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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

e course after the first and last infusions.

An overall elevation in cholesterol efflux capacity, PreBeta1-HDL, and HDL in serum or plasma was observed among all dosing regimens. PreBeta1-HDL was increased 20-fold among dosing regimens. Cholesterol efflux capacity and PreBeta1-HDL peaked immediately following infusion and returned to near baseline at 24 hours. HDL level increased following PreBeta1-HDL, peaked at 24 to 48 hours, and sustained elevation 72 hours after infusion.

Safety and PK profiles were separately evaluated in the 36 healthy patients receiving the three dosing regimens of CSL112.  No treatment-emergent serious adverse events (AE) were reported, no abnormalities were observed in serum biochemistry, hematology and urine parameters, and no significant changes were seen in platelet function, vital signs or ECG associated with CSL112 treatment. The most common AE reported was vessel puncture site hematoma (18 of 36), which was reported by similar proportions of patients receiving either CSL112 or placebo.

"Development of products that increase cholesterol efflux from the artery wall represents an emerging area in atherosclerosis discovery," said Dr. Samuel Wright, PhD, Global Strategic Director for Cardiovascular Therapeutics at CSL Limited and study co-author. "Prior approaches have centered on addressing only HDL cholesterol levels. CSL112 holds promise as a new therapy that may be used in addition to other treatments, such as anti-platelet agents, to provide early event reduction."

Additional CSL112 Research
Data from a randomized single ascending dose study of 57 healthy subjects were also presented at the AHA 2012 Scientific Sessions and demonstrated that a single infusion of CSL112 at dose levels of 5 to 135 mg/kg immediately caused dose-proportional elevation in apoA-I and changes to key biomarkers of the early steps in reverse cholesterol transport. These changes from baseline occurred in a dose- a
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SOURCE CSL Limited
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