Nestle Nutrition and Phosphagenics to Commence Phospha E(R) Phase 2 Clinical Trial

Oct 04, 2007, 01:00 ET from Phosphagenics Limited

    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
     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 of proven pharmaceutical
 and nutraceutical products. The Company's core technology is built around
 the science and application of phosphorylation, a process where the
 addition of a phosphate group has been found to enhance the
 bioavailability, activity and safety of existing pharmaceuticals and
 nutraceuticals, as well as to assist in the production of drug delivery
 platforms. Phosphagenics' shares are listed on the Australian Stock
 Exchange (POH) and the London Stock Exchange's Alternative Investment
 Market (PSG). In March 2006, an ADR - Level 1 program was established in
 the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to
 trade in Phosphagenics' stock on the 'over-the-counter' market. This has
 now been upgraded to the International OTCQX, a new premium market tier in
 the US for international exchange-listed companies, operated by Pink
 Sheets, LLC.
     For more information and to view the clinical trial results in full,
 please visit Phosphagenics' web site at
     About Nestle Nutrition
     Nestle Nutrition is an autonomous business within the Nestle group
 managing and developing the group's specialty nutrition brands. Through
 science-based nutrition products and services, Nestle Nutrition helps
 enhance the quality of people's lives by supporting health and providing
 care for specific consumer groups with special nutrition needs at every
 stage of life.
     About 22,000 employees in more than 70 markets are part of Nestle
 Nutrition. Its product portfolio - covering infant nutrition, healthcare
 nutrition, performance nutrition and weight management - includes such
 trusted and well-recognized brands as: NAN, GERBER, LACTOGEN, NESLAC,

SOURCE, OPTIFAST, POWERBAR, MUSASHI and JENNY CRAIG. More information at: About the Phosphagenics / Nestle Pre-Clinical Studies The final results of the two pre-clinical dose response trials announced to the market on December 14th, 2006, confirmed that when given orally, Phospha E(R) significantly reduced many of the key biomarkers associated with metabolic syndrome, inflammation and cardiovascular disease. Additionally, the most appropriate dosage required to commence human clinical trials was also determined. In these trials, animals treated with varying doses of Phospha E were shown to have statistically significant reductions in key parameters such as plaque formation, aortic vascular dysfunction, cholesterol, triglycerides and LDL-C (so called bad cholesterol). About Metabolic Syndrome Metabolic syndrome is characterized by a group of metabolic risk factors - abdominal obesity and elevated blood pressure, cholesterol, triglycerides and blood glucose. The root causes of metabolic syndrome are overweight/obesity, physical inactivity, and genetic factors. It is estimated that about 27% of adults in the US have metabolic syndrome and that one in three overweight or obese people in the US have this condition. The condition is being diagnosed with increasing frequency. About Phospha E(R) Phospha E(R) is a patented derivative of vitamin E that has superior properties compared to its parent molecule. For example, Phospha E has been shown to be better absorbed than vitamin E, both orally and through the skin, to lower cholesterol and triglycerides, prevent the formation of plaque in heart arteries, as well as having unique anti-inflammatory properties. Phospha E has applications across all three nutraceutical market segments, and is currently sold internationally as a dietary supplement by NBTY Inc. (under the name of Ester-E(TM)) and is marketed worldwide in the personal care market as Vital ET(TM) by ISP Corporation. Safe Harbor Statement This press release contains forward-looking statements based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from the Phosphagenics' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations.

SOURCE Phosphagenics Limited