De: PR Newswire
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: New England Journal of Medicine
Publishes NXY-059 Study, the First International
Study of a Neuroprotectant to Show Reduced
Disability Following Acute Ischemic Stroke
8 de fevereiro de 2006 21:23 HORALOCAL
New England Journal of Medicine Publishes NXY-059
Study, the First International Study of a
Neuroprotectant to Show Reduced Disability
Following Acute Ischemic Stroke
LONDON, Feb. 8 /PRNewswire/ -- 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 <3 vs. mRS >3;
p=0.02), compared to placebo(1).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 centres 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
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 that 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
centres 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(2,3).
The SAINT trials for 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. 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.For further
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.
-- A preliminary analysis of SAINT I was
first presented at the European Stroke Congress
in May 2005.
-- The Modified Rankin Scale (mRS) is a
commonly used global disability scale for
assessing outcome following a stroke, and is a
scale favored by regulatory authorities and
clinicians. It is a simple measure of disability
used in the rehabilitation phases of stroke.
There are six outcome levels on the scale,
progressing from no disability (mRS=0) to severe
-- Grade 0= No symptoms at all
-- Grade 1= No significant disability despite
symptoms; able to carry out all usual duties and
-- Grade 2= Slight disability; unable to
carry out all usual duties and activities
-- Grade 3= Moderate disability; requiring
some help, but able to walk without assistance
-- Grade 4= Moderate severe disability;
unable to walk without assistance, and unable to
attend to own bodily needs without assistance
-- Grade 5= Severe disability; bedridden,
incontinent, and requiring constant nursing care
-- The National Institute of Health Stroke
Scale (NIHSS) provides a quantitative assessment
of the neurologic examination. This scale
assesses neurologic impairment, providing a
measure of stroke severity.
-- 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 NXY-059 in adult patients with
acute intracerebral hemorrhage. This study is
complete and is due to report in Q1 2006.
-- There are two major types of stroke:
ischemic and hemorrhagic.
-- Ischemic stroke occurs when the blood
supply to an area of the brain is interrupted in
some manner, i.e. a blood clot blocks or plugs a
blood vessel in the brain. The clot can be
formed in a blood vessel supplying the brain
when the wall of unhealthy arteries becomes
clogged with a build-up of fatty deposits and
cholesterol. Alternatively, the clot can be
formed in another part of the body, usually the
heart, and then travel up to the brain.
Approximately 88% of strokes in the U.S. are
-- Hemorrhagic stroke occurs when a blood
vessel ruptures with consequent bleeding in or
on the surface of the brain. Hemorrhagic strokes
can be caused by a number of disorders that
affect the blood vessels, including
long-standing high blood pressure and cerebral
aneurysms. An aneurysm is a weak or thin spot on
a blood vessel wall.
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(R), one of the fastest growing global
antipsychotics and ZOMIG(R), 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, stroke, pain control and anesthesia.
1. Lees, K.R.et al. NXY-059 for Acute
Ischaemic Stroke: the SAINT I Trial. New England
Journal of Medicine, 354;6; 32-44
2. Kuroda S, Tsuchidate R, Smith M-L, et al.
Neuroprotective effects of a novel nitrone, NXY-059,
after transient focal ischemia in the rat. J
Cereb Blood Flow Metab 1999;18:778-787.
3. Sydserff SG, Borelli AR, Green AR, et al.
Effect of NXY-059 on infarct volume after
transient or permanent middle cerebral artery
occlusion in the rat; studies on dose, plasma
concentration and therapeutic time window. Br J
4. Van Swieten JC, Koudstaal PJ, Visser MC,
Schouten HJA, Van Gijn J. Interobserver
agreement for the assessment of handicap in
stroke patients. Stroke. 1988; 19:604-607.5.
2006 AHA Heart Disease and Stroke Statistics.
. Accessed on January, 23, 2006.
CONTACT: Julie Saunders of AstraZeneca,
+44-7810-528368, or Julie.Saunders@AstraZeneca.com;
or Anne Ferguson
of Porter Novelli, +44-207-853-2285, or
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