News

Kiadis Pharma receives IND approval from FDA to start pivotal clinical trial with ATIR™ 08-07-2010
Biopharmaceutical Company Kiadis Pharma announced today that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start the pivotal clinical study for its product ATIR™ in the United States. Kiadis Pharma is currently... read more 

Kiadis Pharma Provides ATIR™ Update: Two Year Follow-Up Data Show No Cases of Transplant Related Mortality - FDA grants ATIR™ Orphan Drug Status as a Medicinal Cell Based Therapy to Reduce Transplant Related Mortality 28-04-2010
Kiadis Pharma today provided an update on its cell therapy product ATIR™ developed for mismatched bone marrow transplants. ATIR™ continues to show excellent clinical results in patients who received a mismatched bone marrow transplantation from a family member donor. The two year follow up data... read more 

Kiadis Pharma announces collaboration with the Julius Maximilians University of Würzburg, Germany. Dr. Mielke continues his collaboration with Kiadis Pharma on ATIR™

Biopharmaceutical company Kiadis Pharma announces today the clinical development collaboration for its lead product ATIR™ with Dr. Stephan Mielke and Professor Dr. Hermann Einsele from the Allogeneic Stem Cell Transplant Center, Division of Hematology and Oncology, Department of Internal Medicine II at the Julius-Maximilians University of Würzburg, Germany.  Principal investigator of this collaboration will be Dr. Mielke.

Previously, Dr. Mielke initiated the ongoing phase II clinical study for ATIR™ as principal investigator at the Hematology Branch of the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH) in Bethesda, Maryland, USA, together with Dr. John Barrett, Chief of the Allogeneic Stem Cell Transplant Section at the Hematology Branch.  The investigators selected ATIR™ for a clinical study after a pre-clinical research program and have published the pre-clinical data showing promising results with Kiadis Pharma’s ATIR™ in eliminating alloreactive T-cells from donor grafts (Mielke et al. Blood 2008).  Dr. Mielke and colleagues additionally developed a reliable large scale manufacturing protocol with a “GMP-like” semi-closed system for cell processing with ATIR™.

 

“We are extremely pleased with this collaboration which shows the interest of leading transplantation physicians to continue working with our lead product ATIR™ as well as to participate in setting up our next clinical study in Europe” says Dr. Manja Bouman, CEO of Kiadis Pharma.

 

According to Dr. Mielke selective allodepletion with ATIR™ carries significant potential for improving the outcome of mismatched (haploidentical) transplants by allowing early immune reconstitution with less severe or no acute Graft versus Host Disease (GvHD).  Therefore, Dr. Mielke and his team and Kiadis Pharma are planning to initiate a clinical phase III study for mismatched (haploidentical) transplantations in blood cancer patients at the Julius-Maximilians University of Würzburg.

 

About ATIR™
ATIR™ is designed to prevent life-threatening acute GvHD by eliminating the immune cells from the donor graft that otherwise attack the patient’s body. Useful donor immune cells that can fight infections and remaining tumor cells are, however, spared, allowing rapid and safe donor immune reconstitution post transplantation.  Acute GvHD is a major complication of allogeneic bone marrow transplantations.  By preventing the occurrence of acute GvHD, ATIR™ enables the use of a mismatched donor and consequently addresses a significant limitation in bone marrow transplantations, which is the timely availability of a donor.  Moreover, it could improve the general outcome of bone marrow transplants.

 

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