Diamyd’s Phase III study in Europe now approved in all nine countries

Diamyd Medical announces today that the European Phase III study with the diabetes vaccine Diamyd® has now been approved in all nine of the planned European countries.

Diamyd Medical’s Phase III study in Europe includes a total of 320 patients in nine countries, and aims to evaluate the Diamyd® vaccine’s effect in preserving the insulin producing capacity in children and adolescents with recent-onset type 1 diabetes. In Phase II studies, the vaccine has been shown to either halt or slow the autoimmune destruction process and preserve the remaining insulin production. “Approvals in the major countries, Germany, France and Italy, significantly accelerate recruitment in Europe. These new approvals provide us with an additional 26 clinics,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “So far 85 patients in the previously approved countries have been treated and approximately 20 additional patients are currently in screening.” Diamyd Medical is conducting clinical Phase III studies with the diabetes vaccine Diamyd® for type 1 diabetes in the US and Europe. The European study has now been approved and initiated in Sweden, Slovenia, Finland, the UK, the Netherlands, Spain, Italy, Germany and France. The Diamyd® vaccine is also being studied in several research-financed studies. These include a Norwegian diabetes prevention and mechanism study involving 150 participants, a mechanism and efficacy study funded by NIDDK/TrialNet in 126 recent-onset type 1 diabetes patients and a combination study with 84 patients financed by National Institutes of Health (NIH).

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