An Ebola drug developed by a company with just nine employees has been used to treat two infected Americans who recently have shown signs of improvement.
The treatment, developed by Mapp Biopharmaceutical Inc., a closely-held company based in San Diego, was given to Kent Brantly and Nancy Writebol, both of whom were infected while working with aid groups in Liberia, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a telephone interview.
“You can’t make judgments based on two patients,” Fauci said when asked if the drug may help tame the disease in the future. Each patient received one dose in Liberia before being flown to the U.S., according to Fauci.
Brantly, a doctor, arrived in Atlanta on Aug. 2 and is under treatment at Emory University Hospital. Writebol, an aid worker, is set to arrive in Atlanta tomorrow and will be treated at the same hospital.
A “limited amount” of the drug, dubbed ZMapp, was sent at sub-zero temperatures last week from Kentucky BioProcessing LLC, a subsidiary of Reynolds American Inc., which makes the treatment from tobacco plants, spokeswoman Maura Payne said in a telephone interview. Samaritan’s Purse, a U.S.-based charity that worked with the two Americans in Liberia, requested the treatment, she said.
Both American patients were infected while working in an Ebola treatment center in Liberia, one of three West Africa countries reeling from an outbreak that’s sickened 1,603 people and killed 887, according to the World Health Organization.
The disease is spread through contact with blood or other body fluids. It occurs through touching a sick person, or when broken skin comes into contact with infectious fluids on things such as soiled clothing, bed linen, or used needles.
Both Writebol and Brantly have shown signs of improvement, relatives and supporters have said over the last two days.
Writebol’s husband “told me Sunday her appetite has improved,” said Bruce Johnson, head of SIM USA, Writebol’s charity group, in a statement. “She requested one of her favorite dishes -- Liberian potato soup -- and coffee. We are so grateful and encouraged to hear that Nancy’s condition remains stable and that she will be with us soon.”
David Writebol will travel back to the U.S. separately in a few days, SIM said in the statement released Monday.
Brantly’s wife, Amber, said Sunday that her husband was feeling better, and she thanked Emory University Hospital for accepting him for treatment.
“He is in good spirits,” Amber Brantly said in a statement. “He thanked everyone for their prayers and asked for continued prayer for Nancy Writebol’s safe return.”
Citing unnamed sources, CNN was the first to report Monday the drug used is Mapp’s. Officials at Mapp said they wouldn’t comment on the use of their drug.
There is no cure for Ebola, although several companies -- including Mapp -- are working on drug candidates, some of which are being tested in animals. Normally, patients are given fluids, blood transfusions and antibiotics with the hope their immune systems can fight off Ebola’s onslaught.
Mapp’s drug is being developed with Toronto-based Defyrus Inc., which has six employees, according to Chief Executive Officer Jeff Turner. ZMapp is a “cocktail” of monoclonal antibodies that help the immune system attack the virus.
ZMapp’s predecessor, MB-003, protected three out of seven rhesus macaques in a study run by Mapp and the U.S. Army Medical Research Institute of Infectious Diseases.
“Quantities on hand are very small,” said Kentucky BioProcessing representative Payne. This may limit the amount used for the patient’s treatment, Fauci said.
Although no drugs to treat Ebola are approved by U.S. regulators, the Food and Drug Administration can approve an emergency application to provide access to unapproved drugs, FDA spokeswoman Stephanie Yao said in an email.
Approval for emergency drug use outside of a clinical trial can be made within 24 hours, Yao wrote. Shipment and treatment with the drug could begin even before completed written forms are submitted to the FDA, which can approve the use of an experimental treatment by telephone in an emergency.
“The FDA stands ready to work with companies and investigators treating these patients who are in dire need of treatment,” Yao said. She declined to say whether the FDA had allowed any drug to be used in the Ebola outbreak.
Medical care of the two U.S. citizens may take two to three weeks if all goes well, Bruce Ribner, an infectious disease specialist at Emory, said in an Aug. 1 news conference.
The Atlanta-based CDC, which confirmed the Brantly and Writebol cases are the first ever on U.S. soil, is working with the hospital and transport company to make sure evacuation of the two patients goes safely, said Barbara Reynolds, an agency spokeswoman.
“We’re here to make sure the transportation process and the care here in the U.S. ensures there’s no spread,” Reynolds said. “It’s important to remember this is not an airborne virus, it requires close contact with body fluids. It’s minimal risk as long as the people caring for the patient use meticulous procedures.”