B.C. Ebola remedy developer Tekmira's share value spikes

The price of shares ina B.C. pharmaceuticalcompany that has been working to develop an Ebola counter-measurerose sharply this week withnews that the deadlyoutbreak in West Africa hasintensified.

Though human testing of Tekmira Pharmaceuticals'treatment TKM-Ebolawas put on hold last month due to safety concerns,investors scrambled to buy its stock Friday, sending shares up 7.5per cent to $13.77 in Nasdaq trading Friday, and up more than 50per cent over the past two weeks.

Ebola belongs to a family of viruses that can cause serioushemorrhagic fevers.The recent outbreak, which has killed 729 people in fourdifferent countries since February, is the worst since thedisease was discovered in the mid-1970s.

Tekmira had previously published proof-of-concept data thatshowed its treatment resulted in 100 per cent protection from alethal dose of Zaire Ebola virus in infected primates.

The company started an early-stage clinical human trial for thetreatment in January and was granted fast-track status from theU.S. Food and Drug Administration on March 5, pushingshares 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

On Friday, aNorth Carolina physician initiated a petitiononWednesday on the Change.org website, asking the FDA to release the hold onTekmira's treatment.

I'm not advocating that they take it out of the lab andstart using it in West Africa. What I'm advocating is that thetrials be accelerated.-Dr. AhmedTejan-Sie, who initiated Change.org petition

"I'm not advocating that they take it out of the lab andstart using it in West Africa. What I'm advocating is that thetrials be accelerated,"said the petitioner, Dr. AhmedTejan-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 Fridayseeking comment.

In a July 21 news release, the company said itis "mindful of the need for this important therapeutic insituations such as the ongoing Ebola outbreak in West Africa."

"TKM-Ebola is currently an unapproved agent and theregulatory framework to support its use in Africa has not beenestablished at this time," the company added.

What if you start giving it to people who are almost deadand they die, but it's not the drug's fault? Then you blame thedrug.- Dr. ThomasGeisbert, Universityof Texas

Dr. Thomas Geisbert of the University of Texas MedicalBranch has done animal studies on the Tekmiraanti-Ebola therapy, and saidthere 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 afflictingdeveloping 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 thecourse of infection.

Geisbert also said given the widespread mistrust of doctors inWest Africa, which has driven dozens of victims to evadetreatment, such an event could jeopardize the drug'sprospects.

"What if you start giving it to people who are almost deadand they die, but it's not the drug's fault? Then you blame thedrug."