Pharming to seek GRAS for lactoferrin
will be seeking GRAS status for its recombinant human lactoferrin
(rhLF).
After announcing positive results from a key study with rhLF, Pharming said it would use them for Generally Regarded as Safe (GRAS) registration of rhLF for nutritional applications.
The company said that the results demonstrate that : "rhLF can be consumed orally at high amounts with no adverse effect". In order to come to these conclusions, Pharming noted it had conducted an extensive animal toxicology study in cooperation with the Netherlands TNO Institute for Nutrition and Food Research to observe the effect of the oral intake of rhLF.
"I am very pleased with the positive outcome of this study with recombinant human lactoferrin, as well as the positive results in animal studies with human fibrinogen," said Dr. Francis Pinto, CEO of Pharming. "Based on these achievements, Pharming will consider making additional investments to accelerate the development of these innovative products."
Pharming plans to start preparing its GRAS filing along with an expert opinion on use of rhLF for nutritional applications after it has published the study's results.
"We will be filing for GRAS in the first half of next year and hope to be granted the status by the end of the year," Frans Deloos, the project manager told NutraIngredientsUSA.com.
Human lactoferrin is a natural protein that helps to fight and prevent infections and strengthens the body's defense system. The protein is present in substantial quantities in mother's milk and plays an important role in the defense system of infants. The protein is also present in various body fluids and continues to play an important role against a wide range of bacterial, fungal and viral pathogens in adults.
