Catalyst Reaches Enrollment Target for its U.S. Phase II Cocaine Trial
Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that
acquires, in-licenses, develops and commercializes prescription drugs for the
treatment of drug addiction, announced today that it has reached its patient
enrollment target in its Phase II trial evaluating CPP-109 for the treatment
of cocaine addiction. CPP-109 is Catalyst’s tablet formulation of vigabatrin
being developed as a treatment for cocaine and methamphetamine addiction, as
well as other addictions and obsessive-compulsive disorders.
The randomized, double-blind, placebo-controlled clinical trial is
assessing safety and efficacy of CPP-109 over a 12 week treatment period, with
an additional 12 weeks of follow-up. The specified total of 180 patients have
now been enrolled at 11 leading addiction research facilities across
United States
the second quarter of 2009.
“Meeting the trial’s enrollment target represents an outstanding
accomplishment for the addiction field,” said
Director, Cincinnati Addiction Research Center, and Coordinating Principal
Investigator of Catalyst’s clinical trial. “At the present time there is no
approved pharmacological treatment for cocaine dependence, a chronic brain
disorder associated with a very high level of dysfunction, and immense anguish
for the afflicted individuals and their families, as well as a major public
health problem to society. This is a double-blind, placebo-controlled trial of
a promising medication. An effective medication for treating cocaine addiction
has been eagerly awaited for a long time by numerous individuals, families,
and treatment providers, and this milestone brings us one step closer to the
goal.”
“On behalf of everyone at Catalyst Pharmaceutical Partners, I would like
to offer our sincere appreciation to the patients, their families, and all of
the outstanding healthcare professionals who are participating in this trial,”
said
forward with great anticipation to the results of this landmark cocaine
dependency trial and the opportunity to improve treatment outcomes of such
patients everywhere.”
About the Phase II Cocaine Trial
The Phase II trial is designed as a randomized, double-blind, placebo-
controlled, intent-to-treat, multi-center trial to evaluate the safety and
efficacy of CPP-109 as a treatment for cocaine addiction. Under the trial
protocol, patients are being treated for a period of 12 weeks, with an
additional 12 weeks of follow-up. The primary objective of the trial is to
demonstrate that a larger proportion of CPP-109-treated subjects than placebo-
treated subjects are cocaine-free during their last two weeks of treatment
(weeks 11 and 12). Additionally, Catalyst intends to measure a number of
secondary endpoints based on reductions of cocaine use and craving.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company
focused on the development and commercialization of prescription drugs for the
treatment of addiction and obsessive-compulsive disorders. The Company has
obtained from Brookhaven National Laboratory an exclusive worldwide license
for Brookhaven’s patent portfolio in
to use vigabatrin to treat a wide variety of substance addictions and
obsessive-compulsive disorders. Catalyst has also been granted rights to
Brookhaven’s vigabatrin-related foreign patents or patents pending in more
than 30 countries. The Company’s initial product candidate is CPP-109, which
is Catalyst’s version of vigabatrin. CPP-109 has been granted “Fast Track”
status by the U.S. Food & Drug Administration (FDA) for the treatment of
cocaine addiction. This indicates that the FDA has recognized that CPP-109 is
intended for the treatment of a serious or life-threatening condition for
which there is no effective treatment and which demonstrates the potential to
address unmet medical needs. For more information about the Company, please
visit www.catalystpharma.com.
This press release contains forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties which may cause
the Company’s actual results in future periods to differ materially from
forecasted results. A number of factors, including the Company’s ability to
successfully complete those clinical trials required for it to file a new drug
application for CPP-109, the Company’s ability to complete such trials on a
timely basis within the budgets established for such trials, the Company’s
ability to protect its intellectual property and those other factors described
in the Company’s Annual Report on Form 10-K for 2007 and the Company’s
Quarterly Report on Form 10-Q for the quarter ended
the Company has filed with the U.S. Securities and Exchange Commission (SEC),
could adversely affect the Company. Copies of the Company’s filings with the
SEC are available from the SEC, may be found on the Company’s website or may
be obtained upon request from the Company. The Company does not undertake any
obligation to update the information contained herein, which speaks only as of
this date.
SOURCE Catalyst Pharmaceutical Partners, Inc.