Cell Therapy News/Articles, page-5658

Clinical trials for potential virus treatments are taking longer than expected.

Clinical trials for some of the most promising experimental drugs are taking longer than expected, even as the pandemic continues to wreak havoc in the United States and treatments are needed more than ever.

Researchers at a dozen clinical trial sites said that testing delays, staffing shortages, space constraints and reluctant patients were complicating their efforts to test monoclonal antibodies — man-made drugs that mimic the molecular soldiers made by the immune system.

As a result, once-ambitious deadlines are slipping. The drug maker Regeneron, which previously said it could have emergency doses of its antibody cocktail ready by the end of summer, has shifted to talking about how “initial data” could be available by the end of September.

And Eli Lilly’s chief scientific officer, who had said in June that its antibody treatment might be ready in September, said this week that he now hopes for something before the end of the year.

“Of course, I wish we could go faster — there’s no question about that,” said the executive, Dr. Daniel Skovronsky. “I guess in my hopes and dreams, we enroll the patients in a week or two, but it’s taking longer than that.”

One major hurdle has been testing. According to the rules of the Regeneron trial, a patient must be treated with the antibodies within seven days of the onset of symptoms. Both the Regeneron and Eli Lilly trials require giving the drug within three days of taking a test that comes back positive, but with turnaround times in some areas lagging for five days or more, keeping within those time frames has proved difficult.

https://www.nytimes.com/2020/08/14/world/covid-19-coronavirus.html