CORAL GABLES, Fla., March 29, 2011 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that researchers at the University of Pennsylvania have commenced a 60 subject, double-blind, placebo-controlled, investigator-sponsored study to evaluate the use of CPP-109 (vigabatrin) for the treatment of patients addicted to both cocaine and alcohol.
The researchers hope that the results from their study of CPP-109 will support the conduct of a larger clinical trial that could support FDA approval of CPP-109 as a treatment for cocaine and alcohol co-dependency. Such results, if successful, would also expand upon the initial promising results reported by Brodie, et al. in November 2009 in the American Journal of Psychiatry, in which significantly increased abstinence from alcohol use in subjects taking vigabatrin was also reported.
This study will be conducted by a team of researchers led by Kyle M. Kampman, M.D., Associate Professor of Psychiatry through his affiliation with the University of Pennsylvania School of Medicine's Treatment Research Center. In this trial, 60 subjects will receive either CPP-109 or matching placebo, in addition to weekly counseling for eight weeks. The primary outcome measures are cocaine abstinence confirmed by twice weekly urine drug screens and alcohol abstinence measured by self-report. Recruitment is targeted to be completed in 12 months. The study is being conducted at the University of Pennsylvania Treatment Research Center.
Catalyst will provide CPP-109 and matching placebo, and financial support to conduct eye-safety examinations to facilitate the study. The National Institute on Drug Abuse (NIDA) is providing the majority of funding for the study as a part of the pilot study program included in a P50 center grant headed by Helen Pettinati, Ph.D., Research Professor of Psychiatry.
This study is part of pilot project program being conducted at the University of Pennsylvania, the goal of which is to rapidly screen medications for the treatment of comorbid cocaine and alcohol dependence in small clinical trials. The pilot project program seeks to utilize state of the art techniques to ensure excellent medication adherence and treatment retention so that reliable results can be obtained rapidly to inform future larger trials.
Patrick J. McEnany, Catalyst's Chief Executive Officer, commented, "We are very pleased to collaborate with the University of Pennsylvania on this important study in addition to our on-going NIDA collaboration for our Phase II(b) cocaine dependence trial. NIDA's commitment to these trials continues to support the potential of CPP-109 for treating substance addiction."
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting addiction and diseases of the central nervous system. Catalyst has two products in development, and is currently evaluating its lead product candidate, CPP-109 (vigabatrin, a GABA aminotransferase inhibitor), for the treatment of cocaine addiction. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions. Catalyst is also developing CPP-115, another GABA aminotransferase inhibitor that is more potent than vigabatrin and has reduced side effects (e.g., visual field defects, or VFDs) from those associated with vigabatrin. Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy and for use in the reduction or elimination of addictive liability in the treatment of pain. CPP-115 has been granted orphan-drug designation for the treatment of infantile spasms by the FDA. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about the Company, go to .
Forward-Looking Statements
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 anticipated timing of the results from the clinical study described in this press release, whether CPP-109 will ultimately be determined to be effective in treating substance abuse, and the other factors described in the Company's filings 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, may be found on the Company's website 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.
CONTACT: Patrick J. McEnany Catalyst Pharmaceutical Partners, Inc. Chief Executive Officer (305) 529-2522 pmcenany@catalystpharma.com Melody Carey Rx Communications Group Co-President (917) 322-2571 mcarey@rxir.com