Tokai Pharmaceuticals Announces Presentation of AR-V7 Clinical Trial Assay at the Prostate Cancer Foundation's Annual Scientific Retreat

Tokai Pharmaceuticals, Inc.

, a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally-driven diseases, today announced that a detailed overview of its AR-V7 clinical trial assay will be presented tonight at a poster session during the 22nd Annual Prostate Cancer Foundation Scientific Retreat in Washington, DC. The AR-V7 clinical trial assay reliably detects both full-length androgen receptor (AR) and the AR-V7 splice variant under a variety of conditions in AR-positive circulating tumor cells of men with treatment-naïve metastatic castration resistant prostate cancer (mCRPC). The AR-V7 splice variant, a truncated form of the AR, has been associated with non-response to commonly-used oral therapies for mCRPC. The assay is currently being used to screen patients for eligibility to participate in ARMOR3-SV, Tokai's pivotal trial designed to evaluate whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to Xtandi® (enzalutamide) in 148 treatment-naïve, AR-V7+ mCRPC patients. Topline results from ARMOR3-SV are anticipated by the end of 2016. "We believe there is a significant unmet medical need for patients with AR-V7 positive metastatic castration resistant prostate cancer," said Karen J. Ferrante, M.D., Chief Medical Officer and Head of Research and Development of Tokai. "Given the Prostate Cancer Foundation's mission to accelerate research and heighten awareness of the disease, we are pleased to present our assay at its annual meeting. The assay is a critical component of our ARMOR3-SV trial, which is the first pivotal study in prostate cancer trial to employ a precision medicine approach for patient selection." A copy of the presentation will be available on the publications page of Tokai's website, www.tokaipharma.com.