ENGLEWOOD, Colo., June 25 /PRNewswire/ -- Researchers at the 5th International Stroke Society World Congress in Vancouver, B.C., today announced that a man-made blood clotting drug, recombinant factor VIIa (NovoSeven(R)), currently used to treat bleeding in hemophiliacs, is the first effective medical treatment for hemorrhagic stroke. NovoSeven(R) is a genetically engineered blood clotting protein derived from baby hamster kidney cells. This Phase II study determined that if NovoSeven(R) is given intravenously within four hours of stroke onset, the drug could reduce the growth of hematoma, thus limiting the amount of brain tissue damage.
Intracerebral hemorrhage (ICH) occurs when a blood vessel in the brain ruptures and blood spills into the brain. The brain tissue dies at the area of the ICH, but blood can also clot causing a hematoma. The hematoma puts pressure on surrounding tissues in the brain causing additional damage and disability to the patient. This worldwide study of 400 patients in a randomized, double-blind, placebo-controlled trial compares three doses of NovoSeven(R) with placebo. Both long-term and short-term benefits were demonstrated for patients treated with NovoSeven(R).
"This study of NovoSeven(R) is an exciting development that gives us hope in furthering the treatment of hemorrhagic stroke, which is the deadliest form of stroke," says Dr. Dan Hanley, Chairmen of the National Stroke Association Professional Advisory Committee and Professor of Neurology and Neurosurgery at John Hopkins Medical Institution.
ICH accounts for 10 to 15 percent of all strokes. After the initial stroke, the hematoma will continue to grow in more than a third of these patients. More than half of these patients will die. The protection of further bleeding is an important step in lessening the impact of ICH on stroke patients. With each brain cell death, the chance of disability and death increases.
NovoSeven(R) is not currently registered with the FDA as a stroke treatment. Complete analysis and peer review of the data are pending. Further studies will be needed.
Based in Englewood, Colo., National Stroke Association is a leading, independent national nonprofit organization devoting 100 percent of its efforts and resources to stroke. For more information contact NSA at 1-800-STROKES (767-6537) or visit http://www.stroke.org/.
National Stroke Association
CONTACT: Diane Mulligan-Fairfield, Vice President, NationalCommunications of National Stroke Association, +1-720-273-0927