First children vaccinated in Diamyd®-study in order to prevent diabetes

with the diabetes vaccine Diamyd®. The purpose of the study is to investigate whether vaccination with Diamyd® may prevent or delay that children, with high risk to develop type 1 diabetes, get the disease. This is the first time ever that vaccination is tested with the purpose to prevent this chronic disease.

The children participating in the Diamyd®-study are at high risk of developing type 1 diabetes. It has been concluded that they all have an ongoing autoimmune disease process, where their insulin-producing cells are being destroyed by their own immune system. If the destruction is not stopped, it can with time lead to type 1 diabetes. Today there is no treatment that can prevent the progress of the disease. "We are hoping that treatment with Diamyd® will alter this situation, so that we in the future could help children already before they develop type 1 diabetes," says Helena Elding Larsson, pediatrician at the UMAS university hospital in Malmö and researcher at Lund University. “So far three children have been treated with two injections each of the Diamyd® vaccine or placebo,” states Elding Larsson. The objective is to evaluate whether vaccination with Diamyd® could delay or halt the progress of the disease, so that the children do not develop type 1 diabetes. Diamyd Medical reported on March 4 this year that the Swedish Medical Products Agency had approved the study. "If the Diamyd® vaccine would be able to prevent or delay this serious disease, which primarily affects children and adolescents, we are facing a medical breakthrough," says Elisabeth Lindner, President and CEO of Diamyd Medical. The study, which is the first of its kind, is double-blind and placebo controlled and includes a total of 50 children ages four and above. Half of the children will receive two injections of the Diamyd® vaccine, and half will receive placebo (a non-active medication). In type 1 diabetes, the children's blood sugar must be checked and insulin injections must be taken several times a day, while careful attention must be paid to diet and exercise. Type 1 diabetes is a chronic disease for which there is currently no cure. The disease must be strictly controlled in order to avoid the serious complications associated with diabetes. A few studies aiming to prevent type 1 diabetes have been conducted worldwide, but no one has yet been able to affect the progress of the disease. Researchers have for a long time been convinced that the active substance in Diamyd® (GAD) may prevent type 1 diabetes. Now the development of the drug has progressed far enough to initiate a prevention study in children.

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