Clinical Innovations, Inc. Will be Participating in the Phase 3 Study DEFEND for Type 1 Diabetes

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) July 14, 2009 -- Clinical Innovations, Inc. announced today that it is now recruiting for DEFEND, a Phase 3 study enrolling patients with newly diagnosed autoimmune type 1 diabetes in Costa Mesa, Riverside and Santa Ana. In DEFEND (Durable Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) the safety and efficacy of otelixizumab, an investigational novel targeted immunotherapeutic anti-CD3 monoclonal antibody, are being evaluated.

Investigators with Clinical Innovations commented on the study: “We are excited to be involved in this pivotal Phase 3 study of otelixizumab. If successfully developed, otelixizumab may offer patients an innovative treatment option, consisting of a single short treatment course that may preserve residual beta cell function and improve disease control.”

About the DEFEND Study

DEFEND is a randomized, placebo-controlled Phase 3 trial designed to enroll approximately 240 young adult patients, age 18 to 35, with newly diagnosed autoimmune type 1 diabetes. DEFEND is being conducted at over 100 centers in North America and Europe. The trial is designed to evaluate whether a single course of otelixizumab, administered within 90 days of the initial diagnosis of autoimmune type 1 diabetes, will reduce the amount of administered insulin required to control blood glucose levels by inhibiting the destruction of beta cells. The primary endpoint will be a measurement of C-peptide, a surrogate measure of beta cell function. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), reductions in hypoglycemic events, and long-term disease complications in patients with established type 1 diabetes in the Diabetes Control and Complications Trial (DCCT).

For additional information about DEFEND, please visit www.DefendAgainstDiabetes.com

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