Xenothera announces receivability of its Clinical Trial Application at the Czech Republic regulatory agency for a first in man clinical trial of LIS1 in kidney transplanted patients with dose escalation.
Nantes, June 21st, 2019 – Xenothera announces receivability after its submission of a Clinical Trial Application (CTA) with Czech Republic regulatory agency for a Phase I/II trial of its LIS1 product developed as induction treatment in solid organ transplantation. Upon CTA clearance, Xenothera plans to initiate a mono centric trial with volunteering kidney transplant patients. The clinical trial is planned at the Praha Institute for Clinical and Experimental Medicine. The initiation of this clinical trial is a key step and will generate first-in-human data with LIS1 product. The primary endpoint is safety. Clinical and biological parameters encompass rejection, infection, re-admission and target T lymphocyte depletion. The study will enroll patients who will be monitored for 3 months.