Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States
AMSTERDAM, July 8 /PRNewswire/ -- 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 ATIRTM 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.
ATIRTM is designed for blood cancer patients in need of allogeneic bone marrow transplantation, who do not have a matched donor available. ATIRTM 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.
ATIRTM 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 ATIRTM. These results compare favorably to outcomes of bone marrow transplantations from a fully matching donor.
This approval follows the FDA's decision to grant ATIRTM 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.
ATIRTM is a personalized cell based therapy of donor T-lymphocytes depleted of alloreactive T-cells and is infused after a patient receives a mismatched bone marrow transplantation to reduce Transplant Related Mortality. ATIRTM is designed to prevent severe acute GvHD while providing an early immune reconstitution to fight infections and remaining tumor cells, thereby reducing TRM and improving overall survival.
Moreover, it enables the use of a mismatched, related (haploidentical) donor, thus providing virtually everyone with an immediately available donor and treatment, addressing a high unmet medical need. Today patients eligible for an allogeneic transplantation, but without a matched donor available, have no treatment options left. ATIRTM can be considered a truly individualized medicine since it is prepared for each patient specifically.
About Kiadis Pharma
Kiadis Pharma is an oncology focused biopharmaceutical company developing products that offer novel treatment options for terminally ill cancer patients addressing significant unmet medical needs. The key focus indication for Kiadis Pharma is the limitations and complications of hematopoietic stem cell transplantation procedures.
Kiadis Pharma is located in Amsterdam, The Netherlands.