Medivation commences patient treatment in clinical trial of MDV3100 in advanced prostate cancer

Medivation, Inc. (Nasdaq: MDVN) today announced treatment of the first patient in a Phase 3 clinical trial of the investigational drug MDV3100 in advanced prostate cancer. Known as AFFIRM, the trial will evaluate the novel androgen receptor antagonist MDV3100 in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

"Late stage prostate cancer remains an obvious and large unmet clinical need," said David Hung, M.D., president and chief executive officer of Medivation. "However, many earlier stage prostate cancers are also inadequately treated, as evidenced by their progression, often rapidly, to late stage disease. Our ultimate goal is to develop MDV3100 for the broadest possible spectrum of prostate cancer disease states. The first step is to develop this product candidate for patients with the most advanced disease and in greatest need. However, we believe that patients with earlier-stage disease may also benefit given the attributes of MDV3100, and we look forward to expanding development to include those patients in potential future studies."

The randomized, placebo-controlled, double-blind, multi-national AFFIRM trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo.