Amsterdam, The Netherlands, September 30, 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 it has obtained regulatory approvals from the national authorities both in Canada and in Belgium to start a further Phase II clinical trial with its lead product ATIR101™. In this new trial the safety and efficacy of using a second dose of ATIR101™ will be studied (NCT02500550 / EudraCT 2015-002821-20).
ATIR101™ is a cell-based product designed to enable stem cell transplantations from partially matched (haploidentical) family donors for blood cancer patients who do not have a matching stem cell donor available. Previously announced results obtained in prior and ongoing clinical studies confirm the safety and efficacy of a single dose of ATIR101™ at 2×106 cells/kg, with no grade III-IV (life-threatening) acute Graft versus Host Disease (GvHD) occurring, despite the fact that no prophylactic immune suppressants were used. Furthermore, only limited severe infections and relapses were reported in those studies. The aim of the new Phase II trial is to test whether the administration of a second dose of ATIR101™ to a stem cell transplantation at a later point during treatment could further improve the transplantation outcome.
The study will commence in Canada and Belgium and the Company plans to expand the study to the USA and other European countries pending regulatory approvals. A total of 15 leukaemia patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) or myelodysplastic syndrome (MDS) will be enrolled. Kiadis Pharma expects to enroll the first patient into this study in Q4 2015.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are excited to initiate another Phase II study with ATIR101™ on track with plans communicated at the time of our IPO. We have already demonstrated the potential of ATIR101™ to better protect patients against transplant related mortality and provide anti-leukaemia reactivity. The fully functional T-cells in ATIR101™, collected from a partially mismatched, haploidentical family-donor, are able to fight infections and residual tumour cells without eliciting acute grade III/IV GvHD in any patient as a result of Kiadis Pharma’s technology. In this next Phase II study we want to explore whether this effect can be even further maximized by administering a second dose of ATIR101™.”
