Further Information
Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing cells of the pancreas. Diet, exercise and the administration of insulin are used to manage the condition, but there are no current therapies that prevent the underlying cause of the condition, which is the loss of beta cell function resulting from an autoimmune attack.

Otelixizumab halts the immune system attack on the beta cells, thereby allowing them to continue to produce natural insulin. In an 80-patient Phase II study it was demonstrated that in patients with new-onset type 1 diabetes, a six day course of therapy with otelixizumab preserves the function of insulin-producing beta cells in the pancreas and reduces the amount of administered insulin needed to control blood glucose levels for at least 18 months.

At 6, 12, and 18 months, beta cell function was more effectively maintained in otelixizumab-treated subjects than in placebo-treated subjects as assessed by C-peptide release. Daily insulin dose increased in the placebo group, but not in the otelixizumab group.

Tolerx, Inc., announced in early January 2010 the completion of patient enrolment in its Phase III clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab in patients with new-onset autoimmune type 1 diabetes.

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