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Tokai Pharmaceuticals Announces Updated Phase 2 Data on Galeterone in Patients with Advanced Prostate Cancer to be Presented at the ESMO 2014 Congress

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Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI) , a biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases, today announced that updated, interim results from the company’s ongoing Phase 2 clinical trial, ARMOR2, of its lead drug candidate, galeterone, in patients with castration resistant prostate cancer (CRPC) will be presented at the European Society for Medical Oncology (ESMO) 2014 Congress, September 26-30, in Madrid, Spain. The presentation entitled “Galeterone in 4 patient populations of men with CRPC: Results from ARMOR2″ will be presented by Mary-Ellen Taplin, M.D., associate professor of medicine, director of genitourinary clinical research, Dana-Farber Cancer Institute, Harvard Medical School, and co-principal investigator of ARMOR2, as an oral presentation on Monday, September 29, 2014 from 2:00 to 3:45pm (CEST).

About Galeterone

Galeterone is a highly selective, multi-targeted, oral small molecule drug candidate being developed for the treatment of castration-resistant prostate cancer that acts by disrupting androgen receptor (AR) signaling, the key driver of prostate cancer growth, via multiple mechanisms of action. Galeterone combines the mechanisms of action of CYP17 inhibition and androgen receptor antagonism with an additional mechanism of androgen receptor degradation. Current available therapies disrupt the pathway at a single point. To Tokai’s knowledge, galeterone is the only drug candidate in clinical trials that disrupts the pathway at multiple points.

About Tokai Pharmaceuticals

Tokai Pharmaceuticals is a biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases. The company’s lead drug candidate, galeterone, is a highly selective, multi-targeted, oral small molecule drug candidate being developed for the treatment of patients with 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 Tokai and galeterone, please visit www.tokaipharma.com.

Forward-looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, intellectual property, cash resources, financial position and projected costs, 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 the Company’s cash resources will be sufficient to fund the Company’s continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether galeterone will advance through the clinical trial process on the anticipated timeline and 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 the Company’s Registration Statement on Form S-1. In addition, the forward-looking statements included in this press release represent the Company’s views as of September 22, 2014. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to September 22, 2014.

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