Cortex Pharmaceuticals, Inc. Says Drug Falls Short In Study

IRVINE, Calif.--June 21, 2006--Cortex Pharmaceuticals, Inc., announced that results from two studies with its lead AMPAKINE® 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.