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Tokai Pharmaceuticals Announces Presentations at the 2015 Genitourinary Cancers Symposium

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Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI) , a clinical-stage biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally driven diseases, today announced the supporting of a CME course discussing AR-V7 in prostate cancer and a poster presentation of the design and rationale for ARMOR3-SV, the planned pivotal Phase 3 trial of galeterone in AR-V7 positive castrate-resistant prostate cancer (CRPC) patients, at the 2015 Genitourinary Cancers Symposium (ASCO GU) in Orlando, Florida.

  • Data and Perspectives: Clinical Investigators Review Key Publications and Current Cases in Advanced Prostate Cancer (Thursday, February 26, 2015; 7-9pm; Rosen Shingle Creek, Panzacola H, Level 1)
  • Abstract 259: Androgen Receptor Modulation Optimized for Response in Splice Variant (ARMOR3-SV): A Randomized, Open-Label, Multicenter, Controlled Study of Galeterone Compared with Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate-Resistant Prostate Cancer (CRPC) (Board #D2, Gatlin Ballroom B; Friday, February 27, 2015; 12:15-1:45pm, 6-7pm)

“We are pleased to present ARMOR3-SV protocol details as well as supportive data that provides the rationale for galeterone as a treatment for the AR-V7 positive patient population,” stated Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. “We believe the ARMOR3-SV trial will support the use of galeterone in AR-V7 patients who have been shown to have significant unmet need given their poor responses to existing hormonal agents. Final preparations of the AR-V7 assay and trial center start-up are underway and we remain on track to begin enrolling patients in the first half of this year.”

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 the company and galeterone, please visit

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, 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 data from early clinical trials 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, including whether ARMOR3-SV will be initiated when anticipated; whether a companion diagnostic 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 the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2014. In addition, the forward-looking statements included in this press release represent the Company’s views as of February 26, 2015. The Company anticipates that subsequent events and developments may 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 February 26, 2015.

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