12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from the U.S. FDA for the potential treatment of metastatic castration-resistant prostate cancer (CRPC).
Tokai recently completed ARMOR1, a Phase 1 proof-of-concept study of galeterone in patients with CRPC, part of the ARMOR (Androgen Receptor Modulation Optimized for Response) clinical development program, and Tokai plans to initiate a Phase 2 clinical trial in patients with CRPC in the second half of the year.