Kiadis Pharma Reports ATIR(TM) Clinical Data, Further Supporting Its Potential In Mismatched Bone Marrow Transplantations

Main Category: Blood / Hematology
Also Included In: Transplants / Organ Donations;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 09 Apr 2009 - 1:00 PDT

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Biopharmaceutical company Kiadis Pharma reported preliminary clinical data on ATIR(TM) showing its potential in mismatched bone marrow transplantations. Data was presented by the company's principal investigator Dr. Denis Claude Roy during the prestigious Presidential Symposium at the Annual European Bone Marrow Transplantation meeting (EBMT) in Goteborg, Sweden, on Monday, March 30, 2009. Only the 6 highest ranked presentations, representing the most promising new developments in the transplantation field, were selected for this Symposium.

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.

Dr. Denis-Claude Roy, Head of Stem Cell Therapy of the Hospital Maisonneuve-Rosemont, Montreal, Canada says: "These are fascinating results, demonstrating the feasibility of performing mismatched transplantations with an ATIR(TM) infusion. These results may give hope to patients who currently cannot be treated because of limited donor availability. In the future ATIR(TM) may allow mismatched transplantations to be performed in virtually all patients who cannot find a donor thereby improving the outcome of the whole procedure."

Dr. Manja Bouman, CEO of Kiadis Pharma, says: "Kiadis Pharma is pleased with the election of our ATIR(TM) data to be presented at the Presidential Symposium of the EBMT. It shows the interest in our approach by the medical community. On the basis of these highly encouraging results we are currently preparing for a multinational registration study with ATIR(TM) in mismatched transplantation procedures."

Source: Kiadis Pharma

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