Home  Media Press releases 2005
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| 4 May 2005 | 2005-05-04T01:00:00.0000000+01:00 |
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FIRST RESULTS FROM SAINT I TRIAL SHOW ASTRAZENECA’S CEROVIVE (NXY-059) DEMONSTRATES A REDUCTION IN DISABILITY IN PATIENTS WITH ACUTE ISCHEMIC STROKE
AstraZeneca today announced that a first analysis of data from the SAINT I trial involving more than 1700 patients shows 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). However, on the National Institute of Health Stroke Scale (NIHSS), there was no significant difference between the treatment groups in measurement of change in neurological impairment. The clinical significance of these findings need to be assessed in light of the outcome of SAINT II and CHANT.
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Half of the SAINT I phase III trial’s 1700 patients were randomised to receive CEROVIVE (NXY-059). The incidence and profile of adverse events was similar to placebo.
This result, together with the ongoing phase III SAINT II trial will enable AstraZeneca to continue its evaluation of the efficacy and safety profile of CEROVIVE (NXY-059) in acute ischemic stroke patients. AstraZeneca plans to file regulatory submissions in the second half of 2006. Such filings for CEROVIVE will be dependent on the final data package, including results from SAINT II and CHANT.
“We are encouraged by these data and what this could mean for stroke patients, as acute ischemic stroke is a condition for which an effective and well tolerated treatment is urgently needed. However, the full potential of CEROVIVE will only be clear after completion of the clinical development programme”, commented Dr Tomas Odergren, Global Product Director for CEROVIVE (NXY-059) at AstraZeneca.
The SAINT trials for CEROVIVE (NXY-059) 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.
The CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial will also continue as planned. CHANT is a double-blind, randomised, placebo-controlled, parallel-group, multi-centre, Phase IIb study to assess the safety and tolerability of CEROVIVE (NXY-059) in adult patients with acute intracerebral hemorrhage. The independent data safety monitoring board recently conducted a planned safety review on the first 200 patients and recommended the trial to proceed per plan. The trial will involve 150 centres in 21 countries.
CEROVIVE (NXY-059), 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.
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Notes to Editors:
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.
· In Neuroscience, AstraZeneca markets several products including SEROQUEL, one of the fastest growing global antipsychotics; and ZOMIG, a migraine therapy and a leader within the global triptan market. The Neuroscience pipeline includes investigational compounds for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.
· All product names appear in upper case. CEROVIVE is a trademark of the AstraZeneca group of companies.
· Modified Rankin Scale (MRS): the most commonly used global disability scale for assessing stroke patients. It is a simple measure of independence primarily used in the rehabilitation phases of stroke.
· National Institute of Health Stroke Scale (NIHSS): provides a quantitative assessment of the neurological examination findings that are most relevant to stroke patients. This scale assesses neurological impairment, providing a measure of the severity of the stroke and was developed specifically for use in acute stroke trials.
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