Tolerx Announces Amendment to Phase 3 DEFEN...(ient course of otelixizumab therapy whic...)

It is estimated that, in the United States, approximately 36,000 patients are diagnosed each year with autoimmune type 1 diabetes. Of those newly diagnosed, approximately 35% are adolescent patients between the ages of 12 and 17 years who are now eligible for enrollment in the DEFEND trial.

About the DEFEND Study

DEFEND 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 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.

About Otelixizumab

Otelixizumab is a targeted T cell immunomodulator being developed for the treatm
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