16.09.2014 12:42:42
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OncoGenex Completes Patient Enrollment In Phase 3 Trial Of Custirsen
(RTTNews) - OncoGenex Pharmaceuticals, Inc. (OGXI) Tuesday said it has finished patient enrollment in its Phase 3 AFFINITY trial, which evaluates the potential of Custirsen to improve survival outcomes in men with metastatic castrate-resistant prostate cancer or CRPC. AFFINITY trial is an international, randomized, open-label study in which 630 patients have been randomized to receive second-line Jevtana and prednisone with or without custirsen. The company said timing of the survival primary endpoint data is event-driven and results are expected in late 2015 or early 2016.
Earlier, the U.S. Food and Drug Administration or FDA had granted fast track designation for the evaluation of Custirsen in the AFFINITY trial.
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