Home  Media Press releases 2004
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| 14 October 2004 | 2004-10-14T00:00:00.0000000+01:00 |
| PHASE III TRIALS FOR CEROVIVE (NXY-059) WILL CONTINUE AS PLANNED FOLLOWING INTERIM DATA ANALYSIS
AstraZeneca announced today that the Phase III trials (SAINT I and II) to determine the effect of CEROVIVE (NXY-059) on disability and neurological recovery in acute ischemic stroke patients will continue as planned. This decision is based upon a recommendation from the Independent Data and Safety Monitoring Board (IDMB) and the trial Steering Committee. | The decision follows a recent IDMB interim analysis of these trials, which included data on stroke outcomes after a three-month follow-up period in 1,000 patients. The purpose of this analysis was to assess whether it would be futile (not meaningful) to continue patient enrolment in the SAINT trials when looking at the degree of post-stroke disability experienced by patients who received drug as compared to patients who received placebo, and to determine if there were safety concerns.
The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide in approximately 400 centres across approximately 40 countries (Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America) to evaluate the effect of the compound in acute ischemic stroke patients. The safety of patients included in the trials is being continually evaluated.
Additionally, the CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial initiated enrolment in August 2004. CHANT is a double-blind, randomized, placebo-controlled, parallel-group, multi-centre, Phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of CEROVIVE (NXY-059) in adult patients with acute intracerebral hemorrhage. The trial will involve 150 centres in 21 countries.
CEROVIVE (NXY-059), a neuroprotectant with free-radical trapping properties, is a drug under development by AstraZeneca and licensed from Renovis, Inc.
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Notes to Editors:
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 over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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