The Diamyd
® vaccine for type 1 diabetes is the company's furthest developed product. Two parallel Phase III studies are ongoing in the US and Europe. Both studies are randomized, double-blind and placebo controlled. 320 young recent-onset type 1 diabetes patients will be included in each study. One third of the patients will be treated with two injections of Diamyd
® 20 µg, one third will be treated with four injections of Diamyd
® 20 µg, and one third will receive four injections of placebo.
The results from each study will be analyzed 15 months after all patients have received their first injection. If the study results are positive, they will be used for market registration of the product. Professor Johnny Ludvigsson of the Linköping University Hospital in Sweden is the principal investigator for the European study, while Professor Jerry Palmer of the University of Washington in Seattle is the lead investigator for the US study.
Diamyd Medical reported positive results from a similar completed 30-month randomized double-blind placebo controlled Phase II study of 70 children and adolescents with type 1 diabetes. Significant long-term efficacy was demonstrated in preserving beta cell function, i.e. endogenous insulin producing capacity. The treatment was well received by patients, their doctors and family members. The results also strongly support the safety of Diamyd
®. No serious side effects related to the Diamyd
® treatment were reported in the study. The study was published in the fall of 2008 in the prestigious journal
The New England Journal of Medicine.