"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.