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November 9, 2007
Cougar Biotechnology Presents Positive CB7630 Phase II Data at Chemotherapy Foundation Symposium
Interim Phase II Results Support Efficacy of CB7630 in Chemotherapy Refractory Prostate Cancer Patients
Los Angeles, CA, November 9, 2007 - Cougar Biotechnology, Inc. (OTCBB: CGRB) today announced that results from ongoing Phase II clinical trials of its investigational drug, CB7630 (abiraterone acetate) were presented at the Chemotherapy Foundation Symposium XXV, Innovative Cancer Therapy for Tomorrow, on November 9, 2007. The Chemotherapy Foundation Symposium is currently taking place in New York City.
During his oral presentation entitled "Anti-tumor activity of abiraterone acetate in castration resistant prostate cancer," Daniel Danila, M.D. from Memorial Sloan-Kettering Cancer Center presented data from ongoing Phase II trials of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy (COU-AA-003). The data from this trial is further detailed below.
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy (COU-AA-003)
The Phase II trial of CB7630 in patients with advanced prostate cancer who have failed docetaxel-based chemotherapy is being conducted at numerous locations in the United States and United Kingdom. In the trial, CB7630 is administered orally, once daily, to patients with castration resistant prostate cancer who have failed treatment with androgen deprivation therapy and failed treatment with first line docetaxel-based chemotherapy. To date, a total of 44 patients have been enrolled in the trial.
In his oral presentation, Dr. Danila provided an update on the 10 patients in this Phase II trial who have been treated at Memorial Sloan-Kettering Cancer Center. Of the 10 patients who have been treated in the Phase II trial, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. Of the 10 patients treated, 4 patients (40%) experienced a confirmed decline in PSA levels of greater than 50%. Of the 5 evaluable patients with measurable tumor lesions, 1 patient (20%) experienced a partial radiological response (as measured by the RECIST criteria).
Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "We are pleased to have the opportunity to present clinical data on CB7630 at a prominent meeting like the Chemotherapy Foundation Symposium and view it as an important opportunity to build awareness of the drug prior to the advancement of the clinical development of CB7630 into Phase III trials that are currently scheduled for next year. Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added, "The data from the CB7630 Phase II trial presented at the Chemotherapy Foundation Symposium continues to support the potential role of the drug in the treatment of CRPC. We continue to have strong confidence in the potential of CB7630 in this patient population."
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.
Contact
Alan H. Auerbach
Chief Executive Officer and President
+1 310-943-8040
ahauerbach@cougarbiotechnology.com
Mariann Ohanesian
Director of Investor Relations
+1 310-943-8040, Ext. 117
mohanesian@cougarbiotechnology.com
Russo Partners, LLC
David Schull
+1 212-845-4271
David.Schull@eurorscg.com
Andreas Marathovouniotis
+1 212-845-4253
Andreas.Marathis@eurorscg.com
Forward-Looking Statements:
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 the timing of potential clinical trial initiations, benefits to be derived from Cougar's drug development programs, including the potential advantages of CB7630, 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.
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
