Cougar Biotechnology Announces Initiation of Phase I/II Trial for CB7630 (Abiraterone Acetate).LOS ANGELES -- Cougar cougar: see puma. cougar or puma or mountain lion or panther Species (Puma concolor) of large, graceful cat that lives in a wide variety of habitats in the Americas, from southern Alaska to Patagonia. 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 lyase /ly·ase/ (li´as) any of a class of enzymes that remove groups from their substrates (other than by hydrolysis or oxidation), leaving double bonds, or that conversely add groups to double bonds. , for the treatment of advanced prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . 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-naive hormone refractory prostate cancer (HRPC HRPC Hormone-Refractory Prostate Cancer HRPC Hormone-Resistant Prostate Cancer HRPC Hudson River Parks Conservancy HRPC Health Research and Policy Center ) with a rising PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. (prostate specific antigen PSA (Prostate specific antigen) A tumor marker associated with prostate cancer. Mentioned in: Tumor Markers ) 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 The British Journal of Cancer a twice-monthly professional medical journal of Cancer Research UK (a registered charity in the United Kingdom), published on their behalf by the Nature Publishing Group (a division of Macmillan Publishers Ltd). 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 FRCP Fellow of the Royal College of Physicians. FRCP abbr. Fellow of the Royal College of Physicians , 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 Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I 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 FACS Fellow of the American College of Surgeons. FACS abbr. Fellow of the American College of Surgeons FACS fluorescence-activated cell sorter. , 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." 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. Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.
Notes:
The Institute of Cancer Research
1. 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.
2. 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.
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