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news.Tolerx has started a pivotal Phase III clinical trial that is evaluating otelixizumab in autoimmune new onset type 1 diabetes.
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Defend is a randomized, placebo controlled Phase III trial designed to enroll approximately 240 adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. Defend is being conducted at multiple centers in North America and Europe.
The trial will evaluate whether a single course of otelixizumab, administered not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes, will reduce the amount of administered insulin required to control blood glucose levels by inhibiting the destruction of beta cells.
The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function.
As a result of the initiation of patient dosing in Defend, Tolerx will receive a $15 million milestone payment from GlaxoSmithKline.
Douglas Ringler, president and CEO of Tolerx, said: “We believe otelixizumab has the potential to provide an important new treatment option for patients with newly diagnosed autoimmune type 1 diabetes.”