Healthcare Industry News: Organon
News Release - September 12, 2007
Cortex Files AMPAKINE CX717 IND for ADHDCX717 Blocks Fentanyl-induced Respiratory Depression Without Blocking Analgesic Effects
IRVINE, Calif.--(HSMN NewsFeed)--Cortex Pharmaceuticals, Inc. (AMEX: COR ) Chairman, President and CEO, Roger G. Stoll, Ph.D., announced at the Bear Stearns 20th Annual Healthcare Conference held in New York City that the Company has submitted the AMPAKINEŽ CX717 Investigational New Drug ("IND") Application for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD") with the Division of Psychiatry Products of the Food and Drug Administration ("FDA"). Dr. Stoll mentioned that filing the IND was a high priority for both the Company and for patients with this affliction given the promising data generated last year in a small Phase IIa pilot study in this population. That study showed statistical significance for changes in the ADHD rating scale for CX717 without the cardiovascular and other side effects seen with the current stimulant-based treatments.
At the same conference, Dr. Stoll reported that in research recently conducted by Dr. John Greer at the University of Alberta, CX717 has demonstrated the ability of AMPAKINE drugs to block the risk of fatal overdose with the schedule II opioid, fentanyl, in rats due to respiratory depression, without inhibiting fentanyl's analgesic effect. Dr. Stoll also announced that the Province of Alberta has just granted Dr. Greer an Advanced Education and Technology award of $322,800 in support of further research into the prevention and treatment of respiratory depression with AMPAKINE drugs, matching a similar amount funded by Cortex. The Company is planning to initiate the first study in this indication in humans early next year.
Dr. Stoll also discussed recent results in animal studies, where Low Impact AMPAKINE CX717 and High Impact AMPAKINE CX614 were found effective in overcoming the respiratory depression caused by fentanyl. The potential for both acute and chronic applications of AMPAKINE drugs for the treatment of respiratory depression disorders may be realized due to these animal findings.
With the recently announced financing, Cortex will be working to develop additional AMPAKINE clinical drug candidates. An IND for CX701 is anticipated to be filed during the fourth quarter of 2007, and CX1763 is undergoing IND-enabling studies as well. Therefore, Cortex is planning to have three AMPAKINE compounds in clinical development by mid-2008.
A replay of the presentation can be accessed by logging onto http://cc.talkpoint.com/BEAR002/091007a_sc/?entity=cortex and will be available for 30 days following the conference.
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. Cortex 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 an alliance with N.V. Organon for the treatment of schizophrenia and depression. In December 2006, Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of AMPAKINE compounds in the treatment of neurodegenerative diseases on a global basis. Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing AMPAKINE compounds. For additional information regarding Cortex, please visit Cortex Pharmaceuticals' 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.
Source: Cortex Pharmaceuticals
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