* 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 Drug and vaccine companies are
racing to conduct clinical trials of potential treatments for
Ebola but it will be 2015 before there are any initial results
and much later before significant quantities could be available,
executives said on Friday.
In interviews on the sidelines of a meeting hosted by the
World Health Organisation (WHO), they said that efforts would
focus on developing safe and efficient products for human use
that could win fast-tracked regulatory approval.
ZMapp, by Mapp Biopharmaceutical Inc., has been given to
seven infected people, including two American aid workers and a
Briton who all recovered, but it remains unproven and supplies
have run out. The U.S. government pledged up to $42.3 million
this week to accelerate its testing.
Dr. Larry Zeitlin, president of the California-based Mapp
Biopharmaceutical, said that Washington's support was vital to
conduct early stage safety studies of the experimental drug as
the jury is still out on both its safety and efficacy.
"The U.S. support will enable us to figure out what the
appropriate dose is and scale up manufacturing. With a drug you
have not only to make it, but make it consistently to the same
quality. The award given us is for 18 months. We will probably
be in human trials beginning in 2015," Zeitlin told Reuters.
"We don't have data indicating whether ZMapp is safe in
humans, we don't have data that it works in humans. That is the
whole point of performing clinical trials," he said.
At this point, Zeitlin said that he expected most of the
production to go into clinical trials rather than so-called
ZMapp is among eight experimental drugs and two candidate
vaccines deemed by the WHO to have potential against the virus
that has killed at least 1,900 people in West Africa since
March. The WHO has warned that 20,000 people could be at risk.
The current strain of Ebola has an overall death rate of
about 50 percent.
On Thursday, the U.N. agency called for pharmaceutical
companies and regulatory agencies to work together to accelerate
development of the most promising treatments.
The two-day talks, attended by nearly 200 experts, are due
to end later on Friday with a WHO statement.
Drugs include AVI 7537, made by Sarepta Therapeutics Inc.
, which was tested on animals and completed phase 1
human safety studies, but had to be put to the side in late 2011
due to U.S. budget cuts, said Dr. Michael Wong, senior medical
director for infectious diseases at Sarepta.
"We still have drug substance that is still stable. We are
ramping up another human trial," Wong told Reuters.
From 60 to 80 percent of rhesus monkeys given AVI 7537
survived, while all of those in the test group died, he said.
A phase 1 human safety study under the U.S. Food and Drug
Administration found "no safety or tolerance issues at all".
"We are looking at ways we can support the WHO if they feel
the best way of looking at some agents is through some form of a
trial," Wong said.
"Because the epidemic is unprecedented and still rolling,
they are looking at several different approaches. The theme is
to try to do a thorough, careful and ethical job but to do it
Human safety trials are due to begin this week on a vaccine
from GlaxoSmithKline Plc and later this year on one from
NewLink Genetics Corp
"We are working on a vaccine and have been asked by WHO to
make it available as quickly as possible to help control this
outbreak. Phase 1 studies started this week at NIH (the U.S.
National Institutes of Health)," Dr. Ripley Ballou, of
GlaxoSmithKline Biologicals SA, Rixensart, Belgium told Reuters.
"We hope to have at the end of the year a good sense if the
vaccine is safe and well-tolerated in five trials, involving
120-150 people. We'll have the data that we need by the end of
the year but actually the studies will go for one year.
"Most important is that we can select the dose for the next
phase," Ballou said.
The WHO talks, marked by testimony from health officials
from Guinea, Liberia and Nigeria, were "eye-opening," he said.
"For anybody who is contemplating product development it
reinforces how challenging this is going to be, it is a real
(Reporting by Stephanie Nebehay; editing by Ralph Boulton)