U.S.
health officials say Ebola treatment trial to start soon in Liberia
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[January 23, 2015] (Reuters)
- U.S. health officials said on Thursday
that they are planning to start larger, decisive clinical trials in
Liberia in the next two weeks to determine if two new Ebola treatments
under development are safe and effective.
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One of the treatments is being developed by GlaxoSmithKline and
another by Newlink Genetics Corp with Merck & Co.
The U.S. government and leading drugmakers have accelerated their
efforts to bring a vaccine or treatment to market since the Ebola
outbreak reached crisis proportions in West Africa last year. That
includes speeding to human trials treatments that had only been
tested in non-human primates.
The treatments are advancing even as the World Health Organization
said the epidemic in West Africa appears to be ebbing.
There have been 21,724 cases of Ebola reported in nine countries in
the past year since the epidemic began in Guinea, including 8,641
deaths, according to the latest WHO figures.
The officials, speaking on a conference call, also said that they
expect to soon start phase 1 and phase 2 clinical trials - an
earlier stage than the trials for the other two treatments - of the
ZMapp Ebola virus treatment that is being developed by privately
held Mapp Biopharmaceutical Inc.
They said they believe they have produced enough ZMapp to supply the
trials, which are awaiting approval from the U.S. Food and Drug
Administration and will likely start two to three weeks later.
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Dr. Robin Robinson, Director of the U.S. government's Biomedical
Advanced Research and Development Authority, said it expects to have
thousands of doses of the ZMapp drug available by the end of the
year for commercial use if the treatment is proved effective in the
trials.
In Liberia, about 27,000 people are expected to take part in the
trial for the treatments from GlaxoSmithKline, Merck and NewLink. In
Sierra Leone, where the officials said they are also considering
moving forward with a trial, they are targeting healthcare workers
and expect to include about 6,000 people. Sierra Leone has yet to
decide which treatment would be used in that trial, the officials
said.
(Reporting by Bill Berkrot and Caroline Humer; editing by Andrew Hay
and Christian Plumb)
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