NEW BRUNSWICK, N.J., April 10 /PRNewswire/ -- WellGen, Inc. today
announced that it 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
Study Leads to Additional Structure-Function Claims for Supporting Immune
In addition to the potent anti-inflammatory benefits already known for the
ingredient, the human study of WG0401 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
WellGen, Inc., based in New Brunswick, NJ, is a biotechnology company that
is discovering and developing products for food, therapeutics, and dietary
supplement markets with a strategic focus on functional foods. WellGen's
proprietary technology platform is a method of screening the effect of food
and related substances on the expression of genes associated with human health
conditions. The company has developed proprietary substances that help reduce
risk and severity for a variety of diseases. Please visit our website at
www.wellgen.com for more information.