Biospherics Incorporated (Nasdaq: Binc) reported today it has learned from its licensee for tagatose, Arla Foods, that significant progress has been made in determining the safety of the low calorie sweetener.
Biospherics officials said Arla had informed them that, at a meeting on May 15, the Expert Panel determining whether tagatose is Generally Recognized As Safe (GRAS) for use in foods and beverages, was close to resolving the issue and that specific data from a Biospherics study might help speed the process.
Biospherics CEO, Dr. Gilbert Levin, said that he welcomed the opportunity to provide data from a one-year study of the sweetener which the Company undertook at the University of Maryland. “We obtained excellent results in the clinical trial conducted on human patients at the University of Maryland’s School of Medicine which might allow the Expert Panel to reach a favorable conclusion,” he said.
According to Dr. Levin large doses of tagatose were taken orally by the patients every day for a year with no untoward effects on safety. “We were so impressed with these results that we had recently asked Arla Foods to present them to the Panel,” he said.
The clinical trial of tagatose, at the University of Maryland, was partly funded by the State of Maryland which awarded a grant through its Maryland Industrial Partnerships Program (MIPS).
GRAS status would permit commercialization of the Biospherics’ full-bulk, low-calorie sweetener for use in foods and beverages in the U.S. MD Foods, which licensed these applications of Biospherics’ patented technology, was recently merged with the Swedish firm, Arla, to form Arla Foods. Arla Foods officials continue to express confidence that tagatose will qualify as GRAS.
Biospherics Inc. is a biotechnology research company founded by Dr. Gilbert Levin, who also performed research as part of NASA’s mission to Mars in 1976 where Biospherics technology helped test soil samples. As a related project, Biospherics began research on non-fattening sweeteners and, in the 1990’s discovered that tagatose, a natural sugar found in certain berries and dairy products, tastes like table sugar and is low in calories. The Company then invented a “green” process to make the sweetener economically using whey as the raw material.
Certain statements contained herein are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on March 3, 1999.