Peter A. Gottlieb, MD, Associate Professor of Pediatrics and Medicine at the Barbara Davis Center at the University of Colorado at Denver, known for his involvement in many types of clinical trials for the prevention and treatment of diabetes, noted that, "The continuous otelixizumab dose regimen optimization efforts have been a major translational research focus. These important research efforts are enabling us, in the DEFEND development program, to evaluate the potential ability of otelixizumab to provide a long-term immunologic remission after a short course of therapy. If successful in the clinic, this would be a significant step forward."

Tolerx also announced today its intention to conduct a second confirmatory Phase 3 study of otelixizumab in new-onset autoimmune type 1 diabetes. Further details of the design and timing of the study, to be named DEFEND-2, will be forthcoming.

"The on-time completion of patient enrollment in DEFEND-1 represents a major milestone for Tolerx," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx. "We are very grateful for the dedication of the patients, their caregivers and our clinical trial investigators for making it possible to reach our enrollment target. As part of our clinical development program to reach regulatory approval for otelixizumab, we will now quickly transition to the launch of DEFEND-2, a confirmatory study, to maintain enrollment momentum and enthusiasm generated to date in the type 1 diabetes community."

SOURCE Tolerx, Inc.