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Kiadis Pharma Announces ATIR Interim Clinical Results

Thursday, October 11, 2007 General News J E 4
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AMSTERDAM, Netherlands, Oct. 10 Kiadis Pharma todayannounced interim results of a physician initiated European Phase II clinicalstudy for its lead product ATIR. Professor Velardi from the University ofPerugia in Italy presented the successful treatment of thirteen end stageblood cancer patients with a mismatched bone marrow transplantation during the5th workshop on "Haploidentical Stem cell Transplantation" in Catania, Italy.The results are an important milestone in the development of ATIR as arevolutionary approach to provide a safe and potentially life-savingmismatched bone marrow transplantation as treatment option for end-stage bloodcancer patients.

Bone marrow transplantations are currently limited because of the highrisk of Graft versus Host Disease (GvHD). This is a severe and potentiallylife-threatening complication in which the donor immune cells recognize andattack the patient's tissues and organs. Therefore it is currently essentialthat the patient and donor blood systems (the human leukocyte antigens, HLA)are highly similar in order to reduce the chance of acute GvHD. As aconsequence, bone marrow transplantations strongly rely on the availability ofa matching donor. However, the timely availability of a matching donor is alimiting factor for many patients to receive a bone marrow transplantation.Kiadis Pharma's ATIR is under development to prevent acute GvHD by eliminationof the immune cells causing acute GvHD. A successful development would enablethe performance of mismatched donor transplantations, including donor immunecells that can fight infections and the cancer without causing GvHDcomplications. Because ATIR eliminates acute GvHD causing cells, thetransplantation can be performed without the currently standard immunesuppressant regime post transplantation. This subsequently allows the donorimmune system to rapidly develop helping the patient to fight infections,another major life threatening complication of bone marrow transplantations.

Professor Velardi, a key opinion leader in the field of mismatchedallogeneic transplantations, has presented the clinical results of thirteenend stage blood cancer patients who received bone marrow transplants frommismatched donors, including donor immune cells that are selectively depletedof acute GvHD causing cells using ATIR. No immune suppressants were used posttransplantation as a standard regime. No patient has developed lethal acuteGraft versus Host Disease, the major complication that prohibits the use ofthis treatment without ATIR. The patients rapidly developed a new donor immunesystem as assessed by the rapid expansion of immune cells in the patients.Detailed analysis revealed the presence of pathogen specific donor immunecells in the patients. In particular immune cells recognizing pathogenicfungi, like Aspergillus and viruses like Cytomegalovirus (CMV) could bedetected post transplantation.

These specific pathogens are the major cause of death by infections afterbone marrow transplantation. This shows that the ATIR treated immune cells arefunctional and could fight infections without causing lethal acute GvHD inthese patients.

"Bone marrow transplantations are often the only treatment option left forend-stage blood cancer patients. But too many patients simply do not find asuitable matched donor in time," said Dr. Andrea Velardi, M.D., Professor ofClinical Immunology at the University of Perugia. "The interim results of ourstudy show a rapid immune reconstitution in transplanted patients providedwith ATIR treated immune cells from mismatched donors. Without ATIR treatmentthis would not be possible because of the high risk of acute Graft versus HostDisease (GvHD) with mismatched donor immune cells. This is obviously a veryhopeful development for a large patient group."

The physician initiated European ATIR Phase II trial by Prof. AndreaVelardi, M.D. is the se
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