Tokai Announces Presentation of Galeterone Data in Models of the AR-V7 Splice Variant at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

BOSTON--()--Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, today announced the presentation of new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models expressing the androgen receptor (AR) splice variant AR-V7 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Today’s presentation supports earlier clinical findings of positive results with galeterone in men with treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) whose prostate tumors have C-terminal loss—the loss of the portion of the AR that contains the ligand binding domain. C-terminal loss, generally, and AR-V7, specifically, have been associated with non-response to abiraterone (Zytiga®) and enzalutamide (Xtandi®) in mCRPC. The AR-V7 splice variant is believed to be the most common form of C-terminal loss.

Tokai is evaluating galeterone in ARMOR3-SV, an ongoing pivotal trial designed to determine whether treatment with galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide in approximately 148 treatment-naïve, AR-V7+ mCRPC patients. Topline results from ARMOR3-SV are anticipated by the end of 2016.

About Tokai Pharmaceuticals
Tokai Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases. The company’s lead drug candidate, galeterone, is a highly selective, oral small molecule being developed for the treatment of patients with metastatic 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 our future expectations, plans and prospects, including statements about our 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 our cash resources will be sufficient to fund our continuing operations for the period anticipated; whether data from early clinical trials of galeterone 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; whether a companion diagnostic based on an AR-V7 clinical trial assay 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 our quarterly report on Form 10-Q for the three months ended June 30, 2015. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Tokai Pharmaceuticals Inc.
Investors:
Lee Kalowski, 617-225-4305
Chief Financial Officer
lkalowski@tokaipharma.com
or
Argot Partners
David Pitts/Maeve Conneighton, 212-600-1902
david@argotpartners.com
maeve@argotpartners.com
or
Media:
Ten Bridge Communications Inc.
Dan Quinn, 781-475-7974
dan@tenbridgecommunications.com

Release Summary

Tokai announced today the presentation of new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models expressing the androgen receptor (AR) splice variant AR-V7.

Contacts

Tokai Pharmaceuticals Inc.
Investors:
Lee Kalowski, 617-225-4305
Chief Financial Officer
lkalowski@tokaipharma.com
or
Argot Partners
David Pitts/Maeve Conneighton, 212-600-1902
david@argotpartners.com
maeve@argotpartners.com
or
Media:
Ten Bridge Communications Inc.
Dan Quinn, 781-475-7974
dan@tenbridgecommunications.com