GM antibody technology a shot in the arm for Agen

Agen Biomedical is putting an improved version of its 20-year-old cash cow out to graze in fresh pastures.

Since 1982, Agen's monoclonal antibody diagnostic tests for blood clots have earned the Queensland biotech more than $60 million.

Now Agen and its ASX listed parent company Agenix Ltd, have built on the clot-binding antibody technology to initiate a new phase of growth for the business.

Going beyond diagnostic lab tests, Agenix has created a genetically-modified antibody which can pinpoint the site of blood clots in a patient.

First human trials of the new product, Thromboview, are scheduled to begin this year in four locations, including hospitals in Brisbane and Melbourne.

If clinical trials and the approval process are successful, Thromboview could be generating revenues by 2007, said Agenix CEO Don Home.

Thromboview works by using a clot-binding antibody originally of mouse origin which has been genetically modified for use in humans by Agenix with help from UK antibody and protein engineering company Biovation.

Attached to the antibody is a radio-labelled molecule. When the antibody and its passenger molecule are injected into a patient, they will bind to any clot and signal its location to a special imaging camera.

The worldwide market for diagnosis of clotting diseases such as pulmonary embolism and deep vein thrombosis is worth more than $1.4 billion, according to New York investment bank GTH Capital. Agenix believes Thromboview could capture 10 per cent of the market.

Two million people in the US alone suffer from blood clots in the legs and 600,000 develop pulmonary thrombosis in which clots move to the lungs.

Pulmonary embolisms kill 60,000 annually in the US, a higher figure than die from breast cancer, according to Agenix. In Australia, they cause about 4000 deaths a year.

Techniques for locating clots currently range from ultrasound and MRI to CAT and ventilation perfusion scans, but each has shortcomings.

Agenix turns over $18 million annually on exports to 50 countries and has initiated a Nasdaq listing process which will help fund Thromboview's trial and approval costs.

Agenix has outsourced management of the clinical trials to Kendle International Inc. Researchers from the University of California at San Diego and Eli Lilly Research Labs cardiovascular expert Prof Paul Eisenberg are also involved.

Agenix also has 30 per cent of the canine heartworm diagnostic market, and is investigating products which would protect medical devices implanted in humans from rejection reactions.