Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) 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 (GvHD).
"We are very encouraged by this IND approval received from the FDA. We look forward to starting treatment of US patients in our ongoing multinational, pivotal clinical study, in which patients in Europe and Canada are already being treated," commented Manja Bouman, CEO of Kiadis Pharma.
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 (TRM) 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.
This approval follows the FDA's decision to grant ATIR™ an Orphan Drug Designation as a cell-based therapy for the reduction of Transplant Related Mortality caused by GvHD and/or infections following allogeneic bone marrow transplantation.
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