Medivation Receives FDA Permission to Initiate Phase 3 Trial of MDV3100 in Castration-Resistant Prost...( SAN FRANCISCO March 18 /- Medivation ...),Health

SAN FRANCISCO, March 18 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that it has received written permission from the U.S. Food and Drug Administration (FDA) to begin a pivotal Phase 3 trial of MDV3100, its novel androgen receptor antagonist, in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed docetaxel-based chemotherapy. The placebo-controlled, double-blind, multinational trial will enroll approximately 1,200 patients who will be randomized (2:1) to receive either MDV3100 or placebo. The primary endpoint of the trial will be overall survival.

"This is a significant milestone in the development of this important novel investigational drug," said David T. Hung, M.D., president and chief executive officer of Medivation. "We look forward to starting the trial and rapidly executing a comprehensive Phase 3 development program for MDV3100. Given the encouraging results seen to date in our ongoing Phase 1-2 trial and the limited life expectancy of men with CRPC who have failed chemotherapy, we will work to begin the Phase 3 clinical development of MDV3100 as quickly as possible this year."

The FDA informed the Company that it could test a dose of MDV3100 up to 240mg/day. There are no driving or other restrictions placed on the activities of participants in the trial. Final trial specifics will be announced when the first patient is enrolled.

MDV3100 Ongoing Phase 1-2 Trial

MDV3100 is being evaluated in an ongoing open-label, U.S., Phase 1-2 study of a total of 140 men with CRPC. Patients in this trial were heavily pretreated, with all having failed standard hormonal therapies and many having also failed docetaxel-based chemotherapy. MDV3100 has consistently demonstrated encouraging anti-tumor activity across dose levels and endpoints
'/>"/>