WellGen, Inc., New Brunswick, NJ, has completed a pivotal study demonstrating that its nutrigenomics technology platform can successfully predict biological activity of natural products in humans. WellGen is a biotechnology company that uses nutrigenomics to discover and develop proprietary functional food ingredients.

“The fundamental principle of nutrigenomics is that food ingredients can control the expression of genes that determine human wellness or disease,” said Dr. Kathleen P. Mullinix, WellGen CEO. “Our study has shown that WellGen’s methodology is valid for discovering natural substances that can positively affect human health through gene expression.”

Using a proprietary ingredient standardized for certain theaflavins in black tea, WellGen’s study has proven that the ingredient’s inflammation-fighting properties can be identified and quantified by the company’s technology such that the findings can be effectively and efficiently translated to consumer applications.

“This is a big step for WellGen and a major step for bringing nutrigenomics into mainstream product development in the food and beverage industry. We have completed the loop that validates WellGen’s discovery process, and now we are moving toward commercializing our first functional ingredient for food applications,” said Dr. Mullinix.

This recently completed double-blind randomized human study has confirmed that the WellGen approach of using cell cultures containing specifically targeted genes is highly predictive in determining that a plant or food extract can positively affect the same gene expression profile in humans. WellGen’s proprietary ingredient, WG0401, delivered consistent activity against inflammation across the entire WellGen discovery and development process, which includes cell-based assays, animal testing and human inflammatory biomarker studies. Inflammation plays an important role in many health states and is linked to such health concerns as arthritis, cardiovascular disease, cancer, and type II diabetes.

WellGen’s proprietary ingredient, WG0401, provided protection to healthy volunteers who were given a potent inflammatory challenge. Healthy volunteers treated with the WellGen extract had inflammatory biomarker levels ranging between two- to six-fold less than the placebo group when challenged with an inflammation-inducing bacterial lipopolysaccharide.

As a proof of efficacy in humans, WellGen uses quantitation of biomarkers of inflammation to demonstrate the biological activity of its proprietary ingredients that have shown positive results in laboratory and animal tests. WellGen uses relevant and quantifiable biomarkers to streamline an ingredient’s evaluation in humans by reducing the duration of human trials and obtaining objective data. Examples of validated biomarkers include glucose levels as related to diabetes or cholesterol levels related to heart health/cardiovascular risk.

In addition to the potent anti-inflammatory benefits already known for the ingredient, the human study of WG0401 also demonstrated immune system defense support. 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 a bacterial challenge. Thus these results indicate that WG0401 can be beneficial in immunoregulation. WG0401, a food ingredient that is derived from black tea and is characterized by an enriched theaflavin content, will be available commercially this year.

WellGen’s inflammation program, its first research initiative, was set up to develop proprietary ingredients with meaningful benefits for functional food applications. WellGen is also in late stage development of a model to prove the same lab-to-man paradigm with a program focused on developing proprietary ingredients for foods that can affect the genes involved in adipocyte (fat cell) development. The objective is to discover functional food ingredients that will combat obesity. WellGen has employed a process that includes gene expression analysis, cell-based assays, animal studies and ex vivo human studies to identify potential candidates that will interfere with fat cell development. The lead ingredient in this program has successfully completed that process and will enter a human biomarker study in the third quarter of 2007.

WellGen is committed to developing proprietary ingredients called “therapeutic nutrition ingredients” using its patented nutrigenomic screening process and its proprietary research models for validating health benefits in humans.