zudem wurde bei keinem Patienten eine sexuelle Disfunktion gemeldet.
Insgesamt 92 Patienten, die anhand ihres IPSS und ihrer Prostatagröße vor dem Beginn der Behandlung randomisiert wurden, nahmen in einem Verhältnis von 2:1 (Behandlung zu Placebo) teil. Nach 90 Tagen belief sich die Anzahl der pro Protokolleffizienz auswertbaren Patienten auf 21 (Durchschnittsalter: 64,5 Jahre) von 31, die vor dem Beginn der Behandlung in der Placebo-Gruppe waren. Bei den 61 Patienten, die der PRX302-Gruppe angehörten, waren es 52 (Durchschnittsalter: 63,7 Jahre). Der Rückgang der auswertbaren Patienten waren auf Verstöße gegen das Protokoll, auf medizinische Eingriffe und auf den Ausstieg von Patienten zurückzuführen und beinhaltete drei Patienten, die zur Behandlung der BPH eine Operation benötigten (allesamt aus der Placebo-Gruppe).
Die detaillierten Ergebnisse dieser Studie werden von Professor Mostafa Elhilali im Rahmen einer Podiumsdiskussion bei der Jahreshauptversammlung der American Urological Association präsentiert werden, welche von 29. Mai bis 3. Juni 2010 in San Francisco stattfinden wird.
Telefonkonferenz
Protox wird heute um 8:45 Uhr (Eastern Time) eine Telefonkonferenz und ein Live-Webcast abhalten, um über diese Ergebnisse zu sprechen. Um die Konferenz per Telefon abzurufen, wählen Sie bitte 647-427-7450 oder 1-888-231-8191. Bitte wählen Sie sich etwa zehn Minuten vor dem Beginn der Telefonkonferenz ein, um Ihre Teilnahme zu gewährleisten. Die Telefonkonferenz wird 30 Tage lang archiviert werden. Um die Telefonkonferenz aufzurufen, wählen Sie bitte 416-849-0833 oder 1-800-642-1687 und geben Sie die Reservierungsnummer 50203392, gefolgt von der Rautetaste ein.
Ein Live-Audio-Webcast der Konferenz wird unter www.protoxtherapeutics.com verfügbar sein. Bitte stellen Sie die Verbindung mindestens zehn Minuten vor dem Beginn der Telefonkonferenz her, um sicherzustellen, dass ausreichend Zeit für einen Software-Download, der eventuell für eine Verbindung zum Webcast erforderlich ist, zu haben. Das Webcast wird 30 Tage lang archiviert werden.
Über PRX302 PRX302 ist das führende Arzneimittel der unternehmenseigenen Technologieplattform PORxin. PORxin-Arzneimittel sind Poren bildende Vorläufersubstanzen, die durch spezifische Proteasen aktiviert werden, welche an der Oberfläche der angepeilten Zellen in erhöhten Mengen produziert werden. PRX302 wird erzeugt, indem das natürlich vorkommende Toxin Proaerolysin so manipuliert wird, dass es von einem prostataspezifischen Antigen (PSA) einem Enzym, das bei Patienten, die an Prostatakrebs und BPH leiden, überproduziert wird aktiviert wird. Nach der Aktivierung sorgen die Löcher in den Zellen dafür, dass deren Inhalt ausfließt, was schließlich zum Absterben der Zelle führt.
Über BPH BPH ist ein häufiger urologischer Zustand, der von schmerzhaften und unangenehmen Symptomen geprägt ist, wie etwa Schwierigkeiten beim Beginn des Harnlassens, Harndrang, Tröpfeln, unvollständiges Entleeren der Blase, mehrmaliges harndrangbedingtes Aufwachen in der Nacht und manchmal auch das Vorkommen von Blut im Urin. Mehr als die Hälfte aller Männer werden bis zu ihrem 60. Lebensjahr Symptome von BPH aufweisen und nicht weniger als 90 % könnten nach dem 80. Lebensjahr an BPH erkranken. Die aktuellen oralen Therapien führen vor allem zu einem Rückgang der Symptome und können eine Reihe von Nebenwirkungen auslösen, einschließlich sexueller Disfunktion und Hypotension. Man schätzt, dass in den sieben größten Märkten der Welt jährlich etwa 10 Millionen Männer mit oralen Therapien behandelt werden und dass diese Produkte in den USA einen Jahresumsatz von etwa $ 4 Milliarden einbringen. Chirurgische Alternativen, einschließlich kleinerer invasiver Eingriffe, können eine sexuelle Disfunktion, Inkontinenz und viele andere ernsthafte Nebenwirkungen verursachen, die in Zusammenhang mit diesem Eingriff stehen. Chirurgische Maßnahmen können einen Krankenhausaufenthalt, eine erhebliche Genesungszeit und eine Katheterisierung für eine gewisse Zeit erfordern. Auf den sieben größten Märkten werden jedes Jahr etwa 600.000 chirurgische Eingriffe durchgeführt.
Über Protox Protox Therapeutics ist ein führendes Unternehmen bei der Weiterentwicklung von neuartigen rezeptororientierten Fusionsproteinen. Zwei neuartige Arzneimittelkandidaten, die von den unternehmenseigenen Plattformen INxin und PORxin stammen, werden zurzeit im Rahmen dreier klinischer Programme entwickelt. Protox führendes Programm, PRX302 (PORxin), lieferte bei seinem placebo-kontrollierten Phase-2b-Versuch, genannt TRIUMPH, zur Behandlung der gutartigen Prostatahyperplasie (BPH oder Prostatavergrößerung) äußerst positive Ergebnisse. Abgesehen von diesen positiven Ergebnissen wiesen die Daten der Phase-2a-Studie nach 12 Monaten eine Nachhaltigkeit auf. PRX302 wird auch zur Behandlung von lokalisiertem Prostatakrebs evaluiert. Ein klinischer Phase-2a-Versuch, bei dem PRX221 (INxin) zur Behandlung von primären Gehirntumoren evaluiert wird, wurde bereits abgeschlossen und das Arzneimittel erlangte die Fast Track Designation und den Orphan Drug Status von der US FDA und der EMEA. Protox arbeitet auch mit den U.S. National Institutes of Health (NIH) an einem Forschungsprogramm, dessen Schwerpunkt auf der Entdeckung der nächsten Generation von ausschließlich menschenorientierten Arzneimitteln.
Bestimmte Aussagen in dieser Pressemitteilung könnten als vorausblickend erachtet werden. Solche Aussagen beinhalten bekannte und unbekannte Risiken, Ungewissheiten und andere Faktoren, die dazu führen könnten, dass sich die tatsächlichen Ergebnisse, Leistungen oder Erfolge erheblich von jenen unterscheiden, die in solchen Aussagen zum Ausdruck gebracht wurden, weshalb diese Aussagen keine Garantie für zukünftige Leistungen oder Ergebnisse darstellen. Sämtliche vorausblickenden Aussagen basieren auf den aktuellen Ansichten von Protox sowie auf den Annahmen infolge von Informationen, die Protox im Moment zur Verfügung stehen, und stehen unter anderem in Zusammenhang mit der erwarteten Finanzleistung, Geschäftsprognosen, Strategien, behördlichen Entwicklungen, der Marktakzeptanz und zukünftigen Verbindlichkeiten. Die Leser sollten sich nicht auf diese vorausblickenden Aussagen verlassen, da diese nur zum Zeitpunkt der Veröffentlichung dieser Pressemitteilung gültig sind. Aufgrund der Risiken und Ungewissheiten, einschließlich der Risiken und Ungewissheiten, die Protox in seinen Veröffentlichungen identifiziert, könnten sich die tatsächlichen Ergebnisse erheblich von den aktuellen Erwartungen unterscheiden. Protox schließt eine Verpflichtung zur Aktualisierung oder Überprüfung seiner vorausblickenden Aussagen weder infolge neuer Informationen noch infolge zukünftiger Ereignisse aus.
Für weitere Informationen James Beesley, Senior Director, Investor Relations, Protox Therapeutics, (604) 484-0975, jbeesley@protoxtherapeutics.com
Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 DW 241, mmoore@equicomgroup.com
Für die Richtigkeit der Übersetzung wird keine Haftung übernommen! Bitte englische Originalmeldung beachten
Die englische Originalmeldung finden Sie unter: http: //www .irw-press.at/press_html.aspx?messageID=15625
NEWSLETTER REGISTRIERUNG: Aktuelle Pressemeldungen dieses Unternehmens direkt in Ihr Postfach: http://www.irw-press.com/alert_subscription.php?lang= de∈ =CA74373H1064
Mitteilung übermittelt durch IRW-Press.com. Für den Inhalt ist der Aussender verantwortlich. Kostenloser Abdruck mit Quellenangabe erlaubt.
ISIN CA74373H1064
AXC0160 2010-01-11/17:19
bei einem marktpotenzial von 4 mrd dollar könnte das produkt bzw.protox sehr interessant werden ,oder ?
grosse sprünge hat es seit der nachricht noch nicht gemacht ,hmm.
Bei einem marktkapital von ca. 50 mio ist sehr viel luft nach oben ,
ich denke ich werde heute beobachten bei den amis und eventuell kaufen ...
grosse sprünge hat es seit der nachricht noch nicht gemacht ,hmm.
Bei einem marktkapital von ca. 50 mio ist sehr viel luft nach oben ,
ich denke ich werde heute beobachten bei den amis und eventuell kaufen ...
Antwort auf Beitrag Nr.: 38.716.954 von jebbatch am 12.01.10 13:35:55Ich würde an Deiner stelle nicht warten günstiger wird es nicht! Wenn Protox erstmal bekannt gibt das sie einen Cooperationspartner suchen bzw. in übernahme verhandlungen sind dann kennt die Aktie nur noch einen weg! Ich warte noch auf ein UPDATE meines BB bin gespannt was die sagen zum weiteren verlauf! Ich denke der Anstig der letzten Tage ist momentan durch die News eingepreist! Wenn die Anleger jedoch erst mal kapiert haben das Protox jetzt nur noch Geld benötigt für den letzten schritt zur Zulassung des Produktes dann geht hier die Post ab! Positiver konnten die News nicht sein! Protox ist für mich der sicherste Verdoppler für 2010!
Ich glaube nicht das eine Partnerschaft so schnell kommen wird deshalb denke ich wird bald eine KE kommen könnte also sein das der kurs bald wieder sinkt ...Riskantes investment !!!
Management believes that current cash resources should enable the Company to execute its core business plan/priority initiatives and meet its projected cash requirements into Q2, 2010.
Versant
PROTOX THERAPEUTICS
Positive Phase II TRIUMPH data enhance partnership potential for lead drug PRX302
Recommendation: BUY
Symbol/Exchange: PRX/TSX
Sector: Healthcare & Biotechnology
All dollar values in C$ unless otherwise noted.
Current price:
.82
One-year target: $1.75 3
Dividend/dividend yield: NA
Target return: 113%
EVENT
Protox reported positive data from its 92-patient
Phase II benign prostatic hyperplasia (BPH) trial
(TRIUMPH trial) testing lead drug PRX302.
BOTTOM LINE
Highly positive and valuation revised accordingly.
Phase II PRX302/BPH data should be attractive to
partners that we expect to fund future PRX302
clinical testing. Protox’s Q3/09 cash was $4.1M
and operating expenses were $2M so we believe
Protox has sufficient capital to fund operations to
mid-2010, but not to fund future trials.
Maintaining BUY, target increased to $1.75
(was $1.00), based on NPV, 25x EPS, 15x EV-to-
EBITDA (F2016 estimates, 35% discount rate).
FOCUS POINTS
: Excluding drop-outs (comparable number of
placebo and PRX302 patients), PRX302-treated
patients showed average improvement of IPSS
scores from baseline of 9.1 at three months
compared to 5.8 for placebo. Strong statistical
significance with p-value of 0.24; placebo quite
high but similar to other recent BPH trials.
: Performance better in patients with more severe
BPH; in those patients (40 in total), PRX302-
treated patients showed average IPSS
improvement of 10.8 at three months (5.8 for
placebo unchanged). Recall patients in openlabel
Phase I/II trials exhibited IPSS
improvement of up to 11 points so PRX302 data
similar to prior trials.
: One-year follow-up data expected in H2/10, but
we expect cash-contributing partners to show
tangible interest before then; our model assumes
more comprehensive Phase II/III trial could start by H1/11.
Management believes that current cash resources should enable the Company to execute its core business plan/priority initiatives and meet its projected cash requirements into Q2, 2010.
Versant
PROTOX THERAPEUTICS
Positive Phase II TRIUMPH data enhance partnership potential for lead drug PRX302
Recommendation: BUY
Symbol/Exchange: PRX/TSX
Sector: Healthcare & Biotechnology
All dollar values in C$ unless otherwise noted.
Current price:
.82
One-year target: $1.75 3
Dividend/dividend yield: NA
Target return: 113%
EVENT
Protox reported positive data from its 92-patient
Phase II benign prostatic hyperplasia (BPH) trial
(TRIUMPH trial) testing lead drug PRX302.
BOTTOM LINE
Highly positive and valuation revised accordingly.
Phase II PRX302/BPH data should be attractive to
partners that we expect to fund future PRX302
clinical testing. Protox’s Q3/09 cash was $4.1M
and operating expenses were $2M so we believe
Protox has sufficient capital to fund operations to
mid-2010, but not to fund future trials.
Maintaining BUY, target increased to $1.75
(was $1.00), based on NPV, 25x EPS, 15x EV-to-
EBITDA (F2016 estimates, 35% discount rate).
FOCUS POINTS
: Excluding drop-outs (comparable number of
placebo and PRX302 patients), PRX302-treated
patients showed average improvement of IPSS
scores from baseline of 9.1 at three months
compared to 5.8 for placebo. Strong statistical
significance with p-value of 0.24; placebo quite
high but similar to other recent BPH trials.
: Performance better in patients with more severe
BPH; in those patients (40 in total), PRX302-
treated patients showed average IPSS
improvement of 10.8 at three months (5.8 for
placebo unchanged). Recall patients in openlabel
Phase I/II trials exhibited IPSS
improvement of up to 11 points so PRX302 data
similar to prior trials.
: One-year follow-up data expected in H2/10, but
we expect cash-contributing partners to show
tangible interest before then; our model assumes
more comprehensive Phase II/III trial could start by H1/11.
Antwort auf Beitrag Nr.: 38.717.625 von BrauchGeld am 12.01.10 14:49:18Glaubst Du wirklich das sich die Pharma Konzerne so eine gelegenheit durch die Finger gehen lassen? Und selbst wenn eine KE wäre auch O.K denn dann würde man es selbst finanzieren und Produzieren wäre auch super der Kurs würde in jedem fall steigen! Und ob schnell oder langsam auf jeden fall 2010!
Antwort auf Beitrag Nr.: 38.717.625 von BrauchGeld am 12.01.10 14:49:18Ach übrigens durch eine KE wäre man natürlich in einer gestärkten Position bei einer Übernahme!
das waren doch erst ergebnisse der Phase II oder ?
und Phase II ist doch auch nichts endgültiges ,oder sehe ich da was falsch ?
und Phase II ist doch auch nichts endgültiges ,oder sehe ich da was falsch ?
Antwort auf Beitrag Nr.: 38.717.859 von DermitdemBrokertanzt am 12.01.10 15:08:55kannst du meine frage beantworten?
Antwort auf Beitrag Nr.: 38.719.610 von Hoizzo am 12.01.10 17:38:38Protox wird u.a von dem BB der Hebel empfohlen.
Gruss Tokajo
Gruss Tokajo
Antwort auf Beitrag Nr.: 38.719.858 von tokajo am 12.01.10 18:01:08danke, wo sehen die das KZ?
Antwort auf Beitrag Nr.: 38.717.890 von jebbatch am 12.01.10 15:11:28Hi! Ein bisschen spät aber besser als garnicht ja Protox hat jetzt die Phase II hinter sich! Jetzt benötigen sie Geld für Phase III! Dies würden sie durch eine KE oder Partnerschaft bzw. eine übernahme wäre auch möglich bekommen! Und ja der BB der HEBEL hat Protox empfohlen die sehen das KZ bei 1,80$ wenn eine übernahme ansteht wird es wohl noch wesentlich weiter hoch gehen! Bis dann!
Antwort auf Beitrag Nr.: 38.717.890 von jebbatch am 12.01.10 15:11:28Das Ergebnis der Phase II ist entgültig und sehr Positiv!
Denke auch, dass der momentane Kurs ein Witz ist, hier kanns explosiv nach oben gehen.
nicht schön diese Kurse ich überlege nachzukaufen
bin mir der Lage nicht ganz sicher es könnte auch noch unter 0,50
Eier gehen wie schätzt Ihr das ein ???????
das Kursziel ????? ob das so kommt ??????
bin mir der Lage nicht ganz sicher es könnte auch noch unter 0,50
Eier gehen wie schätzt Ihr das ein ???????
das Kursziel ????? ob das so kommt ??????
