DARPA Extends Research Funding for the Prevention of Sleep Deprivation, Which Includes AMPAKINE Technology.

Business Editors/Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--June 8, 2004

Wake Forest University scientist, Sam Deadwyler, Ph.D., receives a $5.1 Million grant extension to evaluate additional compounds in novel

primate model

Cortex Pharmaceuticals, Inc. (AMEX: COR), announced that funding to Dr. Sam A. Deadwyler, Professor and Vice Chairman, Department of Physiology and Pharmacology at Wake Forest University School of Medicine, has been extended by DARPA (Defense Advanced Research Projects Agency) for additional testing of AMPAKINE(R) compounds to reverse the effects of sleep deprivation in non-human primates. This model accurately measures decrements in cognitive performance and reaction time after monkeys have been deprived of sleep for 30-36 hours.

This model utilizes rhesus macaque monkeys that are trained to respond to computer images projected onto a white screen by moving their arm to place a cursor initially in a start circle and then a specific image is displayed. The screen then goes blank from 1-30 seconds and then two to six images are randomly selected by the computer and projected on the screen. The monkey then has to select the first image from the group of images and place the cursor on it. This technique is called a visual delayed-match-to-sample (DMS) task. These monkeys are trained to respond to a high overall level (80%) of performance. Under carefully controlled conditions and constant medical monitoring, the monkeys are individually sleep-deprived for 30-36 hours and re-tested at that time. According to Dr. Deadwyler, when monkeys are sleep deprived their performance accuracy on the task is significantly reduced by 15-25%, and their reaction times slowed by at least 50% in all monkeys. In an attempt to combat cognitive deficits associated with sleep deprivation, DARPA-funded investigators at Wake Forest have been using this monkey model to discover new therapies, such as the AMPAKINE CX717. According to Dr. Deadwyler, a single dose of 0.8 mg/kg, completely reversed the performance deficits associated with sleep-deprivation. In addition, specific brain EEG changes that occur after sleep deprivation were returned to the non-sleep-deprived state in the CX717 group, but not in the control group. Thus, CX717 counteracted the effects of periods of prolonged sleep deprivation when given immediately before testing.

Dr. Roger G. Stoll, Chairman, President & CEO, of Cortex commented, "With this extended DARPA grant, Dr. Deadwyler will be able to profile several of the newer and more potent AMPAKINE compounds from the Company's vast AMPAKINE library for their impact on sleep deprivation. DARPA is interested in preventing cognitive degradation as a result of sleep deprivation, because in combat, soldiers and pilots sometimes need to stay alert for extended periods of time to complete their mission."

"This research has direct application to civilian situations such as jet lag, accidents in the workplace resulting from rotating shifts, and clinical disorders, i.e., narcolepsy and sleep apnea," according to Dr. Deadwyler.

Rationale for the DARPA Grant Extension

DARPA is evaluating novel approaches, like the AMPAKINE pharmacology, to treat impaired performance associated with sleep deprivation. Deficits in cognitive performance and reaction time can be alleviated by AMPAKINE compounds. These agents can selectively increase cerebral activation without the deleterious effects of excessive arousal that may result in impaired performance.

About DARPA:

DARPA - The Defense Advanced Research Projects Agency (DARPA) is the central research and development organization for the Department of Defense (DoD). It manages and directs selected basic and applied research and development projects for DoD, and pursues research and technology where risk and payoff are both very high and where success may provide dramatic advances for traditional military roles and missions. The agency was established on February 7, 1958.

DARPA Website: www.darpa.mil

About WFUBMC:

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. It is licensed to operate 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America's Best Hospitals" by U.S. News & World Report.

WFUBMC Website: www.wfubmc.edu

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/)

Note - This press release contains forward-looking statements concerning Cortex's research and development activities. Such activities are subject to a number of risk factors, including the risks that Cortex's proposed products may be unsafe or ineffective for any or all of their proposed indications; and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete, In addition, competitors may challenge or design around Cortex's patents or develop competing technologies. Also, that Cortex may be unable to secure additional capital needed to continue such research activities. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products require additional research, lengthy and costly clinical testing and regulatory approval. The compounds are investigational drugs and have not yet been approved for the treatment of any disease.