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Home > News/Media Room > Press Releases
Press Releases - Experimental drug therapy could open new window for
treatment of deadly stroke
6/7/2005
A new type of drug therapy that is currently being tested in Canada
could significantly reduce the death rate caused by the deadliest form
of stroke . According to the Heart and Stroke Foundation, new
developments in stroke research make it more important than ever that
Canadians recognize and react to the warning signs of stroke.
Used to treat people with a bleeding disorder known as hemophilia,
studies indicate that recombinant Factor VIIa (rFVIIa, or “rFactor7a”)
can stop the bleeding in the brain associated with an intracerebral
hemorrhage (ICH) and minimize additional damage if it is administered
during the early stages of a hemorrhagic stroke .
Like tissue plasminogen activator (tPA), the “clot-busting drug” used to
treat ischemic stroke , rFVIIa seems to work best when given early after
the onset of symptoms, a time when most of the ongoing bleeding occurs.
“Existing treatments like tPA, and potential new treatments for stroke,
underline that it is critical that Canadians recognize the warning signs
of stroke and act quickly by getting to an appropriate medical facility
as soon as symptoms occur,” says Heart and Stroke Foundation
spokesperson, Dr. Andrew Demchuk. “The longer the delay, the greater
the risk of permanent brain damage, disability and death. It is tragic
when a patient ignores these serious signs and we miss an opportunity to
help.”
The Heart and Stroke Foundation estimates that intracerebral hemorrhages
account for approximately 10 percent of all strokes that occur in Canada
each year. “ Intracerebral hemorrhage is essentially like a bruise in
the brain. Unfortunately early on this bruise can continue to grow and
result in devastating injury to the brain,” says Demchuk.
These strokes can often affect younger individuals. Four out of every
10 patients with intracerebral hemorrhage will die within 30 days, a
toll that is more than double that of ischemic stroke (the most common
type of stroke, caused by the blockage of a brain artery and subsequent
death of portions of brain). In 2002/03, there were 4,700
hospitalizations in Canada due to intracerebral hemorrhage and 1,800
deaths.
In the Phase II safety trial that was just completed, rFVIIa cut the
risk of death by 30 per cent and resulted in at least one more patient
in 10 fully recovering from their hemorrhage. “A second trial is about
to commence to confirm the findings of the first study before the drug
could be considered as a standard treatment in Canada,” says Demchuk,
director of the Calgary Stroke Program involved in the international
trial.
The warning signs of intracerebral hemorrhage are similar to those of
other types of strokes, although the symptoms, such as paralysis on one
side or problems speaking, may be particularly severe.
The warning signs of stroke are:
Ø Weakness - Sudden weakness, numbness or tingling in the face,
arm or leg
Ø Trouble Speaking - Sudden temporary loss of speech or trouble
understanding speech
Ø Vision Problems - Sudden loss of vision, particularly in one
eye, or double vision
Ø Headache - Sudden severe and unusual headache
Ø Dizziness - Sudden loss of balance, especially with any of the
above signs.
Anyone experiencing these symptoms should call 9-1-1 or their medical
emergency number immediately.
Victims of an intracerebral hemorrhage may experience a change in their
level of consciousness and a headache (usually described as “the worst I
ever had”) may be accompanied by vomiting. The only way to accurately
distinguish the type of stroke that is occurring – and thus appropriate
treatment – is immediate CT (commuted tomography ) scanning of the
brain. “All Canadians who present early with devastating stroke
symptoms should be preferentially transported to hospitals with CT scan
facilities,” says Demchuk.
To help improve the health outcomes after stroke, the Heart and Stroke
Foundation of Canada and the Canadian Stroke Network are leading the
development of a Canadian Stroke Strategy, with the goal that
coordinated stroke care from prevention through treatment to
rehabilitation be available in every province by 2010.
“It is more important than ever that people get to the hospital quickly
and that timely access to acute stroke care is available across the
country,” says Heart and Stroke Foundation spokesperson Dr. Daniel
Selchen of Toronto. “In Ontario, for example, the development of
integrated stroke care within the health care system doubled the
proportion of ischemic stroke patients who received tPA.”
