NOVELOS THERAPEUTICS INC Blockbuster oder nichr?!
Seite 36 von 51 Neuester Beitrag: 03.01.11 20:48 | ||||
Eröffnet am: | 09.03.09 22:34 | von: schmidt2000 | Anzahl Beiträge: | 2.262 |
Neuester Beitrag: | 03.01.11 20:48 | von: erdo | Leser gesamt: | 196.174 |
Forum: | Hot-Stocks | Leser heute: | 78 | |
Bewertet mit: | ||||
Seite: < 1 | ... | 33 | 34 | 35 | | 37 | 38 | 39 | ... 51 > |
als hätten Insider den Kurs gestern nochmal hochgepusht, um dann zu guten Preisen verkaufen zu können.
hat jemand informationen bzw. nen link zu den geschehnissen hier?
bzw warum stürzt der kurs ins bodenlose?
http://www.ariva.de/news/...eet-the-Primary-Survival-Endpoint-3293076
steck die kohle lieber in geely. ;-)
der rest ist ja im link weiter oben zu erlesen.
das ist die zweite genta!
habe die news mal gerade halbwegs übersetzt...die sind wirklich sehr schlecht.
Ich kenne das Unternehmen zu wenig um die Tragweite dieser zu erkennen.
oh mann, ridge hat vollkommen recht.
finger weg bis sich alles beruhigt hat. hier kann man sich momentan nur die finger verbrennen....
Hab Gott sei dank heut mittag ne größere posi verkauft, weil ich gedacht hab ich könnt abends billiger einsteigen. Denn rest konnt ich nur noch bei 0.37 loswerde. Ich hätte nicht gedacht, dass das Ziel verfehlt wird. Nicht einmal die 10 Monate erreicht...
Haben die Ergebnisse irgend welche Auswirkungen auf NOV-005?
Novelos Therapeutics Pivotal Phase 3 Lung Cancer Trial Does Not Meet the Primary Survival Endpoint
Detailed Trial Results Expected in 2010
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the primary endpoint of improvement in overall survival was not met in Novelos' pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy. Detailed trial results are expected to be presented via appropriate scientific venue later this year.
This randomized, controlled, open-label Phase 3 trial, conducted under a Special Protocol Assessment (SPA) and Fast Track designation, had enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, evaluated NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial was improvement in overall survival. Enrollment commenced in November 2006, target enrollment was achieved in March 2008, and the 725 event (patient death) was announced in early January 2010. According to the trial's Statistical Analysis Plan (SAP), a total of 725 events were required to detect a 25% improvement (12.5 months versus 10 months) in overall median survival (hazard ratio of 0.8) with 85% power and a two-sided significance level of 0.05. No interim analysis was performed.
"We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint," said Harry Palmin, President and CEO of Novelos. "We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions. In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents. We will conduct a thorough analysis of all the data, and expect to present detailed Phase 3 lung cancer trial results later this year. Meanwhile, we are scheduled to present new NOV-002 preclinical data at the AACR Annual Meeting in April 2010, and we are on track for results from a NOV-002 Phase 2 breast cancer trial in 3Q 2010. We are also on track to initiate a Phase 2 hepatitis C trial shortly, with our second compound NOV-205."
About NSCLC
NSCLC accounts for about 87% of lung cancer, which is the leading cause of cancer death in the U.S. According to the American Cancer Society, approximately 215,000 people were expected to be diagnosed with lung cancer in 2008 in the U.S., with approximately 162,000 deaths. Approximately 1,500,000 new cases of lung cancer were expected worldwide in 2007 and approximately 1,350,000 deaths were projected from lung cancer in 2007. Only about 16% of NSCLC patients are diagnosed early enough to be eligible for surgery. Platinum-based chemotherapy regimens are standard first-line treatment for advanced NSCLC patients. During treatment, patients are subject to serious chemotherapy-induced adverse effects. According to results of 12 Phase 3 clinical trials published from 2001-2008, the one-year survival rate for patients receiving paclitaxel and carboplatin first-line therapy was on average only about 40%, the weighted average for median survival was 9.7 months and the objective tumor response (defined as greater than 30% tumor shrinkage) rate was about 27%. Overall, fewer than 5% of advanced non-small cell lung cancer patients survive five years. Improving on the standard of care in unselected advanced NSCLC remains challenging and elusive.
About NOV-002 for NSCLC
NOV-002 is a small molecule compound based on a proprietary formulation of oxidized glutathione that acts together with chemotherapy as a chemopotentiator and a chemoprotectant by regulating redox-sensitive cell signaling pathways. The pivotal Phase 3 trial of NOV-002 in 903 advanced NSCLC patients in combination with first-line chemotherapy did not meet the primary endpoint of improvement in overall survival. Previously, three separate Phase 2 trials demonstrated clinical activity and safety of NOV-002 in combination with first-line chemotherapy in NSCLC. NOV-002 has an extensive safety database, and has also demonstrated improved recovery from chemotherapy toxicity in cancer patients. NOV-002 does not appear to be chemotherapy specific or tumor specific.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound that completed a Phase 3 trial for lung cancer, acts together with chemotherapy as a chemopotentiator and a chemoprotectant. NOV-002 is also in Phase 2 development for early-stage breast cancer and chemotherapy-resistant ovarian cancer. Novelos has a partnership with Mundipharma, an independent associated company of Purdue Pharma, to develop and commercialize NOV-002 in Europe and Asia (excluding China). Novelos' second compound, NOV-205, acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have been partnered with Lee's Pharm in China. For additional information about Novelos please visit www.novelos.com.
