Medivation, Inc. (MDVN) has formally begun its phase III trial of the investigational drug MDV3100 with men who have advanced prostate cancer. The clinical trial known as AFFIRM will evaluate the novel androgen receptor antagonist, MDV3100, in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.
AFFIRM is a randomized, placebo-controlled, double-blind, multi-national trial that is expected to enroll approximately 1,200 men at sites in the United States, Canada, Europe, South America, Australia and South Africa. The primary endpoint of the trial is overall survival (the FDA’s gold standard). The secondary endpoints include progression-free survival, safety and tolerability.
MDV3100 works as an anti-androgen drug like bicalutamide (casodex) and it has shown to have an approximately five fold higher binding affinity for the androgen receptor (AR) compared to the commonly used antiandrogen, bicalutamide (casodex).