NEUREN REPORTS SAFETY DATA ON BRAIN INJURY DRUG

Neuren Pharmaceuticals has successfully completed a Phase I safety and tolerability trial of its second lead candidate, NNZ-2566, which is being developed to treat traumatic brain injury. The results from the study were referred to the independent data safety monitoring committee, which confirmed the safety profile of the drug.

The Phase I trial involved 28 healthy volunteers in four groups who received one of four escalating doses of NNZ-2566 (0.1, 1.0, 10.0 and 20.0 mg/kg). The maximum dose of 20 mg/kg, delivered over a 10-minute period of infusion, significantly exceeded that of Neuren's lead compound, Glypromate, for which the maximum Phase I dose was 3 mg/kg/hr in a 15-minute and four-hour infusion. An extension of the NNZ-2566 Phase I trial is anticipated to run early this year to evaluate pharmacokinetics with longer infusions of 12 or 24 hours, which takes into account the often greater severity of traumatic brain injury.

Neuren's NNZ-2566 has been developed in collaboration with the U.S. Army's Walter Reed Army Institute of Research. Planning is now well under way for a Phase II trial to take place in 2007. NNZ-2566 is a novel molecule that has a profile suitable for both intravenous infusion and chronic oral delivery. It has been shown to be protective in numerous in vitro and in vivo models of brain injury.