Gilead Sciences (NASDAQ:GILD)
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2 Months : From Feb 2020 to Apr 2020
By Joseph Walker
Researchers have begun the first study in the U.S. of an experimental drug aimed at treating the novel coronavirus, the National Institutes of Health said Tuesday.
Researchers at the University of Nebraska have started testing an experimental antiviral drug from Gilead Sciences Inc., the NIH said. The first U.S. study subject is an American who is among 13 passengers who were quarantined on the Diamond Princess cruise ship and transported recently to the University of Nebraska Medical Center on Feb. 17 for further isolation and possible treatment, the NIH said. Eleven of those 13 passengers are infected by the virus, according to the Centers for Disease Control and Prevention.
The NIH-sponsored study is part of public health officials' race to determine quickly whether the Gilead drug, called remdesivir, is effective in treating Covid-19, the illness caused by the new coronavirus. The study is designed to enroll up to nearly 400 patients globally, who will be randomly selected to receive remdesivir or a placebo.
While the illness has led to thousands of fatalities world-wide, most people who become infected experience flu-like symptoms such as fever and cough before recovering on their own, health officials have said.
The U.S. remdesivir study is scheduled to be completed in April 2023, but researchers could have preliminary results within a year, said Andre Kalil, a professor of internal medicine at the University of Nebraska who is leading the study for NIH. The timing is dependent on how quickly the outbreak is contained. "In the worst case scenario, if the outbreak just goes crazy and things get way worse than predicted, then the 400 patients will be enrolled really fast, in a few months," Dr. Kalil said.
"This is probably the most rapid trial initiation we've seen in American history, because the trial was just designed a few weeks ago at the NIH, and we were able to get started right away," he said.
The NIH is also expected by the end of April to start testing in healthy volunteers an experimental coronavirus vaccine developed by Moderna Inc. The Cambridge, Mass., drugmaker said Monday it had shipped its first batch of the experimental vaccine. A vaccine could prevent new infections but wouldn't treat confirmed cases.
To be included in the remdesivir study, patients will have to have more advanced disease, including pneumonia-like symptoms, said Dr. Kalil. That would exclude the 80% or more of infected patients who suffer only mild symptoms similar to those of the flu or common cold.
The NIH is aiming to enroll patients in countries around the world where patients are infected, such as in Japan and Italy, said Dr. Kalil. The study will also allow for new experimental treatments to be introduced if and when they become available, he said.
Earlier this month, Chinese researchers began studying remdesivir in two clinical trials, but have struggled to enroll patients quickly because of the way the study is designed, The Wall Street Journal has reported. The Chinese studies will enroll patients with severe disease who were infected within just 12 days before starting the trial, and patients with moderate disease infected within the prior eight days, and who haven't tried other medications. That criteria rules out most candidates for the studies, the Journal reported.
The NIH said it designed the U.S. study after taking into account the design of the Chinese studies.
Gilead is supplying the trial with remdesivir at no cost and is providing input on the study's design and conduct, a company spokeswoman said.
Enrollment in the Chinese studies is also slowing down because the rate of newly infected patients has slowed in the country, said Bruce Aylward, head of an international team of scientists sent by the World Health Organization to China, on a conference call with reporters on Tuesday.
Gilead's remdesivir has shown promise in animal studies and lab experiments as a treatment for Middle East respiratory syndrome, or MERS, and severe acute respiratory syndrome, or SARS, which are caused by other coronaviruses.
In late January, remdesivir was given as emergency treatment to a 35-year-old man Washington state infected with the new coronavirus. His condition improved rapidly after receiving the drug, and he was later discharged from the hospital.
These preliminary data for the drug are encouraging, scientists say, but have to be confirmed in controlled clinical studies before remdesivir can be approved for general use. "We don't know if the medication will have the same effect in human beings [as in animals], and that's why we need to test in this randomized trial," said Dr. Kalil, the NIH study's lead researcher.
Gilead, based in Foster City, Calif., has been ramping up manufacturing of the experimental drug to supply clinical trials and prepare for wider demand if the medicines proves effective.
Gilead's share price is up 7.9% this year based on the company's efforts to develop a treatment for the novel coronavirus, which, according to the NIH, has infected more than 79,000 people globally and killed about 2,600 people in just a few months. The vast majority of infections and fatalities have occurred in China, where the virus originated.
--Betsy McKay contributed to this article.
Write to Joseph Walker at email@example.com
(END) Dow Jones Newswires
February 25, 2020 17:59 ET (22:59 GMT)
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