US begins testing Ebola treatment in early-stage trial
Washington, May 27: US researchers have started the first-in-human trial evaluating an experimental treatment for Ebola virus disease, the National Institutes of Health (NIH) Clinical Centre said in a statement.
The Phase 1 clinical trial, named as VRC 608, is examining the safety and tolerability of a single monoclonal antibody called mAb114, developed from an Ebola survivor.
Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
"We hope this trial will establish the safety of this experimental treatment for Ebola virus disease -- an important first step in a larger evaluation process," said Anthony S. Fauci, Director at the National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, US
"Ebola is highly lethal, and reports of another outbreak in the DRC (the Democratic Republic of Congo) remind us that we urgently need Ebola treatments.
"This study adds to NIAID efforts in conducting scientifically and ethically sound biomedical research to develop countermeasures against Ebola virus disease," Fauci added.
MAb114 is a monoclonal antibody -- a protein that binds to a single target on a pathogen -- isolated from a human survivor of the 1995 Ebola outbreak in a city in the DRC.
Researchers from the NIAID discovered that survivor retained antibodies against Ebola 11 years after infection.
They isolated the antibodies and tested the most favourable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising.
The researchers illustrated that MAb114 binds to the hard-to-reach core of the Ebola virus surface protein and blocks the protein's interaction with its receptor on human cells.
A single dose of mAb114 protected non-human primates days after lethal Ebola virus infection.
In the trial, which would be fully enrolled by July 2018, the first three participants will receive a 5 milligram per kilogram intravenous infusion of mAb114 for 30 minutes.
The team will evaluate safety data to determine if the remaining participants can receive higher doses (25 mg/kg and 50 mg/kg).
Participants will have blood taken before and after the infusion and will bring a diary card home to record their temperature and any symptoms for three days.
Participants will visit the clinic approximately 14 times over six months to have their blood drawn to see if mAb114 is detectable and to be checked for any health changes, the report said.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and haemorrhage (severe bleeding).
First discovered in humans in 1976 in the DRC, the largest outbreak, occurred in West Africa from 2014 to 2016. It caused more than 28,600 infections and more than 11,300 deaths, according to the World Health Organization.
In May 2018, the DRC reported new Ebola outbreak. While there are no licensed treatments available for Ebola virus disease yet, multiple experimental therapies are being developed.
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England sticking with Key, McCullum and Stokes despite Ashes humbling
London (AP): England is not sacking anybody following the 4-1 Ashes loss in Australia.
A review of the tour by the England and Wales Cricket Board, announced within hours of the final match in January, was concluded on Monday. Firing people would “be the easy thing to do,” ECB chief executive Richard Gould said but he insisted, "This is not the time to throw everything out."
Managing director Rob Key, coach Brendon McCullum and captain Ben Stokes kept their jobs after the best England side to go to Australia in 14 years lost the Ashes in 11 days with two games to spare.
“Moving people on can sometimes be the easy thing to do. That's not the route that we're going to take,” Gould said. “I've seen the driving ambition and determination that we're lucky enough to have within our leadership group to take the lessons from the Ashes and move forward.”
Gould previously was the chief executive of Bristol City soccer club and said the ECB would not follow the same route as soccer's hire-and-fire culture.
“Cricket is a very unique sport in that it takes a team of leadership ... it's not like football where there's a single point of failure or success with a manager," he said. He added the ECB would not “select or deselect management based on a popularity campaign.”
The main criticisms of England's tour were poor preparation, player misbehavior, and selection mistakes.
At a press conference at Lord's, Gould and Key said McCullum and Stokes have not had a “bust up,” they did not want McCullum to “completely change” but “to evolve,” the behavior of some players was “unprofessional,” there will be more consequences for underperforming, and a commitment to “better long-term planning” ahead of major test series.
Some changes were already implemented for the Twenty20 World Cup, where England reached the semifinals. Gould implied that performance saved McCullum.
Key acknowledged that England supporters would be disappointed to see the management team go unpunished.
“I know people want punishment and that people then should be sacked for that,” Key said. “That doesn't mean we don't feel like we've gone through some serious pain: Brendon, myself, Ben. It's been as tough a time as I think I've had.”
