Cortex Reports Positive Effects of its AMPAKINE-R- CX717 in Human Slee

Cortex Reports Positive Effects of its AMPAKINE-R- CX717 in Human Sleep Deprivation Study

    Business Editors
    Rodman & Renshaw Techvest Global Healthcare Conference 2005


    IRVINE, Calif.--(BUSINESS WIRE)--May 2, 2005--

Preliminary analysis suggests CX717, when compared to placebo, increased wakefulness in a dose-related manner and improved performance of those subjects that were impaired
    Cortex Pharmaceuticals, Inc. (AMEX: COR), announced that preliminary analysis suggests that CX717, when compared to placebo, increased wakefulness in a dose-related manner and improved performance in healthy male subjects that became impaired during 27 hours without sleep. The study was performed in the United Kingdom at the Academic Clinic for Disorders of Sleep and Wakefulness within the Human Psychopharmacology Research Unit at the Medical Research Centre, School of Biomedical and Molecular Sciences, University of Surrey by Dr. Julia Boyle, Acting Director of the Research Unit and Professor Anthony N. Nicholson, Medical Director and Visiting Professor of Aviation Medicine, King's College London.
    According to Dr. Boyle, "There is evidence that it is the low levels of performance in individuals particularly affected by sleep deprivation that are alleviated by CX717, and that this effect is seen with many measures of performance and across the whole dose range studied from 100 mg through 300 mg to 1000 mg."
    Professor Anthony N. Nicholson, a clinical neuroscientist who specialises in the pharmacology of the sleep-wakefulness continuum, said "We found that all the three doses of CX717 had an alerting effect in subjects deprived of sleep overnight. With the 100 mg dose there was evidence of increased wakefulness overnight, but an alerting effect was not seen during the recovery sleep the following morning. With both the 300 mg and 1000 mg doses the overnight alerting effect extended well into the next day recovery sleep, and the effect was greater with the higher dose. These findings, and the studies on performance, indicate clearly that the alerting effects and the duration of the alerting effects of CX717 are dose related".
    In the study, 16 young healthy men were administered three different doses of CX717 and a placebo control in a randomized, double-blind, four-way crossover design. All subjects were sleep deprived for 27 hours during which time they were tested on measures of memory, attention, vigilance, reaction time, and executive function. Propensity to fall sleep was measured with a modified wakefulness test given at 4 AM on the night of testing. The integrity of recovery sleep was assessed by polysomnography.
    Dr. Roger Stoll, Cortex's Chairman, President & CEO, stated "the results from this study are very encouraging and begin to validate our AMPAKINE pharmacology in humans. This study supports our development approach for CX717. We plan to conduct pilot studies in variety of brain disorders that might benefit from AMPAKINE pharmacology including Alzheimer's Disease, Attention Deficit Hyperactivity Disorder (ADHD), and sleep disorders."
    Cortex believes AMPAKINE compounds could selectively increase cerebral arousal without increasing somatic arousal and may prove useful for improving performance and decreasing the excessive daytime somnolence associated with shift work, narcolepsy and other conditions caused by sleep deprivation. Narcolepsy is an Orphan Drug indication, which could reduce both the cost and time to market for a potential therapeutic agent from Cortex.

    About excessive daytime somnolence (EDS)

    The National Commission on Sleep Disorders estimates that 40 million Americans are either chronically or intermittently affected with various sleep disorders. In addition to the tremendous personal pain and suffering they inflict, sleep disorders are a tremendous drain on the productivity and safety of our country: falling asleep at the wheel is one of the most costly and devastating problems on American highways; accidents in the workplace due to sleep deprivation are commonplace and damaging to industry; the annual direct cost to society is over $15 billion. AMPAKINE products may also be useful in the treatment of a variety of sleep disorders associated with EDS including narcolepsy, jet lag and shift work sleep disorder.
    Roger G. Stoll, Ph.D., Chairman, President and CEO will discuss the preliminary findings at the Rodman & Renshaw 2nd Annual Global Healthcare Conference in Paris on Wednesday, May 4th at 10:30 AM (local time) at the Intercontinental Hotel.
    As previously announced, a live webcast of the presentation can be accessed by logging onto http://www.wsw.com/webcast/rrshq5/cor/ and a replay will be available for 45 days following the conference.

    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 products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company's patents or develop competing technologies; 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.

--30--MEM/ny*

CONTACT: Cortex Pharmaceuticals, Inc. Roger G. Stoll, Ph.D. Chairman, President and CEO 949-727-3157 or The Investor Relations Group Damian McIntosh / Dian Griesel, Ph.D. 212-825-3210

KEYWORD: CALIFORNIA FRANCE INTERNATIONAL EUROPE TRACK INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY ADVERTISING/MARKETING CONFERENCE CALLS TRADESHOW PRODUCT SOURCE: Cortex Pharmaceuticals, Inc.

Copyright Business Wire 2005