Teva and OncoGenex announced the initiation of a Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC). This trial, known as the SYNERGY trial, is a randomized, controlled, global study being conducted at approximately 125 cancer centers in 800 patients with metastatic CRPC who have disease progression and require first-line docetaxel/prednisone chemotherapy. Patients will be randomized to receive treatment with either docetaxel/prednisone plus custirsen or with docetaxel/prednisone alone. The primary endpoint of the trial is to determine whether overall survival is longer in the custirsen treatment arm. The trial design is based on the Phase 2 trial results demonstrating clinical benefits of custirsen treatment with a hazard ratio consistent with a 49% reduction in the rate of death and a median overall survival of 23.8 months compared to 16.9 months.
Custirsen utilizes second-generation antisense technology to target and inhibit production of clusterin, a protein involved in resistance of cancer tumors to treatments.
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