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news.Tolerx has announced that, following the end of Phase II FDA meeting, it is proceeding toward the initiation of a Phase III study of otelixizumab in new-onset type 1 diabetes.
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The Phase III study, known as Defend, 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.
Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events and reduction of long term disease complications in established diabetics in the Diabetes Control and Complications Trial (DCCT). Defend enrollment is expected to begin in mid-2008.
Douglas Ringler, president and CEO of Tolerx, said: “The rigorous science behind our Phase II clinical program has provided us with valuable insights that facilitated our moving forward into Defend with an optimized dosing regimen that has the potential to transform the treatment paradigm for type 1 diabetes.”