Kiadis Pharma N.V.
Hieronder vindt u informatie uit het register openbaarmaking voorwetenschap. Deze informatie is door de organisatie verstrekt.
Publicatie datum
30 jul 2015 - 07:00
Statutaire naam
Kiadis Pharma N.V.
Titel
Kiadis Pharma Announces Full Enrolment of its Phase II Clinical Study with Lead Product, ATIR101™
Bericht
~ 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
Gerelateerde downloads
Datum laatste update: 01 september 2024