As the worst Ebola outbreak in history continues to spread, a Vancouver pharmaceutical company may be one step closer to testing a potential treatment.
On Thursday, the U.S. Food and Drug Administration modified the clinical hold on Tekmira Pharmaceutical’s Ebola drug. The move changed the full clinical hold on the drug, TKM-Ebola, to a partial hold.
Though TKM-Ebola has yet to be proven safe on humans, the switch may allow Tekmira to give the drug to people.
"This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus," said a statement from Tekmira issued Thursday afternoon.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," Tekmira President Dr. Mark Murray said in the release.
"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.”
The statement also said earlier studies with the drug, published in the journal The Lancet, showed that TKM-Ebola was 100 per cent effective at treating "non-human primates."
Tekmira has a $140-million contract with the U.S. government to develop TKM-Ebola. But in July, the FDA halted a small study of the drug in adults to request additional safety information from the firm.
The current Ebola outbreak has infected more than 1,000 people in West Africa. The World Health Organization says Ebola's fatality rate is up to 90 per cent.
There are no licenced drugs or vaccines for Ebola. There are several different drugs in development, although none have been rigorously tested in human populations.
Experimental Ebola treatments up for debate
The WHO has organized a meeting next week for ethicists to debate whether experimental drugs should be used and who should be given the limited quantities of new drugs.
TKM-Ebola is not the same treatment that has been used on two missionaries being treated in the U.S. They have both been given ZMapp, an experimental treatment by Mapp Biopharmaceutical Inc., after contracting Ebola in Liberia.
ZMapp is also still in experimental stages and there are extremely limited supplies of the drug.
Information on Mapp Biopharmaceutical's website says the drug combines components of the drugs MB-003 and ZMAb.
MB-300 offered 100 per cent protection to primates when given immediately after Ebola exposure, NBC reported on Monday.
The second drug, ZMab, was 100 per cent effective in primates a day after exposure. It was 50 per cent effective after two days, says the website for Dreyfus, a Toronto company that collaborated with Mapp to develop ZMapp.
With files from The Associated Press
