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MELBOURNE, Australia, Oct. 4 /PRNewswire-FirstCall/ -- Phosphagenics Limited (ASX: POH, AIM: PSG, OTCQX: PPGNY) and Nestle Nutrition (Nestle) today announced that they will jointly commence a phase 2 human clinical trial in Australia to establish the efficacy of Phosphagenics' Phospha E(R) in the management of metabolic syndrome.
Ethics approval has been obtained to conduct the double-blind phase 2 clinical trial, which will commence shortly.
Metabolic syndrome is characterized by a group of risk factors that increase the risk of diabetes, coronary heart disease and other diseases associated with plaque build up in artery walls, such as stroke. The American Heart Association estimates that 47 million U.S. residents have metabolic syndrome.
Dr. Esra Ogru, Executive Vice President Research & Development at Phosphagenics, said: "It is very rewarding to see Phospha E progress down the clinical trial path after years of pre-clinical testing. We have reached a very exciting stage of the development of this product and are delighted to be aligned with the world's largest nutrition company as our partner."
Nestle will fund the phase 2 clinical trials and will be granted a worldwide exclusive license for the use of Phospha E in medical foods, while Phosphagenics will manufacture and supply Phospha E to Nestle. The final commercial arrangements are expected to be completed by the end of this year.
This new collaboration builds upon two pre-clinical dose response trials performed by Nestle and Phosphagenics in 2006. The results of these trials confirmed that, when given orally, Phospha E significantly reduced many of the key biomarkers associated with metabolic syndrome, inflammation and cardiovascular disease.
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology
company focused on the discovery of new and cost effective ways to enhance
the bioavailability, activity, safety and delivery o
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