2013-01-28 12:30:44 -
Pancreatic islet transplantation has shown short-term efficacy with some evidence of long-term efficacy, as well as a satisfactory safety profile, according to the Guidance issued by NICE (National Institute for Health and Clinical Excellence), the UK medicines regulator. The National Specialised Commissioning Team (NSCT) formerly National Commissioning Group (NCG) has approved reimbursement for this procedure as a treatment option for type 1 diabetes patients experiencing hypoglycemic episodes that occur without warning and cannot be managed with current treatments. Type 1 diabetes is a disease affecting some 20 million people worldwide. In Europe only the strict UK regulator and Swiss health authorities have approved NHS reimbursement for this procedure that in the future may get even more space as a treatment
option in patients with type 1 diabetes thanks to Reparixin. Developed by Dompé, one of Italy’s leading biopharmaceutical companies, Reparixin has shown to improve transplantation efficiency.
“Over the last 15 years, transplantation of pancreatic islet cells from donors into patients with severe type 1 diabetes, has moved from a relatively rare experimental procedure, to a more commonplace successful clinical treatment” - said Paul Johnson, Director of the Oxford Islet Transplant Programme. “Current data show, for example, that every year 15-25 of these transplants are performed in the United Kingdom, about 20 in Italy, c. 10 in France and Germany. However, despite considerable success worldwide, in most countries islet transplantation remains funded through research grants. In the UK, this procedure is now fully funded by the National Health Service (NHS) and is free for any patient who meets the inclusion criteria. It is therefore, really important that islet transplantation can be offered as a fully reimbursed life-saving treatment for patients throughout Europe and other parts of the world.”
The new frontier of research for a cure for type 1 diabetes has been the focus of attention of experts from all over the world at the Symposium titled “Current issues in pancreas/islet transplantation” held as part of the AIDPIT/EPITA Winter Symposium in Innsbruck (Austria).
Reparixin is a potent selective inhibitor of interleukin-8, a chemokine that plays a key role in the inflammatory response involved in the reduced efficacy of pancreatic islet transplantation. Reparixin was developed to specifically inhibit inflammation, preserve implanted cells function and hence improve the efficiency of the procedure. A recently launched randomized double-blind multicenter Phase III clinical trial is underway in 8 centres of 5 countries in Europe and the United States enrolling some 50 patients, i.e., about half the total number of patients undergoing this innovative treatment procedure every year. The study is designed to assess the efficacy of Reparixin in improving the efficiency of pancreatic islet transplantation, protecting transplanted cells function and graft survival as well as increasing the number of patients achieving insulin independence.
“The pharmaceutical industry has taken up the challenge of doing research in ‘hot fields’ and is committed to investing in areas where small patient populations have tremendous treatment needs” - said Eugenio Aringhieri, CEO, Dompé Group. “For this virtuous process to continue it is paramount to have a regulatory environment that warrants proper assessment as well as clear, consistent access rules. This has long been advocated but is now an absolute priority as this is the only way to truly respond to the treatment needs of patients.”
The role of pancreatic islet transplantation has emerged clearly during the Symposium in which some of the world’s leading experts in the field have participated. While the benefits for patients and national healthcare systems are apparent, at present the use of this procedure is still limited due to both the small number of centres where it can be performed and various factors involved in the progressive decline in transplanted pancreatic islet function. The inflammatory response that patients develop in the days following cell infusion, which is done by a simple injection into the portal vein, reduces cell function by 50 percent in the first week, with obvious repercussions on the ultimate efficacy of the procedure.
“My efforts as a scientist have always been focused on developing treatment approaches for diabetes prevention and cure. In particular, I have contributed to the experimental and clinical progress of pancreatic islet transplantation, a procedure that I am certain can become a true alternative to organ transplantation” – said Prof. Camillo Ricordi, Director of the Diabetes Research Institute, Miami, one of the world’s top diabetes experts. “Results shown so far by Reparixin confirm that targeted anti-inflammatory treatment can give a crucial contribution not only to prevent transplant rejection, but also to the establishment of pancreatic islet transplantation as a fully-fledged procedure. We hope that its treatment potential be confirmed so that the results of this technique can be optimised but especially significantly improve patients’ quality of life and at the same time reduce the risk associated with protracted immunosuppression that today is necessary for these patients.”
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