( examination of the blood vessels. 183...)CSL Therapy That Mimics 'Good' Cholesterol May Reduce Plaque Volume,in Coronary Arteries,Health

183 patients received placebo (n=60), 40 mg/kg (n=111) or 80 mg/kg (n=12) of CSL-111. The higher dosage of CSL-111 was discontinued early because of transient liver function test abnormalities. The 40mg/kg dose was safe and generally well tolerated.

The results were based on data from 145 patients who had two sequential IVUS procedures. The main findings were that there was a reduction in coronary plaque volume after infusions of CSL-111 of 3.4 percent and after placebo of 1.6 percent, which were not statistically significantly different. However, when compared to baseline, the reduction for patients infused with CSL-111 was statistically significant (p< 0.001), but this was not the case in the placebo group. Other assessments of the plaque, such as characterization indexes or changes in plaque that are different than volume measurements, on IVUS and coronary score on QCA, were significantly different between CSL-111 and placebo. Interestingly, the difference in coronary score between patients that had 4 weeks of CSL-111 and those given placebo was similar to those observed after two years of statin treatment (compared with no statin).

"Overall, these results strongly suggest that CSL-111 is biologically active, and that short term infusions of CSL-111 result in a rapid, favourable effect on coronary atherosclerotic plaque," said Jean-Claude Tardif, M.D., of the Montreal Heart Institute, University of Montreal, and lead author of the study. "These data strongly support the conduct of further clinical studies to assess whether CSL-111 will provide a clinical benefit to patients with ACS."

"This study is a significant step in our development of CSL-111," said Dr. Andrew Cuthbertson, Chief Scientific Officer, CSL Ltd. "CSL recognizes the value that CSL-111 may provide in preventing further cardiovascular events in patients with ACS. We are committed to exploring the full therapeutic potential of this treatme
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