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Cortex Receives $770,000 Grant From NIMH for Schizophrenia Research.

- Preliminary Clinical Results Published in Journal of Clinical

Psychopharmacology -

IRVINE, Calif., Oct. 17 /PRNewswire/ --

Cortex Pharmaceuticals, Inc. (Amex: COR) today announced it has been notified that the National Institutes of Mental Health (NIMH) will fund the Company's grant application, "Therapeutic Potential of AMPAKINEs in Schizophrenia." It is anticipated that the grant will cover a period of two years and provide total funding of $769,818. The Principal Investigator for the grant is Steven A. Johnson, Ph.D., Director of Clinical Research at Cortex. This grant represents a Phase II Small Business Innovative Research (SBIR) follow-on to research previously funded by the SBIR Research Program.

"This award will allow us to follow-up on previously reported clinical tests of our AMPAKINE(R) CX516 as a potential combination therapy for schizophrenia," said Vincent F. Simmon, Ph.D., President and Chief Executive Officer of Cortex. "Earlier tests were encouraging, with AMPAKINE-treated patients showing improvement in a number of clinical and neurocognitive scores."

"Schizophrenia involves several categories of symptoms," stated Dr. Johnson. "Currently available antipsychotics effectively control positive symptoms (hallucinations and delusions), but do not always alleviate persistent negative symptoms (withdrawal and apathy) or cognitive deficits."

This award will support a Phase IIb study of CX516 as a combination therapy in schizophrenia patients concomitantly treated with olanzapine. The trial will employ a randomized, double blind, placebo controlled design in which the placebo group receives olanzapine plus placebo and the active group receives olanzapine plus CX516. A total of eighty patients will be enrolled in the trial, to be performed by Dr. Donald Goff, M.D. of Massachusetts General Hospital and Harvard University in Boston, MA.

Separately, Cortex announced the publication of an article entitled "A Placebo-Controlled Pilot Study of the AMPAKINE CX516 Added to Clozapine in Schizophrenia" in the October 2001 issue of the Journal of Clinical Psychopharmacology. The authors include Donald Goff, M.D., the Principal Investigator of the study, Gary Lynch, Ph.D., Professor of Psychiatry and Human Behavior at University of California, Irvine and Steven A. Johnson, Ph.D. The authors reported that "CX516 was tolerated well and was associated with moderate to large between-group effect sizes compared with placebo, representing improvement in measures of attention and memory. These preliminary results suggest that CX516 and other AMPAKINE compounds hold promise for the treatment of schizophrenia."

In 1999, Cortex licensed exclusive rights to its AMPAKINE technology as a potential treatment for schizophrenia to Organon. As recently reported, Organon is currently entering a Phase II study of an AMPAKINE as a therapy for the disorder. "We believe that this grant-funded study of an AMPAKINE compound as a combination therapy may be useful in progressing the drug development of Organon," added Dr. Simmon.

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 weakening or loss of these connections is thought to be responsible for memory difficulties from Alzheimer's disease and to contribute to cognitive dysfunction in schizophrenia. A recently completed study with an AMPAKINE compound in patients with schizophrenia indicated improvement in a number of symptoms also common to patients with attention deficit hyperactivity disorder ("ADHD"). Cortex has alliances with Organon for the potential treatment of schizophrenia and depression, with Shire Pharmaceuticals Group for the evaluation and potential licensing of AMPAKINE compounds as a treatment for ADHD and with Les Laboratoires Servier for the development of AMPAKINE compounds to potentially treat the neurodegenerative effects associated with aging and disease, including Alzheimer's disease.


Note -- This press release contains forward-looking statements concerning the Company's research and development activities and business development plans. Actual results may differ materially, depending on a number of risk factors, including the risks that the Company may be unable to secure additional capital needed to continue its operations; that the agreements with its corporate partners, Organon, Shire and Servier will not result in any commercial products or that any additional milestone payments will be earned by the Company; that the Company may be unable to arrive at corporate partnerships with other pharmaceutical companies on acceptable terms and therefore be required to independently fund clinical development of AMPAKINE compounds through the sale of additional equity securities or otherwise; that the Company's proposed products may at any time be found to be toxic or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company's patents or develop competing technologies; 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 yet been shown to have efficacy in the treatment of any disease.

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Publication:PR Newswire
Date:Oct 17, 2001
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