T-Guard™ has been granted Orphan Designation in the EU and in the US for the treatment of Graft-versus-Host Disease (GVHD), a frequent and potentially life-threatening complication of bone marrow or blood stem cell transplantation. March 2014, Xenikos has started a Phase 1/2 trial in 20 patients with severe acute GVHD who have failed corticosteroids at the Radboud University Medical Center (Radboudumc) Nijmegen, The Netherlands. September 2015 this trial has been extended to the University Hospital Muenster (UKM), Germany, after approval of the Paul Ehrlich Institute. It is expected that the last patient will be enrolled in Q1 2016. The primary endpoint will be the overall response rate at Day 28. Secondary endpoints include: six months overall survival and the safety and tolerability of T-Guard.
On the basis of the positive preliminary results, preparations have been started for a randomized comparative EU/US Phase 2 study, in which T-Guard will be compared to the best Standard of Care. In addition, Xenikos aims to further explore T-Guard’s therapeutic potential in alternative indications that might benefit from ‘resetting’ of the immune system, like solid-organ rejection and selected autoimmune diseases.