Diamyd US Phase III study well under way

Diamyd Medical announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company’s lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.

One hundred patients are now enrolled in the company’s US Phase III study called DiaPrevent at 33 diabetes centers throughout the USA and more sites will be added. The study will include 320 children and adolescents between 10 and 20 years of age, recently diagnosed with type 1 diabetes. “After FDA’s approval to include children down to 10 years of age, which is enabling us to add pediatric sites, the recruitment rate has shown a remarkable increase. Numerous sites have been added with more to come. Last month one new patient per day received their first injection and the recruitment rate is accelerating," says Elisabeth Lindner, CEO and President of Diamyd Medical. More than 430 children have received Diamyd® or placebo in the global Phase III program. To date, no serious side effects related to the drug have been reported, which supports the strong safety profile seen in previous studies with Diamyd®. The global Phase III program aims to investigate whether Diamyd® can halt or slow the autoimmune destruction of beta cells in type 1 diabetes, preserving the body's own ability to control blood sugar levels. An improved blood sugar control reduces the risk for both acute and long-term diabetes complications. Diamyd® has been shown, in Phase II studies, to preserve the remaining beta cell function in children and adolescents recently diagnosed with type 1 diabetes. The DiaPrevent study centers were opened for children as young as 10 years of age during autumn 2009 after previously having included only age 16-20 years. New study sites are added as they receive ethics board approvals. More information about the DiaPrevent study can be found at www.diaprevent.com and at www.diaprevent.diamyd.com. The parallel European Phase III study was fully recruited in November 2009 and results are expected during spring 2011.

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