Catalyst Announces Positive Results For Vigabatrin Trial

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Catalyst Pharmaceutical announced positive initial top-line results from an investigator-initiated Phase II double-blind, placebo-controlled trial, which demonstrates that vigabatrin is effective for the treatment of cocaine addiction. Catalyst's lead compound, CPP-109, is bioequivalent to vigabatrin.

This 103 subject trial is the first randomized, double-blind, placebo-controlled clinical trial studying vigabatrin's effectiveness in treating cocaine addiction. These data show that a statistically significantly greater number of subjects treated with vigabatrin were able to abstain from cocaine usage during the last three weeks of the dosing period compared to those receiving placebo. Achievement of abstinence for an extended period during treatment is the critical first step for cocaine addicted patients to potentially achieve abstinence for much longer time periods. The data confirm the positive results seen in two previous open-label trials conducted in 2003 and 2004 by the same investigators.

Commenting on the trial results, Patrick J. McEnany, Catalyst's Chairman and Chief Executive Officer, stated, "This trial represents a key development in the field of cocaine addiction research. CPP-109, our product candidate based on vigabatrin, could have a significant impact on how patients struggling with cocaine addiction will be treated in the future. We believe that the success of the trial provides scientific proof of concept. We are highly encouraged by the top-line results and look forward to publication of the results in a peer-reviewed journal. Catalyst will also evaluate the methodology and results for their potential applicability to our ongoing U.S. Phase II trial evaluating CPP-109 for the treatment of cocaine addiction and to our planned U.S. Phase II trial evaluating CPP-109 for the treatment of methamphetamine addiction."

About The Trial

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This trial is the third in a series of human trials conducted in Mexico, which successfully tested the safety and efficacy of vigabatrin to treat cocaine and/or methamphetamine addiction. These trials followed more than 15 years of animal studies conducted by Dr. Stephen Dewey at Brookhaven National Laboratory. All three human trials were conducted under the direction of Dr. Jonathan Brodie, the Marvin Stern Professor of Psychiatry at the New York University (NYU) School of Medicine and Dr. Emilia Figueroa, Director of the Clinica Integral de Tratamiento Contra las Adicciones, S.A. de C.V. The first two trials were small open-label studies. The trial's protocol was approved by NYU's Institutional Review Board in May 2006 and the Federal Commission for Sanitary Risks Protection (Mexico) in September 2006 and is registered at http://www.clinicaltrials.gov with the identifier NCT00527683. Catalyst provided financial support through an unrestricted gift to NYU.

One hundred and three community-based, non-hospitalized cocaine addicted individuals participated in this investigator-initiated, randomized, double- blind, placebo-controlled trial conducted at a single site in Mexico City. All subjects had ready access to cocaine and were self-motivated to stop their use. The trial was designed to show whether vigabatrin treatment could significantly increase abstinence compared to placebo. Subjects were randomly assigned to either a placebo or vigabatrin and were treated for a period of nine weeks. Of the 103 participants in the trial, 50 were treated with vigabatrin and 53 received placebo. Twice-weekly urine screening tests were obtained from each subject in order to objectively evaluate each subjects' cocaine use. All subjects were also offered one group counseling session per week.

The primary outcome measure of the trial was negative urine tests for cocaine for the last three weeks of the nine-week trial.

A total of 18 subjects fulfilled the criteria for the primary outcome measure. Of these, 14 (28%) were treated with vigabatrin versus four (7.6%) who were treated with placebo. A logistic regression utilizing years of cocaine use and average amount per day at baseline yielded statistically significant treatment differences. The p-value was 0.009.

There were no serious adverse events reported in this trial.

"These positive results demonstrate that there is hope for the millions of individuals who suffer from the life threatening consequences of this terrible illness," said Dr. Brodie. "It also demonstrates how a dedicated team of basic scientists and clinicians who persevere in a mission can produce important medical advances by taking an idea from the bench to the community."

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