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PostPosted: Tue Aug 05, 2014 9:29 am 
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Ebola 'Secret Serum': Small Biopharma, The Army, And Big Tobacco

CNN reported yesterday that American missionary Ebola patients, Dr. Kent Brantly and Nancy Writesbol, received an experimental “secret serum” against the virus while hospitalized in Liberia.

But while the biotech product, called ZMapp™, is indeed still experimental – it’s not yet approved for human use, and not yet even in phase I clinical trials – it’s far from secret.

The three-antibody mixture originated with Mapp Biopharmaceuticals, a small San Diego-based company established in 2003 and led by Larry Zeitlin, Ph.D., a Johns Hopkins-trained reproductive biologist who became an expert in “plantibodies,” antibody therapeutics produced in, and purified from, bioengineered plants.

The ZMapp three-antibody cocktail isn’t a vaccine. Instead, it provides an artifical immune response against sugar-tagged proteins on the outside of the Ebolavirus.

The tobacco species, Nicotiana bethamiana, is a common plant molecular biology tool. Shown here is the process of agroinfiltration, where a solution of a recombinant agrobacterium is used to insert new genetic material into the plant. Credit: Wikimedia Commons, user Chandres. The tobacco species, Nicotiana bethamiana, is a common plant molecular biology tool. Shown here is the process of agroinfiltration, where a solution of a recombinant agrobacterium is used to insert new genetic material into the plant. Credit: Wikimedia Commons, user Chandres.
The tobacco species, Nicotiana bethamiana, is a common plant molecular biology tool. Shown here is the process of agroinfiltration, where a solution of a recombinant agrobacterium is used to insert new genetic material into the plant. Credit: Wikimedia Commons, user Chandres.

This general biotherapeutic approach is called passive immunity. By injecting the patient with ready-made antibodies raised in the laboratory to latch onto specific parts of an infectious agent, their body can mount an immediate immune response. Passive immunity is therefore different from a vaccine that might require weeks for the person to make their own antibodies against the virus.

These three antibodies represent a clever strategy against the virus. One of the antibodies binds up a form of Ebolavirus protein that seems to be sent off by the virus as a decoy against the immune response.


Dividend of biowarfare research

The product first described yesterday by CNN is the result of a convoluted convergence of U.S. and Canadian federal agencies and industrial partners that’s typical for treatments of potential value against biowarfare and bioterrorism.

As with other companies working on small molecules and biologicals against Ebola and other hemorrhagic fever viruses, MappBio was the beneficiary of grants and contracts from federal agencies that include the National Institute of Allergy and Infectious Disease (NIAID), the Department of Defense Advanced Research Projects (DARPA), and the Defense Threat Reduction Agency (DTRA).

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has been a critical driver of much of this work as they maintain biosafety level-4 facilities in Frederick, Maryland, an have extensive expertise with non-human primates as a model for human infectious diseases.

The ZMapp product is the result of a collaboration between Mapp, San Diego-based LeafBio, and Toronto-based Defyrus Inc, “a private, life sciences biodefence company that collaborates with military and public health R&D partners in the United States, Asia and Canada.” The Public Health Agency of Canada is the Defyrus partner north of the border.

Far from secret, Zeitlin and colleagues have co-authored several papers in high-profile journals, such as Proceedings of the National Academy of Sciences and Science Translational Medicine, with a USAMRIID team led by microbiologist Gene Olinger.

The antibody mixture prevented the death of small groups of monkeys infected with Ebolavirus infection: six of six monkeys survived when given the antibodies one hour after infection while four of six survived when given the antibodies 48 hours after infection.


For comparison, Dr. Kent Brantly didn’t receive ZMapp until nine days after he showed symptoms.

What’s confusing at this point is whether the published antibody mixture is the same that has been used in Dr. Brantly and, reportedly, Nancy Wrightbol. Mapp’s antibody mixture is termed MB-003 but in a press release from Mapp and LeafBio, ZMapp is described as “an optimized cocktail combining the best components of MB-003 (Mapp) and ZMAb (Defyrus/PHAC).

