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Tolerx Expands Phase 3 'DEFEND' Trial of Otelixizumab in Europe
Date:3/10/2009

CAMBRIDGE, Mass., March 10 /PRNewswire/ -- Tolerx, Inc., today announced that DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), the Phase 3 trial of otelixizumab, an investigational novel targeted immunotherapeutic, has begun enrollment of new onset autoimmune type 1 diabetes patients in Europe. In DEFEND, preserving beta cell function subsequent to the administration of otelixizumab is the primary outcome that is being evaluated. This outcome will be assessed by measuring C-peptide levels (a surrogate of endogenous insulin secretion) and by measuring reductions in the amount of injected insulin used to maintain excellent glycemic control.

DEFEND continues to actively recruit subjects in the United States, Canada, Sweden, Finland, Germany, Italy, and the UK. Tolerx anticipates that enrollment will soon commence at clinical sites in Spain and Denmark.

"Our participation in DEFEND reflects our research priorities to support the development of innovative immune intervention for type 1 diabetes patients. We have begun dosing otelixizumab in DEFEND and are excited about its potential to be an effective treatment option for type 1 diabetics," stated Dr. Paolo Pozzilli, Professor University Campus Bio-Medico, Rome Italy.

"We are pleased that an increasing number of excellent clinical researchers in Europe and North America have started DEFEND at their sites and look forward to their continued participation in this important effort. We believe that a single short course of otelixizumab may have the potential to preserve residual beta cell function and offer people with autoimmune type 1 diabetes improved disease control" said Dr. Louis Vaickus, Chief Medical Officer of Tolerx. He continued "We are seeking in DEFEND to conclusively demonstrate this understanding."

About the DEFEND Study

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SOURCE Tolerx, Inc.
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