February 2, 2011 — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced top-line results from an exploratory clinical study with its AMPAKINE® compound, CX1739 in subjects with sleep apnea. The study enrolled 20 relatively healthy adults with moderate-to-severe obstructive sleep apnea, 16 of which were administered a single oral dose of CX1739 and 4 of which received matching placebo for one night. The objective of the study was to further explore safety and tolerability in the sleep apnea population, as well as to assess putative efficacy of CX1739 on a range of sleep apnea parameters assessed by overnight polysomnography.The study demonstrated that selected oxygen saturation parameters were statistically improved by one dose of CX1739, but the interpretation of these results was complicated by a reduced sleep time during the night following drug treatment. CX1739 did not reduce the mean apnea/hypopnea index (AHI; frequency of apnea or hypopnea events per hour of sleep). However, in the AHI responder analysis, defined as a greater than 40% reduction in the AHI, three subjects (20%) in the CX1739 treatment group were responders, and there were no responders in the placebo group. Furthermore, CX1739 significantly (p<0.05) reduced the apnea/hypopnea time (AHT; cumulative time of all apneas and hypopneas over the night) between the baseline and the treatment night by an average of 21 min, compared to an increase of 12 min in the placebo group. In the AHT responder analysis, defined as a greater than 40% reduction in the AHT, five subjects (30%) in the drug treatment group were responders, with no AHT responders in the placebo group.
There were also statistically significant improvements in a number of blood oxygenation measurements: mean blood oxygen saturation was increased (p<0.01); minimum blood oxygen saturation was increased (p < 0.001); there was a reduction in the total time that blood oxygen saturation was reduced below 90% (p<0.01); and a reduction of the number of times per hour of sleep time that the blood oxygen saturation went below 90% (p<0.05).
Sleep efficiency, the percent of time asleep while in bed for the eight hour session, was significantly (p<0.001) reduced by about 20% after administration of CX1739, although the level of daytime sleepiness, determined by the Clinical Global Impressions Daytime Vigilance test given the morning following treatment, was unaffected by CX1739... Cortex Pharmaceuticals' Press Release -
