Diamyd discussing potential consolidation of Phase III trials

Diamyd Medical is conducting two clinical Phase III trials of the Diamyd® diabetes vaccine in children and adolescents with recent onset type 1 diabetes: one in the US and one in nine European countries. In parallel the company is discussing with the regulatory agencies about combining the two trials into one global trial.

In addition to reducing costs, combining the trials would mean that countries with the fastest rate of patient recruitment could contribute to the greatest extent. The Phase III program encompasses ten countries: Italy, Finland, France, the Netherlands, Slovenia, Spain, the UK, Sweden, Germany and the US. The plan is for the global trial to serve as the basis for market approval in both Europe and the US. Diamyd Medical’s continued intention is to report Phase III data during the fourth quarter of 2010. Patient recruitment is growing sharply at present, as more clinics are being added. There are currently 74 active recruiting clinics in the US and Europe, 34 of which have joined since the beginning of the year. “We estimate that the expanded number of clinics will enable us to screen 100 children and adolescents in April,” says Elisabeth Lindner, President and CEO of Diamyd Medical.

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