Novelos Therapeutics, Inc.
One Gateway Center, Suite 504
Newton, MA 02458
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
Contacts:
Novelos Therapeutics, Inc.
COMPANY
Harry S. Palmin, 617-244-1616 x11
President and CEO
hpalmin@novelos.com
or
INVESTOR RELATIONS
Stephen Lichaw, 201-240-3200
slichaw@novelos.com
Diese randomisierte, kontrollierte, offene Phase-3-Studie, im Rahmen eines "Special Protocol Assessment (SPA) und Fast-Track-Einstufung durchgeführt hatte 903 Patienten mit Stadium IIIB / IV NSCLC, die alle histologischen Untergruppen umfasst eingetragen sind. Der Prozess führte über rund 100 Studienzentren in 12 Ländern ausgewertet, NOV-002 in Kombination mit First-Line-Paclitaxel und Carboplatin-Chemotherapie im Vergleich zu Paclitaxel und Carboplatin allein. Der primäre Endpunkt der Studie war die Verbesserung im Gesamtüberleben. Einschreibung begann im November 2006 wurde das Rekrutierungsziel März 2008 erreicht, und die 725-Ereignis (Tod Patienten) wurde angekündigt, Anfang Januar 2010. Nach den Studien Statistical Analysis Plan (SAP), insgesamt 725 Veranstaltungen waren erforderlich, um eine 25% ige Verbesserung zu erkennen (12,5 Monate versus 10 Monate) in insgesamt mediane Überleben (Hazard Ratio 0,8) mit 85% mehr Leistung und ein zweiseitiges Signifikanzniveau von 0,05. Nr. vorläufigen Analyse durchgeführt wurde.
Wir sind sehr enttäuscht, dass unsere Zulassungsstudie der Phase 3 Lungenkrebs-Studie nicht den primären Endpunkt Überleben, sagte Harry Palmin, President und CEO von Novelos. Wir waren von einem positiven Ergebnis auf unsere statistischen Modellrechnungen und erklärte Annahmen hoffnungsvoll. Im Rückblick scheint es, unseren Simulationen wurden durch ungenaue Daten vor Gericht abweichend von unseren statistisches Modell, die Auswirkungen der Zensur Muster und Kontrollgruppe Überleben über unseren Erwartungen auf historische Präzedenzfälle basiert. Wir werden eine gründliche Analyse aller Daten führen, und erwarten, dass detaillierte gegenwärtigen Phase 3 Lungenkrebsstudie Ergebnisse noch in diesem Jahr. Mittlerweile sind wir voraussichtlich vor neue NOV-002 präklinischen Daten auf der AACR-Jahrestagung im April 2010, und wir sind auf dem richtigen Weg für die Ergebnisse aus einer NOV-002 Phase-2-Brustkrebs-Studie im 3. Quartal 2010. Wir sind auch auf dem Weg, ein Phase-2-Hepatitis-C-Studie einzuleiten, kurz, mit unserem zweiten Verbindung NOV-205.
daher wollte ich ja auch auf die entsprechenden news warten. denn es hätte sich, bei einer positiven meldung, immer noch ein aufsprung gelohnt.
so wird das eine zweite genta. aber bis hier mal ein gescheiter zock geht, werde ich vorerst mal meine kohle woanders reinstecken.
ich werde hier das geschehen weiterhin beobachten.
Die eventuelle Zulassung war im Preis inkludiert. Jetzt lieferte die Phase 3 kein Ergebnis wie erhofft...und schon fällt das Kartenhaus zusammen.
PS was sagen den Storm und kleiner Prinz jetzt dazu? Immer noch so euphorisch?
Novelos lung-cancer drug trial falls shortBoston Business Journal - by Craig M. Douglas
Print Email Reprints RSS Feeds LinkedIn Share Send this story to a friend
Email address of friend (insert comma between multiple addresses):
Your email address:
Add a brief note:
Enter words from the security image above:
Get new image | Image verificationAudio verification | reCAPTCHA™
Related News
Novelos commences plan to raise $9M
Drug developer Novelos Therapeutics Inc. said its recent phase-3 trial for a new lung-cancer drug candidate failed due to inaccurate statistical modeling leading up to the testing.
The Newton, Mass.-based company said the results for its NOV-002 cancer therapy in patients with advanced non-small cell lung cancer were received Feb. 23. and will be formally presented at an “appropriate” scientific venue later this year.
“Upon evaluation and review of the data contained in the report, we determined that the primary endpoint of improvement in overall survival was not met in the trial,” the company said in a regulatory filing Wednesday.
Among the reasons cited for the failed trial, Novelos said flawed “internal simulations” and higher-than-expected survival rates among patients in its control arm were largely to blame.
Novelos (OTC: NVLT) booked $77 million in revenue and a net loss of $9.4 million in the nine months ended Sept. 30.