“This is an incredible time in stroke research and care,” says Sally
Brown, CEO of the Heart and Stroke Foundation of Canada. “Twenty years
ago, there were no treatments for either ischemic or hemorrhagic
strokes. The clinical outlook was pretty grim. Now new treatments are
being developed and there is a better chance for survival and recovery
for people who have a stroke.”
June is Stroke Awareness Month. For more information on stroke,
including a list of the warning signs of stroke, or to obtain resources
for people living with stroke, call 1-888-473-4636 or visit
www.heartandstroke.ca
The Heart and Stroke Foundation (www.heartandstroke.ca) is a leading
funder of heart and stroke research in Canada. Our mission is to
improve the health of Canadians by preventing and reducing disability
and death from heart disease and stroke through research, health
promotion and advocacy.
The trial of rFVIIa is entirely funded by Novo Nordisk A/S.
http://www.novonordisk.com/investors/rd_pipeline/rd_pipeline.asp?showid=
9
NovoSeven®, traumatic brain injury
: Bleeding in emergencies, Traumatic brain injury
: Phase 2
Exploratory phase 2. Novo Nordisk has initiated an explorative
multi-centre, multi-national, randomised, double-blind,
placebo-controlled, dose escalation trial on safety and efficacy with
patients experiencing a TBI. Injuries from penetrating objects such as
gun shots and knives are not included in the definition of TBI.
Each subject will receive a single intravenous injection with either
active drug or placebo within 5 hours of injury. The doses are divided
into five dose tiers of 40, 80, 120, 160 and 200 µg/kg.
Traumatic brain injury (TBI) occurs as a result of a sudden injury to
the head. TBI is defined as the presence of focal lesions of low, mixed
or high density on CT examination.
TBI is most commonly caused by road traffic accidents and is primarily
affecting younger men.
http://tinyurl.com/7lx8x
Update on Novo Nordisk's clinical trial programme on NovoSeven (R)
Author(s)
Dejgaard A
Corporate source(s)
Dejgaard A, Novo Nordisk AS, Kroghoejsvej 9E1, DK-2880 Bagsvaerd,
Denmark, [log in to unmask]
Source
Blood Coagulation and Fibrinolysis 2003, Vol. 14, pg. S39-S41
Abstract
Recombinant coagulation factor Vila (rFVIIa; Novoseven(R), Novo Nordisk
A/S, Bagsvaerd, Denmark) is registered in most regions of the world for
the treatment of bleeding episodes in haemophilia patients with
inhibitors to factor VIII or IX. Since its initial availability, there
have been several case stories on the investigational use of rFVIIa as a
haemostatic agent in a variety of bleeding patients. Novo Nordisk
recognizes the need to establish clinical guidance, and when possible,
regulatory approvals for indications with bleeding episodes of various
aetiologies. Currently, the safety and efficacy of rFVIIa is being
investigated in 11 multinational, phase II trials, involving more than
1500 patients. Most of these trials have been designed to establish the
efficacy of rFVIIa as a rescue treatment in episodes of severe life-
threatening (upper gastrointestinal bleeding, stem cell transplantation,
intra-cerebral haemorrhage and trauma). The remaining focus is on the
prophylactic use of rFVIIa to improve haemostasis during surgery
(orthotopic liver transplantation and liver resection), with the aim of
avoiding or reducing the need for blood transfusions. In addition, Novo
Nordisk is also continuing studies in haemophilia patients with
inhibitors to increase therapeutic knowledge within this indication.
Studies addressing dosages and regimens in subpopulations are presently
ongoing. (C) 2003 Lippincott Williams Wilkins.
For more information contact:
Sharon Edwards 416-489-7111 ext. 455 or
416-305-1016
Elissa Freeman 416-489-7111 ext. 316 or
416-565-5605
Jane-Diane Fraser 613-569-4361, ext 273
For provincial media contacts, please see “contact us” at
www.heartandstroke.ca/media
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