The target 23 patients have now been enrolled
Amsterdam, the Netherlands, July 30, 2015, 7.00 CEST – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Euronext Brussels: KDS), a recently listed clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces full enrolment of patients into its ongoing Phase II clinical study with its lead product, ATIR101™.
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. The ongoing Phase II study with ATIR101™ is an international multi-centre study in which a total of 23 leukaemia patients, including patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) and myelodysplastic syndrome (MDS), will be enrolled and treated with ATIR101™ as part of their transplant regimen.
The primary endpoint of the study is the rate of Transplant Related Mortality (TRM) at six months after allogoneic hematopoietic stem cell transplantation (HSCT). To date, 21 out of the 23 enrolled patients have received their HSCT, 19 of which have also been dosed with ATIR101™. The remaining patients are at various stages of treatment, either being prepared for HSCT or being dosed with ATIR101™. The 23rd patient is expected to undergo treatment with ATIR101™ in Q3 2015 and the study will remain open for enrolment until this final patient has been treated. Read-out of the primary endpoint results is expected in Q1 2016.
Dr. Jeroen Rovers, Chief Medical Officer of Kiadis Pharma, said: “We are grateful to all investigators in Canada, Belgium, Germany and the UK for collaborating with us and assisting us with the enrolment of patients into this study. We will continue to work with them in order to provide the best care possible for all patients involved in the study. We would also like to thank the patients, donors and their families for their participation.”
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “Full enrolment into the study is an important milestone for Kiadis Pharma and one which we set out to achieve as stated at the time of our recent successful IPO. The study has been progressing well since the publication of the positive interim data at ASH in 2014 and we expect read-out on the primary endpoint, Transplant Related Mortality at six months after HSCT, to be available in the first quarter of 2016. Reaching this enrolment target brings us one step closer to bringing our lead product, ATIR101™, to the market and to the thousands of blood cancer patients who are in need of a transplant.”
Interim data from a pre-specified interim analysis in this study were presented by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and Chair of the study, at the 2014 American Society of Hematology (ASH) Annual Meeting in San Francisco. These data confirmed the safety of ATIR101™ administration with no grade III-IV (life-threatening) acute Graft versus Host Disease (GVHD) occurring, despite the fact that no prophylactic immune suppressants were used. Only a limited number of grade I-II GVHD events were reported, all of which were treated successfully. Furthermore, no relapses were reported in any of the first ten patients, with four out of the ten patients in follow-up for more than one year at the time of the interim analysis. These data are in line with the data previously reported from Kiadis Pharma’s Phase I/II study with 19 patients.