Human trial plans for second NZ drug

By Owen Hembry

Auckland biotechnology company Neuren Pharmaceuticals has had another dose of good results for its brain trauma drug and is entering discussions with the US Army to take it to stage III human clinical trials.

The molecule, named NNZ-2566, was developed under the leadership of New Zealand scientist Professor Peter Gluckman and could be used to treat brain injury, stroke, multiple sclerosis and Parkinson's disease.

Previous preclinical tests on rats showed 50 per cent less brain inflammation and a 50 per cent improvement in physical coordination after brain trauma.

But latest results, after longer exposure to the drug, increased the drop in neurological deficit to 70 per cent. Neuren CEO David Clarke said the results were sufficient to start stage III human clinical trials.

Neuren already has one other brain drug ready for phase III trials. Last month the drug glypromate was given permission by US officials to fast track to phase III.

Glypromate helps stem the loss of brain function after coronary artery bypass grafting surgery.

Clarke said NNZ-2566 was performing extremely well in tests.

"The US Army have told us that this is the best result they've seen for any compound they've tested in these types of models for brain injury."

The company is entering discussions with the US Army about starting the clinical trials.

Neuren says 1.5 million head injuries in the US every year represents a market worth more than US$1 billion ($1.49 billion).

In March, Neuren signed a deal with the Walter Reed Army Institute of Research to develop the drug through to human trials.

Under this agreement Walter Reed are working to optimise dose and timing of drug administration in animal models while Neuren is responsible for manufacture, pharmacology and toxicology.

If talks are successful Clarke said clinical trials would start in early 2006. But this last stage before launching to market could take up to five years to complete.

The intended commercial rights would give the US Army royalty free access to the drug while Neuren held the remaining global rights.

Walter Reed has also selected Neuren to help test a specialised model for faster, cheaper prediction of clinical outcomes in traumatic brain injury cases for use during human trials.

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