Amsterdam, The Netherlands, October 20, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that the first patient has been enrolled into its repeat-dosing Phase II clinical trial, CR-AIR-008, with its lead product ATIR101™. The patient was enrolled in Hamilton, Canada within a month of receiving regulatory approval for the study from the Canadian authorities.
In this new trial the safety and efficacy of administrating a second dose of ATIR101™ after the initial stem cell transplantation to patients with blood cancer, to further improve the outcome of their stem cell transplantation, will be studied (NCT02500550 / EudraCT 2015-002821-20).
The study has now been approved by authorities in Canada, Belgium and the United Kingdom, with approval pending in Germany. The Company also plans to expand the study to the USA pending regulatory approval. A total of 15 leukaemia patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) or myelodysplastic syndrome (MDS) will be enrolled.
Dr. Irwin Walker, Professor of Medicine at the McMaster University in Hamilton and Principal Investigator of the study, commented: “We are very excited about participating in this repeat dosing study with ATIR101™. Already, a single-dose administered in the previous Phase II study had shown very promising data. We are therefore keen on contributing to this next development step.”
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are very pleased about the dynamics in our ATIR101™ development and the progress we have made on-track since our recent IPO. We believe that this new study will add additional important data for the outline of a best study design for a Phase III trial that we anticipate to start in the second half of next year. We believe that ATIR101™ has the potential to add significant value in reducing infections and relapse rates and to avoid severe acute GVHD that is seen with other current approaches.”
