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Cougar Biotechnology Announces Acceptance of CTA for Abiraterone Acetate

Posted on: Wednesday, 5 October 2005, 12:02 CDT

Cougar Biotechnology, Inc., a privately held biotechnology company, today announced that its Clinical Trial Authorization (CTA) for the Company's drug CB7630 (abiraterone acetate) has been accepted by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA). This will allow Cougar to conduct a Phase I/II 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 Kingdom.

The Phase I/II trial of CB7630 will be conducted at the Institute of Cancer Research, in the Cancer Research UK Centre for Cancer Therapeutics and at The Royal Marsden Hospital in the United Kingdom with Dr. Johann S. de Bono, MD, FRCP, MSc, PhD, as the principal investigator of the trial. "CB7630 (abiraterone acetate) is an innovative drug that could offer clinical benefit to patients with hormone refractory prostate cancer," said Dr. de Bono. "As patients with hormone refractory disease have limited treatment alternatives, we are eager to begin this Phase I/II trial to further investigate the safety and efficacy of abiraterone acetate."

Dr. Arie Belldegrun, MD, FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "CB7630 is a novel, targeted therapy that could represent an important second-line therapy for patients with advanced prostate cancer who fail first-line hormonal treatment." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added: "Advancing the development of CB7630 has been one of the Company's key corporate objectives this year. We are therefore pleased to be able to accomplish this milestone."

About Cougar Biotechnology

Cougar Biotechnology 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 has completed Phase I clinical trials in prostate cancer; CB3304, which is currently being tested in a Phase I trial in non-Hodgkin's lymphoma; and CB1089, which has been clinically tested in a number of solid tumor types.

Cougar recently entered into a merger agreement with GVC Venture Corp., a public reporting company with no operations and only nominal assets and liabilities. Pursuant to the terms of the merger agreement, Cougar will merge with a wholly-owned subsidiary of GVC Venture, with Cougar remaining as the surviving company and a wholly-owned subsidiary of GVC Venture. Upon completion of the proposed merger, Cougar's stockholders will hold approximately 97 percent of GVC Venture's outstanding equity, the management of Cougar will replace the management of GVC Venture, and GVC Venture will adopt and thereafter implement Cougar's business plan. The proposed merger is expected to be completed by the fourth quarter of 2005.

Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.

Notes:

The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust work in partnership to form Europe's largest comprehensive cancer center.

Source: Business Wire

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