Gluten can be found in wheat, rye, barley and oats. When gluten is consumed, it can cause a wide range of complaints from chronic tiredness, iron deficiency, osteoporosis, itchy rash, and headaches to various digestive symptoms. Coeliac disease damages the lining of the small intestine and can lead to significant medical complications such as autoimmune disease, infertility, liver failure and cancer. Coeliac disease usually develops in childhood and is life-long, but early diagnosis and treatment can reduce the risk of adverse health complications. Dr Tye-Din said the newly developed testing strategy showed coeliac disease potentially affected at least one in 60 Australian women and one in 80 men. Previous estimates had the number of Australians with coeliac disease as no more than one in 100. Although this study is the first to reveal that more than half of Australians have genetic risk factors for developing coeliac disease, it is not yet known why the disease develops in only some people. Dr Tye-Din, who is also a gastroenterologist at The Royal Melbourne Hospital, said the findings were surprising and shed new light on the medical burden of coeliac disease in Australia. “It is concerning that a significant number of people in the community with coeliac disease have not been diagnosed,” he said. “Accurate and timely diagnosis is important for the health of patients with coeliac disease. Making a diagnosis based on a blood test alone or commencing a gluten-free diet without a confirmatory bowel biopsy is inappropriate and can impose an unnecessary and lifelong treatment.
ImmusanT commences Nexvax2 clinical trials for celiac disease in New Zealand, Australia and the U.S.
is to determine the safety, tolerability and pharmacokinetic profile of Nexvax2 in patients with celiac disease well controlled by a gluten-free diet. ImmusanT plans to enroll 30 adult subjects at approximately four trial sites. “We are kicking-off a robust clinical program that we hope demonstrates Nexvax2 dramatically reduces the body’s immune response to dietary gluten so patients can resume a normal diet and return to good health,” said Patrick H. Griffin, M.D., Chief Medical Officer of ImmusanT. “Our clinical development program will allow us to further examine the role of antigen-specific T cells in celiac disease activation and in the re-establishment of tolerance to gluten.” “There has been tremendous enthusiasm about Nexvax2 from patients and the medical community and this will provide terrific momentum for advancing our clinical program,” said Leslie J. Williams, President and CEO of ImmusanT. BD (Becton, Dickinson and Company) is supplying novel intradermal injection solutions to ImmusanT to administer Nexvax2 in its clinical program. These solutions are based on BD’s commercialized intradermal injection technology, BD Soluvia Microinjection System. BD has a longstanding history of developing and commercializing novel prefillable vaccine delivery systems. As compared with the traditional intradermal injection method, BD’s intradermal injection technologies allow for a clinician to use an injection technique that is perpendicular to the skin. This helps simplify the administration process while improving the success of intradermal injections.