Tobacco therapeutics

What is known is that the antibodies are produced in a Australian strain of the tobacco plant (Nicotiana benthamiana) by Kentucky Bioprocessing in Owensboro, Kentucky, a contract R&D and protein production company that was acquired in January by Reynolds America, Inc, the parent company of R.J. Reynolds Tobacco.

In 2007, Mapp engaged KBP to manufacture a post-exposure treatment for Ebola infection, according to David Howard, head of external communications for RAI Services Company.

Recently, said Howard, “KBP complied with a request from Emory University Hospital and Samaritan’s Purse to provide a limited amount of ZMapp.” But Howard stressed that ZMapp is not approved for human use in North America or any other country but an IND for the product was likely to have been submitted by the end of 2014.

The limited product information sheet published overnight by LeafBio and Mapp reiterate that extremely small amounts of the product remains available. Howard said that scale-up for anticipated human trials would take “two months or longer.”

Why “plantibodies?”

ZMapp isn’t produced in the waving fields of tobacco one would find in Kentucky, Virginia, or North Carolina. Instead, the version of tobacco used by KBP is one that is easily manipulated with recombinant DNA techniques and amenable to automated greenhouse operations.

This same tobacco species is one also used by Medicago USA for development of a pandemic influenza virus.

The USAMRIID, Mapp, and KBP team published work in 2012 demonstrating the the three antibodies produced in Nicotiana benthamiana were superior to those made in Chinese hamster ovary (CHO) cells, the most common FDA-approved host for human therapeutics that certain sugar molecules for biological activity.

http://www.forbes.com/sites/davidkroll/ ... g-tobacco/

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PostPosted: Tue Aug 05, 2014 9:47 am 
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U.S. government had role in Ebola drug given aid workers

MARILYNN MARCHIONE, AP Chief Medical Writer

Two American aid workers infected with Ebola are getting an experimental drug so novel it has never been tested for safety in humans and was only identified as a potential treatment earlier this year, thanks to a longstanding research program by the U.S. government and the military.

The workers, Nancy Writebol and Dr. Kent Brantly, are improving, although it's impossible to know whether the treatment is the reason or they are recovering on their own, as others who have survived Ebola have done. Brantly is being treated at a special isolation unit at Atlanta's Emory University Hospital, and Writebol was expected to be flown there Tuesday in the same specially equipped plane that brought Brantly.

They were infected while working in Liberia, one of four West African nations dealing with the world's largest Ebola outbreak. On Monday, the World Health Organization said the death toll had increased from 729 to 887 deaths in Guinea, Sierra Leone, Liberia and Nigeria, and that more than 1,600 people have been infected.

In a worrisome development, the Nigerian Health Minister said a doctor who had helped treat Patrick Sawyer, the Liberian-American man who died July 25 days after arriving in Nigeria, has been confirmed to have the deadly disease. Tests are pending for three other people who also treated Sawyer and are showing symptoms.

There is no vaccine or specific treatment for Ebola, but several are under development.

The experimental treatment the U.S. aid workers are getting is called ZMapp and is made by Mapp Biopharmaceutical Inc. of San Diego. It is aimed at boosting the immune system's efforts to fight off Ebola and is made from antibodies produced by lab animals exposed to parts of the virus.

In a statement, the company said it was working with LeafBio of San Diego, Defyrus Inc. of Toronto, the U.S. government and the Public Health Agency of Canada on development of the drug, which was identified as a possible treatment in January.

The drug is made in tobacco plants at Kentucky BioProcessing, a subsidiary of Reynolds American Inc., in Owensboro, Kentucky, said spokesman David Howard. The plant "serves like a photocopier," and the drug is extracted from the plant, he said.

Kentucky BioProcessing complied with a request from Emory and the international relief group Samaritan's Purse to provide a limited amount of ZMapp to Emory, he said. Brantly works for the aid group.

The Kentucky company is working "to increase production of ZMapp but that process is going to take several months," Howard said. The drug has been tested in animals and testing in humans is expected to begin later this year.

The U.S. Food and Drug Administration must grant permission to use experimental treatments in the United States, but the FDA does not have authority over the use of such a drug in other countries, and the aid workers were first treated in Liberia. An FDA spokeswoman said she could not confirm or deny FDA granting access to any experimental therapy for the aid workers while in the U.S.

