Aterovax's sPLA2 Activity Test Significantly Improves Prediction of Cardiovascular Events in Large Prospective Study.

Data Presented at American Heart Association Scientific Sessions

PARIS -- Aterovax SA, a company developing innovative products for atherosclerosis, today announced data demonstrating that its blood test for secretory phospholipase A2 (sPLA2) activity significantly improves cardiovascular risk prediction in patients with stable coronary artery disease (CAD) over a 5 year period, independent of established risk markers, including C-reactive protein. sPLA2 is in a family of pro-inflammatory enzymes linked to the formation and destabilization of atherosclerotic plaques. Aterovax's sPLA2 activity test was used in 3778 patients in the PEACE (Prevention of Events with Angiotensin ConvertingEnzyme Inhibition) trial and the results were presented at the American Heart Association's annual scientific sessions.

"There is growing evidence that testing for sPLA2 activity may provide an additional layer of information that goes above and beyond traditional cardiovascular risk factors and biomarkers," noted lead investigator in the study, Michelle O'Donoghue of the TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital in Boston.

"This study continues to support the role of sPLA2 activity as a prognostic tool for assessing cardiovascular risk," Dominique Surun, CEO of Aterovax explained. "We believe our test for sPLA2 activity, once approved, could provide highly relevant information to help identify individuals who are at increased risk of cardiovascular events."

Study Details

The PEACE trial is a randomized, multi-center study of trandolapril vs placebo in 8,290 patients with stable coronary artery disease (CAD). sPLA2 activity levels identified individuals at increased risk of cardiovascular death (CVD) and the combination of CVD, myocardial infarction (MI) or stroke during 5 years of follow-up. After adjusting for baseline differences, individuals with the highest levels of sPLA2 activity had a 78% higher risk of CVD and a 56% higher risk of CVD, MI or stroke than patients with the lowest levels of sPLA2 activity. In addition, sPLA2 activity was a stronger marker for risk prediction than other established biomarkers, including C-reactive protein and lipoprotein-associated phospholipase A2.

About Atherosclerosis and sPLA2

Although clinical complications of atherosclerosis can arise from narrowing of the arteries, the most severe clinical events follow the rupture of a plaque. Inflammation, which is implicated in the formation of early fatty streaks as well as at the onset of adverse cardiovascular events, causes cells within the plaque to secrete enzymes that degrade and weaken the fibrous cap, leading to rupture of unstable plaques and thrombus (clot) formation. Ruptured plaques are the cause of acute coronary events and sudden cardiac death. However, thrombotic complications that arise from rupture or fissure (small rupture) of a vulnerable plaque may be clinically silent, yet contribute significantly to plaque progression and ultimately stenosis. It is therefore important to identify patients in whom disruption of a vulnerable plaque is likely to result in a clinical event.

The phospholipases A2 (PLA2) superfamily of enzymes plays a key role in the inflammatory process by generating chemical intermediates. By detecting the activity of secretory PLA2 (sPLA2), the risk of experiencing a cardiovascular event can be determined. Recently, nine large independent international clinical studies, both in clinical and non-clinical populations, demonstrated the strong positive correlation existing between sPLA2 activity and atherosclerotic cardiovascular disease.

About Aterovax

Aterovax is developing innovative products for the cardiovascular disease market based on a unique understanding of atherosclerosis, the condition responsible for most cardiovascular problems. Aterovax's first product is a diagnostic blood test to measure activity of secretory phospholipase A2 (sPLA2), a powerful biomarker that provides physicians with clinically relevant information about the presence of a destabilized atherosclerotic plaque. Detecting and measuring this complex processes is critical to monitoring the pathology of atherosclerosis. Currently, the sPLA2 activity test is only available for research applications however, when approved by regulatory authorities it will be used to diagnose coronary heart disease in asymptomatic individuals and to predict pathological events in patients with existing cardiovascular disease. In the future, Aterovax aims to leverage its expertise to develop additional immunotherapeutic products that prevent atherosclerotic plaque formation and progression, thereby covering the continuum from cardiovascular disease diagnosis to treatment. The Company was founded in Paris, France in 2006 with financing from the SEFTI fund, a specialist European cardiovascular fund from Societe Generale Asset Management. For more information visit www.aterovax.com.