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 University of Montreal. "I am a strong believer that ATIR(TM) will open up a whole new treatment field for a very large patient group which currently has no treatment options left."
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