U.S. Department of Defense Awards $1.2 Million to Study the Use of Vigabatrin to Reduce the Addictive Liability of Opiates While Still Effectively Managing Pain

November 10, 2009

CORAL GABLES, Fla., Nov. 10 /PRNewswire-FirstCall/ — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) today reported that a team of neuroscientists at The Feinstein Institute for Medical Research at North Shore-Long Island Jewish Health System (LIJ) has received a $1.2 million grant from the U.S. Department of Defense (DOD) to conduct an animal study of the use of vigabatrin in combination with opiates to effectively manage pain while reducing the potential for opiate addiction. Opioid abuse is one of the many substance addiction indications covered under Catalyst’s exclusive license of Brookhaven National Laboratory’s vigabatrin patent portfolio. With this in mind, Catalyst has agreed to provide CPP-109, Catalyst’s version of vigabatrin, to facilitate the study.

The research team is led by Wynne K. Schiffer, Ph.D. and Stephen L. Dewey, Ph.D. of The Feinstein Institute for Medical Research and Jonathan D. Brodie, M.D., Ph.D. from the Department of Psychiatry at New York University’s School of Medicine. Drs. Dewey and Brodie are the co-inventors on the vigabatrin-related patents that Catalyst has licensed from Brookhaven and are members of Catalyst’s Scientific Advisory Board. Drs. Schiffer and Dewey have recently moved from Brookhaven to The Feinstein Institute.

The impetus for the DOD grant is the problem of pain on the heels of war-related injury. Under-treatment of pain is a serious problem in the Armed Forces and the U.S. Veteran population. Drugs such as morphine and other opiates provide the best pain relief; however, due to the concern of potential addiction, these drugs are often administered at very low doses which frequently under-treat pain. In 2006, more than 354,000 veterans received care in the U.S. Veterans Health Administration hospital programs for substance abuse disorders, including the development of opiate dependence used for the treatment of chronic pain. The goal of the grant is to begin to develop a treatment strategy that seeks to eliminate the addictive liability of morphine while maintaining its ability to manage pain.

About The Study

This is a proof-of-concept animal study that employs a pain paradigm rat model (formalin paw test) in conjunction with a measure of drug-seeking behavior (conditioned place preference) that is commonly used to determine the appetitive value of morphine at doses that are minimally sufficient to effectively manage formalin-induced pain. Brain imaging experiments with Positron Emission Tomography (PET) will be used to show neurochemical and metabolic changes as they relate to efficacy in this proposed treatment strategy. The study will be conducted at The Feinstein Institute.

This study builds upon previous data that have shown vigabatrin’s ability to reduce the abuse liability of many abused compounds, including opiates. On the basis of preliminary data, it is believed that vigabatrin will not diminish the pain relief associated with opiates.

Commenting on the study, Patrick McEnany, Chief Executive Officer of Catalyst stated, “We are pleased to be able to participate in this important investigator study. Opioid abuse is a significant problem within the military as well as our population at-large. We believe that CPP-109 can be effective for a variety of abused substances and look forward to advancing the drug on multiple fronts. The award of this grant to Drs. Schiffer and Dewey and our participation in this study is just one example of our strategy to work with partners in academia, government and industry to advance CPP-109 as a therapy for substance abuse and obsessive-compulsive disorders.”

“The problems of under-treating pain and the development of opiate addiction have pushed providers in opposite directions. This study may uncover a pharmacological intervention to prevent – rather than simply treat – addiction to morphine. If a higher dose of morphine can be used without the risk of addiction, it will benefit not only individuals serving in the armed forces, but also civilians who suffer from chronic pain. We are very enthusiastic about exploring this promising approach to an extremely important question,” said Dr. Schiffer, the Principal Investigator of this federally-funded study.

About The Feinstein Institute for Medical Research

Established in 1999, The Feinstein Institute for Medical Research is a unique research institute on the grounds of the North Shore-LIJ Health System in Manhasset, New York. Over 200 Feinstein investigators work to cure human disease, which is the driving force behind all of the Institute’s activities – from basic science experiments and clinical investigations to the technology transfer standards, graduate school courses, investigative medicine seminars and community outreach programs. The Institute bridges the gap between biomedical research and patient care, accessing hundreds of thousands of patients in the health system. The volume of National Institutes of Health-funded, patient-oriented research programs in The Feinstein Institute is significant: Over 80% of their research projects come under the category of patient-oriented research, and nearly 65% of these projects are supported by federal grants.

About Catalyst Pharmaceutical Partners

Catalyst Pharmaceutical Partners, Inc. is a 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 drug addiction and epilepsy. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents 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. Catalyst has also recently been granted worldwide rights to another patented drug, CPP-115, by Northwestern University. The Company intends to pursue development of CPP-115 for several indications, including drug addiction and epilepsy. 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 those 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.

SOURCE Catalyst Pharmaceutical Partners

Source: newswire

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