Tolerx Advancing Novel Type 1 Diabetes Agent Into Clinical Trial - Diabetes Symptoms and Care

Tolerx is proceeding toward the initiation of a Phase III 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 (FDA) at an End of Phase II meeting.

The Phase III study, known as DEFEND (Durable Response Therapy Evaluation For Early or New>type 1 diabetes and has identified a dosing regimen that thus far has significantly reduced side effects while maintaining important biological activity. This dosing regimen will be used in our Phase III pivotal trial DEFEND.