Coronary Artery Disease ARISE Trial Showed AGI-1067 Did Not Meet Primary Endpoint
- Category: Small Molecules
- Published on Tuesday, 20 March 2007 02:00
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LONDON, UK | Mar 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.
19 March 2007
Patricia O’Connor, Tel: +46 708 46 76 33
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Jörgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065
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 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 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. For more information about AtheroGenics, please visit http://www.atherogenics.com.