Tokai Pharma Announces Initiation Of Phase 3 ARMOR3-SV Trial Of Galeterone

(RTTNews) - Tokai Pharmaceuticals, Inc. (TKAI) announced the initiation of ARMOR3-SV, Tokai's pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC.

ARMOR3-SV will compare galeterone to Xtandi (enzalutamide) in 148 mCRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant. The primary endpoint of ARMOR3-SV is radiographic progression-free survival assessed by blinded independent central review.

ARMOR3-SV has been initiated at more than 15 sites in the United States, with site initiations in Canada and the United Kingdom anticipated later in June. The company expects topline data from ARMOR3-SV to be available by the end of 2016.

Tokai also announced that the components of the AR-V7 clinical trial assay have been finalized by its collaborator, Qiagen (QGEN), and that global deployment of the assay is now underway.