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news.Kiadis Pharma, a biopharmaceutical company, has successfully completed treatment of the last patient on its Atir Phase I/II clinical trial. Atir, a donor lymphocyte cell based product, is under development to prevent acute graft versus host disease and allow early immune reconstitution following a mismatched bone marrow transplantation.
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According to the company, approximately 19 end stage blood cancer patients were treated with no cases of grade III/IV acute graft versus host disease (GVHD) occurring within the first 100 days after Atir infusion, showing the feasibility and tolerability of the addition of Atir in combination with a mismatched transplant procedure.
Following scientific advice from the European Medicines Agency, Kiadis Pharma is preparing to initiate a multi center multinational pivotal study starting recruitment early 2009. In this study the efficacy of Atir will be investigated in patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome eligible for an allogeneic bone marrow transplantation but for whom no matching donor is available.
Manja Bouman, CEO of Kiadis Pharma, said: The results of this clinical trial are very encouraging and it is another important milestone in the development of Atir as a novel approach which may enable a safe and potentially life-saving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients.