Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Sep 29 2010

Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. today announced treatment of the first patient in a second Phase 3 clinical trial of the investigational drug MDV3100, which expands the Phase 3 development of the novel, triple-acting oral androgen receptor antagonist into an earlier-stage patient population.  Known as PREVAIL, the trial will evaluate MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy.  Initiation of the PREVAIL trial triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

"Because patients with both early and advanced  prostate cancer are in need of new treatment options, our goal is to develop MDV3100 for the broadest possible spectrum of disease states," said David Hung, MD, president and chief executive officer of Medivation. "The initiation of the PREVAIL trial marks our expansion of Phase 3 development of MDV3100 into men with advanced prostate cancer who have not yet received chemotherapy.  The PREVAIL trial complements our ongoing Phase 3 AFFIRM trial, which is studying men with advanced prostate cancer who have previously failed chemotherapy.  We remain on track to complete enrollment in the AFFIRM trial by the end of this year."

"We are pleased to expand the MDV3100 program to evaluate the potential benefit of this promising developmental drug candidate given its unique mechanism and differentiating attributes," said Steve Ryder, MD, president, Astellas Pharma Global Development. "We believe that MDV3100 has the potential to establish a new treatment approach for prostate cancer and we look forward to initiating further trials evaluating this exciting new agent."

The randomized, double-blind, placebo-controlled, multi-national Phase 3 PREVAIL trial is expected to enroll approximately 1,700 patients at sites in the United States, Canada, Europe, Australia and Israel.  PREVAIL will enroll patients with metastatic prostate cancer who are progressing despite treatment with androgen deprivation therapy.  The co-primary endpoints of the trial are overall survival and progression-free survival; secondary endpoints include time to first skeletal-related event and time to initiation of cytotoxic chemotherapy. The trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.  Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363.