Antwort auf Beitrag Nr.: 38.723.048 von DermitdemBrokertanzt am 13.01.10 00:45:27moin moin ,
was meinst du mit :Und ja der BB der HEBEL hat Protox empfohlen,wer oder was ist das ,für ne kurze info wäre ich sehr dankbar
sorry bin noch nicht so der experte
was meinst du mit :Und ja der BB der HEBEL hat Protox empfohlen,wer oder was ist das ,für ne kurze info wäre ich sehr dankbar
sorry bin noch nicht so der experte
Antwort auf Beitrag Nr.: 38.726.222 von jebbatch am 13.01.10 13:32:52BB = Börsenbrief
Antwort auf Beitrag Nr.: 38.725.906 von Aktienversteher am 13.01.10 13:00:21Könnte heute schon passieren mit unter 0,50 EUR!
0,74 CAD = 0,494 EUR
Die Aktie kennt nach der veröffentlichung des Ergebnisses der Phase II nur noch den Rückwärtsgang!
0,74 CAD = 0,494 EUR
Die Aktie kennt nach der veröffentlichung des Ergebnisses der Phase II nur noch den Rückwärtsgang!
Antwort auf Beitrag Nr.: 38.732.721 von D2Chris am 14.01.10 08:46:24glaubst du auch oder hmmmmmmm wo hast du deine Infos her BB ????
würdest du jetzt einsteigen ??????
würdest du jetzt einsteigen ??????
heut wird ein grüner Protox Tag, ich fühle das!
Antwort auf Beitrag Nr.: 38.734.311 von Hoizzo am 14.01.10 11:37:39Hallo
Ich hoffe es geht aufwärts hab zu teuer eingekauft wenns nochmal unter 0,50 Euro geht schnapp ich nochmal zu
viel Erfolg
Ich hoffe es geht aufwärts hab zu teuer eingekauft wenns nochmal unter 0,50 Euro geht schnapp ich nochmal zu
viel Erfolg
Antwort auf Beitrag Nr.: 38.734.883 von Aktienversteher am 14.01.10 12:38:28hab gestern nochmal nachgelegt, denke hier ist ne Menge Potential, Studie ist gut, dass wird auch der Markt erkennen müssen!
Antwort auf Beitrag Nr.: 38.733.847 von Aktienversteher am 14.01.10 10:47:28Was glaube ich auch? Einstieg ist auf jeden Fall im Moment für mein dafürhalten recht günstig möglich!
Antwort auf Beitrag Nr.: 38.734.311 von Hoizzo am 14.01.10 11:37:39 schade war kein grüner Tag wann kommen den die Tage wieder ????
Die Aktie hat jetzt 4 Tage in folge im Roten Berreich geschlossen! Schon merkwürdig! "Sell on good News" soweit so gut....aber 4 Tage lang???
Hallo! Ist jemand darüber informiert was der Börsenbrief der Hebel zuletzt über Protox geschrieben hat? Danke!
Protox sollte bald drehen bei 0,45 wäre ein Kauf sehr sinnvoll
glaube ich
glaube ich
Antwort auf Beitrag Nr.: 38.754.619 von Aktienversteher am 18.01.10 08:00:58Achtung liebe Protox Freunde!!! Gestern wurde auf XETRA eine Order 1000Stück zu 0,69€ ausgeführt, also über 30% über Pari!!!!
Da wird also alles gekauft was auf dem Markt in Deutschland angeboten wird! Ich bin mir sicher das wir in den Nächsten Tagen wieder News bekommen werden! Ich denke das Protox nicht erst jetzt nach einem Partner oder aufkäufer sucht sondern das sie bereits in der Vergangenheit wärent der Testphas II schon Aktiv nach einem Partner gesucht haben bzw. verhandlungen geführt haben ist ja auch sinnig wenn man ein Projekt schnell und ohne stillstand vortführen will! Bin gespannt was hier die nächsten Tage passiert! Bis bald!
Da wird also alles gekauft was auf dem Markt in Deutschland angeboten wird! Ich bin mir sicher das wir in den Nächsten Tagen wieder News bekommen werden! Ich denke das Protox nicht erst jetzt nach einem Partner oder aufkäufer sucht sondern das sie bereits in der Vergangenheit wärent der Testphas II schon Aktiv nach einem Partner gesucht haben bzw. verhandlungen geführt haben ist ja auch sinnig wenn man ein Projekt schnell und ohne stillstand vortführen will! Bin gespannt was hier die nächsten Tage passiert! Bis bald!
Antwort auf Beitrag Nr.: 38.769.619 von DermitdemBrokertanzt am 20.01.10 04:57:21meinst nicht dass das auf xetra irgendein lemming war, der
ohne limit gekaut hat ?
ohne limit gekaut hat ?
Antwort auf Beitrag Nr.: 38.771.377 von Sharedealer am 20.01.10 11:14:44Hi! Habe ich auch kurz drüber nachgedacht aber warum sollte es jemand gerade jetzt nach dem sich wieder alles beruigt hat eine sollche order eingeben! Bei diesem wirklich hoch spekulativen investment überlegt man sich wirklich genau was man da macht das Volumen ist in D sehr gering und in USA sind auch nur wenige bereit ihre Aktien zum Momentanen kurs abzugeben! Nein ich glaube hier hat jemand bewust gekauft, wenn eine Partnerschaft mit einem Großen Unternehmen bekannt gegeben wird ist die Aktie schnell bei 2€ sehr schnell! Und langfristig sehe ich Protox bei
10 bis 18 €!! Also bis bald!
10 bis 18 €!! Also bis bald!
Antwort auf Beitrag Nr.: 38.771.957 von DermitdemBrokertanzt am 20.01.10 12:05:38Uiii, wie kommst Du auf 10 - 18 Euro Kursziel
1,50 bis 2 euro sind schnell mal drin....
heute könnte ein guter Kauftag sein wenns noch etwas
runtergeht schauma a mal
runtergeht schauma a mal
kommt schon runter hmmmmmm soll man jetzt
oder später
wie weit kanns noch runter gehen was glaubt ihr ???
oder später
wie weit kanns noch runter gehen was glaubt ihr ???
Antwort auf Beitrag Nr.: 38.779.442 von Aktienschreiner am 21.01.10 09:45:090,45 Euro vielleicht, aber ohne Gewähr
Antwort auf Beitrag Nr.: 38.779.758 von Sharedealer am 21.01.10 10:24:30 irgendwie würds mich schon jucken
hast du aktuelle Infos über Protox ????????
werd mal ein Kauflimit 0,44 eingeben denke da macht man nichts
falsch hmmmmmmmmmmmm
hast du aktuelle Infos über Protox ????????
werd mal ein Kauflimit 0,44 eingeben denke da macht man nichts
falsch hmmmmmmmmmmmm
Antwort auf Beitrag Nr.: 38.779.942 von Aktienschreiner am 21.01.10 10:46:12Habe auch keine neue Info. Aber eine news über eine Kooperation
oder Beteiligung einer grösseren Pharmafirma würde dem Kursverlauf
wohl gut tun
oder Beteiligung einer grösseren Pharmafirma würde dem Kursverlauf
wohl gut tun
so, denke die talsohle haben wir gesehen, jetzt gehts aufwärts!
Antwort auf Beitrag Nr.: 38.798.442 von Hoizzo am 23.01.10 19:24:11Hallo! Hier mal zum verständnis wie weit Protox sind bzw. in Welcher Phase sie sich befinden und was dies bedeutet!
ZUR ERINNERUNG PROTOX BEFINDET SICH IN DER PHASE II; SIE HABEN DIE PHASE II ERFOLGREICH ABGESCHLOSSEN!
Erinnerung: Bevor ein Medikament
überhaupt eine Zulassung erhält,
muss der Wirkstoff einer mehrphasigen,
Jahre dauernden Prüfung unterzogen
werden. In Phase I, einer
vorklinischen Verträglichkeitsprüfung
mit 10 bis 100 gesunden Freiwilligen,
wird die Sicherheit des
pharmakokinetischen Stoffwechsel-,
Bioverteilungs- und Aussonderungsverhaltens
des Wirkstoffes
bestimmt – Ausfallrisiko 90%. In
Phase II erfolgt die klinische Wirksamkeitsprüfung
bei 100 bis 500 Patienten,
um die optimale Dosierung
bestimmen zu können und Hinweise
auf die Wirksamkeit der Indikation
zu bekommen – Ausfallrisiko 60%
bis 80%. In Phase III werden die
Ergebnisse der Phasen I und II an
einer großen Gruppe von Patienten
überprüft, um die Wirksamkeit und
Sicherheit des Wirkstoffes, auch in
Interaktion mit anderen Medikamenten,
zuverlässig bestimmen zu
können – Ausfallrisiko bis zu 20%.
Je weiter, je besser
Erst nach einem erfolgreichen
Durchlaufen dieser 3 Phasen kann
die Zulassung bei der zuständigen
Aufsichtsbehörde beantragt werden.
ZUR ERINNERUNG PROTOX BEFINDET SICH IN DER PHASE II; SIE HABEN DIE PHASE II ERFOLGREICH ABGESCHLOSSEN!
Erinnerung: Bevor ein Medikament
überhaupt eine Zulassung erhält,
muss der Wirkstoff einer mehrphasigen,
Jahre dauernden Prüfung unterzogen
werden. In Phase I, einer
vorklinischen Verträglichkeitsprüfung
mit 10 bis 100 gesunden Freiwilligen,
wird die Sicherheit des
pharmakokinetischen Stoffwechsel-,
Bioverteilungs- und Aussonderungsverhaltens
des Wirkstoffes
bestimmt – Ausfallrisiko 90%. In
Phase II erfolgt die klinische Wirksamkeitsprüfung
bei 100 bis 500 Patienten,
um die optimale Dosierung
bestimmen zu können und Hinweise
auf die Wirksamkeit der Indikation
zu bekommen – Ausfallrisiko 60%
bis 80%. In Phase III werden die
Ergebnisse der Phasen I und II an
einer großen Gruppe von Patienten
überprüft, um die Wirksamkeit und
Sicherheit des Wirkstoffes, auch in
Interaktion mit anderen Medikamenten,
zuverlässig bestimmen zu
können – Ausfallrisiko bis zu 20%.
Je weiter, je besser
Erst nach einem erfolgreichen
Durchlaufen dieser 3 Phasen kann
die Zulassung bei der zuständigen
Aufsichtsbehörde beantragt werden.
heute glaube ich ist ein guter Kauftag es könnte der Boden sein heute
wenns gut läuft müßten 0,60 Euro schnell erreicht sein
schauma a mal allen Investierten viel Glück
Antwort auf Beitrag Nr.: 38.805.148 von Aktienschreiner am 25.01.10 14:32:19Starkes Volumen heute!! Wenn es gut läuft dann kommen sehr schnell News dann kann man diese Aktie wirklich für zwei Jahre liegen lassen und viel Geld einsammeln! Kurzfristig ist hier natürlich auch viel drinn!
Antwort auf Beitrag Nr.: 38.817.986 von DermitdemBrokertanzt am 26.01.10 22:11:31wenn die phase 3 erfolgreich ist, dann knallts gewaltig!
Antwort auf Beitrag Nr.: 38.817.986 von DermitdemBrokertanzt am 26.01.10 22:11:31was macht dich so sicher hast du Infos die das deuten ????
ich hab mir welche gekauft und hoffe das du Recht hast
momentan sind die Anleger noch etwas verunsichert aber wenn
Protox auf 0,50 Euro zusteuert denke ich sind schnell 0,60 Euro
erreicht welche Kursziele existieren ist mir nicht bekannt weist du mehr ???????? freu mich auf eine Antwort
Gruß vom AS
ich hab mir welche gekauft und hoffe das du Recht hast
momentan sind die Anleger noch etwas verunsichert aber wenn
Protox auf 0,50 Euro zusteuert denke ich sind schnell 0,60 Euro
erreicht welche Kursziele existieren ist mir nicht bekannt weist du mehr ???????? freu mich auf eine Antwort
Gruß vom AS
Antwort auf Beitrag Nr.: 38.819.564 von Hoizzo am 27.01.10 09:26:22 wann erfolgt Phase 3 ??????
je früher um so besser was weißt du ??????
je früher um so besser was weißt du ??????
Antwort auf Beitrag Nr.: 38.821.571 von Aktienschreiner am 27.01.10 12:36:51naja, nachdem Phase 2 abgeschlossen ist folgt logischerweise Phase 3.
Antwort auf Beitrag Nr.: 38.822.236 von Hoizzo am 27.01.10 13:52:00ja ja is schon logisch ich meinte in welchem Zeitraum 1 Jahr
2 Jahre ich kenn mich da nicht aus
2 Jahre ich kenn mich da nicht aus
Protox sucht soweit ich über meinen Börsenbrief informiert bin einen Partner um Phase III zu finanzieren bzw. durchzuführen! Wenn diesbezüglich News veröffentlicht werden dann schlät hier ne Bombe ein! Hier geht es um einen Mrd. Geschäft sonder gleichen! Hier ist nur Gedult gefragt! Dieser Wert kann sich schnell verzehnfachen!!
Antwort auf Beitrag Nr.: 38.822.376 von Aktienschreiner am 27.01.10 14:07:36lt. meinen Infos wird schon mit potentiellen Partnern für die weitere Erforschung verhandelt, denke auch, dass sich das dann sehr schön auf einen weiteren Kursschub auswirkt, sobald das klar gemacht wurde. Zeitrahmen kann ich dir auch keinen nennen, leider.
Aber Fakt ist, Protox kann zur echten Granate werden, wie schnell es gehen kann, hat man ja vor kurzem gesehen!
Also Shares festhalten.
Aber Fakt ist, Protox kann zur echten Granate werden, wie schnell es gehen kann, hat man ja vor kurzem gesehen!
Also Shares festhalten.
Kann mir mal bitte jemand eine Hilfestellung geben wie ich
die Shares in Kanada ordern kann. Bin bei Nordnet und kann in Kanada kaufen. Allerdings nimmt die Maske PRX nicht an.
die Shares in Kanada ordern kann. Bin bei Nordnet und kann in Kanada kaufen. Allerdings nimmt die Maske PRX nicht an.
Antwort auf Beitrag Nr.: 38.842.535 von b@rca am 29.01.10 14:51:34Hi, wie es bei Nordnet funktioniert weiss ich nicht, aber bei Cortalconsors und comdirect musst du die deutsche WKN und Börsenplatz Kanada auswählen
Gruss Tokajo
Gruss Tokajo
Antwort auf Beitrag Nr.: 38.843.092 von tokajo am 29.01.10 15:36:44Besten dank. Habe mittlerweile telefonisch dort geordert, da Protox noch nicht in ihrem System ist. Die wollen das ändern und dann kann ich ja darauf ev. zurückgreifen. Nochmal besten dank.
Ich sehe das alles erstmal sehr positiv.
Die haben hier eine beeindruckende Phase 2 Studie und das lässt reichlich spekulationen offen für die Phase 3.
Warum also sollte das hier nicht klappen mit einem "grossen" potienzellen Partner? Andere Biotechs haben ja auch kooperationen, und die haben teilweise noch nicht mal so einen "Zeitzünder" in der Pipeline.
An der Börse wird Phantasie und die Zukunft gehandelt. Ersteres ist ja hier wohl reichlich vorhanden.
Ich denke mal das die Gewinnmitnahmen vorbei sein sollten.
Jetzt sollte das nächste Ziel sein einen potenziellen Partner zu präsentieren, und das sollte den Kurs wieder Auftrieb geben.
Hat jemand von euch ev. einen RT Chart von Kanada und kann den hier mal reinstellen ?
Die haben hier eine beeindruckende Phase 2 Studie und das lässt reichlich spekulationen offen für die Phase 3.
Warum also sollte das hier nicht klappen mit einem "grossen" potienzellen Partner? Andere Biotechs haben ja auch kooperationen, und die haben teilweise noch nicht mal so einen "Zeitzünder" in der Pipeline.
An der Börse wird Phantasie und die Zukunft gehandelt. Ersteres ist ja hier wohl reichlich vorhanden.
Ich denke mal das die Gewinnmitnahmen vorbei sein sollten.
Jetzt sollte das nächste Ziel sein einen potenziellen Partner zu präsentieren, und das sollte den Kurs wieder Auftrieb geben.
Hat jemand von euch ev. einen RT Chart von Kanada und kann den hier mal reinstellen ?
