BUFFALO, NY (Buffalo Business First) -- Researchers at the University at Buffalo are participating in a worldwide clinical trial using a protein found in vampire bat saliva to treat stroke patients.
UB's Department of Neurology and the Jacobs Neurological Institute is the first site in the U.S. to be approved to enroll patients in the trial, which will test the drug desmosteplase as a treatment for acute ischemic stroke.
Ischemic strokes, the most common type of stroke, occur when an artery in the brain is obstructed by a blood clot. The test drug is a plasminogen activator, or blood clot-dissolving agent. The drug has been in trials in Europe for several years by Lundbeck Inc., a Copenhagen manufacturer.
This drug is based on a genetically engineered protein found in vampire bat saliva. Lundbeck says it has the potential to open blood vessels, restore blood flow and minimize damage to the brain.
At UB, the trial began in late January at the Kaleida Health Stroke Care Center in Millard Fillmore Gates Circle Hospital, led by Marilou Ching, MD, a UB assistant professor of neurology. Ching is program director of UB's Vascular Neurology Fellowship Program and the Kaleida Health stroke unit.
The trial, which opened here Jan. 28, will enroll 400 patients worldwide over the next year, including five to 10 from the Buffalo area. Most sites will enroll about five people, but the Buffalo site expects to enroll double because the center typically treats about 1,600 stroke patients annually, making it among the busiest stroke centers in the Northeast.
One of the major benefits of the drug is its ability to be administered up to nine hours after the onset of stroke symptoms. Currently, the only FDA-approved medication to treat acute strokes must be administered within three hours of the onset of symptoms.
Kathy Parkes, research nurse coordinator at Gates, says the qualifications for patients are very specific, which is why the study has yet to enroll any participants to date. Patients must be in the midst of an acute stroke, have no bleeding problems and arrive within nine hours of the onset of symptoms.
It's also a placebo-controlled study, which means patients who qualify have a 50 percent chance of getting the drug versus an inactive medication.
In addition to the patients coming directly to Gates, the hospital will spread the word among other Kaleida hospitals as well as stroke programs in other parts of the state that are also part of the statewide network of designated stroke centers.
The drug's potential ability to treat people a full six hours later after the onset of symptoms makes it especially valuable.
"Many people tend to minimize their symptoms and think it'll go away," Parkes says, adding that many times that means they arrive at the hospital too late to receive current treatments. "This gives us an extra six hours to treat - if they get here in time."
This is the third and four trial for the drug. Preliminary results in the second round of trials showed no benefit of two doses of the drug over placebo. Parkes says researchers felt the population studied was too broad, as it was applied to all strokes.
This time around, researchers hope to target individuals having strokes in a particular area of the brain.
"We know there will be somebody out there that will have this kind of stroke, and hopefully, they will be able to be treated," she says.