Cortex's CX717 Clinical Hold Update.IRVINE, Calif. -- Cortex Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange : COR) has completed the in-life phase of both the one week acute primate study and the two week acute rat toxicology studies with its AMPAKINE(R) compound CX717. The tissue samples are now being prepared for histopathology his·to·pa·thol·o·gy n. The science concerned with the cytologic and histologic structure of abnormal or diseased tissue. Histopathology The study of diseased tissues at a minute (microscopic) level. assessments. These studies were part of the toxicology assessments requested by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and are essential for a decision to lift the clinical hold. 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 Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . 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 or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. 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 mild cognitive impairment (MCI), n memory loss generally associated with aging; does not affect normal independent functioning of an individual. , Alzheimer's disease and anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. . (http://www.cortexpharm.com/) Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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. |
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