Ich glaube das ist die Ruhe vorm Sturm
nächste Woche könnte es sehr schnell nach oben gehen der Boden
ist erreicht jetzt ist das Ziel die Decke allen wünsche ich fette Gewinne
nächste Woche könnte es sehr schnell nach oben gehen der Boden
ist erreicht jetzt ist das Ziel die Decke allen wünsche ich fette Gewinne
Antwort auf Beitrag Nr.: 38.849.862 von b@rca am 31.01.10 05:30:43Ich wollte mir mal die Daten etwas genauer anschauen ,stellte aber fest das die noch gar nicht komplett sind .
Das bedeutet es ist immer noch eine wackelige Angelegenheit was die PIIb-Daten angeht und da PRX auch noch das geld ausgeht bleibt diese Aktie sehr Riskant .
Detailed results from this study will be presented by Professor Mostafa Elhilali during a podium session at the Annual Meeting of the American Urological Association to be held in San Francisco, May 29 - June 3, 2010.
Das bedeutet es ist immer noch eine wackelige Angelegenheit was die PIIb-Daten angeht und da PRX auch noch das geld ausgeht bleibt diese Aktie sehr Riskant .
Detailed results from this study will be presented by Professor Mostafa Elhilali during a podium session at the Annual Meeting of the American Urological Association to be held in San Francisco, May 29 - June 3, 2010.
in der testphase ists immer wacklig und unsicher, daher warten ja auch große kursschwankungen auf die anleger.
dennoch ist die phase 2 ein erfolg.
dennoch ist die phase 2 ein erfolg.
Antwort auf Beitrag Nr.: 38.853.639 von Hoizzo am 01.02.10 11:04:33dennoch ist die phase 2 ein erfolg.
Wie kannst du behaupten das PII ein Erfolg ist wenn doch nur halbe Daten veröffentlicht worden sind ?????
Hier kann immer noch alles den Bach runtergehen was ich euch nicht wünsche ...
Wie kannst du behaupten das PII ein Erfolg ist wenn doch nur halbe Daten veröffentlicht worden sind ?????
Hier kann immer noch alles den Bach runtergehen was ich euch nicht wünsche ...
Antwort auf Beitrag Nr.: 38.853.697 von BrauchGeld am 01.02.10 11:13:59wenns den testpersonen besser geht seh ich das als erfolg an, wenn auch noch kein endgültiges ergebnis feststeht.
risiko gibts natürlich nach wie vor. noch kann einiges passieren.
risiko gibts natürlich nach wie vor. noch kann einiges passieren.
Antwort auf Beitrag Nr.: 38.850.414 von BrauchGeld am 31.01.10 12:20:45Sicher waren es erst Ergebnisse aus der Phase 2b Studie, wo es in San Francisco halt ausfürlichere Resultate dazu geben wird. Bleibe aber erstmal zuversichtlich. Egal ob Phase 2b komplett oder nur zur Hälfte, zur Zeit liest sich das Ganze erstmal sehr gut.Wir werden sehen wie es weiter geht. Bis Mitte 2010 haben sie Zeit Geld/Partner aufzutreiben. Bin auch da sehr zuversichtlich das dies gelingen sollte. Mit diesen bisher guten Ergebnissen sollte es sich gut "hausieren" lassen. Wie dann Phase 3 läuft werden wie dann auch sehen. Sei es wie es will, der Markt mit der Prostata dürfte ein Gewaltiger sein und wird es auch werden, wenn die Zulassung dann auch gelingt. Aber bis dahin ist es noch ein weiter Weg , und es gilt frühzeitig dabei zu sein.
Na bitte. Es kommt Kohle für Phase 3 rein.
VANCOUVER, Feb. 4 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins for the treatment of
prostate disease and other forms of cancer, today announced it intends to
raise gross proceeds of up to CDN$8,000,000 through a brokered private
placement of units ("Units") at a price of CDN$0.55 per Unit. Each Unit is
comprised of one common share of Protox and one-half of a common share
purchase warrant. Each whole warrant will entitle the holder to purchase one
common share of Protox at a price of CDN$0.70 for a two year period from
closing date subject to an acceleration of the expiry date in certain
circumstances.
The Company has retained Dundee Capital Markets to act as lead placement
agent and Canaccord Financial Inc. to act as co-lead placement agent, along
with Versant Partners as co-agent.
The brokered private placement is subject to all necessary regulatory and
stock exchange approvals. Protox intends to use the net proceeds principally
to finance its development and clinical activities. Closing is expected to be
on or about February 26, 2010.
The securities being issued in the private placement are all subject to a
four-month hold period in accordance with applicable Canadian securities laws.
The securities have not been registered under the U.S. Securities Act of 1933,
as amended, or any state securities laws and, until so registered, may not be
offered or sold in the United States or any state or to, or for the account
of, U.S. persons absent registration or an applicable exemption from
registration requirements. This release does not constitute an offer for sale
of securities in the United States.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), has announced positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these
positive results, data from the Phase 2a study demonstrated durability at 12
months. PRX302 is also being evaluated for the treatment of localized prostate
cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment
of primary brain cancer has been completed and the drug has received Fast
Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is
also collaborating with the U.S. National Institutes of Health (NIH) on a
research program focused on the discovery of next generation fully human
targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
VANCOUVER, Feb. 4 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins for the treatment of
prostate disease and other forms of cancer, today announced it intends to
raise gross proceeds of up to CDN$8,000,000 through a brokered private
placement of units ("Units") at a price of CDN$0.55 per Unit. Each Unit is
comprised of one common share of Protox and one-half of a common share
purchase warrant. Each whole warrant will entitle the holder to purchase one
common share of Protox at a price of CDN$0.70 for a two year period from
closing date subject to an acceleration of the expiry date in certain
circumstances.
The Company has retained Dundee Capital Markets to act as lead placement
agent and Canaccord Financial Inc. to act as co-lead placement agent, along
with Versant Partners as co-agent.
The brokered private placement is subject to all necessary regulatory and
stock exchange approvals. Protox intends to use the net proceeds principally
to finance its development and clinical activities. Closing is expected to be
on or about February 26, 2010.
The securities being issued in the private placement are all subject to a
four-month hold period in accordance with applicable Canadian securities laws.
The securities have not been registered under the U.S. Securities Act of 1933,
as amended, or any state securities laws and, until so registered, may not be
offered or sold in the United States or any state or to, or for the account
of, U.S. persons absent registration or an applicable exemption from
registration requirements. This release does not constitute an offer for sale
of securities in the United States.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), has announced positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these
positive results, data from the Phase 2a study demonstrated durability at 12
months. PRX302 is also being evaluated for the treatment of localized prostate
cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment
of primary brain cancer has been completed and the drug has received Fast
Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is
also collaborating with the U.S. National Institutes of Health (NIH) on a
research program focused on the discovery of next generation fully human
targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Antwort auf Beitrag Nr.: 38.889.349 von b@rca am 05.02.10 13:58:45http://www.cnxmarketlink.com/en/releases/archive/February201…
Antwort auf Beitrag Nr.: 38.889.362 von b@rca am 05.02.10 13:59:47Jetzt wird es nicht mehr lange dauern und wir bekommen News, den bei einem derart großen Volumen Umsatz Verhältnis von heute an den Deutschen und US Börsen gleizeitig wird sich auf jeden fall in den Nachsten Tagen oder in der nächsten Woche etwas ergeben! Steigendes Volumen ist immer ein Indikator habe ich zuletzt bei einem meiner Werte beobachtet und vorrausgesagt! Bis bald! Ach ja für viele ist der Umsatzt von heute nicht viel für diesen Wert auf die vergangenheit betrachtet jedoch viel!
PROTOX THERAPEUTICS INC.
PROTOX THERAPEUTICS INC.
Attention Business Editors
Protox to present at the Third International Symposium on Focal Therapy and Imaging of Prostate and Kidney Cancer
VANCOUVER, Feb. 24 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins for the treatment of
prostate disease and other forms of cancer, today announced that Dr. Samuel
Denmeade, Chief Scientific Officer at Protox, will be a speaker at the Third
International Symposium on Focal Therapy and Imaging of Prostate and Kidney
Cancer.
The symposium is being held at the Fairmont Hotel in Washington, D.C.
from February 24th to 27th and will feature international experts who will
provide insight into image-guided diagnosis and minimally invasive focal,
gland-preserving treatment of prostate and kidney cancer. Dr Denmeade's talk
entitled "PRX302: A Targeted PSA-activated Pore Forming Toxin for the
Treatment of Benign and Malignant Diseases of the Prostate" will be presented
on Friday, February 26, 2010.
"Prostate cancer affects 500,000 men around the world every year.
Incidence is increasing due to the fact that lower risk cancers are detected
at an earlier stage in younger men, many of whom undergo treatment which may
be of unclear benefit in terms of life expectancy and may subject them to
considerable morbidity," said Dr. Fahar Merchant, President and CEO of Protox.
"Current approaches such as surgery and radiotherapy carry significant side
effects such as incontinence, impotence and rectal problems because they treat
the whole prostate and consequently damage surrounding structures in most men.
Protox's PSA-activated PRX302 uses a pinpointed new approach called focal
therapy, which can be effective in targeting only the cancerous portion of the
prostate, avoiding collateral damage to tissues surrounding the prostate
gland."
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), has announced positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these
positive results, data from the Phase 2a study demonstrated durability at 12
months. PRX302 is also being evaluated for the treatment of localized prostate
cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment
of primary brain cancer has been completed and the drug has received Fast
Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is
also collaborating with the U.S. National Institutes of Health (NIH) on a
research program focused on the discovery of next generation fully human
targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
PROTOX THERAPEUTICS INC.
Attention Business Editors
Protox to present at the Third International Symposium on Focal Therapy and Imaging of Prostate and Kidney Cancer
VANCOUVER, Feb. 24 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins for the treatment of
prostate disease and other forms of cancer, today announced that Dr. Samuel
Denmeade, Chief Scientific Officer at Protox, will be a speaker at the Third
International Symposium on Focal Therapy and Imaging of Prostate and Kidney
Cancer.
The symposium is being held at the Fairmont Hotel in Washington, D.C.
from February 24th to 27th and will feature international experts who will
provide insight into image-guided diagnosis and minimally invasive focal,
gland-preserving treatment of prostate and kidney cancer. Dr Denmeade's talk
entitled "PRX302: A Targeted PSA-activated Pore Forming Toxin for the
Treatment of Benign and Malignant Diseases of the Prostate" will be presented
on Friday, February 26, 2010.
"Prostate cancer affects 500,000 men around the world every year.
Incidence is increasing due to the fact that lower risk cancers are detected
at an earlier stage in younger men, many of whom undergo treatment which may
be of unclear benefit in terms of life expectancy and may subject them to
considerable morbidity," said Dr. Fahar Merchant, President and CEO of Protox.
"Current approaches such as surgery and radiotherapy carry significant side
effects such as incontinence, impotence and rectal problems because they treat
the whole prostate and consequently damage surrounding structures in most men.
Protox's PSA-activated PRX302 uses a pinpointed new approach called focal
therapy, which can be effective in targeting only the cancerous portion of the
prostate, avoiding collateral damage to tissues surrounding the prostate
gland."
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), has announced positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these
positive results, data from the Phase 2a study demonstrated durability at 12
months. PRX302 is also being evaluated for the treatment of localized prostate
cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment
of primary brain cancer has been completed and the drug has received Fast
Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is
also collaborating with the U.S. National Institutes of Health (NIH) on a
research program focused on the discovery of next generation fully human
targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
Antwort auf Beitrag Nr.: 38.996.451 von DermitdemBrokertanzt am 23.02.10 18:53:26... wie kommst du denn auf den schmalen grat?
hmmmm, komisch das nur die letzte zeit immer wieder verkauft wird.
hmmmm, komisch das nur die letzte zeit immer wieder verkauft wird.
Antwort auf Beitrag Nr.: 39.005.798 von P3_2011 am 24.02.10 20:26:59Na ja wie gesagt ich habe News erwartet und heute hat es welche gegeben! Die Kurse sind für mich ganz klare Kaufkurse ich sammle mit abstauberlimit ein sobald Phase III durch ist sehe ich genau wie bei Mannkind kurse um die 6Euro! Bis bald!
Antwort auf Beitrag Nr.: 39.007.275 von DermitdemBrokertanzt am 25.02.10 01:20:54"sobald Phase III durch ist..."
Und wann ist damit frühestens zu rechnen?
Und wann ist damit frühestens zu rechnen?
Antwort auf Beitrag Nr.: 39.011.728 von Milesint am 25.02.10 15:26:22Wenn Du alles verfolgt hast dann weißt Du das anfang des Jahres eine KE durchgeführt wurde das Geld ist also vorhanden und Phase III wird natürlich zeitnah durchgeführt so das ich davon ausgehe das wir spähtestens ende des Jahres mit ergebnissen rechnen können!
Hier NEWS bezüglicher KE von heute!!!!!!!!!!!!!!!!!
News Releases
Printer friendly version
Protox Revises Terms Of Private Placement
Vancouver, British Columbia, February 25, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins for the treatment of prostate disease and other forms of cancer, today announced that it has revised the terms of the private placement financing announced on February 4, 2010. The Company intends to raise gross proceeds of up to approximately CDN$6,500,000 through a brokered private placement of units (“Units”) at a price of CDN$0.45 per Unit. Each Unit is comprised of one common share of Protox and one-half of a common share purchase warrant. Each whole warrant will entitle the holder to purchase one common share of Protox at a price of CDN$0.65 for a five year period from closing date subject to an acceleration of the expiry date in certain circumstances.
The Company has retained Dundee Capital Markets as lead placement agent and Canaccord Financial Inc. as co-lead placement agent, along with Versant Partners as co-agent.
The brokered private placement is subject to all necessary regulatory and stock exchange approvals. Protox intends to use the net proceeds principally to finance its development and clinical activities. Closing is expected to be in mid-March 2010.
The securities being issued in the private placement are all subject to a four-month hold period in accordance with applicable Canadian securities laws. The securities have not been registered under the U.S. Securities Act of 1933, as amended, or any state securities laws and, until so registered, may not be offered or sold in the United States or any state or to, or for the account of, U.S. persons absent registration or an applicable exemption from registration requirements. This release does not constitute an offer for sale of securities in the United States.
S
About Protox
News Releases
Printer friendly version
Protox Revises Terms Of Private Placement
Vancouver, British Columbia, February 25, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins for the treatment of prostate disease and other forms of cancer, today announced that it has revised the terms of the private placement financing announced on February 4, 2010. The Company intends to raise gross proceeds of up to approximately CDN$6,500,000 through a brokered private placement of units (“Units”) at a price of CDN$0.45 per Unit. Each Unit is comprised of one common share of Protox and one-half of a common share purchase warrant. Each whole warrant will entitle the holder to purchase one common share of Protox at a price of CDN$0.65 for a five year period from closing date subject to an acceleration of the expiry date in certain circumstances.
The Company has retained Dundee Capital Markets as lead placement agent and Canaccord Financial Inc. as co-lead placement agent, along with Versant Partners as co-agent.
The brokered private placement is subject to all necessary regulatory and stock exchange approvals. Protox intends to use the net proceeds principally to finance its development and clinical activities. Closing is expected to be in mid-March 2010.
The securities being issued in the private placement are all subject to a four-month hold period in accordance with applicable Canadian securities laws. The securities have not been registered under the U.S. Securities Act of 1933, as amended, or any state securities laws and, until so registered, may not be offered or sold in the United States or any state or to, or for the account of, U.S. persons absent registration or an applicable exemption from registration requirements. This release does not constitute an offer for sale of securities in the United States.
S
About Protox
auf zu neuen höhen!!
Antwort auf Beitrag Nr.: 39.357.637 von Hoizzo am 18.04.10 17:28:45
Schön wär's!
Doch nichts Genaues weiß man nicht!
Schön wär's!
Doch nichts Genaues weiß man nicht!
Antwort auf Beitrag Nr.: 39.396.233 von Milesint am 24.04.10 17:05:55Protox Signs $75 Million License Agreement with Kissei for Commercialization of Prx302 in Japan for BPH and Prostate Disease
Vancouver, British Columbia, April 29, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has entered into an exclusive US $75 million license agreement with Kissei Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4547) for the development and commercialization of its PSA-activated pro-drug, PRX302, in Japan for BPH, prostate cancer and other diseases of the prostate. Protox retains exclusive rights to PRX302 in all other territories.
Under the terms of the agreement, Protox will receive an upfront payment of US $3 million and is eligible to receive a near term milestone payment of US $5 million, as well as progressive payments of up to US $67 million upon achievement of specific development, regulatory and commercial milestones. In addition Protox will receive a double-digit royalty fee plus a drug supply fee based on product sales. Kissei will be responsible for all costs associated with further development, regulatory approvals, commercialization and marketing of PRX302 in Japan.
