IRVINE, CA (August 24, 2011) — Cortex Pharmaceuticals, Inc. [OTCBB (CORX.OB)] announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent that protects the use of Ampakine® molecules for the treatment or prevention of respiratory depression. This patent broadly covers all Ampakine molecules, including competitor compounds, and provides patent protection into 2027. The patent is licensed exclusively to Cortex from the University of Alberta, and is based on the pioneering research of Dr John Greer.
Dr Greer stated, “It is striking how well Ampakines enhance the activity of brain cells in the respiratory rhythm generator. This offers the potential to effectively counter respiratory depression caused by a host of factors ranging from opiate analgesics, anesthetics through to pathological conditions. We are very encouraged by the pre-clinical and clinical data and continue to focus on this exciting opportunity to translate our basic neuroscience research to the clinic.”
Ampakine compounds have previously demonstrated proof-of-concept in the prevention of opiate-induced respiratory depression in both animal models and in a human clinical study. In these double-blind, placebo-controlled, cross-over clinical trials, baseline breathing rates were significantly depressed by the potent opiate, alfentanil. A single oral dose of the Ampakine, CX717 prevented alfentanil-induced respiratory depression without interfering with the desired analgesic effects of the opiate.
Earlier this year, Cortex reported results from a Phase IIa sleep lab study with its lead Ampakine molecule, CX1739 in subjects with moderate to severe sleep apnea. The results from this study suggested a potential opportunity for CX1739 in the treatment of central sleep apnea, which is often seen in heart failure patients and chronic opiate users. This same brain region, the respiratory rhythm generator, also plays a role in central sleep apnea, a form of central respiratory depression which occurs during sleep in approximately 30-40% of heart failure patients.
“The presence of central sleep apnea in heart failure patients leads to a reduced heart function, which often leads to a reduced life span. Existing evidence suggests that treating sleep apnea can have long-term beneficial effects on these patients, in terms of heart function and quality of life,” stated Mark Varney, President and CEO of Cortex. “We are currently planning to test CX1739 for its ability to attenuate central sleep apnea in this patient population, and are eager to begin these studies.”
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a clinical-stage neuroscience company focused on the discovery, development and commercialization of a novel class of glutamate modulators called Ampakine® compounds, which have been shown to enhance impaired breathing by stimulation of AMPA-type glutamate receptors in neurons in the brain stem. Ampakine compounds also represent a novel approach for improving impaired cognition associated with low levels of glutamate neurotransmission commonly associated with mental disorders and neurological diseases. These deficits are improved by Ampakine modulators to amplify glutamatergic communication between brain cells. For additional information regarding Cortex, please visit the Company’s website at http://www.cortexpharm.com www.cortexpharm.com.
Forward-Looking Statement
Note — This press release contains forward-looking statements concerning the Company’s research and development activities. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. The success of such activities depends on a number of factors, including the risks that the Company’s proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that patents may not issue from the Company’s patent applications; that competitors may challenge or design around the Company’s patents or develop competing technologies; that the Company may have insufficient resources to undertake proposed clinical studies and that preclinical or 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 preclinical and clinical testing and regulatory approval. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this press release. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Contacts:
Company Contact:
Mark A. Varney, Ph.D.
President ad CEO
Cortex Pharmaceuticals, Inc.
949.727.3157
Investor Contact:
Erika Moran/Dian Griesel, Ph.D.
Media Contact:
Janet Vasquez
The Investor Relations Group
212.825.3210