Diamyd Medical announced that the Swedish Medical Products Agency (MPA) in Europe and the FDA in the US, has approved the Company’s application to commence Phase III studies with the therapeutic diabetes vaccine Diamyd(R)
"I am extremely glad that we now can offer our recently diagnosed type 1 diabetes patients the possibility to participate also in the European study," says Professor Johnny Ludvigsson, Linkoping, Sweden, Principal Investigator for the study.
Diabetes teams from approximately 20 Swedish pediatric clinics will meet in Linkoping, Sweden on April 4 to go through details for the study, which will comprise 306 new onset type 1 diabetes patients. Diamyd Medical is planning to file clinical trial applications in another 3-4 European countries and include additionally 20 clinics in the study.
"The approval from the Swedish MPA is another important step in the development of Diamyd(R) towards the market," says Elisabeth Lindner, President and CEO of Diamyd Medical. "Last week we received authorization from the FDA to start a parallel Phase III trial in the US, and together with TrialNet’s planned study in the US, the interest in Diamyd is strong. We receive daily inquiries from parents of patients wanting to participate in our studies."
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