Tokai Pharmaceuticals has gained FDA fast track designation for galeterone (TOK-001) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC).
Galeterone disrupts androgen receptor (AR) signaling, the key driver of CRPC, through a novel triple mechanism of action.
The oral drug selectively inhibits CYP17 lyase to prevent testosterone synthesis, antagonizes testosterone binding to the AR and degrades the AR protein.
Tokai Pharmaceuticals president and chief executive officer Martin Williams said the company believes the FDA's decision further validates the potential therapeutic utility of galeterone for the treatment of prostate cancer.
"Despite recent progress in prostate cancer treatment, CRPC often becomes resistant to androgen deprivation therapy and galeterone's unique triple mechanism of action may offer an important therapeutic advance," Williams added.
"We are very encouraged by the recent positive results from our ARMOR1 clinical study, and we look forward to advancing galeterone into Phase 2 development in patients with CRPC later this year."
