Tokai Pharmaceuticals announced that galeterone (TOK-001) has received Fast Track designation from the 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.

Galeterone is an oral drug for the treatment of prostate cancer that disrupts androgen receptor signaling via a novel triple mechanism of action. In preclinical studies, galeterone works via three mechanisms of action, acting as a highly selective CYP17 lyase inhibitor, as an androgen receptor antagonist, and decreasing androgen receptor levels in prostate tumors.

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