– 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.
Arthur Lahr, CEO of Kiadis Pharma, commented: “We are pleased to have completed enrollment into this Phase II study and can now fully focus on enrollment of the Phase III study. The single dose 1-year results from this study further increase and support the data in the marketing authorization application (MAA) we submitted to the European Medicines Agency (EMA) in April 2017. The Company remains on track to potentially obtain (conditional) EMA approval for ATIR101™ in Q4 2018 which would allow for a European launch in H2 2019.”
