Kiadis Pharma has dosed the last patient in its Phase II trial evaluating the safety and efficacy of two doses of ATIR101 in patients with a hematologic malignancy who received hematopoietic stem cell transplantation from a half-matched donor.
The last patient of the Phase II CR-AIR-008 (008) trial has received a single dose of ATIR101.
The trial enrolled a total of 15 patients. Six of them 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.
The remaining nine patients were treated with a single dose of ATIR101. Five of them are in one-year post-treatment of ATIR101.
Results of the 008 trial are consistent with the previously conducted 23-patient CR-AIR-007 single dose Phase II trial of ATIR101, which received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) last year.
Kiadis Pharma CEO Arthur Lahr said: “The single dose one-year results from this study further increase and support the data in the marketing authorisation application (MAA) we submitted to the European Medicines Agency (EMA) in April 2017.
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“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.”
Kiadis Pharma is also set to conduct a Phase lll trial of ATIR101 across Europe and North America. The trial already enrolled its first patient in December last year.