Ebola Drug Made From Tobacco Plant Saves U.S. Aid Workers

A tiny San Diego-based company provided an
experimental Ebola treatment for two Americans
infected with the deadly virus in Liberia. The
biotechnology drug, produced with tobacco plants,
appears to be working.
In an unusual twist of expedited drug access, Mapp
Biopharmaceutical Inc., which has nine employees,
released its experimental ZMapp drug, until now only
tested on infected animals, for the two health
workers. Kentucky BioProcessing LLC, a subsidiary of
tobacco giant Reynolds American Inc. (RAI),
manufactures the treatment for Mapp from tobacco
plants.
The first patient, Kent Brantly, a doctor, was flown
from Liberia to Atlanta on Aug. 2, and is receiving
treatment at Emory University Hospital. Nancy
Writebol, an aid worker, is scheduled to arrive in
Atlanta today and will be treated at the same
hospital, according to the charity group she works
with. Both are improving, according to relatives and
supporters.
Each patient received at least one dose of ZMapp in
Liberia before coming to the U.S., according to
Anthony Fauci, director of the National Institute of
Allergy and Infectious Diseases.
"There's a very scarce number of doses," and it's not
clear how many each patient needs for treatment,
Fauci said. "I'm not sure how many doses they'll get."
Citing unnamed sources, CNN yesterday reported
that the drug used for the treatment is Mapp's.
Tobacco Plant
The tobacco plant production system was developed
because it was a method that could produce
antibodies rapidly in the event of an emergency, he
said.
To produce therapeutic proteins inside a tobacco
plant, genes for the desired antibodies are fused to
genes for a natural tobacco virus, said Arntzen. The
tobacco plants are then infected with this new
artificial virus, he said.
"The infection results in the production of antibodies
inside the plant," Arntzen said. The plant is
eventually ground up and the antibody is extracted,
he said. The whole process takes a matter of weeks.
When confronted by reporters about the Ebola
infections in Liberia and subsequent treatments,
Whaley said he needed to get up to speed on the
developing events.
"This is all new to me," said Whaley, who was dressed
in shorts, a well-worn T-shirt and flip-flops while
addressing reporters' questions outside the
company's offices in a San Diego business park. "I
just don't want to give out any inaccurate
information, that's all."

Ethical Questions
Ebola and virology experts believe the use of the
Mapp drug for Brantly and Writebol is unusual in the
annals of emergency drug treatments. While
potentially saving lives, the cases raise questions
about who should have the right to receive
experimental drugs years before they gain FDA
approval.
"There are a lot of Africans that are also dying,"
Robert Garry, a virologist at Tulane University, said in
a telephone interview. "If we are going to do it for the
Americans then we should certainly step up our game
for the Africans."
Although no drugs to treat Ebola are approved by U.S.
regulators, the Food and Drug Administration can
approve an emergency application to provide access
to unapproved drugs, Stephanie Yao, an FDA
spokeswoman, said in an e-mail.

Emergency Approval
Approval for emergency drug use outside of a clinical
trial can be made within 24 hours, Yao wrote.
Shipment and treatment with the drug could begin
even before completed written forms are submitted
to the FDA, which can approve the use of an
experimental treatment by telephone in an
emergency.
"The FDA stands ready to work with companies and
investigators treating these patients who are in dire
need of treatment," Yao said. She declined to say
whether the FDA had allowed any drug to be used in
the Ebola outbreak.
Erica Ollmann Saphire, a molecular biologist at the
Scripps Research Institute in San Diego, worked with
Mapp and the other biotechnology companies to
develop models of the Ebola virus and potential
antibodies.
She directs a global consortium given the job of
modeling the virus and the mixture of antibodies
needed to defeat it. She said the drug was approved
for the two American medical workers in Liberia under
a compassionate-use doctrine, because it's not even
scheduled for clinical trials until next year.

To contact the reporters on this story: Robert
Langreth in New York at rlangreth@bloomberg.net;

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