Diamyd completes patient screening for DiaPrevent Phase III study

Diamyd MedicalNov 10 2010

“The study has been met with strong interest by the American diabetes community and I want to thank everyone who has contributed to the recruitment effort.”

Diamyd Medical (STO:DIAMB)(Pink Sheets:DMYDY) has completed the screening of patients for the US Phase III study, DiaPrevent, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age have already been enrolled in the study and have received their first injection of the antigen-based therapy Diamyd® or placebo.

"We expect to reach the enrollment target of 320 patients in the near future with the patients already enrolled and the ones waiting for their screening results," says Elisabeth Lindner, CEO and President of Diamyd Medical. "The study has been met with strong interest by the American diabetes community and I want to thank everyone who has contributed to the recruitment effort."

At the same time, the parallel European Phase III study is progressing according to plan, with the first results anticipated by the spring of 2011. All patients have received their 4 injections of Diamyd® or placebo, and more than 70 percent have completed their 15 month visit. When all patients have completed their 15 month visit, the data will be processed and analyzed.

The global Phase III program aims to investigate whether Diamyd® can halt or slow the destruction of beta cells in the pancreas in type 1 diabetes, preserving the body's own ability to control the blood sugar level. This in turn reduces the risk of both short and long term diabetes complications. In Phase II studies, the Diamyd® therapy has been shown to slow the loss of beta cell function compared to placebo.