AstraZeneca Announces SAINT II Trial Results Showed No Efficacy in Acute Ischaemic Stroke
26 October 2006
Results from the SAINT II (Stroke Acute Ischemic NXY-059 Treatment) trial, announced today by AstraZeneca, showed that the investigational drug NXY-059 did not meet its primary outcome of a statistically significant reduction in stroke-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 treatment benefit.
In addition, NXY-059 did not cause a statistically significant improvement in neurological status versus placebo on the National Institutes of Health Stroke Scale (NIHSS) (p=0.70).
There was no evidence of NXY-059 lowering the incidence of symptomatic intracranial haemorrhage when administered with rt-PA (p=0.56).
Mortality and the incidence and profile of adverse events in patients receiving NXY-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 stroke patients in view of the significant unmet medical need. AstraZeneca plans no further development of NXY-059 in acute ischemic stroke but will analyse the pooled data from the SAINT I and SAINT II trials in close cooperation with the SAINT Steering Committee and Renovis, to ensure learnings for further stroke research are identified and communicated.”
AstraZeneca will work with the SAINT II Steering Committee to ensure that the data is presented at the International Stroke Congress meeting in February 2007.
John Patterson, Executive Director of Development, AstraZeneca said: “These clinical trial results, while not without precedent given the challenging nature of the science, are disappointing for patients looking for new treatments for stroke and for AstraZeneca as we seek to build our research and development pipeline.“
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