Tekmira in talks about unapproved Ebola drug
The Canadian PressThursday, August 14, 2014
VANCOUVER - Tekmira Pharmaceuticals Corp. (TSX:TKM) is in discussions about making its experimental Ebola drug available to infected patients, but says there is no guarantee the treatment can be used to help quell the outbreak in West Africa.
On a conference call with stock analysts on Wednesday, Tekmira CEO Mark Murray expressed "deep concern" over the crisis, but struck a cautious tone when asked what role the Vancouver-based company's drug, called TKM-Ebola, could play in helping tackle it.
"Given the severity of the situation we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols," Murray said.
That includes talks with government and non-government groups in various countries, including the World Health Organization, but Murray declined to give details on what sorts of scenarios are under discussion.
On Tuesday, the WHO said it would be ethical for unproven treatments to be used for the current Ebola outbreak, which has killed more than 1,000 people. The Canadian government has said it would redirect hundreds of doses of an experimental vaccine to the outbreak response.
"Our therapeutic TKM-Ebola is currently such an unapproved investigational agent and the regulatory framework to support its use in Africa has not yet been established," said Murray.
"There can be no assurance that an appropriate framework for the use of this product will be found."
Tekmira is in the middle of a Phase 1 clinical study of TKM-Ebola, which involves about 28 human subjects.
On the call, Murray said Tekmira has an inventory of the drug for the trial and is exploring what it would take to manufacture more. Production would likely take a matter of months, he said.
Last month, the U.S. Food and Drug Administration imposed a "clinical hold" on the study after some safety concerns emerged.
But last week, the FDA said it would partially lift the clinical hold, potentially enabling TKM-Ebola to be used in patients infected with the deadly virus. Restrictions remain on testing the drug on healthy subjects, but Tekmira expects that matter to be resolved by the fourth quarter of this year.
Tekmira has a $140-million contract from the U.S. Defense Department to develop TKM-Ebola.
In the days following FDA's decision, Tekmira's stock price see-sawed wildly, gaining about 60 per cent over two days before dropping about 21 per cent on Tuesday. On Wednesday, shares were up slightly at $20.38.
Also Wednesday, Tekmira said its net loss in the second quarter was $6.1 million, or 28 cents per share, widening from $3 million, or 21 cents per share, in the same period a year earlier.
Revenue dropped to $1.8 million from $2.8 million in the same 2013 quarter.
— By Lauren Krugel in Calgary
Follow @LaurenKrugel on Twitter