A major breakthrough is about to be released that has received Fast Track designation from the U.S. Food and Drug Administration (FDA) to speed development as a potential treatment of CRPC.
ARMOR (Androgen Receptor Modulation Optimized for Response) is Tokai’s clinical development program for the evaluation of galeterone (TOK-001) in patients with castration-resistant prostate cancer (CRPC). Galeterone (TOK-001) is a first-in-class, multi-targeted, small molecule, oral drug for the treatment of castration-resistant prostate cancer (CRPC) that disrupts androgen receptor (AR) signaling, the key driver of CRPC, via a novel triple mechanism of action. Preclinical studies have shown that galeterone selectively inhibits CYP17 lyase to prevent testosterone synthesis, antagonizes testosterone binding to the AR and degrades the AR protein. Galeterone is currently being evaluated in a Phase 2 study in patients with CRPC.
Phase 2 clinical trial evaluating the efficacy and safety of a new oral formulation of galeterone in four distinct populations of CRPC patients: 1) metastatic treatment-naïve patients; 2) non-metastatic treatment-naïve patients; 3) patients who have progressed while taking Zytiga® (abiraterone acetate) and 4) patients who have progressed while taking Xtandi® (enzalutamide). The primary endpoints of the study are reduction in prostate-specific antigen (PSA) levels and safety. The secondary endpoints include tumor responses by RECIST, levels of circulating tumor cells and markers of CYP17 lyase inhibition and AR modulation. Patients who respond to therapy will have the opportunity to continue treatment in an extension arm of the trial. ARMOR2 is being conducted globally at leading prostate cancer treatment centers.
Galeterone was reformulated prior to the initiation of the ARMOR2 clinical trial in order to increase the drug exposure and mitigate the effect of food on oral bioavailability. The new formulation has been shown to be unaffected by diet, and therefore can be taken with or without food.
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