Wednesday 14 December 2005
Cougar Biotechnology, Inc, a privately held biotechnology company, today announced that the first patient has been enrolled in the Phase I/II trial of the Company’s drug CB7630 (abiraterone acetate), an orally active inhibitor of the steroidal enzyme 17alpha-hydroxylase/C17,20 lyase, for the treatment of advanced prostate cancer. The Phase I/II trial is being 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.
The Phase I/II study is an open label, dose escalating study to evaluate the safety and efficacy of CB7630 administered daily to patients with chemotherapy-naïve hormone refractory prostate cancer (HRPC) with a rising PSA (prostate specific antigen) despite hormonal therapy. A previous phase I study, conducted at The Institute of Cancer Research and at The Royal Marsden
Hospital and published in the British Journal of Cancer in June 2004, has demonstrated that CB7630 is safe, well tolerated and inhibits testosterone generation in patients with HRPC.
Dr. Johann S. deBono, MSc, PhD, MD, FRCP, the principal investigator of the trial, said “We are pleased to be able to begin enrolling patients in this Phase I/II trial. The previous Phase I clinical trial results of CB7630 demonstrated an impressive initial indication of the potency of CB7630 in patients with prostate cancer. We greatly look forward to continuing enrollment in this Phase I/II trial and further investigating the safety and efficacy of this novel, targeted therapy.”
Dr. Arie Belldegrun, MD, FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology said, “Inhibition of 17alpha-hydroxylase/C17,20 lyase represents a promising new approach to the treatment of HRPC. As patients with HRPC have very limited treatment alternatives, CB7630 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 “Initiating the Phase I/II clinical trial of CB7630 is an important milestone for the Company and for the clinical development of the drug. We are pleased to be able to accomplish this milestone and look forward to the future advancement of the clinical development of CB7630.”
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For more information, please contact:
Alan H. Auerbach, Cougar Biotechnology, Inc.
Tel: +1 310 443 4209
Notes to editors
- 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.
- Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.
- The Institute of Cancer Research is Europe’s leading cancer research centre with expert scientists working on cutting edge research. It was founded in 1909 to carry out research into the causes of cancer and to develop new strategies for its prevention, diagnosis, treatment and care. For more information please visit www.icr.ac.uk
- The Institute works in a unique partnership with The Royal Marsden NHS Foundation Trust, forming the largest comprehensive cancer centre in Europe. This relationship enables close daily contact with those on the frontline in the fight against cancer - the clinicians, the carers and most importantly, the patients.
Please note:
Unfortunately the press office are unable to answer queries from the general public. For general cancer information please refer to The Institute's cancer information page.