Sinai Hospital reports results from Phase 2a trial of apo A-I infusion therapy CSL112

Researchers from the Sinai Center for Thrombosis Research presented findings from a Phase 2a trial substudy that examined the antiplatelet effects of CSL112, a novel apolipoprotein A-I (apo A-I) infusion therapy, at the American Heart Association 2013 Scientific Sessions.

The Phase 2a study evaluated the safety and pharmacokinetic and pharmacodynamic properties of a single dose of CSL112 in patients with stable atherothrombotic disease on chronic dual antiplatelet therapy. Results presented by Pierluigi Tricoci, MD, PhD, MHS, Duke Clinical Research Institute showed that CSL112 increased apo A-I levels, the active component of HDL and there were no serious adverse events reported.

Further, results presented by Andreas Gille, MD, PhD, CSL Limited showed that CSL112 also enhanced key biomarkers of the early steps of reverse cholesterol transport with strong elevations in cholesterol efflux capacity observed across all CSL112 regimens.

Paul A. Gurbel, MD, Director, Sinai Center for Thrombosis Research at the Sinai Hospital of Baltimore led an important evaluation of platelet function to assess the potential antiplatelet properties of CSL112. In a separate presentation, Gurbel reported that CSL112 did not significantly influence platelet aggregation in response to arachidonic acid, adenosine diphosphate and collagen.

"CSL112 is a promising new treatment for patients with high risk cardiovascular disease," said Gurbel. "Since CSL112 had no significant influence on platelet aggregation, it is anticipated that patients should not face an increased bleeding risk while receiving this infusion therapy along with concomitant antiplatelet agents."