Drug Shows Promise in Reducing Disability
After Stroke,
Says U.T. Researcher
Study published in New England Journal of Medicine
HOUSTON – (February 8, 2006) – Data from the Stroke Acute Ischemic NXY-059 Treatment I (SAINT I) trial, published today in the New England Journal of Medicine, show that the use of an investigational drug, NXY-059, resulted in a statistically significant reduction in stroke-related disabilities.
“This is the first pivotal study of a neuroprotectant to show reduced disability following an acute ischemic stroke,” said James Grotta, M.D., director of The University of Texas Medical School at Houston’s Stroke Program, who serves on the steering committee of the SAINT I trial and is a study co-author.
Analysis of the data showed 4.4 percent more patients treated with NXY-059 were free of symptoms, and 3.7 percent more patients were able to walk without help and were less dependent on others, compared to placebo results.
Grotta, the UT Medical School’s Roy M. and Phyllis Gough Huffington Distinguished Chair in Neurology, said he was pleased with the results, but cautioned that effective stroke treatment remains difficult to obtain for the majority of patients.
“Most people with a stroke don’t get to a hospital in time to receive existing treatments,” he said. “In fact, only about three to five percent of stroke patients qualifies for and gets the most advanced treatment in a timely manner. NXY-059, if approved, might be given to a substantially larger proportion of stroke patients as a result of this study.”
The study involved 1,722 patients in 158 centers from 24 countries who were treated within six hours of onset of stroke symptoms. Clinical benefit was seen at the earliest time assessed (seven days), and persisted through the end of the study (90 days). The treatment effects were not influenced by the time to treatment, the severity of stroke, or use of thrombolysis.
“Stroke is the number one cause of disability in the United States for adult Americans, so it’s a huge public health problem. About 600,000 to 700,000 new strokes occur every year,” said Grotta.
A confirmatory second phase three study, SAINT II, which involves 3,200 patients at approximately 350 centers around the world, is currently underway.
NXY-059 is an investigational drug under development by AstraZeneca and licensed from Renovis, Inc. NXY-059 was previously referred to as Cerovive.
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