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Tokai Pharmaceuticals Presents Updated Phase 2 Data on Galeterone in Patients with Advanced Prostate Cancer at ESMO 2014

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Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI) today announced updated interim results from its ongoing Phase 2 clinical trial, ARMOR2, evaluating galeterone as a treatment for patients with castration-resistant prostate cancer (CRPC). These data demonstrated clinically meaningful reductions in prostate-specific androgen (PSA) levels, a marker of prostate cancer growth. Expanded data in patients with C-terminal loss also provide additional support for galeterone’s potential activity in CRPC patients whose tumors express androgen receptor (AR) splice variants, which are believed to be associated with resistance to hormonal agents commonly used to treat CRPC.

The data were presented today at the European Society for Medical Oncology (ESMO) 2014 Annual Meeting in Madrid in an oral presentation titled “Galeterone in Four Castrate Resistant Prostate Cancer (CRPC) Populations: Results from ARMOR2″ 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.

“Resistance to therapy is among the most important clinical challenges we face in treating patients with advanced prostate cancer, making the need for new treatment options a critical priority,” said Dr. Taplin. “These updated results continue to show clinically meaningful reductions in PSA levels in patients treated with galeterone, and I believe provide additional support for galeterone’s clinical potential in addressing androgen receptor splice variants that are believed to be associated with treatment resistance to agents commonly used in the treatment of CRPC.”

Additional Data from ARMOR2

The ongoing ARMOR2 trial, for which enrollment is now complete, is a two-part Phase 2 study designed to confirm the dose of galeterone (Part 1) and demonstrate safety and efficacy in distinct CRPC patient cohorts (Part 2). At the conclusion of Part 1 of the study, a once-daily galeterone dose of 2550 mg was selected for Part 2 based upon review of safety, efficacy and pharmacokinetic data.

The interim results presented include data that was collected as of August 15, 2014 on 107 patients in Part 1 and Part 2 of the trial who were treated with galeterone at a daily dose of 2550 mg. Among 39 treatment na”ive metastatic CRPC patients, 85% achieved a maximal reduction in PSA levels of at least 30% (PSA30) and 77% achieved a maximal reduction in PSA levels of at least 50% (PSA50). Among 60 combined non-metastatic and metastatic treatment na”ive CRPC patients, 83% achieved a PSA30 and 70% achieved a PSA50. Among 30 abiraterone-refractory patients, 37% had a PSA decline during the treatment period and among nine enzalutamide-refractory patients, 44% had a PSA decline during the treatment period.

Galeterone was well tolerated, with approximately 90% of reported adverse events (AEs) classified as Grade 1 or 2.

Additional Data on Treatment in Patients with C-Terminal Loss in ARMOR2

In Part 2 of ARMOR2, the company is also characterizing circulating tumor cells for AR C-terminal loss based on preclinical data showing galeterone activity in splice variants that cause a C-terminal deletion, including AR-V7. As of August 15, 2014, seven treatment-na”ive CRPC patients had been identified as having C-terminal loss in a retrospective subset analysis of treatment-na”ive patients in the ARMOR2 trial. Six of these patients had maximal reductions in PSA levels of at least 50%. The seventh patient, who did not show any PSA reduction, discontinued therapy due to an adverse event unrelated to galeterone after approximately six weeks in the trial and did not receive the full treatment regimen.

Of the six responders, four elected to continue into an optional extension phase of the trial following the initial 12 week treatment period. As of August 15, 2014, the time on treatment for the patients in the extension phase, ranged from 155 days to 274 days.

Independent clinical data presented at ESMO on Sunday, September 28 from researchers at Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center and Epic Sciences, Inc. (Posters 237P and 238P) showed an association between non-responsiveness to abiraterone and enzalutamide and the presence of C-terminal loss using the same assay used in ARMOR2.

“Based on a growing body of evidence, CRPC patients with splice variants resulting in the loss of the C terminal appear to be resistant to hormonal agents commonly used to treat CRPC,” said Jodie Morrison, president and chief executive officer of Tokai Pharmaceuticals. “We believe that our positive findings in treatment naive patients showing AR C-terminal loss support that galeterone may hold promise as a treatment for these patients. We look forward to initiating our pivotal Phase 3 trial, ARMOR3-SV, in this population in the first half of next year.”

Broadcast of Briefing with Clinical Investigators, September 29, 2014 at 5 p.m. CEST/11 a.m. EST

Tokai will host a briefing with clinical investigators, Drs. Mary-Ellen Taplin and Emmanuel Antonarakis, who will review their ESMO presentations. A listen-only broadcast can be accessed at 5:00 p.m. CEST/11 a.m. EST by dialing 1-866-305-1460, using the access code 1105407. The presentations can be accessed via the Investors & Media section of Tokai’s website at http://investors.tokaipharma.com.

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 actively 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 the company 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 interim results obtained in clinical trials such as the results in this release will be indicative of the final results obtained in the trials and 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 and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company can establish companion diagnostics arrangements for its planned Phase 3 trial; 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 29, 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 29, 2014.

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