It is probably still years off, but it is worth watching. Galetrone (TOK-001) has just completed phase II trials with the results scheduled to be released at ASCO-GU at the end of the month. I will be attending this conference and will be present for their presentation and report it to you from the conference. From listening to the excitement in the air we will probably find out that the results of this investigational treatment are excellent (or so we hope).
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. In preclinical studies TOK-001 have inhibited CYP17 lyase to prevent testosterone synthesis, antagonizes testosterone binding to the AR and degrades the AR protein, a triple play.
The FDA has given TOK-001 fast tract status which should speed its testing and then hopefully its approval for the treatment of us men with advanced prostate cancer.
The trial is referred to as ARMOR (Androgen Receptor Modulation Optimized for Response). ARMOR is evaluating the efficacy and safety of a new oral formulation of TOK-001 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.
The men who respond to therapy will have the opportunity to continue treatment in an extension arm of the trial. ARMOR2 is being conducted globally.
TOK-001 is a potential new treatment which needs our careful watching.
Joel T. Nowak, M.A., M.S.W.