AstraZeneca PLC
26 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 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.'
-Ends-
26 October 2006
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