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Cortex To Present Data From Adult ADHD Study At AACAP Meeting

Posted on: Tuesday, 5 September 2006, 09:00 CDT

Clinical trial results from Cortex Pharmaceuticals, Inc.'s (AMEX: COR) lead AMPAKINE(R) compound, CX717, were accepted for presentation at the annual meeting of the American Academy of Child and Adolescent Psychiatry in San Diego on October 27, 2006. Dr. Lenard Adler, Director for the Adult ADHD Program, and Associate Professor of Psychiatry and Neurology at New York University School of Medicine and lead study investigator, will present the positive findings from the Phase IIa clinical trial of CX717 in adults with attention deficit / hyperactivity disorder (ADHD). As previously announced, the primary finding from the study was that, by repeated measures analysis, CX717 at a dose of 800 mg twice a day (n = 23) was significantly more effective than placebo on the total ADHD Rating Scale (p=0.0024) and on both the hyperactivity (p=0.0168) and inattentiveness (p=0.0273) subscales. The 200 mg twice a day dose (n=28) did not separate from placebo. Sleep disturbances and headaches were the most frequently reported adverse events. No significant safety concerns or changes in cardiovascular parameters were observed with either dose of CX717.

About the adult ADHD study

This Phase IIa study evaluated the efficacy, tolerability and safety of CX717 in treatment of adults with ADHD. A randomized, double-blind, multi-center, 2-period crossover study compared 2 doses of CX717 (either 200 mg twice a day or 800 mg twice a day) with placebo. Each treatment period lasted 3 weeks with a 2-week washout in between. Subjects met DSM-IV criteria for adult ADHD and had moderate to severe symptoms. The primary efficacy measure was the change from baseline on the ADHD-Rating Scale with prompts (ADHD-RS). Sixty-eight (68) male subjects, 19-50 years old, were randomized. Fifty-one (51) subjects, 28 in the low dose component and 23 in high dose component, returned for efficacy assessments in both treatment periods and comprised the intention-to-treat population.

About Cortex Pharmaceuticals:

Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer's disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety disorders. (http://www.cortexpharm.com/)

Forward-Looking Statement

Note - This press release contains forward-looking statements concerning the Company's research and development activities. The success of such activities depends on a number of factors, including the risks that the Company's proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical test and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.

Source: Business Wire

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