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  1. #1
    Senior Member JohnDoe2's Avatar
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    Top secret serum likely saved U.S. Ebola patients

    BREAKING NEWSBREAKING NEWS

    Top secret serum likely saved U.S. Ebola patients





    Both received an experimental drug

    Dr. Kent Brantly's condition dramatically improved after he received the medication, a source says. After two doses, Nancy Writebol showed significant improvement. FULL STORY



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    Secret serum likely saved Ebola patients

    By Dr. Sanjay Gupta and Danielle Dellorto, CNN
    updated 12:55 PM EDT, Mon August 4, 2014
    Your video will begin momentarily
    STORY HIGHLIGHTS

    • Experimental Ebola drug ZMapp given to Dr. Kent Brantly and Nancy Writebol
    • Experimental drug had only been tested in monkeys
    • Brantly was given the Ebola drug after his condition deteriorated
    • Within an hour, source says his symptoms dramatically improved



    (CNN) -- Three top secret, experimental vials stored at subzero temperatures were flown into Liberia last week in a last-ditch effort to save two American missionary workers who had contracted Ebola, according to a source familiar with details of the treatment.

    On July 22, Dr. Kent Brantly woke up feeling feverish. Fearing the worst, Brantly immediately isolated himself. Nancy Writebol's symptoms started three days later. A rapid field blood test confirmed the infection in both of them after they had become ill with fever, vomiting and diarrhea.


    It's believed both Brantly and Writebol, who worked with the aid organization Samaritan's Purse, contracted Ebola from another health care worker at their hospital in Liberia, although the official Centers for Disease Control and Prevention case investigation has yet to be released.


    A representative from the National Institutes of Health contacted Samaritan's Purse in Liberia and offered the experimental treatment, known as ZMapp, for the two patients, according to the source.


    The drug was developed by the biotech firm Mapp Biopharmaceutical Inc. The patients were told that this treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.

    Photos: Ebola outbreak in West Africa
    According to company documents, four monkeys infected with Ebola survived after being given the therapy within 24 hours after infection.

    Two of four additional monkeys that started therapy within 48 hours after infection also survived. One monkey that was not treated died within five days of exposure to the virus.


    Brantly and Writebol were aware of the risk of taking a new, little understood treatment; informed consent was obtained from both Americans, according to two sources familiar with the care of the missionary workers. In the monkeys, the experimental serum had been given within 48 hours of infection. Brantly didn't receive it until he'd been sick for nine days.


    The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice's blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.


    The Ebola virus causes viral hemorrhagic fever, which refers to a group of viruses that affect multiple organ systems in the body and are often accompanied by bleeding.


    Early symptoms include sudden onset of fever, weakness, muscle pain, headaches and a sore throat. They later progress to vomiting, diarrhea, impaired kidney and liver function -- and sometimes internal and external bleeding.


    The ZMapp vials reached the hospital in Liberia where Brantly and Writebol were being treated Thursday morning. Doctors were instructed to allow the vials to thaw naturally without any additional heat. It was expected that it would be eight to 10 hours before the medicine could be given, according to a source familiar with the process.


    Brantly asked that Writebol be given the first dose because he was younger and he thought he had a better chance of fighting it, and she agreed. However, as the first vial was still thawing, Brantly's condition took a sudden turn for the worse.


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    Brantly began to deteriorate and developed labored breathing. He told his doctors he thought he was dying, according to a source with firsthand knowledge of the situation.

    Knowing his dose was still frozen, Brantly asked if he could have Writebol's now-thawed medication. It was brought to his room and administered through an IV. Within an hour of receiving the medication, Brantly's condition dramatically improved. He began breathing easier; the rash over his trunk faded away. One of his doctors described the events as "miraculous."


    By the next morning, Brantly was able to take a shower on his own before getting on a specially designed Gulfstream air ambulance jet to be evacuated to the United States.


    Writebol also received a vial of the medication. Her response was not as remarkable, according to sources familiar with the treatment.

    However, doctors on Sunday administered Writebol a second dose of the medication, which resulted in significant improvement.


    She was stable enough to be evacuated back to the United States and is expected to arrive before noon Tuesday.


    ZMapp has not been approved for human use, and has not even gone through the clinical trial process, which is standard to prove the safety and efficacy of a medication. The process by which the medication was made available to Brantly and Writebol is highly unusual. It may have fallen under the U.S. Food and Drug Administration's "compassionate use" regulation, which allows access to investigational drugs outside clinical trials.


    Getting approval for compassionate use is often long and laborious, but in the case of Brantly and Writebol, they received the medication within seven to 10 days of their exposure to the Ebola virus.


    On July 30, the Defense Threat Reduction Agency, an arm of the military responsible for any chemical, biological, radiological, nuclear and high-yield explosive threats, allotted additional funding to MAPP Biopharmaceutical due to "promising results."


