26th Oct 2006 07:01
AstraZeneca PLC26 October 2006 AstraZeneca Announces SAINT II Trial Results NXY-059 Showed No Efficacy in Acute Ischaemic Stroke Results from the SAINT II (Stroke Acute Ischemic NXY-059 Treatment) trial,announced today by AstraZeneca, showed that the investigational drug NXY-059 didnot meet its primary outcome of a statistically significant reduction instroke-related disability, as assessed by the modified Rankin Scale (mRS) (p=0.33, odds ratio 0.94) compared to placebo. Subgroup analyses, including time to treatment, did not demonstrate a treatmentbenefit. In addition, NXY-059 did not cause a statistically significant improvement inneurological status versus placebo on the National Institutes of Health StrokeScale (NIHSS) (p=0.70). There was no evidence of NXY-059 lowering the incidence of symptomaticintracranial haemorrhage when administered with rt-PA (p=0.56). Mortality and the incidence and profile of adverse events in patients receivingNXY-059 were similar to placebo. Tomas Odergren, Vice President, Global Product Director for NXY-059, said: "NXY-059's lack of efficacy in the SAINT trial II is disappointing for strokepatients in view of the significant unmet medical need. AstraZeneca plans nofurther development of NXY-059 in acute ischemic stroke but will analyse thepooled data from the SAINT I and SAINT II trials in close cooperation with theSAINT Steering Committee and Renovis, to ensure learnings for further strokeresearch are identified and communicated." AstraZeneca will work with the SAINT II Steering Committee to ensure that thedata is presented at the International Stroke Congress meeting in February 2007. John Patterson, Executive Director of Development, AstraZeneca said: "Theseclinical trial results, while not without precedent given the challenging natureof the science, are disappointing for patients looking for new treatments forstroke and for AstraZeneca as we seek to build our research and developmentpipeline." -Ends- 26 October 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033Chris Major, Tel: +44 (0) 207 304 5028 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Jorgen Winroth, Tel: +1 (212) 579 0506Ed Seage, Tel: +1 302 886 4065 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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