TOK-001 enters clinical trials for CRPC


A new, oral drug called TOK-001, made by Tokai Pharmaceuticals, will shortly enter Phase I/II clinical trials for the treatment of castration-resistant prostate cancer (CRPC).

According to a company media release, issued yesterday, TOK-001 combines three different mechanisms of action — each of which is known to have potential to disrupt the pathways that lead to progression of “normal” CRPC. TOK-001 acts as an androgen receptor antagonist; like ketoconazole and abiraterone actetate, TOK-001 also acts as a CYP17 lyase inhibitor; and TOK-001 can also decrease androgen receptor levels in prostate tumors.

The Phase I/II clinical program for initial evaluation of the activity of TOK-001 is known as the Androgen Receptor Modulation Optimized for Response or ARMOR program. In the first phase of the program (ARMOR1) investigators will assess the safety and efficacy of once-daily treatment with TOK-001 in 9 patients with CRPC. This phase of the study will evaluate escalating dose levels of TOK-001. The second phase of the trial (ARMOR2) will enroll about 40 patients, who will receive one of two target dosing regimens as identified by the Phase I results. The primary endpoints of the ARMOR program are safety and reduction in PSA levels from baseline levels measured at first visit. Patients who respond to TOK-001 therapy will have the opportunity to continue treatment after completion of the Phase I/II study.

For trial details, see the ClinicalTrials.gov web site. The trial is basically open to men with metastatic CRPC. For additional information, it is worth reading the article by Luke Timmerman on Xconomy.com. Tokai is based in Cambridge, MA.

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