CSL presents positive data for potential new heart attack therapy

Australian blood products and vaccine maker CSL (ASX:CSL) says results of a Phase IIa trial of CSL112 in patients with stable cardiovascular disease have shown a dramatic and rapid increase in key indicators of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance.

Rapid removal of cholesterol following a heart attack may be a new mechanism for stabilizing vulnerable plaque lesions and lowering the high risk of subsequent attacks, says CSL, which presented the study results at the American Heart Association 2013 Scientific Session.

CSL112 is a novel formulation of apolipoprotein A-I (apoA-I), the active component of high-density lipoprotein (HDL) or “good cholesterol.” It is purified from human plasma and reconstituted to form HDL particles suitable for intravenous infusion. Effectively, instead of discarding unused blood components left over from making hemophilia, burns and immune-system treatments, CSL could extract HDL and infuse it into patients

Will proceed to Ph IIb

The Phase IIa study was a randomized, multicenter, double-blind, placebo-controlled trial that evaluated the effects of a single-dose administration of CSL112 in 44 patients over a 90 day period. In addition to positive results for key biological indicators, the trial data also demonstrated favorable safety and tolerability for this potential new therapy and have given CSL confidence to proceed to a phase 2b study.

“Patients who experience an acute coronary event have a high risk of suffering another heart attack, stroke or other cardiovascular event, particularly within the first 30 days,” said Andrew Cuthbertson, chief scientist for CSL, adding: “The results of this clinical study of CSL112 support our continued enthusiasm for its development as a novel approach to address this important treatment void.”

CSL has announced a global Phase IIb clinical trial program which will include sites in Australia. The trial will seek to assess multiple dose administration of CSL112 compared with placebo in about 1,200 heart attack patients. The final design of the trial is currently being reviewed by regulators.

Philip Aylward, Cardiologist at the South Australian Health and Medical Research Institute and Director of Medicine, Cardiac and Critical Care at Flinders Medical Centre, will lead the Australian arm of the study which will involve a number of sites nationally.

“We know there is a need for better approaches to reduce the high risk of early recurrent cardiovascular events after a heart attack,” said Prof Aylward, adding: “CSL112 is a promising treatment targeting the unstable coronary plaques causing these events and deserves further investigation.”