Tolerx Presents Otelixizumab Phase 2 Dose Optimization Data At The IDF's 20th World Diabete...(F or E arly or N ew-Onset Type 1 D ia...)

Date:10/21/2009

For Early or New-Onset Type 1 Diabetes) is a randomized, placebo-controlled Phase 3 trial intended to enroll approximately 240 patients, age 12 to 45, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at over 100 study 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 preserve beta cell function as measured by C-peptide, a surrogate measure of beta cell function. The primary endpoint will be a measurement of C-peptide. For information about DEFEND, please visit www.DefendAgainstDiabetes.com.

About the TTEDD Study

TTEDD is a non-randomized, open-label Phase 2 study intended to enroll approximately 100 patients, age 18 to 45, with autoimmune type 1 diabetes. The purpose of TTEDD is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

About Type 1 Diabetes

Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating its blood glucose (sugar) level. There are two major types of diabetes: type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is a disorder of the body's immune system. In type 1 diabetes, the immune system attacks and destroys the insulin-producing beta cells in the pancreas. As a result of the decrease in endogenous (natural) insulin production, patients must monitor their glucose levels frequently and administer insulin regularly to control their blood glucose levels.

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SOURCE Tolerx, Inc. Copyright©2009 PR Newswire. All rights reserved

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