NEW YORK – U.S. scientists will begin enrolling patients as soon as next week in clinical safety trials of GlaxoSmithKline PLC’s experimental Ebola vaccine as the death toll from the disease rises in West Africa.
The National Institutes of Health’s Vaccine Research Center received approval from the Food and Drug Administration to start the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, said Wednesday in a telephone interview. A Phase 1 trial is the first test of a drug or vaccine in humans to assess safety and whether it works similarly to how it does in animals.
The current outbreak has killed 1,427 people in four countries and may soon claim more deaths than all previous Ebola outbreaks combined. The NIH and London-based Glaxo are jointly developing the experimental vaccine, which doesn’t contain any infectious Ebola virus. Health authorities are discussing whether to give the vaccine to at-risk people in West Africa, Kurilla said.
“Exactly how all that will be done is yet to be seen and is a topic of a number” of conference calls every day, he said.
Researchers may need to study the vaccine in humans for about a month to assess its effect, Kurilla said. NIH Director Francis Collins is scheduled to speak Thursday about the agency’s work on Ebola vaccines. GlaxoSmithKline declined comment on the trial, though the company had previously said it was working with regulators on trials.
NewLink Genetics Corp., based in Ames, Iowa, also is working on an Ebola vaccine and said Wednesday it has contracted with a third party to manufacture the product and augment its current supply, which the company said is adequate to begin pre-clinical trials.
Kurilla will serve as a subject-matter expert next week when the World Health Organization is scheduled to meet and discuss Ebola drugs and vaccines under development.
Treatments include those from Mapp Biopharmaceutical Inc., Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc. and Tekmira Pharmaceuticals Corp., Kurilla said.
Mapp’s experimental medicine ZMapp is “front and center in terms of what people consider a good intervention,” Kurilla said.
Some Ebola patients, including American health workers Kent Brantly and Nancy Writebol, have been treated with ZMapp though the closely held San Diego-based company has said their supply is exhausted.
Japanese drugmaker Fujifilm said it has sufficient stockpiles of its experimental flu drug favipiravir that may work against Ebola. Japan is prepared to provide unregistered Ebola drugs on request, Chief Cabinet Secretary Yoshihide Suga said in a briefing on Monday.
Fujifilm’s U.S. partner, MediVector Inc. in Boston, is in talks with the FDA to submit an application to use the drug in humans for Ebola, Amy Derrick-Frost, a spokeswoman for Department of Defense, said on Aug. 9. The Defense Department has prioritized the completion of a study that tests the drug in Ebola-infected monkeys.
BioCryst’s BCX4430 has been tested in nonhuman primates against a similar virus, Marburg, which Kurilla expects “would predict a positive impact on Ebola.” NIH contracted with BioCryst to develop the drug through Phase 1 trials as a treatment for hemorrhagic fever viruses. The contract may total as much as $26 million, according to a statement from the company.
A study using the drug on nonhuman primates is gearing up now, Kurilla said. “It depends on when they can get the monkey,” he said.
Tekmira’s experimental Ebola drug is under a partial clinical hold though the FDA has said the Canadian drugmaker could possibly give the medicine to infected patients. Tests of the drug, known as TKM-Ebola, were delayed due to safety concerns.
WHO advisers determined earlier this month experimental treatments against Ebola are ethical to use to help infected patients. More than 2,600 cases have been reported in Liberia, Guinea, Sierra Leone and Nigeria since December, the WHO has said.
Kurilla expects WHO to also discuss a class of drugs known as selective estrogen receptor modulators as a possible treatment. Scientists published research last year in the journal Science Translational Medicine showing such drugs, which are hormone therapies used to treat breast cancer and infertility, may work against Ebola.
More than $430 million will be needed to bring the worst Ebola outbreak on record under control, according to a draft document laying out the WHO’s strategy. The African Development Bank will prepare an additional $150 million in funding above the $60 million it already pledged to help the countries fight the virus.
The U.S. Agency for International Development said Wednesday it will provide an additional $5 million to help combat the outbreak, bringing its total to $19.6 million.
“The additional funding will be used to provide health equipment and emergency supplies, train and support health care workers on infection control and case management, support public outreach campaigns, and help build the capacity of local health care and emergency response systems,” according to a statement from the agency.
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