Furthermore, the original tissue slides from the 13 week primate study have been assessed by an expert pathology working group of five histopathologists and a written consensus report has been prepared. In addition to these examinations, Cortex has completed the extended assessment of additional tissue samples from that same set of primates.
The timelines defined by Cortex at its annual shareholder meeting this past May for conducting the extra toxicology testing requested by the Food and Drug Administration are being met by Cortex and its contract research organizations. At present Cortex is on schedule for meeting its target date for submission of its complete response to the FDA by the beginning of September, 2006. The agency has committed to a 30 day review of this data upon such a submission.
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 data from the proposed studies is inadequate to allow the FDA to remove the clinical hold on CX717, that the Company's proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical testing 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.
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: Lynne Granito 212-825-3210
Source: Cortex Pharmaceuticals, Inc.
