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 

Promising clinical data from Kiadis Pharma’s lead product ATIR™ presented by NIH investigators

Biopharmaceutical company Kiadis Pharma announces the presentation of results obtained so far in a physician initiated clinical study for ATIR™ led by Dr. Stephan Mielke* and Dr. John Barrett* of the National Heart, Lung, and Blood Institute (NHLBI) a department of the National Institutes of Health (NIH) at the 34th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) held from 30th March to 2nd April 2008 in Florence, Italy. 

 

At the EBMT meeting in Florence Dr. Mielke will present results of the ongoing phase II clinical trial of ATIR™ in matched allogeneic transplantations that is running at the NIH under an FDA approved IND. Thus far the results are promising, with no acute GVHD observed in the patients treated and early immune reconstitution. 

 

The investigators from the NIH, Dr. Barrett and Dr. Mielke have recently published data showing the selective elimination of alloreactive T cells from donor grafts by Kiadis Pharma’s lead product ATIR (Mielke et al. Blood, 2007).

 

About ATIR™
Kiadis Pharma is developing ATIR™ for the prevention of acute GvHD and early immune reconstitution following an allogeneic bone marrow transplantation using mismatched donors.  ATIR™ selectively eliminates immune cells that could otherwise attack the patient’s body after an allogeneic bone marrow transplantation and cause acute GvHD.  Because the risk for acute GvHD is eliminated no immune suppressants have to be used post transplantation allowing early immune reconstitution in these patients reducing risk of opportunistic infections.  Eliminating the risk for acute GvHD and early immune reconstitution can improve the outcome of current allogeneic transplantations and, moreover, allows the use of a mismatched donor enabling virtually all eligible patients to find a donor. Kiadis Pharma’s ATIR™ product is under evaluation in two “mismatched donor” trials. The clinical phase II study by the NIH has extended the use of ATIR™ in HLA-matched transplantations.

 

*Note
Dr John Barrett is the Chief of the Allotransplant Section at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) in Bethesda, MD, USA, where the trial is being performed. Dr Stephan Mielke, who initiated this study as principal investigator at the NHLBI, is currently working at the Julius-Maximilians University of Würzburg, Germany and continues as the lead associate investigator on the protocol.

 

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