“This transaction represents strong validation of PRX302 given Kissei’s established leadership in the Japanese urology market and proven track record in drug development,” said Dr. Fahar Merchant, President and CEO of Protox. “We are delighted to execute this license agreement and we are convinced that in Kissei we have found a partner who is fully committed to bring PRX302 to the Japanese market in a timely manner. For Protox, this significant milestone provides a non-dilutive infusion of cash while preserving our flexibility for developing and marketing PRX302 in the rest of the world.”
Kissei obtained Japanese regulatory approval of URIEFâ (silodosin), an alpha-blocker for dysuria associated with BPH in 2006. Kissei rapidly established robust growth of URIEFâ, which is now the second largest selling alpha blocker in Japan. Kissei also has another urology drug in late stage clinical development.
"This agreement reinforces our product pipeline and enhances our presence in the urological field in Japan,” said Mr. Mutsuo Kanzawa, President and CEO of Kissei. “We look forward to contributing to the well being of BPH patients by increasing their treatment choices and believe the in-licensing of PRX302 compliments the strong reputation of silodosin, our leading global strategic product in the BPH field.”
About Kissei Pharmaceutical
Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around world through developing and offering innovative drugs. Kissei is actively pursuing collaboration with many companies to strengthen its R&D pipeline, and also promoting the global expansion by licensing out the original agents as an important management strategy. Kissei ranks urology as one of its major R&D areas and is putting a great deal of effort into the development of novel therapeutic agents. So far, an agent for treatment of dysuria associated benign prostatic hyperplasia, "silodosin" which was originally developed by Kissei was launched in the U.S., South Korea and approved in EU and filed for NDA in China. In addition, a therapeutic agent for over active bladder, KUC-7483 has been invented by Kissei, and currently Phase 3 clinical trials are ongoing. For more information on Kissei, please see the international website http://www.kissei.co.jp/.
About PRX302
PRX302 is the lead drug in the company’s PORxin™ technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $4 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. Protox’s lead program, PRX302 (PORxin), achieved its primary clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox’ current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
2006 Protox Therapeutics Inc. All Rights Reserved. Legal Disclaimer.
What's New
April 29, 2010
Protox Signs $75 Million License Agreement with Kissei for Commercialization of Prx302 in Japan for BPH and Prostate Disease
March 31, 2010
Protox Reports 2009 Financial Results and Achievements
March 16, 2010
Protox Completes Private Placement
February 25, 2010
Protox Revises Terms Of Private Placement
Events
January 11, 2010 - 8:45 am ET
Protox Therapeutics Conference Call - Webcast Link
Stock Quote
LAST TRADE: $0.59
TRADE TIME: 2:59PM EST
CHANGE: $0.00 (0.00%)
PREV CLOSE: $0.59
OPEN: $0.60
BID: $0.59
ASK: $0.60
Vancouver, British Columbia, April 29, 2010 – Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has entered into an exclusive US $75 million license agreement with Kissei Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4547) for the development and commercialization of its PSA-activated pro-drug, PRX302, in Japan for BPH, prostate cancer and other diseases of the prostate. Protox retains exclusive rights to PRX302 in all other territories.
Under the terms of the agreement, Protox will receive an upfront payment of US $3 million and is eligible to receive a near term milestone payment of US $5 million, as well as progressive payments of up to US $67 million upon achievement of specific development, regulatory and commercial milestones. In addition Protox will receive a double-digit royalty fee plus a drug supply fee based on product sales. Kissei will be responsible for all costs associated with further development, regulatory approvals, commercialization and marketing of PRX302 in Japan.
“This transaction represents strong validation of PRX302 given Kissei’s established leadership in the Japanese urology market and proven track record in drug development,” said Dr. Fahar Merchant, President and CEO of Protox. “We are delighted to execute this license agreement and we are convinced that in Kissei we have found a partner who is fully committed to bring PRX302 to the Japanese market in a timely manner. For Protox, this significant milestone provides a non-dilutive infusion of cash while preserving our flexibility for developing and marketing PRX302 in the rest of the world.”
Kissei obtained Japanese regulatory approval of URIEFâ (silodosin), an alpha-blocker for dysuria associated with BPH in 2006. Kissei rapidly established robust growth of URIEFâ, which is now the second largest selling alpha blocker in Japan. Kissei also has another urology drug in late stage clinical development.
"This agreement reinforces our product pipeline and enhances our presence in the urological field in Japan,” said Mr. Mutsuo Kanzawa, President and CEO of Kissei. “We look forward to contributing to the well being of BPH patients by increasing their treatment choices and believe the in-licensing of PRX302 compliments the strong reputation of silodosin, our leading global strategic product in the BPH field.”
About Kissei Pharmaceutical
Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around world through developing and offering innovative drugs. Kissei is actively pursuing collaboration with many companies to strengthen its R&D pipeline, and also promoting the global expansion by licensing out the original agents as an important management strategy. Kissei ranks urology as one of its major R&D areas and is putting a great deal of effort into the development of novel therapeutic agents. So far, an agent for treatment of dysuria associated benign prostatic hyperplasia, "silodosin" which was originally developed by Kissei was launched in the U.S., South Korea and approved in EU and filed for NDA in China. In addition, a therapeutic agent for over active bladder, KUC-7483 has been invented by Kissei, and currently Phase 3 clinical trials are ongoing. For more information on Kissei, please see the international website http://www.kissei.co.jp/.
About PRX302
PRX302 is the lead drug in the company’s PORxin™ technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and bothersome symptoms that include difficulty in initiating a urine stream, a sense of urgency, dribbling, incomplete emptying of the bladder, waking several times during the night to urinate and sometimes the presence of blood in the urine. More than half of all men will have symptoms of BPH by the age of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral therapies mainly provide symptomatic relief and can trigger a range of side effects including sexual dysfunction and hypotension. It is estimated that in the seven largest global markets approximately 10 million men are treated annually with oral therapies and these products encompass approximately U.S. $4 billion of sales each year. Surgical options, including minimally invasive procedures, can cause sexual dysfunction, incontinence as well as other more serious procedure-related effects. Surgical measures can require hospitalization, significant recovery time and requires catheterization for variable time intervals. Nearly 600,000 surgical procedures are conducted annually in the seven largest markets.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted fusion proteins. Two novel drug candidates derived from the company’s INxin™ and PORxin™ platforms are being developed in three clinical programs. Protox’s lead program, PRX302 (PORxin), achieved its primary clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition to these positive results, data from the Phase 2a study demonstrated durability at 12 months. PRX302 is also being evaluated for the treatment of localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA and EMEA. Protox is also collaborating with the U.S. National Institutes of Health (NIH) on a research program focused on the discovery of next generation fully human targeted therapeutics.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox’ current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
James Beesley
Director, Investor Relations
Protox Therapeutics
604-688-0199
jbeesley@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
2006 Protox Therapeutics Inc. All Rights Reserved. Legal Disclaimer.
What's New
April 29, 2010
Protox Signs $75 Million License Agreement with Kissei for Commercialization of Prx302 in Japan for BPH and Prostate Disease
March 31, 2010
Protox Reports 2009 Financial Results and Achievements
March 16, 2010
Protox Completes Private Placement
February 25, 2010
Protox Revises Terms Of Private Placement
Events
January 11, 2010 - 8:45 am ET
Protox Therapeutics Conference Call - Webcast Link
Stock Quote
LAST TRADE: $0.59
TRADE TIME: 2:59PM EST
CHANGE: $0.00 (0.00%)
PREV CLOSE: $0.59
OPEN: $0.60
BID: $0.59
ASK: $0.60
echt super NEWS....
Antwort auf Beitrag Nr.: 39.431.922 von Hoizzo am 30.04.10 11:33:58
Ich glaube, der Milliardenmarkt rückt näher!
Ich glaube, der Milliardenmarkt rückt näher!
Antwort auf Beitrag Nr.: 39.432.748 von Milesint am 30.04.10 12:55:36heute + 70 %....... mein tip!
Antwort auf Beitrag Nr.: 39.433.450 von Hoizzo am 30.04.10 14:13:42Tradinghalt in Kanada!
was meint ihr, ziehts nach börsenschluß frankfurt drüben an??
+ 10 % sind ja nix für diese tolle news.
+ 10 % sind ja nix für diese tolle news.
Irgendwas läuft da im hintergrund der Kurs hat sich super erholt obwohl der Gesamtmarkt fällt und das Volumen ist seid Tagen in USA sehr hoch!
Antwort auf Beitrag Nr.: 39.460.208 von DermitdemBrokertanzt am 05.05.10 13:51:04in den usa ist doch fast kein handel, in kanada schon.
ich denke dass wir hier ne perle im depot haben, wenn wir in asien bekannt sind und phase 3 abgeschlossen ist gehts rund.
diese geldspritze war für mich der ritterschlag.
ich denke dass wir hier ne perle im depot haben, wenn wir in asien bekannt sind und phase 3 abgeschlossen ist gehts rund.
diese geldspritze war für mich der ritterschlag.
Antwort auf Beitrag Nr.: 39.460.313 von Hoizzo am 05.05.10 14:03:50Ja Canada meinte ich doch!!
Im Moment scheint hier Ruhe eingekehrt zu sein.
Eher ein gutes Zeichen, da man sich in "Ruhe" anderen Dingen zuwenden kann in der Gewissheit oder zumindest in der Hoffnung, dass die Zusammenarbeit von Protox und Kissei (letzte Meldung) sich als höchst fruchtbar erweisen wird.
Na ja, Ruhe-Störungen im Sinne von Kursrücksetzern lassen sich natürlich auch anderweitig nutzen, z. B. zum Nachkauf ...
Eher ein gutes Zeichen, da man sich in "Ruhe" anderen Dingen zuwenden kann in der Gewissheit oder zumindest in der Hoffnung, dass die Zusammenarbeit von Protox und Kissei (letzte Meldung) sich als höchst fruchtbar erweisen wird.
Na ja, Ruhe-Störungen im Sinne von Kursrücksetzern lassen sich natürlich auch anderweitig nutzen, z. B. zum Nachkauf ...
PROTOX THERAPEUTICS INC.
Attention Business/Financial Editors
Protox reports first quarter 2010 financial results
VANCOUVER, May 13 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today released
financial results for the first quarter 2010, ended March 31, 2010.
"The first quarter of 2010 marked significant achievements for the
company, namely the announcement of positive top-line results from the TRIUMPH
study and the subsequent completion of a five million dollar financing," said
Dr. Fahar Merchant, President and CEO of Protox. "In April we announced a
strong regional partnership with Kissei Pharmaceutical Co. in Japan for the
PRX302 prostate programs. This transaction provides the company with
non-dilutive cash and represents strong technology validation for PRX302 given
Kissei's established leadership in the Japanese urology market."
<<
Q1 2010 Highlights
- Announced positive top-line results from the TRIUMPH study showing
that it had achieved its primary clinical endpoint of a
statistically significant improvement in International Prostate
Symptom Score (IPSS) for subjects treated with PRX302 versus
subjects receiving placebo.
- Closed a brokered private placement raising net proceeds of $4.8
million from the issuance of 11,285,388 units at a price of $0.45
per unit. Each Unit is comprised of one common share of Protox and
one-half of a common share purchase warrant. Each whole warrant
entitles the holder to purchase one common share of Protox at a
price of $0.65 for a five year period from closing date subject to
an acceleration of the expiry date in certain circumstances.
Highlights Subsequent to Quarters End
- On April 29, 2010, the Company announced that it had entered into a
US $75 million license agreement with Kissei Pharmaceutical Co.,
Ltd. for the development and commercialization of PRX302 in Japan
for BPH, prostate cancer and other diseases of the prostate.
FINANCIAL RESULTS
-------------------------------------------------------------------------
Three months ended: Mar 31 2010 Dec 31 2009 Sep 30 2009 Jun 30 2009
-------------------------------------------------------------------------
Interest income $0.5 $ 1.3 $ 3.3 $ 10.4
Total expenses 1,638.0 1,719.3 2,191.7 1,814.7
Net loss (1,637.5) (1,717.9) (2,189.9) (1,812.2)
Loss per share (0.02) (0.02) (0.03) (0.02)
-------------------------------------------------------------------------
Three months ended: Mar 31 2009 Dec 31 2008 Sep 30 2008 Jun 30 2008
-------------------------------------------------------------------------
Interest income $ 32.5 $ 63.9 $ 90.8 $ 50.0
Total expenses 2,296.0 2,555.6 2,587.0 1,936.9
Net loss (2,263.5) (2,491.7) (2,496.1) (1,886.7)
Loss per share (0.03) (0.03) (0.03) (0.03)
-------------------------------------------------------------------------
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
Expenses, in particular R&D costs, are influenced by a number of factors
including the scope of clinical development and research programs pursued; the
type and size of clinical trials undertaken; the number of clinical trials
that are active during a particular period of time; the rate of patient
enrollment; and are ultimately a function of decisions made to continue the
development and testing of a product candidate based on supporting safety and
efficacy from clinical trial results. Consequently, expenses vary from period
to period. G&A expenses will be dependent on the personnel and infrastructure
required to support the corporate, clinical and business development
objectives and initiatives of the Company.
Total expenses for the three months ended March 31, 2010 ("2010-Q1")
decreased over the comparative quarter in 2009 as the Company had
significantly reduced clinical activity in 2010-Q1 compared to the comparative
quarter as the double-blinded placebo controlled TRIUMPH study had completed
enrolment and there were no other on-going clinical trials enrolling subjects
during this period.
The Company reported a net and comprehensive loss of $1.6 million or
$0.02 per share in 2010-Q1 compared to $2.3 million or $0.03 per share for the
three months ended March 31, 2009 ("2009-Q1"). The decrease of $0.6 million in
net loss over the comparative period in 2009 was primarily driven by the
decrease in research and development activity due primarily to the completion
of enrolment in the TRIUMPH study, as well as the impact of our efforts to
reduce costs across all areas of the Company, including general and
administration. This was partially offset by an increase in stock based
compensation during 2010-Q1 which resulted from the issuance of 2,405,000
options in the latter half of 2009.
Research and development ("R&D") costs of $1.0 million were incurred
during 2010-Q1: a decrease of $606,000 (38%) from $1.6 million incurred in the
2009-Q1 comparative period. The decrease for the period reflects the effect of
the consolidation of our research and development programs to focus on our
lead BPH program and the completion of enrolment in the double-blinded placebo
controlled TRIUMPH study.
Direct costs incurred in 2010-Q1 for our PRX302 clinical programs for the
treatment of BPH and prostate cancer as well as activities associated with
maintaining our PRX321 program totaled $748,000 compared to $1.4 million for
2009-Q1.
2010-Q1 general and administrative costs of $567,000 decreased slightly
from $619,000 in the 2009-Q1 comparative period. General and administrative
costs will generally vary from period to period depending on the specific
business development, market research and shareholder relations initiatives
undertaken and related travel required at such time to support the Company's
corporate objectives. The general and administrative costs incurred in 2010-Q1
were reduced as a result of the measures implemented through 2009 to
consolidate and focus available resources on our lead clinical BPH program,
TRIUMPH, offset by the higher level of activities in 2010-Q1 relating to the
successful pursuit of additional financing and our first licensing agreement.
At March 31, 2010, the Company had cash and cash equivalents of $5.2
million, representing a net increase of $3.4 million from December 31, 2009.
The Company had working capital of $4.2 million at March 31, 2010, an increase
of $3.4 million from December 31, 2009.
As at May 13, the Company has 96, 301,477 common shares issued and
outstanding. In addition, the Company has 6,647,500 options outstanding to
purchase common shares of the Company. Of the options currently outstanding,
approximately 3.9 million are exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.50 to $1.00 and with
an average exercise price of $0.69.
The Company also has 6,919,015 common share purchase warrants outstanding
which expire between May 2010 and March 2015 and entitle warrant holders to
purchase common shares at a prices ranging between $0.27 and $0.71.
Furthermore, 6,367,269 of these common share purchase warrants are subject to
an acceleration of the expiry date if the closing price of the underlying
Common Shares is higher than $1.75 per common share for a period of 10
consecutive trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information: James Beesley, Senior Director, Investor
Relations, Protox Therapeutics, (604) 484-0975,
jbeesley@protoxtherapeutics.com; Michael Moore, Investor Relations, Equicom
Group, (416) 815-0700 x 241, mmoore@equicomgroup.com/
More on this organization
PROTOX THERAPEUTICS INC.
NEWS RELEASES (136)
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© 2009 CNW Group Ltd
Attention Business/Financial Editors
Protox reports first quarter 2010 financial results
VANCOUVER, May 13 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today released
financial results for the first quarter 2010, ended March 31, 2010.
