Cougar Biotechnology Announces Approval of IND for Abiraterone Acetate
Posted on: Thursday, 2 February 2006, 12:00 CST
Cougar Biotechnology, Inc., a privately held biotechnology company, today announced that its Investigational New Drug (IND) application for the Company's drug CB7630 (abiraterone acetate) has been approved by the U.S. Food and Drug Administration (FDA). This will allow Cougar to conduct a Phase I clinical trial of CB7630, an orally active inhibitor of the steroidal enzyme 17alpha-hydroxylase/C17,20 lyase, for the treatment of advanced prostate cancer in the United States.
The Phase I trial of CB7630 will be conducted at the University of California San Francisco Comprehensive Cancer Center with Charles J. Ryan, M.D., as the principal investigator of the trial. "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."
Dr. Arie Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "This is an important milestone for the Company and for CB7630. We look forward to initiating the Phase I clinical trial of CB7630 in the U.S., which complements the Phase I trial that we initiated late last year in the United Kingdom." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added, "Approval of the IND for CB7630 was a key corporate objective for the Company this year. We look forward to initiating the Phase I trial of CB7630 in the coming months."
About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based private biotechnology company established to in-license and develop clinical stage drugs, with a specific focus on the field of oncology. Cougar's oncology portfolio includes CB7630, which is currently being tested in a Phase I clinical trial in prostate cancer; CB3304, which is currently in a Phase I trial in non-Hodgkin's lymphoma; and CB1089, which has been clinically tested in a number of solid tumor types.
Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.
Source: Business Wire
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