Additional data from Tokai’s galeterone Phase 1 study on CRPC

May 18 2012

Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that additional data from a Phase 1 safety and proof-of-concept study evaluating lead candidate, galeterone (TOK-001), in patients with castration-resistant prostate cancer (CRPC) will be highlighted in a poster presentation titled, "Phase I clinical trial of galeterone (TOK-001), a multifunctional anti-androgen and CYP17 inhibitor in castration resistant prostate cancer (CRPC)," abstract number 4665, on Sunday, June 3, 2012, 8:00 a.m. to 12:00 p.m. (CDT) at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO).    

CRPC is an advanced, difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of androgen deprivation therapy. Galeterone is a proprietary small molecule, oral drug for the treatment of CRPC that disrupts the growth and survival of prostate cancer cells via a novel triple mechanism of action. The study findings, presented for the first time last month at the AACR Annual Meeting, show galeterone demonstrated efficacy and was well-tolerated in patients with CRPC. Additionally, preclinical data will be presented at ASCO elucidating the mechanisms of action of galeterone.

"While other approved and experimental CRPC therapies act via a single target, galeterone is highly differentiated as the only prostate cancer drug in development that combines three distinct mechanisms of action in one compound for a unique multi-target approach," said Martin D. Williams, president and chief executive officer, Tokai Pharmaceuticals. "Galeterone acts in three ways against the key driver of CRPC, androgen receptor signaling - it blocks ligand synthesis, blocks ligand receptor binding, and degrades the receptor itself. The efficacy observed in the galeterone ARMOR1 study, with both biochemical and radiological responses, combined with a favorable safety profile, support our Phase 2 clinical trial program to be initiated in the second half of 2012."