CORAL GABLES, Fla., June 30 /PRNewswire-FirstCall/ -- 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, today announced that it has begun enrollment for its randomized, double-blind, placebo-controlled U.S. 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.
Catalyst’s web site 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 about the trial will soon be available on www.clinicaltrials.gov (search for Catalyst).
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 U.S. 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 enroll 180 methamphetamine addicted patients at 15 leading addiction treatment clinical centers 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.”
About Methamphetamine Addiction
Methamphetamine is a highly addictive stimulant that affects the central nervous system. Abuse of the drug leads to devastating medical, psychological and social consequences.
According to the 2005 SAMHSA Survey on Drug Use and Health, an estimated 10.4 million people age 12 or older (4.3 percent of the population) have tried methamphetamine at some time in their lives. Approximately 1.3 million reported past-year methamphetamine use, and 512,000 reported current (past-month) use. Approximately 535,000 patients sought treatment for methamphetamine and other stimulant abuse in 2006. In addition, according to the 2006 SAMHSA Survey, an estimated 22.6 million people in the United States suffered from dependence on illicit drugs.
According to the Office of National Drug Control Policy, the costs of drug abuse to society were an estimated $180 billion in 2002 in the United States. According to the United Nations Office on Drugs and Crime, in 2005 there were approximately 4.1 million users of cocaine and 2.8 million users of amphetamine-type stimulants across Europe.
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 based on vigabatrin is CPP-109. 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, go to 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 our ability to successfully complete the clinical trials required for us to file a new drug application for CPP-109, our ability to complete such trials on a timely basis within the budgets we establish for such trials, our ability to protect our 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 March 31, 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.
CONTACT: Patrick J. McEnany, Chief Executive Officer, Catalyst
Pharmaceutical Partners, Inc., +1-305-529-2522,
pmcenany@catalystpharma.com; Eric Goldman, +1-917-322-2563,
egoldman@rxir.com, or Melody Carey +1-917-322-2571, mcarey@rxir.com, both
of Rx Communications Group for Catalyst Pharmaceutical Partners, Inc.
Web site: http://www.catalystpharma.com/
