CORAL GABLES, Fla., Feb. 23 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced today that it has signed a non-binding Letter of Intent with the National Institute on Drug Abuse (NIDA) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst’s formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with Veteran’s Administration Cooperative Studies Program, will provide substantial resources for the trial and that Catalyst will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost.
“Currently, there are no FDA-approved medications to battle cocaine addiction,” said Dr. David McCann, Associate Director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA. “We are involved because we are encouraged by findings from prior animal and human studies that suggest promise for this medication as a treatment for the nation’s estimated 2.1 million cocaine abusers.”
“We will build on the knowledge and experience gained from the five previous human trials that have been conducted with vigabatrin to treat cocaine and methamphetamine addiction,” said Douglas Winship, Catalyst’s Vice President of Regulatory Operations. “This collaboration will enable us to conduct a Phase II(b) registration-directed trial of CPP-109 as required by the FDA. We expect to commence enrollment of patients by early summer of 2010 and to complete enrollment within 12 months.”
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 required execution of a definitive clinical trial agreement between NIDA and Catalyst with respect to the clinical trial described in this press release and those 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, Chief Executive Officer, Catalyst
Pharmaceutical Partners, +1-305-529-2522, pmcenany@catalystpharma.com; or
Melody Carey, Co-President, Rx Communications Group, +1-917-322-2571,
mcarey@rxir.com
Web site: http://www.catalystpharma.com/
