NIH puts hold on $30 million trial of potential stroke drug

Related article Misconduct concerns, possible drug risks should stop major stroke trial, whistleblowers say BY Charles Piller The National Institutes of Health (NIH) has paused the start of a major human trial of an experimental drug aimed at protecting the brain after stroke. At the same time, the agency launched an investigation into recently aired concerns about the drug’s safety and whether lab studies supporting its promise contain manipulated images and data. The agency’s 16 November move came 3 days after a Science investigation into studies of the candidate drug, called 3K3A-APC. Whistleblowers argued that data from an earlier phase 2 trial, sponsored by a company called ZZ Biotech, hinted that 3K3A-APC might actually increase deaths or disabilities in stroke patients. They further identified potential scientific misconduct in dozens of papers, some on 3K3A-APC or related topics, by University of Southern California (USC) neuroscientist Berislav Zlokovic and colleagues. Zlokovic, a cofounder of ZZ Biotech, did not respond to a request for comment on NIH’s actions. The NIH-funded phase 3 trial, involving 1400 people who just had an acute ischemic stroke, had been scheduled to begin in coming months. But Pooja Khatri, co-investigator of the national coordinating center of StrokeNet—a consortium slated to conduc...
Source: ScienceNOW - Category: Science Source Type: news