Writebol, 59, has been in isolation at her home in Liberia since she was diagnosed last month. She's now walking with assistance and has regained her appetite, said Bruce Johnson, president of SIM USA, the Charlotte, North Carolina-based group that she works for in Africa.

Writebol has received two doses of the experimental drug so far, but Johnson was hesitant to credit the treatment for her improvement.

"Ebola is a tricky virus and one day you can be up and the next day down. One day is not indicative of the outcome," he said. But "we're grateful this medicine was available."

Brantly, 33, also was said to be improving. Besides the experimental dose he got in Liberia, he also received a unit of blood from a 14-year-old boy, an Ebola survivor, who had been under his care. That seems to be aimed at giving Brantly antibodies the boy may have made to the virus.

Samaritan's Purse initiated the events that led to the two workers getting ZMapp, according to a statement Monday by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health. The Boone, North Carolina-based group contacted U.S. Centers for Disease Control and Prevention officials in Liberia to discuss various experimental treatments and were referred to an NIH scientist in Liberia familiar with those treatments.

The scientist answered some questions and referred them to the companies but was not officially representing the NIH and had no "official role in procuring, transporting, approving, or administering the experimental products," the statement says.

In the meantime, dozens of African heads of state were in Washington for the U.S.-Africa Leaders Summit, a three-day gathering hosted by President Barack Obama. U.S. health officials on Monday spoke with Guinean President Alpha Conde and senior officials from Liberia and Sierra Leone about the Ebola outbreak.

The Defense Department has long had a hand in researching infectious diseases, including Ebola. During much of the Cold War period this served two purposes: to keep abreast of diseases that could limit the effectiveness of troops deployed abroad and to be prepared if biological agents were used as weapons.

The U.S. military has no biological weapons program but continues to do research related to infectious diseases as a means of staying current on potential threats to the health of troops. It may also contribute medical expertise as part of interagency efforts in places like Africa where new infectious disease threats arise.

The hospital in Atlanta treating the aid workers has one of the nation's most sophisticated infectious disease units. Patients are sealed off from anyone not in protective gear. Ebola is only spread through direct contact with an infected person's blood or other bodily fluids, not through the air.

The CDC last week told U.S. doctors to ask about foreign travel by patients who come down with Ebola-like symptoms, including fever, headache, vomiting and diarrhea. A spokesman said three people have been tested so far in the U.S. — and all tested negative. Additionally, a New York City hospital on Monday said a man was being tested for Ebola but he likely didn't have it.

Writebol and her husband, David, had been in Liberia since last August, sent there by SIM USA and sponsored by their home congregation at Calvary Church in Charlotte. At the clinic, Nancy Writebol's duties included disinfecting staff entering or leaving the Ebola treatment area.

"Her husband, David, told me Sunday her appetite has improved and she requested one of her favorite dishes - Liberian potato soup — and coffee," SIM's Johnson said.

___

AP writers Krista Larson in Dakar, Senegal, Mike Stobbe and Stephanie Nano in New York, and Robert Burns in Washington contributed to this report.

http://www.uppermichiganssource.com/new ... -Df3fldWGc

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PostPosted: Tue Aug 05, 2014 10:44 am 
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Latest update : 2014-08-05
Two American aid workers rushed back to the US after contracting the Ebola virus have responded positively to an experimental drug developed in a government and military research programme.

The workers, Nancy Writebol and Dr. Kent Brantly, are improving, according to medical sources widely quoted in the US media.

At this stage it remains impossible to know whether the new treatment, called ZMapp, is the reason for their improvement or if they are recovering on their own, as others who have survived Ebola have done.

Brantly is currently at a special isolation unit at Atlanta’s Emory University Hospital, and Writebol was being flown there Tuesday in the same specially equipped plane that brought Brantly.

They were infected while working in Liberia, one of four West African nations dealing with the world’s largest Ebola outbreak.

On Monday, the World Health Organization said the death toll had increased from 729 to 887 deaths in Guinea, Sierra Leone, Liberia and Nigeria, and that more than 1,600 people have been infected.

