Autoimmune diabetes vaccine ready for final clinical trial
Study of vaccine based on LiU discovery indicates a long-term effect on insulin-producing cells.
Diamyd, a vaccine for autoimmune diabetes which originated through LiU research, is now a step closer to clinical usage. The third and final assessment report of the study of effects on children who are recent-onset type I patients, indicates a long-term significant and positive effect on insulin-producing cells.
"We note with satisfaction that the effects remain even two and a half years after treatment," says Dr. Johnny Ludvigsson, professor of pediatrics at Linköping University and director of the study.
The drug's active component, GAD65, a glutamic acid decarboxylase-based vaccine, induces immunotolerization. Early vaccination can help the patient deal more readily with the disease and reduce potential complications.
"The most recent findings give strong support to the concept and we are now ready to introduce a phase III study to treat 306 children in Sweden and other European countries," Dr. Ludvigsson continues. "Together with colleagues in the United States I will conduct a parallel study in the United States with an equal number of young patients."
A phase III study is the final part of the clinical trial that always precedes approval of a new drug.
The autoantigen GAD65 was discovered through LiU research. In the early 1980s, its presence was demonstrated in Swedish diabetic children. The discovery was widely reported in scientific journals after an initial publication in Nature.
Last updated: 2009-06-03