Healthcare Industry News:  Neuren Pharmaceuticals 

Biopharmaceuticals Cardiology Surgery Neurology

 News Release - April 27, 2006

Brain Protectant Drug Successfully Completes Safety Trial

MELBOURNE, Australia, April 27 (HSMN NewsFeed) -- A report by the Australian Heart Foundation states that cardiovascular disease will rise from one-in-six to one-in-four by 2051, according to a report released in 2005. This is reflected in the number of patients undergoing coronary artery bypass (CABG) surgery, which has grown rapidly in the past couple of decades, particularly in Australia and the US. CABG surgery is performed about 400,000 times annually in the US alone, making it one of the most commonly performed major operations.

CABG surgery is advised for selected groups of patients with significant narrowings and blockages of the heart arteries (coronary artery disease). CABG surgery creates new routes around narrowed and blocked arteries, allowing sufficient blood flow to deliver oxygen and nutrients to the heart muscles.

Impaired cognition is a known complication of these procedures and some loss of brain function has been reported in up to 70% of patients at discharge. There is currently no treatment.

Neuren Pharmaceuticals successfully completed its Phase 2 trial of its brain protectant drug, Glypromate, at five sites in Australia and New Zealand including the Alfred Hospital in Melbourne, last week. The trial involved 33 patients undergoing CABG surgery and was aimed at assessing the safety of Glypromate.

Neuren will now speak to the US regulatory body, Food and Drug Administration (FDA), in preparation for a Phase 3 trial to test the efficacy as a protectant from neurocognitive disturbance following CABG surgery of Glypromate planned for later this year. The Phase 3 trial will involve 520 patients at sites in Australasia, the United States and in Europe. Neuren will be one of very few Australian-listed biotechnology companies entering Phase 3 this year.

Due to the lack of treatment in this area, and the increasing need, the FDA has intimated it fast track the process of Glypromate route to market. This is very unusual for the FDA to do and highlights the significance of these trials.

What is CABG?

A Coronary artery bypass graft (CABG) is an operation to bypass a narrowed or blocked segment of a coronary artery using a graft. Usually, this graft is a length of vein taken from the leg (saphenous vein) although, often a small length of artery from the chest wall (internal mammary artery) and/or occasionally the arm is used -- it is quite usual to need two, three or even four grafts.

The grafts taken from the leg and forearm are connected to the aorta at one end while the other end is attached to the coronary artery, bypassing the blockage or narrowing. If the internal mammary artery is used as a graft, it usually remains attached to its own blood supply, with its end sewn onto the coronary artery.

All grafts are sewn to the affected artery bypassing the narrowed part, thus providing a new channel which blood can flow through to the heart muscle. As a result, there will be an improvement in blood flow and relief to angina symptoms.

Benefits of surgery

CABG surgery is performed primarily to relieve angina symptoms. By improving the blood flow to the heart muscle, surgery can result in a more active and better quality of life, with less or no angina and less medication. Lifestyle changes can also help prevent a recurrence.

Taken from National Heart Foundation of New Zealand website.

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, GlypromateŽ 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 http://www.neurenpharma.com.


Source: Neuren Pharmaceuticals

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