U.S. ARMY TO TEST NEUREN'S TREATMENT FOR BRAIN INJURY
Neuren Pharmaceuticals has announced that physicians from Madigan Army Medical Center will conduct an investigator-initiated Phase II trial to determine the safety and efficacy of Glypromate in reducing brain injury caused by out-of-hospital cardiac arrest. The trial will start in mid-2007 and will be managed by The Henry M. Jackson Foundation for the Advancement of Military Medicine.
The investigational new drug application will be submitted to the FDA by Army investigators rather than by Neuren. The company's only financial commitment will be compensation to the Jackson Foundation for administrative costs incurred in coordinating the study. Neuren will retain all commercial rights to the drug.
Among patients who survive sudden cardiac arrest, up to 80 percent suffer neurological damage resulting from lack of blood flow and oxygen to the brain. There are no drugs approved to reduce the neurological damage caused by cardiac arrest. Neuren believes that Glypromate for this indication will be eligible for orphan drug designation. In addition, Neuren intends to apply for FDA fast-track status, which provides for accelerated clinical development and review.
Glypromate is a peptide fragment of IGF-1 that has been shown to act by multiple pathways to protect brain tissue from injury. Neuren has successfully completed a Phase I safety study and a Phase IIa safety and pharmacokinetics study and plans to initiate a Phase III study in late 2006.