Headline Results From CHANT Safety and Tolerability Study In Intracerebral Hemorrhage (ICH) Show NXY-059 Achieved Key Endpoints
14 Mars 2006 - 9:30AM
PR Newswire (US)
WILMINGTON, Del., March 14 /PRNewswire-FirstCall/ -- AstraZeneca
today announced results from the phase IIb safety and tolerability
trial for NXY-059 in acute intracerebral hemorrhage (ICH) patients,
CHANT (Cerebral Hemorrhagic And NXY-059 Treatment). Although
AstraZeneca is developing NXY-059 for the treatment of Acute
Ischemic Stroke (AIS), it was felt important to assess the safety
and tolerability of NXY-059 in ICH, as treatment may be initiated
prior to a neuroimaging confirmation of the diagnosis of AIS. The
data showed that the safety and tolerability of NXY-059 in ICH
patients was similar to placebo, with comparable mortality rates
(20% in each group) and there was no difference seen between the
NXY-059 and placebo groups on the secondary endpoint of stroke
outcomes in the study. 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-center, 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 randomized 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 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. 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. 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 favored 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 centers 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. In the United States, AstraZeneca
is a $10.77 billion healthcare business with more than 12,000
employees. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information
about AstraZeneca, please visit: http://www.astrazeneca-us.com/
DATASOURCE: AstraZeneca CONTACT: Kellie Caldwell, AstraZeneca
Public Relations, +1-302-885-1435, Ed Seage, AstraZeneca Investor
Relations, +1-302-886-4065 Web site: http://www.astrazeneca-us.com/
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