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news.Medivation and Astellas Pharma have completed patient recruitment in a randomised, double-blind, placebo-controlled Phase 3 Affirm study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy.
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Medivation and Astellas Pharma said that the trial is evaluating 160mg/day of MDV3100 versus placebo.
Conducted at sites in the US, Canada, Europe, Australia, South America and South Africa, the Phase 3 Affirm trial’s primary endpoint is overall survival, and secondary endpoints include progression-free survival, safety and tolerability.
Medivation chief medical officer Lynn Seely said that there has been a lot of positive news for advanced prostate cancer patients over this past year, and the completion of patient enrollment in Affirm is yet another significant achievement in the development of new therapies to treat this devastating disease.
Astellas Pharma Global Development president Steve Ryder said that while Affirm is focused on patients with the most advanced stage of disease, earlier stage prostate cancer patients are also in need of new treatment options.
"The first step in our expanded development of MDV3100 into earlier stage patients is our ongoing Phase 3 Prevail trial, in which we are studying advanced prostate cancer patients who are chemotherapy naive," Ryder said.
Medivation and Astellas entered into a global agreement to jointly develop and commercialise MDV3100 in October 2009.