AMP.L Regulatory News (AMP)

11 Apr 2007 11:31

Amphion Innovations PLC11 April 2007 Amphion Innovations plc Partner Company WellGen Completes Human Study Paving Way for Nutrigenomics to Play Important Role in Mainstream Product Development 11 April 2007 - Amphion Innovations plc (LSE: AMP), a developer of companies inlife sciences and technology, today announces that one of its Partner Companies,WellGen, Inc., has announced that it has completed a pivotal study demonstratingthat its nutrigenomics technology platform can successfully predict biologicalactivity of natural products in humans. WellGen is a biotechnology company thatuses nutrigenomics to discover and develop proprietary functional foodingredients. Amphion's fully-diluted ownership stake in WellGen was 17.39% as of31 December 2006. Using a proprietary ingredient standardized for certain theaflavins in blacktea, WellGen's study has proven that the ingredient's inflammation-fightingproperties can be identified and quantified by the company's technology suchthat the findings can be effectively and efficiently translated to consumerapplications. WellGen's proprietary ingredient, WG0401, provided protection to healthyvolunteers who were given a potent inflammatory challenge. Healthy volunteerstreated with the WellGen extract had inflammatory biomarker levels rangingbetween two-to-six fold less than the placebo group when challenged with aninflammation-inducing bacterial lipopolysaccharide. This recently completed double-blind randomized human study has confirmed thatthe WellGen approach of using cell cultures containing specifically targetedgenes is highly predictive in determining that a plant or food extract canpositively affect the same gene expression profile in humans. WellGen'sproprietary ingredient, WG0401, delivered consistent activity againstinflammation across the entire WellGen discovery and development process, whichincludes cell based assays, animal testing, and human inflammatory biomarkerstudies. Inflammation plays an important role in many health states and islinked to such health concerns as arthritis, cardiovascular disease, cancer, andtype II diabetes. Study Leads to Additional Structure-Function Claims for Supporting Immune SystemDefense In addition to the potent anti-inflammatory benefits already known for theingredient, the human study of WG0401 demonstrated immune system defensesupport. Based on the analysis of the biomarkers used in the studies, WellGen,Inc. discovered that its WG0401 enhances the response of the immune system to abacterial challenge. Thus these results indicate that WG0401 can be beneficialin immunoregulation. WG0401, a food ingredient that is derived from black teaand is characterized by an enriched theaflavin content, will be availablecommercially this year. WellGen's inflammation program, its first research initiative, was set up todevelop proprietary ingredients with meaningful benefits for functional foodapplications. WellGen is also in late stage development of a model to prove thesame lab-to-man paradigm with a program focused on developing proprietaryingredients for foods that can affect the genes involved in adipocyte (fat cell)development. The objective is to discover functional food ingredients that willcombat obesity. WellGen has employed a process that includes gene expressionanalysis, cell based assays, animal studies and ex vivo human studies toidentify potential candidates that will interfere with fat cell development.The lead ingredient in this program has successfully completed that process andwill enter a human biomarker study in the third quarter of 2007. WellGen is committed to developing proprietary ingredients called "therapeuticnutrition ingredients" using its patented nutrigenomic screening process and itsproprietary research models for validating health benefits in humans. As a proof of efficacy in humans, WellGen uses quantitation of biomarkers ofinflammation to demonstrate the biological activity of its proprietaryingredients that have shown positive results in laboratory and animal tests.WellGen uses relevant and quantifiable biomarkers to streamline an ingredient'sevaluation in humans by reducing the duration of human trials and obtainingobjective data. Examples of validated biomarkers include glucose levels asrelated to diabetes or cholesterol levels related to heart health/cardiovascularrisk. Dr. Kathleen P. Mullinix, WellGen CEO, said: "The fundamental principle of nutrigenomics is that food ingredients can controlthe expression of genes that determine human wellness or disease. Our study hasshown that WellGen's methodology is valid for discovering natural substancesthat can positively affect human health through gene expression. This is a bigstep for WellGen and a major step for bringing nutrigenomics into mainstreamproduct development in the food and beverage industry. We have completed theloop that validates WellGen's discovery process, and now we are moving towardcommercializing our first functional ingredient for food applications." WellGenPatricia Lucas-Schnarre732-214-8834 ext. 319 Amphion Innovations plcJosh Berkman646 747-7158 Financial DynamicsBen AtwellJohn Gilbert44 207 269 7169 About WellGen WellGen, Inc., based in New Brunswick, NJ, is a biotechnology company that isdiscovering and developing products for food, therapeutics, and dietarysupplement markets. WellGen's technical platform is a method of screening theeffect of food and related substances on the expression of genes associated withhuman health conditions. The company has developed proprietary substances thathelp reduce risk and severity for a variety of diseases. Please visit ourwebsite at www.wellgen.com for more information. About Amphion Innovations plc Amphion Innovations plc is listed on the AIM Exchange in London under the symbolAMP. Amphion's business is the formation, financing, management and developmentof life sciences and technology companies, working in partnership withcorporations, governments, universities and entrepreneurs seeking tocommercialize their intellectual property. This information is provided by RNS The company news service from the London Stock Exchange