From Wake Forest University Baptist Medical Center
Wake Forest commercializes new soy technologies through licenses
WINSTON-SALEM, N.C. -- Wake Forest University School of Medicine has licensed three soy-related technologies to Physicians Laboratories of Kernersville, which will use the technologies to develop "medical foods," according to Dean Stell, assistant director of technology asset management.
Aaron T. Tabor MD, president and medical director of Physicians Laboratories, said the company planned to start clinical trials soon on using soy to slow memory loss.
Medical foods, which are regulated by the U.S. Food and Drug Administration, are available only 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," Tabor explained.
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 based on 15 years of research on plant estrogens and more than 45 years of research on atherosclerosis.
Stell said that in addition to memory loss, the technologies also include using plant estrogens in hormone replacement therapy and in preventing endometriosis with plant estrogens.
Physicians Laboratories Inc. already markets soy protein on its web site under the Revival brand name as dietary supplements, which are not as heavily regulated as medical foods.
The initial study on soy and prevention of memory loss will be a pilot study involving 25-50 patients in nursing homes. "If the results are promising, we would look to expand that trial greatly through our own funding and government funding."
Tabor said his company was planning clinical trials for the other two technologies "We want to develop a product for the nutritional management of endometrioisis," he said. "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.
"It's exciting for us to have some of our research findings be implemented into practice," said Clarkson. "I'm also excited by the scientific integrity by which Dr. Tabor has gone about implementing our research findings."
"This is what our office is all about," said Spencer Lemons, director of Technology Asset Management, "leveraging the research capabilities and expertise of the medical school with local, national and international companies to help create products that can potentially benefit the public."
"The fact that we can work with a local company in this instance, just makes it that much sweeter." Physicians Laboratories began about 3 1/2 years ago, and has grown to 90 employees and about $20 million a year in sales. The company markets soy under the Revival brand name, selling exclusively over the Internet and by telephone.
The company has focused on clinical trials, Tabor said, and has about ten under way. Meantime, the products are being sold as dietary supplements. Tabor said with dietary supplements, the company can make structure or function claims, such as soy promotes healthy cholesterol levels or soy lowers the risk of heart disease or soy promotes healthy memory but not treatment claims.. Tabor said the company would be working further with Clarkson's team on soy compounds that may lower the risk of breast cancer.
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