MedivationMedivation, Inc has received written permission from the US 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 enrol 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, president and chief executive officer of Medivation. "We look forward to starting the trial and rapidly executing a comprehensive phase-3 development programme 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 is a novel small-molecule androgen receptor antagonist that inhibits androgen receptor function by blocking nuclear translocation of the androgen receptor and DNA binding.

Medivation is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options.