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Phosphagenics completes Phospha-E® pre-clinical trials with Nestlé Nutrition
Studies verify the potential benefits of Phospha-E® in preventing and treating cardiovascular disease and metabolic syndrome
Key Points:
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Phosphagenics has completed the two pre-clinical studies undertaken as part of a Nestlé Nutrition research agreement to commercialise Phospha-E® for use in nutritional products.
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Phospha-E® significantly reduced the specific biomarkers associated with metabolic syndrome, inflammation and cardiovascular disease, consistent with the results from previous studies.
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The studies also determined the most appropriate dose of Phospha-E® required to treat metabolic syndrome and cardiovascular disease, allowing for the commencement of human clinical trials.
Phosphagenics Limited (“Phosphagenics”) (ASX: POH) (AIM: PSG) announced today that it had completed its Phospha-E® pre-clinical trial program with Nestlé Nutrition. This milestone has cleared the way for Nestlé Nutrition to decide whether it will exercise its option to further develop Phospha-E®.
The collaborative study, announced in April 2006, was part of an agreement made between Phosphagenics and Nestlé Nutrition to develop Phosphagenics’ patented vitamin E product, Phospha-E®, for use as a nutritional product in the prevention and treatment of metabolic syndrome.
The final results of the two pre-clinical multi-dose response trials confirmed that when given orally, Phospha-E® 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).
Dr Esra Ogru, Executive Director of Research and Development at Phosphagenics said: “These results further build on our findings from previous pre-clinical trials that Phospha-E® has the potential to reduce cardiovascular disease, and now allows us to commence human clinical trials.”
Harry Rosen, Managing Director of Phosphagenics added: "While we need to wait until Nestlé Nutrition decides whether to exercise its option, these findings are a very positive step towards the commercialisation of Phospha-E® in the specialised nutrition market. Phosphagenics is looking forward to continuing to work with Nestlé Nutrition, one of the world’s leading specialised nutrition companies.”
ENDS….
APPENDIX AND NOTES TO EDITORS
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.
Phosphagenics’ 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). An ADR – Level 1 program has been established in the US with the Bank of New York (PPGNY) for US investors to trade in Phosphagenics’ stock on the ‘over-the-counter’ market.
For more information, please visit Phosphagenics’ web site at
www.phosphagenics.com
About Nestlé Nutrition
Nestlé Nutrition is an autonomous business within Nestlé managing and developing the group's speciality nutrition brands. Through science-based nutrition products and services, Nestlé 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 14 600 employees in more than 100 countries are part of Nestlé Nutrition. Its product portfolio – covering infant nutrition, healthcare nutrition, performance nutrition and weight management – includes such trusted and well-recognised brands as: Nestlé (comprising product brands Nan, Lactogen, Neslac, Cerelac…), Nutren, Peptamen, PowerBar, Musashi and Jenny Craig. More information at: www.nestlenutrition.com.
About the Phosphagenics Ltd/ Nestlé Nutrition Research Agreement
Under the terms of the agreement, Nestlé Nutrition has been contributing funding towards two full dose-response pre-clinical studies in return for obtaining an option to exclusively license Phospha-E® for use as a nutritional product, targeting the prevention and treatment of metabolic syndrome. Given that the pre-clinical trials are now complete, Nestlé Nutrition has the opportunity to exercise this licence option upon payment of an option fee.
If Nestlé Nutrition exercises this option, the agreement requires that Nestlé Nutrition will launch within 12 months of regulatory approval a product with health claims for metabolic syndrome, and that Phosphagenics will be responsible for the manufacture of, and sale to, Nestlé Nutrition of Phospha-E®.
Phospha-E®
Phospha-E® 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 & 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 Zila Nutraceuticals Inc (under the name of Ester-ETM) and is marketed worldwide in the personal care market as Vital ETTM by ISP Corporation.
About metabolic syndrome
Metabolic syndrome is a multifactorial risk factor for cardiovascular disease and diabetes. 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.
Contact details:
Dr Esra Ogru
Phosphagenics Ltd
Executive Director Research & Development
+61 3 9605 5900 or +61 (0)402 080 846
Mr Harry Rosen
Phosphagenics Ltd
Managing Director
+61 3 9605 5900 or +61 (0)421 322 757 | 
