Catalyst Pharmaceutical Partners Begins Enrollment for Its U.S. Phase II Clinical Trial of CPP-109 in Patients with Cocaine...( - Additional Clinical T...),Health

- Additional Clinical Trial Sites To Be Added -

- Fast Track Status With FDA -

CORAL GABLES, Fla., Jan. 25 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, today 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 http://www.catalystpharma.com 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 http
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