Ebola drug trials set to begin
Washington: The trial of a promising experimental Ebola drug ZMapp, that has been administered to seven people so far but is yet to be approved by regulators, is set to begin.
The World Health Organisation (WHO) is convening a major meeting this week to prioritise the most promising experimental Ebola drugs and vaccines, and to discuss how clinical studies can best be carried out in the chaotic environment of a deadly disease epidemic, the journal Nature reported.
Manufactured by Mapp Biopharmaceutical of San Diego, California, the drug was given to seven patients on a case-by-case, compassionate use basis.
The next steps are likely to be the introduction of small-scale trials for both safety and efficacy, in which people with Ebola receive the drugs in an organised manner and the outcomes are systematically recorded," explained Daniel Bausch of Tulane University in New Orleans, Louisiana.
Ebola's high mortality rate also means that if a drug works, this should be easy to detect even in trials involving just a few dozen patients.
"At the same time, doctors and clinicians must better structure the data obtained from cases of compassionate use to increase their scientific value," Bausch added.
The WHO meeting will also discuss vaccines.
Because these are designed for people not infected with the virus, the ethical equation for testing vaccines is different, the Nature report said.
Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, has announced that the agency is working with vaccine makers and an international research consortium, including the Wellcome Trust, to conduct phase I safety trials of two vaccines.
The trials will be carried out in healthy volunteers in the United States, the United Kingdom, Gambia and Mali.
Sify
The World Health Organisation (WHO) is convening a major meeting this week to prioritise the most promising experimental Ebola drugs and vaccines, and to discuss how clinical studies can best be carried out in the chaotic environment of a deadly disease epidemic, the journal Nature reported.
Manufactured by Mapp Biopharmaceutical of San Diego, California, the drug was given to seven patients on a case-by-case, compassionate use basis.
The next steps are likely to be the introduction of small-scale trials for both safety and efficacy, in which people with Ebola receive the drugs in an organised manner and the outcomes are systematically recorded," explained Daniel Bausch of Tulane University in New Orleans, Louisiana.
Ebola's high mortality rate also means that if a drug works, this should be easy to detect even in trials involving just a few dozen patients.
"At the same time, doctors and clinicians must better structure the data obtained from cases of compassionate use to increase their scientific value," Bausch added.
The WHO meeting will also discuss vaccines.
Because these are designed for people not infected with the virus, the ethical equation for testing vaccines is different, the Nature report said.
Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, has announced that the agency is working with vaccine makers and an international research consortium, including the Wellcome Trust, to conduct phase I safety trials of two vaccines.
The trials will be carried out in healthy volunteers in the United States, the United Kingdom, Gambia and Mali.
Sify
