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US ramps up Ebola response in the Congo, tests new drug

The U.S. has ramped up its efforts to help respond to the Ebola outbreak in the Democratic Republic of the Congo — mobilizing epidemiologists and other public health workers, providing new funding and testing a new medicine aimed at killing the highly contagious and deadly hemorrhagic fever virus.

The U.S. National Institutes of Health is preparing to send a new experimental drug, which is being tested in a U.S. clinical trial, to the Democratic Republic of the Congo, or DRC, the agency's top disease expert said.

"I got a letter and responded to minister of health of Democratic Republic of the Congo asking if we could deploy that under their auspices to do it in a clinical trial," Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, or NIAID, said during a May 22 Washington healthcare forum hosted by the Wall Street Journal.

Fauci said the drug is a monoclonal antibody — a protein that binds to a single target on a pathogen — and was developed by a research team at the NIAID's Vaccine Research Center under a partnership with the U.S. Army Medical Research Institute of Infectious Diseases and the Defense Advanced Research Projects Agency.

AstraZeneca PLC's U.S. unit, MedImmune, manufactured the drug, known as mAb114, for the NIH for the clinical testing, the agency said.

The NIH said mAb114 was isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, DRC.

The NIAID researchers and scientists from the National Institute of Biomedical Research in the DRC — including Jean-Jacques Muyembe, who was among the team involved in the original detection of Ebola in 1976 — and the Institute for Biomedical Research in Switzerland discovered that the survivor retained antibodies against Ebola 11 years after infection, the NIH said.

They isolated the antibodies and tested the most favorable ones in the laboratory and nonhuman primate studies and selected mAb114 as the most promising, the agency added.

Clinical trial

The NIH's phase 1 trial, which is seeking to enroll up to 30 healthy, adult volunteers by July, is examining the safety and tolerability of mAb114.

The first three trial participants are receiving a 5-milligram intravenous infusion of mAb114 for 30 minutes.

The U.S. study team is then expected to evaluate the safety data to determine if the remaining participants can receive higher doses of 25 and 50 milligrams.

The participants in the U.S. trial will have blood taken before and after the infusion and are being asked to record temperature and any symptoms over three days. They are expected to have 14 follow-up visits to the NIH's clinic in Bethesda, Md., over six months to have their blood checked to see if mAb114 is detectable and if there are any health changes.

Fauci noted there are no licensed treatments available for Ebola, although there are multiple experimental therapies in development, including Mapp Biopharmaceutical Inc.'s experimental drug ZMapp — a cocktail composed of three humanized monoclonal antibodies manufactured in tobacco plants bioengineered specifically to produce large quantities of the proteins.

Fauci told members of Congress last week that supplies of ZMapp were being deployed to the DRC.

He noted Gilead Sciences Inc. is also developing a new monoclonal antibody to treat Ebola.

Sending help

Health and Human Services Secretary Alex Azar — who announced during a May 22 address at the World Health Assembly in Geneva, Switzerland, that the U.S. was providing up to $7 million in additional assistance to the DRC Ebola response, bringing the nation's total commitment to up to $8 millionsaid he was briefed by the World Health Organization on the outbreak and was monitoring the situation.

Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, said the agency's office in the DRC has mobilized staff, "several of whom have extensive experience from the 2014 West Africa Ebola epidemic."

"We are also deploying Ebola response experts to DRC to assist," he wrote on Twitter.

He said the CDC was working closely with WHO and the DRC ministry of public health to provide on-the-ground expertise to help combat the current outbreak.

"Disease knows no borders. By protecting people from Ebola elsewhere in the world, we protect Americans at home," Redfield said.

The DRC government declared the outbreak on May 8 after two cases were confirmed. Since then, about 50 people have been infected, with about 30 of those dying of the virus.

The WHO and the DRC government also started administering an experimental vaccine from Merck & Co. Inc. late last week to try to prevent the further spread of the virus.