SYNERGY Trial to Continue as Planned Following Completion of Interim Efficacy Analysis
BOTHELL, Wash. and VANCOUVER, British Columbia, Nov. 19, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that the SYNERGY trial is continuing as planned per the recommendation of the Independent Data Monitoring Committee (IDMC).
The primary registration Phase 3 SYNERGY trial is designed to evaluate a survival benefit for custirsen in combination with first-line docetaxel chemotherapy in men with metastatic castrate-resistant prostate cancer (CRPC). Approximately 1,023 men have been enrolled to SYNERGY at 140 sites primarily in North America and Europe. SYNERGY completed enrollment in 2012 and final survival results are expected to be announced by mid-2014.
"The recommendation for SYNERGY to continue to final analysis is not surprising as the criteria to achieve statistical significance on the interim are considerably more stringent than the criteria required for the final analysis," stated Scott Cormack, President and CEO of OncoGenex. "We do not believe these results can be interpreted to predict the final outcome of SYNERGY and we eagerly anticipate the reporting of final survival results next year."
OncoGenex and custirsen co-development and commercialization partner, Teva Pharmaceutical Industries, Ltd., continue to remain blinded to all SYNERGY data and analyses, including details regarding survival and statistical evaluations. The IDMC also remains blinded to the details of the interim efficacy data and analyses.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new 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 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is currently being evaluated in seven randomized Phase 2 trials for a variety of cancers and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company's Twitter account: https://twitter.com/OncoGenex_IR.
OncoGenex' Forward Looking Statements
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 completion and reporting of results 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, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, 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 candidates 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 the quarter ended September, 2013. 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.
SOURCE OncoGenex Pharmaceuticals, Inc.