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Phosphagenics Reports Superior Pre-clinical Cholesterol Results from APA-01 and Atorvastatin Combination
Date:1/30/2008

as opposed to atorvastatin alone. The combination also caused a decrease of 92% in triglycerides levels compared to 72% with atorvastatin alone.

Effects on Biomarkers of Inflammation

APA-01, combined with atorvastatin, enhanced the statin's effects on lowering inflammation that contributes to the development of atherosclerotic plaques. Reductions occurred in final plasma levels of 23 cytokines that were measured. Following 24 weeks of treatment with various doses of APA-01 and atorvastatin, a statistically significant reduction occurred in a number of cytokines including IL-1B, IL-10, G-CSF, GM-CSF, IFN-y, MCP-1, and RANTES compared to control and these decreases were greater than with either compound alone and appeared to be somewhat dose-dependent.

Effects on Atherosclerotic Plaque Progression

Atherosclerotic lesions were significantly elevated following incorporation of the high-fat high-cholesterol diet in all animals compared to animals maintained on the regular, rodent diet for the 24-week study period. The effect of the combination treatment of APA-01 combined with atorvastatin appeared to cause a trend toward decreased aortic lesions, but these were not statistically significant.

Commenting on the study results, Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said, "Current therapies for atherosclerosis focus on drugs that lower serum cholesterol levels. Experimental and clinical evidence suggests that the efficacy of these drugs may also be related to their ability to reduce oxidative stress and inflammation in the endothelium, or blood vessel lining, where atherosclerotic plaques develop. We believe that APA-01's apparent enhancement of a statin's anti-inflammatory functions could potentially provide a novel therapeutic approach to treating atherosclerosis."

Atorvastatin is the world's largest selling drug with sales of US$13.6 billion annually and is the primary contributor to
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SOURCE Phosphagenics Limited
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