Tolerx, Inc. is proceeding toward the initiation of a Phase 3 study of otelixizumab in new-onset type 1 diabetes. Tolerx is initiating this pivotal trial after reviewing the results of the otelixizumab development program with the US Food and Drug Administration at an End of Phase 2 meeting.

The Phase 3 study, known as DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), will be conducted at multiple centers in North America and Europe and will evaluate whether a single course of otelixizumab reduces the amount of administered insulin required for control of blood glucose levels by inhibiting destruction of beta cells. DEFEND enrollment is expected to begin mid-2008.

This article was published in Drug Discovery & Development magazine: Vol. 11, No. 5, May, 2008, pp. 30.