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Kiadis Pharma (Kiadis) has reported the first patient enrollment in its multinational registration clinical trial with Atir. 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 company said that 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.
Atir, 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 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.
Reportedly, Atir thereby 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 has been granted orphan drug designations from both the FDA and the EMEA.
Manja Bouman, CEO of Kiadis, said: “We are very pleased to initiate the registration study following positive clinical results from the phase I/II study with Atir. Atir 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.”