The company, which specialises in cancer, also says the composition can be used in the treatment of cancer through pharmaceutical intervention.
A patented protein complex known as HAMLET, derived from human breast milk, and related complexes like BAMLET derived from bovine alpha-lactalbumin, can kill more than 40 types of cancer cells from different origins and also have proven antiviral activity, said the company.
Two proof-of-concept clinical trials have confirmed the complex is safe and effective for use in humans.
Writing in its European patent, the cancer specialist said it found that compositions incorporating HAMLET have biological activity in the treatment or prevention of gastrointestinal cancer, in particular colon cancer, and can be effective in nutraceutical form, including dairy products like yoghurt.
“In vitro studies have shown that HAMLET is protease resistance, suggesting that by surviving the harsh gastrointestinal environment HAMLET may reach and kill cells that are sensitive to its effects, including colon cancer progenitors,” the company wrote.
“...Whilst the use of complexes such as HAMLET have been demonstrated previously as being therapeutic in the treatment of a range of pre-existing cancers, including mucosal cancers, and for the prophylactic treatment of bacterial infection, it has not been shown previously that it is useful in the prevention of cancer. Thus this finding opens up a new approach to the prophylaxis of proliferative disease.”
Nutrition: A new therapeutic approach
For use as a preventative health measure, rather than cancer treatment, Hamlet Pharma said the level of complex used should be from 1µg to 200 mg per dose, daily.
The company said treatment was of particular interest to people susceptible to colon cancer; those carrying the mutated APC gene.
“Peroral HAMLET administration presents a conceptually new therapeutic approach in colon cancer, potentially killing tumour cells and shifting surviving cells to a more benign phenotype. Based on this activity spectrum, the use of HAMLET and its variant forms as an oral prophylactic would be of great value, especially in families genetically prone to colon cancer.”
Beyond cancer prevention and treatment, the firm said in a nutraceutical form, the complex can be consumed as “part of a normal diet”, providing “nutritional benefits” and protecting against other conditions like bacterial infections, viral infections and papillomas.
Hamlet Pharma said the composition is made from fragments of the polypeptide alpha-lactalbumin – ideally with no more than 50 amino acids to keep costs down and ensure the mix is workable – along with a fatty acid, lipid or salt and an acidifying agent to reduce the pH to less than four.
Whilst the crude protein can be extracted from various milk sources, including human, the company said the “most convenient” source when using it in food is bovine, ovine or caprine. A native protein is also preferable when developing the composition for food.
Cow's milk is one particularly interesting source, it said, as it is readily available, has the known efficacy of BAMLET, and contains up to 4% w/v protein, the company said, although this percentage is variable depending on the breed of cow and the cow's diet. However, a protein content of between 3.1-3.9% is “typical” amongst European cows, it said.
Hamlet Pharma said the milk simply has to be defatted or processed with ammonium sulphate to extract the crude protein and then the final blended composition could be heat-treated at temperatures between 35-70°C, ideally at 50°C. The blend could then be dried, lyophilised or freeze-dried into powder form. Then, it said, the composition can be added to a range of dairy products like yoghurt, milk, infant formula, crème fraiche, cheese or butter, among others.
Source: WIPO Patent No EP3295953
Published: March 21, 2018. Filed: August 8, 2013.
Title: “Milk protein – fatty acid complex”
Authors: Hamlet Pharma AB