Tokai Pharmaceuticals' Galeterone Receives Fast Track Designation from the FDA for the Treatment of Advanced Prostate Cancer

Published: Jun 12, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate, galeterone (TOK-001), has received Fast Track designation from the U.S. Food and Drug Administration (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.

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