Corp. has been approved by U.S. regulators. The Food
and Drug Administration had previously put tests of the
drug on hold. The Vancouver-based company said
yesterday that the agency altered the therapy's status to
possibly allow its use in those infected with the virus that
has killed 932 people in West Africa since March.
"We have been closely watching the Ebola virus
outbreak and its consequences, and we are willing to
assist with any responsible use of TKM-Ebola," Tekmira's
Chief Executive Officer Mark Murraysaid in a statement.
"The foresight shown by the FDA removes one potential
roadblock to doing so." Stephanie Yao, an FDA
spokeswoman, said she couldn't discuss specific products
and deferred questions to Tekmira. The company didn't
say in the statement if or when it would begin tests, only
that it might, and didn't say how much of the drug is
available. Julie Rezler, a Tekmira spokeswoman, didn't
return calls for comment after the statement was
released. The World Health Organization is planning to
convene a panel of medical ethicists next week to
explore the use of experimental drugs for Ebola. The U.S.
also is developing policy about how such medicines
should be distributed in future outbreaks, said Anthony
Fauci, director of the National Institute of Allergy and
Infectious Diseases. Tekmira's drug wasn't the treatment
administered to two American aid workers infected with
Ebola in Liberia. The aid workers, Kent Brantly and
Nancy Writebol, each received a dose of Mapp
Biopharmaceutical Inc.'s experimental therapy, called
ZMapp, in Liberia before being flown to the U.S. They
are being treated at Emory University Hospital in Atlanta
and have shown signs of improvement. Nigeria's health
ministry said it had written to the director of the U.S.
Centers for Disease Control and Prevention requesting
access to Mapp's drug. Human testing of Tekmira's Ebola
treatment was put on hold last month due to safety
concerns. Tekmira said the studies were suspended
because of an inflammatory, flu-like response in healthy
volunteers taking higher doses of the drug. The company
previously said it expected the hold to be resolved by the
end of the year.
The drug stops the action of specific Ebola virus genes,
which keeps the virus from making more of itself, said
Thomas Geisbert, a virologist at University of Texas
Medical Branch at Galveston. In a 2010 study,
researchers tested the drug on four monkeys, giving
them seven doses of the medicine after they were
infected with high doses of Ebola. The drug worked to
protect them from the disease. It is one of only three
treatments that have been shown to completely protect
monkeys against Ebola, Geisbert said in an e-mail. Yao,
the FDA spokeswoman, said earlier this week that while
the agency couldn't comment on the development of a
specific product like TKM-Ebola, it individually considers
each human study based on the risks and benefits
involved. "A future proposal for a study or emergency
use in a different population, for example in patients
with disease, might have an acceptable risk-benefit
balance," she said. "If the benefits of studying the
product on an individual outweigh the risks, we may
consider permitting that study to proceed." TKM-Ebola
had earlier been fast-tracked by regulators in a process
designed to expedite the review of drugs for serious
conditions and unmet medical needs. The therapy is in
the first of three stages of clinical trials usually required
by regulators for approval. Besides Mapp's antibody
therapy and Tekmira's treatment, the U.S. National
Institute of Health is developing a vaccine, which may
begin enrollment in a Phase 1 clinical trial by this fall.
Other companies developing drugs for the deadly
disease include Fujifilm Holdings Corp., BioCryst
Pharmaceuticals Inc., and Sarepta Therapeutics Inc. The
Ebola virus has sickened 1,711 people in West Africa in
the latest outbreak, according to the World Health
Organization. It has no cure. The current treatment is to
hydrate patients, replace lost blood and use antibiotics to
fight off opportunistic infections. The hope is that the
patient's immune system will be able to ward off the
disease. Ebola has historically killed as many as 90
percent of those who contract it. The current outbreak has
claimed the lives of about 60 percent of its victims.
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