MELBOURNE, Australia, Oct. 4 /PRNewswire-FirstCall/ -- Phosphagenics Limited 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 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 www.phosphagenics.com
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, CERELAC, BOOST, NUTREN, PEPTAMEN, RESOURCE, OPTIFAST, POWERBAR, MUSASHI and JENNY CRAIG. More information at: www.nestlenutrition.com.
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.
CONTACT: Harry Rosen, President and CEO, +61-3-9605-5900, or Mary Bennett,
Investor Relations Manager, +61-3-9605-5907, both of Phosphagenics Limited;
or U.S. Investor and Media, Brian Ritchie of FD, +1-212-850-5683, for
Phosphagenics
Web site: http://www.phosphagenics.com/
http://www.nestlenutrition.com//
