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UPDATE 2-US Ebola patient receives experimental drug from Chimerix
(Rewrites throughout with details on patient receiving drug and
how it works)
Oct 6 (Reuters) – After nearly a week in hospital, the first
Ebola patient diagnosed in the United States began to receive an
experimental therapy initially developed to treat other viral
diseases, according to the Dallas hospital where he lies in
critical condition.
Federal health officials had said for days that the family
of the Liberian man, Thomas Eric Duncan, had been told about
experimental therapies to treat the deadly virus. As recently as
Sunday, they said they were unaware whether or not Duncan, who
fell ill about a week after arriving in Texas from Liberia on
Sept. 20, was receiving any.
On Monday, however, a spokeswoman for Texas Health
Presbyterian Hospital said Duncan began receiving a drug called
brincidofovir, made by Durham, North Carolina-based Chimerix Inc
, on Saturday afternoon. The drug, which comes in tablet
form, has never been tested on laboratory animals infected with
Ebola let alone in human Ebola patients.
Questions had been raised on social media about why Duncan
had not received experimental treatments after he was admitted
to the hospital on Sept. 28. Medical experts said the choice of
the Chimerix drug may have been influenced both by the
deterioration in Duncan’s condition and the therapy’s safety
profile.
“When a patient becomes sick enough, there may be a feeling
of, ‘should we give it a shot?’,” said bioethicist Dr. Kevin
Donovan of Georgetown University Medical Center. “This alone may
have tilted them toward using it, rather than having him die
‘untreated.'”
At least three other Ebola patients flown to the United
States from countries in West Africa where the virus has killed
more than 3,400 people received experimental drugs.
The patients included two U.S. aid workers treated at Emory
University Hospital in Atlanta, Georgia, who received Mapp
Biopharmaceutical’s ZMapp in July and August. A third U.S. aid
worker treated Nebraska Medical Center in Omaha, who received
Tekmira Pharmaceutical’s TKM-Ebola last month.
All three recovered, but it is scientifically impossible to
say whether the drugs played a role in their recovery, something
only rigorous clinical trials can determine.
‘AVAILABLE FOR IMMEDIATE USE’
Dr. Thomas Frieden, director of the U.S. Centers for Disease
Control and Prevention (CDC), told reporters on Sunday that
Duncan was apparently not receiving experimental therapies, in
part because there are no more doses of ZMapp, a cocktail of
three antibodies.
Asked about TKM-Ebola, Frieden said it “can be quite
difficult for patients to take” and “can actually make someone
sicker.”
Neither supply nor administration is apparently an issue
with brincidofovir, which was first developed to treat
adenovirus infections in people with weakened immune systems.
“Chimerix has brincidofovir tablets available for immediate
use in clinical trials,” the company said in a statement. It
also said on Monday that the U.S. Food and Drug Administration
approved its emergency use for Ebola patients and that it was
working to set up clinical trials.
TKM-Ebola is given intravenously. “IV access can be quite
challenging with a medically compromised patient,” Dr.
Christopher Kratochvil, chief medical officer at UNeHealth,
parent of the University of Nebraska Medical Center, said in an
interview.
Shares in Chimerix rose 4.7 percent on Monday and shares in
TKM-Ebola manufacturer Tekmira fell nearly 19 percent.
Another consideration in the choice of drugs for Duncan
might have been safety. Ebola is infamous for causing massive
fluid loss, which can lead to electrolyte imbalances that stress
the heart and kidneys. Brincidofovir, also called CMX-001, has
been tested in more than 1,000 patients without raising safety
concerns, including kidney toxicity, the company said.
Chimerix faced a firestorm of criticism this year when it
initially declined to provide the drug on a “compassionate use”
basis to 8-year-old Joshua Hardy, a Virginia boy who developed a
potentially-fatal adenovirus infection after a bone marrow
transplant for kidney cancer.
The company relented and enrolled the boy in a clinical
trial. He went home from the hospital in July, but the incident
led Chimerix to replace its chief executive.
CMX-001 is a compound called a nucleotide analog. Its
molecules behave enough like those that form the genetic
material (nucleotides) of viruses such as Ebola that the
microbes incorporate it into their DNA or RNA, a sister
molecule.
But CMX-001 is different enough that, once incorporated, it
prevent a virus’s genetic material from replicating. That stops
the virus from spreading throughout the body.
When West Africa’s Ebola outbreak was reported last March,
Chimerix sent brincidofovir to government labs, including at the
CDC and National Institutes of Health, to be tested against
test-tube samples of the Ebola virus. It showed “potent
activity,” the company said.
(Reporting by Sharon Begley and Toni Clarke; Editing by Michele
Gershberg and Grant McCool)
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