Catalyst Pharmaceutical Partners, Inc., a biopharmaceutical company that acquires or in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction and obsessive compulsive disorders, announced that it has begun enrollment for its randomized, double-blind, placebo-controlled US phase II clinical trial evaluating CPP-109 for the treatment of patients addicted to methamphetamine. CPP-109, an orally administered, small molecule drug which inhibits psychostimulant-induced dopamine release, is Catalyst's version of vigabatrin.

In April 2008, Catalyst held a kick-off training meeting in Scottsdale, Arizona with the clinical investigators and study coordinators who will conduct the trial. Approximately 40 attendees, including clinicians and staff representing 15 clinical trial sites, attended the meeting. Catalyst expects to immediately begin screening patients for inclusion in this trial and expects initial top-line results of the phase II clinical trial to be available during the summer of 2009.

Patrick J. McEnany, chief executive officer of Catalyst, commented, "We are excited to follow up on our cocaine trial with the initiation of our second, large-scale US phase II trial with CPP-109, this time as a potential treatment for methamphetamine addiction. As with cocaine, we believe that CPP-109 may offer the potential to provide patients suffering from methamphetamine addiction, as well as the physicians and clinicians that treat them, with a safe and effective pharmacotherapy option."

The phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multicenter trial to evaluate the safety and efficacy of CPP-109 as a treatment for methamphetamine addiction. The trial is expected to enrol 180 methamphetamine addicted patients at 15 leading addiction treatment clinical centres in the United States. Patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary endpoint of the study is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be methamphetamine-free during their last two weeks of treatment (Weeks 11 and 12). Additionally, Catalyst will be measuring several secondary endpoints based on reduction in craving and of methamphetamine use.

"Vigabatrin has previously shown the potential to be a non-addictive drug treatment for cocaine and methamphetamine addiction in two pilot studies and one Phase II double-blind trial conducted in Mexico. We are excited to now be able to seek to determine the therapeutic benefit of our product in methamphetamine addicted patients enrolled in a larger, well-designed, placebo-controlled trial conducted under our sponsorship," said Douglas Winship, Vice President of Regulatory Operations for Catalyst. "There are currently no adjunctive drug products approved for the treatment of this population. As a result, drug therapies are desperately needed which can improve abstinence achievement rates of behavioral therapy currently obtained by addiction treatment specialists, and reduce recidivism."

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 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.