Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of CB7630 (Abiraterone A...
11 February 2009 - 12:05AM
Business Wire
Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that
it has reached agreement with the U.S. Food and Drug Administration
(FDA) under a Special Protocol Assessment (SPA) for its planned
Phase III clinical trial of the Company's lead drug candidate
CB7630 (abiraterone acetate) in patients with chemotherapy na�ve
castration resistant prostate cancer. The SPA is a written
agreement between the Company, as the trial's sponsor, and the FDA
regarding the design, endpoints, and planned statistical analysis
approach of the Phase III trial to be used in support of a New Drug
Application (NDA). The European Medicines Agency (EMEA) has also
provided protocol advice consistent with that of the FDA regarding
the Company's Phase III trial design and ability to support the
submission of an EU Market Authorization Application (MAA).
Pursuant to the SPA, the Phase III trial will be a randomized,
double-blind, placebo-controlled trial of CB7630 plus prednisone in
patients with metastatic castration resistant prostate cancer 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
agreed upon 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 an NDA/MAA for Accelerated or Conditional Approval
from the regulatory agencies. Cougar anticipates that it will begin
patient enrollment in this Phase III trial later this quarter.
Alan H. Auerbach, Chief Executive Officer and President of
Cougar Biotechnology, said, "Obtaining FDA agreement on the overall
Phase III trial design, and more specifically patient population
and primary endpoints, represents an important milestone in the
global development of CB7630 and for Cougar as a company."
Arturo Molina, M.D., M.S., FACP, Chief Medical Officer and
Executive Vice President of Clinical Research and Development of
Cougar, added, "We are pleased to be able to reach agreement with
the FDA on our Phase III trial design for patients with
chemotherapy na�ve castration resistant prostate cancer. We look
forward to commencing patient enrollment in this Phase III trial
shortly."
About Cougar Biotechnology, Inc.
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 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 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 clinical trial
initiation dates, the potential advantages of CB7630 and its
potential for use in the treatment of castration resistant
chemotherapy na�ve prostate cancer, and Cougar�s ability to obtain
accelerated or conditional approval of CB7630 for the treatment of
castration resistant prostate cancer. 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. 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.
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