(Scanned from the applicant's description) An estimated 25 million persons in the United States have had peptic ulcer disease during their lifetimes. A high proportion, over 90 percent, of these cases are caused by infection with helicobacter pylori (H. pylori). Preliminary research has found that bovine lactoferrin, a native antibiotic in bovine milk, is inhibitory to the growth of H. pylori and lactoferrin is a potential therapeutic agent for the prevention and treatment of H. pylori infection. The proposed Phase I research will investigate the feasibility of using native bovine lactoferrin to treat and prevent H. pyloric infections and ulcers in humans. The study will determine if consuming milk or milk-based nutraceutical beverage containing high levels of bovine lactoferrin is bacteriostatic or bactericidal to H. pylori bacteria in volunteers with H. pylori infection but no preexisting ulcers. Volunteers will be screened to determine the presence of H. pylori and placed on a 21-day regime of consuming the proposed high lactoferrin nutraceutical beverage. The effect of the lactoferrin treatment on the H. pylori will be monitored. If successful, Phase II research will involve a larger and longer-term prevention study as well as a study on the use of the high lactoferrin nutraceutical beverage in conjunction with current treatment regimes for ulcers.
Sales of one proton pump inhibitor, Losec/Prilosec, used to treat ulcers were $4.4 billion during 9 months in 1999. The market for a nutraceutical that prevents or is effective in treating ulcers would be huge. Trans Ova Genetics and Dairilean have current business relationships with several large pharmaceutical and nutraceutical companies that would facilitate commercialization of the product.
