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Wellington participants sought for Phase 2 of Coeliac Vaccine Trials

Press Release – Coeliac New Zealand
A coeliac disease vaccine currently undergoing investigation with the aim to protect patients from the harmful effects of gluten is looking for kiwi volunteers for the Phase 2 clinical trial.

Having achieved success in Phase 1 trials both in New Zealand and Australia researchers are now seeking participants in Wellington, Auckland and Havelock North for the next stage.

Coeliac New Zealand general manager Dana Alexander said the programme is identifying a way to desensitise the body’s immune response to gluten for people living with coeliac disease, in a similar way to turning off an allergic response.

“If successful, the vaccine would enable people with the disease to be free from the risk of being ‘glutened’ which would be particularly beneficial when dining away from the home or where safe gluten free options aren’t available.”

Coeliac disease is caused by an immune reaction to the gluten protein. The autoimmune disease is estimated to currently affect 1 in 70 New Zealanders and 1.4 per cent of the global population.

University of Oxford-trained Dr Bob Anderson, who hails from Dunedin, has been working on Nexvax2 at Massachusetts biotech company ImmusanT since 2012.

His research identified the toxic peptides of gluten that led to the design of the targeted immune treatment and subsequent Phase 1 trials.

Dr Anderson said his research looked at “gatekeeper” immune recognition genes – most often HLA-DQ2.5.

In 2014, Phase 1 trials in locations including Auckland taught researchers that coeliac symptoms are triggered by T cells rapidly responding to gluten peptides, and that the immune system can be retrained to ignore gluten peptides by administering repeated doses of Nexvax2.

Dr Anderson tested the “toxic” sequence of the A-gliadin protein. Blood analysis was then used to measure the immune reaction causing coeliac disease. Dr Anderson’s team then saw the potential for treating coeliac disease with a “vaccine-like” approach, utilizing key (toxic) gluten fragments recognized by T cells. Dr Anderson established a research programme and worked with Dr Jason Tye-Din in Melbourne at the Walter and Eliza Hall Institute, where they investigated a “peptide-based therapeutic vaccine” to treat established coeliac disease. The first study of Nexvax2 in coeliac volunteers was completed in 2009.

New Zealand volunteers, study sites and scientists played a central role in Nexvax2 because until now there have been no medications approved for the treatment of coeliac disease.

“The Phase 2 study is designed to show regular Nexvax2 injections protect against the effects of one-off gluten exposure in patients doing their best to maintain a strict gluten-free diet.

“The goal with Nexvax2 is not to replace the gluten-free diet, but to protect against acute symptoms due to inadvertent gluten exposure, an all too common problem faced by coeliac patients on a frequent basis.”

The Coeliac New Zealand’s Dining Out programme was launched two years ago to improve best practice for people with Coeliac Disease. Whilst this programme has helped to provide reassurance when dining out that the restaurant has made a commitment in providing safe gluten-free food, it is hoped Nexvax2 may someday go one step further and allow for relaxation of dietary restrictions, Dr Anderson added.

Coeliac NZ (CNZ) has a long relationship with Dr Anderson and Dr Tye-Din.

CNZ relies entirely on the generosity of donors and is seeking donations for the Gluten Free For Life Research Fund. Please consider making a donation to this dedicated Coeliac NZ research fund at https://givealittle.co.nz/org/coeliacnz

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