The FDA has approved Cougar Biotechnology's investigational new drug application for its lead product, CB7630, for the treatment of advanced prostate cancer. The approval allows the company to begin testing the drug in humans.
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The phase I trial of CB7630 will be conducted at the University of California San Francisco Comprehensive Cancer Center with Dr Charles Ryan, as the principal investigator of the trial. The company initiated a similar trial of the drug in the UK last year.
“Due to the limited number of treatment options for patients that fail first line hormonal therapy, we are very eager to investigate CB7630 (abiraterone acetate) as a potential second line hormonal therapy,” said Dr Ryan. “CB7630 represents a novel drug with a unique mechanism of action that could confer clinical benefit to hormone refractory prostate cancer patients.”