– Results from the single dose 1-year follow up consistent with prior Phase II study
– Data supports already submitted marketing authorization application
Amsterdam-Duivendrecht, The Netherlands, January 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell therapy products aiming to make bone marrow transplantations safer and more effective for patients, today announces that the last patient in the Phase II CR-AIR-008 (‘008’) trial has received a single dose of ATIR101™.
This exploratory Phase II trial (clinicaltrials.gov identifier: NCT02500550) was designed to evaluate the safety and efficacy of two doses of ATIR101™ in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical (half-matched) donor.
A total of 15 patients were recruited into the trial. Six of these patients received two doses of ATIR101™ before the independent data monitoring committee (IDMC) recommended that the trial should continue treating patients with one dose of ATIR101™ (announced on December 21, 2016). The remaining nine patients on the trial have now been treated with a single dose of ATIR101™. Of these nine patients, five patients are 1-year post treatment and results are consistent with the previously conducted 23-patient CR-AIR-007 single dose Phase II trial. (more…)