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Novel Apolipoprotein A-I Therapy, CSL112, May Represent New Option for Reducing Recurrent Heart Attack Risk, Early CSL Studies Show
Date:11/5/2012

LOS ANGELES, Nov. 5, 2012 /PRNewswire/ -- Infusions of a novel formulation of apolipoprotein A-I (apoA-I) – the main component of high-density lipoprotein (HDL) – rapidly increased the presence of key biomarkers associated with reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance, according to data from a Phase 1 study sponsored by CSL Limited. Rapid removal of cholesterol following a heart attack may play a role in stabilizing vulnerable plaque lesions and lowering the high risk of subsequent attacks.

"In our study, CSL112 dramatically elevated measures of cholesterol efflux capacity, a newly recognized marker of HDL function, and rapidly raised blood levels of apoA-I," said Andreas Gille, MD, PhD, CSL Head of Clinical and Translational Science Strategy, and lead study author. "This is a very exciting early finding when viewed in the context of reducing the risk of recurrent heart attacks. We look forward to further developing CSL112 with the goal of meeting a significant unmet medical need in the acute coronary syndrome patient population."

Data from two CSL112 Phase 1 studies presented at the American Heart Association (AHA) meeting demonstrated a positive safety and pharmacokinetic (PK) profile for CSL112, warranting progression to Phase 2 development. CSL112 will be studied for the early reduction of recurrent cardiovascular events in acute coronary syndrome (ACS) patients.

Study Design and Key Findings
Biomarkers of cholesterol movement following infusions of CSL112 were observed in 36 healthy subjects. Three dosing regimens were studied, including 4 once-weekly infusions of 3.4g, 4 once-weekly infusions of 6.8g, and 8 twice-weekly infusions of 3.4g. Subjects were randomized to CSL112 or placebo (3:1, respectively). All biomarker responses were dose dependent and showed similar magnitude and tim
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