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Tracking the next pandemic: Avian Flu Talk

ZMapp

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    Posted: August 05 2014 at 7:46pm
Google ZMapp and and see what the USA has in it's back pocket. They had to bring it out to save the Dr. now in Atlanta but now the cat is out of the bag.

People in Africa are pissed and I can't say they are wrong to be upset. They had excellent Dr./Nurses that have died and maybe could have been saved.

Let us hope it works as well as it has on the Dr. in Atlanta.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jen147 Quote  Post ReplyReply Direct Link To This Post Posted: August 06 2014 at 6:31am
I was thinking the same FluMom, but it doesn't sound like it was too much of a secret, if Samaritan's Purse was able to research & inquire about ZMapp it leads one to believe that those in Africa could have done the same.  Could also have to do with $$$, I think were it not for Samaritan's Purse these Medevacs might never have happened.  I read an article the other day that said medevac hadn't even been considered for Brantly & Whitebol.  I think SP has footed the bill for most of the transport, care & now ZMapp.  So it may be one of those situations where someone finally stood up with the money to do something & decided to act instead of waiting around.  But according to this article it doesn't sound like it was a closely guarded secret.  This is a good article, esp check that last section "Why ZMapp":
 
American Ebola victims are the subjects of a science experiment
 
August 5, 2014
 

In the absence of official confirmation about how the two American patients with Ebola are being treated, rumor and speculation filled the void.

First were the reports that the blood serum of a teenage Ebola survivor may have saved Dr. Kent Brantly and Nancy Writebol, who contacted the deadly disease in Liberia while working with the Christian aid organization Samaritan's Purse. The latest  news centers around an experimental "secret serum" called ZMapp. Already, CNN's Dr. Sanjay Gupta has proclaimed that the medicine "appears to have worked."

Sadly, Dr. Gupta seems to be over-promising. Here's why.

Treating Ebola with the blood of a survivor

The science behind the first alleged treatment — using the blood serum of a survivor to cure those who are suffering — is the subject of controversy in the Ebola research community, said Dr. Thomas Geisbert, a professor or microbiology and immunology at the University of Texas Medical Branch.

"Back in 1995 during the large outbreak of Ebola Zaire virus in the Democratic Republic of the Congo, there were reports that convalescent serum was used from people who survived Ebola to treat people who were infected," he said.

A small case series report about the treatment involving eight patients was published in the Journal of Infectious Diseases. Only one of the eight people died, a fatality rate much lower than the then-outbreak, which killed some 80 percent of those infected.

Unfortunately, however, the serum theory was not confirmed by later studies. "When we tested that hypothesis in a lab, and took convalescent blood from animals who survived and gave it to Ebola-infected animals, they all died," said Dr. Geisbert. "There was the belief that most of those patients treated were in the process of recovering anyway."

The "secret serum"

Yesterday, the "secret serum" called ZMapp emerged as the primary treatment of the Americans. This is an antibody therapy developed by several stakeholders — Mapp Biopharmaceutical, Inc. and LeafBio in San Diego, Defyrus Inc. from Toronto, the U.S. government and the Public Health Agency of Canada — to treat Ebola. It's made up of a cocktail of monoclonal antibodies, which are just lab-produced molecules that mimic the body's immune response.

To create these molecules, scientists gave mice Ebola proteins and watched the animals' immune systems respond. After identifying the antibodies that fought off the disease in mice, they created almost identical antibodies from plants for use in humans. The idea is that, when given to Ebola-infected people, the drug will boost their immune system so that they too can eliminate the virus.

But this drug has never undergone testing in people, only monkeys. The data on the efficacy of ZMapp in monkeys has never even been published.

Studies on similar drugs are not entirely confidence inducing, either. In this study, two of the four monkeys given monoclonal antibodies 48 hours after exposure to Ebola survived. In this second study, the animals had a 43 percent survival rate when given the drug cocktail after the onset of symptoms. So even though the treatment of monoclonal antibodies decreased the mortality rate — if given close to exposure of the illness —  scientists haven't moved past these tiny animal studies to testing in actual people.

Mapp Biopharmaceuticals is also just one of some 25 labs in seven countries working on these antibody cocktails for Ebola, and none of them have entered a phase one trial in humans, according to the journal Science. For this reason Dr. Martin Hirsch, a Harvard virologist, told Vox, "It’s too premature to say that the patients being treated miraculously improved."

That doesn't mean ZMapp isn't a promising therapy, however. It just means the American Ebola victims are effectively undergoing a science experiment. Even if they survive, it wasn't necessarily the drug that saved their lives. Over 20 percent of people who get this type of Ebola survive. To know whether the drug truly works, it needs to be properly tested in clinical trials. And doing that will require funding drug companies and governments may not want to invest.

Why ZMapp?


According to the US National Institute of Allergy and Infectious Diseases, Samaritan's Purse contacted CDC officials working in Liberia. They asked about the status of several experimental Ebola treatments that they had identified for possible use in the infected American missionaries.

