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February 11, 2014
06:11 EDTOGXIOncoGenex reports target number of events reached in Phase 3 SYNERGY trial
OncoGenex Pharmaceuticals announced that the pre-specified number of events required for final analysis of the Phase 3 SYNERGY trial has been reached. The primary efficacy endpoint of SYNERGY will analyze overall survival benefit for custirsen in combination with standard first-line docetaxel chemotherapy and prednisone in men with metastatic castrate-resistant prostate cancer. Overall survival results will remain blinded until all study data have been thoroughly reviewed and prepared for final analysis. Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel/prednisone. The FDA also agreed on the design of the SYNERGY trial via the Special Protocol Assessment process.
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September 16, 2014
06:32 EDTOGXIOncoGenex completes patient enrollment in Phase 3 AFFINITY trial
OncoGenex Pharmaceuticals announced that patient enrollment has been completed in the Phase 3 AFFINITY trial. The international, randomized, open-label Phase 3 AFFINITY trial is designed to evaluate the potential of custirsen to improve survival outcomes in approximately 630 men with metastatic castrate-resistant prostate cancer. Patients have been randomized to receive second-line Jevtana and prednisone with or without custirsen.

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