Tolerx announced the initiation of a confirmatory Phase 3 trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. This study, known as DEFEND-2, is a randomized, placebo-controlled trial designed to enroll up to 400 patients, age 12-45, with newly diagnosed autoimmune type 1 diabetes. Otelixizumab is administered as a single course, given not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes. The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function that has been endorsed by the FDA at 12 months after dosing.

Otelixizumab is a T cell immunomodulator that targets CD3, a T lymphocyte receptor involved in normal cell signaling.  Data suggest that the antibody may work in patients with type 1 diabetes who have residual beta cells by blocking the function of effector T cells that mistakenly attack and destroy insulin-producing beta cells, while stimulating regulatory T cells that are understood to protect against effector T cell damage, thus preserving the beta cells’ ability to make insulin.

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