Cardiovascular diseases, including heart attack and stroke, are the leading causes of mortality in developed nations and by 2010, are projected to become the leading cause of mortality worldwide.
Current treatments are generally only able to halt the progression of plaque buildup in blood vessels, the cause of cardiovascular disease. However, a new class of drugs, most notably Apo AIMilano, has been shown to actually reduce plaque size.
Apo AI is the major protein associated with high density lipoprotein (HDL), or "good cholesterol", whose function is to remove excess cholesterol from arteries. Variants of this protein, specifically Apo AIMilano, have demonstrated the ability to cause atherosclerotic plaque regression. Based on clinical results, patients will require large doses of Apo AIMilano per treatment. High doses, combined with the millions of patients that could benefit from this treatment, creates an enormous potential demand for these compounds. Current production systems have critical manufacturing barriers and appear unable to meet this demand.
To solve the manufacturing and dosing challenges, SemBioSys is producing Apo AIMilano in genetically engineered safflower. We believe that plants may be the only cost-effective production vehicle for these life-saving drugs.
What We Have Accomplished
We have successfully achieved commercial levels of Apo AIMilano accumulation in safflower and have demonstrated biologic activity in 7 preclinical models. Consistent functionality in 2 independent in vivo studies have demonstrated
- rapid mobilization of cholesterol from the arterial wall;
- lessening of plaque lipid content;
- decreased immune reactivity in aortic plaque; and
- reduction of total plaque volume versus controls.
Data for SemBioSys' Apo AIMilano was presented at the American College of Cardiology's 59th Annual Scientific Session in March 2010.
What We Are Working On
We are seeking with an industry leader in cardiovascular disease to drive the advanced development and commercialization of plant-derived Apo AIMilano.