Teva and Oncogenex annouce initiation of second Phase 3 trial of Custirsen
Teva Pharmaceuticals Industries Ltd.and OncoGenex Pharmaceuticals, Inc. announced the initiation of SYNERGY, a global 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). The SYNERGY trial is the second of three Phase 3 trials to be initiated under a global collaboration and license agreement between Teva and OncoGenex to develop and commercialize custirsen.
The SYNERGY trial is a randomized, controlled, global Phase 3 trial to be conducted in approximately 125 cancer centers and with designated recruitment of 800 men 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.
The initiation of SATURN, the first Phase 3 trial with custirsen was announced by Teva and OncoGenex in June 2010. This global Phase 3 trial will enrol patients with metastatic CRPC who have previously responded to first line docetaxel/prednisone treatment but subsequently have disease progression that involves pain despite opioid usage.
Custirsen has received Fast Track designation from the U.S. Food and Drug Administration (FDA). Both the SATURN trial and the SYNERGY trial are being conducted through the Special Protocol Assessment (SPA) process. In addition, the European Medicines Agency indicated that the Committee for Medicinal Products for Human Use was in overall agreement with the custirsen development plan for commercialization.
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