October 8, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Canadian drug company Tekmira Pharmaceuticals first realized its experimental Ebola therapy might have wider applications when its partners and scientists started asking if they could take the drug with them to Africa last year, Chief Executive Mark Murray told a biotech industry panel Tuesday.
Murray was addressing the lunchtime crowd at the BIO Investor Forum at the Palace Hotel in San Francisco on Oct. 7.
Tekmira has had a contract with the U.S. Department of Defense for four years to develop the therapy, TKM-Ebola, a drug technology known as ribonucleuic acid interference, or RNAi.
But the company was still caught by surprise when interest in the drug spiked following a lethal outbreak of the virus in West Africa earlier this summer, said Murray, and has continued to grow as it spread to the U.S. last week.
“We didn’t anticipate the special need, but we have since added resources to that part of the business and so far been able to keep up with demand,” said Murray, who added he is still astonished at how thoroughly the Vancouver-based company has been immersed in an illness it had considered a secondary part of its pipeline.
TMK-Ebola was authorized by the U.S. Food and Drug Administration on Sept. 22 to be given as an experimental drug in an “expanded access” program to people with confirmed or suspected Ebola virus infections.
Such programs have been the subject of much Wall Street debate this month as biotech companies with antiviral therapies have become the prime focus of traders and regulators alike.
Clinicians and drug developers can often leapfrog the arduous FDA approval process when approved for expanded access, by providing experimental drugs to patients with serious or life-threatening diseases who may not otherwise qualify for clinical trials of a drug.
“We are always interested in an opportunity to test an agent like ours in patients,” which is why Tekmira has worked hand in hand with World Health Organization to administer the drug.
“It is still very challenging because most of the medical infrastructure in West Africa is now on its heels. The ability to pull this off in West Africa is very challenging,” said Murray.
“In order for the data to be recognized by the FDA, it has to be controlled, and how you control something like that in such an outbreak situation is difficult and unknowable,” he said. “We don’t drive the bus ourselves, so we have to be very collaborative.”
Tekmira said that since the drug will be tested in far from clinical settings, it is “relying on WHO experts to support how it is designed and how the data coming out of it would be interpretable.“
“We are relying on their guidance in many ways,” said Murray.
Still, even with that additional mandate, there is only so much Tekmira can do to stem the tide of Ebola infection, said Murray.
“The best role we can play is limited. We cannot do much, we are a small organization,” he said. “But we can provide an investigational therapeutic in places where we can do it responsibly, and we do, and will continue to do so.”
