NEW ORLEANS, March 26 /CNW/ -- 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).
ACS is the term used to describe unstable angina and myocardial
infarction (heart attack). It is estimated to be responsible for up to
600,000 admissions to the hospital per year in the US. Despite improvements
in management over many years, ten to fifteen percent of patients still
experience a serious cardiovascular problem in the 12 months following an
episode of ACS.
CSL-111 is a patented biologic product, consisting of apolipoprotein A-I
purified from human plasma that is reconstituted to form a particle that
chemically and biologically resembles human HDL. A 40 mg/kg dose of CSL-111
results in an approximately 50 percent elevation in blood HDL levels, which
remain above normal for one week. It was discovered and is manufactured at
CSL Behring in Switzerland.
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 four 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 two-three 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.
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
"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 treatment and will consult with international experts to
evaluate next steps."
FORWARD LOOKING STATEMENT
The materials in this presentation speak only as of the date of these
materials, and include forward looking statements about our financial results
and estimates, business prospects and products in research that involve
substantial risks and uncertainties, many of which are outside the control of,
and are unknown to, CSL. You can identify these statements by the fact that
they use words such as "anticipate," "estimate," "expect," "project,"
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terms of similar meaning in connection with any discussion of future operating
or financial performance. Among the factors that could cause actual results
to differ materially are the following: the success of research and
development activities, decisions by regulatory authorities regarding whether
and when to approve our drug applications as well as their decisions regarding
labeling and other matters that would affect the commercial potential of our
products; competitive developments affecting our current growth products; the
ability to successfully market new and existing products in Australia and
other countries; difficulties or delays in manufacturing; trade buying
patterns, fluctuations in interest and currency exchange rates; legislation or
regulations throughout the world that affect product production, distribution,
pricing, reimbursement or access; legal defense costs, insurance expenses,
settlement costs and the risk of an adverse decision or settlement relating to
product liability, patent protection or governmental investigations, growth in
costs and expenses; and CSL's ability to protect its patents and other
intellectual property throughout the world. The statements being made in this
presentation do not constitute an offer to sell, or solicitation of an offer
to buy, any securities of CSL.
CSL is a global specialty biopharmaceutical company that develops,
manufactures and markets products to treat and prevent serious human medical
conditions. Innovation and new product development for unmet medical needs
continue to drive CSL's growth.
The CSL Group includes: CSL Behring, CSL Bioplasma and CSL Biotherapies
For more information about CSL Limited, visit http://www.csl.com.au .
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