Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).  In this clinical study conducted by the Juvenile Diabetes Research Foundation (JDRF) Center for Beta Cell Therapy in Diabetes based in Brussels, patients treated with otelixizumab were characterized by the preservation of function of insulin-producing beta cells in the pancreas compared to patients treated with placebo for up to 4 years after treatment.  The data from this study are the first placebo-controlled demonstration of long term effects resulting from an innovative immunologic intervention in newly diagnosed T1DM cases.

The study results reported in Diabetologia were obtained through a collaboration between clinical and laboratory researchers in Belgium, France, Germany and the United Kingdom that was made possible by a grant from the JDRF (New York). The Belgian Diabetes Registry collected and analyzed blood samples and centralized data.

"The availability of four year efficacy and safety data with otelixizumab further advances our clinical development program in type 1 diabetes," said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx. "Tolerx is grateful to all the patients, caregivers, clinical trial investigators, and the JDRF for conducting and funding this study.  Tolerx is excited to be continuing the development of otelixizumab, and we look forward to very shortly initiating our second Phase 3 trial (DEFEND-2) in new onset autoimmune type 1 diabetes."    

Dr. Daniel Pipeleers, Director of the JDRF Center Brussels commented "Our data provide strong support to a novel disease modifying treatment for new-onset T1DM patients.  The data showed that immune modulation by otelixizumab dampen the autoimmune destruction process thereby preserving residual beta cells and their contribution to glycemic control."        

In this reported study, otelixizumab administration was associated with transient symptoms during dosing including flu-like syndrome and transient perturbation of Epstein Barr Virus (EBV).  During the 48 months of follow-up there were no EBV related symptoms, no higher incidence of infections, and no lymphoproliferative or other types of cancer observed.  Following the 18 month efficacy results of the present study, Tolerx has optimized the otelixizumab dosing regimen to minimize adverse events, with encouraging data on clinical effect.   This optimized dosing regimen is now being fully evaluated in a Phase 3 clinical study called DEFEND-1, which completed enrollment in January 2010, and will be confirmed in a second pivotal study, DEFEND-2.  DEFEND-2 is intended to begin in the first half of 2010.    

SOURCE Tolerx, Inc.