Misconduct concerns, possible drug risks should stop major stroke trial, whistleblowers say

In 2022, the U.S. National Institutes of Health (NIH) placed a large bet on an experimental drug developed to limit brain damage after strokes. The agency committed up to $30 million to administer a compound called 3K3A-APC in a study of 1400 people shortly after they experience an acute ischemic stroke, a perilous condition in which a clot blocks blood flow to part of the brain. The gamble seemed warranted. Lab studies, most by a longtime grantee, prominent University of Southern California (USC) neuroscientist Berislav Zlokovic, had generated promising data. A small safety study of the drug, sponsored by a company Zlokovic co-founded called ZZ Biotech, was also encouraging. Analyses of data from the phase 2 trial hinted that the treatment reduced the number of tiny, asymptomatic brain hemorrhages after stroke patients received either surgery to remove the clot, the clot-busting drug tissue plasminogen activator (tPA), or both. For many years, scientists have tried to reduce the brain cell death, bleeding, and inflammation that can follow a stroke, some of which results from disruption of the blood-brain barrier—a system of tiny blood vessels that delivers oxygen and nutrients but shields the brain from toxic substances. tPA, the only approved stroke drug in the United States and Europe, can vastly reduce death and disability by clearing a stroke’s blockage, but the drug, too, can cause dangerous brain bleeding. 3K3A-APC could help mitigate such dam...
Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research