LONDON, 4th February 2010. Fostrap, CM&D Pharma Limited's new product designed to benefit patients with hyperphosphatemia (abnormally high levels of phosphates in the blood), is being tested in two pivotal clinical trials prior to launch. Over 180 patients with advanced Chronic Kidney Disease (CKD) are being actively recruited across two randomised, double-blind, placebo-controlled studies in the USA and Japan.
The Fostrap study in the USA is being led by Dr Geoffrey A. Block, MD, Associate Clinical Professor at the University of Colorado, and Director of the Denver Nephrologists group. In this trial 90 patients receiving haemodialysis (HD) and 30 diagnosed with CKD will be recruited. Further details on this study can be seen by clicking here.
Medical Advisors to the Japan study are Dr Tadao Akizawa, MD, Professor at the Showa University School of Medicine, Tokyo, and Dr Masafumi Fukagawa, MD, Professor at the Tokai University School of Medicine, Tokyo. Sixty-four HD patients are being recruited in this multicentre trial, which is designed to confirm and extend the results from the pilot Fostrap study published in the Journal of the American Society of Nephrology (J Am So Nephrol 20:639-644, 2009). Further details on this study can be found by clicking here.
CM&D Pharma Research and Development Director Dr Cristina Comelli said:
"These pivotal studies, both led by world authorities in the treatment of hyperphosphatemia, will provide the clinical community and patients with important information about our innovative product, Fostrap. In both trials Fostrap treatment is adjunctive to existing therapy, to show that greater control over the patients' illness can be achieved with the addition of our chitosan-loaded chewing gum. We expect the results to be available within 2010."
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About Fostrap:
Fostrap treats hyperphosphatemia by binding to phosphorus in the saliva, thus reducing the total phosphate load in the gastrointestinal (GI) tract. Fostrap chewing gum does not release either the chitosan, or the chitosan-phosphorus complex, into the GI tract and thus does not interfere with the absorption of any other medications. Fostrap is presented as a pleasant-tasting chewing gum.
About CM&D:
CM&D Pharma Limited is a European niche specialty company founded in 2007 by Danilo Casadei Massari, which plans to become one of the few pan-European pharmaceutical companies with its own commercial organisation targeting specialists in the five major European markets (France, Germany, Italy, Spain and the UK). It is developing its own niche products and technology platform in-house.
Contact:
Stephen Appelbee, CEO: +44 20 7259 8488
appelbee@cmdpharmaltd.com
www.cmdpharmaltd.com
