Tolerx presents otelixizumab preclinical research at 46th EASD

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the presentation of preclinical research describing the mechanism of action of otelixizumab at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, Tolerx also announced that the first European patient was enrolled in DEFEND-2, a confirmatory Phase 3 clinical trial evaluating otelixizumab in autoimmune new-onset type 1 diabetes. 

"We are very pleased to enroll the first European patient in the DEFEND-2 study, because the European diabetes community and patients are a critical component of DEFEND-2.  We look forward to continued patient enrollment in both the U.S. and Europe in this Phase 3 clinical trial," said Dr. Lou Vaickus, Chief Medical Officer of Tolerx. "We are also delighted to share our recent research findings at EASD using a model of human T cell reactivity in which a dual mechanism of action of otelixizumab is suggested, a finding which may be of importance in our Phase 3 type 1 diabetes studies."

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.