AstraZeneca PLC
04 May 2005
FIRST RESULTS FROM SAINT I TRIAL SHOW ASTRAZENECA'S CEROVIVE (NXY-059)
DEMONSTRATES A REDUCTION IN DISABILITY IN PATIENTS WITH ACUTE ISCHEMIC STROKE
SAINT II and CHANT trials for CEROVIVE will continue as planned
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.
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.
AstraZeneca is encouraged by these data 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.
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.
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.
-ENDS-
Wednesday 4th May 2005
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