Cortex Reports Issuance of Next Generation of AMPAKINE® Patents

Cortex Pharmaceuticals, Inc. (OTCBB:CORX) announced the issuance by The United States Patent and Trademark Office (USPTO) of two key patents that protect the next generation of AMPAKINE® compounds. Specifically, these new AMPAKINE patents cover a series of compounds including the lead preclinical compounds, CX2007 and CX2076. These compounds exhibit a long duration of action and excellent pharmacokinetic properties, making them ideal for a once-a-day therapy.

The USPTO issued both a composition-of-matter patent and a divisional patent covering methods of use, including the treatment for a broad range of breathing disorders such as opioid-induced respiratory depression, sleep apneas, stroke-induced central sleep apnea, congenital hypoventilation syndrome, obesity hypoventilation syndrome, sudden infant death syndrome, Cheney-Stokes respiration, and additional orphan drug indications. These issued patents will provide protection from competitors through August 2028.

“These two sets of patents are significant for Cortex in different ways,” said Mark Varney, Ph.D., Cortex President and CEO. “One defines a new composition-of-matter patent, while the other protects our ability to use these compounds for the treatment of opioid-induced respiratory depression and other related breathing disorders for which no approved oral medication exists.” Dr. Varney also stated, “The CX2007 and CX2076 patent provides added protection to our portfolio of patents covering specific AMPAKINE molecules and their uses, particularly in breathing-related disorders such as opioid-induced respiratory depression.”

Cortex previously reported the issuance by the USPTO of the composition-of-matter patent for the Company’s lead oral “low impact” AMPAKINE, CX1739, which is currently in Phase II development, as well as CX1942, the first water soluble AMPAKINE for intravenous administration. The related patent provides protection for these compounds through July 2028. More recently, the Company also announced the issuance of a broad method-of-use patent providing protection for the use of AMPAKINE molecules in treating breathing-related disorders such as opioid-induced respiratory depression. “Viewed together, these patents reflect the expanding scope of Cortex’s AMPAKINE patent portfolio over the next 16-18 years, and in particular the Company’s focus on breathing-related disorders,” stated Dr. Varney.

Drug Induced Respiratory Depression

Drug-induced respiratory depression (RD) is a life-threatening condition caused by analgesic, hypnotic, and anesthesia medications. RD is a leading cause of death from the overdose of abused prescription and illicit drugs, but RD can also arise during normal, physician-supervised procedures such as post-operative analgesia, and as a result of out-patient management of chronic pain. Currently, the most common treatment of opioid-induced respiratory depression is to administer an opiate receptor antagonist such as naloxone. Opioid antagonists do dramatically reverse RD, but at the expense of reduced effectiveness of the management of severe pain. Data accumulated to date has demonstrated that AMPAKINE compounds have the ability to prevent respiratory depression due to opioid painkillers without interfering with the desired analgesic properties. AMPAKINE compounds, unlike opioid antagonists, also appear to be effective in preventing RD in animals treated with other types of commonly prescribed central nervous system depressants, without affecting their desired effect.

Cortex Pharmaceuticals, Inc.

Cortex, located in Irvine, California, is a clinical-stage specialty pharmaceutical company focused primarily on the discovery, development and commercialization of positive AMPA-type glutamate receptor modulators. Cortex has pioneered a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. Recent research has focused on the use of AMPAKINE compounds for the potential treatment or prevention of respiratory depression induced by opioid analgesics, anesthetic agents and benzodiazepines, as well as the potential treatment for central sleep apnea. For additional information regarding Cortex, please visit the Company’s website at http://www.cortexpharm.com

Forward-Looking Statement

Note — this press release contains forward-looking statements concerning the Company’s operating 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 may not generate sufficient cash from operations and from external financing to continue as a going concern; that the Company may not be successful in securing any licensing, partnering or M&A arrangements; 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.