ATIR(TM), a donor lymphocyte cell based preparation depleted of allo-reactive T-cells, is under development to prevent acute Graft versus Host Disease (GvHD) and allow for early immune reconstitution following a bone marrow transplantation with a fully mismatched (haplo-identical) donor.
Dr. Roy's presentation of clinical results from 19 end stage blood cancer patients with high risk leukemia and/or lymphoma using ATIR(TM) was very well received. These patients, each of whom did not have a matched donor available, were treated in a phase I/II dose escalating study with ATIR(TM) in a mismatched transplantation setting. No immune suppressants were used, which is in contrast to conventional transplant procedures. Nevertheless, no cases of severe grade III/IV acute GvHD occurred after ATIR(TM) infusion. Furthermore, the clinical data showed a reduction in the frequency of infectious episodes in the cohorts treated with the higher doses of ATIR(TM), as compared to the low dose cohorts. To date, patients in the higher dose cohorts show high survival rates (75%) with no transplant related mortality (TRM).
These results show that the selective depletion of allo-reactive T-cells in the ATIR(TM) cell based product by the proprietary photo-sensitizing agent TH9402 is highly effective and can result in fast and adequate immune reconstitution in combination with the prevention of acute GvHD in bone marrow transplantations using a mismatched donor.
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SOURCE Kiadis Pharma