An experimental drug designed to treat patients infected with the deadly ebola virus could be back on track for human testing following a decision from the US Food and Drug Administration today. The agency lifted a halt on testing TKM-Ebola, a drug made by Canadian pharmaceutical company Tekmira, that up until last month had been given special fast-track status by the FDA to help speed it through various regulatory hurdles. The FDA put the brakes on that process in early July, asking for more information on how the drug works when given to patients in higher doses. Today Tekmira said that it had received a verbal confirmation from the FDA that it could test the drug on patients who were actually infected with the virus, while connecting the move to the ebola outbreak in West Africa that's tallied up 932 deaths thus far.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," Tekmira's CEO Dr. Mark Murray said in a statement. "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." NOT THE ONLY EBOLA DRUG IN THE WORKS Tekmira's drug has the backing of the US government as part of a $140 million defense contract. Ahead of the FDA halt, the company was testing it on healthy humans after finding a 100 percent success rate on treating infected primates with a deadly dose of the virus. The drug is joined by an experimental serum called ZMapp co-developed by a pair of US and Canadian drug makers (as well as the US government and Canada's Public Health Agency) that's designed to target the virus with a jolt of lab-produced antibodies. Like TKM-Ebola, it's been tested in primates, though not clinical trials with humans. According to the World Health Organization, ebola has now infected 1,711 and led to 932 deaths across Guinea, Liberia, Nigeria, and Sierra Leone.
The outbreak has wrecked havoc in the region, with its presence in densely-populated cities allowing the virus to be spread more easily. The virus is spread between humans through body fluids, and there's no cure or vaccine available. Health officials have noted that it's actually quite difficult to be infected by someone who has the virus, but have warned that mutation and adaptation are a possibility if the situation is not contained.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," Tekmira's CEO Dr. Mark Murray said in a statement. "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." NOT THE ONLY EBOLA DRUG IN THE WORKS Tekmira's drug has the backing of the US government as part of a $140 million defense contract. Ahead of the FDA halt, the company was testing it on healthy humans after finding a 100 percent success rate on treating infected primates with a deadly dose of the virus. The drug is joined by an experimental serum called ZMapp co-developed by a pair of US and Canadian drug makers (as well as the US government and Canada's Public Health Agency) that's designed to target the virus with a jolt of lab-produced antibodies. Like TKM-Ebola, it's been tested in primates, though not clinical trials with humans. According to the World Health Organization, ebola has now infected 1,711 and led to 932 deaths across Guinea, Liberia, Nigeria, and Sierra Leone.
The outbreak has wrecked havoc in the region, with its presence in densely-populated cities allowing the virus to be spread more easily. The virus is spread between humans through body fluids, and there's no cure or vaccine available. Health officials have noted that it's actually quite difficult to be infected by someone who has the virus, but have warned that mutation and adaptation are a possibility if the situation is not contained.
