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 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."
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/IV) Graft versus Host Disease. ATIR(TM) thereby significantly improves the outcome of the transplant procedure. Moreover, it enables the use of a mismatched, related (haplo-identical) donor, thus providing virtually everyone with an immediately available donor and treatment, thereby addressing a high unmet medical need as patients eligible for an allogeneic transplantation but without a matched donor available in general have no treatment options left.
ATIR(TM) has been granted orphan drug designations from both the FDA and the EMEA.
About Kiadis Pharma
Kiadis Pharma is an oncology focused biopharmaceutical development company with cell based products in clinical development. The company develops products that offer novel treatment options for terminally ill cancer patients and address significant unmet medical needs. The key focus indication for Kiadis Pharma is limitations and complications of bone marrow transplantation procedures. Kiadis Pharma is located in Amsterdam, The Netherlands. For more information about Kiadis Pharma, please visit http://www.kiadis.com.
English release is provided by Kiadis Pharma. Equivalent translations are from a third party.
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