    American Ebola patient 'seems to be improving'


    http://www.cnn.com/2014/08/04/health...html?hpt=hp_t1

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    Mystery Ebola virus serum manufactured by San Diego firm


    Two people in protective clothing carry a body at an Ebola isolation ward in Liberia. (Getty Images)

    By MONTE MORIN contact the reporter

    The serum given to Christian aid workers infected with the deadly Ebola virus was manufactured using plants
    The experimental Ebola virus serum was created by a San Diego firm, Mapp Biopharmaceutical Inc.

    An experimental serum given to Christian aid workers infected with the deadly Ebola virus was manufactured by a San Diego pharmaceutical firm using plants, the company and U.S. health authorities disclosed Monday.

    As Dr. Kent Brantly fights for his life in a special containment unit at Emory University Hospital in Atlanta, and missionary Nancy Writebol prepares to be evacuated from Liberia on Tuesday, details began to emerge about a mysterious treatment they were given shortly after they became infected.


    Related story: Proper medical care can greatly reduce lethality of Ebola virus Monte Morin, Tina Susman


    The drug, which was produced by Mapp Biopharmaceutical Inc., is called ZMapp and has not been evaluated for safety in humans, according to a company statement.

    "As such, very little of the drug is currently available," said company President Larry Zeitlin in a statement.


    The drug is a cocktail of three "humanized" monoclonal antibodies that are manufactured in a group of fragrant plants or bushes known by the genus name Nicotiana.


    Monoclonal antibodies fight viral invaders by locking onto antigens - projections on the surface of a virus that are used to cling to and then enter target cells in the body.


    In the case of the Ebola virus, these antigens project like spikes from the virus' long, spaghetti-like body.

    lRelated
    NATION NOW Ebola patient got experimental serum, missionary group says SEE ALL RELATED

    Once these antigens lock onto the surface of a cell, the virus enters and uses the host cell's machinery to begin mass-producing copies of itself. Antibodies, which can be produced by the immune system or administered as a drug, thwart the ability of antigens to lock onto target cells.

    A CNN report that the drug had prompted a "miraculous" recovery and that Brantly's condition improved within an hour after treatment was greeted with skepticism by longtime Ebola virus researchers.

    CAPTIONDr. Kent BrantlyAssociated Press / WSB-TV Atlanta
    With all involved wearing full protective gear, a man believed to be Ebola patient Dr. Kent Brantly is helped from an ambulance at Emory University Hospital in Atlanta on Saturday.

    "I would be ecstatic if Larry's product helped save these people, but I also need to be extremely cautious," said Thomas Geisbert, a professor of microbiology and immunology at the University of Texas Medical Branch at Galveston.

    "To say the whole thing cleared up in an hour, that doesn't happen in reality," Geisbert said. "That's like something that happens in a movie."


    Ebola virus infection typically begins with flu-like symptoms, such as achy muscles, fever and malaise. As the disease progresses, patients suffer bleeding, rashes, vomiting and diarrhea. If the patients do not receive proper medical care, they can suffer deadly organ failure from the loss of fluids.


    Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Disease, said the company had manufactured only three "courses" of the drug, and that two of them were provided to the American patients.

    "This was the first time it was put into humans, because all the previous work was done on animals and the results had been encouraging," Fauci said.


    Fauci said it was hard to say whether or not the medication had been effective. "If you ask Sanjay Gupta, he says the effect was dramatic, but when you have one patient, you have nothing to compare it to. You can't make a definitive statement," Fauci said.

    Full Coverage
    Deadly Ebola outbreak spreads out of control in Africa READ MORE STORIES

    Fauci's agency provided a statement Monday describing how the drug came to be administered to Brantly and Writebol.

    The Christian aid organization Samaritan's Purse had contacted U.S. Centers for Disease Control and Prevention officials in Liberia to discuss the status of experimental treatments they were aware of, the statement said.


    Those officials referred the aid group to a National Institutes of Health scientist who was assisting in the Ebola outbreak response in West Africa.


    "The scientist was able to informally answer some questions and referred them to appropriate company contacts," the statement read.

    "She was not officially representing NIH and NIH did not have an official role in procuring, transporting, approving or administering the experimental products."


    Though some have criticized the decision to transport Brantly and Writebol to the U.S. for treatment, fearing that it would cause the disease to spread here, officials say it is "extraordinarily unlikely."


    Proper hospital procedures will keep the virus isolated, they say, and afford the two patients care that will enable their bodies to fight off the virus.


    There is no vaccine or cure for Ebola. The virus has a mortality rate as high as 90%, depending on the strain. It is transmitted through bodily fluids, but not through the air, experts say.


    Follow @montemorin for science news

    http://www.latimes.com/science/scien...804-story.html
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