The in vitro research presented at EASD demonstrated that otelixizumab affects two important T cell subsets which may be critical for its effect in vivo in type 1 diabetes. In this model system that employs the mixed lymphocyte reaction (MLR), otelixizumab caused a simultaneous decrease in the growth of antigen-specific T killer/effector cells while enhancing the growth of regulatory T cells. This differential effect was most pronounced at lower doses.  The Tolerx data appeared in a poster presentation at EASD (Poster # 443), entitled "Otelixizumab differentially modulates human regulatory and non-regulatory T cells."

The new research findings support existing data suggesting that otelixizumab may work in patients with new-onset type 1 diabetes by blocking the function of T killer/effector cells that mistakenly attack and destroy insulin-producing beta cells, while simultaneously stimulating T regulatory cells that are thought to protect against future T killer/effector destruction. Clinical data from the recently completed DEFEND-1 Phase 3 study and the ongoing DEFEND-2 confirmatory Phase 3 study will be evaluated in light of these new findings to determine whether this dual effect of otelixizumab is consistent with results from patients who have received otelixizumab.

SOURCE Tolerx, Inc.