The Diamyd® products, the GAD-based diabetes vaccines for type 1 diabetes and LADA, are Diamyd Medical's furthest advanced products. They have been demonstrated to slow or arrest the destruction of insulin producing beta cells, which is characteristic of autoimmune diabetes. GAD (glutamic acid decarboxylase) is a protein present in the beta cells of the pancreas and is one of the most important targets when the immune system attacks these cells in autoimmune diabetes. Treatment with Diamyd® is thought to induce tolerance to GAD, thereby intervening in the autoimmune attack and preserving the capacity to produce insulin in patients with autoimmune diabetes, i.e. type 1 diabetes and LADA.

Diamyd® for type diabetes is intended for the treatment of children and adolescents with recent-onset type 1 diabetes. The product is currently undergoing Phase III clinical trials in Europe (9 countries) and the US. Results from the Phase III trials are expected by the end of 2010, which means that the product could receive market approval in 2011.

Diamyd® for LADA is intended to prevent LADA patients from becoming insulin dependent. The LADA patients are typically adults and are characterized and discriminated from type 2 diabetes patients by elevated levels of antibodies to GAD. This product has reached Phase II in clinical trials.

The Autoimmune Process

In type 1 diabetes, destruction of the insulin producing beta cells begins long before any symptoms appear. For unknown reasons, the body's own immune system begins to destroy the beta cells. The symptoms of diabetes only become apparent when 10 to 20 percent of the ability to produce insulin remains. At this point the body does not have enough beta cells left to be able to produce enough of the vitally needed insulin. Typical symptoms are increased urine volumes and increased thirst, as well as increasing fatigue, weakness, hunger and rapid weight loss. Shortly nausea and stomach pain may occur. The condition can rapidly become worse if the patient does not receive care. Sometimes children are even unconscious when they arrive at the hospital on an emergency basis. The ones affected by the disease must receive immediate treatment with insulin, and often needs to remain in the hospital for several days after the diagnosis. The symptoms of the disease can develop quite rapidly, from a few days to a few months, even though the destruction of the beta cells has been under way for a much longer period. Antibodies against GAD is one of the biomarkers characteristic of the disease. GAD-antibodies can be detected long before any clinical symptoms of the disease appear. The presence of GAD-antibodies and certain other biomarkers identify persons who are at high risk of developing type 1 diabetes.

Diamyd® may stop the autoimmune process

Despite modern insulin treatment, the fundamental problem of beta cell destruction continues, and finally all of the beta cells are destroyed and the body can no longer produce any insulin at all. Diamyd® treatment is intended to halt or slow the autoimmune destruction process and save the remaining beta cells.

Prevention

Studies have demonstrated that the Diamyd® vaccine is most efficacious early in the disease process, in recent-onset type 1 diabetes patients. If these results can be confirmed in larger studies, the next logical step is further testing of the vaccine in persons with a high risk of developing diabetes, i.e. prevention studies, in order to stop the disease before symptoms develop. Prevention studies have already been initiated, where researchers intend to evaluate the Diamyd® vaccine in children and adults at risk of developing type 1 diabetes.

Trials with Diamyd®

Diamyd Medical is currently conducting two clinical Phase III studies in type 1 diabetes: one in Europe and one in the US. The studies apply to persons diagnosed with type 1 diabetes within the past three months. Furthermore there are several initiated and ongoing independent trials with Diamyd®, please see links in the right column for more information.