T-Guard™ was granted Orphan Designation in the EU and in the US for the treatment of steroid resistant acute Graft-versus-Host Disease (GVHD). This is a frequent and potentially life-threatening complication of bone marrow or blood stem cell transplantation for which currently no registered therapy exists.
Xenikos presented T-Guards’ favorable results in patients with steroid resistant acute GVHD during an oral presentation at the ASH in Atlanta. A scientific publication of that trial will be submitted shortly to a high-ranked peer-reviewed journal. Inspired by the positive preliminary results, preparations for pivotal phase 3 studies in the USA and EU are currently ongoing. Preparations for pivotal phase 3 studies in the US and EU are currently ongoing; both studies are planned to begin in 2019.
Xenikos aims to further explore T-Guard’s therapeutic potential in alternative indications that might benefit from rebalancing of the immune system, like solid-organ rejection and selected autoimmune diseases.'