FISH OILS AS CARDIOVASCULAR AGENTS

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Studies in the medical literature since the 1970's have strongly suggested that eicosapentaenoic acid (EPA) is a significant modulator of thromboxane and prostaglandin activity, primarily in its role as a precursor of the "3" class of thromboxanes and prostaglandins. Recently a 20-year epidemiological study uncovered a strong correlation between increased fish consumption and decreased cardiovascular disease mortality in a Dutch population. A diet containing greater than 400 mg per day of EPA gave greater than a 50% reduction in cardiovascular disease mortatlity, compared with a diet containing no fish oil. It appears possible from this and other studies that relatively low intake of EPA-rich oils on a chronic basis may substantially reduce the risk of cardiovascular mortality. PGE Technology has recently processed a fish oil to contain 30% EPA without heavy metal or PCB contamination. The major obstacle to approval of this oil as a pharmaceutical is its instability to oxidation. Phase I research will focus on stabilizing EPA-rich oils using tocopherols and a new class of semi-synthetic phospholipids, the Lipid X surfactants. These surfactants are unique in being completely miscible with oils, and so will solubilize the tocopherols. If the resistance to oxidation can be raised to greater than an ACM of 8 hours, Phase II studies would include toxicology studies of Lipid X administered orally to animals, with a goal of obtaining FDA approval of Lipid X as a food additive.