Tolerx has reported changes to the protocol for its phase 3 clinical trial – DEFEND. The trial is testing the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.
The DEFEND protocol amendment includes two key changes to the study, expansion of the eligible patient age range from 18-35 years to 12-45 years, and the shortening of the infusion time for each administration of otelixizumab from 2 hours to 30 minutes.
Repoprtedly, both of these changes are supported by clinical data derived from Tolerx’s ongoing phase 2 study – TTEDD.
Peter Gottlieb, associate professor of Pediatrics and Medicine at the Barbara Davis Center at the University of Colorado at Denver, and a principal investigator in the DEFEND study, said: From a clinical perspective, I believe this amendment significantly improves the protocol for the DEFEND trial. Most notably, through the expansion of the patient age range to include adolescents, Tolerx is widening the options available to physicians interested in providing new investigational treatment options to this important and growing adolescent patient population.