Cerovive

AstraZeneca PLC 04 May 2005 FIRST RESULTS FROM SAINT I TRIAL SHOW ASTRAZENECA'S CEROVIVE (NXY-059) DEMONSTRATES A REDUCTION IN DISABILITY IN PATIENTS WITH ACUTE ISCHEMIC STROKE SAINT II and CHANT trials for CEROVIVE will continue as planned AstraZeneca today announced that a first analysis of data from the SAINT I trial involving more than 1700 patients shows a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke (p= 0.038), as measured by the Modified Rankin Scale (MRS). However, on the National Institute of Health Stroke Scale (NIHSS), there was no significant difference between the treatment groups in measurement of change in neurological impairment. The clinical significance of these findings need to be assessed in light of the outcome of SAINT II and CHANT. Half of the SAINT I phase III trial's 1700 patients were randomised to receive CEROVIVE (NXY-059). The incidence and profile of adverse events was similar to placebo. This result, together with the ongoing phase III SAINT II trial will enable AstraZeneca to continue its evaluation of the efficacy and safety profile of CEROVIVE (NXY-059) in acute ischemic stroke patients. AstraZeneca plans to file regulatory submissions in the second half of 2006. Such filings for CEROVIVE will be dependent on the final data package, including results from SAINT II and CHANT. AstraZeneca is encouraged by these data as acute ischemic stroke is a condition for which an effective and well-tolerated treatment is urgently needed. However, the full potential of CEROVIVE will only be clear after completion of the clinical development programme. The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide in approximately 400 centres across 40 countries to evaluate the effect of the compound in acute ischemic stroke patients. These countries and regions include: Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America. The CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial will also continue as planned. CHANT is a double-blind, randomised, placebo-controlled, parallel-group, multi-centre, Phase IIb study to assess the safety and tolerability of CEROVIVE (NXY-059) in adult patients with acute intracerebral hemorrhage. The independent data safety monitoring board recently conducted a planned safety review on the first 200 patients and recommended the trial to proceed per plan. The trial will involve 150 centres in 21 countries. CEROVIVE (NXY-059), an investigational drug under development by AstraZeneca and licensed from Renovis, Inc., has a proposed mechanism of action of free radical trapping. It is being studied as a neuroprotectant in clinical trials based on effects seen in experimental models of acute ischemic stroke. Modified Rankin Scale (MRS): the most commonly used global disability scale for assessing stroke patients. It is a simple measure of independence primarily used in the rehabilitation phases of stroke. National Institute of Health Stroke Scale (NIHSS): provides a quantitative assessment of the neurological examination findings that are most relevant to stroke patients. This scale assesses neurological impairment, providing a measure of the severity of the stroke and was developed specifically for use in acute stroke trials. -ENDS- Wednesday 4th May 2005 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 US Investor Enquiries: Ed Seage +1 302 886 4065 Jorgen Winroth +1 212 579 0506 This information is provided by RNS The company news service from the London Stock Exchange

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AstraZeneca (AZN)
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