Via The Globe and Mail: B.C. pharmaceuticals firm cleared to test Ebola drug. Excerpt:
U.S. regulators have cleared the way for a Canadian drug developer to test its experimental Ebola treatment on some infected patients, raising new hope in the Ebola outbreak in Africa and sending the company’s share price soaring.
Burnaby, B.C.-based Tekmira Pharmaceuticals Corp. had begun trials on a drug called TKM-Ebola, designed to “silence” disease-causing genes in the Ebola virus.
After healthy patients began taking it as part of the first phase of a clinical trial, the U.S. Food and Drug Administration (FDA) put a clinical hold on the drug to explore possible side effects that emerged. But Tekmira announced late Thursday that the FDA has agreed to change its dictate to a partial hold, paving the way for the drug to be administered to infected Ebola patients whose lives are at risk.
World health authorities are on high alert over an outbreak of the deadly Ebola virus in three West African countries. Nigerian President Goodluck Jonathan declared a national state of emergency on Friday, as the World Health Organization warned the Ebola crisis is likely to worsen.
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” Tekmira’s president and CEO, Mark Murray, said in a statement. “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 stock rose 47.3 per cent to $23 on the Toronto Stock Exchange on Friday, once news of the FDA’s clearance was disclosed after trading ended on Thursday.
The drug has yet to be proven to work on humans, but produced 100-per-cent protection from otherwise lethal doses of the Ebola virus when used to treat non-human primates. The company is developing its experimental Ebola treatment under a $140-million (U.S.) contract with the U.S. Department of Defence, and the FDA gave it a “Fast Track” designation in March.