Jan 11, 2007 — FDA approval last week of Anthera’s Investigational New Drug (IND) application for its lead cardiovascular compound A-002 means the company will move forward with a multi-center phase 2 clinical trial (PLASMA — Phospholipase Levels And Serological Markers of Atherosclerosis). The study will examine the effect of A-002 on secretory phospholipase A2 (sPLA2) levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis.
PLASMA is expected to complete enrollment by the fourth quarter of 2007.
"PLASMA is intended to determine whether inhibition of sPLA2, an important trigger of the inflammatory response, can reduce systemic levels of inflammatory markers known to be predictors of coronary heart disease events,” stated Robert S. Rosenson, M.D., professor of Medicine and director, Lipoprotein Disorders and Clinical Atherosclerosis Research, Division of Cardiovascular Medicine at the University of Michigan and the Principal Investigator for the PLASMA trial.
“The study will serve as a basis for future trials that investigate the effects of sPLA2 inhibition on atherosclerosis progression and cardiovascular events."
For more information visit www.PLASMAtrial.com or www.anthera.com .