(Adds CEO comment, details of change)
By Rod Nickel
Aug 7 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
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.
Shares of Burnaby, British Columbia-based Tekmira surged 40
percent last week as the worst-ever outbreak of the Ebola virus
intensified. The buying spree came even as human tests of
Tekmira's treatment, TKM-Ebola, were put on hold last month.
Tekmira's drug has only been tested in a few dozen healthy
people. The FDA stopped its study in July because of safety
concerns among people taking the highest doses of the drug who
experienced problematic immune responses.
The hold meant that that particular study cannot proceed,
but it does not prevent the company from submitting a new study
proposal, say in people already infected with Ebola, for whom
any safety risks from the treatment would be mitigated by the
risk of dying.
In that case, "the benefit-risk ratio changes completely," a
source within the FDA told Reuters last week. "Anything that
would shift the risk-benefit to a more favorable outcome could
potentially allow the authorization of that study."
In that case, the source said, a company would have a
partial clinical hold in which the original study in healthy
patients remained on hold and the new study in sick patients
Tekmira stock finished trading on Thursday in Toronto up 6.6
percent at C$15.61, after a late rally prior to a trading halt
pending the news.
(Reporting by Rod Nickel in Winnipeg, Manitoba; additional
reporting by Julie Steenhuysen in Chicago; Editing by Bernard