|Ebolavirus under an electron microscope--Courtesy of CDC|
On Monday Tekmira noted that the FDA had cleared the regulatory path needed to allow the use of its experimental Ebola treatment on a compassionate use basis. And then today the Vancouver-based biotech followed up with the news that it is collaborating with health officials on a fast-tracked study of Ebola therapies in Africa, a one-two punch that helped bolster its stock price ($TKMR) as investors gambled on a successful outcome forged out of a lethal outbreak.
The news marks a dramatic turnaround for Tekmira, which just weeks ago was dealing with a clinical hold for TKM-Ebola, an RNAi drug. Concerns about a potential cytokine storm in patients have been swept away by the urgent demand to counter the growing epidemic in Africa. Ebola typically kills about half of the people who are hit by the virus, and more than 2,000 have died so far as the outbreak flares in West Africa. Now health officials will choose among potential remedies developed by Mapp Biopharmaceuticals, Tekmira and Sarepta as well as others for testing at ground zero of the outbreak.
The Wellcome Trust is putting up about $5 million to do expedited studies in Africa, with the money earmarked to fund the production of more of these drugs as well as establish trial sites in West Africa. Mapp's antibody cocktail ZMapp earned widespread attention when it was given to Westerners who had been infected by Ebola. The recovery of two victims treated with ZMapp made headlines around the world, as did a successful primate study. For Sarepta ($SRPT), it's a chance to take a second crack at Ebola after losing a U.S. government contract that had funded its earlier work. Tekmira's drug in a Phase I study involving healthy volunteers was the most advanced of all the programs at the time the outbreak began.
Officials at the World Health Organization are now saying that without a quick response in the region, there could be 21,000 cases of Ebola in 6 weeks. None of the experimental drugs are available in sufficient quantity to blunt that trend on a short-term basis.
"The Ebola situation in West Africa is an ongoing tragedy of immense proportions and we urgently need to know whether any of these investigational treatments can save lives," noted Dr. Peter Horby, an associate professor at the University of Oxford. "In essence we need straightforward clinical trials, as for any drug for any disease, but new ways of working will be needed to provide rapid and reliable answers in perhaps the most challenging outbreak we have ever encountered. Effective drugs will not only help individual patients but will also increase community confidence in the value of Ebola treatment centres, thereby improving our chances of controlling the outbreak through isolation and treatment of infectious patients."
- here's the release