AstraZeneca announced today that SAINT II, the phase III clinical trial to evaluate the efficacy of NXY-059/Cerovive on disability in acute ischemic stroke patients, has been recommended to continue as planned following a scheduled interim safety review undertaken by the Independent Data and Safety Monitoring Board (IDMB) and the trial Steering Committee.

The recommendation follows a recent IDMB interim safety analysis of the trial, which included safety data in 1,597 patients. The safety review was agreed following the decision by AstraZeneca to expand the size of the SAINT II trial from 1,700 to 3,200 patients.

"The IDMB's recommendation to continue SAINT II as planned is welcome news," said Tomas Odergren, Vice President of Development, NXY-059/Cerovive, "We interpret this recommendation as further support that NXY-059/Cerovive is well tolerated in acute ischemic stroke patients. This is an important characteristic of NXY-059/Cerovive in a population of patients previously found to be highly vulnerable to adverse effects of many other drug candidates tested to date."

The SAINT II trial aims to confirm the positive findings of the SAINT I trial, which showed NXY-059/Cerovive to be the first neuroprotectant to demonstrate a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke (p=0.038), as measured by the modified Rankin Scale (mRS). Importantly, no major safety concerns or tolerability problems emerged with NXY-059/Cerovive during the conduct of the SAINT I trial, beyond those expected in trials involving patients with acute stroke.

The decision to increase patient enrolment in the SAINT II trial was taken following the SAINT I trial, in order to improve the statistical powering of SAINT II and provide a definitive conclusion to the positive results seen in SAINT I. Dependent on the results of a full evaluation of the efficacy and safety profile of NXY-059/Cerovive from both the SAINT trials, in addition to the phase II CHANT trial, AstraZeneca plans to file regulatory submissions in the first half of 2007.

The SAINT II trial is being conducted worldwide in approximately 350 centres across approximately 30 countries (in Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America) to evaluate the effect of the drug in acute ischemic stroke patients.

CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) is a double-blind, randomized, placebo-controlled, parallel-group, multi-center, Phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of NXY-059/Cerovive in adult patients with acute intracerebral hemorrhage. The trial, which involves 130 centres in 21 countries, has completed recruitment and results are expected in Q1 2006.

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

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products.

AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

CEROVIVE (NXY-059) is a registered trademark of the AstraZeneca group of companies.


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