IRVINE, Calif., June 13 /PRNewswire/ --  Cortex Pharmaceuticals, Inc. (Amex: COR) announced today that its corporate partner, Shire Pharmaceuticals Group, Plc (Nasdaq: SHPGY; LSE: SHP.L) will initiate enrollment in a Phase II Study with CX516 (Shire code SPD420), in patients with Attention Deficit Hyperactivity Disorder (ADHD). The AMPAKINE family of drugs represent a new pharmacological approach to treating ADHD. Preclinical and human studies with SPD420 (AMPAKINE CX516) have shown that this compound appears to improve a number of aspects of cognitive functions including attention, distractibility, problem solving, memory and verbal learning. Patients with ADHD typically have impairments in each of these critical domains.

The Phase II study will be double blind, with patients randomized to drug or placebo for four weeks. The study is designed to evaluate the safety and efficacy of SPD420 compared to placebo in 114 adult male and female ADHD patients at 12 investigative sites across the United States. Patients will be screened for ADHD by a structured clinical interview utilizing standardized criteria for inclusion and exclusion. The primary efficacy outcome measures will be the ADHD-Rating Scale (ADHD-RS) and the Clinical Global Impression Scale (CGI). It is anticipated that this trial will take approximately one year to complete.

Vincent F. Simmon, Ph.D., President and CEO of Cortex Pharmaceuticals, said "If the study proves effective, Shire has the right to convert its option for SPD420, or newer AMPAKINE compounds, into an exclusive worldwide license under a previously negotiated development and licensing agreement. Should Shire elect to execute this agreement, Cortex would receive an upfront fee, milestone payments based on successful clinical and commercial development, research support for additional AMPAKINE compounds, and royalties on sales. Shire will bear the cost for the clinical development. We are pleased to be working with Shire, which has established a preeminent position in the treatment of ADHD. The AMPAKINE drugs may represent a novel, non-controlled (not regulated by the Drug Enforcement Agency) approach for treating ADHD. Existing drugs based on amphetamine or derivatives of amphetamine are effective, but may have side effects that reduce compliance."

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 AMPAKINE CX516 in patients with schizophrenia indicated improvement in a number of symptoms also common to patients with ADHD. In addition to the alliance with the Shire Pharmaceuticals Group, Cortex has partnerships with NV Organon for novel AMPAKINE compounds to treat schizophrenia and depression and Les Laboratoires Servier of Paris, to whom Cortex has licensed unique AMPAKINE molecules in Europe and Asia for a number of age and disease related neurodegenerative conditions including Alzheimer's disease, Mild Cognitive Impairment and dementias associated with diseases such as multiple sclerosis and Parkinson's disease. Cortex has retained the AMPAKINE rights for the large neurodegenerative disease market in Australia, New Zealand and most of the Americas, including the United States.

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, as discussed in the Company's Securities and Exchange Commission filings, including the risks 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 the Company's proposed products will require additional research, lengthy and costly clinical testing and regulatory approval; that clinical studies may at any point be suspended or take substantially longer than anticipated to complete; that the agreements with Shire, Organon and Servier will not result in any commercial products or that any additional milestone payments or royalties 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 its AMPAKINE technology for other indications through the sale of additional equity securities or otherwise; that the Company may be unable to secure additional capital needed to continue its operations; and that competitors may challenge or design around the Company's patents or develop competing technologies. AMPAKINE compounds are investigational drugs and have not yet been shown to have efficacy in the treatment of any disease.

SOURCE Cortex Pharmaceuticals, Inc.

Website: http://www.cortexpharm.com 

CO: Cortex Pharmaceuticals, Inc.; Shire Pharmaceuticals Group, Plc

ST: California

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