Diamyd executes agreement with US National Institutes of Health for a type 1 diabetes trial

27-Nov-2007

Diamyd Medical announced that it has executed a Clinical Trial Agreement with the National Institute of diabetes and Digestive and kidney diseases (NIDDK) for a planned clinical study with the Diamyd® GAD-alum diabetes vaccine in 126 new onset type 1 diabetes patients. The clinical study will be conducted by the NIDDK-sponsored consortium Type 1 Diabetes TrialNet. Under the terms of the agreement, Diamyd Medical will supply clinical-grade material (i.e. Diamyd® and placebo) for the trial.

The trial will include extensive immunological studies to clarify the mechanism of action and to evaluate the correlation between the clinical and immunological outcomes of GAD-alum Diamyd® treatment in recent onset type 1 diabetes patients. Such a detailed analysis may provide important information into the ability of Diamyd® to protect islet cells from autoimmune attack as a mechanism for maintaining insulin production. Additionally, the immunological data may prove beneficial for designing future diabetes prevention studies.

GAD65, a autoantigen in autoimmune diabetes, is the active substance in Diamyd. GAD65 is also an enzyme that converts the excitatory neurotransmitter glutamate to the inhibitory transmitter GABA. In this context, GAD may have an important role not only in diabetes but also in several central nervous system-related diseases. Diamyd Medical has an exclusive worldwide license from the University of California at Los Angeles regarding the therapeutic use of the GAD65 gene.

https://www.bionity.com/en/news/74928/diamyd-executes-agreement-with-us-national-institutes-of-health-for-a-type-1-diabetes-trial.html