Efforts Accelerated to Push Untested Ebola Drugs into Clinical Trials

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Efforts Accelerated to Push Untested
Ebola Drugs into Clinical Trials     Vaccine developed by Canadian government
could be mass produced within months.
While the Ebola-related death toll in West Africa
continues to rise, drug manufacturers are
stepping up their efforts to advance experimental
treatments for the disease into the clinical trial
phase.
A vaccine called VSV-EBOV that was developed
by the Government of Canada and licensed for
further development to American firm NewLink
Genetics Corp through subsidiary BioProtection
Systems Corp has shown promise in animal
testing, but it has yet to be used in humans.
Earlier this week, Canada announced it will
donate up to 1000 doses of VSV-EBOV to the
World Health Organization (WHO) to aid in
halting the spread of the virus, which has killed
more than 1000 people, with more than 1800
confirmed and suspected cases.
Last week, BioProtection Systems received a $1
million contract with the US Defense Threat
Reduction Agency (DTRA) for studies on the
vaccine to bring it closer to human clinical trials.
“There is an urgent need for a medical
countermeasure against the deadly Ebola virus,”
said Charles Link, MD, chairman and chief
executive officer of NewLink in a press release .
“This Ebola vaccine has been 100% effective in
preventing lethal infection when given to non-
human primates before they are infected with the
virus. The vaccine also acts rapidly enough to
have significant efficacy even when given to
animals that have recently received a typically
lethal dose of Ebola virus.”
Dr. Link told Reuters that NewLink will be able
to produce tens of thousands of doses for the
drug within the next 2 months.
Efforts to develop a vaccine were accelerated
following the decision by a WHO ethical panel
that there is a moral obligation to use
experimental treatments on patients in the
disease-ravaged region. Two companies that are
also receiving funding from the DTRA have
promising Ebola treatment candidates in early
development.
A drug by BioCryst Pharmaceuticals, called
BCX4430, has exhibited the potential to treat a
broad spectrum of activity in multiple viruses
with a favorable preliminary safety profile. The
drug has shown efficacy in a small study of
nonhuman primates, but has yet to be evaluated
in humans.
A treatment from Tekmira Pharmaceuticals Corp,
called TKM-Ebola, had an FDA phase I clinical
hold changed to a partial hold on August 7, 2014,
which will allow for testing in humans.
A third drug, ZMapp, showed promising results in
treating infected American aid workers Dr. Kent
Brantly and Nancy Writebol, who showed signs
of recovery after receiving the treatment.
However, supplies of ZMapp have now been
exhausted. Director of the National Institute of
Allergy and Infectious Diseases Anthony Fauci,
MD, wrote in an essay in the New England
Journal of Medicine on Wednesday that
production of ZMapp has been scaled up, but he
added that the process would take time.
Despite the dire need, objections have been
raised in the American medical community about
the potential dire consequences of using
untested treatments in human patients.
“To use this drug without having any information
on its human benefits or dangers runs the risk of
mistakenly thinking it is either effective or not
based upon anecdotal evidence, a difficulty that
could prove disastrous for later in this outbreak
or future ones,” said Philip M. Rosoff, MD,
director of the Clinical Ethics Program at Duke
University Hospital, in a press release.
“Desperately sick people and their families make
decisions under very trying circumstances. Often,
they are willing to try anything that they believe
—or can be led to believe—may offer some hope
of improvement or a cure. As such, they can be
ripe targets for those who would take advantage
of their desperation and plight. Thus, extra
caution and thought must be given to using
experimental and possibly dangerous treatments
in this population.”