Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Effect of concomitant food intake on pharmacokinetics of abiraterone acetate, a 17-alpha hydroxylase/C17,20-lyase inhibitor in androgen independent prostate cancer (AIPC).
The Phase I dose ranging trial was conducted at the University of California, San Francisco Comprehensive Cancer Center with Charles J. Ryan, M.D., Assistant Clinical Professor of Medicine, as the principal investigator. CB7630 was administered once daily to chemotherapy-naive patients with castration refractory prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies.
Of the 27 patients who were enrolled in the study, 18 patients were administered CB7630 on an empty stomach while 9 patients received CB7630 on a full stomach (with a high fat calorie meal). Seventeen of 27 patients (63%) had received prior treatment with ketoconazole, a drug that is currently widely used off-label as a secondary hormonal therapy. Treatment with CB7630 was found to be well tolerated in both the fasted and fed groups. The safety profile of the drug was seen to be unaffected by administration of the drug with food. Overall, in the 27 patients who were treated with CB7630 in both the fasted and fed groups, 16 of 27 patients (59%) experienced a greater than 50% decline in prostate specific antigen (PSA) levels. Furthermore, 11 of the 18 patients (61%) in the fasted group and 5 of the 9 patients (56%) in the fed group experienced a greater than 50% decline in PSA levels.
Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "We are pleased to be able to demonstrate not only that CB7630 is active in patients who have failed ketoconazole, but also that the safety profile of the drug is not affected by food intake." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added, "We continue to be pleased with the clinical data being generated on CB7630. We greatly look forward to the continued development of CB7630 in both the second line hormone therapy and second line chemotherapy settings."
About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based 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, a targeted inhibitor of the 17-alpha hydroxylase/c17,20 lyase enzyme, which is currently being tested in Phase II clinical trials in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in hematological malignancies and CB1089, an analog of vitamin D, which has been clinically tested in a number of solid tumor types.
Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements related to benefits to be derived from Cougar's drug development programs, including the potential advantages of CB7630 and its potential for use in the treatment of CRPC and in second line hormone and chemotherapy treatment settings. Such statements 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 only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in clinical trials, and drug development and commercialization, including the uncertainty of whether results in testing of CB7630 will be predictive of results in later stages of development. For a discussion of these and other factors, please refer to Cougar's annual report on Form 10-KSB for the year ended December 31, 2006 as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Cougar undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Alan H. Auerbach, Chief Executive Officer and President
Mariann Ohanesian, Director of Investor Relations
Russo Partners, LLC
David Schull, +1-212-845-4271
Andreas Marathovouniotis, +1-212-845-4253
Posted: October 2007