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Publication in the Journal PLoS Biology Supports Cortex Pharmaceutical's CX717 AMPAKINE Compound As a Potential New Treatment for Cognitive Impairments

Posted on: Tuesday, 23 August 2005, 09:01 CDT

Leading scientists from Wake Forest University Baptist Medical Center have demonstrated in a unique primate model that the AMPAKINE(R) CX717, a member of a novel class of pharmaceuticals under development at Cortex Pharmaceuticals (AMEX: COR), improved cognitive performance and also reversed the deleterious effects of sleep deprivation. This research at Wake Forest provided the basis for conducting the Phase II sleep deprivation study in humans, which confirmed CX717 improved wakefulness, memory, cognition and attention without causing systemic stimulation in subjects that were sleep deprived as reported in the Company's May 4, 2005 press release.

Samuel A. Deadwyler, Ph.D. and his colleagues have published, in the journal Public Library of Science, Biology (an open access, peer reviewed, freely available online publication at www.plosbiology.org) a comprehensive article supporting CX717 as a likely treatment for cognitive impairments entitled, Facilitation of Task Performance and Removal of the Effects of Sleep Deprivation by an AMPAKINE (CX717) in Nonhuman Primates.

The Wake Forest study results dovetail closely with Cortex Pharmaceuticals' own ongoing clinical studies. Improved attention in the primates receiving CX717 in the Wake Forest study, as indicated by shorter response times, bodes well for the 60 patients in a three week CX717 Attention Deficit (ADHD) trial and the 45 subjects in the Night-Shift Work Study underway and sponsored by Cortex and the Defense Advanced Research Projects Agency (DARPA).

"The Wake Forest primate model led to predictions relevant to human task performance under conditions of sleep deprivation and circadian rhythm disruption. We are now testing those predictions in humans in clinical settings using CX717 and preliminary results are very encouraging," says Roger Stoll, Ph.D., Chairman, President and CEO of Cortex.

The improvement in short term memory observed in primates on CX717 in Dr. Deadwyler's study, accompanied by relevant changes in brain glucose utilization measured by PET scans, bolsters Cortex's belief that similar results will be seen in the Company's CX717 PET scan study in mild-moderate Alzheimer's disease trial currently ongoing.

AMPAKINE drugs acting through the AMPA-receptor are designed to up-regulate glutamate, the principal excitatory neurotransmitter in the brain. Deterioration of AMPA-receptor mediated brain activity in patients following sleep deprivation and in Alzheimer's and other neurological and psychiatric disorders associated with loss of memory and cognition. AMPAKINE drugs may also increase the amount growth factors in the brain, which, in turn, may help treat the underlying causes of these various conditions.

AMPAKINE drugs act to increase the strength of signals at key connections between brain cells. The weakening or loss of these connections is thought to be responsible for memory difficulties and/or disorders associated with both neurological and psychological diseases including schizophrenia, Mild Cognitive Impairment (MCI), Alzheimer's disease, Attention Deficit Hyperactivity Disorder (ADHD), and depression. The AMPKINE CX717 amplifies signals in the brain, like a hearing aid does for the hearing impaired, making it easier to encode new information.

Cortex Pharmaceuticals anticipates completing the second and third AMPAKINE CX717 Phase IIa studies: one for Attention Deficit Hyperactivity Disorder (ADHD) and the other for mild to moderate Alzheimer's disease (AD) by the end of this year. The fourth Phase IIa trial, a DARPA funded trial simulating shift work is scheduled to be initiated at the beginning of September.

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. 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.

Source: Business Wire

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