When people say, “You are what you eat,” they intuitively sense the strong relationship between food and human health. Over the last several years these folk understandings have been confirmed by hard science, and a whole new specialty, dubbed nutrigenomics, was born. Scientists working in this field are now analyzing the relationship between the foods we eat and the activity of genes in our bodies.

Genes are not merely passive determinants of hair color or even susceptibility to certain diseases, but rather they play a dynamic, active role in our daily lives. Exercise, for example, awakens genes in our muscles that produce proteins to use energy sources more effectively, and hunger turns on genes that affect insulin levels.

WellGen Inc., a biotechnology company established in 1997 by Rutgers University and the University of Medicine and Dentistry of New Jersey, is using new research in the field of nutrigenomics to develop ingredients for the food industry that promote wellness. The six-year-old company has already begun to market a product derived from black tea to the food supplement industry as an anti-inflammatory, and it is testing an anti-obesity ingredient derived from a citrus fruit.

Although supplements will play a role in WellGen’s marketing strategy, its ultimate goal is to sell these natural ingredients to food and beverage companies as additives that offer health and wellness benefits. Kathleen P. Mullinix, WellGen’s CEO and president, believes the company’s products will supply the innovation these companies need.

WellGen currently has seven employees, which Mullinix expects to increase to 15 by the end of next year. In June it received a patent for its black tea extract, and in October it closed a round of financing, raising over $9 million from private investors. Its lead investor is Amphion Innovations, a developer of new technology and life science businesses, and others are Rutgers University and the UMDNJ. WellGen is listed on the AIM stock exchange in the United Kingdom.

WellGen is already talking to major food companies about licensing its anti-inflammatory product to market leaders in different food and drink categories. One company might use it as an ingredient for cookies and biscuits, another for yogurt, and a third for beverages.

What is especially intriguing about WellGen is the way it fills its pipeline and then tests potential products. As recommended in 2005 by the Food and Drug Administration, WellGen is using biological materials to measure the effects of its ingredients on the body. In the past a lot of this feedback was obtained not by using objective scientific measurement, but by asking study participants how they felt. The FDA has come to realize that subjective reports by study participants are difficult to quantify, however. One reason that this is so is that the placebo effect can be huge. If people think they should feel better, they may well report that this is the case.

Instead of assessing the effects of nutrients on health by asking study participants questions, WellGen is counting on the more objective results that can be obtained through a study of the genes affected by these nutrients.

“We’re using genes whose functions have been validated in the past 15 years of genomics as surrogates for health conditions we are interested in,” explains Mullinix.

For the studies of its anti-inflammatory tea extract, WellGen measured the level of about 20 protein markers in the blood of participants. Because genes do their work in the body by producing proteins, these proteins serve as “markers” for the genes.

WellGen conducted its first trial, the LPS challenge, in 2006. The purpose of this trial was to see if its tea extract would limit the inflammatory response to a highly inflammatory challenge. The 12 study participants were divided into two groups: one received WG0401, as the tea extract was tagged, for a week, and the other got a placebo. At the end of the week, says Mullinix, all the participants were given lipopolysaccharide, a highly inflammatory substance that makes people feel sick — with fever, chills, aches, and pains.

To physically measure the product’s effects, WellGen looked at about 20 proteins related to inflammation. The participants who had not taken the extract had a huge increase in these proteins, whereas the group that did take it showed between a two-and six-fold decrease, depending on the protein being measured.

MDS Laboratories in New Orleans, the contract research organization which did this study, also asked study participants anecdotally whether they were experiencing any side effects from WG0401, like nausea or gastrointestinal problems — the principal reason people stop taking anti-inflammatories. They reported no side effects.

But while objective scientific data is essential, anecdotal evidence also has its place, and Mullinix adds some of her own.

Beyond reading test results, she has also become convinced of WG0401’s effectiveness through personal experience. After not playing tennis for a while, she took it up again, but found that her hip would start to bother her after a few games. “I was running off the tennis court and grabbing Advil,” she reports. So, following suit with others associated with WellGen, she decided to try the supplement, and found that it stopped the pain.

The second study, called the Wingate Aerobic Challenge, was designed to look at muscle soreness caused by inflammation in response to an extreme physical challenge. It also looked at recovery time. This study was done at the Rutgers exercise physiology department with a group of 18 very fit athletes.

Nine of the athletes were treated for a week with the extract, and nine were treated with a placebo. Then they got on exercise bikes and were asked to pedal at a high rate, against back pressure on the pedals. Again the researchers looked for effects on the protein markers for inflammation, and also gave people a questionnaire to collect anecdotal information about how fast they recovered from the aches and pains. Examining protein markers in blood samples, they found that the tea extract inhibited the inflammatory response as compared to the placebo control. Anecdotally, people who had taken the extract also reported less fever, and fewer chills, aches, and soreness.

Mullinix sees a significant market potential for this anti-inflammation ingredient.

“If we live to be old enough,” she says, “we will have degenerative conditions that will give us joint pain and aches that are results of inflammatory processes.” Inflammation also plays a role in cardiovascular and gum disease, as well as joint problems, and to the degree that the extract can inhibit inflammatory processes, it may prevent or at least delay the onset of these diseases and conditions.

A second product now being tested shows promise in helping people to manage their weight.

In attempting to find the Holy Grail of weight loss, pharmaceuticals have taken three approaches, says Mullinix. The first, followed by Synaptic Pharmaceutical Corporation, now Lundbeck Research USA, was to control appetite via the central nervous system.

