Medivation, Astellas enroll 1,199 patients in MDV3100 Phase 3 AFFIRM study in advanced prostate cancer

Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. today announced that patient enrollment was completed on November 15, 2010 in the Phase 3 AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy.  The companies also announced that clinical development of MDV3100 in Japan has commenced, with the initiation of patient dosing in a Phase 1-2 clinical study.

"There has been a lot of positive news for advanced prostate cancer patients over this past year, and the completion of patient enrollment in AFFIRM is yet another significant achievement in the development of new therapies to treat this devastating disease," said Lynn Seely, M.D., chief medical officer of Medivation.  

"While AFFIRM is focused on patients with the most advanced stage of disease, earlier stage prostate cancer patients are also in need of new treatment options," said Steve Ryder, MD, president, Astellas Pharma Global Development. "The first step in our expanded development of MDV3100 into earlier stage patients is our ongoing Phase 3 PREVAIL trial, in which we are studying advanced prostate cancer patients who are chemotherapy naive. In addition, we and our partner Medivation plan to initiate two Phase 2 trials in earlier stage prostate cancer early next year."

The randomized, double-blind, placebo-controlled Phase 3 AFFIRM study enrolled 1,199 patients. The trial is evaluating 160 mg/day of MDV3100 versus placebo. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, safety and tolerability. The AFFIRM study is being conducted at sites in the United States, Canada, Europe, Australia, South America and South Africa.