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Tolerx Initiates Confirmatory Phase 3 Clinical Trial, DEFEND-2, with Otelixizumab for Type 1 Diabetes
Date:6/28/2010

age 12 to 45 with new-onset type 1 diabetes. In the confirmatory study, otelixizumab is administered as a single course, given not more than 90 days after the initial diagnosis of autoimmune type 1 diabetes.  The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function that has been endorsed by the U.S. Food and Drug Administration (FDA) at 12 months after dosing.  Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events, fewer hyperglycemic excursions, and a reduction in long-term disease complications in established type 1 diabetes patients, as referenced in the Diabetes Control and Complications Trial (DCCT).

"Tolerx is aggressively moving forward in our clinical development of otelixizumab.  We are excited by the potential of this novel drug candidate to change the type 1 diabetes treatment paradigm by inhibiting disease progression and perhaps halting the disease by inducing an immunologic remission," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx.  "The first patients have been dosed in the DEFEND-2 study, and we believe our study is designed with the robustness and rigor to confirm the efficacy and safety of otelixizumab in a broad patient population."

For additional information about DEFEND-2, 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. Ther
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SOURCE Tolerx, Inc.
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