UPDATE 1-Tekmira Ebola drug gets regulator change for possible human use

Thu Aug 7, 2014 5:44pm EDT
 
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(Adds CEO comment, details of change)

By Rod Nickel

Aug 7 (Reuters) - Tekmira Pharmaceutical Corp said on Thursday that the U.S. Food and Drug Administration had modified its clinical hold status on Tekmira's experimental Ebola treatment to enable its potential use in humans infected with the virus.

The FDA told Burnaby, British Columbia-based Tekmira that it had modified the full clinical hold on the drug to a partial clinical hold, the company said in a statement.

"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," said Dr. Mark Murray, Tekmira's chief executive officer. "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 recent Ebola outbreak has killed nearly 1,000 people in West Africa.

The World Health Organization (WHO) on Wednesday said it would convene a meeting of medical ethics experts next week to consider the implications of making experimental Ebola drugs more widely available.

Tekmira's Ebola treatment is one of three worldwide that have shown especially promising results in monkeys, but it is unproven in humans.

Tiny California biotech Mapp Biopharmaceutical gained international prominence this week when its drug was given to two U.S. aid workers who contracted Ebola in West Africa and have since shown signs of improvement.   Continued...