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Neuren's brain-protectant drug successfully completes safety trial
By Elaine Rigoli
Tampa, Fla., April 27 - Neuren Pharmaceuticals successfully completed the phase 2 trial of its brain-protectant drug Glypromate at five sites in Australia and New Zealand last week, which involved 33 patients undergoing coronary artery bypass graft (CABG) surgery.
Neuren said it will now speak with the Food and Drug Administration as it prepares for a phase 3 trial to test the efficacy as a protectant from neurocognitive disturbance following CABG surgery of Glypromate planned for later this year.
The phase 3 trial will involve 520 patients at sites in Australasia, the United States and in Europe, according to a news release.
CABG surgery, advised for selected groups of patients with significant narrowings and blockages of the heart arteries, creates new routes around arteries to allow sufficient blood flow to deliver oxygen and nutrients to the heart muscles.
Impaired cognition is a known complication of these procedures and some loss of brain function has been reported in up to 70% of patients at discharge. There is no treatment, the release said.
Neuren is a Melbourne, Australia-based biotechnology company developing novel therapeutics in the fields of neurotherapy and metabolic disorders.
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