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Tokai Pharmaceuticals Presents Updated Interim Galeterone ARMOR2 Data Showing Activity in Patients with Castration-Resistant Prostate Cancer (CRPC) Including Those Showing a Variant Form of Prostate Cancer Resistant to Hormone Therapy

CAMBRIDGE, Mass. & BARCELONA, Spain--(BUSINESS WIRE)--Nov. 19, 2014-- Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI) today announced updated interim results from its ongoing ARMOR2 Phase 2 clinical trial of galeterone in castration-resistant prostate cancer (CRPC) patients. These interim results from the trial support the potential of galeterone to treat CRPC expressing androgen receptor (AR) splice variants, including AR-V7. The presence of AR C-terminal loss generally, and AR-V7 specifically, has been linked to poor responsiveness to hormonal agents commonly used to treat CRPC.

The data were presented today at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in an oral presentation titled “Activity of Galeterone in Castrate-Resistant Prostate Cancer (CRPC) with C-Terminal AR Loss: 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.

“Recent data have shown that the AR-V7 splice variant of the androgen receptor can be a predictor of resistance to treatment with enzalutamide and abiraterone,” said Dr. Taplin. “We believe AR-V7 and other related variants are a mechanism of resistance in this disease and patients who have them may have a poorer prognosis.”

Results Support Galeterone Potential in the treatment of Patients with C-Terminal Loss

In Part 2 of ARMOR2, the company is characterizing circulating tumor cells for the presence of AR C-terminal loss. As previously reported, seven treatment-naïve CRPC patients have been identified as having C-terminal loss in a retrospective subset analysis; 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 12 week treatment regimen. As of October 14, 2014, the data cutoff for the presentation, the median time to PSA progression among the seven patients is 7.3 months, as defined by the Prostate Cancer Working Group 2 (PCWG2) criteria.

Of the six responders with AR C-terminal loss, four elected to continue into an optional extension phase of the trial following the initial 12 week treatment period. As of October 14, 2014, the time on treatment for these patients in the extension phase ranged from 155 days to more than 334 days.

“In the subset of seven patients who had circulating tumor cells with a higher ratio of N-terminal compared to C-terminal androgen receptors and so were likely to have the AR-V7 variant, six had favorable PSA responses to galeterone. This suggests that the presence of AR-V7 in circulating tumor cells does not preclude response to galeterone as has been shown to be the case for abiraterone and enzalutamide in independent clinical studies of those compounds,” Dr. Taplin said.

Based on the results demonstrated in ARMOR2 in patients with AR C-terminal loss and positive preclinical data in multiple AR-V7 models, the company expects to initiate ARMOR3-SV, an open-label Phase 3 registrational trial in the first half of 2015. In ARMOR3-SV, patients will be screened and those testing positive for AR-V7 will then be randomized to receive either galeterone or enzalutamide. The trial will have a primary endpoint of radiographic progression-free survival, with secondary endpoints that include overall survival, skeletal-related events and time to cytotoxic therapy.

“The continued encouraging efficacy and tolerability from ARMOR2 demonstrate that galeterone has the potential to become an important treatment option for CRPC patients, including AR-V7 patients with high unmet need,” said Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. “We remain on track to initiate ARMOR3-SV, the first biomarker-based registrational trial of its kind in prostate cancer, in the first half of 2015 with top line results targeted for the end of 2016.”

Clinically Meaningful PSA Reductions, Favorable Safety Profile in CRPC Patients

ARMOR2 is a two-part Phase 2 study designed to confirm the dose of galeterone and demonstrate safety and efficacy in treatment-naïve metastatic and non-metastatic CRPC patients.

The interim results presented include data collected as of October 14, 2014, on 107 patients in Part 1 and Part 2 of the trial who were treated with galeterone at a daily oral dose of 2550 mg. Consistent with a prior interim analysis, among 39 treatment naïve 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 naïve CRPC patients, 83% achieved a PSA30 and 70% achieved a PSA50.

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

About Galeterone

Galeterone is a highly selective, multi-targeted, oral small molecule drug candidate being developed for the treatment of CRPC that acts by actively disrupting 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. To Tokai’s knowledge, galeterone is the only drug candidate currently in clinical trials that disrupts the AR signaling pathway at multiple points and includes a mechanism of AR degradation.

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 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 November 19, 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 November 19, 2014.

Source: Tokai Pharmaceuticals, Inc.

Pure Communications, Inc.
Susan Heins, 864-286-9597

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