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|March 08, 2012 4:00 p.m.|
|Teva and OncoGenex Announce Updates to Custirsen Development Program in Advanced Prostate Cancer|
Second Phase 3 Trial Evaluating Survival Benefit of Custirsen Planned to Initiate in 2012
In a revised agreement between the two companies, the clinical trial program will now include the initiation of a Phase 3 study to evaluate if custirsen has the potential to improve survival rates for prostate cancer patients when combined with the recently-approved, second-line chemotherapy drug Jevtana® (cabazitaxel).
The new trial, which aims to enroll approximately 630 men and is expected to begin later this year, will be conducted in lieu of the Prostate Cancer Saturn Study, a trial designed with a primary endpoint of measuring a durable pain palliation benefit for custirsen in second-line treatment of CRPC. The shift in focus to evaluate overall survival in second-line prostate cancer is a result of numerous, recently-approved agents that are redefining the standard of care in this patient setting.
"The amendments made to the Phase 3 program reflect the rapidly-evolving CRPC landscape and our commitment to ensure custirsen data are aligned with requirements to demonstrate improvements in survival across the treatment continuum," said
Custirsen's other Phase 3 study, SYNERGY, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year. The companies are increasing the enrollment from 800 to 1000 patients to optimize the potential to be submitted to regulatory agencies independent of additional Phase 3 studies. The increase in enrollment is not expected to alter timelines for completion of the study.
Additional details on the updates to the custirsen development program will be discussed during the OncoGenex Quarterly Earnings Call to be held this afternoon,
Custirsen is the only compound currently in development designed to inhibit the production of clusterin, a protein commonly over-produced in cancer cells, and one cause of treatment resistance. In Phase 2 trials of patients with metastatic CRPC, custirsen combined with docetaxel showed a 6.9 month improvement in overall survival over docetaxel alone. Additionally, 50 percent of patients experienced durable pain palliation for a duration of 12 weeks or longer. Custirsen has received Fast Track designation from the
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and
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This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial initiation and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that final trial results will not demonstrate the same or any potential benefit as observed in preliminary trial results, the risk that subsequent studies may not confirm earlier trial results, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Quarterly Report on Form 10-Q for third quarter ended September 30, 2011. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
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