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Diamyd(R) Study Published in Prestigious New England Journal of Medicine
Date:10/9/2008

results are considered to be of such quality and clinical value strengthens our position in the medical and industrial worlds," says Elisabeth Lindner, president and CEO of Diamyd. "We are now moving forward preparing the market introduction of Diamyd(R)."

About the article:

"GAD Treatment and Insulin Secretion in Recent-Onset Type 1 Diabetes"

J Ludvigsson et al., N Engl J Med 2008;359 (Epub ahead of print 10.1056/NEJMoa0804328)

About Diamyd(R) Type 1:

Diamyd(R) Type 1 is the treatment of recently diagnosed patients with the Diamyd(R) diabetes vaccine. Diamyd(R) Type 1 is a simple treatment without any serious side effects. This treatment is now being tested in Phase III studies in Europe and the US. The company plans to complete the application for market approval in late 2010. The annual market for Diamyd(R) Type 1 is estimated at about one billion dollars.

About the mechanism of action:

Type 1 diabetes is an autoimmune disease in which the body's own immune system attacks the cells in the body that produce insulin. The active ingredient in Diamyd(R) is glutamic acid decarboxylase (GAD), which is a dominant antigen in type 1 diabetes. By treating with GAD formulated as a vaccine, the patient's immune system is affected in such a way that it down regulates the attack on the insulin-producing cells. Stopping this autoimmune process is the cornerstone in curing type 1 diabetes.

Immunological analyses from the Phase II study as presented in the New England Journal of Medicine help to form an understanding of the Diamyd(R) vaccine's mechanism of action. A significant increase in regulatory T-cell activity was seen, which is considered decisive in counteracting the course of autoimmune diseases.

About the Phase II study:

The Phase II study now being presented comprised 70 patients aged 10-18 with type 1 diabetes. The patients, who received two injections of Diamyd(R), retained their own ability to pro
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SOURCE Diamyd Medical AB (publ)
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