New Clinical Study of T-Guard™ in the Treatment of Graft versus Host Disease (GVHD) begins in The Netherlands

Nijmegen, the Netherlands, January 13, 2014 - Xenikos B.V. today announced the start of a new clinical study in the Netherlands of T-Guard™ for treatment of Graft versus Host Disease (GVHD), a frequent and potentially life-threatening complication of bone marrow and blood stem cell transplantation. The Phase I/II trial began on January 6, 2014 following approval from the relevant Dutch authorities late in 2013

T-Guard™ is a combination of two toxin-loaded anti-T-cell antibodies that shows promise as a therapeutic tool for safely and swiftly resetting the body’s immune system in T cell mediated diseases. T-Guard is currently being developed for the treatment of acute Graft versus Host Disease (GVHD), a feared and potentially life-threatening complication of hematopoietic stem cell transplantation. There are presently no registered therapies for acute GVHD patients, who have failed standard first-line corticosteroid therapy and the prognosis for these patients is very poor. The new Phase I/II clinical trial will explore the safety and efficacy of T-Guard™ in 20 patients with severe steroid-refractory acute GVHD.

The study is being conducted at Radboud university medical center in Nijmegen, the Netherlands – a leading Dutch academic medical center that incorporates specialist hematology capabilities. Experts at the hospital carry out approximately 60-70 transplants per year and are eager to find a new, effective treatment option that can reduce the significant negative impacts of acute GVHD on outcome and transplant patients’ Quality of Life. The study will be managed by a team of dedicated hematology specialists, nurses, and data analysts, lead by Dr. Walter van der Velden, MD., PhD. Internist-Hematologist and Principal Investigator of the study.

The primary endpoint of the study will be the overall response rate at Day 28, (the current standard primary endpoint of acute GVHD trials). Secondary endpoints include: six months overall survival and the safety and tolerability of T-Guard™. An interim analysis, evaluating both T-Guard™'s efficacy and safety, is anticipated in the third quarter of 2014. The final trial outcomes are expected during mid 2015.

Xenikos plans to expand the study into Germany, at the University Hospital Münster, Germany, upon receipt of approval for the trial by the relevant German authority, the Paul Ehrlich Institute.

“The start of our latest trial means we can take another major step forward in bringing T-Guard™ to patients to rectify the current lack of registered treatment options for GVHD,” said Ypke van Oosterhout, Chief Executive Officer of Xenikos. “We anticipate that the results will strengthen the evidence of T-Guard™’s promise in the treatment of severe acute GVHD.”

Press Release Xenikos - Start of T-Guard Phase I-II study in acute GVHD_20140113.pdf