Cortex' CX717 Released from Clinical Hold by FDA.IRVINE, Calif. -- Cortex Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :COR) received notification from the U.S. Food and Drug Administration (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. ) on the afternoon of Friday, October 6, 2006 that the clinical hold placed on its AMPAKINE[R] CX717 on March 31, 2006 was lifted. The Company may now resume the clinical trials that were underway at the time the clinical hold was put into effect. A detailed formal letter from the FDA is expected to follow within 10 days. In agreeing to the lifting of the hold, Cortex committed to an FDA specified dose range for CX717. The Company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. The Company will then share those results with the FDA and mutually determine if the new information supports clinical investigations at higher dosage levels for CX717. Roger Stoll, Ph.D., Chief Executive Officer of Cortex, commented, "The release from clinical hold is an important step for Cortex and the CX717 clinical program. It is fortunate that the Company had the foresight to initiate the three-month toxicology trials early this summer, so that we can have further information from these studies available before year end 2006." After receiving the formal letter from the FDA regarding the lifting of the clinical hold, the Company will hold a conference call to update shareholders on the next steps with the CX717 program. About Cortex Pharmaceuticals Cortex, located in Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007). , 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 neurotransmitter, chemical that transmits information across the junction (synapse) that separates one nerve cell (neuron) from another nerve cell or a muscle. Neurotransmitters are stored in the nerve cell's bulbous end (axon). 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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