U.S. doctor was treated with experimental Ebola drug TKM-Ebola
An American doctor who is recovering from Ebola at a Nebraska hospital got an experimental Canadian drug as part of his treatment, hospital officials disclosed this week.
Dr. Rick Sacra started receiving TKM-Ebola, manufactured by Canadian drug firm Tekmira, on Sept. 5, the day he arrived at Nebraska Medical Center in Omaha, hospital officials said in a statement. The drug, which is designed to stop the Ebola virus from replicating, was administered to Sacra over seven days.
Sacra had also received blood plasma transfusions from Dr. Kent Brantly, a fellow missionary who has recovered from the disease and was discharged from Emory University Hospital last month. The World Health Organization earlier this month recommended blood transfusions from survivors as a way of boosting an Ebola patient’s immune system by pumping in antibodies that successfully fought the virus.
Doctors at the hospital, who last week said they expect Sacra to make a full recovery, warned Tuesday against assuming the drug is a “magic bullet.”
“We don’t know if it was Dr. Sacra’s own immune system, the supportive therapy we provided, the blood transfusion from Dr. Brantly, TKM-Ebola or a combination of all these factors that helped Dr. Sacra recover,” said Dr. Angela Hewett, associate medical director of the hospital’s biocontainment unit.
Sacra, an obstetrician, contracted the disease while treating patients in Liberia. He was evacuated to Nebraska, where he has been recovering.
TKM-Ebola has not been fully cleared for use by the U.S. Food and Drug Administration, but its manufacturer announced Monday that it had reached an agreement with the agency on “an appropriate regulatory and clinical framework” to allow its use in suspected or confirmed Ebola patients in the U.S.
The firm said it reached a similar agreement with drug regulators in Canada.
The drug is being developed by Tekmira under a $140-million contract with the U.S. Department of Defense. The company began Phase 1 clinical trials of the drug to test its safety in healthy adults. Those trials were later put on hold by the FDA.
In August, Tekmira announced that the FDA was switching its “full clinical hold” on TKM-Ebola to a “partial clinical hold,” reportedly opening the door for its possible use in Ebola patients.
In a statement, the company said supplies of the drug are limited, but that it has now been administered to “a few” patients, and that repeat doses have been “well-tolerated.” A company spokeswoman declined to say how many of those patients were being treated in the U.S.
FDA spokeswoman Stephanie Yao said that federal law bars the agency from discussing specific drugs being developed.
Hospital spokesman Taylor Wilson said last-minute negotiations between hospital staff, the FDA, the U.S. Centers for Disease Control and Prevention and pharmaceutical companies were taking place up until the time Sacra arrived at the hospital and began treatment.
“Our folks were kind of working up until the last minute before the patient arrived to be able to administer the drug,” including obtaining approval from a university review board, Wilson said.
The board also cleared the blood transfusion from Brantly, Wilson said.
The use of TKM-Ebola under “emergency” protocols does not constitute a clinical trial, officials at Tekmira said.
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