Vasogen Announces Results from Phase III SIMPADICO Trial in Peripheral Arterial Disease
Study Did Not Meet Primary Endpoint
Vasogen Inc. announced the results from the 553-patient phase III SIMPADICO trial of its Celacade(TM) technology (Celacade) in peripheral arterial disease (PAD). While the SIMPADICO study did not reach the primary endpoint of change in maximal treadmill walking distance, Celacade significantly reduced high sensitivity C-reactive protein (hs-CRP), a pre-specified endpoint and a widely recognized Marker of systemic inflammation associated with increased cardiovascular risk, including heart failure, stroke, and heart attack.
"We are obviously disappointed that Celacade was not shown to improve walking distance in PAD, one of the most difficult endpoints in which to demonstrate a therapeutic benefit," stated Dr. Jeffrey Olin, Professor of Medicine at the Mount Sinai School of Medicine. "It is very interesting to note, however, the finding of a significant reduction in C-reactive protein, a well recognized inflammatory marker that is associated with increased risk of cardiovascular events. Given this finding, and the fact that otherwise successful therapies have failed to demonstrate a walking distance improvement in PAD, I look forward to the results of the ongoing trial of Celacade in chronic heart failure, where inflammation plays an important role."
Scientific evidence and findings from both clinical and population studies indicate that chronic inflammation contributes to the development and progression of atherosclerosis, leading to heart attack, stroke, and PAD, and is important in the development and progression of heart failure. C-reactive protein (CRP) is a non-specific acute-phase reactant produced by the liver in response to inflammation and is a valuable marker of cardiovascular risk. Prospective studies have shown high sensitivity CRP (hs-CRP) to be a predictor of increased cardiovascular risk in both men and women and that it may be a better predictor of the risk for heart attacks than cholesterol. Evidence suggests patients with elevated hs-CRP and normal cholesterol levels are at greater risk than those with normal hs-CRP and high cholesterol levels.
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