FDA switches course on Tekmira drug as Ebola panic triggers policy review

Tekmira CEO Mark Murray

Shares of Tekmira ($TKMR) got a boost Thursday night after the company spread the word that the FDA had switched its full clinical hold on an experimental Ebola drug to a partial hold, clearing the path to its possible use to fight a sudden outbreak in Africa that has been sparking chilling headlines the world over.

The FDA had placed the hold on the Vancouver-based biotech's therapy after investigators grew concerned about signs of cytokine release among patients, a condition that can quickly escalate into a lethal reaction if left to run its course. Investigators are still being held back from using the drug in a dose-ascending portion of a Phase I trial. But after two Americans were apparently helped by a different experimental therapy being advanced in partnership with the NIH, the focus now is on the prospective use of a whole slate of experimental drugs that are still running the first lap of human studies or in late animal trials.

Officials at Health and Human Services, meanwhile, are telling reporters that the agency is setting up a group to review the use of these early-stage drugs. And the WHO is convening its own group to review how these drugs might be used on dying or desperately ill patients.

News that a pair of Americans who were infected by Ebola, a lethal virus that can quickly overwhelm the body, responded to a therapy from Mapp Biopharmaceutical set off a cable news sensation. And now a lineup of biotechs from Sarepta ($SRPT) to Toronto-based Defyrus are raising the possibility of ramping up production to see how these drugs work in the field.

Health officials facing widespread panic in the face of an outbreak, or the chance of one--something that seems to roll around every few years--often become suddenly pliant about the rules on drug development. The only market for these drugs is controlled by governments around the world. 

For a small biotech and a legion of investors, though, the prospect of an overnight windfall and the sudden global attention can be impossible to ignore.

"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. The foresight shown by the FDA removes one potential roadblock to doing so," said Dr. Mark Murray, CEO at Tekmira. "This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols."

Shares of Tekmira were up 8% on the news. 

- here's the release from Tekmira
- read the report from Reuters

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