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Tokai Pharmaceuticals' galeterone well-tolerated in patients with advanced prostate cancer
Date:3/31/2012

gy at the University of Washington School of Medicine, and their colleagues at leading prostate cancer research centers in the United States. The Phase 1 proof-of-concept clinical trial, part of the ARMOR (Androgen Receptor Modulation Optimized for Response) clinical development program for the evaluation of galeterone, enrolled 49 patients and was a dose-finding study to evaluate escalating dose levels of galeterone. The study also evaluated safety and reduction in prostate-specific antigen (PSA) levels from baseline levels measured at first visit. Patients who responded to therapy had the option to continue treatment with galeterone in an extension arm of the trial.

Most side effects were minor and included fatigue, nausea and diarrhea. Early efficacy tests demonstrated that 49 percent of patients had prostate-specific antigen (PSA) reductions of 30 percent or more; 11 of these patients had reductions of 50 percent or more. In addition, CT scans revealed a significant reduction in tumor size for some patients.

"We are pleased with the results of our Phase 1 proof-of-concept study, which demonstrated galeterone tolerability and efficacy in a difficult-to-treat, resistant prostate cancer patient population," said Martin D. Williams, president and chief executive officer, Tokai Pharmaceuticals. "Galeterone is the only prostate cancer therapy in development that combines three distinct mechanisms of action in one compound for a unique multi-target approach. The reductions in PSA levels seen in nearly half of all patients evaluated in our Phase 1 study are meaningful in a dose-escalation study and supportive of our Phase 2 clinical trial set to initiate later this year."

In the Phase 1 study, researchers observed transient, non-serious elevated liver function tests in 15 patients, most of whom were asymptomatic. Eleven of these patients stopped galeterone treatment, and of those, six of seven patients were rechallenged and successfully ret
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Contact: Caton Lovett
caton@purecommunicationsinc.com
910-232-7166
Pure Communications Inc.
Source:Eurekalert

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