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Catalyst Pharmaceutical Partners Initiates A Registration-Directed U.S. Phase II(b) Clinical Trial In Collaboration With The National Institute On Drug Abuse And Veteran's Administration Cooperative Studies Program
CORAL GABLES, Fla., Nov. 18, 2010 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that in collaboration with the National Institute on Drug Abuse (NIDA) and the Veterans Administration (VA) Cooperative Studies Program, it has initiated a registration-directed U.S. Phase II(b) clinical trial of CPP-109 in patients with cocaine addiction. CPP-109, Catalyst's version of vigabatrin, is an orally administered drug, which inhibits psychostimulant-induced dopamine release. CPP-109 is Catalyst's lead compound to treat stimulant addiction.
Patrick J. McEnany, Chief Executive Officer of Catalyst, commented, "The support from NIDA and the VA further validates our enthusiasm for CPP-109 as a potential treatment for cocaine addiction. We look forward to their participation, financial support and guidance as we jointly advance this large-scale trial. Our hope is to provide patients suffering from cocaine addiction, as well as the physicians and clinicians who treat them, with a safe and effective treatment option."
It is anticipated that NIDA, in cooperation with the Veteran's Administration Cooperative Studies Program, will provide substantial resources for the trial, and that Catalyst will contribute approximately $2.8 million in resources as part of the estimated $10 million trial cost. Catalyst expects initial top-line results from this trial to be available during the second quarter of 2012.
A kick-off training meeting for the trial is being held starting today in Miami Beach, Florida. More than 100 attendees, including NIDA and VA staff involved in the study, and clinicians, counselors and staff representing 12 clinical trial sites, are attending the meeting.
The U.S. Phase II(b) trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multicenter study to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. The trial is expected to enroll approximately 200 cocaine dependent patients at 12 leading addiction treatment clinical research centers in the United States. Patients will be treated with CPP-109 or placebo for a period of 9 weeks, with an additional 4 weeks of follow-up. The primary endpoint is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be cocaine-abstinent during their last two weeks of treatment (weeks 8 and 9). Additionally, Catalyst will be measuring several secondary endpoints based on reductions of cocaine use. The trial will be registered in the near future on
"We will build on the knowledge and experience gained from the previous human trials that have been conducted with vigabatrin to treat cocaine and methamphetamine addiction, in particular with respect to assuring medication compliance and targeting patients seeking treatment," said Douglas Winship, Catalyst's Vice President of Regulatory Operations. "Our partnership with NIDA and the VA Cooperative Studies Program will enable us to conduct a registration-directed trial of CPP-109 as required by the FDA."