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The randomized, double-blind, placebo-controlled clinical trial isassessing safety and efficacy of CPP-109 over a 12 week treatment period, withan additional 12 weeks of follow-up. The specified total of 180 patients havenow been enrolled at 11 leading addiction research facilities across theUnited States. Catalyst expects to have top-line results from the trial duringthe second quarter of 2009.
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"Meeting the trial's enrollment target represents an outstandingaccomplishment for the addiction field," said Eugene Somoza, M.D., Ph.D.,Director, Cincinnati Addiction Research Center, and Coordinating PrincipalInvestigator of Catalyst's clinical trial. "At the present time there is noapproved pharmacological treatment for cocaine dependence, a chronic braindisorder associated with a very high level of dysfunction, and immense anguishfor the afflicted individuals and their families, as well as a major publichealth problem to society. This is a double-blind, placebo-controlled trial ofa promising medication. An effective medication for treating cocaine addictionhas been eagerly awaited for a long time by numerous individuals, families,and treatment providers, and this milestone brings us one step closer to thegoal."
"On behalf of everyone at Catalyst Pharmaceutical Partners, I would liketo offer our sincere appreciation to the patients, their families, and all ofthe outstanding healthcare professionals who are participating in this trial,"said Douglas Winship, Vice President of Regulatory Operations. "We lookforward with great anticipation to the results of this landmark cocainedependency trial and the opportunity to improve treatment outcomes of suchpatients 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 andefficacy of CPP-109 as a treatment for cocaine addiction. Under the trialprotocol, patients are being treated for a period of 12 weeks, with anadditional 12 weeks of follow-up. The primary objective of the trial is todemonstrate 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 ofsecondary endpoints based on reductions of cocaine use and craving.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical companyfocused on the development and commercialization of prescription drugs for thetreatment of addiction and obsessive-compulsive disorders. The Company hasobtained from Brookhaven National Laboratory an exclusive worldwide licensefor Brookhaven's patent portfolio in the United States relating to the rightto use vigabatrin to treat a wide variety of substance addictions andobsessive-compulsive disorders. Catalyst has also been granted rights toBrookhaven's vigabatrin-related foreign patents or patents pending in morethan 30 countries. The Company's initial product candidate is CPP-109, whichis Catalyst's version of vigabatrin. CPP-109 has been granted "Fast Track"status by the U.S. Food & Drug Administration (FDA) for the treatment ofcocaine addiction. This indicates that the FDA has recognized that CPP-109 isintended for the treatment of a serious or life-threatening condition forwhich there is no effective treatment and which demonstrates the potential toaddress unmet medical needs. For more information about the Company, pleasevisit www.catalystpharma.com.
This press release contains forward-looking statements. Forward-lookingstatements involve known and unknown risks and uncertainties which may causethe Company's actual results in future periods to differ materially fromforecasted results. A number of factors, including the Company's ability tosuccessfully complete those clinical trials required for it to file a new drugapplication for CPP-109, the Company's ability to complete such trials on atimely basis within the budgets established for such trials, the Company'sability to protect its intellectual property and those other factors describedin the Company's Annual Report on Form 10-K for 2007 and the Company'sQuarterly Report on Form 10-Q for the quarter ended September 30, 2008 thatthe Company has filed with the U.S. Securities and Exchange Commission (SEC),could adversely affect the Company. Copies of the Company's filings with theSEC are available from the SEC, may be found on the Company's website or maybe obtained upon request from the Company. The Company does not undertake anyobligation to update the information contained herein, which speaks only as ofthis date.
SOURCE Catalyst Pharmaceutical Partners, Inc.
