Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe
Tolerx, Inc., announced that DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), the Phase 3 trial of otelixizumab, an investigational novel targeted immunotherapeutic, has begun enrollment of new onset autoimmune type 1 diabetes patients in Europe. In DEFEND, preserving beta cell function subsequent to the administration of otelixizumab is the primary outcome that is being evaluated.
This outcome will be assessed by measuring C-peptide levels (a surrogate of endogenous insulin secretion) and by measuring reductions in the amount of injected insulin used to maintain excellent glycemic control.
DEFEND continues to actively recruit subjects in the United States, Canada, Sweden, Finland, Germany, Italy, and the UK. Tolerx anticipates that enrollment will soon commence at clinical sites in Spain and Denmark.
DEFEND is a randomized, placebo-controlled Phase 3 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 throughout Europe and North America. The trial is designed to 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.
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