UPDATED: Tekmira tempers expectations as regulators clear Ebola drug for emergency use
UPDATE: The U.S. Centers for Disease Control (CDC) on Tuesday issued a new report estimating that the Ebola outbreak could infect between 550,000 and 1.4 million by January 20, depending on the number of unreported cases thus far. The official tally stands at 5,864, but some say the number could actually be as high as 20,000.
"Extensive, immediate actions -- such as those already started -- can bring the epidemic to a tipping point to start a rapid decline in cases," said CDC spokespeople in a statement.
- Regulators from the U.S. and Canada on Monday approved use of Tekmira's Ebola medication TKM-Ebola for emergency use in Canadian and American patients. Doses of the drug will also be sent to afflicted regions in West Africa.
- TKM-Ebola has already been used on several patients, including American doctor Rick Sacra at the Nebraska Medical Center. Company spokespeople say the treated patients have responded well to repeated infusions without adverse events.
- Wellcome Trust, a public health charity, announced on Tuesday that it had established a $5.25 million grant to help speed up clinical trials of Ebola drugs from Tekmira, Sarepta Therapeutics, and Mapp Biopharmaceuticals. The grant and program involve partners including the World Health Organization and Doctors Without Borders.
Tekmira closed up 17% on Monday and had gained another 7.75% on pre-market trading Tuesday thanks to the news. But company spokespeople were quick to point out that the largely ad hoc trial process could be a bumpy ride.
"[I]t must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials," said Tekmira CEO Mark J. Murray in a statement. "These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome."
So far, Mapp Biopharma's ZMapp has shown some of the most promise of any Ebola drug in development -- but as with many of the other pipeline treatments, supplies are limited. Last week, the first UK volunteer received GSK's experimental Ebola vaccine, which is being developed in conjunction with the U.S. National Institutes for Health (NIH).