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Cougar Biotechnology, Inc. (CGRB) announced the initiation of a Phase III clinical trial (COU-AA-302) of its lead drug candidate CB7630 (abiraterone acetate) in patients with chemotherapy-naive castration-resistant prostate cancer (CRPC). The COU-AA-302 Phase III trial is a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic CRPC who have not yet received treatment with chemotherapy. The trial is expected to enroll approximately 1,000 patients who will be randomized (1:1) to receive either CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia. The co-primary endpoints of the trial are progression free survival and overall survival. The Company plans to use the progression free survival data from the trial as the basis for submission of a New Drug Application and a Marketing Authorization Application for Accelerated and Conditional Approval from the regulatory agencies.
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