Cortex and Top Alberta Government Officials Meet to Discuss Progress on Ampakine Compounds at the 2008 Bio Conference
"This joint collaboration demonstrates how government and industry can work together to potentially solve a serious and occasionally fatal post-operative complication that may occur in 10-15% of high risk surgical patients," explained Roger G. Stoll, Ph.D., Cortex's Chairman, President and Chief Executive Officer. "Dr. Greer's company undertook additional screening of AMPAKINE compounds that provided the scientific justification to the German regulatory authorities to permit two CX717 Phase II studies to get underway earlier this year," said Dr. Stoll.
During an interim analysis of data from the RD-02 study, the Data Safety Monitoring Board (DSMB) saw no safety issues, but recommended including some additional patients in the study before proceeding to final analysis of the data. The first study, RD-01, was performed by a top respiratory depression investigator in Frankfurt, Germany. Despite receiving regulatory approval a couple of weeks after Study RD-02 got underway in Berlin, the RD-01 study has completed enrollment and dosing of all subjects. After the DSMB completes the quality control procedures, it will begin analysis of the related RD-01 data. The purpose of the DSMB is to provide an objective, independent safety monitoring of new chemical entities being tested in humans. Based on this information and the need to enroll additional subjects, the company now feels that it will receive reportable information for both studies by the end of July 2008.
About Dr. Greer, the University of Alberta and TEC Edmonton
Dr. John J. Greer is a Scientist of the Alberta Heritage Foundation for Medical Research. He is a Professor in the Department of Physiology, Centre for Neurosciences at the University of Alberta -0-
University Contact: Jason Darrah Communications Manager, TEC Edmonton 780.492.3129
About Cortex Pharmaceuticals, Inc.
Cortex is a neuroscience company located in Irvine, California that focuses on the discovery and clinical development of AMPAKINE(R) molecules, a platform technology that represents a new approach to treating psychiatric disorders, neurological diseases and brain mediated breathing disorders. The Company has pioneered a novel class of proprietary pharmaceuticals called AMPAKINE compounds that positively modulate the AMPA-type glutamate receptor complex, amplifying the effect of the most prominent brain neurotransmitter, glutamate, at the synapse, leading to excitation of brain circuits that appear to affect memory, cognition and a unique brain stem structure thought to be responsible for inspiratory drive and the maintenance of breathing rhythm.
Many neurodegenerative disorders could potentially benefit from enhanced binding of glutamate by AMPAKINE compounds, which has been demonstrated in standard animal models of Alzheimer's, Huntington's diseases, Parkinson's disease and potential uses in many other neurodegenerative diseases. Many psychiatric diseases, including Attention Deficit Hyperactivity Disorders (ADHD), depression, and schizophrenia occur as a result of imbalances in the brain's neurotransmitter system. Proof of Concept in adult ADHD patients has been demonstrated with CX717. Cortex currently has an alliance with Schering-Plough (formerly Organon) for the treatment of schizophrenia and depression. In 2006 Cortex terminated its research collaboration with Les Laboratoires Servier and in turn worldwide rights to neurodegenerative diseases, sexual dysfunction, and anxiety were returned to Cortex. Servier retained three compounds from the research collaboration and may develop them for neurodegenerative diseases, sexual dysfunction, and anxiety in all markets in the original license. For additional information regarding Cortex, please visit the Company's website at 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 Company's proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical test 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.
Cortex Pharmaceuticals, Inc.
Roger G. Stoll, Ph.D., 949-727-3157
Chairman, President and CEO
The Investor Relations Group
Erika Moran/ Dian Griesel, Ph.D., 212-825-3210
Posted: June 2008