The bioactive has previously been referred to as m.doc, the tradename for the company's woundcare product based on a different variation of the same technology. The bioactive will go under a different name that is yet to be decided.
Alltracel is currently investigating the effects of the bioactive in combination with other cholesterol-lowering approaches.
A study investigating the dosage, timing and efficacy of the bioactive in combination with plant sterols and omega-3 is currently underway and is expected to be completed in early June, with the results announced at the end of the month.
Chief marketing officer Noel Toolan told NutraIngredients.com that the bioactive's mode of action is different from that of sterols or omega-3, "so the effect would be additive".
A research team at UCD's Conway Institute of Biomolecular and Biomedical Research reported last year that the bioactive's mechanism involves interactions with cholesterol, bile salts and very low density lipoproteins in the gut.
"One of the functions of bile salts is to extract proteins from what you eat. If the bile salts are bound with the [bioactive] particles than they are not very efficient in extracting cholesterol," said Alltracel technical director Ciaran O'Reilly at the time.
Plant sterol-containing foods work by preventing absorption of cholesterol in the gut. It is thought that they either reduce the solubility of cholesterol or, because they are very similar in structure with cholesterol, they compete with cholesterol for space in the micelles, structures that solubilise lipids in the intestine. This in turn results in less cholesterol being transported into the blood stream.
If the current combination study reports positively, the next step will be to advance to a comprehensive preclinical trial that will feed into human trials later in the year.
"Depending on the findings, we may go for further combinations or go to human trials with the same or different partners," he said. "The route to market is pretty clear."
As for the potential, he said: "If we combine with the right bio-active we could have a multi-functional ingredient for the mass market. That is the way we are going."
Toolan is this week in Japan, involved in discussions with potential partners in the functional foods industry - both multinationals and niche food companies.
In the Japanese market he said that it is a good fit with current functional food trends, where cholesterol-lowering products are the fastest growing category as more and more people adopt a Western diet and, consequently, cholesterol levels.
Discussions are also underway with US and EU-based multinationals, and niche EU companies. Regulatory approval has been initiated in the US but not yet in the EU, where the bioactive will most likely be considered a novel food.
Today Allracell announced the successful completion of pre-clinical studies into the combined effects of its bioactive and statin drugs, which showed a decrease in expression of the adhesion molecule ICAM-1 in blood vessels, involved in the progression of atherosclerotic plaques; a reduction in inflammation; a decrease in serum LDL cholesterol levels; and an improvement in HDL/LDL ration.
However it is likely that the bioactive will be available for use in functional foods before it is available as a pharmaceutical.
It is not yet clear whether patients would be encouraged to use both the statin combination and food approaches, but in market terms the company is not looking at as an either/or.
"It is not illogical to have the technology present in both drugs and non-drugs," said Toolan. "Pharmaceutical companies are looking for better and safer cures, and the food drive fits in with the shift towards healthy eating."
The first research on the anti-atherosclerosis benefits was published in the November 2005 issue of the Life Sciences Journal.