"The first quarter of 2010 marked significant achievements for the
company, namely the announcement of positive top-line results from the TRIUMPH
study and the subsequent completion of a five million dollar financing," said
Dr. Fahar Merchant, President and CEO of Protox. "In April we announced a
strong regional partnership with Kissei Pharmaceutical Co. in Japan for the
PRX302 prostate programs. This transaction provides the company with
non-dilutive cash and represents strong technology validation for PRX302 given
Kissei's established leadership in the Japanese urology market."
<<
Q1 2010 Highlights
- Announced positive top-line results from the TRIUMPH study showing
that it had achieved its primary clinical endpoint of a
statistically significant improvement in International Prostate
Symptom Score (IPSS) for subjects treated with PRX302 versus
subjects receiving placebo.
- Closed a brokered private placement raising net proceeds of $4.8
million from the issuance of 11,285,388 units at a price of $0.45
per unit. Each Unit is comprised of one common share of Protox and
one-half of a common share purchase warrant. Each whole warrant
entitles the holder to purchase one common share of Protox at a
price of $0.65 for a five year period from closing date subject to
an acceleration of the expiry date in certain circumstances.
Highlights Subsequent to Quarters End
- On April 29, 2010, the Company announced that it had entered into a
US $75 million license agreement with Kissei Pharmaceutical Co.,
Ltd. for the development and commercialization of PRX302 in Japan
for BPH, prostate cancer and other diseases of the prostate.
FINANCIAL RESULTS
-------------------------------------------------------------------------
Three months ended: Mar 31 2010 Dec 31 2009 Sep 30 2009 Jun 30 2009
-------------------------------------------------------------------------
Interest income $0.5 $ 1.3 $ 3.3 $ 10.4
Total expenses 1,638.0 1,719.3 2,191.7 1,814.7
Net loss (1,637.5) (1,717.9) (2,189.9) (1,812.2)
Loss per share (0.02) (0.02) (0.03) (0.02)
-------------------------------------------------------------------------
Three months ended: Mar 31 2009 Dec 31 2008 Sep 30 2008 Jun 30 2008
-------------------------------------------------------------------------
Interest income $ 32.5 $ 63.9 $ 90.8 $ 50.0
Total expenses 2,296.0 2,555.6 2,587.0 1,936.9
Net loss (2,263.5) (2,491.7) (2,496.1) (1,886.7)
Loss per share (0.03) (0.03) (0.03) (0.03)
-------------------------------------------------------------------------
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
Expenses, in particular R&D costs, are influenced by a number of factors
including the scope of clinical development and research programs pursued; the
type and size of clinical trials undertaken; the number of clinical trials
that are active during a particular period of time; the rate of patient
enrollment; and are ultimately a function of decisions made to continue the
development and testing of a product candidate based on supporting safety and
efficacy from clinical trial results. Consequently, expenses vary from period
to period. G&A expenses will be dependent on the personnel and infrastructure
required to support the corporate, clinical and business development
objectives and initiatives of the Company.
Total expenses for the three months ended March 31, 2010 ("2010-Q1")
decreased over the comparative quarter in 2009 as the Company had
significantly reduced clinical activity in 2010-Q1 compared to the comparative
quarter as the double-blinded placebo controlled TRIUMPH study had completed
enrolment and there were no other on-going clinical trials enrolling subjects
during this period.
The Company reported a net and comprehensive loss of $1.6 million or
$0.02 per share in 2010-Q1 compared to $2.3 million or $0.03 per share for the
three months ended March 31, 2009 ("2009-Q1"). The decrease of $0.6 million in
net loss over the comparative period in 2009 was primarily driven by the
decrease in research and development activity due primarily to the completion
of enrolment in the TRIUMPH study, as well as the impact of our efforts to
reduce costs across all areas of the Company, including general and
administration. This was partially offset by an increase in stock based
compensation during 2010-Q1 which resulted from the issuance of 2,405,000
options in the latter half of 2009.
Research and development ("R&D") costs of $1.0 million were incurred
during 2010-Q1: a decrease of $606,000 (38%) from $1.6 million incurred in the
2009-Q1 comparative period. The decrease for the period reflects the effect of
the consolidation of our research and development programs to focus on our
lead BPH program and the completion of enrolment in the double-blinded placebo
controlled TRIUMPH study.
Direct costs incurred in 2010-Q1 for our PRX302 clinical programs for the
treatment of BPH and prostate cancer as well as activities associated with
maintaining our PRX321 program totaled $748,000 compared to $1.4 million for
2009-Q1.
2010-Q1 general and administrative costs of $567,000 decreased slightly
from $619,000 in the 2009-Q1 comparative period. General and administrative
costs will generally vary from period to period depending on the specific
business development, market research and shareholder relations initiatives
undertaken and related travel required at such time to support the Company's
corporate objectives. The general and administrative costs incurred in 2010-Q1
were reduced as a result of the measures implemented through 2009 to
consolidate and focus available resources on our lead clinical BPH program,
TRIUMPH, offset by the higher level of activities in 2010-Q1 relating to the
successful pursuit of additional financing and our first licensing agreement.
At March 31, 2010, the Company had cash and cash equivalents of $5.2
million, representing a net increase of $3.4 million from December 31, 2009.
The Company had working capital of $4.2 million at March 31, 2010, an increase
of $3.4 million from December 31, 2009.
As at May 13, the Company has 96, 301,477 common shares issued and
outstanding. In addition, the Company has 6,647,500 options outstanding to
purchase common shares of the Company. Of the options currently outstanding,
approximately 3.9 million are exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.50 to $1.00 and with
an average exercise price of $0.69.
The Company also has 6,919,015 common share purchase warrants outstanding
which expire between May 2010 and March 2015 and entitle warrant holders to
purchase common shares at a prices ranging between $0.27 and $0.71.
Furthermore, 6,367,269 of these common share purchase warrants are subject to
an acceleration of the expiry date if the closing price of the underlying
Common Shares is higher than $1.75 per common share for a period of 10
consecutive trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information: James Beesley, Senior Director, Investor
Relations, Protox Therapeutics, (604) 484-0975,
jbeesley@protoxtherapeutics.com; Michael Moore, Investor Relations, Equicom
Group, (416) 815-0700 x 241, mmoore@equicomgroup.com/
More on this organization
PROTOX THERAPEUTICS INC.
NEWS RELEASES (136)
QUOTES AND CHARTS: PRX.(TSX)
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PRINTER FRIENDLY
SUBSCRIBE TO PORTFOLIO E-MAIL
© 2009 CNW Group Ltd
Antwort auf Beitrag Nr.: 39.518.365 von Milesint am 14.05.10 09:09:19und weiter gehts...
Antwort auf Beitrag Nr.: 39.615.104 von Milesint am 01.06.10 17:10:21
PROTOX THERAPEUTICS INC.
Attention Business Editors
Protox to present Phase 2b BPH data at the Annual Meeting of the American Urological Association
VANCOUVER, June 1 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today announced that
two oral podium presentations on the company's lead candidate, PRX302, will be
made at the 2010 Annual Meeting of the American Urological Association (AUA).
These presentations will include six month data from the Phase 2b clinical
study of PRX302 called TRIUMPH, in patients with moderate to severe benign
prostatic hyperplasia (BPH). The annual AUA meeting is the world's largest
gathering of urology professionals and takes place May 29 - June 3 at the
Moscone Convention Center in San Francisco, California.
Dr. Mostafa M. Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator
and Stephen Jarislowsky Chair of Urology at McGill University, will deliver
both podium presentations on Tuesday, June 1, 2010 as follows:
<<
Session: Late-Breaking Science Forum
Title: Results of a Phase IIb Double-Blinded Placebo-Controlled Study of
Transperineal Intraprostatic Injection of a PSA-Activated Protoxin (PRX
302) in Patients with Moderate to Severe LUTS
Location, Date and Time: Moscone South, Room 103, Tuesday, June 1, 2010,
1:00 PM (PST)
Session: Benign Prostatic Hyperplasia; Medical and Hormonal Therapy
Title: Evaluation of Transperineal Prostatic Administration of a PSA
activated Protoxin (PRX302) in Men with LUTS secondary to BPH
Location, Date and Time: Moscone North Building, Room 120, Podium 52,
Tuesday, June 1, 2010, 3:30 PM (PST)
>>
About PRX302
PRX302 is the lead drug in the company's PORxin(TM) technology platform.
PORxin drugs are pore-forming pro-drugs that are activated by specific
proteases produced at elevated levels on the surface of target cells. PRX302
has been generated by engineering the naturally occurring toxin proaerolysin
so that it is activated by prostate-specific antigen (PSA), an enzyme that is
overproduced in patients suffering from prostate cancer and BPH. Once
activated, the drug punches holes in the cells causing the contents to leak
out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and
bothersome symptoms that include difficulty in initiating a urine stream, a
sense of urgency, dribbling, incomplete emptying of the bladder, waking
several times during the night to urinate and sometimes the presence of blood
in the urine. More than half of all men will have symptoms of BPH by the age
of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral
therapies mainly provide symptomatic relief and can trigger a range of side
effects including sexual dysfunction and hypotension. It is estimated that in
the seven largest global markets approximately 10 million men are treated
annually with oral therapies and these products encompass approximately U.S.
$4 billion of sales each year. Surgical options, including minimally invasive
procedures, can cause sexual dysfunction, incontinence as well as other more
serious procedure-related effects. Surgical measures can require
hospitalization, significant recovery time and requires catheterization for
variable time intervals. Nearly 600,000 surgical procedures are conducted
annually in the seven largest markets.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMEA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
PROTOX THERAPEUTICS INC.
Attention Business Editors
Protox to present Phase 2b BPH data at the Annual Meeting of the American Urological Association
VANCOUVER, June 1 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today announced that
two oral podium presentations on the company's lead candidate, PRX302, will be
made at the 2010 Annual Meeting of the American Urological Association (AUA).
These presentations will include six month data from the Phase 2b clinical
study of PRX302 called TRIUMPH, in patients with moderate to severe benign
prostatic hyperplasia (BPH). The annual AUA meeting is the world's largest
gathering of urology professionals and takes place May 29 - June 3 at the
Moscone Convention Center in San Francisco, California.
Dr. Mostafa M. Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator
and Stephen Jarislowsky Chair of Urology at McGill University, will deliver
both podium presentations on Tuesday, June 1, 2010 as follows:
<<
Session: Late-Breaking Science Forum
Title: Results of a Phase IIb Double-Blinded Placebo-Controlled Study of
Transperineal Intraprostatic Injection of a PSA-Activated Protoxin (PRX
302) in Patients with Moderate to Severe LUTS
Location, Date and Time: Moscone South, Room 103, Tuesday, June 1, 2010,
1:00 PM (PST)
Session: Benign Prostatic Hyperplasia; Medical and Hormonal Therapy
Title: Evaluation of Transperineal Prostatic Administration of a PSA
activated Protoxin (PRX302) in Men with LUTS secondary to BPH
Location, Date and Time: Moscone North Building, Room 120, Podium 52,
Tuesday, June 1, 2010, 3:30 PM (PST)
>>
About PRX302
PRX302 is the lead drug in the company's PORxin(TM) technology platform.
PORxin drugs are pore-forming pro-drugs that are activated by specific
proteases produced at elevated levels on the surface of target cells. PRX302
has been generated by engineering the naturally occurring toxin proaerolysin
so that it is activated by prostate-specific antigen (PSA), an enzyme that is
overproduced in patients suffering from prostate cancer and BPH. Once
activated, the drug punches holes in the cells causing the contents to leak
out and ultimately cell death.
About BPH
BPH is a common urological condition characterized by painful and
bothersome symptoms that include difficulty in initiating a urine stream, a
sense of urgency, dribbling, incomplete emptying of the bladder, waking
several times during the night to urinate and sometimes the presence of blood
in the urine. More than half of all men will have symptoms of BPH by the age
of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral
therapies mainly provide symptomatic relief and can trigger a range of side
effects including sexual dysfunction and hypotension. It is estimated that in
the seven largest global markets approximately 10 million men are treated
annually with oral therapies and these products encompass approximately U.S.
$4 billion of sales each year. Surgical options, including minimally invasive
procedures, can cause sexual dysfunction, incontinence as well as other more
serious procedure-related effects. Surgical measures can require
hospitalization, significant recovery time and requires catheterization for
variable time intervals. Nearly 600,000 surgical procedures are conducted
annually in the seven largest markets.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMEA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
ist ja ruhig geworden....
www.finanznachrichten.de
PROTOX THERAPEUTICS INC.
Attention Business/Financial Editors
Protox reports Second Quarter 2010 financial results
VANCOUVER, Aug. 11 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today released
financial results for the second quarter 2010, ended June 30, 2010.
"The second quarter was very positive for Protox with the announcement of
a US $75 million license agreement with Kissei Pharmaceutical, a partner with
an impressive track record in the Japanese urology market," said Dr. Fahar
Merchant, President and CEO of Protox. "This strategic agreement provides
strong validation for our PRX302 program and non-dilutive cash, while allowing
us to preserve marketing rights for PRX302 in the rest of the world."
Q2 2010 Highlights
<<
- On April 29, 2010, the Company announced that it had entered into
a US $75 million license agreement with Kissei Pharmaceutical Co.,
Ltd. for the development and commercialization of PRX302 in Japan
for BPH, prostate cancer and other diseases of the prostate.
- Two oral podium presentations were delivered at the 2010 Annual
Meeting of the American Urological Association by Dr. Mostafa M.
Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator and
Stephen Jarislowsky Chair of Urology at McGill University.
Presentations included positive six month data from the PRX302
Phase 2b TRIUMPH clinical study, in patients with moderate to
severe benign prostatic hyperplasia.
Financial Results
June 30 March 31 December 31 September 30
Three months ended: 2010 2010 2009 2009
-------------------------------------------------------------------------
Revenue, net of
royalties $ 2,850.2 $ - $ - $ -
Interest income 1.7 0.5 1.3 3.3
Total expenses 1,559.3 1,638.0 1,719.3 2,191.7
Net income (loss) 1,093.1 (1,637.5) (1,717.9) (2,189.9)
Income (loss) per
share 0.01 (0.02) (0.02) (0.03)
June 30 March 31 December 31 September 30
Three months ended: 2009 2009 2008 2008
-------------------------------------------------------------------------
Interest income $ 10.4 $ 32.5 $ 63.9 $ 90.8
Total expenses 1,814.7 2,296.0 2,555.6 2,587.0
Net loss (1,812.2) (2,263.5) (2,491.7) (2,496.1)
Loss per share (0.02) (0.03) (0.03) (0.03)
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
The Company reported net and comprehensive income of $1.1 million ($0.01
per share) in the three months ended June 30, 2010 ("2010-Q2") compared to a
net loss of $1.8 million ($0.02 per share) for the three months ended June 30,
2009 ("2009-Q2"). On a year-to-date basis, the Company recorded a loss of
$544,000 ($0.00 per share) for the six months ended June 30, 2010 compared to
a loss of $4.1 million ($0.05 per share) for the six months ended June 30,
2009. The swing in net income (loss) of $2.9 million in the current quarter
was a result of the receipt of net license revenue of $2.9 million from the
Kissei agreement entered into in April 2010, less Japanese withholding taxes,
as well as continued efforts to manage costs across all areas of the Company.
Total expenses for the three months ended June 30, 2010 decreased by
$255,000 over the comparative quarter in 2009. This was driven by a reduction
in research and development expenditures with our TRIUMPH study nearing
completion and offset by an increase in business development activities to
support our licensing activities.
Expenses, in particular research and development expenditures, are
influenced by a number of factors including the scope of clinical development
and research programs pursued; the type and size of clinical trials
undertaken; the number of clinical trials that are active during a particular
period of time; and the rate of patient enrollment; and are ultimately a
function of decisions made to continue the development and testing of a
product candidate based on supporting safety and efficacy from clinical trial
results. Consequently, expenses vary from period to period. General and
Administrative expenses are dependent on the personnel and infrastructure
required to support the corporate, clinical and business development
objectives and initiatives of the Company. Operating costs are expected to
remain flat for the balance of the year as the Company continues the
development of the PRX302 BPH program. In addition, we anticipate that our
business development activities will continue as we pursue further regional
and/or global licensing opportunities.
The Company earned US $3.0 million (CAD $3.0 million) in license revenue
during 2010-Q2 and 2010-YTD as a result of the Kissei license agreement. The
payment triggered a royalty payment to John Hopkins University and the
University of Victoria of $210,000 under the terms of our PORxin license
agreement for benign prostate hyperplasia.
