Tolerx expands Ph III otelixizumab trial in Europe

US drug developer Tolerx has expanded a Phase III trial of otelixizumab into Europe. The DEFEND study of the investigational targeted  immunotherapeutic is now enrolling new-onset autoimmune type 1 diabetes  patients in Sweden, Finland, Germany, Italy and the UK, with further  recruitment at clinical sites in Spain and Denmark.

In DEFEND, preserving beta cell function subsequent to the  administration of otelixizumab is the primary outcome that is being  evaluated by the measurement of C-peptide levels - a surrogate of  endogenous insulin secretion - and by measuring reductions in the amount  of injected insulin used to maintain glycemic control. The trial is  scheduled to enroll a total of 240 patients.