DARPA to Sponsor Evaluation of the AMPAKINE CX717 in a New Study in Shift Work

IRVINE, Calif.--(BUSINESS WIRE)--June 21, 2005--Cortex Pharmaceuticals, Inc. (AMEX: COR) announced that the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense is sponsoring a new CX717 study. Results from this study could help confirm and extend the positive findings with CX717 from the recently completed sleep deprivation study.

Rationale for the Study: The new study will evaluate the cognitive performance and objective alerting effects of CX717 utilizing a simulated night shift work paradigm. Volunteers will undergo four nights of simulated shift work during which they will be "on shift" (high work load) from 11:00 P.M. to 7:00 A.M. The volunteers will also be restricted to only four hours of recovery sleep on each of the four study days. Three different doses of CX717 will be compared to placebo in randomized, double-blind, parallel-group design. The study medication will be given daily prior to the simulated night shift activities. Outcome measures will include the maintenance of wakefulness test, cognitive performance tests, and polysomnography during the recovery sleep period.

According to Dr. Roger G. Stoll, Chairman, President and CEO of Cortex, "Cortex will supply CX717 and matching placebos for the study. DARPA will fund a military research organization to conduct the study. The first volunteers are expected to be enrolled this summer and we expect that the study should be concluded near the end of the year. Positive results from this study could move CX717 closer toward a marketable indication, namely to improve wakefulness in patients with Excessive Daytime Sleepiness (EDS), while at the same time provide the military with a simulated situation that more closely approximates the adverse sleep conditions often faced by soldiers during military operations."

Cortex announced on May 3, 2005 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.

About Excessive Daytime Sleepiness (EDS) and Shift Work

There are direct benefits to the broader civilian population from this AMPAKINE(R) study in 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 narcolepsy, jet lag and rotating shift workers in the workplace.

About DARPA

DARPA is the central research and development organization for the U.S. Department of Defense. Its primary responsibility is to help maintain technological superiority for the U.S. military and to guard against unforeseen technological advances by potential adversaries. The Agency was founded in 1958, and, over the years, has been responsible for advances in computer networking (DARPA created the ARPANET, the predecessor to today's Internet), advanced materials, ballistic missile defense, space launch vehicles, information processing, advanced computer displays, and many other areas.

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.