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Tokai Pharmaceuticals Announces Presentation of AR-V7 Clinical Trial Assay at the Prostate Cancer Foundation's Annual Scientific RetreatTokai Pharmaceuticals, Inc. (NASDAQ: TKAI), 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. About Tokai Pharmaceuticals Tokai Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases. The company's lead drug candidate, galeterone, is a highly selective, oral small molecule being developed for the treatment of patients with metastatic castration-resistant prostate cancer. The company's ARDA drug discovery program is focused on the identification and evaluation of compounds that are designed to disrupt androgen receptor signaling through enhanced androgen receptor degradation and are targeted to patients with androgen receptor signaling diseases, including prostate cancer. For more information on the company and galeterone, please visit www.tokaipharma.com. Forward-looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, intellectual property, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether our cash resources will be sufficient to fund our continuing operations for the period anticipated; whether data from early clinical trials of galeterone will be indicative of the data that will be obtained from future clinical trials; whether galeterone will advance through the clinical trial process on the anticipated timeline; whether a companion diagnostic based on an AR-V7 clinical trial assay can be developed successfully and on a timely basis; whether the results of ARMOR3-SV will warrant submission for regulatory approval of galeterone and whether such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if galeterone obtains such approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the three months ended June 30, 2015. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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