New England Journal of Medicine Publishes NXY-059 Study, the First International Study of a Neuroprotectant to Show Reduced Disa
February 08 2006 - 5:01PM
PR Newswire (US)
WILMINGTON, Del., Feb. 8 /PRNewswire-FirstCall/ -- 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 less than
or equal to 3 vs. mRS >3; p=0.02), compared to placebo. 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 centers 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 fantastic
achievement." 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 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
centers 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. The SAINT trials for NXY-059 are
being conducted worldwide in approximately 400 centers 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. This press release
contains forward-looking statements with respect to AstraZeneca's
business. By their nature, forward-looking statements and forecasts
involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a
number of factors that could cause actual results and developments
to differ materially. For a discussion of those risks and
uncertainties, please see the company's Annual Report/Form 20-F for
2004. First Call Analyst: FCMN Contact:
Cheryl.vitale@astrazeneca.com DATASOURCE: AstraZeneca CONTACT:
Julia Walker of AstraZeneca, +1-302-885-5172 Web site:
http://www.astrazeneca-us.com/ Company News On-Call:
http://www.prnewswire.com/comp/985887.html
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