Kiadis Pharma announces positive clinical results for ATIR™ in mismatched bone marrow transplantations - Kiadis Pharma proceeds with pivotal trial ATIR™

Biopharmaceutical company Kiadis Pharma announces today that it 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 (GvHD) and allow early immune reconstitution following a mismatched bone marrow transplantation.  Nineteen end stage blood cancer patients were treated with no cases of grade III/IV acute 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 EMEA 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 AML, ALL or MDS eligible for an allogeneic bone marrow transplantation but for whom no matching donor is available.

"Bone marrow transplantations are often the only treatment option left for end-stage blood cancer patients. But too many patients simply do not find a suitable matched donor in time” says Dr. Denis-Claude Roy of the Maisonneuve-Rosemont Hospital in Montreal, the principal investigator on the study. “Our study shows a rapid immune reconstitution in transplanted patients provided with ATIR™ treated immune cells from mismatched donors. Without ATIR™ treatment this would not be possible because of the high risk 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 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.”

About ATIR™
ATIR™ is under development to allow early immune reconstitution while preventing life-threatening GvHD, a major complication of allogeneic bone marrow transplantations. GvHD is a condition caused by the donor immune cells attacking the patient’s tissues and organs. Allogeneic bone marrow transplantations today require that the patient and donor immune systems are highly similar in order to reduce the risk of GvHD and therefore these transplantations rely on matching donors. By eliminating those immune cells which could attack the patient’s body and thus preventing the occurrence of GvHD, ATIR™ enables the use of a mismatched donor. This means ATIR™ will address a significant limitation in bone marrow transplantations, which is the timely availability of a donor.

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