A coeliac disease vaccine that aims to protect patients
from the harmful effects of gluten has entered Phase 2 clinical
Research is showing that up to 10 per cent of people with type 1
diabetes also live with coeliac disease, often undiagnosed, as the
general symptoms of coeliac, such as tiredness, may be attributed
Following the commencement of global trials
led by US-based pharmaceutical company ImmusanT, the Australian
trials started at the Royal Melbourne Hospital Clinical Trials
Centre in Melbourne and will now roll out in Perth, Adelaide,
Brisbane, Mackay and the Sunshine Coast.
Led by the Walter and Eliza Hall Institute's
head of coeliac research and gastroenterologist at the Royal
Melbourne Hospital Dr Jason Tye-Din, the Melbourne trial of
Nexvax2® (RESET CeD) is now recruiting for patients with coeliac
Coeliac disease is caused by an immune
reaction to the gluten found in wheat, rye and barley.
The autoimmune disease is becoming
increasingly prevalent, and is estimated to currently affect
one in 70 Australians and 1.4 per cent of the global
Dr Tye-Din said volunteer participation
was crucial to the success of the trials. "The vaccine is designed
to target the 90 per cent of coeliac disease patients with the
HLA-DQ2 genetic form of disease," he said.
Dr Tye-Din said he was very excited about the
commencement of Phase 2 trials because of the therapy's potential
to one day enable patients to safely have gluten in their diet.
"A successful therapy that can restore normal
gluten tolerance would revolutionise coeliac disease management,"
Nexvax2® is designed to restore what is lost
in coeliac disease, which is the ability of the immune system to
President of Coeliac Australia Mr Michael
Bell said the organisation's members and many thousands of
Australians with coeliac disease had been looking forward to the
announcement of Phase 2 trials.
"Many have been following the development of
Nexvax2 for more than a decade and are hopeful the trials will take
us one step closer to an effective treatment for coeliac disease,"
Mr Bell said.
Dr Tye-Din has been leading the way in
understanding what triggers coeliac disease in a combined effort
involving patients, clinicians and scientists for more than a
Initiated by Dr Bob Anderson, now chief
scientific officer for ImmusanT, and Dr Tye-Din in 2003, the
Institute's coeliac research program identified the toxic parts (or
peptides) of gluten that led to the design of the targeted immune
treatment and subsequent Phase I trials undertaken in
"The results from national and international
Phase 1 trials showed that the therapy was safe and well tolerated
even at the highest doses used, and also showed an intended
biological effect on the immune system in patients with coeliac
"The Phase 2 trials build on the data from
earlier studies and it is great that Australia is still playing a
pivotal role in this work," Dr Tye-Din said.
For a list of sites offering the trial around
Australia, please visit the Coeliac