WellGen prepares for nutrigenomic launch

WellGen's first food-derived nutrigenomic product could be on the market as early as next year, if research continues according to plan and a suitable commercial partner can be found.

After ten years of research and development, the first product is likely to be theaflavins from black tea, which have been shown to turn off a number of genes involved in inflammation.

One of the most exciting new areas in food and wellness, nutrigenomics involves working out which chemicals in foods have the ability to turn on and off certain genes that are responsible for disease prevention.

New Jersey-based WellGen was spun off from Rutgers University in 1997. Together with the University of Medicine and Dentistry of New Jersey, Rutgers developed the means of screening food to detect active ingredients. However development began in earnest in 1999, when CEO David Evans became the first full-time employee.

With the appointment of Arthur Finnel as chief financial officer this month, WellGen now has a six-strong management team drawn from a broad range of industries. It renewed and expanded its research contract and licensing agreement with Rutgers in June, and two more managerial appointments are in the pipeline.

Evans told NutraIngredients-USA.com that the company's expertise is in "leveraging the technology and working with the scientists to find new bioactive compounds that could have a significant effect on response to human disease". To take the resulting ingredients to market he plans to enter into partnerships.

Theaflavins have already been shown to turn off genes involved in inflammation in mouse and horse models. The next step, said Evans, is to carry out pre-clinical trials in animals, and then human clinical trials.

"That is the key milestone for us, and the whole area of nutrigenomics," he said. He added that the research may be in place as early as next year, and that a launch to the market could follow swiftly.

"Assuming we don't misstep along the way, we think it could have some benefit for people with arthritis."

There may also be applications for the theaflavin technology in the area of sports, as minor aches and pains are caused by inflammation, which could be reduced by the down-regulation of the genes responsible.

What is more, inflammation is a factor in a number of other health conditions, including psoriasis, certain cancers, cardiovascular disease and, to some extent, obesity.

Evans said that initially, the theaflavins would be ideally delivered in dietary supplement form. Another viable approach could be to put the theaflavins back into tea to deliver a higher concentration to consumers.

Theaflavins are already available as food and supplement ingredents through a number of suppliers including Applied Food Sciences and Nashai Biotech, but WellGen's will be the first developed according to nutrigenomic principles.

As for the concentration of theaflavins in black tea, it depends on brewing technique or origin of the tea. Certainly it is known that theaflavins are not present in green tea, which is produced by steaming rather than fermentation.

In the United States, food ingredients must be affirmed as GRAS (generally recognized as safe) before they are introduced to the market.

"In the regulatory environment, it is advantageous that we start with food as a source material, as unlike many chemicals it has a history of safe use - even though we are delivering the compounds in a higher concentration," said Evans. "We have compiled substantial safety studies."

Another keen area of investigation is chemicals found in the peel of certain species of orange, which have been found to turn on a gene involved in cancer protection.

However it remains to prove how they can prevent cancer in humans, as this will involve clinical trials over a long period of time.