Cortex Pharmaceuticals, Inc. (AMEX: COR, http://www.cortexpharm.com), was notified by the German regulatory agency which approves the use of narcotic drugs that it can proceed with the trial which will use alfentanil, an opiate analgesic. With this approval the enrollment of subjects into the dose response study evaluating the ability of CX717 to prevent respiratory depression caused by opiate analgesics has begun. The study is a placebo controlled, double blinded, cross-over design with three doses of CX717compared to placebo. Depending on the pace of subjects being enrolled, Cortex at this point believes that top-line data will be available from this study by the end of June, 2008. Currently, the only available means of preventing respiratory depression induced by the combination of multiple opioids medications like fentanyl, morphine and codeine in the operating room is either to have the patients re-intubated in order to attach them to a respirator or to utilize opioid reversal agents, such as naloxone (Narcan�). Intubation is a costly procedure and may lead to additional days of hospitalization. The use of. naloxone, a narcotic antagonist, eliminates the analgesic effect of the opioid medication as well as countering the respiratory depression, which is considered a significant drawback to its use. If the German AMPAKINE� studies are successful, pre-surgical or post- surgical administration of CX717 could potentially improve the safety margin for giving these powerful analgesic agents, which would provide a valuable tool for anesthesiologists and surgeons to optimize pain management in surgical patients. This would be especially true in high risk surgical patients such as those over the age of sixty-five, those with a history of sleep apnea, respiratory illnesses or obese patients. Further information about the design of the two clinical studies which the Company is conducting in Germany can be obtained by reading the press release on the initial approval by the BfArM issued on March 3, 2008. Cortex Pharmaceuticals, Inc. is a neuroscience company located in Irvine, California that focused on the discovery and clinical development of AMPAKINE� 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 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 Cortex Pharmaceuticals� Website at www.cortexpharm.com. PLEASE NOTE; Cortex is currently changing its website, www.cortexpharm.com, and anticipates that it will be available for use before the end of April, 2008. At that time additional data related to the use of AMPAKINE� drugs in the treatment of respiratory depression can be obtained from that site. 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 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 Pharm (AMEX:COR)
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