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news.Cougar Biotechnology, a developer of clinical stage drugs for the treatment of cancer, has signed an agreement with the FDA under a special protocol assessment for its planned Phase III clinical trial of the company's lead drug candidate CB7630 in patients with chemotherapy naive castration resistant prostate cancer.
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The special protocol assessment (SPA) is a written agreement between the company, as the trial’s sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis approach of the Phase III trial to be used in support of a new drug application (NDA).
The European Medicines Agency has also provided protocol advice consistent with that of the FDA regarding the company’s Phase III trial design and ability to support the submission of an EU market authorization application (MAA).
Pursuant to the SPA, the Phase III trial will be a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration resistant prostate cancer 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 agreed upon 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 an NDA/MAA for accelerated or conditional approval from the regulatory agencies. Cougar anticipates that it will begin patient enrollment in this Phase III trial later in first quarter of 2009.
Alan Auerbach, CEO and president of Cougar Biotechnology, said: Obtaining FDA agreement on the overall Phase III trial design, and more specifically patient population and primary endpoints, represents an important milestone in the global development of CB7630 and for Cougar as a company.