New Hope on Horizon for Treatment of Deadliest Form of Stroke; New Drug May Be First

Effective Medical Treatment for Hemorrhagic Stroke

To: National Desk

Contact: Diane Mulligan-Fairfield of the National Stroke Association, 720-841-1114

ENGLEWOOD, Colo., Jan. 11 /U.S. Newswire/ -- Israeli Prime Minister

Ariel Sharon continues to show improvement from his hemorrhagic stroke, but it is clear that
doctors had a difficult time getting the bleeding in his brain under control. Now there may be new
hope in treating hemorrhagic stroke. Currently in phase three of a worldwide clinical trial,
recombinant factor VII (NovoSeven(r)) has shown positive results in significantly reducing the
amount of blood that collects in the brain after a hemorrhagic stroke.

Hemorrhagic Stroke occurs when a blood vessel in the brain bursts and blood collects, putting
pressure on the brain and causing brain-cell death. NovoSeven(r), approved to treat hemophilia,
is proving to possibly be the first effective medical treatment to stop the amount of blood the brain
collects.

"Every drop of blood that gathers counts when we are talking about something as delicate as the
brain", said Dr. Stephan Mayer, National Stroke Association spokesperson, Associate Professor
of Clinical Neurology & Neurosurgery and Director of Neurological Intensive Care Unit of
Columbia University "NovoSeven(r) has the capability of preventing nearly a teaspoon of bleeding
in hemorrhagic stroke patients."

During the trial period, NovoSeven(r) has been seen to create a thirty-eight percent reduction in
the mortality rate of the stroke patients that were studied. The trial is expected to be completed in
late 2006. If the study yields positive results, NovoSeven(r) can easily be recognized as one of
the biggest breakthroughs in stroke treatment to date.

"We are in a golden period of discovery when it comes to stroke treatment," said Dr. Mayer who
is also the principal investigator for this trial.

Time is extremely important in treating hemorrhagic stroke because brain cells are dying every
second the brain is being compressed. Recognizing stroke symptoms, calling 911 and treating
stroke as an emergency will always be critical to surviving a stroke.

"Hopefully the day will come where all hospitals are fully equipped to treat stroke patients", said
Jim Baranski, National Stroke Association CEO "If NovoSeven(r) proves to be as successful as
early results are indicating, seeing it in stroke centers across the country would seem like a step
in the right direction."

About NSA:
National Stroke Association is a leading national non-profit organization devoting its efforts and
resources to stroke. Contact the NSA at 1-800-STROKES or visit http://www.stroke.org.

http://www.usnewswire.com/

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/© 2006 U.S. Newswire 202-347-2770/

Hemophiliac drug may help stroke victims

Thursday, January 12, 2006
BY ANGELA STEWART
Star-Ledger Staff

People who experience the deadliest and most crippling type of stroke, like the one suffered by
Israeli leader Ariel Sharon, may benefit from a drug that stops blood from collecting in the brain,
increasing their chances of survival and reducing disability, doctors said yesterday.

The clot-forming drug already has been approved as a treatment for hemophiliacs, to prevent
them from bleeding to death. Called recombinant activated factor VIIa or NovoSeven, the drug is
made by Princeton-based Novo Nordisk and is in Phase III clinical trials as a treatment for
cerebral hemorrhage.

This type of stroke occurs when a blood vessel in the brain bursts and bleeds into the
surrounding tissue. When given intravenously within four hours of stroke symptoms, the drug has
been found to accelerate the clotting process, reducing damage to brain

In a Phase II study, reported last February in the New England Journal of Medicine, the drug was
responsible for a 38 percent reduction in mortality. Patients also were three times more likely to
survive without severe disability.

"Every drop of blood that gathers counts when we are talking about something as delicate as the
brain," said lead trial investigator Stephan Mayer, associate professor of neurology &
neurosurgery and director of the Neurological Intensive Care Unit at Columbia University Medical
Center in New York.

"NovoSeven has the capability of preventing nearly a teaspoon of bleeding in hemorrhagic stroke
patients," added Mayer.

Results of the Phase III portion of the trial, which involves about 150 sites worldwide, are
expected next year, he said.

"This would be a huge breakthrough if approved (by the Food and Drug Administration)," Mayer
said.

Although hemorrhagic strokes account for about 15 percent of all strokes, they are responsible for
more than 30 percent of all stroke deaths, according to the National Stroke Association.

"We recently confirmed that up to 40 percent of brain hemorrhage patients have ongoing bleeding
after they reach the hospital. This drug appears to stop that bleeding," said Daniel Hanley, vice
chairman of the stroke association and a professor of neurology at Johns Hopkins Medical
Institutions.

Exercise can significantly reduce stroke risk

BY JEFF DAVIS
KEEP IT FIT

Witnessing Dick Clark's triumphant return to TV on New Year's Eve was as painful for me as it
was courageous of him. Millions of people around the world cringed and cried as they listened to
the man with one of the most recognizable voices in the world struggle through simple sentences
and wrestle with phrases that would have been simple for him a short time ago.

