Sep. 23, 2009 (PR Newswire) --
SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- 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.
Information about patient eligibility and enrollment can be obtained by calling the AFFIRM study hotline toll-free at 1-888-782-3256.
About MDV3100
MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer. The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more compIete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100.
