AstraZeneca
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.

– 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.

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