Tolerx Announces Amendment to Phase 3 DEFEN...( CAMBRIDGE Mass. Aug...)

CAMBRIDGE, Mass., Aug. 11 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced changes to the protocol for its Phase 3 clinical trial DEFEND, which is testing the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

The DEFEND (Durable Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) protocol amendment includes two key changes to the study: expansion of the eligible patient age range from 18-35 years to 12-45 years, and the shortening of the infusion time for each administration of otelixizumab from 2 hours to 30 minutes. Both of these enhancements are supported by clinical data derived from Tolerx's ongoing Phase 2 study called TTEDD.

"From a clinical perspective, I believe this amendment significantly improves the protocol for the DEFEND trial," said Peter A. Gottlieb, MD, Associate Professor of Pediatrics and Medicine at the Barbara Davis Center at the University of Colorado at Denver, and a principal investigator in the DEFEND study. "Most notably, through the expansion of the patient age range to include adolescents, Tolerx is widening the options available to physicians interested in providing new investigational treatment options to this important and growing adolescent patient population."

Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx, also commented on the news: "We are pleased with this amendment on multiple levels and are hopeful that both the expansion of the target population and the more convenient dosing regimen will further expand the enthusiasm for this trial in the diabetes community. Our commitment to type 1 diabetes patients is evidenced in our efforts to develop a short, conven
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