The second is to influence the plumbing, that is, the absorption of nutrients out of the gut. Mullinix cites Xenical, sold over the counter as Alli, as an example of the second approach. Xenical inhibits the absorption of nutrients, but has serious side effects.

The third direction, which Mullinix prefers, prevents the absorption of fats, either mechanically or by influencing the burning of calories.

WellGen’s citrus extract, which follows this third approach, inhibits the maturation of fat cells, rendering them incapable of storing fat.

WellGen has licensed from HMGene the right to use the genes involved in fat cell development. Early work on the citrus extract included testing mouse cells from fatty tissue. To test for the presence of fat, the cells were exposed to a red dye that binds to fat. As the cells absorb fat, they turn red. “We have wonderful pictures of plates of cells,” says Mullinix. “In the presence of WG0301 (the extract), they are not red, because they are not picking up fat.”

In other work mice placed on high-fat diets and given the extract had a 30 percent decrease in weight gain as compared with controls. In collaboration with the University of Maryland researchers are now looking at the extract’s effect on human cells from fatty tissue in the belly. They are conducting their experiments by placing the tissue in Petri dishes. The protocol for human studies has been approved, and experiments are expected to begin this quarter to see if the citrus extract affects humans in the same way that it affects mice.

In addition to testing the citrus extract, WellGen is focusing on building its pipeline and on follow-up products.

WellGen was established 10 years ago, but it remained within Rutgers and UMDNJ for four years while its screening technology was being perfected. This patented process identifies food and plant extracts that regulate gene expression.

WellGen’s initial chief executive officer, and first employee, was David Evans. He signed on in 2001. He was followed by a chief scientific officer in 2003 and a vice president for marketing and product development, Patricia Lucas-Schnarre, in 2004. The company’s initial focus was on finding a natural substance for cancer treatment and prevention, working particularly on intestinal cells and looking at colon cancer.

In short order WellGen decided to change its direction.

“If you want to be a health and wellness company,” says Mullinix, “you can’t be claiming that you are treating a disease, because that is therapeutics.” The early employees decided that it was more realistic to think of WellGen as a developer of natural products that promote health and wellness.

Mullinix, 63, has been with WellGen since August, 2006, two months after Evans died suddenly from an infectious disease acquired from a tick bite.

After graduating from Trinity College in 1965 with a bachelor of arts in chemistry and receiving a doctorate in chemical biology from Columbia University in 1969, Mullinix spent three years at Harvard University on a postdoctoral fellowship. She then moved to the National Institutes of Health, where she ran a laboratory looking at gene expression and DNA synthesis from 1972 to 1979.

Mullinix served as associate director of NIH’s intramural program until 1981, when she was invited back to Columbia University as vice provost. She was interested, she says, because biotech was just starting up, and she wanted to start a business for the university in the commercial licensing of intellectual property.

“I really like thinking about big picture science,” she says. “How can you take early stage discoveries, and how can they be used?”

Calling herself a biologist by avocation, Mullinix explains, “I’m always thinking about how you can use science to improve public health, how you can combine this with that. I was more interested in that than in doing lab work.”

In 1987 Mullinix left Columbia to start the biotech that became Synaptic Pharmaceutical, where she served as chairman, president, and CEO. She was its first employee, and she jokes that it was she who bought the pencils. “We focused on finding genes that are drug targets and using them as drug discovery systems,” she says. The company, now Lundbeck Research USA, has a facility with hundreds of people in Paramus.

Mullinix, who sees herself more as a startup person, left the company in 2002 after a stint of 12 years, because her interests lay more in development and commercialization and very early stage technologies. She then formed a consulting company, advising investors on biotechnology and pharmaceutical business opportunities, and getting interested in what she calls “the natural products space.”

“You have to believe there is a basis to some of the lore around the health benefit-providing properties of natural ingredients,” she says, citing Taxol, the widely-prescribed cancer drug, which comes from the bark of a tree. In her research into this area, she found WellGen on the Internet and called the company to find out what it was up to. But that was as far as the connection went.

She had also begun to think about starting another company when she got the call last June from the chairman of WellGen’s board asking whether she was still interested in the sector. She was dubious, living as she did in New York City and not relishing a commute to New Brunswick, but when she met the people at WellGen, she got very excited about their early-stage technology.

Mullinix grew up in Boston, where her mother was an elementary school teacher and her father worked for the Postal Service. Mullinix has three sons; the older one works in the hotel business in San Francisco, and the twins are both in New York City, one in equities investment and the other in real estate trust investment.

On July 1 the company moved to the Commercialization Center for Innovative Technologies, at the Technology Centre of New Jersey, with 1,600 square feet of laboratory space and 1,600 square feet of office space. It can stay in this space for four years while it spends its early stage equity capital on equipping its laboratories and hiring research staff.

As for competitors, Mullinix says that WellGen has come so early to the infant science of genomic research into beneficial nutrients that no authentic competitors exist yet.

WellGen’s license to its nutrigenomics screening platform gives it a leg up, says Mullinix. This technology can be used to find ingredients affecting any health condition that has validated genes associated with it. Mullinix is optimistic about developments in the field of nutrigenomics and says, “There is room for a lot of winners.”

WellGen Inc., 675 Route 1 South, North Brunswick 08902-8520; 732-565-3890; fax, 732-565-3896. Kathleen P. Mullinix, CEO. Home page: www.wellgen.com.

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