Tokai Pharmaceuticals Announces Presentation at the 2015 ASCO Annual Meeting

Poster Highlights Protocol and Rationale for ARMOR3-SV, a Pivotal Trial of Galeterone in Patients with AR-V7 Positive Castration-Resistant Prostate Cancer

ARMOR3-SV Remains on Track to Begin 2Q 2015, with Topline Data Expected by End of 2016

BOSTON--()--Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally driven diseases, today announced a poster presentation outlining the design and rationale for ARMOR3-SV, the planned pivotal Phase 3 trial of galeterone in AR-V7 positive castration-resistant prostate cancer (CRPC) patients, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2 in Chicago, Illinois.

The poster, titled “Androgen Receptor Modulation Optimized for Response: Splice Variant (ARMOR3-SV) -- Randomized, Open-label, Multicenter, Controlled Study of Galeterone vs Enzalutamide in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expressing AR-V7 Splice Variant” (Abstract Number TPS5069, Poster Board #63a), is being presented today, Saturday, May 30, from 1:15 PM to 4:45 PM CT at the Genitourinary (Prostate) Cancer Poster Session of the meeting, located in S Hall A.

“We believe the planned pivotal trial will support the use of galeterone in patients expressing AR-V7, which has been linked to poor responses to existing hormonal agents,” stated Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. “We are honored to have the opportunity to present the design of the first precision medicine-based pivotal trial in prostate cancer, together with supportive clinical data, at ASCO this year and we look forward to initiating this Phase 3 clinical trial this quarter.”

ARMOR3-SV is Tokai’s planned pivotal Phase 3 clinical trial that will compare galeterone to Xtandi® (enzalutamide) in 148 metastatic CRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor (AR). These truncated ARs are missing the C-terminal end of the receptor that contains the ligand binding domain, which is known as C-terminal loss. The primary endpoint of ARMOR3-SV will be radiographic progression-free survival (rPFS), measured from the time of patient randomization to the time of radiographic evidence of disease progression or time of death from any cause. Tokai plans to begin ARMOR3-SV in the second quarter of 2015, with topline data expected by the end of 2016.

In a retrospective analysis of the Phase 2 ARMOR2 trial, galeterone was associated with clinical responses in patients identified as having C-terminal loss, with 6 of 7 (86%) patients achieving a 12-week PSA50 response (the one non-responder discontinued therapy due to an adverse event unrelated to galeterone and did not receive the full treatment regimen). It is believed that one of galeterone’s mechanism of action, androgen receptor degradation, does not require a functional ligand binding domain to disrupt the activation of the pathway and tumor growth and thus galeterone may have activity even in the presence of C-terminal loss, such as AR-V7. In contrast, Zytiga® (abiraterone acetate) and Xtandi, two commonly used oral therapies for metastatic CRPC, have been associated with poor responses in patients lacking a functioning ligand binding domain.

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, 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 three months ended March 31, 2015. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any subsequent date. 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.

Contacts

Tokai Pharmaceuticals
Investor:
Lee Kalowski, 617-225-4305
Chief Financial Officer
or
Argot Partners
David Pitts/Maeve Conneighton, 212-600-1902
david@argotpartners.com
maeve@argotpartners.com
or
Media:
Pure Communications, Inc.
Susan Heins, 864-286-9597

Contacts

Tokai Pharmaceuticals
Investor:
Lee Kalowski, 617-225-4305
Chief Financial Officer
or
Argot Partners
David Pitts/Maeve Conneighton, 212-600-1902
david@argotpartners.com
maeve@argotpartners.com
or
Media:
Pure Communications, Inc.
Susan Heins, 864-286-9597