SB221, a mixture of traditional Chinese herbal extracts, is under development for both treatment and prevention of vascular endothelial dysfunction-related diseases. Deterioration of vascular endothelial membrane, common among the elderly and those patients that smoke, are obese or suffer from diabetes, hypertension, high cholesterol, can lead to diseases such as atherosclerosis, renal failure, and retinopathy. SB221, through multi-mechanistic pathways, is shown to prevent damage to the vascular endothelial membrane and restore endothelial function.

Animal pharmacology studies have shown that SB221 prevents the integrity of the vascular endothelium and its vasodilation from deterioration in SHR rat model. Moreover, SB221 demonstrated effectiveness in restoring the vascular endothelial function in animals suffering from mild-to- moderate endothelial damage. The animal studies also exhibited profound anti-hypertensive effect in SHR rats, following repeated oral administration of SB221. In-vitro studies with SB221 revealed significant biological activities in various known disease targets, such as inflammatory factors, PDE, platelet, and SOD, etc. SB221 showed no genetic toxicity. Toxicology studies in rats found no apparent signs of toxicity or adverse events at administration dose up to 3000 mg/kg/day for 13 weeks.

Two SB221 Phase II human clinical trials on the indications of cardiovascular endothelial dysfunction and essential hypertension are in progress. A double-blind, randomized, cross-over, placebo-controlled study on the endothelial dysfunction was conducted in patients with >3 atherosclerotic risk factors. The second Phase II clinical trial with double-blind, randomized, placebo-controlled design was tested in essential mild-hypertensive patients. Both studies were conducted to evaluate the safety profile and efficacious responses of SB221 after repeated oral doses in patients suffering cardiovascular diseases. Preliminary results of the studies showed no meaningful adverse events on these patients.