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Early clinical data show galeterone safe, effective against prostate cancer
Date:3/31/2012

CHICAGO Patients with castration-resistant prostate cancer had limited side effects and in many cases a drop in prostate-specific antigen expression with galeterone (TOK-001), a small-molecule oral drug, according to phase I data presented at the AACR Annual Meeting 2012, held here March 31 - April 4.

Castration-resistant prostate cancer (CRPC) is an advanced form of prostate cancer that occurs when the disease progresses after treatment with androgen deprivation therapy. Galeterone works against CRPC by blocking the androgen receptor, reducing levels of the ligand that binds to the receptor and degrading the androgen receptor protein.

"This drug has a novel combined mechanism of action," said co-lead researcher R. Bruce Montgomery, M.D., associate professor of medical oncology at the University of Washington School of Medicine in Seattle, Wash. "Cancer cells are sly and mutate to get around drugs. The fact that this drug hits the prostate cancer cell in three different ways may help prevent resistance. It is a well-tolerated drug that could potentially be more effective than drugs we have now."

In the ARMOR1 study, Montgomery and colleagues assigned 49 patients with CRPC to one of eight dose regimens in single or split oral escalation doses of 650 mg, 975 mg, 1,300 mg, 1,950 mg or 2,600 mg every day for 12 weeks. None of the patients had received chemotherapy for their prostate cancer.

Researchers reported that no patients reached a maximum tolerated dose. Most side effects were minor and included fatigue, nausea and diarrhea. Researchers observed transient, nonserious elevated liver function tests in 15 patients, many of whom were asymptomatic. Eleven of these patients temporarily stopped galeterone treatment, and six returned to treatment with no recurring liver function test elevations. One serious complication occurred involving rhabdomyolysis in the setting of simvastatin therapy and underlying renal insufficiency. '/>"/>

Contact: Jeremy Moore
Jeremy.Moore@aacr.org
215-446-7109
American Association for Cancer Research
Source:Eurekalert

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