"Medical Foods" Under Development

Applied Genetics News,  April, 2002  

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Wake Forest University School of Medicine (Medical Center Blvd., Winston-Salem, NC 27157; Tel: 800/446-2255; Website: www.wfubmc.edu/school) has licensed three soy-related technologies to Physicians Laboratories (1031 E. Mountain St., Bldg. 302, Kernersville, NC 27284; Tel: 336/993-7445, Fax: 336/722-7712), which will use the technologies to develop "medical foods," according to Dean Stell, assistant director of technology asset management.

Physicians Laboratories plans to start clinical trials soon on using soy to slow memory loss. Medical foods are regulated by the U.S. Food and Drug Administration and only available by prescription. If the medical benefits of a food can be demonstrated through clinical trials, then manufacturers are permitted to make medical claims. "If you have the evidence, you can say your product is for the nutritional management of memory disorders," explains Aaron T. Tabor, president and medical director.

The technologies were originally developed by Thomas B. Clarkson DVM, professor of pathology (comparative medicine) and other members of the Comparative Medicine Clinical Research Center. Stell says that in addition to memory loss, the technologies also include using plant estrogens in hormone replacement therapy and in preventing endometriosis.

The initial study on soy and prevention of memory loss will be a pilot study involving 25 to 50 patients in nursing homes. "If the results are promising, we would look to expand that trial greatly through our own funding and government funding."

Clinical trials are planned for the other two technologies "We want to develop a product for the nutritional management of endometriosis," says Tabor. "That would be one of the claims we would hope to win for the second soy patent."

The third study will compare soy combined with hormone replacement therapy against hormone replacement therapy alone, with the goal of increasing bone density or lowering cholesterol.

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