US Authorities Remove Restrictions From Experimental Ebola Drug

U.S. health authorities have eased safety restrictions on an
experimental drug to treat Ebola, a move that could clear the way for
its use in patients infected with the deadly virus.




Canadian drugmaker Tekmira Pharmaceuticals Corp. said the U.S. Food and
Drug Administration modified a hold recently placed on the company’s
drug after safety issues emerged in human testing.



The company has a $140 million contract with the U.S. government to
develop its drug, TKM-Ebola, which targets the genetic material of
Ebola. But last month the FDA halted a small study of the injection in
adults to request additional safety information.



Tekmira said Thursday the agency “verbally confirmed” changes to the
hold that may allow the company to make the drug available, although it
has yet to be proven as safe and effective.



Two Americans diagnosed with Ebola recently received a different
experimental drug called ZMapp, made by Mapp Biopharmaceutical Inc. of
San Diego. It is aimed at boosting the immune system’s efforts to fight
off Ebola and is made from antibodies produced by lab animals exposed
to parts of the virus.



The U.S. aid workers were first treated in Liberia. And while the FDA
must grant permission to use experimental treatments in the United
States, it does not have authority over the use of such a drugs in
other countries.



The FDA’s move Thursday comes amid an Ebola outbreak in West Africa
that health officials warn could sicken more people than all previous
outbreaks of the disease combined. More than 1,700 people have been
sickened in the current outbreak, which began in March. Nearly 1,000
have died, according to the World Health Organization.



Currently, there are no licensed drugs or vaccines for the deadly
disease. Several are in various stages of development, but none have
been rigorously tested in humans.



The FDA in March granted Tekmira “fast track” status for its Ebola
drug, a designation designed to speed up approval of high-priority
drugs by granting companies extra meetings with FDA scientists. Early
studies of TKM-Ebola in monkeys suggested it could block high doses of
the Ebola virus. But on July 21, the company based in Vancouver,
British Columbia, announced the FDA had halted a small dosing study of
the drug in 28 healthy adults. The company said regulators had
questions about a type of drug reaction that can cause nausea, chills,
low blood pressure and shortness of breath.



Tekmira’s CEO Mark Murray praised the FDA for modifying the restriction on Thursday.



“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,” Murray said. “The foresight shown by the FDA removes one
potential roadblock to doing so.”



FDA spokeswoman Stephanie Yao said she could not confirm the company’s
announcement since FDA regulations bar the agency from disclosing
information about experimental drugs. She did note that the agency
places clinical holds on studies based on the risks and benefits to
patients. Patients in the Tekmira study were healthy volunteers.



Tekmira’s U.S.-traded shares jumped 89 cents, or 6.7 percent, to close
at $14.27 in regular trading. They climbed another $1.18 cents, or 8.3
percent, to $15.45 in afterhours trading. [ABC News]