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Tolerx Initiates Dosing of Otelixizumab, a Novel Type 1 Diabetes Agent, in DEFEND, a Phase 3 Clinical Trial
Date:8/6/2008

Milestone achievement triggers $15 million payment from collaborator

GlaxoSmithKline

CAMBRIDGE, Mass., Aug. 6 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced the initiation of a pivotal Phase 3 clinical trial that is evaluating otelixizumab in autoimmune new onset type 1 diabetes. As a result of the initiation of patient dosing in DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), Tolerx will receive a $15 million milestone payment from GlaxoSmithKline.

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 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. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events, and a reduction in long-term disease complications in established type 1 diabetics in the Diabetes Control and Complications Trial (DCCT).

"We are excited to have dosed the first patient in DEFEND and look forward to continued patient enrollment in this Phase 3 clinical trial. The initiation of DEFEND represents the culmination of a methodical, dose-ranging development plan, including the successful outcome from an end-of-Phase 2 meeting at FDA. We believe otelixizumab has the potential to provide an important new treatment option for patients with newly dia
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SOURCE Tolerx, Inc.
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