Neuren launches Phase 3 Trial in NZ
Neuren Pharmaceuticals has launched the New Zealand arm of its Phase 3 trial of Glypromate®, one of the first compounds developed in New Zealand by a New Zealand company to enter a global Phase 3 clinical trial.
Glypromate® has been developed by the ASX-listed company to protect brain function, the loss of which is a common side-effect of cardiac surgery. Approximately 70% of patients who have cardiac surgery with cardiopulmonary bypass experience a cognitive decline and half of these will still exhibit impairment three months later.
The Phase 3 trial will be double-blind and placebo controlled involving approximately 600 patients in Australia, New Zealand and the United States. Participants undergo a computerised test of cognitive functions, such as memory and attention, prior to and after surgery to assess how successful Glypromate® has been at protecting the brain during cardiac surgery.
Patient recruitment has already started in New Zealand. It is planned that 200 New Zealand patients will take part in the trial with final data from available in mid-2009.
"We are very pleased to launch the New Zealand arm of this exciting and ground-breaking Phase 3 trial. If the results are positive, we will conduct one further Phase 3 trial and then seek to register Glypromate® with the FDA and other regulators around the world for commercial use," Neuren CEO David Clarke says.
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