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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
LOS ANGELES, CA, USA | April 29, 2008 | Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that it has started enrolling patients in its Phase III clinical trial (COU-AA-301) of the Company's lead drug candidate CB7630 (abiraterone acetate). 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 H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, said, "Commencing the Phase III trial of abiraterone acetate represents an important milestone in the global development of CB7630. The COU-AA-301 trial represents one of several options for registration of CB7630 in prostate cancer that Cougar intends to pursue. 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."
Arturo Molina, M.D., M.S., FACP, Cougar's Senior Vice President of Clinical Research and Development, added, "The results of our Phase II trials of CB7630 have shown strong evidence of antitumor activity in patients with metastatic, castration-resistant prostate cancer who have failed docetaxel-based chemotherapy; therefore, we are pleased to be able to initiate the COU-AA-301 trial in this patient population."
About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology company established to in-license and develop clinical stage drugs, with a specific focus on the field of oncology. Cougar's oncology portfolio includes CB7630, a targeted inhibitor of the 17-alpha hydroxylase/c17,20 lyase enzyme, which is currently being tested in Phase III clinical trials in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in multiple myeloma; and CB1089, an analog of vitamin D, which has been clinically tested in a number of solid tumor types.
SOURCE: COUGAR BIOTECHNOLOGY, INC. |
