OncoGenex updates Phase 3 SYNERGY trial of custirsen

theflyonthewall.com

OncoGenex Pharmaceuticals (OGXI) announced that the SYNERGY trial is continuing as planned per the recommendation of the Independent Data Monitoring Committee, or 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, or 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. OncoGenex and custirsen co-development and commercialization partner, Teva Pharmaceutical (TEVA), 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.

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