Diamyd close to important milestone
Diamyd Medical announces today that 90 percent of the total 320 children and adolescents with type 1 diabetes due to participate in the company’s European Phase III study with the diabetes vaccine Diamyd® have now been included and have received injections of Diamyd® or placebo. The company expects all participants to have been included in the study by November 2009.
Diamyd Medical is conducting a global Phase III program with the diabetes vaccine Diamyd® comprising a study in nine countries in Europe and a study in the US. In each study 320 children and adolescents aged 10-20 newly diagnosed with type 1 diabetes will take part. “We are now close to our first important milestone in the Phase III program,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “We expect the study to be fully recruited by November 2009.” “The results will be analyzed during spring 2011, when all patients have participated in the study for 15 months.” The purpose of the study is to investigate whether the Diamyd® vaccine can delay or stop the break-down of beta cells in the pancreas and hence preserve the body’s own ability to control the blood sugar in patients newly diagnosed with type 1 diabetes. This could in turn reduce the risk for acute and long-term diabetic complications. In the study, two thirds of participants are receiving the Diamyd® vaccine and one third is receiving placebo (an inactive substance). The study is conducted at 70 clinics in Europe. As previously announced, the company is investing in accelerated patient recruitment for the parallel US Phase III study with the diabetes vaccine Diamyd® through recruitment campaigns and an increase in the number of participating US pediatric diabetes clinics.