AMSTERDAM, December 4 Biopharmaceutical company KiadisPharma announces today that it has successfully completed treatment of thelast patient on its ATIR(TM) phase I/II clinical trial. ATIR(TM), a donorlymphocyte cell based product, is under development to prevent acute Graftversus Host Disease (GvHD) and allow early immune reconstitution following amismatched bone marrow transplantation. Nineteen end stage blood cancerpatients were treated with no cases of grade III/IV acute GvHD occurringwithin the first 100 days after ATIR(TM) infusion, showing the feasibilityand tolerability of the addition of ATIR(TM) in combination with a mismatchedtransplant procedure.
Following scientific advice from the EMEA Kiadis Pharma is preparing toinitiate a multi center multinational pivotal study starting recruitmentearly 2009. In this study the efficacy of ATIR(TM) will be investigated inpatients diagnosed with AML, ALL or MDS eligible for an allogeneic bonemarrow transplantation but for whom no matching donor is available.
"Bone marrow transplantations are often the only treatment option leftfor end-stage blood cancer patients. But too many patients simply do not finda suitable matched donor in time" says Dr. Denis-Claude Roy of theMaisonneuve-Rosemont Hospital in Montreal, the principal investigator on thestudy. "Our study shows a rapid immune reconstitution in transplantedpatients provided with ATIR(TM) treated immune cells from mismatched donors.Without ATIR(TM) treatment this would not be possible because of the highrisk of acute Graft versus Host Disease with mismatched donor immune cells.This is obviously a very hopeful development for a large patient group."
Dr. Manja Bouman, CEO of Kiadis Pharma, says "The results of thisclinical trial are very encouraging and it is another important milestone inthe development of ATIR(TM) as a novel approach which may enable a safe andpotentially life-saving mismatched bone marrow transplantation as a treatmentoption for end-stage blood cancer patients."
For the complete press release please go to: http://www.kiadis.com/news
English release is provided by Kiadis Pharma. Equivalent translations arefrom a third party.
SOURCE Kiadis Pharma