An Australian scientist says an E. coli treatment developed in the mid-90's could have saved victims of the recent European outbreak, but it was not commercialised due to a lack of interest at the time.

University of Adelaide professor James Paton has told www.freshfruitportal.com he developed the treatment with Adrienne Paton and Renato Morona after the South Australian outbreak in early 1995.

University of Adelaide professor James Paton

"It was extremely frustrating, as there would have been ample time for a commercial partner to take the product through the lengthy regulatory processes and clinical trials for it to have been approved and available for use in humans during this outbreak," Paton says.

"We are convinced that if it had been administered to patients early in the course of disease, it would have significantly reduced the severity of illness and is likely to have saved lives.

"Also, it could have been administered to people who had been exposed to others who were infected, or who had eaten a suspected food source, and hence are at high risk of becoming infected. It is likely that the therapeutic agent would have completely prevented disease in such people."

The development

The Adelaide outbreak happened over the months of January and February in 1995, caused by fermented mettwurst sausages with several Shiga toxigenic E. coli (STEC) strains, mostly belonging to stereotype 0111.

The disease led to 150 reported cases of diarrhoeal disease of which 23 people developed haemolytic uraemic syndrome (HUS) and one child died. It was this that spurred the group of scientists to develop a treatment which was successfully tested on animals.

"The treatment is a harmless bacterial strain that was engineered to expresses a molecular mimic of the receptor for Shiga toxin all over its surface," says Paton.

"This is capable of binding and neutralizing large amounts of Shiga toxin. When fed to animals infected with a virulent STEC strain, it bound all the free toxin in the gut, preventing it from being absorbed into the bloodstream, and thereby preventing any disease."

Photo: E. Coli blog

Paton says research granting bodies such as Australia's National Health and Medical Research Council and the Australian Research Council gave funding support from 2002 to 2005, but the private sector did not respond to the researchers' positive results.

"This (funding) enabled us to make some refinements to the original Shiga toxin-binding construct to make it more suitable both for mass production and for use in humans, as well as developing the other disease treatments," says Paton.

"However, we were unable to find a commercial partner to fund the final clinical development phase. This is an example of the so-called 'valley of death', where a product has advanced beyond the research phase where there is access to government funding agencies, but is either too early or not considered lucrative enough to be picked up by commercial entities with the capacity to fund clinical development and licensure."

Germany has recorded 2,300 infections of the disease to date with 22 deaths, according to Der Spiegel.

Paton is a National Health and Medical Research Council (NHMRC) Australia Fellow and works at the University of Adelaide's School of Molecular and Biomedical Science.

www.freshfruitportal.com