SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model. The company has demonstrated that safflower Apo AI(Milano) increased cholesterol mobilization substantially in mice which, in conjunction with analytical and in vitro assays, indicates that safflower Apo AI(Milano) is physiologically and pharmaceutically comparable to microbially-produced Apo AI. In human trials, microbially-produced Apo AI(Milano) has been shown to remove plaque from arteries (plaque regression), and holds potential for addressing one of the greatest unmet medical needs today—the reversal of atherosclerosis.
Apo AI is a naturally occurring human protein being developed as a cardiovascular therapy to stabilize and reverse atherosclerotic plaque deposition for the prevention and treatment of cardiovascular disease. Apo AI is the major apolipoprotein associated with HDL, which naturally removes plaque from arteries. If successfully commercialized, predicted high dosing (multiple grams per course of patient treatment) coupled with a large patient population would be expected to drive volume demand of several tons of Apo AI(Milano) per year. SemBioSys’ proprietary safflower derived Apo AI(Milano) is a des I, 2 variant of Apo AI(Milano).