Healthcare Industry News: Organon
News Release - June 8, 2006
Cortex Announces Update on CX717 Clinical HoldIRVINE, Calif.--(HSMN NewsFeed)--June 8, 2006--Cortex Pharmaceuticals, Inc. (AMEX: COR ) announced that it has provided to the U.S. Food and Drug Administration the preclinical research plan for removal of the current clinical hold on AMPAKINEŽ CX717. The FDA recently provided a written response finding the proposed research plan to be acceptable. Both parties felt that the clarity of the proposed actions was sufficient such that a scheduled conference call for June 9, 2006 was no longer necessary.
"Cortex worked hard to address the concerns of the FDA and we are pleased that our proposals were on target in responding to the questions which the agency raised regarding CX717. We currently are on schedule with the timelines proposed for conducting the additional preclinical studies. In fact, Cortex has already completed the review of the relevant histological materials from a previously completed preclinical toxicology study, which was part of the FDA request to Cortex. As stated at our annual shareholder meeting, we plan to submit all the data to the FDA in September 2006. If the data obtained from the acute high dose toxicology studies are assessed positively by the FDA, we believe the FDA will remove CX717 from the current clinical hold," said Dr. Roger G. Stoll, President, CEO and Chairman of Cortex.
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/)
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.
Source: Cortex Pharmaceuticals
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