Diamyd Medical received approval from the Swedish Medical Products Agency to conduct Phase II of its diabetes vaccine trial, the company announced in a recent press release. The study began four years ago with people with Type 1 diabetes. At that time, participants were split into two groups: one that was given a placebo and one that was injected with the Diamyd diabetes vaccine.
Initial data shows that patients treated with the vaccine shortly after diagnosis were in a much better condition, the company says. In fact, the initial data shows that the vaccine was able to stop or reduce the destruction of beta cells, key in the production of insulin, which is a main symptom of Type 1 diabetes.
The company also says safety data continues to look good and that there are no serious side effects. The study period is 7 years. “The fact that two single injections still seem to have an effect 4 years later is very good news,” says Elisabeth Lindner, CEO and President of Diamyd Medical
Diamyd is conducting a global Phase III program for the vaccine, which includes 640 children and adolescents newly diagnosed with Type 1 diabetes in nine European countries and one parallel study in the US.
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