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news.Cortex Pharmaceuticals, a neuroscience company, has received the UK's Medicines and Healthcare product Regulatory Agency approval 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.
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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, the company said.
Mark Varney, president and CEO of Cortex, said: “CX1739 has been very well tolerated in Phase I healthy volunteer studies, and we are excited to be able to proceed with an efficacy study in sleep apnea. We anticipate starting subject enrollment in February and completing the study in the second quarter of 2009.”