In the future, the Company is eligible to earn a near term milestone
payment of US $5 million and an additional US $67 million in milestone and
product supply revenues as well as double digit royalties on sales of PRX302
in Japan.
Research and development expenditures were $893,000 for 2010-Q2, a
decrease of $377,000 from $1.3 million for 2009-Q2. Year to date expenditures
for the six months ended June 30, 2010 were $1.9 million compared to $2.9
million for the same period in fiscal 2009. The decrease in research and
development expenditures for 2010-Q2 and for the six months ended June 30,
2010 was due to the maturing of the Company's current BPH program as only one
trial was active during 2010-Q2 - the fully enrolled double-blinded placebo
controlled TRIUMPH - compared to three active trials in 2009-Q2.
For the remainder of the year, we expect to continue to incur costs
related to the further clinical, manufacturing and regulatory activities
associated with our PRX302 PBH program.
General and administrative ("G&A") costs for 2010-Q2 were $605,000 - a
slight increase over the previous quarter and an increase of $107,000 compared
to the same period in 2009. On a year-to-date basis, G&A expenditures were
$1.2 million for the six months ended June 30, 2010 and $1.1 for the
comparative period in 2009. General and administrative costs will generally
vary from period to period depending on the specific business development,
market research and shareholder relations initiatives undertaken and related
travel required at such time to support the Company's corporate objectives.
The increase in the G&A expenditures in the current quarter and on a
year-to-date basis reflect the high level of business development activity
undertaken by the company in pursuit of regional and/or global licensing
arrangements. For the remainder of the year, we expect the G&A expenditures to
remain at the current levels.
At June 30, 2010, the Company had cash and cash equivalents of $6.7
million, representing an increase of $5.0 million from December 31, 2009. The
Company had working capital of $5.4 million at June 30, 2010, an increase of
$4.6 million from December 31, 2009.
As at August 10, the Company has 96,303,443 common shares issued and
outstanding. In addition, the Company has 7,558,500 options outstanding to
purchase common shares of the Company. Of the options currently outstanding,
approximately 3.9 million are exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.50 to $1.00 and with
an average exercise price of $0.71.
The Company also has 6,542,023 common share purchase warrants outstanding
which expire between May 2011 and March 2015 and entitle warrant holders to
purchase common shares at prices ranging between $0.27 and $0.65. Furthermore,
6,367,269 of these common share purchase warrants are subject to an
acceleration of the expiry date if the closing price of the underlying Common
Shares is higher than $1.75 per common share for a period of 10 consecutive
trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information: James Beesley, Senior Director, Investor
Relations, Protox Therapeutics, 604-484-0975, jbeesley@protoxtherapeutics.com;
Michael Moore, Investor Relations, Equicom Group, 619-467-7067,
mmoore@equicomgroup.com/
More on this organization
PROTOX THERAPEUTICS INC.
NEWS RELEASES (139)
QUOTES AND CHARTS: PRX.(TSX)
PROTOX THERAPEUTICS INC.
Attention Business/Financial Editors
Protox reports Second Quarter 2010 financial results
VANCOUVER, Aug. 11 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, today released
financial results for the second quarter 2010, ended June 30, 2010.
"The second quarter was very positive for Protox with the announcement of
a US $75 million license agreement with Kissei Pharmaceutical, a partner with
an impressive track record in the Japanese urology market," said Dr. Fahar
Merchant, President and CEO of Protox. "This strategic agreement provides
strong validation for our PRX302 program and non-dilutive cash, while allowing
us to preserve marketing rights for PRX302 in the rest of the world."
Q2 2010 Highlights
<<
- On April 29, 2010, the Company announced that it had entered into
a US $75 million license agreement with Kissei Pharmaceutical Co.,
Ltd. for the development and commercialization of PRX302 in Japan
for BPH, prostate cancer and other diseases of the prostate.
- Two oral podium presentations were delivered at the 2010 Annual
Meeting of the American Urological Association by Dr. Mostafa M.
Elhilali, OC, M.D., Ph.D. Chief Co-Principal Investigator and
Stephen Jarislowsky Chair of Urology at McGill University.
Presentations included positive six month data from the PRX302
Phase 2b TRIUMPH clinical study, in patients with moderate to
severe benign prostatic hyperplasia.
Financial Results
June 30 March 31 December 31 September 30
Three months ended: 2010 2010 2009 2009
-------------------------------------------------------------------------
Revenue, net of
royalties $ 2,850.2 $ - $ - $ -
Interest income 1.7 0.5 1.3 3.3
Total expenses 1,559.3 1,638.0 1,719.3 2,191.7
Net income (loss) 1,093.1 (1,637.5) (1,717.9) (2,189.9)
Income (loss) per
share 0.01 (0.02) (0.02) (0.03)
June 30 March 31 December 31 September 30
Three months ended: 2009 2009 2008 2008
-------------------------------------------------------------------------
Interest income $ 10.4 $ 32.5 $ 63.9 $ 90.8
Total expenses 1,814.7 2,296.0 2,555.6 2,587.0
Net loss (1,812.2) (2,263.5) (2,491.7) (2,496.1)
Loss per share (0.02) (0.03) (0.03) (0.03)
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
The Company reported net and comprehensive income of $1.1 million ($0.01
per share) in the three months ended June 30, 2010 ("2010-Q2") compared to a
net loss of $1.8 million ($0.02 per share) for the three months ended June 30,
2009 ("2009-Q2"). On a year-to-date basis, the Company recorded a loss of
$544,000 ($0.00 per share) for the six months ended June 30, 2010 compared to
a loss of $4.1 million ($0.05 per share) for the six months ended June 30,
2009. The swing in net income (loss) of $2.9 million in the current quarter
was a result of the receipt of net license revenue of $2.9 million from the
Kissei agreement entered into in April 2010, less Japanese withholding taxes,
as well as continued efforts to manage costs across all areas of the Company.
Total expenses for the three months ended June 30, 2010 decreased by
$255,000 over the comparative quarter in 2009. This was driven by a reduction
in research and development expenditures with our TRIUMPH study nearing
completion and offset by an increase in business development activities to
support our licensing activities.
Expenses, in particular research and development expenditures, are
influenced by a number of factors including the scope of clinical development
and research programs pursued; the type and size of clinical trials
undertaken; the number of clinical trials that are active during a particular
period of time; and the rate of patient enrollment; and are ultimately a
function of decisions made to continue the development and testing of a
product candidate based on supporting safety and efficacy from clinical trial
results. Consequently, expenses vary from period to period. General and
Administrative expenses are dependent on the personnel and infrastructure
required to support the corporate, clinical and business development
objectives and initiatives of the Company. Operating costs are expected to
remain flat for the balance of the year as the Company continues the
development of the PRX302 BPH program. In addition, we anticipate that our
business development activities will continue as we pursue further regional
and/or global licensing opportunities.
The Company earned US $3.0 million (CAD $3.0 million) in license revenue
during 2010-Q2 and 2010-YTD as a result of the Kissei license agreement. The
payment triggered a royalty payment to John Hopkins University and the
University of Victoria of $210,000 under the terms of our PORxin license
agreement for benign prostate hyperplasia.
In the future, the Company is eligible to earn a near term milestone
payment of US $5 million and an additional US $67 million in milestone and
product supply revenues as well as double digit royalties on sales of PRX302
in Japan.
Research and development expenditures were $893,000 for 2010-Q2, a
decrease of $377,000 from $1.3 million for 2009-Q2. Year to date expenditures
for the six months ended June 30, 2010 were $1.9 million compared to $2.9
million for the same period in fiscal 2009. The decrease in research and
development expenditures for 2010-Q2 and for the six months ended June 30,
2010 was due to the maturing of the Company's current BPH program as only one
trial was active during 2010-Q2 - the fully enrolled double-blinded placebo
controlled TRIUMPH - compared to three active trials in 2009-Q2.
For the remainder of the year, we expect to continue to incur costs
related to the further clinical, manufacturing and regulatory activities
associated with our PRX302 PBH program.
General and administrative ("G&A") costs for 2010-Q2 were $605,000 - a
slight increase over the previous quarter and an increase of $107,000 compared
to the same period in 2009. On a year-to-date basis, G&A expenditures were
$1.2 million for the six months ended June 30, 2010 and $1.1 for the
comparative period in 2009. General and administrative costs will generally
vary from period to period depending on the specific business development,
market research and shareholder relations initiatives undertaken and related
travel required at such time to support the Company's corporate objectives.
The increase in the G&A expenditures in the current quarter and on a
year-to-date basis reflect the high level of business development activity
undertaken by the company in pursuit of regional and/or global licensing
arrangements. For the remainder of the year, we expect the G&A expenditures to
remain at the current levels.
At June 30, 2010, the Company had cash and cash equivalents of $6.7
million, representing an increase of $5.0 million from December 31, 2009. The
Company had working capital of $5.4 million at June 30, 2010, an increase of
$4.6 million from December 31, 2009.
As at August 10, the Company has 96,303,443 common shares issued and
outstanding. In addition, the Company has 7,558,500 options outstanding to
purchase common shares of the Company. Of the options currently outstanding,
approximately 3.9 million are exercisable into an equivalent number of common
shares of the Company at exercise prices ranging from $0.50 to $1.00 and with
an average exercise price of $0.71.
The Company also has 6,542,023 common share purchase warrants outstanding
which expire between May 2011 and March 2015 and entitle warrant holders to
purchase common shares at prices ranging between $0.27 and $0.65. Furthermore,
6,367,269 of these common share purchase warrants are subject to an
acceleration of the expiry date if the closing price of the underlying Common
Shares is higher than $1.75 per common share for a period of 10 consecutive
trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. Protox's lead program, PRX302 (PORxin), achieved its primary
clinical endpoint from its Phase 2b placebo controlled trial called TRIUMPH,
to treat benign prostatic hyperplasia (BPH or enlarged prostate). In addition
to these positive results, data from the Phase 2a study demonstrated
durability at 12 months. PRX302 is also being evaluated for the treatment of
localized prostate cancer. A Phase 2a clinical trial evaluating PRX321 (INxin)
for the treatment of primary brain cancer has been completed and the drug has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMA. Protox is also collaborating with the U.S. National Institutes of Health
(NIH) on a research program focused on the discovery of next generation fully
human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information: James Beesley, Senior Director, Investor
Relations, Protox Therapeutics, 604-484-0975, jbeesley@protoxtherapeutics.com;
Michael Moore, Investor Relations, Equicom Group, 619-467-7067,
mmoore@equicomgroup.com/
More on this organization
PROTOX THERAPEUTICS INC.
NEWS RELEASES (139)
QUOTES AND CHARTS: PRX.(TSX)
Ein deutlicher Kursanstieg in den letzten Tagen. Oder doch nur das übliche Auf und AB zwischen 0,23 und 0,28 €? Weiß jemand Näheres?
Langsam kommt der Zug in Fahrt
a bissl dauerts no bis zum Gipfl
hmmmmmmmmmm 25 % sind da bestimmt noch drin
a bissl dauerts no bis zum Gipfl
hmmmmmmmmmm 25 % sind da bestimmt noch drin
Antwort auf Beitrag Nr.: 40.446.918 von Aktienschreiner am 03.11.10 17:37:01
Hoffen wir es!
Vermutlich wird es in der kommenden Woche den nächsten Quartalsbericht geben. Ergebnisse klinischer Studien dürften allerdings als Extra-Meldung herausgehen.
Hoffen wir es!
Vermutlich wird es in der kommenden Woche den nächsten Quartalsbericht geben. Ergebnisse klinischer Studien dürften allerdings als Extra-Meldung herausgehen.
Antwort auf Beitrag Nr.: 40.447.427 von Milesint am 03.11.10 18:27:16 ja hoff ma a mal die die jetzt einsteigen haben ja recht gute Kurse
bei mir ist da schon noch a weiter Weg hin
schauma a mal na säng mas scho
bei mir ist da schon noch a weiter Weg hin
schauma a mal na säng mas scho
Komisch, dass sich hier noch niemand über den Kursanstieg wundert!
Dann freu ich mich eben alleine.- Kurz vor Grün!
Dann freu ich mich eben alleine.- Kurz vor Grün!
PROTOX THERAPEUTICS INC.
Attention Business/Financial Editors
PROTOX REPORTS THIRD QUARTER 2010 FINANCIAL RESULTS
VANCOUVER, Nov. 15 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted therapeutic fusion proteins, today
released financial results for the third quarter, ended September 30, 2010.
"On the back of a $75M license agreement with Kissei in the second
quarter, the announcement this quarter of a financing of up to $35M by the
private equity giant, Warburg Pincus, represents a huge vote of confidence in
Protox and our BPH program" said Dr Fahar Merchant, President and CEO of
Protox. "We are delighted that an investor of such caliber has stepped forward
to support PRX302 through to its final stages of development. In Warburg
Pincus, Protox will have access to considerable sector specific expertise and
a partner with an enviable track record of building shareholder value."
Q3 2010 Highlights
<<
-- The Company entered into an investment agreement with Warburg Pincus for
an investment of up to $35 million. A special meeting of Protox
shareholders is scheduled for November 16, 2010 to approve the
investment, and the first tranche of $10 million is expected to close
shortly thereafter.
-- On July 13, 2010 and September 16, 2010, patents were allowed in Europe
and Singapore respectively, related to the PORxin patent family entitled
"Method of Treating or Preventing Benign Prostatic Hyperplasia Using
Modified Pore-Forming Proteins" and on September 28, 2010, a second
divisional patent was allowed in the US related to the PORxin patent
family entitled "Proaerolysin Containing Protease Activation Sequences
and Methods of Use for Treatment of Prostate Cancer".
>>
Financial Results
<<
Three September 30 June 30 2010 March 31 2010 December 31 2009
months 2010
ended:
Revenue $ - $ 2,850.2 $ - $ -
Interest 9.9 1.7 0.5 1.3
income
Total 1,602.1 1,559.3 1,638.0 1,719.3
expenses
Net (1,578.5) 1,093.1 (1,637.5) (1,717.9)
income
(loss)
Income (0.02) 0.01 (0.02) (0.02)
(loss)
per share
Three September 30 June 30 2009 March 31 2009 December 31 2008
months 2009
ended:
Interest $ 3.3 $ 10.4 $ 32.5 $ 63.9
income
Total 2,191.7 1,814.7 2,296.0 2,555.6
expenses
Net loss (1,812.2) (2,263.5) (2,491.7)
(2,189.9)
Loss per (0.03) (0.02) (0.03) (0.03)
share
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
The Company reported net and comprehensive loss of $1.6 million ($0.02
per share) in the three months ended September 30, 2010 ("2010-Q3") compared
to a net loss of $2.2 million ($0.03 per share) for the three months ended
September 30, 2009 ("2009-Q3"). On a year-to-date basis, the Company recorded
a loss of $2.1 million ($0.02 per share) for the nine months ended September
30, 2010 compared to a loss of $6.3 million ($0.08 per share) for the nine
months ended September 30, 2009. The decrease of $611,000 in net loss in the
current quarter is due to continuing efforts to manage costs across all areas
of the Company, as well as the completion of the active phase of the lead
study resulting in reduced clinical activity.
Total expenses for the quarter ended September 30, 2010 decreased by
$590,000 with respect to the comparative period in 2009. This was driven by a
reduction in research and development expenditures with the completion of the
active phase of the TRIUMPH study and efforts to manage costs across the
Company. Overall, operating costs are expected to remain flat for the balance
of the year as the Company continues the development of PRX302 for the
treatment of benign prostatic hyperplasia ("BPH"). Protox anticipates that
their business development activities will decrease in the fourth quarter as a
result of securing Warburg Pincus as a funding partner.
The Company did not earn any license revenue during third quarter of
2010. However, the Company earned US$3.0 million (CAD$3.0 million) during the
nine months ended September 30, 2010 as a result of the Kissei license
agreement. The receipt of this revenue triggered a sub-license fee to John
Hopkins University and the University of Victoria of $210,000 under the terms
of their PORxin license agreement for BPH.
In the future, the Company is eligible to earn a near term milestone
payment of US$5 million and an additional US$67 million in milestone payments,
product supply revenues as well as drug supply fees and double digit royalties
on sales of PRX302 in Japan.
Research and development expenditures were $990,000 for the third quarter
of 2010, a decrease of $520,000 from $1.5 million over for the comparative
quarter in 2009. Year to date expenditures for the nine months ended
September 30, 2010 were $2.9 million compared to $4.4 million for the same
period in fiscal 2009. The decrease in research and development expenditures
for 2010-Q3 and for the nine months ended September 30, 2010 was due to the
maturing of the Company's current BPH program as the active phase of the lead
trial was completed during the third quarter of 2010 - the double-blinded
placebo controlled TRIUMPH study - compared to three active trials in the
third quarter of 2009.
