Celiac.com 03/30/2012 - A company called Microtest Laboratories is manufacturing doses of what they claim may be the first effective vaccine treatment for celiac disease. At this point, the only treatment for celiac disease is to avoid gluten in the diet.
Other companies are working on vaccines for celiac disease, and several working trials are underway. However, this new drug's creator, ImmusanT, based in Cambridge says that, unlike other vaccines, which prevent an infection, their drug, Nexvax2 works by changing the immune system so it no longer attacks gluten.
Regarding the path from concept to manufacturing for Nexvax2, Richter says that the process has been anything but straightforward. "It's arty process," he told a local reporter, "you have to develop protocols for all the manufacturing and plans to do all of the work aseptically. You have to get all those protocols and plans approved through the regulatory process. Then you have to do the work.”
Microtest is initially manufacturing 9,000 vials for ImmusanT: two 3,000-dose batches of vaccine and a 3,000-dose batch of inert placebo to be used in the clinical trial. Richter says that the control group contains everything except the active vaccine.
ImmusanT is looking to start the first clinical trials in the second quarter of this year by testing the doses on people with celiac disease. The full article, in Massliveonline.com quotes Leslie J. Williams, president and CEO of ImmusanT, as saying that “The test will be if it [the vaccine] induces a tolerance for gluten in the diet."
The report says that Williams and the company hope to get the vaccine commercially available by 2017. Will the company succeed? Will they have a successful vaccine available in just five short years? Let us know what you think.