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26 February 2009: New study shows Fostrap helps treat high phosphate levels in kidney disease patients
Chertsey, UK (26 February, 2009) — A new study published in the Journal of the American Society of Nephrology shows that Fostrap™ chewing gum can help treat high phosphate levels in chronic kidney disease (CKD) patients receiving dialysis. The results show that the addition of Fostrap to current medical therapy significantly reduced salivary and serum phosphate levels and may have the potential to prevent cardiovascular disease in these patients.
High levels of phosphate (hyperphosphatemia) commonly occur in CKD patients on dialysis and are regarded as a primary cause of calcium build up which in turn may lead to additional complications in the form of heart disease, bone disease and joint problems. Even when patients are on a restricted diet and take medications to reduce their hyperphosphatemia, about half of them cannot reduce phosphate to recommended levels. As many as 1.5 million patients are estimated to be undergoing haemodialysis today. [source: www.globaldialysis.com]
The authors concluded that adding Fostrap to traditional phosphate binders could be a useful approach for improving the treatment of high phosphate levels in haemodialysis patients.
“This is an exciting time for CM&D Pharma Ltd with Fostrap showing it could provide major benefits for patients suffering from kidney disease. This reinforces our philosophy of developing our own products for a worldwide market in areas of unmet need” commented Stephen Appelbee, CEO for CM&D
Fostrap is a phosphate (PO4) binder containing a muco-adhesive and food grade complex carbohydrate (chitosan). Available as a pleasant tasting gum, Fostrap works by inactivating phosphorus in the saliva, thus avoiding interactions with other medications which act through the gastrointestinal tract. It is currently being reviewed by the UK Food Standards Agency for approval for use as a Food for Special Medical Purposes, and CM&D hope to launch the product next year.
Other products being developed by CM&D Pharma Ltd include SilSOS™, a nasal decongestant containing a novel anti-infective, Eviendep™ for the prevention of recurrence of intestinal polyps and Recoclix™ for the reduction of pelvic pain resulting from Irritable Bowel Syndrome and Inflammatory Bowel Disease.
CM&D Pharma Limited is a European specialty company founded by Danilo Casadei Massari in 2007. The company’s philosophy is to develop proprietary medicines for marketing through subsidiaries in the five major European markets (France, Germany, Italy, Spain and the UK), whilst outlicensing them in other countries worldwide. The Company’s recent acquisition of Biohealth Italia srl in Italy is the first of five planned over the next two years.
About the study
Researchers tested whether there might be a benefit to binding salivary phosphate during periods of fasting, in addition to using a phosphorus-restricted diet and phosphate binders with meals. Vincenzo Savica, MD, of the University of Messina, and Lorenzo A. Calò MD, PhD, of the University of Padova, Italy and their colleagues recruited 13 dialysis patients with high blood phosphate levels to chew 20 mg of phosphate-binding chewing gum twice daily for two weeks between meals, in addition to their prescribed phosphate-binding regimen.
Dr. Savica and Dr. Calò’s team found that salivary phosphate and blood phosphate levels significantly decreased during the first week of chewing, and by the end of two weeks, salivary phosphate
decreased 55% and blood phosphate decreased 31% from levels measured at the start of the study. Salivary phosphate returned to its original level by day 15 after discontinuing the chewing gum, whereas blood phosphate took 30 days to return to its original value.
About hyperphosphataemia
Hyperphosphataemia is a common medical condition that occurs in patients whose kidneys are undergoing failure. Patients have unusually high levels of a chemical called phosphate in their blood and this can lead to heart disease, bone disease and joint problems. It occurs particularly in patients who are receiving dialysis.
About the market
The worldwide market for the leading phosphate binders is currently estimated to be about $ 800 million and steadily growing.
For further information please contact:
Stephen Appelbee, CEO, CM&D Pharma:
Tel: +44 1932 796083
E mail: appelbee@cmdpharmaltd.com,
Fostrap™, SilSOS™, Eviendep™ and Recoclix™ are trademarks of CM&D Pharma Limite
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