Thursday, August 14, 2014 6:34 am
The epidemic has claimed more than 1,000 lives, mainly in Sierra Leone, Liberia and Guinea, but has no proven cure or vaccine, prompting authorities to consider experimental options to stem the outbreak.
Tekmira has been in touch with regulatory authorities to evaluate “options for use of our investigational drug within accepted clinical and regulatory protocols,” the company said in a statement.
To that end, Tekmira is holding “discussions with government agencies and NGOs, including the WHO, in various countries on the potential use of TKM-Ebola to treat Ebola virus infected individuals.”
The Canadian company developed TKM-Ebola under a $140 million contract with the US Defense Department. The laboratory is currently conducting phase-one clinical trials on non-infected people.
Tests on monkeys have shown the drug provided 100 percent protection from an otherwise lethal dose of Ebola, the company said.
However, so far, TKM-Ebola has not been approved as a treatment for humans.
The drug was given a “fast track” designation in March by the US drug regulator, the FDA, but that was later suspended. However, faced with the growing epidemic, the FDA partially lifted its hold on trials, opening the possibility of using the drug on infected patients.
Tekmira chief Mark Murray said Wednesday he had “reasonable confidence we can address the FDA concerns and move forward.”
He refused to give details on production levels or current stocks of the drug, saying just that “obviously we have inventory because we have a clinical study underway.”
And he added “I don’t have an answer” to whether the company could or would increase production.
On Wednesday, Canada supplied the World Health Organization with a thousand doses of an experimental Ebola vaccine to try to contain the outbreak.
According to the latest figures from the WHO, 1,069 people have died out of a total of 1,975 confirmed cases.
Guinea on Wednesday declared a state of emergency, following similar declarations from Sierra Leone, Liberia and Nigeria.