Tammy J. Gay
“This could change the way strokes are treated. This new investigational drug could potentially be the first in a generation of more powerful drugs that could save thousands of lives and millions of dollars.”
- Creed Pettigrew, M.D.,
professor of neurology, UK College of Medicine and
director of the UK Stroke Program
Jan. 22, 2003 (Lexington, Ky.) -- A new anti-stroke drug synthesized to resemble a “clot-busting” protein found in vampire bat saliva is under investigation by University of Kentucky stroke researchers.
UK is one of only 12 sites in the United States to study this potential new treatment for strokes.
“This could change the way strokes are treated,” said Creed Pettigrew, M.D., professor of neurology, UK College of Medicine and director of the UK Stroke Program, who is the local principal investigator in the research drug trial. “This new investigational drug could potentially be the first in a generation of more powerful drugs that could save thousands of lives and millions of dollars.”
Stroke is now viewed as a “brain attack” that should be managed as a medical emergency, much like myocardial infarction or heart attack. Most strokes are caused by a blockage of an artery supplying blood to one region within the brain. Once the artery is blocked, brain cells that receive oxygen and nutrients carried in fresh blood will die unless the artery can be re-opened to restore blood flow.
In nature, vampire bats feed by drinking blood of sleeping prey. A protein that is present in bat saliva keeps the blood from clotting so the bat can feed. The investigational drug, desmoteplase (DSPA), resembles this protein and dissolves blood clots that form in brain arteries. The drug is synthesized from cells grown in culture and is not extracted from the bat saliva. PAION GmbH is the manufacturer of DSPA.
At this time, there is only one clot-busting drug approved by the Federal Drug Administration for the treatment of stroke. However, it can only be used up to three hours after the documented onset of symptoms of a stroke, limiting the number of patients treated to 2 to 5 percent of the eligible population.
The investigational drug may have three advantages over the current approved drug. First, the investigational drug potentially can be given as late as nine hours after the onset of symptoms, which could double or triple the number of stroke patients who could be treated with a clot-busting drug.
Second, the drug can be given as a single injection by vein over two minutes, rather than as an infusion that takes an hour. This time difference may enhance recovery because more brain cells could be salvaged through successful reperfusion.
Third, the risk of bleeding elsewhere in the body, a recognized complication of clot-busting therapy, should be lower with the investigational drug because it has no activity in the absence of a blood clot that forms only in the brain of a stroke patient.
The phase I/II trial, entitled DEDAS (for Dose Escalation Study of Desmoteplase in Acute Ischemic Stroke), sponsored by PAION GmbH of Aachen, Germany, is designed to identify the right dose of DSPA for a more comprehensive study that will determine if the drug meets its potential as an effective treatment for stroke.
The DEDAS research team at UK will use state-of-the-art magnetic resonance imaging (MRI) techniques to identify stroke patients who are candidates for enrollment and treatment. The 16 American medical centers participating in the trial are expected to enroll a total of 106 patients.
Other UK faculty who are members of the DEDAS research team at the UK College of Medicine include Anand Vaishnav, M.D., assistant professor of neurology, and Steve Ryan, M.D., associate professor of neurology. Similar studies also are underway in Europe, Singapore and Australia.
Stroke affects more than 730,000 people each year in the United States and results in more than 150,000 deaths. It is the third most common cause of death among adults in the United States and in Kentucky, exceeded only by heart disease and cancer. Stroke is the most common cause of long-term disability among American adults with more than four million stroke survivors. The overall cost of medical care, rehabilitation, nursing home confinement, and lost work productivity due to stroke exceeds $43 billion annually in the United States.
For inquiries about patient eligibility or other details of the DEDAS study, call UK Health Connection at (859) 257-1000 or (800) 333-8874.