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October 5, 2005
Cougar Biotechnology Announces Acceptance of CTA for Abiraterone Acetate
Los Angeles, CA, October 5, 2005 - 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. deBono, 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, 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 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.
Contact
Alan H. Auerbach
Cougar Biotechnology, Inc.
+1 310 443 4209
ahauerbach@cougarbiotechnology.com
Note: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust work in partnership to form Europe's largest comprehensive cancer centre.
This press release contains forward-looking statements that involve risks and uncertainties that could cause Cougar's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Cougar's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Cougar's product candidates, the risk that the results of clinical trials may not support Cougar's claims, Cougar's reliance on third-party researchers to develop its product candidates and its lack of experience in developing pharmaceutical products. Cougar assumes no obligation to update these forward-looking statements, except as required by law.
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
