France’s Inserm in Talks With Guinea on Ebola Drug Trial for Ill
France’s state health institute, Inserm, is in talks with Guinea authorities on the first clinical trials of experimental Ebola therapies to be used on patients in the West African country.
Inserm is considering two trials, each involving at most 15 patients, to test compounds from Fujifilm Holdings Corp. (4901) and Tekmira Pharmaceuticals Corp. (TKMR), said Jean-Francois Delfraissy, director of Inserm’s Institute of Microbiology and Infectious Diseases. Discussions with Guinea officials began this week and no decision has been made, he said.
“We are at the stage of starting to talk with authorities, to see whether this can potentially be done, for patients who don’t have too many symptoms yet,” Delfraissy said in a telephone interview yesterday.
Inserm’s possible trials would add to the race to develop treatments for Ebola, which has infected more than 3,000 people and killed more than 1,550 in Liberia, Sierra Leone, Guinea and Nigeria in this outbreak. The epidemic is on pace to kill more people than all previous Ebola outbreaks combined, and the World Health Organization declared it a global health emergency, that could eventually infect 20,000.
Senegal reported its first case yesterday, a 21-year-old college student from Guinea. The country is now the fifth in West Africa to confirm the presence of Ebola. A separate, unrelated outbreak was reported in the Democratic Republic of Congo this week.
Scientists at the U.S. National Institutes of Health’s Vaccine Research Center plan to begin enrolling patients next week in an early-stage trial of GlaxoSmithKline Plc’s experimental Ebola vaccine. Another experimental drug made by Mapp Biopharmaceutical Inc., ZMapp, has been used to treat health workers who fell ill while caring for Ebola patients.
In a trial in monkeys, 18 of the animals that got ZMapp after being infected with Ebola for three to five days survived, while three monkeys who didn’t get the drug died, according to results published yesterday in the journal Nature.
Sakoba Keita, head of the epidemic prevention unit at Guinea’s Health Ministry, confirmed that Guinea is in talks with France on the experimental Ebola treatments. “There has been as yet no letter of formalization, but an agreement in principle has been obtained,” Keita said by phone yesterday.
Representatives at Tekmira and Fujifilm didn’t immediately respond to requests for comment. The U.S. Food and Drug Administration said Aug. 8 that Tekmira’s TKM-Ebola treatment could be given to infected people. U.S. researchers are working to get Fujifilm’s flu drug favipiravir approved for use in humans with Ebola. The medicine is being tested in monkeys, with preliminary data expected in mid-September.
The two mid-stage trials contemplated by Inserm would be designed to show whether the compounds have an “anti-Ebola activity on human beings, which we don’t know yet right now,” Delfraissy said. They won’t start for at least two months, he said. Another trial, testing a combination of different compounds, could be considered later, he said.
Inserm also is discussing the trials with the Geneva-based WHO and Doctors Without Borders, Delfraissy said. The French institute may consider moving on to other countries later, Delfraissy also said.
“For now, it’s Guinea,” he said. “If we were to go elsewhere afterward it would be Liberia, where the situation is even more complicated. We have contacts there as well, with clinicians, but we have had no contact with Liberian authorities.”
Ebola is spread through direct contact with bodily fluids from an infected person. It causes fever, diarrhea, muscle pain, vomiting and, as it progresses, can lead to bleeding from the eyes, ears and nose. In the past, the fatality rate has been as high as 90 percent. About 52 percent of those infected in the current outbreak have died.
There’s no approved drug for the illness. Doctors treat patients by keeping them hydrated, replacing lost blood and using antibiotics to fight off opportunistic infections. The goal is for the body’s immune system to eventually beat the disease.
“People are waiting for help, for results, and for the time being we don’t have the products yet,” Delfraissy said.
The number of people falling ill is accelerating, and more than 20,000 people may be infected with Ebola before the outbreak in West Africa is controlled, the WHO said yesterday.
“It’s important to remain cautious because there are too many announcements on Ebola right now,” Delfraissy said.
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