Cortex Pharmaceuticals, Inc. (AMEX: COR), announced that results from two studies with its lead AMPAKINE(R) drug, CX717, will be presented at the Sleep 2006 meeting in Salt Lake City, UT. Dr. Thomas Balkin, Chief, Department of Behavioral Biology, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, will briefly present the top-line findings from the simulated night shift work study conducted at WRAIR and funded by the Defense Advanced Research Projects Agency (DARPA). That study assessed the effect of CX717 on cognitive performance and alertness across 4 nights of simulated night shift work and restricted daytime sleep. The primary finding from the study was that CX717 did not enhance cognitive performance relative to treatment with placebo. However, similar to the observations in the previously reported UK sleep deprivation study, CX717 did alter the recovery sleep architecture as measured by EEG polysomnography in a dose-related manner. The 1000 mg dose of CX717 statistically (p less than 0.05) reduced the amount of slow wave sleep during each of the 4 recovery sleep periods and increased (p less than 0.05) the minutes of wake time after sleep onset during 2 of the 4 recovery sleep periods. CX717 was well tolerated, and no serious adverse events or other significant safety concerns were observed.
Additionally, two presentations will be made detailing the positive findings from the UK sleep deprivation study performed at the University of Surrey in the United Kingdom. Dr. Julia Boyle, Acting Head, Human Psychopharmacology Research Unit, University of Surrey, Guildford, UK will present the primary results from the study. Dr. Nicola Wright, Centre for Human Sciences, QinetiQ, Farnborough, UK will present new data using spectral EEG polysomnography to evaluate the effect of CX717 on the recovery sleep period during the study. In support of the key study findings, the spectral EEG analysis indicated that CX717 increased the level of arousal during recovery sleep.
Differences in study design and the implementation of certain study procedures may have contributed to some of the divergent results between the shift work simulation study and the UK study. While Cortex has received a study report from WRAIR, we look forward to receiving the full data set in order to compare the exact differences in drug performance between the two sleep studies.
From a business perspective, the Company’s licensing discussions have focused on ADHD, Alzheimer’s disease, and other neurodegenerative disorders. The top-line findings from the DARPA-sponsored study do not have a direct impact on the potential of CX717 in those disorders. Cortex’s strategy has always been to retain the sleep deprivation uses as well as Orphan Drug uses of the low impact AMPAKINE(R) drugs for its internal development program. Cortex does not anticipate that future partnering discussions would include sleep disorder indications such discussions are unlikely to be affected by the shift work study findings.
“Our Phase II pilot program which included studies in sleep deprivation, ADHD, and Alzheimer’s disease was designed to help us determine the most promising development pathway for CX717,” said Dr. Roger Stoll, Chairman & CEO of Cortex. “While we are pleased to see some of the findings from the UK study confirmed in the DARPA-sponsored study, given the strong signal from our study in adults with ADHD our current plan is to prioritize ADHD in our future studies with CX717. We also remain committed to the program in Alzheimer’s disease as we await the results from our Phase II study in that disorder. Moreover, we anticipate having the opportunity to conduct additional studies on sleep disorders with either CX717 or with CX701, a back-up compound that should enter clinical trials early next year.”
Cortex will host a conference call and webcast later today, at 2:00 p.m. ET, to further elaborate on this information. Following the conference call, the company will open the phone lines to answer questions from investors and members of the media. Those who wish to participate may do so using the following dial-in information: In the United States, call (877) 407-0782. Internationally, call (201) 689-8567. An audio replay of the conference call will be available through Wednesday, June 28, 2006 by dialing (877) 660-6853 for U.S. participants and (201) 612-7415 for international participants. When prompted, participants should enter account number 286 and conference ID number 206297. For the webcast please use the following link: http://www.vcall.com/IC/CEPage.asp?ID=106039. A replay of the webcast will be available through June 28, 2006.
About the shift work simulation study
The shift work study was a randomized, double-blind, placebo-controlled, parallel group study in healthy young adult male volunteers. Fifty (50) subjects were assigned to one of three CX717 dose groups or placebo. Study medication was taken once per evening for four days. Each night subjects were assessed on a variety of cognitive parameters and tests of alertness in a protocol designed to simulate night shift work. The subjects’ daytime sleep was restricted to 4 hours per day to mimic operational conditions involving chronic, restricted sleep.
About Cortex Pharmaceuticals
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company 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 alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including Mild Cognitive Impairment, Alzheimer’s disease and anxiety disorders. (http://www.cortexpharm.com/)
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 additional tests and activities may further delay clinical studies. 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.
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