4th May 2005 07:02
AstraZeneca PLC04 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 trialinvolving more than 1700 patients shows a statistically significant reductionversus placebo on the primary outcome of disability after an acute ischemicstroke (p= 0.038), as measured by the Modified Rankin Scale (MRS). However, onthe National Institute of Health Stroke Scale (NIHSS), there was no significantdifference between the treatment groups in measurement of change in neurologicalimpairment. The clinical significance of these findings need to be assessed inlight of the outcome of SAINT II and CHANT. Half of the SAINT I phase III trial's 1700 patients were randomised to receiveCEROVIVE (NXY-059). The incidence and profile of adverse events was similar toplacebo. This result, together with the ongoing phase III SAINT II trial will enableAstraZeneca to continue its evaluation of the efficacy and safety profile ofCEROVIVE (NXY-059) in acute ischemic stroke patients. AstraZeneca plans to fileregulatory submissions in the second half of 2006. Such filings for CEROVIVEwill be dependent on the final data package, including results from SAINT II andCHANT. AstraZeneca is encouraged by these data as acute ischemic stroke is a conditionfor which an effective and well-tolerated treatment is urgently needed.However, the full potential of CEROVIVE will only be clear after completion ofthe clinical development programme. The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide inapproximately 400 centres across 40 countries to evaluate the effect of thecompound in acute ischemic stroke patients. These countries and regionsinclude: Europe, Asia, Australia, New Zealand, South Africa, United States,Canada and Latin America. The CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial will also continueas planned. CHANT is a double-blind, randomised, placebo-controlled,parallel-group, multi-centre, Phase IIb study to assess the safety andtolerability of CEROVIVE (NXY-059) in adult patients with acute intracerebralhemorrhage. The independent data safety monitoring board recently conducted aplanned safety review on the first 200 patients and recommended the trial toproceed per plan. The trial will involve 150 centres in 21 countries. CEROVIVE (NXY-059), an investigational drug under development by AstraZeneca andlicensed from Renovis, Inc., has a proposed mechanism of action of free radicaltrapping. It is being studied as a neuroprotectant in clinical trials based oneffects seen in experimental models of acute ischemic stroke. Modified Rankin Scale (MRS): the most commonly used global disability scale forassessing stroke patients. It is a simple measure of independence primarily usedin the rehabilitation phases of stroke. National Institute of Health Stroke Scale (NIHSS): provides a quantitativeassessment of the neurological examination findings that are most relevant tostroke patients. This scale assesses neurological impairment, providing ameasure of the severity of the stroke and was developed specifically for use inacute stroke trials. -ENDS- Wednesday 4th May 2005 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087 US Investor Enquiries: Ed Seage +1 302 886 4065Jorgen Winroth +1 212 579 0506 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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