AMSTERDAM, November 30 /PRNewswire/ -- Biopharmaceutical company Kiadis Pharma announces today that the first patients have been enrolled in its multinational registration clinical trial with ATIR(TM). The study is designed to show reduction in transplant related mortality (TRM) after one year following an allogeneic stem cell transplantation with a mismatched (haplo-identical) donor in blood cancer patients eligible for an allogeneic stem cell transplantation but without having a matched donor available.
The study is currently open for enrollment in centers in Europe and Canada and is designed to serve as a registration trial for European approval.
"We are very pleased to initiate the registration study following excellent clinical results from the phase I/II study with ATIR(TM)." says Dr. Manja Bouman, CEO of Kiadis Pharma. "ATIR(TM) has shown a low TRM at one year post transplantation and a high overall survival in a patient population with no standard treatment options left. As an orphan product addressing a high unmet need, we aim to take advantage of a fast development path for ATIR(TM)."
"As the pioneer of ATIR(TM) I am very excited about this next major
development milestone, a multinational registration study" says Dr. Denis
Claude Roy of the
ATIR(TM), a donor lymphocyte preparation depleted of alloreactive
T-cells, is under development to reduce transplant related mortality (TRM)
following an allogeneic hematopoietic stem cell transplantation (HSCT).
ATIR(TM) is designed to provide early immune reconstitution to fight
infections and remaining tumor cells (by eliminating the use of prophylactic
immune suppressants) while preventing acute severe (Grade III
|SOURCE Kiadis Pharma|
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