Whatever the motivation behind his return, Clark demonstrated the damage caused by a stroke
and the amazing results of several months of rehabilitative training and the body's ability to
almost completely relearn tasks we often take for granted.

A stroke is caused when blood flow is prevented from reaching part of the brain. A stroke can
lead to damaged or destroyed brain cells, which causes the loss of whatever function controlled
by that area. While strokes may vary in severity, they are among the top causes of death and
adult disability.

Stroke strikes about 700,000 Americans each year, but the vast majority of people survive. Close
to 5 million stroke survivors are managing their health today, according to WebMD.

There generally are two types of strokes: ischemic and hemorrhagic. During an ischemic stroke,
the blood flow to the brain is decreased and a portion of the brain may be completely cut off from
the flow of blood. This decreased flow is caused by a clot in an artery. About 80 percent of
strokes are ischemic.

A hemorrhagic stroke occurs when an artery in the brain leaks or bursts.

The results of both types are very similar. After about four minutes without blood, the affected
tissue becomes damaged and may die. The body tries to restore blood and oxygen flow to the
brain by enlarging other blood vessels near the starving area. If the blockage is in a large blood
vessel, the body may not be able to supply enough blood and permanent brain damage may
occur.

There are many risk factors associated with a stroke. You can reduce many of them through
enlightenment, diligence and discipline

High blood pressure is the second most important risk factor following age. Having diabetes also
greatly increases your chances of stroke because of circulation problems associated with the
disease.

High cholesterol has a domino effect. It can lead to coronary artery disease that can cause a
heart attack, which, because of decreased circulation, can lead to stroke. There also are other
heart conditions that can lead to stroke.

Smoking and secondhand smoke has been shown to increase the chances of stroke. In fact, daily
cigarette smoking can increase the risk of stroke by 21/2 times. Also, heavy use of alcohol or
binge drinking greatly increases the risk.
Physical inactivity and obesity, which sometimes go hand in hand, are serious risk factors as well.

Some medications such as anticoagulants, birth control pills, steroids or hormone replacement
therapy may slightly heighten your susceptibility to stroke.

The key to avoiding a stroke is to get regular medical exams, especially if you embody one or
more of the above preventable risk factors and get moving. Moderate exercise for at least 30
minutes, five days a week can greatly decrease your chances of stroke.

Make this year one of discipline and diligence. I'll keep supplying the enlightenment.

NEUROLOGY 2005;65:1914-1918
© 2005 American Academy of Neurology

Cerebral microbleeds are common in ischemic stroke but rare in TIA

D. J. Werring, PhD, L. J. Coward, MRCP, N. A. Losseff, MD, H. R. Jäger, MD and M. M.
Brown, FRCP

From the Stroke Research Group, Institute of Neurology, University College London, National
Hospital for Neurology and Neurosurgery, London, UK.

Address correspondence and reprint requests to Dr Brown, Stroke Research Group, Institute of
Neurology, University College London, National Hospital for Neurology and Neurosurgery, Queen
Square, London WC1N 3BG, UK; e-mail: m.brown@ion.ucl.ac.uk

Background: In patients with stroke, gradient-echo MRI commonly detects microbleeds,

indicating small artery disease with increased risk of macroscopic intracranial bleeding.
Antithrombotic treatments are frequently prescribed after TIA and stroke, but there have been no
previous studies of microbleeds in TIA. Because microbleeds may predict the hemorrhagic risk of
antithrombotic treatments, we studied the prevalence of microbleeds, risk factors, and
pathophysiologic mechanisms in patients with ischemic stroke and TIA.

Methods: One hundred twenty-nine consecutive patients with ischemic stroke or TIA were
studied with MRI including T2, fluid-attenuated inversion recovery, and gradient-echo MRI
sequences. Blinded observers counted microbleeds and graded white matter T2 hyperintensities
throughout the brain. TIA patients with previous ischemic stroke were excluded.

Results: Sixty-seven percent of patients had ischemic stroke; 33% had TIA. Microbleeds were
found in 23% of ischemic stroke patients but only 2% of TIA patients (p < 0.001). There were no
significant differences in conventional risk factors or the severity of white matter disease on T2
MRI between stroke and TIA patients. Patients with microbleeds were more often hypertensive
(81 vs 59%; p = 0.04) and had more severe MRI white matter disease on T2 MRI (p = 0.003).

Conclusions: Microbleeds are common in ischemic stroke but rare in TIA, an observation not
explained by differences in vascular risk factors or severity of white matter disease seen on T2
MRI. This finding has implications for the safety of antithrombotic therapy and clinical trial design
in the two groups. Microbleeds may also be a new marker for severe microvascular pathology with
increased risk of permanent cerebral infarction.
Supported by the Sir Jules Thorn Trust and the Stroke Association (D.J.W.); the Reta Lila Weston
Trust for Medical Research (Chair in Stroke Medicine; M.M.B.); and the Stroke Association and a
grant from Sanofi-Synthelabo (L.J.C.).

Disclosure: The authors report no conflicts of interest.

Received April 19, 2005. Accepted in final form September 1, 2005.

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