Kiadis Pharma Announces Clinical Study with NIH

July 9, 2007 – Oncology focused pharmaceutical company Kiadis Pharma B.V. announced today that physicians at the U.S. National Institutes of Health (NIH) will begin a clinical phase II trial with Kiadis Pharma’s ATIR product. Following existing trials in Canada and Europe that focus on ‘mismatched’ bone-marrow transplants, this will be the first clinical trial with ATIR as treatment for conventional HLA matched transplants. ATIR was selected after a pre-clinical research program and will be investigated as a treatment option for terminally ill blood cancer patients.

“We are extremely proud that NIH, as the leading medical research authority in the United States, has selected ATIR for a clinical trial. We believe that it underlines the promise of our product and expands the potential application for ATIR to a broader range of patients undergoing bone-marrow transplants.” said Manja Bouman, CEO, Kiadis Pharma.

NIH investigators leading the trial are Dr. Stephan Mielke and Dr. John Barrett of the Hematology Branch of the NIH's National Heart, Lung, and Blood Institute (NHLBI), who have been approved by the NHLBI Institutional Review Board and the U.S. Food and Drug Administration (FDA) to conduct the study.

Bone marrow transplantations are broadly recognized as a treatment option for patients suffering from blood cancer, such as leukemia and lymphoma. Despite its promising results, the occurrence of life-threatening complications often compromises the outcome of patients undergoing transplantation.

The team of Dr. Mielke and Dr. Barrett aims to significantly improve the outcome of bone-marrow transplantation procedures for blood cancer patients. The investigators selected ATIR for a clinical study after a pre-clinical research program (Mielke et al. 2006). The new study by NIH focuses on improving donor transplantation procedures and complements the ongoing clinical trials with ATIR at the University of Perugia in Italy and Maisonneuve-Rosemount Hospital in Montreal, Canada.

According to Dr. Barrett of NHLBI: “Our study focuses on the development of transplant approaches that can significantly improve the outcome for patients by minimizing graft-versus-host disease (GVHD) and non-relapse mortality, and increase anti-leukemic effects. The clinical protocol has been designed to evaluate the safety and efficacy of ATIR as an improved selective depletion procedure in HLA-matched transplants.”

About NIH
The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

(Mielke et al. 2006) Mielke,S., Nunes,R., Rezvani,K., Fellowes,V.S., Fan,Y., Solomon,S.R., Scotto,C., Read,E.J. & Barrett,A.J. (2006). High Efficiency Clinical Scale Selective Depletion of Alloreacting T Cells Using Expanded T Lymphocytes as Antigen-Presenting Cells and a TH9402-Based Photodepletion Technique in HLA-Mismatched and Matched Donor-Recipient Pairs.  ASH Annual Meeting Abstracts, 108, 721.