Catalyst Pharmaceutical Partners, Inc. Announces Commencement of Phase I(a) Safety Study for CPP-115
CORAL GABLES, Fla., Dec. 13, 2011 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that it has commenced its first in man Phase I(a) safety study for its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor.
"We are extremely pleased to now have two drugs, CPP-115 and CPP-109, in the clinic," said Patrick J. McEnany, Catalyst's President and Chief Executive Officer. "Our preclinical experience to date with CPP-115 has demonstrated its potential for certain addiction and epilepsy indications. We hope to offer providers and their patients safe and effective therapies for addiction, as well as safer, more effective medications for infantile spasms and other central nervous system (CNS) diseases than those currently available. We expect to report the results of this study at the end of the first quarter or the beginning of the second quarter of 2012."
The Phase I(a) study is a randomized, double-blind, single ascending dose study in six cohorts of eight normal healthy volunteers, totaling 48 healthy subjects. The study is designed to evaluate the basic human safety characteristics of CPP-115, including CNS side effects, and respiratory and cardiovascular safety.
CPP-115 is a novel GABA aminotransferase inhibitor and an analogue of vigabatrin that is more potent than vigabatrin (CPP-109) and has reduced side effects (e.g., visual field defects, or VFDs and sedation) from those associated with vigabatrin in preclinical studies. Catalyst is planning to develop CPP-115 for several indications, including epilepsy (initially infantile spasms), drug addiction and for other selected CNS disease indications. CPP-115 has been granted orphan-drug designation by the FDA for the treatment of infantile spasms.
CPP-115 is the lead compound being developed by Catalyst under its license agreement with Northwestern University. Dr. Richard B. Silverman, the John Evans Professor of Chemistry at Northwestern University, led the team of scientists that invented CPP-115. Dr. Silverman holds more than 40 patents and is the inventor of Pfizer's drug, pregabalin (Lyrica®).
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of addiction and epilepsy. Catalyst has two products in development, CPP-109 and CPP-115, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109 (vigabatrin), 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 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 Catalyst, 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 whether CPP-115 will be safe for use in humans, whether CPP-115 will be effective for the treatment of addiction, infantile spasms or other CNS indications, whether CPP-115 will ever be approved for commercialization, and those 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
Chief Executive Officer
Catalyst Pharmaceutical Partners
Rx Communications Group
Source: Catalyst Pharmaceutical Partners, Inc.
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