Human lactoferrin safety backed in study

16-Jul-2012 - Last updated on 17-Jul-2012 at 14:51 GMT

Human lactoferrin derived from genetically modified cows’ milk is safe, according to data from a randomised, cross-over double blind, placebo-controlled study sponsored by the Dutch Food and Nutrition Delta.

Dutch biotech firm Pharming is part of that group and project manager Frans de Loos told us the study would help Pharming and “the four or five other companies” working in human lactoferrin achieve approval for its use in infant formulas and other products.

Some research has shown human lactoferrin can boost the immune system more effectively than bovine lactoferrin, although this is inconclusive. The GM technology sees human genetic matter inserted into cows so that they product human lactoferrin.

Human lactoferrin is not as yet approved for use in foodstuffs anywhere in the world, but the European Food Safety Authority (EFSA) has issued GM guidelines that has given some sectors hope their products may be approved.

“Infant formula is the primary market but it is not the only one as human lactoferrin is suited to many products for people with challenged immune systems,” de Loos said. “With infants, breast milk is still the best but in those cases where mothers can’t breast feed, then formula can be better with human lactoferrin.”

In addition to the kind of safety data demonstrated in the study that may be peer-reviewed and published in “6-8 months”, animal wellbeing data was required along with toxicological material and gene descriptions.

Loos said the trial was one of the first pieces of clinical research to use human lactoferrin.

The study

It employed 24healthy subjects aged 25 to 49 years who consumed recombinant human lactoferrin for two weeks at a daily dose of 0, 300 or 1000mg, in combination with 10grams of skimmed milk powder.

No differences were demonstrated between the lactoferrin and placebo groups.

De Loos said the company was looking for end-product partners as these were alkso required to win regulatory approval.

He said human lactoferrin was no more expensive than the bovine form except for infrastructure costs like second fences required to keep GM cows.

Hey said whey protein concentrates extracted from GM cows could yield human lactoferrin concentrates of 30-35%.

Bruno Giannetti, COO of Pharming said in astatement: "We conclude that these latest results confirm previous findings and together provide a very good basis to use rhLF (recombitant human lactoferrin) as a food ingredient and support for our ongoing discussions with potential partners and buyers for the project."

EFSA's technical report on GM can be found here.