Phase 3 study of MVD3100 for the treatment of advanced prostate cancer

Medivation, Inc. announced treatment of the first patient in a Phase 3 clinical trial of its investigational drug MDV3100 in advanced prostate cancer. This randomized, placebo-controlled, double-blind, multi-national trial (known as AFFIRM) is expected to enroll approximately 1,200 patients. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This study will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer (CRPC) who were previously treated with docetaxel-based chemotherapy.

MDV3100 is a triple-acting, oral anti-androgen that slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions. MDV3100 is designed to block testosterone binding to the androgen receptor, impede movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibit binding to DNA.

For more information please call (415) 543-3470 or visit www.medivation.com.