Diamyd Medical reports that the United States Food and Drug Administration (FDA) has approved the experimental use of Diamyd vaccine in children as young as three years of age in the TrialNet GAD study, enrolling 126 new onset type-1 diabetes patients in North America.
The TrialNet GAD study, conducted by an international network of leading paediatric and adult endocrinologists and immunologists, has previously enrolled new onset type 1 diabetes patients from 16 to 45 years of age but is now allowed by the US FDA to enrol and administer the Diamyd vaccine to children as young as three years of age.
“This is very encouraging news,” says Elisabeth Lindner, CEO and president at Diamyd Medical. “The approval to enrol small children in the TrialNet study is based on an US FDA review of safety data from our ongoing phase-III trials and further supports that the Diamyd vaccine's safety profile is strong.”
The TrialNet study is a double-blind, randomized, placebo-controlled trial, which aims to enrol a total of 126 new onset type-1 diabetes patients at 16 TrialNet sites in the US and Canada. One third of the participants will receive three injections with the Diamyd vaccine, one third will receive two injections with the Diamyd vaccine and one third will receive placebo (inactive drug). The purpose of the study is to determine whether the Diamyd vaccine will preserve the body's ability to make its own insulin to help control blood sugar.
The trial also includes extensive immunological studies to clarify the mechanism of action of Diamyd and to evaluate the correlation between the clinical and immunological outcomes of Diamyd treatment in new onset type-1 diabetes patients.
Diamyd Medical has approved the protocol and has executed a Clinical Trial Agreement with the National Institute of Diabetes and Digestive and Kidney Diseases, part of the US National Institutes of Health, to supply clinical-grade material (i.e. Diamyd and placebo) for this trial. TrialNet is sponsored by the National Institutes of Health and supported by Juvenile Diabetes Research Foundation International and the American Diabetes Association.
Diamyd Medical is a Swedish diabetes company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications.