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Pin to quick picksGlaxosmithkline Share News (GSK)

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UPDATE 2-WHO backs use of experimental Ebola drugs in West Africa outbreak

Tue, 12th Aug 2014 11:45

* Ethics panel cautions supplies will be limited

* Medics need "informed consent, community involvement"

* Vaccine testing usually takes years (Updates throughout with quotes, details, background)

By Kate Kelland and Stephanie Nebehay

LONDON/GENEVA, Aug 12 (Reuters) - It is ethical to offerunproven drugs or vaccines to people infected or at risk in WestAfrica's deadly Ebola outbreak, a World Health Organisationpanel of medical ethics experts ruled on Tuesday, but cautionedsupplies will be limited.

The panel said any provision of experimental Ebola medicineswould require "informed consent, freedom of choice,confidentiality, respect for the person, preservation of dignityand involvement of the community".

The drugs should also be properly tested in the bestpossible clinical trials, it said.

The West Africa Ebola virus epidemic - the world's largestand most deadly so far - has killed at least 1,013 of the morethan 1,848 people it has infected in Guinea, Liberia, SierraLeone and Nigeria. The WHO has declared it an internationalhealth emergency.

"Ebola outbreaks can be contained using availableinterventions like early detection and isolation, contacttracing and monitoring, and adherence to rigorous procedures ofinfection control," the panel said. "However, a specifictreatment or vaccine would be a potent asset to counter thevirus."

The ethics panel met to discuss whether various experimentaldrugs and vaccines being developed for Ebola might be used inthe outbreak, despite not having been fully tested or licensed.

"A number of interventions have been through the laboratoryand animal study phases of development," it said in a statementissued by the WHO.

It said it was likely that so-called "first in man" trials -the first tests of a drug in humans - would be conducted overthe next two to four months, but cautioned that even after thatand if the trials proved successful, supplies would be limited.

"It is ... likely that the number of doses available forfurther study and/or deployment from end 2014 onwards willremain insufficient to meet demand," the statement said.

The ethics meeting was called after experimental Ebola drugZMapp, made by U.S. biotech company Mapp Biopharmaceutical, wasgiven to two American health workers infected with Ebola inLiberia.

DRUGS SCARCE

The scarce experimental drug, of which a WHO spokeswomansaid only 12 doses had been made, was due to be given to twoLiberian doctors after U.S. authorities approved its export,Monrovia's information minister said on Tuesday. This would bethe first time the treatment has been used on Africans.

A 75-year-old priest in Spain who also received ZMapp hassince died. He contracted Ebola in Liberia.

"In the particular circumstances of this outbreak, andprovided certain conditions are met, the panel reached consensusthat it is ethical to offer unproven interventions with as yetunknown efficacy and adverse effects, as potential treatment orprevention," the panel's statement said.

There are no licensed treatments or vaccines for Ebola. Aswell as Mapp, several other biotech companies and research teamshave been working on potential drugs.

Companies with possible treatments include TekmiraPharmaceuticals, Biocryst Pharmaceuticals andSiga Technologies.

GlaxoSmithKline and U.S. scientists at the NationalInstitute of Allergy and Infectious Diseases hope to start aclinical trial of an experimental Ebola vaccine as soon as nextmonth, after promising test results in primates.

It would normally take many years to move such a vaccinethrough three phases of clinical testing but some officials havesuggested emergency procedures could be put in place to make itavailable in 2015, assuming it works in the early test phase.

Another experimental vaccine from Johnson & Johnson's Crucell unit should enter Phase I clinical trials inlate 2015 or early 2016, while Profectus Biosciences is alsoworking with U.S. scientists on another preclinical vaccine. (Additional reporting by Ben Hirschler, writing by KateKelland; Editing by Janet Lawrence)

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