On November 7, 2015 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported the presentation of new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models expressing the androgen receptor (AR) splice variant AR-V7 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston (Press release, Tokai Pharmaceuticals, NOV 7, 2015, View Source;p=RssLanding&cat=news&id=2110153 [SID:1234508097]).
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Today’s presentation supports earlier clinical findings of positive results with galeterone in men with treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) whose prostate tumors have C-terminal loss—the loss of the portion of the AR that contains the ligand binding domain. C-terminal loss, generally, and AR-V7, specifically, have been associated with non-response to abiraterone (Zytiga) and enzalutamide (Xtandi) in mCRPC. The AR-V7 splice variant is believed to be the most common form of C-terminal loss.
Tokai is evaluating galeterone in ARMOR3-SV, an ongoing pivotal trial designed to determine whether treatment with galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide in approximately 148 treatment-naïve, AR-V7+ mCRPC patients. Topline results from ARMOR3-SV are anticipated by the end of 2016.