"CDC officials referred them to an NIH scientist who was on the ground in West Africa assisting with outbreak response efforts and broadly familiar with the various experimental treatment candidates," said an NIH spokesperson. "The scientist was able to informally answer some questions and referred them to appropriate company contacts to pursue their interest in obtaining experimental product."

Right now, Samaritan's Purse will not confirm why ZMapp ended up being the chosen treatment.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jen147 Quote  Post ReplyReply Direct Link To This Post Posted: August 06 2014 at 2:28pm
Tobacco-derived 'plantibodies' enter the fight against Ebola
 
Aug 6th 2014
 
(Reuters) - Drugmakers' use of the tobacco plant as a fast and cheap way to produce novel biotechnology treatments is gaining global attention because of its role in an experimental Ebola therapy.

The treatment, which had been tested only in lab animals before being given to two American medical workers in Liberia, consists of proteins called monoclonal antibodies that bind to and inactivate the Ebola virus.

For decades biotech companies have produced such antibodies by growing genetically engineered mouse cells in enormous metal bioreactors. But in the case of the new Ebola treatment ZMapp, developed by Mapp Pharmaceuticals, the antibodies were produced in tobacco plants at Kentucky Bioprocessing, a unit of tobacco giant Reynolds American.

The tobacco-plant-produced monoclonals have been dubbed "plantibodies."

"Tobacco makes for a good vehicle to express the antibodies because it is inexpensive and it can produce a lot," said Erica Ollmann Saphire, a professor at The Scripps Research Institute and a prominent researcher in viral hemorrhagic fever diseases like Ebola. "It is grown in a greenhouse and you can manufacture kilograms of the materials. It is much less expensive than cell culture."

In the standard method of genetic engineering, DNA is slipped into bacteria, and the microbes produce a protein that can be used to combat a disease.

A competing approach called molecular "pharming" uses a plant instead of bacteria. In the case of the Ebola treatment, Mapp uses the common tobacco plant, Nicotiana benthanmianas.

The process is very similar. A gene is inserted into a virus that is then used to infect the tobacco plant. The virus acts like a micro-Trojan Horse, ferrying the engineered DNA into the plant.

Cells infected with the virus and the gene it is carrying produce the target protein. The tobacco leaves are then harvested and processed to extract the protein, which is purified.

ZMapp's protein is a monoclonal antibody, which resembles ordinary disease-fighting antibodies but has a highly specific affinity for particular cells, including viruses such as Ebola. It attaches itself to the virus cells and inactivates them.

APPROVAL PROCESS

The drug so far has only been produced in very small quantities, but interest in it is stoking debate over whether it should be made more widely available to the hundreds of people stricken with Ebola in Africa while it remains untested.

"We want to have a huge impact on the Ebola outbreak," Mapp CEO Kevin Whaley said in an interview at company headquarters in San Diego. "We would love to play a bigger role."

Whaley said he was not aware of any significant safety issues with the serum. He would not discuss whether the company has been contacted about providing the drug overseas.

But he did note the novel manufacturing process carries its own risk, and would have to be cleared by the U.S. Food and Drug Administration as part of the approval process.

The FDA would, for example, have to be satisfied that the plant extraction process had not led to contamination of the resulting drug.

The tobacco plant grows quickly, said Reynolds spokesman David Howard, and "it takes only about a week (after the genes are introduced) before you can begin extracting the protein."

He declined to say how much medication each plant can yield or whether Kentucky Bioprocessing is in a position to produce ZMapp in significant quantities.

Scripps' Saphire said it can still take anywhere from one to three months to produce the ZMapp serum for wider use given the complexities of the process.

PENTAGON FUNDING

In 2007, Kentucky Bioprocessing entered into an agreement with Mapp Biopharmaceutical and the Biodesign Institute of Arizona State University to refine the tobacco-plant approach. The approach attracted funding support from the Pentagon's Defense Advanced Research Projects Agency (DARPA).

For all the hope, however, the plant technique has delivered few commercial products. In 2012 the FDA okayed a drug for the rare genetic disorder Gaucher disease from Israel's Protalix BioTherapeutics and Pfizer. Called Elelyso, it is made in carrot cells, and is the only such drug to reach the market.

Other companies have fallen far short, though it is not clear if the technique was to blame. Calgary-based SemBioSys Genetics Inc, which used safflowers to produce an experimental diabetes drug, folded in 2012 before it finished clinical trials.

Even Kentucky Bioprocessing, which at one point was developing monoclonal antibodies against HIV (the virus that causes AIDS), C. difficile bacterial infection, and the human papillomavirus, has dropped the last two projects, Howard said.

Last year Mitsubishi Tanabe Pharma Corp acquired a majority share of Quebec City-based Medicago, which is developing influenza and other vaccines using the tobacco-plant technology. The other 40 percent is owned by tobacco giant Philip Morris International.

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