Diamyd type 1 diabetes vaccine stalls in European trials

Tue, 10 May 2011
The antigen-based therapy Diamyd has reported disappointing results from its European Phase III trial for people who have been newly diagnosed with type 1 diabetes, it has emerged.

The findings from the trial showed that the drug treatment did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, measured using meal-stimulated C-peptide, in patients just diagnosed with the type 1 version of diabetes .

The study was carried out at over 60 clinics in nine different countries in Europe and involved over 320 patients between the ages of 10 and 20 who were diagnosed with type 1 diabetes within the first three months of beginning the study. Diamyd was not able to show a sufficient preservation of beta cell function after 15 months of follow-up as compared with a placebo, despite a slight positive effect being exhibited, and it being well tolerated by a similar number of adverse events across treatment groups.

Peter Zerhouni, acting president and CEO of Diamyd Medical, commented "Although we had hoped for a better outcome of the European Phase III trial, we will now further analyze the study results together with data from other ongoing studies to better understand and determine the precise therapeutic impact of this approach as well as the best path forward for the program."
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