(Reuters) - NewLink Genetics Corp, which
licensed an Ebola vaccine developed by Canadian government scientists,
has enough doses on hand to launch the first human safety trial of an
Ebola vaccine this summer, its chief executive said on Wednesday.
The company has also lined up two contract manufacturing companies
and possibly a third and will be able to produce tens of thousands
of vaccine doses within "the next month or two," Dr Charles Link
said in an interview.
The largest Ebola outbreak in history, which has killed more than
1,000 people in West Africa, has lent an unprecedented urgency to
efforts to develop vaccines and treatments, which for years had
largely languished.
Last week, the Ames, Iowa-based company's wholly owned subsidiary,
BioProtection Systems Corp, received $1 million from the United
States Defense Threat Reduction Agency (DTRA) for more pre-clinical
toxicology studies, including stepped-up manufacturing, to allow
human trials to begin quickly. The vaccine was developed by
scientists at the Public Health Agency of Canada.
"DTRA said, 'we want this to move quickly,'" Link said. "Before
that, I'd have said it would take eight to 10 months before we could
launch human studies, but now it's a matter of weeks."
Only one treatment, made by Tekmira Pharmaceuticals, had even begun
human safety trials, while the others had been tested only in
non-human primates.
In addition to NewLink, pharmaceutical giant GlaxoSmithKline is
awaiting approval from the U.S. Food and Drug Administration (FDA)
to begin a human safety trial of an experimental vaccine, possibly
as soon as next month.
The World Health Organization said on Tuesday that two experimental
Ebola vaccines were set to enter clinical trials in the coming weeks
and that there could be enough early-stage data to consider their
emergency use late this year.
"There is a way to fast-track clinical trials," WHO Assistant
Director-General Marie-Paule Kieny said.
WHO's interest has acted like a starter's pistol in the race to get
Ebola drugs or vaccines into the field. On Wednesday, Dr. Anthony
Fauci, director of the National Institute of Allergy and Infectious
Diseases, wrote in an essay in the New England Journal of Medicine
that "production scale-up" of ZMapp is under way but will take time.
ZMapp is the cocktail of antibodies, produced by Mapp
Biopharmaceutical of San Diego, given to two American medical
workers who contracted Ebola and were evacuated to Atlanta.
Also on Wednesday, Canada's Tekmira Pharmaceuticals said it was
discussing options for its experimental Ebola treatment with
governments and other agencies, including the WHO.
DISCUSSIONS WITH GOVERNMENT
NewLink is attempting to fast-track its clinical trials.
Link said the company does not have to wait for manufacturing to
ramp up before launching a safety trial of its vaccine: "We reserved
plenty of doses" from ongoing studies in lab animals "to do the
first human studies."
The company is in discussions with the U.S. Centers for Disease
Control and Prevention (CDC), the National Institutes of Health and
Walter Reed Army Medical Center about where to conduct that trial
and how to recruit volunteers. To get robust data, Link said, the
vaccine should be given to between 20 and 100 healthy volunteers,
all of whom would give informed consent.
Members of the military as well as medical workers on the front
lines of the Ebola outbreak are the most likely participants, Link
said. Before the trial can go forward, it needs FDA approval, which
he expects to come quickly: "I have never seen the FDA so
supportive," he said.
FDA spokeswoman Erica Jefferson said she could not confirm that the
agency is in discussions with NewLink. "The FDA is generally not
allowed to disclose information about any medical product under
development," she added.
At least one site for the human safety trial will be in the United
States, Link said. But the possibility of conducting a trial in
Africa recruiting medical workers has also been raised in frequent
conversations between his company and the CDC, WHO and other
agencies.
Recruiting volunteers from the U.S. military is also "a distinct
possibility," Link said, given the DTRA support and Walter Reed
discussions: "From what I'm hearing, I'm not worried about finding
volunteers."
The NewLink vaccine uses an attenuated or weakened virus, a pathogen
found in livestock called vesicular stomatitis virus (VSV). One of
the virus's genes is replaced by a gene from the Ebola virus. The
Ebola gene makes a harmless protein that sits on the virus's outer
coat.
The idea is that after the VSV is injected, the body's immune system
will recognize the Ebola protein as foreign and begin making
antibodies that destroy Ebola viruses, all of which have the
protein.
Link is confident in the vaccine's safety and efficacy, based on
results in monkeys. Live, attenuated viruses can cause inflammation
and other adverse reactions, but that may be deemed worth the risk
given Ebola's high fatality rate.
"We're here to help and do whatever we can" in the disastrous Ebola
outbreak, Link said. "My team has been told to get it done
tomorrow."
(Additional reporting by Toni Clarke; Editing by Michele Gershberg
and Jonathan Oatis)
