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Organ Transplantation

How transplants save lives

Almost sixty years have passed since the first successful kidney transplant. It was 1954, and the procedure was performed at Boston’s Peter Bent Brigham Hospital on a pair of monochorial twins, one the donor and the other the receiver. The operation was successful precisely because the girls were genetically identical, and this prevented rejection. Since then, the science of organ replacement has advanced tremendously, also but not only because the number of potentially transplantable organs has greatly increased. Immunology, the science that studies tissue compatibility issues, has allowed a better understanding of the invisible differences that exist between one human being and another, and anti-rejection drugs have been considerably improved, with the serious side effects that initially limited their use now significantly reduced. Today, organ transplantation is no longer a simple surgical procedure that allows patients to gain years of life, but can be considered an actual treatment for many diseases that would force them to be dependent on a machine (like renal insufficiency) or lead to death (as in the case of serious forms of liver cirrhosis).

With a view to improving the results of this therapeutic approach, Dompé focuses its Research & Development activities on two specific areas: liver transplantation and pancreatic islet transplantation.

 

Liver transplantation

Approximately 13,000 liver transplants are performed worldwide every year, one thousand of which in Italy1. Most of these transplants are from deceased donors, but the possibility for live donors of donating part of the liver is progressively growing all over the world. There is still room for further improving the outcome of this procedure, particularly with regard to the inflammatory reaction that typically develops in the early stages immediately following organ replacement, and the consequent risk of early rejection of the transplanted organ.

 

Dompé’s research efforts to improve the outcome of liver transplantation

Dompé has recently signed a partnership agreement with SatRX, a Russian company that specializes in the development of innovative drugs for organ transplant and for the treatment of metabolic diseases like diabetes and obesity. The partnership focuses on the clinical development of Reparixin, an innovative product resulting from Dompé research. The goal is to improve the efficacy of liver transplantation, reducing the probability of rejection of the transplanted organ.

The alliance between the two companies aims to conduct phase II and III clinical trials with the drug, in order to obtain its registration and marketing authorisation in several regions. Reparixin acts on the body’s immune response to reduce the initial inflammatory reaction, which increases the probability of short-term rejection of the transplanted organ and affects its function. The drug’s development for this indication requires the conduct of a Phase II/III, multicentre, open label, randomized study to evaluate the efficacy and safety of Reparixin for the prevention of early rejection in patients who received donor livers and standard immunosuppressive therapy. The study will enrol 35 patients identified at 7 specialised Russian clinical centres.

 

Pancreatic islet transplantation

In the adopted approach, autologous or donor pancreatic islets are infused into the patient’s liver. The end goal is to discontinue insulin treatment. The procedure consists firstly of collecting pancreatic islets; this is followed by their infusion and the formation of units “specialised” in the production of insulin once transplanted into the liver. The outcome, however, can be compromised by the inflammatory reaction that develops immediately after transplantation; this reaction is particularly intense in donor transplants, but is also significant in the case of auto-transplantation.

 

Dompé’s research efforts to improve the outcome of pancreatic islet transplantation

Dompé is developing Reparixin, a new molecule resulting from Dompé research, which will help to improve the long-term outcome of the procedure thanks to its unique mechanism of action. The molecule acts on the body’s immune response, which can affect the pancreatic islets’ function. Reparixin is currently at an advanced clinical development stage for donor transplants in several European countries. Additionally, a clinical trial has been started in the United States to evaluate the role of Reparixin in improving the outcome of autologous pancreatic islet transplantation.

 

Note

1 Sources: http://www.liver-products.com/liver-therapy/liver-transplantation.html per il dato internazionale (consultato in data 15/01/2014), Centro nazionale trapianti per il dato italiano (31 ottobre 2013)