For the remainder of the year, the Company expects to continue to incur
costs related to the further clinical, manufacturing and regulatory activities
associated with their PRX302 BPH program.
General and administrative ("G&A") costs for the third quarter of 2010
were $428,000, a decrease of 30% over the previous quarter and a modest
decrease compared to the same period in 2009. On a year-to-date basis, G&A
expenditures were $1.6 million for the nine months ended September 30, 2010 -
the same level as the comparative period in 2009. The decrease in the G&A
expenditures in the current quarter reflect the high level of activity
undertaken in the previous quarter with respect to the Kissei agreement. For
the remainder of the year, Protox expects the G&A expenditures to remain close
to the current levels.
At September 30, 2010, the Company had cash and cash equivalents of $5.0
million, representing an increase of $3.3 million from December 31, 2009. The
Company had net working capital of $4.0 million at September 30, 2010, an
increase of $3.2 million from December 31, 2009.
As at November 12, 2010, the Company has 96,303,443 common shares issued
and outstanding. In addition, the Company has 7,133,500 options outstanding
to purchase common shares of the Company. Of the options currently
outstanding, approximately 3.9 million are exercisable into an equivalent
number of common shares of the Company at exercise prices ranging from $0.50
to $0.87 and with an average exercise price of $0.65.
The Company also has 6,542,023 common share purchase warrants outstanding
which expire between May 2011 and March 2015 and entitle warrant holders to
purchase common shares at prices ranging between $0.27 and $0.65. Furthermore,
6,367,269 of these common share purchase warrants are subject to an
acceleration of the expiry date if the closing price of the underlying Common
Shares is higher than $1.75 per common share for a period of 10 consecutive
trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics Protox Therapeutics is a leader in advancing
novel, receptor targeted therapeutic fusion proteins. Two drug candidates
derived from the company's INxin(TM) and PORxin(TM) platforms are in clinical
development. Protox's lead program, PRX302 (PORxin), achieved positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). Protox has partnered
with Kissei Pharmaceuticals for the development and commercialization of
PRX302 in Japan. PRX321 (INxin) is being developed for the treatment of
various cancers and has received Fast Track Designation and Orphan Drug Status
from the US FDA and EMA for the treatment of primary brain cancer. For more
information, please visit www.protoxtherapuetics.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks
and uncertainties identified by Protox in its public securities filings;
actual events may differ materially from current expectations. Protox
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
-30-
/For further information:
<<
James Beesley Senior Director, Michael Moore Investor Relations
Investor Relations Protox Equicom Group 619-467-7067
Therapeutics 604-484-0975 mmoore@equicomgroup.com
jbeesley@protoxtherapeutics.com
>>
Attention Business/Financial Editors
PROTOX REPORTS THIRD QUARTER 2010 FINANCIAL RESULTS
VANCOUVER, Nov. 15 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted therapeutic fusion proteins, today
released financial results for the third quarter, ended September 30, 2010.
"On the back of a $75M license agreement with Kissei in the second
quarter, the announcement this quarter of a financing of up to $35M by the
private equity giant, Warburg Pincus, represents a huge vote of confidence in
Protox and our BPH program" said Dr Fahar Merchant, President and CEO of
Protox. "We are delighted that an investor of such caliber has stepped forward
to support PRX302 through to its final stages of development. In Warburg
Pincus, Protox will have access to considerable sector specific expertise and
a partner with an enviable track record of building shareholder value."
Q3 2010 Highlights
<<
-- The Company entered into an investment agreement with Warburg Pincus for
an investment of up to $35 million. A special meeting of Protox
shareholders is scheduled for November 16, 2010 to approve the
investment, and the first tranche of $10 million is expected to close
shortly thereafter.
-- On July 13, 2010 and September 16, 2010, patents were allowed in Europe
and Singapore respectively, related to the PORxin patent family entitled
"Method of Treating or Preventing Benign Prostatic Hyperplasia Using
Modified Pore-Forming Proteins" and on September 28, 2010, a second
divisional patent was allowed in the US related to the PORxin patent
family entitled "Proaerolysin Containing Protease Activation Sequences
and Methods of Use for Treatment of Prostate Cancer".
>>
Financial Results
<<
Three September 30 June 30 2010 March 31 2010 December 31 2009
months 2010
ended:
Revenue $ - $ 2,850.2 $ - $ -
Interest 9.9 1.7 0.5 1.3
income
Total 1,602.1 1,559.3 1,638.0 1,719.3
expenses
Net (1,578.5) 1,093.1 (1,637.5) (1,717.9)
income
(loss)
Income (0.02) 0.01 (0.02) (0.02)
(loss)
per share
Three September 30 June 30 2009 March 31 2009 December 31 2008
months 2009
ended:
Interest $ 3.3 $ 10.4 $ 32.5 $ 63.9
income
Total 2,191.7 1,814.7 2,296.0 2,555.6
expenses
Net loss (1,812.2) (2,263.5) (2,491.7)
(2,189.9)
Loss per (0.03) (0.02) (0.03) (0.03)
share
>>
The Company has not earned any revenue in any of its previous fiscal
years, other than income from interest earned on the Company's investment
balances.
The Company reported net and comprehensive loss of $1.6 million ($0.02
per share) in the three months ended September 30, 2010 ("2010-Q3") compared
to a net loss of $2.2 million ($0.03 per share) for the three months ended
September 30, 2009 ("2009-Q3"). On a year-to-date basis, the Company recorded
a loss of $2.1 million ($0.02 per share) for the nine months ended September
30, 2010 compared to a loss of $6.3 million ($0.08 per share) for the nine
months ended September 30, 2009. The decrease of $611,000 in net loss in the
current quarter is due to continuing efforts to manage costs across all areas
of the Company, as well as the completion of the active phase of the lead
study resulting in reduced clinical activity.
Total expenses for the quarter ended September 30, 2010 decreased by
$590,000 with respect to the comparative period in 2009. This was driven by a
reduction in research and development expenditures with the completion of the
active phase of the TRIUMPH study and efforts to manage costs across the
Company. Overall, operating costs are expected to remain flat for the balance
of the year as the Company continues the development of PRX302 for the
treatment of benign prostatic hyperplasia ("BPH"). Protox anticipates that
their business development activities will decrease in the fourth quarter as a
result of securing Warburg Pincus as a funding partner.
The Company did not earn any license revenue during third quarter of
2010. However, the Company earned US$3.0 million (CAD$3.0 million) during the
nine months ended September 30, 2010 as a result of the Kissei license
agreement. The receipt of this revenue triggered a sub-license fee to John
Hopkins University and the University of Victoria of $210,000 under the terms
of their PORxin license agreement for BPH.
In the future, the Company is eligible to earn a near term milestone
payment of US$5 million and an additional US$67 million in milestone payments,
product supply revenues as well as drug supply fees and double digit royalties
on sales of PRX302 in Japan.
Research and development expenditures were $990,000 for the third quarter
of 2010, a decrease of $520,000 from $1.5 million over for the comparative
quarter in 2009. Year to date expenditures for the nine months ended
September 30, 2010 were $2.9 million compared to $4.4 million for the same
period in fiscal 2009. The decrease in research and development expenditures
for 2010-Q3 and for the nine months ended September 30, 2010 was due to the
maturing of the Company's current BPH program as the active phase of the lead
trial was completed during the third quarter of 2010 - the double-blinded
placebo controlled TRIUMPH study - compared to three active trials in the
third quarter of 2009.
For the remainder of the year, the Company expects to continue to incur
costs related to the further clinical, manufacturing and regulatory activities
associated with their PRX302 BPH program.
General and administrative ("G&A") costs for the third quarter of 2010
were $428,000, a decrease of 30% over the previous quarter and a modest
decrease compared to the same period in 2009. On a year-to-date basis, G&A
expenditures were $1.6 million for the nine months ended September 30, 2010 -
the same level as the comparative period in 2009. The decrease in the G&A
expenditures in the current quarter reflect the high level of activity
undertaken in the previous quarter with respect to the Kissei agreement. For
the remainder of the year, Protox expects the G&A expenditures to remain close
to the current levels.
At September 30, 2010, the Company had cash and cash equivalents of $5.0
million, representing an increase of $3.3 million from December 31, 2009. The
Company had net working capital of $4.0 million at September 30, 2010, an
increase of $3.2 million from December 31, 2009.
As at November 12, 2010, the Company has 96,303,443 common shares issued
and outstanding. In addition, the Company has 7,133,500 options outstanding
to purchase common shares of the Company. Of the options currently
outstanding, approximately 3.9 million are exercisable into an equivalent
number of common shares of the Company at exercise prices ranging from $0.50
to $0.87 and with an average exercise price of $0.65.
The Company also has 6,542,023 common share purchase warrants outstanding
which expire between May 2011 and March 2015 and entitle warrant holders to
purchase common shares at prices ranging between $0.27 and $0.65. Furthermore,
6,367,269 of these common share purchase warrants are subject to an
acceleration of the expiry date if the closing price of the underlying Common
Shares is higher than $1.75 per common share for a period of 10 consecutive
trading days.
For complete financial results, please see our filings at www.sedar.com.
About Protox Therapeutics Protox Therapeutics is a leader in advancing
novel, receptor targeted therapeutic fusion proteins. Two drug candidates
derived from the company's INxin(TM) and PORxin(TM) platforms are in clinical
development. Protox's lead program, PRX302 (PORxin), achieved positive
results from its Phase 2b placebo controlled trial called TRIUMPH, to treat
benign prostatic hyperplasia (BPH or enlarged prostate). Protox has partnered
with Kissei Pharmaceuticals for the development and commercialization of
PRX302 in Japan. PRX321 (INxin) is being developed for the treatment of
various cancers and has received Fast Track Designation and Orphan Drug Status
from the US FDA and EMA for the treatment of primary brain cancer. For more
information, please visit www.protoxtherapuetics.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks
and uncertainties identified by Protox in its public securities filings;
actual events may differ materially from current expectations. Protox
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
-30-
/For further information:
<<
James Beesley Senior Director, Michael Moore Investor Relations
Investor Relations Protox Equicom Group 619-467-7067
Therapeutics 604-484-0975 mmoore@equicomgroup.com
jbeesley@protoxtherapeutics.com
>>
PROTOX CLOSES FIRST $10 MILLION TRANCHE OF WARBURG PINCUS INVESTMENT
- Announces Changes to the Board -
VANCOUVER, Nov. 19 /CNW/ - Protox Therapeutics Inc. (the "Company" or
"Protox") (TSX: PRX), a leader in the development of receptor targeted
therapeutic fusion proteins, today announced it has closed the first tranche
of the investment by Warburg Pincus. The investment was approved by 100% of
the votes cast by shareholders at the recent special shareholders meeting. The
investment is being carried out under the terms of an investment agreement,
under which affiliates of Warburg Pincus will invest up to CDN $35 million in
Protox as set out in management's Information Circular dated October 12, 2010,
which was filed by Protox on the SEDAR website at www.sedar.com.
In conjunction with this closing, Drs. Jim Miller, Alex Giaquinto and
Avtar Dhillon have stepped down from the Board. Dr. Lars Ekman, a prominent
pharmaceutical industry veteran, will assume the Chairmanship of the Protox
Board and will be joined by Mr. Jonathan Leff, a Managing Director of Warburg
Pincus, and Dr. Nishan de Silva, a Principal of Warburg Pincus, as new
appointees to the Board. Mr. Frank Holler, the Chairman since 2003 will remain
on the Board as will Mr. Jim Heppell and Dr. Jack Geltosky. An additional
independent designate acceptable to the Company and Warburg Pincus, as well as
an additional Warburg Pincus designee will be appointed to the Board within 90
days of this closing.
"It is with the guidance and wisdom of Drs. Miller, Giaquinto and Dhillon
that Protox has achieved its current standing and for that we are deeply
thankful," said Dr. Fahar Merchant, President and CEO of Protox
Therapeutics. "I would also like to welcome all our new board members. We are
delighted to have Dr. Ekman as our new Chairman as he brings considerable
leadership, development and commercial expertise that will be of immense
benefit to Protox as we progress our lead PRX302 BPH program for marketing
authorization. We are also very grateful to Mr. Frank Holler, the founding
Chairman of the Board for his leadership, commitment and supporting the
management during the past six years. "
Dr. Lars Ekman is Founder & CEO of Cebix, an Executive-in-Residence of
Warburg Pincus and Executive Partner of Sofinnova Ventures. During 2001 to
2007, Dr. Ekman was EVP & President of Research & Development at Elan
Pharmaceuticals where he advanced Elan's drug development pipeline by securing
four US NDAs, three European MAAs and five INDs. Prior to joining Elan, Dr.
Ekman was EVP, Research and Development at Schwartz Pharma AG (now UCB) and
held various senior scientific and clinical functions from 1984 to 1997 at
Pharmacia (now Pfizer). Dr. Ekman is also a Director of Elan Corporation where
he chairs the Science and Technology Committee. He is also director of
InterMune Inc., Ocera Therapeutics, Inc., ARYx Therapeutics, Inc. and Amarin
Corporation. Dr. Ekman is a board certified surgeon with a Ph.D. in
experimental biology. He obtained his Ph.D. and M.D. from the University of
Gothenburg, Sweden.
Mr. Jonathan Leff is a Managing Director of Warburg Pincus where he
focuses on investments in healthcare. Prior to joining Warburg Pincus, he was
a consultant at Oliver, Wyman & Co. Mr. Leff received an A.B. in government
from Harvard University and an M.B.A. from the Stanford University Graduate
School of Business. Mr. Leff is a director of Allos Therapeutics, Inc., Hana
Biosciences, Inc., Inspire Pharmaceuticals, Inc., InterMune, Inc. and Rib-X.
Mr. Leff also serves on the Board of Directors of the Biotechnology Industry
Organization, and is chairman of the Medical Industry Group of the National
Venture Capital Association. In addition, Mr. Leff is a director of the Spinal
Muscular Atrophy Foundation and a member of the Executive Committee of the
Board of Visitors of Columbia University Medical Center.
Dr. Nishan de Silva is a principal with Warburg Pincus where he focuses
on investments in healthcare. Prior to joining Warburg Pincus, Dr. de Silva
worked at the Sprout Group in healthcare venture capital and at McKinsey &
Company in biotechnology and pharmaceutical strategy. He is also a Director of
Allos Therapeutics, Inc. and Hana Biosciences, Inc. Dr. de Silva holds a B.A.
in Biology from Harvard College, an M.D. from The University of Pennsylvania
School of Medicine and an M.B.A. from The Wharton School.
About Protox Protox Therapeutics is a leader in advancing novel, receptor
targeted therapeutic fusion proteins. Two drug candidates derived from the
company's INxin(TM) and PORxin(TM) platforms are in clinical development.
Protox's lead program, PRX302 (PORxin), achieved positive results from its
Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic
hyperplasia (BPH or enlarged prostate). Protox has partnered with Kissei
Pharmaceuticals for the development and commercialization of PRX302 in Japan.
PRX321 (INxin) is being developed for the treatment of various cancers and has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMEA for the treatment of primary brain cancer. For more information, please
visit www.protoxtherapuetics.com
About Warburg Pincus Warburg Pincus is a leading global private equity
firm. The firm has more than $30 billion in assets under management. Its
active portfolio of more than 110 companies is highly diversified by stage,
sector and geography. Warburg Pincus is a growth investor and an experienced
partner to management teams seeking to build durable companies with
sustainable value. Founded in 1966, Warburg Pincus has raised 13 private
equity funds which have invested more than $35 billion in approximately 600
companies in more than 30 countries. The firm has offices in Beijing,
Frankfurt, Hong Kong, London, Mumbai, New York, San Francisco, Sco Paulo, and
Shanghai. For more information, please visit www.warburgpincus.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information:
<<
James Beesley Investor Michael Moore Investor
Relations Protox Relations Equicom Group
Therapeutics 619-467-7067
604-813-0133 mmoore@equicomgroup.com
jbeesley@protoxtherapeutics.com
- Announces Changes to the Board -
VANCOUVER, Nov. 19 /CNW/ - Protox Therapeutics Inc. (the "Company" or
"Protox") (TSX: PRX), a leader in the development of receptor targeted
therapeutic fusion proteins, today announced it has closed the first tranche
of the investment by Warburg Pincus. The investment was approved by 100% of
the votes cast by shareholders at the recent special shareholders meeting. The
investment is being carried out under the terms of an investment agreement,
under which affiliates of Warburg Pincus will invest up to CDN $35 million in
Protox as set out in management's Information Circular dated October 12, 2010,
which was filed by Protox on the SEDAR website at www.sedar.com.
