Cortex Pharmaceuticals : Ampakine CX1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients

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 -

Cortex : Clinical Study in Sleep Apnea With Its AMPAKINE CX1739

January 27, 2009 — Cortex Pharmaceuticals, Inc. (NYSE Alternext US (COR)) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) gave it permission to proceed with the clinical development of CX1739 in subjects with moderate to severe sleep apnea. The study will be conducted in a UK sleep unit using a double-blind, placebo-controlled design in 20 subjects.

Sleep apnea is a chronic disorder characterized by pauses in breathing during sleep, with the most common type being obstructive sleep apnea. Each episode, called an apnea, lasts long enough so that one or more breaths are missed. Such episodes occur repeatedly throughout sleep and may result in significantly reduced blood oxygenation. If left untreated, sleep apnea can lead to an increased risk of stroke, heart attacks, hypertension, obesity and Type II, maturity onset diabetes, as well as an increased risk of accidents due to excessive sleepiness. The National Institute of Health estimates that over 12 million American adults have sleep apnea. There is currently no drug treatment option available for sleep apnea and the market is considered a multi-billion dollar opportunity in North America alone...

...Data obtained from animal studies have demonstrated that AMPAKINE compounds can specifically stimulate breathing by activating regions in the brain stem. In 2008, Cortex announced positive results of two clinical studies that demonstrated the AMPAKINE CX717 could prevent the depression of breathing induced by an opioid analgesic. Further analyses of these clinical studies also showed that CX717 reduced both the number and duration of apnea events caused by the opioid. Studies in animals suggest that CX1739 is approximately three times better than CX717 at reversing breathing depressed by opioids. CX1739 also stimulates another brain region that regulates muscle tone in the upper airways... Cortex Pharmaceuticals' Press Release -