MIAMI, Oct. 24, 2011 /PRNewswire/ -- In a study to be presented at the CTS-IXA Congress today, Lorenzo Piemonti, M.D., the director of the islet transplantation program at the San Raffaele Diabetes Research Institute of Milan, will show Phase II clinical data that supports the development of Reparixin for use in pancreatic islet transplantation experimental procedure as an alternative to pancreas transplant in patients with advanced stages of Type 1 diabetes who develop a resistance to insulin.
These patients often face frequent hypo- and hyper-glycemic crisis with the risk of serious consequences, particularly to the kidneys. In such cases, pancreas transplant has been the standard procedure, but recently, due to efforts of the transnational scientific community, pancreatic islet transplantation has progressively been affirmed as a potential alternative procedure and new frontier in the treatment of Type 1 diabetes.
"I have always believed that a targeted anti-inflammatory therapy could represent a real contribution to the full affirmation of pancreatic islet transplantation, and I have strongly supported the clinical development of Reparixin," explains Dr. Piemonti, the principal investigator of the Reparixin molecule clinical trial.
Reparixin is a potent and selective inhibitor of chemokine interleukin-8 identified in Dompe's Italian labs. It has been developed with the objective of specifically inhibiting inflammatory response, therefore preserving islet functionality and consequently contributing to the improvement of the efficacy of pancreatic islet transplantation.
Each year, there are 16 new cases of Type 1 diabetes diagnosed per 100,000 children under the age of 16. This amounts to nearly 480,000 patients globally. Type 1 diabetes affects children, adolescents and adults on a global scale.
The pathology of Type 1 diabetes, contrary to that of Type 2 diabetes, originates from an immunologic disorder that leads the body to produce antibodies that attack pancreatic beta cells responsible for the production of insulin. This immune system "error" determines the patient's life-long dependency on insulin.
Pancreatic islets are cells of the pancreas which are responsible for the production of insulin cells which are progressively damaged throughout the course of juvenile diabetes. The nature of these cells is that they can maintain their functionality even when transplanted in organs other than the pancreas.
About the Study
In the transplant procedure the islets were infused in the patient's liver via a simple procedure of infusion of islets which, once implanted, demonstrated control over glycemia. The advantages of such a procedure have been offset by various factors which, starting from the cell isolation, have progressively limited the functionality of the implanted cells. The inflammatory response developed in patients days after the islets infusion has a dramatic influence on the survival of the islets themselves, reducing the functionality by 50 percent in the first 7 days.
Insight from Diabetes Researchers
"The encouraging results of such a study represent an important confirmation and open encouraging possibilities for the consolidation of the islet transplant procedure," said Dr. Piemonti. "The development of a specific anti-inflammatory therapy can further represent potential for the development of a therapy able to prevent the destruction of insulin producing cells by the immune system in the onset of juvenile diabetes. As a matter of fact, at the onset of Type 1 diabetes, the inflammatory response is directed toward pancreatic islets, which play a key role in the keeping of the autoimmune response and therefore in the onset of the pathology."
"My scientific efforts have always been focused on the development of therapies for the cure and the prevention of diabetes, and I have personally contributed to the experimental and clinical progress of the islet transplantation, fully convinced that such procedure represents a concrete and valid alternative to organ transplant," states Professor Camillo Ricordi, director of the Diabetes Research Institute and Cell Transplant Center at the University of Miami, and one of the world's leading scientists on techniques of isolation and pancreatic islet transplantation.
"I have closely and carefully followed Lorenzo Piemonti's studies on Dompe's molecule since its first phases, and current study results reinforce my conviction about Reparixin's potential for the optimization of clinical results in pancreatic islet transplantation," continues Ricordi. "Moreover, I have always believed in the determinant role of the inflammation, not only concerning transplant rejection but also in the onset and development of Type 1 diabetes. Generally speaking, Reparixin has affirmed my belief in the necessity of a synergy between public and private research to provide patients with innovative treatments in areas with high therapeutic need."
For more information on Reparixin and related research, please visit www.dompe.com.
Dompe is one of Italy's leading biopharmaceutical companies, with a solid history of developing innovative drugs for illnesses of high social impact. It pursues this mission by supporting and actively participating in a high-caliber network that covers the entire pharmaceutical pipeline, from research & development through production and distribution. The production site is run according to the highest quality and technological standards in the industry, developing drugs that are sold in more than 60 countries worldwide.
SOURCE Dompe farmaceutici