In conjunction with this closing, Drs. Jim Miller, Alex Giaquinto and
Avtar Dhillon have stepped down from the Board. Dr. Lars Ekman, a prominent
pharmaceutical industry veteran, will assume the Chairmanship of the Protox
Board and will be joined by Mr. Jonathan Leff, a Managing Director of Warburg
Pincus, and Dr. Nishan de Silva, a Principal of Warburg Pincus, as new
appointees to the Board. Mr. Frank Holler, the Chairman since 2003 will remain
on the Board as will Mr. Jim Heppell and Dr. Jack Geltosky. An additional
independent designate acceptable to the Company and Warburg Pincus, as well as
an additional Warburg Pincus designee will be appointed to the Board within 90
days of this closing.
"It is with the guidance and wisdom of Drs. Miller, Giaquinto and Dhillon
that Protox has achieved its current standing and for that we are deeply
thankful," said Dr. Fahar Merchant, President and CEO of Protox
Therapeutics. "I would also like to welcome all our new board members. We are
delighted to have Dr. Ekman as our new Chairman as he brings considerable
leadership, development and commercial expertise that will be of immense
benefit to Protox as we progress our lead PRX302 BPH program for marketing
authorization. We are also very grateful to Mr. Frank Holler, the founding
Chairman of the Board for his leadership, commitment and supporting the
management during the past six years. "
Dr. Lars Ekman is Founder & CEO of Cebix, an Executive-in-Residence of
Warburg Pincus and Executive Partner of Sofinnova Ventures. During 2001 to
2007, Dr. Ekman was EVP & President of Research & Development at Elan
Pharmaceuticals where he advanced Elan's drug development pipeline by securing
four US NDAs, three European MAAs and five INDs. Prior to joining Elan, Dr.
Ekman was EVP, Research and Development at Schwartz Pharma AG (now UCB) and
held various senior scientific and clinical functions from 1984 to 1997 at
Pharmacia (now Pfizer). Dr. Ekman is also a Director of Elan Corporation where
he chairs the Science and Technology Committee. He is also director of
InterMune Inc., Ocera Therapeutics, Inc., ARYx Therapeutics, Inc. and Amarin
Corporation. Dr. Ekman is a board certified surgeon with a Ph.D. in
experimental biology. He obtained his Ph.D. and M.D. from the University of
Gothenburg, Sweden.
Mr. Jonathan Leff is a Managing Director of Warburg Pincus where he
focuses on investments in healthcare. Prior to joining Warburg Pincus, he was
a consultant at Oliver, Wyman & Co. Mr. Leff received an A.B. in government
from Harvard University and an M.B.A. from the Stanford University Graduate
School of Business. Mr. Leff is a director of Allos Therapeutics, Inc., Hana
Biosciences, Inc., Inspire Pharmaceuticals, Inc., InterMune, Inc. and Rib-X.
Mr. Leff also serves on the Board of Directors of the Biotechnology Industry
Organization, and is chairman of the Medical Industry Group of the National
Venture Capital Association. In addition, Mr. Leff is a director of the Spinal
Muscular Atrophy Foundation and a member of the Executive Committee of the
Board of Visitors of Columbia University Medical Center.
Dr. Nishan de Silva is a principal with Warburg Pincus where he focuses
on investments in healthcare. Prior to joining Warburg Pincus, Dr. de Silva
worked at the Sprout Group in healthcare venture capital and at McKinsey &
Company in biotechnology and pharmaceutical strategy. He is also a Director of
Allos Therapeutics, Inc. and Hana Biosciences, Inc. Dr. de Silva holds a B.A.
in Biology from Harvard College, an M.D. from The University of Pennsylvania
School of Medicine and an M.B.A. from The Wharton School.
About Protox Protox Therapeutics is a leader in advancing novel, receptor
targeted therapeutic fusion proteins. Two drug candidates derived from the
company's INxin(TM) and PORxin(TM) platforms are in clinical development.
Protox's lead program, PRX302 (PORxin), achieved positive results from its
Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic
hyperplasia (BPH or enlarged prostate). Protox has partnered with Kissei
Pharmaceuticals for the development and commercialization of PRX302 in Japan.
PRX321 (INxin) is being developed for the treatment of various cancers and has
received Fast Track Designation and Orphan Drug Status from the US FDA and
EMEA for the treatment of primary brain cancer. For more information, please
visit www.protoxtherapuetics.com
About Warburg Pincus Warburg Pincus is a leading global private equity
firm. The firm has more than $30 billion in assets under management. Its
active portfolio of more than 110 companies is highly diversified by stage,
sector and geography. Warburg Pincus is a growth investor and an experienced
partner to management teams seeking to build durable companies with
sustainable value. Founded in 1966, Warburg Pincus has raised 13 private
equity funds which have invested more than $35 billion in approximately 600
companies in more than 30 countries. The firm has offices in Beijing,
Frankfurt, Hong Kong, London, Mumbai, New York, San Francisco, Sco Paulo, and
Shanghai. For more information, please visit www.warburgpincus.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
-30-
/For further information:
<<
James Beesley Investor Michael Moore Investor
Relations Protox Relations Equicom Group
Therapeutics 619-467-7067
604-813-0133 mmoore@equicomgroup.com
jbeesley@protoxtherapeutics.com
Hat jemand einen Realtime-Chart von TSE?
Danke, Gruß
Mephisto
Danke, Gruß
Mephisto
Im Bericht vom 2. Juni heißt es:
"Twelve-month results from the TRIUMPH study are expected in October 2010."
Weiß jemand,warum man noch nichts gehört hat?
"Twelve-month results from the TRIUMPH study are expected in October 2010."
Weiß jemand,warum man noch nichts gehört hat?
Antwort auf Beitrag Nr.: 40.599.828 von Milesint am 26.11.10 18:27:01Laut Unternehmensauskunft werden Ergebnisse der Triumph-Studie (12-Monatszeitraum) voraussichtlich Ende Dezember oder Anfang Januar bekannt gegeben.
Ich persönlich bin eher zuversichtlich, da ich mir nicht vorstellen kann, dass das Investment von Warburg Pincus zustande gekommen wäre, würde man dort am Erfolg von Protox zweifeln. -
Selbstverständlich soll damit jetzt keine Kaufempfehlung verbunden sein. Empfehlenswert scheint dagegen vor allem eins zu sein: Geduld!
Ich persönlich bin eher zuversichtlich, da ich mir nicht vorstellen kann, dass das Investment von Warburg Pincus zustande gekommen wäre, würde man dort am Erfolg von Protox zweifeln. -
Selbstverständlich soll damit jetzt keine Kaufempfehlung verbunden sein. Empfehlenswert scheint dagegen vor allem eins zu sein: Geduld!
eine Schläferaktie doch irgendwann ausm nichts springt sie hoch und rennt
viel Erfolg
viel Erfolg
finanznachrichten heute: (09.12.2010)
PROTOX ANNOUNCES PUBLICATION OF PRX302 CLINICAL DATA FOR BENIGN PROSTATIC HYPERPLASIA IN EUROPEAN UROLOGY
VANCOUVER, Dec. 9 /CNW/ - Protox Therapeutics Inc. (the "Company" or
"Protox") (TSX: PRX), a leader in the development of receptor targeted
therapeutic fusion proteins, today announced publication of positive safety
and efficacy results from the previously reported Phase 1 and 2 trials with
PRX302 in men with moderate to severe BPH (benign prostatic hyperplasia).
Senior author, Dr Sam Denmeade, together with his colleagues at Protox and
Study Investigators, published the results in the Journal, European Urology.
"Having the results of our PRX302 clinical program published in a
prestigious journal such as European Urology is a testament to the importance
of this underserved indication and the need to advance treatments such as
PRX302," said Dr. Fahar Merchant, President and CEO of Protox.
The article, entitled "Phase 1 and 2 Studies Demonstrate the Safety and
Efficacy of Intraprostatic Injection of PRX302 for the Targeted Treatment of
Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia" is
available on-line and can be viewed at:
http://www.europeanurology.com/article/S0302-2838(10)01093-6…
"In these studies, intraprostatic administration of PRX302 produced an
excellent safety profile with evidence of sustained relief of urinary symptoms
in men with moderate to severe BPH," said Dr. Sam Denmeade, Chief Scientific
Advisor of Protox. "These promising results have been further supported by a
randomized BPH study showing that PRX302 produced significant improvement in
urinary symptoms compared to an injected placebo. I believe that PRX302 is an
exciting new approach to an extremely common problem." Dr Denmeade is
co-inventor of PRX302 and Professor of Oncology at the Sidney Kimmel
Comprehensive Cancer Center at Johns Hopkins University School of Medicine.
The reduction in IPSS (International Prostate Symptom Score) with PRX302
in these studies was superior in magnitude to that observed with medical
therapies, which typically produce 3-6-point reductions in IPSS values. The
IPSS reduction resulting from PRX302 approached that observed for minimally
invasive surgical treatments (MIST), which typically reduce IPSS values by
10-12 points. Unlike MIST, PRX302 had no deleterious effect on erectile
function, blood pressure spikes or the need for catheterization. Adverse
events were mild to moderate and transient in nature. Ongoing follow-up of the
open label and placebo controlled study patients will provide further
information as to the expected duration of treatment effect on lower urinary
tract symptoms associated with BPH.
About PRX302
PRX302 is a prostate specific antigen (PSA)-activated pore-forming
protein toxin under development as a novel approach for improving lower
urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH)
without affecting sexual function. PSA is a protease uniquely produced by the
prostate, making PRX302 a novel, first-in-class, targeted pro-drug therapy for
BPH and prostate cancer.
About BPH
BPH is a common urological condition characterized by painful and
bothersome symptoms that include difficulty in initiating a urine stream, a
sense of urgency, dribbling, incomplete emptying of the bladder, waking
several times during the night to urinate and sometimes the presence of blood
in the urine. More than half of all men will have symptoms of BPH by the age
of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral
therapies mainly provide symptomatic relief and can trigger a range of side
effects including sexual dysfunction and hypotension. It is estimated that in
the seven largest global markets approximately 10 million men are treated
annually with oral therapies and these products encompass approximately U.S.
$4 billion of sales each year. Surgical options, including minimally invasive
surgical treatments (MIST), can cause sexual dysfunction, incontinence as well
as other more serious procedure-related effects. Surgical measures can require
hospitalization, significant recovery time and requires catheterization for
variable time intervals. Nearly 600,000 surgical procedures are conducted
annually in the seven largest markets.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
therapeutic fusion proteins. Two drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are in clinical development. Protox's lead
program, PRX302 (PORxin), achieved positive results from its Phase 2b placebo
controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or
enlarged prostate). Protox has partnered with Kissei Pharmaceuticals for the
development and commercialization of PRX302 in Japan. PRX321 (INxin) is being
developed for the treatment of various cancers and has received Fast Track
Designation and Orphan Drug Status from the US FDA and EMEA for the treatment
of primary brain cancer. For more information, please visit
www.protoxtherapuetics.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks
and uncertainties identified by Protox in its public securities filings;
actual events may differ materially from current expectations. Protox
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
To view this news release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/December2010/09/c…
-30-
/For further information:
<<
James Beesley Investor Relations Michael Moore Investor Relations
Protox Therapeutics 604-813-0133 Equicom Group 619-467-7067
jbeesley@protoxtherapeutics.com mmoore@equicomgroup.com
>>
PROTOX ANNOUNCES PUBLICATION OF PRX302 CLINICAL DATA FOR BENIGN PROSTATIC HYPERPLASIA IN EUROPEAN UROLOGY
VANCOUVER, Dec. 9 /CNW/ - Protox Therapeutics Inc. (the "Company" or
"Protox") (TSX: PRX), a leader in the development of receptor targeted
therapeutic fusion proteins, today announced publication of positive safety
and efficacy results from the previously reported Phase 1 and 2 trials with
PRX302 in men with moderate to severe BPH (benign prostatic hyperplasia).
Senior author, Dr Sam Denmeade, together with his colleagues at Protox and
Study Investigators, published the results in the Journal, European Urology.
"Having the results of our PRX302 clinical program published in a
prestigious journal such as European Urology is a testament to the importance
of this underserved indication and the need to advance treatments such as
PRX302," said Dr. Fahar Merchant, President and CEO of Protox.
The article, entitled "Phase 1 and 2 Studies Demonstrate the Safety and
Efficacy of Intraprostatic Injection of PRX302 for the Targeted Treatment of
Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia" is
available on-line and can be viewed at:
http://www.europeanurology.com/article/S0302-2838(10)01093-6…
"In these studies, intraprostatic administration of PRX302 produced an
excellent safety profile with evidence of sustained relief of urinary symptoms
in men with moderate to severe BPH," said Dr. Sam Denmeade, Chief Scientific
Advisor of Protox. "These promising results have been further supported by a
randomized BPH study showing that PRX302 produced significant improvement in
urinary symptoms compared to an injected placebo. I believe that PRX302 is an
exciting new approach to an extremely common problem." Dr Denmeade is
co-inventor of PRX302 and Professor of Oncology at the Sidney Kimmel
Comprehensive Cancer Center at Johns Hopkins University School of Medicine.
The reduction in IPSS (International Prostate Symptom Score) with PRX302
in these studies was superior in magnitude to that observed with medical
therapies, which typically produce 3-6-point reductions in IPSS values. The
IPSS reduction resulting from PRX302 approached that observed for minimally
invasive surgical treatments (MIST), which typically reduce IPSS values by
10-12 points. Unlike MIST, PRX302 had no deleterious effect on erectile
function, blood pressure spikes or the need for catheterization. Adverse
events were mild to moderate and transient in nature. Ongoing follow-up of the
open label and placebo controlled study patients will provide further
information as to the expected duration of treatment effect on lower urinary
tract symptoms associated with BPH.
About PRX302
PRX302 is a prostate specific antigen (PSA)-activated pore-forming
protein toxin under development as a novel approach for improving lower
urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH)
without affecting sexual function. PSA is a protease uniquely produced by the
prostate, making PRX302 a novel, first-in-class, targeted pro-drug therapy for
BPH and prostate cancer.
About BPH
BPH is a common urological condition characterized by painful and
bothersome symptoms that include difficulty in initiating a urine stream, a
sense of urgency, dribbling, incomplete emptying of the bladder, waking
several times during the night to urinate and sometimes the presence of blood
in the urine. More than half of all men will have symptoms of BPH by the age
of 60 and as many as 90% may suffer from BPH after the age of 80. Current oral
therapies mainly provide symptomatic relief and can trigger a range of side
effects including sexual dysfunction and hypotension. It is estimated that in
the seven largest global markets approximately 10 million men are treated
annually with oral therapies and these products encompass approximately U.S.
$4 billion of sales each year. Surgical options, including minimally invasive
surgical treatments (MIST), can cause sexual dysfunction, incontinence as well
as other more serious procedure-related effects. Surgical measures can require
hospitalization, significant recovery time and requires catheterization for
variable time intervals. Nearly 600,000 surgical procedures are conducted
annually in the seven largest markets.
About Protox
Protox Therapeutics is a leader in advancing novel, receptor targeted
therapeutic fusion proteins. Two drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are in clinical development. Protox's lead
program, PRX302 (PORxin), achieved positive results from its Phase 2b placebo
controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or
enlarged prostate). Protox has partnered with Kissei Pharmaceuticals for the
development and commercialization of PRX302 in Japan. PRX321 (INxin) is being
developed for the treatment of various cancers and has received Fast Track
Designation and Orphan Drug Status from the US FDA and EMEA for the treatment
of primary brain cancer. For more information, please visit
www.protoxtherapuetics.com
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks
and uncertainties identified by Protox in its public securities filings;
actual events may differ materially from current expectations. Protox
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
To view this news release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/December2010/09/c…
-30-
/For further information:
<<
James Beesley Investor Relations Michael Moore Investor Relations
Protox Therapeutics 604-813-0133 Equicom Group 619-467-7067
jbeesley@protoxtherapeutics.com mmoore@equicomgroup.com
>>
<a href="http://www.sweetim.com/s.asp?im=gen&lpver=3&ref=11" target="_blank"><img src="http://cdn.content.sweetim.com/sim/cpie/emoticons/000201D1.gif" border="0" title="Click to get more." ></a>
Protox steigt langsam aber sichér in den Börsenhimmel<a href="http://www.sweetim.com/s.asp?im=gen&lpver=3&ref=11" target="_blank"><img src="http://cdn.content.sweetim.com/sim/cpie/emoticons/000203C4.gif" border="0" title="Click to get more." ></a>
Protox steigt langsam aber sichér in den Börsenhimmel<a href="http://www.sweetim.com/s.asp?im=gen&lpver=3&ref=11" target="_blank"><img src="http://cdn.content.sweetim.com/sim/cpie/emoticons/000203C4.gif" border="0" title="Click to get more." ></a>
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