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Tolerx Initiates Confirmatory Phase 3 Clinical Trial, DEFEND-2, with Otelixizumab for Type 1 Diabetes
Date:6/28/2010

CAMBRIDGE, Mass., June 28 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

"For decades, our primary treatment option for patients with type 1 diabetes has been the use of insulin alone to control blood glucose levels, while the underlying autoimmune disease continues to progress," said Dr. Thomas B. Repas, Clinical Assistant Professor, Department of Internal Medicine, University of South Dakota, Sanford School of Medicine, and an investigator in the DEFEND-2 study.  "The future potential of otelixizumab opens up the opportunity for an entirely new treatment approach that can intervene at early onset of type 1 diabetes and potentially break the cycle of the continued progression of this disease that patients manage over their entire lifetime."

DEFEND-2 is a randomized, placebo-controlled confirmatory Phase 3 trial designed to enroll up to 400 patients, age 12 to 45, with newly diagnosed autoimmune type 1 diabetes. DEFEND-2 is being conducted at more than 200 sites in North America and Europe. Building on DEFEND-1, the DEFEND-2 clinical trial similarly evaluates the efficacy and safety of otelixizumab in an additional study population of patients
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SOURCE Tolerx, Inc.
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