Cougar Biotechnology Initiates Phase III Trial of CB7630 (Abiraterone Acetate) in Chemotherapy-Naïve Castration-Resistant Pr...
29 April 2009 - 2:15PM
Business Wire
Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced the
initiation of a Phase III clinical trial (COU-AA-302) of its lead
drug candidate CB7630 (abiraterone acetate) in patients with
chemotherapy-na�ve castration-resistant prostate cancer (CRPC). The
COU-AA-302 Phase III trial is a randomized, double-blind,
placebo-controlled trial of CB7630 plus prednisone in patients with
metastatic CRPC who have not yet received treatment with
chemotherapy. The trial is expected to enroll approximately 1,000
patients who will be randomized (1:1) to receive either CB7630 plus
prednisone or placebo plus prednisone. The trial will be conducted
at approximately 150 sites in North America, Europe and Australia.
The co-primary endpoints of the trial are progression free survival
and overall survival. The Company plans to use the progression free
survival data from the trial as the basis for submission of a New
Drug Application and a Marketing Authorization Application for
Accelerated and Conditional Approval from the regulatory
agencies.
Alan H. Auerbach, Chief Executive Officer and President of
Cougar Biotechnology, said, "Initiation of this Phase III trial of
CB7630 in chemotherapy-na�ve prostate cancer patients represents an
important milestone in the clinical development of CB7630. As these
patients continue to represent a market that is underserved with
current treatments, we are pleased to initiate the COU-AA-302 Phase
III trial in this patient population.�
Arturo Molina, M.D., M.S., FACP, Chief Medical Officer and
Executive Vice President of Clinical Research and Development of
Cougar, added, �The interim results of our Phase II trials of
CB7630 have shown strong evidence of antitumor activity in patients
with metastatic CRPC who have not yet received chemotherapy;
therefore, we are pleased to initiate the COU-AA-302 Phase III
trial in this patient population. Due to the high level of
awareness of CB7630 in the urology and medical oncology
communities, we look forward to aggressively enrolling this Phase
III trial.�
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 III clinical trials in prostate cancer and a Phase I/II trial
in breast 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 "anticipates," "expects," "plans,"
"believes," "intends," and similar words or phrases. These
forward-looking statements include, without limitation, statements
related to the number of subjects to be enrolled in the COU-AA-302
study and the pace of such enrollment, the number if sites at which
COU-AA-302 will be conducted, the conduct of other clinical trials
of CB7630, additional FDA registration strategies for CB7630, 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 chemotherapy-na�ve CRPC and in second-line
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 COU-AA-302. For a discussion of these
and other factors, please refer to Cougar�s annual report on Form
10-K for the year ended December 31, 2008, 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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