Start-up Origo Biosciences has discovered the presence of an anti-cholesterol immunoglobulin in milk and is investigating its commercialisation as an ingredient for functional foods that may, one day, give plant sterols a run for their money.
Research to date has yielded positive results for the ability of the naturally-occurring protein, called anti-cholesterol, to bind to cholesterol in the human digestive tract and prevent its absorption into the blood stream.
High levels of LDL cholesterol in the blood are a serious risk factor for atherosclerosis (hardening of the arteries) and coronary heart disease. Plant sterols are currently the only cholesterol absorption inhibitor for use in foods, according to Origo co-founder Jon Brendsel, and dairy products are one of their most common food carriers.
This could mean that a dairy-derived ingredient could sit very nicely in the cholesterol management category.
Schering-Plough/Merck's Zetia is understood to be the only cholesterol absorption inhibitor drug on the market.
Brendsel explained that the origins of Origo's innovation stem from the work of two of his partners in the biotech field where, several years ago, they investigated the properties of this particular antibody from a drug development perspective.
Although their research did not come to fruition in the pharmaceutical field, they returned to it later as a possible ingredient for use in functional foods.
Anti-cholesterol was previously identified in bovine serum, and there have been a number of studies published on its effects.
Brendsel and his team started conducting tests to see whether it was also present in dairy since milk is widely known for having a number of antibodies in it - in particular colostrum which provides much of the early immunity for new borns (both human and bovine).
For the last year Origo, founded just under three years ago, has been devising a strategy to bring it to market. It has filed a patent of its discovery, and trademarked the name 'Anticholesterol'.
Brendsel said that there are a couple of different pathways, but that it is most interesting is functional foods.
At present the company is involved in discussions with manufacturers whose products showed up good results in tests to establish the best source of the antibody, from a wide state of different whey protein concentrates, colostrums and milk proteins.
A large margin of difference was seen between the best and the worst sources, which Jon said may be due to one of several factors, for instance the origin of the herd or, perhaps more importantly, the processing method used.
In the United States there is a move towards ultra pasteurization of dairy, but when antibodies are subjected to heat in excess of 70 degrees Celsius they have a tendency to unravel and their bioactivity is destroyed.
"We think the antibodies may be dead because of the extreme heat and spray-drying," said Brendsel. While all of the sources tested are pasteurised, some go through a gentler process (that still conforms to ESDA standards), preserving the antibodies.
Origo is working with the producers to ensure consistency of antibody levels and to educate them about ways to retain more bioactivity. It may also look at ways to further concentrate levels of the immunoglobulin.
The company is planning to solicit a health claim for Anticholesterol - likely a structure function claim, said Brendsel, since the indications are that consumers are put off by the unwieldy language of qualified claims. He was not able to give any indication of what the claim will consist of, however, and the health claims process can typically take up to a year, with success not necessarily guaranteed.
If a claim were granted, however, one option for bringing making the antibody available for use in functional foods may be to license the claim for use by makers of dairy products with a higher content. Although health claims are usually available for use by the entire category, Brendsel said that Origo's intellectual property would prevent its use by anyone else.
Alternatively, the producers may team up with Origo to market their dairy sources - whether as they currently exist or in an altered form - under the Anticholesterol brand.
The company has also conducted in vitro tests to measure the level of the immunoglobulin's cholesterol inhibition. Brendsel stressed that the results should be viewed with caution until backed up in vivo, but the data obtained suggests that it could inhibit cholesterol by as much as 60 to 80 per cent.
Similar trials using plant sterols and the drug Zetia (not conducted side-by-side but upon which Origo based its methodology) showed them to have only a 30 to 40 percent inhibitiative effect.
The first animal study using Anticholesterol is currently underway, with more planned, and it is hoped that a human study will begin in the fall.
An indication of the potential for Anticholesterol may be seen in a recent Frost and Sullivan report, "Strategic Analysis of the European Phytosterols Market", which valued the European market at $184.6m in 2005, and estimates this to reach $395.2m in 2012, an increase of 114 per cent.
Although the US functional foods market is less developed than in Europe, sterol-containing dietary supplements have proved popular in that market.