New England Journal of Medicine Publishes NXY-059 Study, the First International Study of a Neuroprotectant to Show Reduced Disa

WILMINGTON, Del., Feb. 8  /PRNewswire-FirstCall/ -- Results from the SAINT I (Stroke Acute Ischemic NXY-059 Treatment) trial, published today in the New England Journal of Medicine, report the effect of AstraZeneca's investigational drug, NXY-059, intended for the treatment of acute ischemic stroke (AIS).  The data showed a statistically significant reduction with NXY- 059 versus placebo on the primary outcome of stroke-related disability, as assessed on the Modified Rankin Scale (mRS) (p=0.038 at 90 days). Additional analysis of the data showed a reduction in the disability of patients at both ends of the scale, with 4.4 percent more patients treated with NXY-059 becoming free of symptoms (mRS 0 vs. mRS > 0; p=0.003) and 3.7 percent more patients able to walk without help and being less dependent on others for bodily needs (mRS less than or equal to 3 vs. mRS  >3; p=0.02), compared to placebo.

SAINT I was a double blind, placebo-controlled phase III study, in which patients were randomized to receive NXY-059 or placebo within six hours of AIS. The study involved 1,722 patients in 158 centers from 24 countries. Clinical benefit was seen at the earliest time point assessed (7 days), and persisted through the end of the study (90 days). The treatment effects were not affected by the time to treatment, the severity of stroke, or use of thrombolysis.

Professor Kennedy Lees, Principal Investigator and Professor of Cerebrovascular Medicine at the University of Glasgow, UK, commented, "This is an exciting result. A treatment confirmed to reduce disability in such a wide range of stroke patients could have a profound effect on the number of families that are devastated by stroke. For a condition that carries a worse prognosis than most forms of cancer, the development of a completely new approach to treatment would be a fantastic achievement."

NXY-059 did not significantly improve neurologic function as measured on the National Institutes of Health stroke scale (NIHSS).  Mortality was unaltered by treatment with NXY-059 compared with placebo.  The most common adverse events for NXY-059 in the study were fever (19 vs. 19.2 percent for NXY-059 and placebo, respectively), constipation (9.8 vs. 11.7 percent), headache (9.6 vs. 9.7 percent), urinary tract infection (8.9 vs. 6.8 percent), stroke in evolution (6.5 versus 8.1 percent) and hypokalemia (6.4 vs. 4.4 percent).

The incidence of symptomatic intracranial hemorrhage (ICH) in patients treated with NXY-059 and alteplase, a tissue plasminogen activator (rt-PA), was lower than in patients treated with placebo and rt-PA (2.5 percent vs. 6.4 percent, p=0.036, post-hoc analysis).

Dr. Tomas Odergren, Global Product Director for NXY-059 at AstraZeneca added: "The results of SAINT I suggest disruption of the ischemic cascade through neuroprotection, which is the proposed mechanism of action for NXY- 059, could have clinical application for a broad range of patients suffering an acute ischemic stroke.  The second phase III study, SAINT II, which will involve 3,200 patients at approximately 350 centers around the world, is well underway."

NXY-059 is an investigational drug under development by AstraZeneca and licensed from Renovis, Inc.  NXY-059 has a proposed mechanism of action of free radical trapping and is being studied as a neuroprotectant in clinical trials based on positive effects seen in experimental models of acute ischemic stroke.

The SAINT trials for NXY-059 are being conducted worldwide in approximately 400 centers 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.  SAINT II is due to report in the first half of 2007.

Subsequent to the outcomes of the CHANT and SAINT II trials, AstraZeneca plans to file regulatory submissions for NXY-059 in Europe and the U.S. in the first half of 2007.

This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2004. 

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