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 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://www.clinicaltrials.gov (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.
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