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* Clinical trials to test safety, efficacy of treatments
* ZMapp president expects human trials to begin in 2015
* GSK vaccine clinical trials under way, data by year-end
By Stephanie Nebehay
GENEVA, Sept 5 (Reuters) - Drug and vaccine companies areracing to conduct clinical trials of potential treatments forEbola but it will be 2015 before there are any initial resultsand much later before significant quantities could be available,executives said on Friday.
In interviews on the sidelines of a meeting hosted by theWorld Health Organisation (WHO), they said that efforts wouldfocus on developing safe and efficient products for human usethat could win fast-tracked regulatory approval.
ZMapp, by Mapp Biopharmaceutical Inc., has been given toseven infected people, including two American aid workers and aBriton who all recovered, but it remains unproven and supplieshave run out. The U.S. government pledged up to $42.3 millionthis week to accelerate its testing.
Dr. Larry Zeitlin, president of the California-based MappBiopharmaceutical, said that Washington's support was vital toconduct early stage safety studies of the experimental drug asthe jury is still out on both its safety and efficacy.
"The U.S. support will enable us to figure out what theappropriate dose is and scale up manufacturing. With a drug youhave not only to make it, but make it consistently to the samequality. The award given us is for 18 months. We will probablybe in human trials beginning in 2015," Zeitlin told Reuters.
"We don't have data indicating whether ZMapp is safe inhumans, we don't have data that it works in humans. That is thewhole point of performing clinical trials," he said.
At this point, Zeitlin said that he expected most of theproduction to go into clinical trials rather than so-called"compassionate care".
ZMapp is among eight experimental drugs and two candidatevaccines deemed by the WHO to have potential against the virusthat has killed at least 1,900 people in West Africa sinceMarch. The WHO has warned that 20,000 people could be at risk.
The current strain of Ebola has an overall death rate ofabout 50 percent.
On Thursday, the U.N. agency called for pharmaceuticalcompanies and regulatory agencies to work together to acceleratedevelopment of the most promising treatments.
The two-day talks, attended by nearly 200 experts, are dueto end later on Friday with a WHO statement.
"RAMPING UP"
Drugs include AVI 7537, made by Sarepta Therapeutics Inc., which was tested on animals and completed phase 1human safety studies, but had to be put to the side in late 2011due to U.S. budget cuts, said Dr. Michael Wong, senior medicaldirector for infectious diseases at Sarepta.
"We still have drug substance that is still stable. We areramping up another human trial," Wong told Reuters.
From 60 to 80 percent of rhesus monkeys given AVI 7537survived, while all of those in the test group died, he said.A phase 1 human safety study under the U.S. Food and DrugAdministration found "no safety or tolerance issues at all".
"We are looking at ways we can support the WHO if they feelthe best way of looking at some agents is through some form of atrial," Wong said.
"Because the epidemic is unprecedented and still rolling,they are looking at several different approaches. The theme isto try to do a thorough, careful and ethical job but to do itfast."
Human safety trials are due to begin this week on a vaccinefrom GlaxoSmithKline Plc and later this year on one fromNewLink Genetics Corp
"We are working on a vaccine and have been asked by WHO tomake it available as quickly as possible to help control thisoutbreak. Phase 1 studies started this week at NIH (the U.S.National Institutes of Health)," Dr. Ripley Ballou, ofGlaxoSmithKline Biologicals SA, Rixensart, Belgium told Reuters.
"We hope to have at the end of the year a good sense if thevaccine is safe and well-tolerated in five trials, involving120-150 people. We'll have the data that we need by the end ofthe year but actually the studies will go for one year.
"Most important is that we can select the dose for the nextphase," Ballou said.
The WHO talks, marked by testimony from health officialsfrom Guinea, Liberia and Nigeria, were "eye-opening," he said.
"For anybody who is contemplating product development itreinforces how challenging this is going to be, it is a realcomplex undertaking."
(Reporting by Stephanie Nebehay; editing by Ralph Boulton)
