Catalyst Reaches Enrollment Target For Its U.S. Phase II Cocaine Trial

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Jan 2009 - 1:00 PDT

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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 reached its patient enrollment target in its Phase II trial evaluating CPP-109 for the treatment of cocaine addiction. CPP-109 is Catalyst's tablet formulation of vigabatrin being developed as a treatment for cocaine and methamphetamine addiction, as well as other addictions and obsessive-compulsive disorders.

The randomized, double-blind, placebo-controlled clinical trial is assessing safety and efficacy of CPP-109 over a 12 week treatment period, with an additional 12 weeks of follow-up. The specified total of 180 patients have now been enrolled at 11 leading addiction research facilities across the United States. Catalyst expects to have top-line results from the trial during the second quarter of 2009.

"Meeting the trial's enrollment target represents an outstanding accomplishment for the addiction field," said Eugene Somoza, M.D., Ph.D., Director, Cincinnati Addiction Research Center, and Coordinating Principal Investigator of Catalyst's clinical trial. "At the present time there is no approved pharmacological treatment for cocaine dependence, a chronic brain disorder associated with a very high level of dysfunction, and immense anguish for the afflicted individuals and their families, as well as a major public health problem to society. This is a double-blind, placebo-controlled trial of a promising medication. An effective medication for treating cocaine addiction has been eagerly awaited for a long time by numerous individuals, families, and treatment providers, and this milestone brings us one step closer to the goal."

"On behalf of everyone at Catalyst Pharmaceutical Partners, I would like to offer our sincere appreciation to the patients, their families, and all of the outstanding healthcare professionals who are participating in this trial," said Douglas Winship, Vice President of Regulatory Operations. "We look forward with great anticipation to the results of this landmark cocaine dependency trial and the opportunity to improve treatment outcomes of such patients everywhere."

About the Phase II Cocaine Trial

The Phase II trial is designed as a randomized, double-blind, placebo- controlled, intent-to-treat, multi-center trial to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. Under the trial protocol, patients are being treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary objective of the trial 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 intends to measure a number of secondary endpoints based on reductions of cocaine use and craving.

About Catalyst Pharmaceutical Partners

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. The Company's initial product candidate is CPP-109, which is Catalyst's version of vigabatrin. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs. For more information about the Company, please visit http://www.catalystpharma.com.

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 Company's ability to successfully complete those clinical trials required for it to file a new drug application for CPP-109, the Company's ability to complete such trials on a timely basis within the budgets established for such trials, the Company's ability to protect its intellectual property and those other factors described in the Company's Annual Report on Form 10-K for 2007 and the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 that the Company has filed 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.

Catalyst Pharmaceutical Partners, Inc.
http://www.catalystpharma.com