Catalyst
Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company
that acquires, in-licenses, develops and commercializes prescription drugs
for the treatment of drug addiction, announced that it has initiated
enrollment of patients for its 180- patient, U.S. Phase II clinical trial
evaluating the use of CPP-109 in treating patients with cocaine addiction.
CPP-109, an orally administered, small molecule drug which inhibits
psychostimulant-induced dopamine release, is Catalyst’s lead compound,
vigabatrin.
The Phase II trial is designed as a randomized, double-blind, placebo-
controlled, intent-to-treat, multi-center study to evaluate the safety and
efficacy of CPP-109 as a treatment for cocaine addiction. Under the study
protocol, patients will be treated for a period of 12 weeks, with an
additional 12 weeks of follow-up. The primary objective of the study 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 will be measuring a
number of secondary endpoints based on reductions of cocaine use and
craving.
Catalyst’s web site catalystpharma includes a listing of the
CPP- 109 study sites and relevant contact information. For more information
about enrolling in this study, please contact the study sites directly.
Additional detailed information can be found on clinicaltrials
(search for Catalyst).
Patrick J. McEnany, Chief Executive Officer of Catalyst, commented: “We
are very pleased to announce the start of active enrollment in our study of
CPP-109 as a potential treatment for cocaine addiction. We expect to add
more clinical trial sites to the 10 previously disclosed in order to
complete the trial as soon as possible. We anticipate initial top-line
results from this trial to be available by year-end.”
Douglas Winship, Catalyst’s Vice President of Regulatory Operations,
stated: “Vigabatrin has previously shown the potential to be a safe and
effective non-addictive drug treatment for cocaine and methamphetamine
addiction in a Phase II double-blind, placebo-controlled trial and two
pilot studies conducted in Mexico. We are excited to now evaluate the
therapeutic benefit of CPP-109 in cocaine-addicted patients enrolled in a
large, double- blind, placebo-controlled trial conducted in the U.S. under
our sponsorship. There are currently no prescription drugs approved for the
treatment of this population. As a result, drug therapies are desperately
needed which can improve abstinence achievement rates of behavioral therapy
administered by addiction treatment specialists, and reduce recidivism. We
have worked diligently with regulatory authorities and the independent
institutional review boards at each of the clinical sites where our trial
will be conducted to be able to finalize and implement our protocol for
this trial.”
On December 7, 2007, Catalyst announced positive initial top-line
results from a 103-patient, investigator-initiated Phase II double-blind,
placebo- controlled trial, in which vigabatrin met its primary efficacy
endpoint of abstinence during the last weeks of treatment for cocaine
addiction. Additional results of this study will be reported when they
become available.
About CPP-109
CPP-109 works by inhibiting an enzyme that normally breaks down gamma
aminobutyric acid (GABA), a dopamine-modulating neurotransmitter. The
resulting excess GABA suppresses the increase in dopamine release caused by
cocaine. All addictive drugs elevate dopamine levels in the parts of the
brain associated with reward and reinforcement. It is thought that this
reinforcing effect is the primary biochemical explanation for addiction.
CPP-109 indirectly keeps dopamine levels in the normal range without
impairing normal dopamine-based mechanisms. It is also thought that this
effect may reduce craving, an effect in addicts which makes it very
difficult for them to stop their drug habit.
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. The Company has obtained from Brookhaven
National Laboratory an exclusive worldwide license for nine patents and
four patents pending in the United States relating to the right 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, also known as
vigabatrin. CPP-109 has been granted “Fast Track” status by the 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. CPP-109 was selected as one
of the five most promising drugs entering Phase II trials in the
July-September 2007 issue of The Ones To Watch, published by Thomson
Scientific, a Thomson Corporation publication.
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 the clinical trials required for it to
file a new drug application for CPP-109, its ability to complete such
trials on a timely basis within the budgets established for such trials,
whether the Company’s trials, which are being conducted in the U.S. under
FDA good clinical practice guidelines, will evidence that CPP-109 is safe
and effective for the treatment of cocaine addiction and methamphetamine
addiction, 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 2006 and the Company’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2007 that the Company has previously 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 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.
Catalyst Pharmaceutical Partners, Inc.
catalystpharma