Ebola Drug ZMapp's Ready for African Testing
BY MAGGIE FOX
U.S. government officials have scraped up enough ZMapp to start testing it in real Ebola patients in Liberia. But the drug's still so hard to make they are shipping it over in small batches as they produce it.
ZMapp's best known as the drug given to the first U.S. Ebola patient, Dr. Kent Brantly — the medical missionary air-evacuated from Liberia for treatment in the U.S.
Brantly survived, but doctors say they don't know whether ZMapp helped. The case created a clamor for the drug, but Mapp Biopharmaceuticals, the small, California-based company that makes it, didn't have much on hand.
Not only is the drug very difficult to produce, but there wasn't much of a market for it before the Ebola epidemic started in West Africa. That meant scarce government funding.
"As it is being filled in vials it is being shipped to West Africa in preparation for clinical trials."
ZMapp consists of three lab-engineered immune system proteins called monoclonal antibodies. They are carefully designed to precisely attack Ebola. A company called Kentucky BioProcessing grows ZMapp's antibodies in tobacco plants in a process that makes a nice product but that is painfully slow. It's so slow that right now there is hardly any ZMapp at all.
"As it is being filled in vials it is being shipped to West Africa in preparation for clinical trials," a health and Human Services Department official told NBC News.
HHS is trying to help speed up production and has been on a search for other companies that can make the monoclonal antibodies. Kentucky BioProcessing can only produce a few dozen doses a month.
But the HHS official says just 50 to 100 treatment courses are needed to start a clinical trial that will tell doctors how well the treatment works. There's enough now to start.
Tests in monkeys suggest ZMapp should work very well.
ZMapp's just one of several treatments being tested against Ebola, which has infected close to 23,000 people and killed more than 9,000 of them since an outbreak started in Guinea a year ago and spread to neighboring Sierra Leone and Liberia.
French researchers are testing a Japanese flu drug called favipiravir in Guinea. Initial results looked positive and the Guinean government has said it wants to make the drug more widely available. But the researchers are cautious and plan to release details on their results at a scientific conference in Seattle later this month.
Favipiravir would be far easier to use than ZMapp. It's a pill; ZMapp must be kept frozen in a tube and infused. Another pill that researchers hoped would work is brincidofovir, made by North Carolina-based Chimerix. But the company's withdrawn its support for those tests.
One problem is that Liberia's done such a good job of controlling Ebola's spread that only a few new patients are becoming infected. Just three new confirmed cases were reported for Liberia in the past week.
But cases are still spreading in Sierra Leone, and officials locked down part of the capital Freetown Friday because of a new case.
Trials of two Ebola vaccines are also under way.
One's started in Liberia and a second U.S. sponsored trial is ready to start soon in Sierra Leone.
U.S. government officials have scraped up enough ZMapp to start testing it in real Ebola patients in Liberia. But the drug's still so hard to make they are shipping it over in small batches as they produce it.
ZMapp's best known as the drug given to the first U.S. Ebola patient, Dr. Kent Brantly — the medical missionary air-evacuated from Liberia for treatment in the U.S.
Brantly survived, but doctors say they don't know whether ZMapp helped. The case created a clamor for the drug, but Mapp Biopharmaceuticals, the small, California-based company that makes it, didn't have much on hand.
Not only is the drug very difficult to produce, but there wasn't much of a market for it before the Ebola epidemic started in West Africa. That meant scarce government funding.
"As it is being filled in vials it is being shipped to West Africa in preparation for clinical trials."
ZMapp consists of three lab-engineered immune system proteins called monoclonal antibodies. They are carefully designed to precisely attack Ebola. A company called Kentucky BioProcessing grows ZMapp's antibodies in tobacco plants in a process that makes a nice product but that is painfully slow. It's so slow that right now there is hardly any ZMapp at all.
"As it is being filled in vials it is being shipped to West Africa in preparation for clinical trials," a health and Human Services Department official told NBC News.
HHS is trying to help speed up production and has been on a search for other companies that can make the monoclonal antibodies. Kentucky BioProcessing can only produce a few dozen doses a month.
But the HHS official says just 50 to 100 treatment courses are needed to start a clinical trial that will tell doctors how well the treatment works. There's enough now to start.
Tests in monkeys suggest ZMapp should work very well.
ZMapp's just one of several treatments being tested against Ebola, which has infected close to 23,000 people and killed more than 9,000 of them since an outbreak started in Guinea a year ago and spread to neighboring Sierra Leone and Liberia.
French researchers are testing a Japanese flu drug called favipiravir in Guinea. Initial results looked positive and the Guinean government has said it wants to make the drug more widely available. But the researchers are cautious and plan to release details on their results at a scientific conference in Seattle later this month.
Favipiravir would be far easier to use than ZMapp. It's a pill; ZMapp must be kept frozen in a tube and infused. Another pill that researchers hoped would work is brincidofovir, made by North Carolina-based Chimerix. But the company's withdrawn its support for those tests.
One problem is that Liberia's done such a good job of controlling Ebola's spread that only a few new patients are becoming infected. Just three new confirmed cases were reported for Liberia in the past week.
But cases are still spreading in Sierra Leone, and officials locked down part of the capital Freetown Friday because of a new case.
Trials of two Ebola vaccines are also under way.
One's started in Liberia and a second U.S. sponsored trial is ready to start soon in Sierra Leone.
No comments:
Post a Comment