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CSL Therapy That Mimics “Good” Cholesterol May Reduce,Plaque Volume in Coronary Arteries

VICTORIA, Australia, March 27, 2007--CSL Limited today announced results from a study published in the Journal of the American Medical Association that suggest infusions of a novel new drug, CSL-111, to acutely raise HDL (“good” cholesterol) levels, may reduce the amount of plaque in the coronary arteries of patients with a recent episode of acute coronary syndrome (ACS).

CSL advised that the Effect of Reconstituted HDL on Atherosclerosis – Safety and Efficacy (ERASE) trial was a phase 2, randomized, blinded, placebo-controlled study conducted at 17 sites throughout Canada and coordinated by the Montreal Heart Institute.

The trial examined whether 4 infusions of CSL-111, given at weekly intervals to patients with a recent episode of ACS, could reduce the volume of plaque in the coronary arteries.

Assessment of the arteries was performed using intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) before and 2-3 weeks after the treatment. IVUS is a technique in which a tiny ultrasound probe is inserted into the coronary arteries to determine the change in plaque during treatment. Coronary angiography is an X-ray examination of the blood vessels.

Dr Andrew Cuthbertson, CSL’s Chief Scientific Officer, advised that 183 patients had received placebo (n=60), 40 mg/kg (n=111) or 80 mg/kg (n=12) of CSL-111. He noted that the higher dosage of CSL-111 was discontinued early because of transient liver function test abnormalities, but the 40mg/kg dose was safe and generally well tolerated.

CSL confirmed that the results were based on data from 145 patients who had 2 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 t
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