US Army to participate in Neuren phase III trials

Auckland biopharma Neuren Pharmaceuticals (ASX:NEU) has executed a memorandum of understanding (MOU) with the Henry M. Jackson Foundation for the Advancement of Military Medicine for inclusion of US Army hospital sites in Neuren's phase III trial of its lead drug Glypromate.

The phase III trial is scheduled to start next year and will assess the effectiveness of the Glypromate in preventing neurocognitive decline following coronary artery bypass grafting surgery (CABG).

In April 2005, Neuren announced that following the successful completion of the phase IIa trial and other phase III prerequisites, the company will file with the US Food and Drug Administration to proceed directly to a phase III major efficacy study, thereby avoiding a phase IIb trial. This brings Neuren two years ahead of schedule and will reduce costs to commercialisation by an estimated AUD$6-8 million.

Under the MOU the Jackson Foundation will coordinate and review the clinical trial plans, assist in the negotiation of definitive agreements for the participation of US Army hospitals in the trial and support preparations for the implementation of the phase III trial.

"Because of the quality and organisation of military medicine and the facilitating role that the Jackson Foundation provides, US military hospitals represent an excellent resource for high quality, cost-effective participation in the Glypromate phase III trial," said Neuren CEO David Clarke in a statement.

Neuren is currently undertaking its phase IIa pharmacokinetics and safety trial of Glypromate at multiple sites in Australia and New Zealand including the Alfred Hospital in Melbourne and at the Auckland City Hospital, the Mercy Ascot Hospital, Waikato Hospital and Wakefield Hospital in New Zealand. The trials are due for completion at the end of 2005 with the results expected before the end of the first quarter 2006.