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Positive Effects of CX516 in Human Sleep Deprivation Study IRVINE, Calif.--(BUSINESS WIRE)--Oct. 21, 2003--08:30 AM US Eastern Timezone Preliminary Findings Suggest CX516, Compared to Placebo, Improves Performance in Dose-Related Fashion in Healthy Subjects After 31 Hours Without Sleep Cortex Pharmaceuticals, Inc. (AMEX: COR) announced that preliminary results from testing its AMPAKINE(R) CX516 showed a positive dose-related response on performance deficits in healthy male subjects after sleep deprivation. The study was performed at the Medical University of South Carolina (MUSC) by Dr. Mark S. George, Distinguished Professor of Psychiatry, Radiology and Neurology. The doses of CX516 administered were all well below those used in the primate sleep deprivation study performed by Dr. Sam Deadwyler, Professor and Vice Chairman, Department of Physiology and Pharmacology at Wake Forest University School of Medicine (manuscript submitted). "In this first human sleep deprivation study, CX516 had a favorable safety profile with no serious adverse events. We are now prepared to test the higher dose that was used in the primate study, and we hope to have this additional information in time to present at the American College of Neuropsychopharmacology (ACNP) annual meeting to be held in San Juan, Puerto Rico from December 7 to 11, 2003," said Dr. George. In the MUSC study, 10 young healthy men were administered three different doses of CX516 or a placebo control in a double blind crossover design. All subjects were sleep deprived for 31 hours before they received the drug or placebo dose. Multiple performance tests were run during the control and treatment phases of the study on each subject. A total of 40 doses were administered during this trial. Cortex is evaluating these effects because all currently prescribed medications to treat impaired performance and Excessive Daytime Sleepiness (EDS) associated with sleep deprivation are scheduled drugs. The marketed prescription medications presently available are known to non-selectively increase both cerebral and somatic arousal, which is often defined as "jitteryness" in humans. While memory can be enhanced by such compounds, there is an unmet medical need to have a product which can enhance performance without also (a) having the potential for substance abuse (scheduled prescription medication), (b) being habit forming, or (c) producing the jitteryness often associated with high doses of caffeine or over-the-counter, non-prescription stimulants. AMPAKINE compounds can selectively increase cerebral arousal without increasing somatic arousal and may prove useful for improving performance and decreasing the EDS associated with narcolepsy and other conditions caused by sleep deprivation. Narcolepsy is an "Orphan Drug" indication, which would reduce both the cost and time to market for a potential therapeutic agent from Cortex. Rationale for the Study There are direct benefits from this AMPAKINE 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. AMPAKINE compounds are known to have no measurable effects on heart rate, and work by turning up the volume of circuits in the brain that are being used, and not affecting other circuits, which are not in use. The compounds are particularly effective in complex tasks that require multi-neuronal circuits, which often are located in the cerebral cortex. Hence, selective cerebral arousal with AMPAKINE compounds seems possible. Use of such agents may often not require chronic dosing and may only require a few doses of medication at any one time. It is therefore possible that a short half-lived compound, such as CX516, or a more potent and longer acting AMPAKINE compound, like CX717, may find application in this type of therapy. About Cortex 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 behavioral problems in patients with 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, Parkinson's disease and Anxiety Disorders. For more information on Cortex Pharmaceuticals, please visit www.cortexpharm.com. About MUSC The Medical University of South Carolina's mission is to preserve and optimize human life in South Carolina and beyond through education, research and health care. Located on the Charleston peninsula, the university educates students from across the state and beyond. It provides primary care services for the local community and serves as a referral center for specialized care for patients from across the state, the nation and the world. 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, the risk 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 would require additional research, lengthy and costly clinical testing and regulatory approval. The AMPAKINE compounds are investigational drugs and have not yet been shown to have efficacy in the treatment of any disease. Contacts: Cortex Pharmaceuticals, Inc. Roger G. Stoll, Ph.D., 949-727-3157 or The Investor Relations Group Investor Contact: Jane Lin/Dian Griesel, Ph.D., 212-825-3210 SOURCE: Business Wire (press release) http://tinyurl.com/rrs7 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn