Swedish MPA approves Ph III diabetes vacc trial

The Swedish Medical Products Agency has approved local firm Diamyd Medical's application to commence Phase III studies of its therapeutic diabetes vaccine. 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 is planning to file clinical trial applications in up to four more European countries and include a further 20 clinics in the study.

"The approval from the Swedish MPA is another important step in the development of Diamyd towards the market," says Elisabeth Lindner, chief executive of the firm. "Last week we received authorization from the [Food and Drug Administration] to start a parallel Phase III trial in the USA, and together with TrialNet's planned study, the interest in Diamyd is strong. We receive daily inquiries from parents of patients wanting to participate in our studies."