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World's first celiac disease vaccine goes into phase 2 studies in Melbourne

A world-first vaccine is tested aimed at interrupting the need for gluten-free diets for celiac disease. Following global trials led…

A world-first vaccine is tested aimed at interrupting the need for gluten-free diets for celiac disease.

Following global trials led by the US drug company ImmusanT Inc, the Australian trials begin at Melbourne’s Royal Clinic Clinical Trials Center and then roll out in Perth, Adelaide, Brisbane, Mackay and the Sunshine Coast.

It is eight years after the Melbourne-designed injection proved to be safe in the first patients with a potential treatment.

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The only treatment for 160,000 Australians with celiac disease – most of them undiagnosed – is a strict lifelong gluten-free diet. [19659003] Coeli ac disease is caused by an immune response to the gluten protein found in wheat, rye and grains.

Nearly 150 patients in Australia, New Zealand and the United States will be recruited in Phase two attempts to receive injections of placebo or active treatment, twice a week for four months. They will include patients from Royal Adelaide Hospital, Advertiser reported.

They will undergo three food challenges throughout the experiment to test symptomatic relief. Some patients will also have a bowel biopsy to check if there is a protective effect on the intestinal lining.

Dr. Jason Tye-Din shows kiaki disease sufferers Riley Nicholls, 11, some blood cells in blood cells cultured in the laboratory at Walter and Eliza Hall Institute in Parkville. Image: Ian Currie

The Nexvax2 vaccine is based on research at Walter and Eliza Hall Institute of Medical Research (WEHI), which identified three peptides in gluten that trigger an immune response in 90 percent of chillias that have the genetic form of the disease.

Researcher Dr Jason Tye-Din, from WEHI and Royal Melbourne Hospital, said that the results of national and international phase 1 studies showed that the therapy was safe and well tolerated even at the highest doses used. [19659003] “It also showed a intended biological effect on the immune system in patients with celiac disease,” said Dr Tys-Din. “Phase 2 studies are based on data from previous studies and it is amazing that Australia still plays a key role in this work.”

The vaccine was desensitized patients by targeting gluten-specific immune cells so that these T cells did not enter attack mode when gluten was present.

“The vaccine is designed to target 90 percent of celiac disease patients with the genetic disease form HLA-DQ2,” he said.

“A successful therapy that can restore normal gluten tolerance would revolutionize celiac disease management.”

The autoimmune disease is becoming widespread and is currently estimated to affect one of 70 Australians and 1.4 percent of the global population, according to WEHI. [19659003] The vaccine is designed to restore what is lost in celiac disease – the immune system’s ability to tolerate gluten.

Dr Tye-Din said that the Phase 2 study was important for “creating clinical evidence of the concept of a treatment that could benefit from the gluten-free diet.”

An analysis of Dr Tye-Din of almost 160 ” gluten-free “meals from 127 companies found that one in 10 contained gluten.

For a list of hospitals that run the trial go to www.coeliac.org.au

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