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 Kiadis Pharma
Kiadis Pharma is an oncology focused pharmaceutical company with four
products in different phases of clinical development. The company develops
products that offer new treatment options for terminally ill cancer
patients and aim to address significant unmet medical needs. Key areas for
Kiadis Pharma are clinical indications in blood cancers and solid tumors.
Kiadis Pharma is headquartered in the Netherlands with facilities in
Groningen, the Netherlands and Montreal, Canada. For more information about
Kiadis Pharma, please visit kiadis
For more information on ATIR: kiadis/ATIR
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 nih.
(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.
Kiadis Pharma B.V.
kiadis/ATIR