Coronary Artery Disease ARISE Trial Showed AGI-1067 Did Not Meet Primary Endpoint
LONDON, March 19, 2007-AstraZeneca today announced that its
collaboration partner AtheroGenics, Inc. (Nasdaq: AGIX) revealed
first results from the ARISE (Aggressive Reduction of Inflammation
Stops Events) phase III clinical outcomes trial which studied
AGI-1067, an investigational anti-atherosclerotic agent with
antioxidant and anti-inflammatory effects, in patients with
coronary artery disease (CAD).
The ARISE trial did not meet its primary endpoint of a
statistically significant relative risk reduction in a composite
cardiovascular endpoint of CV death, resuscitated cardiac arrest,
non-fatal myocardial infarction, non-fatal stroke, use of coronary
revascularisation and for angina pectoris with objective evidence
of ischemia.
AstraZeneca and AtheroGenics will now work together to fully analyse the full data set for AGI-1067, including these first results. After completion of the final analysis, under the terms of the licence and collaboration agreement AstraZeneca has a 45-day period in which to decide whether or not to continue with the collaboration.
-Ends-
19 March 2007
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Notes To Editors
The ARISE study
ARISE was a double-blind, randomised, placebo controlled study
which involved more than 6,000 patients with coronary artery
disease from over 250 centres in Canada, South Africa, the UK and
the US. The study was designed to evaluate the additional benefits
of adding AGI-1067 to current standard of care therapies, on
several outcomes due to coronary vascular events such as death,
heart attack, stroke, revascularisation and hospital admission for
unstable angina.
AstraZeneca
AstraZeneca is a major international healthcare business engaged in
the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of $26.47 billion and leading positions in sales
of gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4 Good
Index.
AtheroGenics
AtheroGenics is focused on the discovery, development and
commercialization of novel drugs for the treatment of chronic
inflammatory diseases, including heart disease (atherosclerosis),
rheumatoid arthritis and asthma. In addition to AGI-1067, the
Company has another clinical-stage development programme studying
AGI-1096, a novel, oral agent in Phase I that is being developed
for the prevention of organ transplant rejection in collaboration
with Astellas. AtheroGenics also has preclinical programmes in
rheumatoid arthritis and asthma utilizing its proprietary vascular
protectant technology.
Posted: March 2007