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news.Cougar Biotechnology has started enrolling patients in its Phase III clinical trial of the company's lead drug candidate CB7630.
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The Phase III trial is a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy. Similar to the patient populations in Cougar’s Phase II trials COU-AA-003 and COU-AA-004, patients are allowed to have received up to two prior chemotherapy regimens before entering the trial.
The trial will enroll approximately 1,160 patients who will be randomized (2:1) 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 primary endpoint of the trial will be overall survival.
Alan Auerbach, CEO and President of Cougar Biotechnology, said: “We also look forward to pursuing additional registration opportunities for CB7630, including a potential Phase III trial of the drug in patients with castration-resistant, chemotherapy-naïve prostate cancer, which we anticipate initiating in the second half of 2008.”