The scientist heading the research is Dr. Bob Anderson, of the Walter and Eliza Hall Institute of Medical Research in Melbourne. According to a press release from the Institute, If the vaccine developmentof Dr Anderson and his scientific team prove successful, a strict gluten free diet for celiacs could become a thing of the past. The point of the vaccine would be to induce autoimmune tolerance to gluten, so the celiac patient’s body would not react in the usual manner and no damage would be inflicted on the small intestine. Before the vaccine’s effectiveness can be confirmed, however, the researchers must first conduct whats known as a Phase I trial to verify how the vaccine acts and affects the body, the side effects associated with increasing doses, and early evidence of effectiveness. The study starting this month in Australia is a Phase I trial. Using forty volunteers with celiac disease, the researchers will attempt to determine the appropriate vaccine dose and to identify any side effects. Dr. Anderson has been studying the role of gluten in celiac disease for many years. In the press release, he said, As both a celiac disease researcher and treating gastroenterologist, I am in an interesting position. I have overseen my basic scientific discovery about the troublesome elements in gluten being translated into an experimental vaccine that may eventually help my patients.The vaccine itself is intended to gradually desensitize the celiac sufferer, so that gluten is tolerated. Consequently, the villi in the small intestine should revive and absorb nutrients in the normal way. Ideally, that would mean the end of gluten-free diets for people with celiac disease. A web page devoted to Dr. Anderson and his work points out that while researchers around the world are working to develop drugs that might help patients with celiac disease, Many of the drugs under development for celiac disease are likely to supplement the gluten free diet and simply provide a safeguard against inadvertent gluten exposure. Vaccines such as the one his group is testing, on the other hand, are likely to replace the gluten free diet if they prove efficacious. In approximately one year from now, if the Phase 1 trial is judged to have been successful, a larger Phase II trial will be conducted with more participants to confirm that the vaccine actually works, according to the press release.
ImmusanT commences Nexvax2 clinical trials for celiac disease in New Zealand, Australia and the U.S.
There are currently no approved medicines available for people with celiac disease, who must manage their condition by eliminating gluten-containing foods from their diet. Advancing the earlier Nexvax2 clinical trial, the new program underway in Australia and New Zealand is a randomized, double-blind, placebo-controlled Phase 1b study evaluating multiple ascending doses of Nexvax2 for the induction of gluten tolerance in patients on a gluten-free diet. ImmusanT expects to enroll 84 subjects at approximately four study sites in the two countries in order to evaluate safety, tolerability and pharmacokinetics, and to select doses for investigation in subsequent studies. The second study, a randomized, double-blind, placebo-controlled Phase 1 trial being conducted in 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. In ImmusanT’s international trials, patients will have a confirmed diagnosis of celiac disease and carry the immune recognition gene HLA-DQ2.