Asia PR News

MELBOURNE, April 28/MediaNet International - AsiaNet/ –

Key points:

- US Army and Neuren make significant progress in joint Traumatic Brain Injury
programme confirming NNZ-2566 as a “very promising candidate for brain trauma”

- In the latest experiment NNZ-2566 shows significant reductions in
non-convulsive seizures following traumatic brain injury

- Non-convulsive seizures are a significant predictor of outcome in Traumatic
Brain Injury, are easily and practically detected and provide an important
additional clinical endpoint

- This new therapeutic target of non-convulsive seizures will be included in
NNZ-2566 Traumatic Brain Injury Phase 2 trial. This will result in increased
sensitivity, earlier detection of effects and lower cost of trials compared to
traditional methods

- The US Army and Neuren have filed a joint patent for non-convulsive seizures
and NNZ-2566

Friday 28 April 2006: Neuren Pharmaceuticals (ASX: NEU) today announced that
it has jointly filed a new patent with the US Army’s Walter Reed Army Institute
of Research (WRAIR) as a result of new experiments showing its compound,
NNZ-2566, significantly reduces non-convulsive seizures following traumatic
brain injury (TBI).

Non-convulsive seizures often occur soon after brain injury and are an
important predictor of patient recovery. Non-convulsive seizures are
significant both as readily detectable predictors of clinical outcome from TBI
as well as being a target for therapeutic intervention.

Dr Frank Tortella, Chief of the Department of Applied Neurobiology at WRAIR
and the Research Director for the Combat Casualty Care Research Program in
Brain Trauma and Neuroprotection, said: “We are very encouraged by the results
with Neuren’s drug. NNZ-2566 is a very promising therapeutic candidate for
brain trauma as evidenced by efficacy across several models of experimental
brain injury, and by its effect on trauma-induced non-convulsive seizures.”

“This clearly reinforces our perspective on the value and significance of
non-convulsive seizures as a therapeutic target for drug intervention.
Development of a safe, effective treatment for brain trauma that can be
delivered after injury by those on the scene, including combat medics or
civilian emergency medical personnel, without the need for extensive and
time-consuming diagnostic workups is an extremely high priority for both our
military and civilian medical communities,” Dr Tortella added.

NNZ-2566 is being developed by Neuren and the WRAIR for acute neurological
conditions and NNZ-2566 has recently begun a Phase 1 safety and tolerability
trial. NNZ-2566 is also available in an oral form targeted towards chronic
neurological conditions.

The benefit of Neuren’s drug in preventing this phenomenon builds on the
already significant evidence of the drug’s effectiveness. It also means that
Neuren will be able to include electroencephalographic (EEG) effects as outcome
measures in planned clinical trials. Use of EEG measurements will permit
earlier detection of an effect in the Phase 2 trials as well as reducing the
cost of the studies.

New techniques for measuring brain waves in patients are pointing to new
ways of measuring damage during stroke and TBI and have shown these early
changes are solid indicators of longer term outcome. The beneficial effects of
NNZ-2566 in reducing seizures strongly suggest that the drug might have similar
benefits in both TBI and stroke patients and the early assessment of these
benefits by the new brain wave monitoring could provide an early signal of the
drug’s efficacy.

In experiments conducted by the WRAIR in an established animal model of
non-convulsive seizures, administration of NNZ-2566 after brain injury resulted
in a reduction in the incidence of seizures, total time in seizure, the average
duration of seizures and an increase in the time between brain injury and onset
of seizures (please see Appendix below).

Mr David Clarke, CEO of Neuren stated: “These findings, together with
earlier positive results in the Army’s traumatic brain injury model, support
Neuren’s confidence in the NNZ-2566 program and provide encouragement to
progress this drug into Phase 2 human clinical trials as soon as practical.
TBI is a critical indication that most clearly calls for a creative, aggressive
approach both to drug development and patient treatment.”

The preclinical research and development work is being conducted with the
WRAIR under a Cooperative Research and Development Agreement. The Phase 2 study
protocol is being jointly developed by Neuren, Army physicians and scientists
involved in the TBI program.

Approximately 2 million people worldwide suffer a TBI each year. Of these,
an estimated 1.5 million are seen in a hospital emergency room or admitted to a
hospital. The market potential for an effective TBI drug has been estimated at
US$1 billion. A drug that is also effective for acute treatment of ischemic
and haemorrhagic stroke would potentially be applicable to an additional 3
million patients with an estimated market potential of US$4 billion worldwide.

Appendix:
The study was conducted in a rat model of brain injury-induced seizures
using the validated and widely-used middle cerebral artery occlusion (MCAO)
model. EEG activity was recorded continuously for 72 hours and analysed for
incidence of seizures, mean duration of individual seizures, total time in
seizure and latency, the time between injury and occurrence of the first
seizure. (For a more complete description of methods, please see: Hartings JA
et al. Experimental Neurology 179:139-149, 2003.)

The study involved 13 control animals that received vehicle only and 11
animals that received drug. The dosing regimen for animals receiving drug was
a 3 mg/kg bolus followed immediately by a 12-hour infusion at 3 mg/kg/hr.
Results are presented in the following table.

Non-convulsive Seizures

Incidence Total Time (sec) Mean Time (sec) Latency (min)
Vehicle 92% 1277 80.2 75.4
NNZ-2566 60% 555 48.7 208.7
Percent change -35% -56% -39% +133%

About Walter Reed Army Institute of Research
Walter Reed is the largest, most diverse, and oldest laboratory in the US Army
Medical Research and Material Command. It conducts research on a range of
military relevant issues, including naturally occurring infectious diseases,
combat casualty care, operational health hazards, and medical defence against
biological and chemical weapons. Walter Reed is the Department of Defense’s
lead agency for infectious disease research and a crucial source of research
support for medical product development.

About Neuren Pharmaceuticals
Neuren Pharmaceuticals (ASX: NEU) is a biotechnology company developing novel
therapeutics in the fields of neurotherapy and metabolic disorders. The Neuren
portfolio consists of six product families, targeting markets with large unmet
needs and limited competition. Neuren has two lead candidates, Glypromate® and
NNZ-2566, targeting a range of acute and chronic neurological conditions.
Neuren has commercial and development partnerships, including Pfizer, the US
Army’s Walter Reed Army Institute of Research and Metabolic Pharmaceuticals.

For more information, please visit Neuren’s website at www.neurenpharma.com

Contact details

Company Media and investor relations
David Clarke
CEO of Neuren
T: 1800 259 181 (Australia)
T: +64 9 3 367 7167 ext 82308
M: +64 21 988 052

Rebecca Piercy
Buchan Consulting
T: +61 2 9237 2800
M: +61 422 916 422

SOURCE: Neuren Pharmaceuticals