{UAH} YUP WE MAKE EBOLA DRUGS

 

Canadian-made experimental Ebola drug not used on US missionary

Vancouver Sun - 21 minutes ago

Tekmira Pharmaceuticals said in an email that no one infected in the
ongoing outbreak in West Africa has been treated with its drug, called
TKM-Ebola.

The Christian relief group Service in Mission or SIM said late last
week that one of its missionaries, Nancy Writebol, had been given an
experimental drug flown into Liberia, where she contracted the disease
while working in an Ebola treatment facility.

Liberia, Guinea and Sierra Leone are battling a months-long outbreak
that has infected at least 1,440 people and killed at least 826.

Another American, Dr. Kent Brantly, was also infected at the same
centre in Liberia. Brantly works with the international relief agency
Samaritan's Purse.

Its president, Franklin Graham, said in a statement last week that
limited supplies of an unnamed experimental drug arrived at the
facility. There was only enough to treat one person, and Brantly asked
that the drug be given to Writebol, Graham said.

Although there are a number of Ebola therapies in development,
Tekmira's is thought to be the furthest along in the regulatory
process. And there has been some speculation among scientists that it
was the one given to Writebol. Meanwhile, the price of the company's
stock has soared as media coverage of the Ebola outbreak has
intensified.

But Tekmira said Writebol did not receive their drug.

"Our investigational therapy TKM-Ebola has not been given to either of
the Samaritan Purse workers or anyone else infected in the current
outbreak, and has not been given to anyone outside of our Phase I
trials," it said in an email.

Based in Burnaby, B.C., Tekmira has been conducting a Phase I clinical
trial in people. That involves giving a treatment to a small number of
healthy volunteers to make sure it is safe to use in people and to
establish what a human dose should be. These preliminary trials are
too small to generate proof of whether a drug works.

TKM-Ebola is what is known as a small-interfering RNA compound.
According to the company's website, these synthetic RNA molecules work
by binding to the RNA produced by the virus, blocking its ability to
make disease-causing proteins.

Because Tekmira is conducting a trial in people, the company would
have some supplies of TKM-Ebola made to human-use standards, known in
the pharmaceutical industry as "current good manufacturing practices"
or cGMP.

Experimental drugs used only in animals do not have to be made
following the stringent safety standards of cGMP regulations.
Companies or government-funded research institutes still testing Ebola
therapies only in animals may not have incurred the considerable
expense of making human grade supplies of their drugs.

Tekmira's clinical trial was recently put on hold by the U.S. Food and
Drug Administration, which asked for additional data related to an
inflammatory reaction seen when the drug was given at higher doses.

Writebol is being transported back to the United States for care. She
is set to arrive in Atlanta, Ga., early Tuesday where she will join
Brantly at Emory University Hospital. The most recent update from SIM
said Writebol is in serious but stable condition.

Brantly arrived at Emory University Hospital on Saturday. TV footage
showed him gingerly stepping out of an ambulance and walking, with
some assistance, into the building.

The hospital said Sunday it would not be updating the public on
Brantly's condition due to patient confidentiality regulations and his
family's wishes.

Emory, which is located adjacent to the main campus of the U.S.
Centers for Disease Control, has built a special isolation unit to
treat patients exposed to serious infectious diseases. The hospital's
website says the unit is physically separate from other patient areas
and has its own equipment and infrastructure which provides "an
extraordinarily high level of clinical isolation."

The Emory facility, built in collaboration with the CDC, is one of
only four such high containment treatment units in the United States.

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