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Kiadis Pharma receives approval to start trial with ATIR

Biopharmaceutical company Kiadis Pharma has received approval for its Investigational New Drug application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR in the United States.

Kiadis Pharma is currently enrolling patients in a multinational pivotal clinical study at hospitals in Europe and Canada.  With the approval of the IND, US hospitals will also participate in this study.

ATIR is designed for blood cancer patients in need of allogeneic bone marrow transplantation, who do not have a matched donor available.  ATIR allows a mismatched family member to act as donor, and is being developed to reduce Transplant Related Mortality without inducing Graft versus Host Disease.

ATIR has shown excellent clinical results in a phase I/II study in patients who received a haploidentical mismatched bone marrow transplantation from a family member donor.  The two year follow up data showed no Transplant Related Mortality and overall survival of 70% in a group of high risk leukemia patients who received an efficacious dose of ATIR.  These results compare favorably to outcomes of bone marrow transplantations from a fully matching donor.

Source: Kiadis Pharma

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