(CNN) -- Three top secret, experimental vials
stored at subzero temperatures were flown
into Liberia last week in a last-ditch effort to
save two American missionary workers who
had contracted Ebola, according to a source
familiar with details of the treatment.
On July 22, Dr. Kent Brantly woke up feeling
feverish. Fearing the worst, Brantly
immediately isolated himself. Nancy Writebol 's
symptoms started three days later. A rapid
field blood test confirmed the infection in both
of them after they had become ill with fever,
vomiting and diarrhea.
It's believed both Brantly and Writebol, who
worked with the aid organization Samaritan's
Purse, contracted Ebola from another health
care worker at their hospital in Liberia,
although the official Centers for Disease
Control and Prevention case investigation has
yet to be released.
A representative from the National Institutes
of Health contacted Samaritan's Purse in
Liberia and offered the experimental
treatment, known as ZMapp, for the two
patients, according to the source.
The drug was developed by the biotech firm
Mapp Biopharmaceutical Inc. The patients
were told that this treatment had never been
tried before in a human being but had shown
promise in small experiments with monkeys.
According to company documents,
four monkeys infected with Ebola
survived after being given the
therapy within 24 hours after
infection. Two of four additional
monkeys that started therapy within
48 hours after infection also
survived. One monkey that was not
treated died within five days of
exposure to the virus.
Brantly and Writebol were aware of the risk of
taking a new, little understood treatment;
informed consent was obtained from both
Americans, according to two sources familiar
with the care of the missionary workers. In the
monkeys, the experimental serum had been
given within 48 hours of infection. Brantly
didn't receive it until he'd been sick for nine
days.
The medicine is a three-mouse monoclonal
antibody, meaning that mice were exposed to
fragments of the Ebola virus and then the
antibodies generated within the mice's blood
were harvested to create the medicine. It
works by preventing the virus from entering
and infecting new cells.
The Ebola virus causes viral hemorrhagic fever,
which refers to a group of viruses that affect
multiple organ systems in the body and are
often accompanied by bleeding.
Early symptoms include sudden onset of fever,
weakness, muscle pain, headaches and a sore
throat. They later progress to vomiting,
diarrhea, impaired kidney and liver function --
and sometimes internal and external bleeding.
The ZMapp vials reached the hospital in Liberia
where Brantly and Writebol were being treated
Thursday morning. Doctors were instructed to
allow the vials to thaw naturally without any
additional heat. It was expected that it would
be eight to 10 hours before the medicine could
be given, according to a source familiar with
the process.
Brantly asked that Writebol be given the first
dose because he was younger and he thought
he had a better chance of fighting it, and she
agreed. However, as the first vial was still
thawing, Brantly's condition took a sudden
turn for the worse.
Brantly began to deteriorate and
developed labored breathing. He
told his doctors he thought he was
dying, according to a source with
firsthand knowledge of the
situation.
Knowing his dose was still frozen,
Brantly asked if he could have
Writebol's now-thawed medication.
It was brought to his room and
administered through an IV. Within
an hour of receiving the
medication, Brantly's condition
dramatically improved. He began
breathing easier; the rash over his
trunk faded away. One of his
doctors described the events as
"miraculous."
By the next morning, Brantly was
able to take a shower on his own
before getting on a specially
designed Gulfstream air ambulance
jet to be evacuated to the United
States.
Writebol also received a vial of the
medication. Her response was not
as remarkable, according to sources
familiar with the treatment.
However, doctors on Sunday
administered Writebol a second dose of the
medication, which resulted in significant
improvement.
She was stable enough to be evacuated back to
the United States and is expected to arrive
before noon Tuesday.
ZMapp has not been approved for human use,
and has not even gone through the clinical
trial process, which is standard to prove the
safety and efficacy of a medication. The
process by which the medication was made
available to Brantly and Writebol is highly
unusual. It may have fallen under the U.S.
Food and Drug Administration's
" compassionate use " regulation, which allows
access to investigational drugs outside clinical
trials.
Getting approval for compassionate use is
often long and laborious, but in the case of
Brantly and Writebol, they received the
medication within seven to 10 days of their
exposure to the Ebola virus.
On July 30, the Defense Threat Reduction
Agency, an arm of the military responsible for
any chemical, biological, radiological, nuclear
and high-yield explosive threats, allotted
additional funding to MAPP Biopharmaceutical
due to "promising results"


http://edition.cnn.com/2014/08/04/health/experimental-ebola-serum/index.html?sr=tw080414ebolaserum1030aStoryPhoto

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