Strategic expansion of Diamyd Medical`s European Phase II trial in Type 1 diabetes
(WorldNews Sweden)

The Swedish Medical Products Agency has approved an expansion of DIAGNODE-2, the Phase II trial where the diabetes vaccine Diamyd® is administered directly into the lymph node, to comprise a total of approximately 106 patients. The expansion, which is awaiting approval in Spain and the Czech Republic, is being made to increase the trial`s statistical power and weight in the development of the antigen-specific intralymphatic immunotherapy Diamyd® for Type 1 diabetes. The application for amendment to allow recruitment of approximately 26 more patients to a total of 106 participants, has been submitted to the Competent Authorities in Sweden, Spain and the Czech Republic. To support the...