Tumor lysis syndrome is a severe and relatively common complication which occurs during chemotherapy in subjects with leukemia and lymphoma. It is characterized by the onset of rapid and serious hyperuricemia and electrolyte imbalance which can, in turn, lead to renal failure and cardiac and neurological disorders with possibly fatal consequences.
"In the Florence trial, Febuxustat faces a double challenge: the prevention of hyperuricemia and kidney damage," said Michele Spina, International Coordinator of the Florence Trial and Co-Director of the Division of Medical Oncology at the National Cancer Institute in Aviano. "The current paradox facing hematologists the treatment of leukemia and lymphoma is that there are effective chemotherapies that can cure but there are no adequate support therapies that protect from the damages of the chemotherapy itself. Studies like this are more than welcome and are no less important in the research of innovative anti-tumor therapies."
Italy heads the study with 10 centers of excellence for the treatment of hematologic malignancies, initiating the enrollment phase of its first patients. "For Menarini and ts researchers, the investigator meeting is the occasion to lay the foundation stone for the study's initiation. Our clinical trial will serve as ambassador of the name "Florence" throughout the world given that it will take place in 12 countries of the European Union and Eastern Europe, also including the Russian Federation and Brazil, and will involve the participation of over 300 patients with lymphoma and/or leukemia," said Dr. Carlo Alberto Maggi, Director of Research of the Menarini Group.
President of Confindustria Firenze, Simone Bettini commented: "Menarini's project is proof that Florence is a dynamic city full of professional know-how and this includes the pharmaceutical sector which represents excellence at the International level for its quality of applied research and continuous innovation. We are one of the three Italian poles of the pharmaceutical industry and the entire territory must focus even more on this sector that invests and creates wealth and employment in a highly specialized area. The sector contributes to the international positioning of Florence and we must be able to collaborate with it and increase its competitiveness."
About Menarini Group
The Menarini Group is the leading Italian pharmaceutical company in the world with a turnover of over €3 million, 17th in Europe and 34th in the world (IMS World Review 2011). It is present with its own products in over 100 countries in Europe, Asia, Africa, Australia and Latin America with a total employee count of over 15,000. Menarini was established 125 years ago and today is present in most major therapeutic areas with particular focus on products in the respiratory, cardiovascular, gastroenterology, and oncology fields, products for the metabolism, antibiotics, drugs used in diabetes treatment, and anti-inflammatory/analgesic agents. Menarini has always pursued two strategic objectives: research and internationalization. Both have given the company excellent results on the world market making it thus possible to invest in the research of innovative drugs for patients all over the world.