IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX:COR - News) received notification from the U.S. Food and Drug Administration (FDA) on the afternoon of Friday, October 6, 2006 that the clinical hold placed on its AMPAKINE® 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, 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. Chairman, President and CEO 949-727-3157 or The Investor Relations Group Damian R. McIntosh/ Dian Griesel, Ph.D. Media Contact: Lynn Granito 212-825-3210
Source: Cortex Pharmaceuticals, Inc.
