Cougar Biotech and FDA agree on new abiraterone trial

According to MarketWatch, Cougar Biotechnology has announced agreement with the US Food & Drug Administration regarding the structure of another Phase III trial of abiraterone acetate in prostate cancer.

The currently ongoing Phase III trial of abiraterone acetate has been restricted to patients who had already failed at least one docetaxel-containing drug regimen. In other words, it was restricted to patients very late in the disease state.

The new Phase III trial will be enrolling approximately 1,000 patients who are chemotherapy-naive, i.e. patients who have failed standard forms of hormone therapy and are “castration resistant” but who have yet to receive any form of chemotherapy. Such a trial, if it gives a positive result, would offer the potential for approval of abiraterone acetate for use significantly earlier in the course of the disease.

The trial will be a randomized, double-blind, placebo-controlled trial of abiraterone acetate (CB7630) plus prednisone in patients with metastatic, castration-resistant prostate cancer who have not yet received treatment with chemotherapy. Patients will be randomized (1:1) to receive either abiraterone acetate 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 this new trial will be progression-free survival and overall survival. Cougar Biotechnology expects to start enrollment of patients into this trial before the end of March 2009.

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