Dr. Tomas Odergren, Global Product Director for NXY-059 at AstraZeneca, commented: “Our evolving understanding of the safety and tolerability profile of NXY-059 in acute stroke conditions is enhanced greatly by the CHANT trial results. The results show that NXY-059 was well tolerated in the studied patients with intracerebral hemorrhage and that the overall safety profile was similar to the profile seen in Acute Ischemic Stroke patients in SAINT I. The potential implications on the way the drug may be used to treat Acute Ischemic Stroke will be subject to the outcome of the second pivotal phase III trial, SAINT II and regulatory approvals.”
CHANT was a double-blind, randomized, placebo-controlled, parallel-group, multi-centre, phase IIb study to evaluate the safety and tolerability of NXY-059 in patients with acute ICH. Stroke outcomes were explored as a secondary objective. Patients were randomised to receive NXY-059 or placebo within six hours of ICH onset. A total of 603 patients from 20 countries were treated.
Safety and tolerability in the CHANT trial were assessed in terms of mortality, adverse events, neuroimaging scans, presence of abnormal findings on vital signs, laboratory assessments and by electrocardiography (ECG). Stroke outcomes were explored using a range of stroke scales including the modified Rankin Scale (mRS), Barthel Index and National Institutes of Health Stroke Scale (NIHSS).
NXY-059 is being studied as a neuroprotectant in phase III clinical trials for the treatment of acute ischemic stroke by AstraZeneca and licensed from Renovis, Inc. NXY-059 has a proposed mechanism of action of free radical trapping.
The phase III efficacy SAINT trials for NXY-059 in acute ischemic stroke (AIS) are being conducted worldwide in approximately 400 centres 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.
Dependent on the outcome of the SAINT II trial, AstraZeneca plans to file regulatory submissions for NXY-059 for acute ischemic stroke in Europe and the U.S. in the first half of 2007.
- ENDS -
March 14, 2006
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Notes to Editors:
- NXY-059 was previously referred to as ‘Cerovive’. NXY-059 will be used from this point forward until a global trademark has been approved.
- The Modified Rankin Scale (mRS) is a commonly used global disability scale for assessing outcome following a stroke, and is a scale favoured by regulatory authorities and clinicians. It is a simple measure of disability used in the recovery and rehabilitation phases of stroke. There are six outcome levels on the scale, progressing from no disability (mRS=0) to severe disability (mRS=5).
- The phase III 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 acute ischemic stroke (AIS). The study involved 1,722 patients in 158 centres from 24 countries.
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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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