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Tokai Pharmaceuticals Announces Initiation of Phase 3 ARMOR3-SV Trial of Galeterone in AR-V7 Positive Metastatic Castration-Resistant Prostate Cancer

Wednesday, June 24, 2015

ARMOR3-SV Represents the First Precision Medicine-Based Pivotal Clinical Trial in Prostate Cancer; Topline Data Expected by the End of 2016
AR-V7 Clinical Trial Assay Components Finalized

Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases, today announced the initiation of ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor (AR) that has been associated with non-responsiveness to commonly-used oral therapies for mCRPC. Tokai also announced today that the components of the AR-V7 clinical trial assay have been finalized by its collaborator, Qiagen (NASDAQ: QGEN; Frankfurt Prime Standard: QIA), and that global deployment of the assay is now underway.

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