B.C. Ebola remedy developer Tekmira's share value spikes
FDA 'stands ready' to work with drug investigators working with Ebola patients 'in dire need'
The price of shares in a B.C. pharmaceutical company that has been working to develop an Ebola counter-measure rose sharply this week with news that the deadly outbreak in West Africa has intensified.
Though human testing of Tekmira Pharmaceuticals' treatment TKM-Ebola was put on hold last month due to safety concerns, investors scrambled to buy its stock Friday, sending shares up 7.5 per cent to $13.77 in Nasdaq trading Friday, and up more than 50 per cent over the past two weeks.
Ebola belongs to a family of viruses that can cause serious hemorrhagic fevers. The recent outbreak, which has killed 729 people in four different countries since February, is the worst since the disease was discovered in the mid-1970s.
Tekmira had previously published proof-of-concept data that showed its treatment resulted in 100 per cent protection from a lethal dose of Zaire Ebola virus in infected primates.
The company started an early-stage clinical human trial for the treatment in January and was granted fast-track status from the U.S. Food and Drug Administration on March 5, pushing shares to their highest ever a few days later.
Clinical trial halted in July
But by the time the trial was put on hold on July 3, Tekmira's drug has only been tested in a few dozen healthy people.
The FDA said it was putting the trial on hold because of safety concerns among people taking the highest doses of the drug who experienced problematic immune responses.
But, on Friday, the FDA said in an emailed statement the agency "stands ready" to work with companies and investigators working with patients "in dire need of treatment."
The hold on Tekmira's existing trial does not prevent the company from submitting a new study proposal, for example in people already infected with Ebola, for whom any safety risks from the treatment would be mitigated by the risk of dying.
Some analysts say that investors are betting that the FDA, under pressure from global health campaigners, will choose to allow Tekmira's trials to proceed, possibly by year's end.
Pressure for trials to continue
I'm not advocating that they take it out of the lab and start using it in West Africa. What I'm advocating is that the trials be accelerated.- Dr. Ahmed Tejan-Sie, who initiated Change.org petition
"I'm not advocating that they take it out of the lab and start using it in West Africa. What I'm advocating is that the trials be accelerated," said the petitioner, Dr. Ahmed Tejan-Sie, who has family in West Africa.
"Given that at least one patient has transferred the disease from Liberia to Nigeria by air travel, the possibility of a global pandemic becomes increasingly likely," Tejan-Sie said. "This should be the last Ebola epidemic without a cure."
As of Saturday afternoon, more than 30,000 people had signed the petition.
Last month, the director of the influential Wellcome Trust global charity said people at high risk of dying from the Ebola outbreak in West Africa should be offered experimental medicines to see if they work.
What is not clear is whether Tekmira or any developers of possible Ebola treatments would choose to test their drugs in patients infected with Ebola, particularly in the midst of a raging epidemic in which emotions and expectations run high.
Cautious steps forward
Tekmira officials did not return calls or emails on Friday seeking comment.
In a July 21 news release, the company said it is "mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa."
"TKM-Ebola is currently an unapproved agent and the regulatory framework to support its use in Africa has not been established at this time," the company added.
What if you start giving it to people who are almost dead and they die, but it's not the drug's fault? Then you blame the drug.- Dr. Thomas Geisbert, University of Texas
Dr. Thomas Geisbert of the University of Texas Medical Branch has done animal studies on the Tekmira anti-Ebola therapy, and said there are few companies willing to develop Ebola treatments. There is "little financial incentive," given the small market potential for a drug that treats a rare disease afflicting developing countries, he said.
Geisbert said the drug "works great in monkeys in the lab," but that is largely because it is given relatively early in the course of infection.
Geisbert also said given the widespread mistrust of doctors in West Africa, which has driven dozens of victims to evade treatment, such an event could jeopardize the drug's prospects.
"What if you start giving it to people who are almost dead and they die, but it's not the drug's fault? Then you blame the drug."