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Tolerx Presents Data at 69th Scientific Sessions of the American Diabetes Association
Date:6/8/2009

to the identification of a dosing regimen that is expected to result in optimal TCR modulation, enhanced tolerability, no immunogenicity, beneficial clinical activity, and an improved safety profile. This regimen is currently being evaluated in the ongoing multinational Phase 3 clinical trial, DEFEND, which is characterizing the safety and efficacy of otelixizumab, a novel anti-CD3 monoclonal antibody, in new onset autoimmune type 1 diabetes patients.

About the DEFEND Study

DEFEND is a randomized, placebo-controlled Phase 3 trial intended 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 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, a surrogate measure of beta cell function. For information about DEFEND, please visit: www.DefendAgainstDiabetes.com.

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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