BOTHELL, Wash. and VANCOUVER, British Columbia, Nov. 6, 2012 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today the completion of patient enrollment in the primary registration Phase 3 study, known as SYNERGY, evaluating custirsen in patients with advanced prostate cancer.
The SYNERGY study is designed to evaluate a survival benefit for custirsen, when added to first-line chemotherapy, in men with metastatic castrate-resistant prostate cancer (mCRPC). The SYNERGY study is the first of two, ongoing, pivotal Phase 3 studies evaluating a potential survival benefit for custirsen treatment in prostate cancer.
Over 1000 men have been enrolled to the SYNERGY study, at 142 sites primarily in North America and Europe. The survival primary endpoint data are event-driven and results are expected by the end of 2013.
"Completing enrollment of SYNERGY is an exciting and important milestone for the custirsen development program and for our company," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "We are one step closer to our goal of truly understanding the clinical benefit of custirsen in a large, randomized Phase 3 study, and to bringing forward a new treatment that could potentially extend the lives of men with prostate cancer."
The SYNERGY trial was initiated based on results of the OncoGenex Phase 2 trial in patients with metastatic CRPC receiving custirsen in combination with first-line docetaxel chemotherapy. These patients experienced a 6.9 month improvement in overall survival in comparison with those patients who received docetaxel alone.
Custirsen has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel. The FDA has also agreed on the design of the SYNERGY trial through the special protocol assessment (SPA) p
|SOURCE OncoGenex Pharmaceuticals, Inc.|
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