IRVINE, Calif.--(BUSINESS WIRE)--April 13, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) indicated on April 3rd that the Company received a phone call from the U.S. Food and Drug Administration (FDA) that a clinical hold was being placed on AMPAKINE CX717 and further clarification would be outlined in a formal letter by the agency. The Company has now received this letter that reviews the rationale for the agency’s action, which is based on preclinical animal data, and outlines the work required for the clinical hold to be removed. Based on the terms in the letter, the Company has begun the process to arrange for discussions with the appropriate experts within the agency to translate the request into specific acute preclinical studies related to the issues and recommendations provided by the agency.
Cortex is going to cooperate fully with the FDA and work diligently to address its concerns. After the FDA and Cortex have agreed upon a plan of work, the Company will inform shareholders of both the scope of the work involved and the anticipated timeframes for completing such studies. The Company’s objective will be to have the FDA remove the clinical hold and allow Cortex to proceed with the clinical studies currently on hold as soon as possible.
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/)
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 additional tests and activities may further delay clinical studies. 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.
Contact: Cortex Pharmaceuticals, Inc. Roger G. Stoll, Ph.D., 949-727-3157 or The Investor Relations Group Damian R. McIntosh / Dian Griesel, Ph.D. Media: Janet Vasquez 212-825-3210
Source: Cortex Pharmaceuticals
