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


IRVINE, Calif. -- Cortex Pharmaceuticals, Inc. (AMEX AMEX

See: American Stock Exchange
: COR) announced that the Defense Advanced Research Projects Agency Defense Advanced Research Projects Agency (DARPA), U.S. government agency administered by the Department of Defense (see Defense, United States Department of).  (DARPA DARPA: see Defense Advanced Research Projects Agency.


(Defense Advanced Research Projects Agency) The name given to the U.S. Advanced Research Projects Agency during the 1980s. It was later renamed back to ARPA.
) 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 ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, 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 wakefulness

believed to occur when the tonic flow of impulses from the reticular activating system exceeds the critical level for sustaining consciousness; reduction of reticular activating system activity is the basis of the pharmacological induction of sedation.
 test, cognitive performance tests, and polysomnography during the recovery sleep period.

According to Dr. Roger G. Stoll, Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 excessive daytime sleepiness Sleep disorders A subjective difficulty in maintaining an awake state, and an increase ease of falling asleep when the person is sedentary; EDS may be quantified with subjective rating scales of sleepiness  (EDS (Electronic Data Systems, Plano, TX, www.eds.com) Founded in 1962 by H. Ross Perot (independent candidate for the President of the U.S. in 1992), EDS is the largest outsourcing and data processing services organization in the country. ), 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 psychopharmacology (sī'kōfär'məkŏl`əjē), in its broadest sense, the study of all pharmacological agents that affect mental and emotional functions.  Research Unit at the Medical Research Centre, School of Biomedical and Molecular Sciences, University of Surrey The University of Surrey is a public university in Guildford, England. It received its charter on 9 September 1966, and was situated near Battersea Park in south-west London. The institution was known as Battersea College of Technology before gaining university status.  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 narcolepsy, a sleep disorder characterized by excessive daytime sleepiness and recurring unwanted episodes of sleep ("sleep attacks"). People with narcolepsy may abruptly fall asleep at almost any time, including while talking, eating, or even walking. , 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 (Advanced Research Projects Agency NETwork) The research network funded by the U.S. Advanced Research Projects Agency (ARPA). The software was developed by Bolt, Beranek and Newman (BBN), and Honeywell 516 minicomputers were the first hardware used as , 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 The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested.  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 mild cognitive impairment (MCI),
n memory loss generally associated with aging; does not affect normal independent functioning of an individual.
, 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.
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Date:Jun 21, 2005
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