Kiadis Pharma N.V.
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Publicatie datum
04 apr 2016 - 16:05
Statutaire naam
Kiadis Pharma N.V.
Titel
Kiadis Pharma presents positive data on the primary endpoint of its single dose Phase II trial with ATIR101™
Bericht
Kiadis Pharma presents positive data on the primary endpoint of its single dose
Phase II trial with ATIR101™
~ Significant increase in Overall Survival and reduction in Transplant Related Mortality observed in comparison to a historical control group ~
~ Zero patients developed grade III-IV acute Graft-versus-Host-Disease upon infusion of ATIR101™ ~
~ Initiation of a randomised Phase III trial in the second half of 2016 ~
~ Management will host a webcast to discuss the data today at 18.00 CET ~
Amsterdam, The Netherlands, April 4, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “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 presents positive results on the primary endpoint of its single dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™ at the 42nd Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in Valencia, Spain.
The data presented in session O042 by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and the principal investigator for the trial, confirms that ATIR101™ can be safely infused, does not cause grade III-IV Graft-versus-Host-Disease (GVHD) and shows a significant reduction in Transplant Related Mortality (TRM) and a significant improvement in Overall Survival (OS) in comparison to a historical control group of patients undergoing a T-cell depleted haploidentical donor transplantation only.
Trial details
Twenty-three leukaemia patients with a median age of 41 years (range 21-64) were enrolled into and treated on this trial from sites in Canada, Belgium, Germany and the United Kingdom. Patients were eligible for an allogeneic hematopoietic stem cell transplantation (HSCT) but could not find a matching donor in time. Sixteen patients had acute myeloid leukaemia (AML) and seven had acute lymphoblastic
Datum laatste update: 21 februari 2026