Cougar Biotechnology Presents Positive CB7630 Phase II Data at EORTC-NCI-AACR Symposium
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Interim Phase II Results Support Efficacy of CB7630 (Abiraterone
Acetate) in Chemotherapy Naive, Ketoconazole Naive Advanced Prostate
Cancer Patients
LOS ANGELES--(Business Wire)--
Cougar Biotechnology, Inc. (NASDAQ:CGRB) today announced that
results from an ongoing Phase II clinical trial of Cougar's
investigational drug CB7630 (abiraterone acetate) were presented today
at the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer
Therapeutics." The Symposium is currently taking place in Geneva,
Switzerland.
The Phase II clinical trial of CB7630 (COU-AA-002) is being
conducted at the University of California, San Francisco Comprehensive
Cancer Center with Dr. Charles J. Ryan, Associate Professor of
Clinical Medicine, as the principal investigator. CB7630, in
combination with prednisone, is administered once daily to
chemotherapy-naive, ketoconazole-naive patients with castration
resistant prostate cancer (CRPC), who had progressive disease despite
treatment with LHRH analogues and other hormonal therapies. All of the
12 evaluable patients who were enrolled in the trial had radiological
evidence of metastatic disease with bone metastases and 2 patients
(17%) had soft tissue metastases.
In his oral presentation entitled, "A Phase II study of
Abiraterone Acetate plus Prednisone in Patients with Castration
Resistant Prostate Cancer (CRPC) and no Prior Therapy with
Ketoconazole," Dr. Ryan presented data on the 12 evaluable patients
treated in the trial. Of these patients, 11 (92%) experienced a
confirmed decline in prostate specific antigen (PSA) levels of greater
than 30%, 9 patients (75%) experienced a PSA decline of greater than
50% and 6 patients (50%) experienced PSA declines of greater than 90%.
In addition, 2 (17%) of the 12 patients experienced undetectable PSA
levels (less than 0.1 ng/ml) after treatment with CB7630. Of the 12
evaluable patients, 10 (83%) continue to be treated with CB7630 for
over 6 months.
Alan H. Auerbach, Chief Executive Officer and President of Cougar
Biotechnology, said, "The data from our COU-AA-002 trial presented at
the AACR-NCI-EORTC Symposium continues to support the potential role
of CB7630 in the treatment of CRPC. We continue to be pleased with the
strong evidence of antitumor activity in patients with
chemotherapy-naive, ketoconazole-naive disease, which represents a
significant unmet medical need in prostate cancer."
Arturo Molina, M.D., M.S., FACP, Cougar's Chief Medical Officer
and Executive Vice President of Clinical Research and Development,
added, "We are pleased with the results of this Phase II study, which
continues to support the potential role of CB7630 as a second-line
hormonal therapy for patients with advanced prostate cancer who fail
first-line hormonal treatment. This patient group continues to
represent a market that is underserved with current treatments."
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 studied in a
Phase III clinical trial in prostate cancer; CB3304, an inhibitor of
microtubule dynamics, which is currently in a Phase I trial in
multiple myeloma; 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 the
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 of prior clinical trials of CB7630
will be predictive of results of later stage clinical trials,
including Cougar's ongoing Phase III clinical trial, COU-AA-301. 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, 2007, 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.
Cougar Biotechnology, Inc.
Alan H. Auerbach, Chief Executive Officer and President
ahauerbach@cougarbiotechnology.com
or
Mariann Ohanesian, Director of Investor Relations
mohanesian@cougarbiotechnology.com
+1-310-943-8040
or
Russo Partners, LLC
David Schull, +1-212-845-4271
David.schull@russopartnersllc.com
or
Andreas Marathovouniotis, +1-212-845-4235
Andreas.marathis@russopartnersllc.com
Copyright Business Wire 2008
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