There is no vaccine or specific treatment for Ebola, but several, including ZMapp, are under development.

‘Increasing production as soon as possible’

The experimental treatment is made by Mapp Biopharmaceutical Inc. of San Diego.

It is aimed at boosting the immune system’s efforts to fight off Ebola and is made from antibodies produced by laboratory mice exposed to the virus.

In a statement, the company said it was working with LeafBio of San Diego, Defyrus Inc. of Toronto, the US government and the Public Health Agency of Canada on development of the drug, which was identified as a possible treatment in January.

The statement says very little of the drug is available and they are “cooperating with appropriate government agencies to increase production as quickly as possible”.

Both treated while in Liberia

The US Food and Drug Administration must grant permission to use experimental treatments in the United States, but the FDA does not have authority over the use of such a drug in other countries.

The aid workers were first treated in Liberia. An FDA spokeswoman said she could not confirm or deny FDA granting access to any experimental therapy for the aid workers while in the US. Writebol, 59, has been in isolation at her home in Liberia since she was diagnosed last month.

She’s now walking with assistance and has regained her appetite, said Bruce Johnson, president of SIM USA, the group she works for in Africa. Writebol received two doses of the experimental treatment while in Liberia.

Johnson was hesitant to credit the treatment for her improvement.

“Ebola is a tricky virus and one day you can be up and the next day down. One day is not indicative of the outcome,” he said. But “we’re grateful this medicine was available.”

Brantly, 33, who works for the international relief group Samaritan’s Purse, was also said to be improving.

Besides the experimental dose he got in Liberia, he also received a unit of blood from a 14-year-old boy, an Ebola survivor, who had been under his care. That seems to be aimed at giving Brantly antibodies the boy may have made to the virus.

(FRANCE 24 with AP)

http://www.france24.com/en/20140805-exp ... a-victims/

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PostPosted: Tue Aug 05, 2014 10:57 am 
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Secret serum: Liberia Ebola drug used on Brantly is only one of many in development
A US biotech firm claims it provided the "secret serum" that may have helped Dr Kent Brantly recover from Ebola in Liberia. It's only one of many drugs in development - most are desperate for funding.

The time is seemingly rife for biotech firms working on Ebola drugs and vaccines to come out and seek a higher profile for their projects.
Much recent research on Ebola has been hindered by a lack of funding.
So it stands to reason that pharmaceutical companies should view this as an opportune moment - as the Ebola virus, which remains incurable, spreads through western Africa.

Two US aid workers have been getting an experimental anti-Ebola drug
One firm, the San Diego-based Mapp Biopharmaceutical, just got lucky.
Mapp Biopharmaceutical claims to have provided the "secret serum" that may have cured US medic Dr Kent Brantly of Ebola, and may also have helped missionary Nancy Writebol recover.
Both were treated in Liberia and have since reportedly been transferred to Emory University Hospital in Atlanta.
A matter of money
The drug they received is said to be ZMapp - a drug that has yet to undergo any human trials.
A statement on the company's website says "ZMapp is composed of three "humanized" monoclonal antibodies manufactured in plants, specifically Nicotiana" and that it was first identified as a drug candidate in January of this year.
In March 2014, Mapp Biopharmaceutical was part of a group awarded a multimillion-dollar grant by the US's National Institutes of Health (NIH) to further research on Ebola.
Others seriously lack funding - in fact, there are many researchers working on potential Ebola drugs and vaccines, all striving to make it to human trials.
For instance, researchers at the University of Cambridge in the UK and the New Iberia Research Center in the US, who have tested an Ebola vaccine on captive chimpanzees - with success.
"It is safe and immunogenic," the researchers write in the journal "PNAS" - meaning, the vaccine induces immune responses which protect the chimpanzees against Ebola.
"If somebody gave me some money and I got permission from the people in the field, I could go and vaccinate wild chimpanzees and gorillas tomorrow," researcher and lead writer Peter Walsh told DW. Walsh is also president of the NGO Apes Incorporated.
As with humans, Ebola is fatal in apes. So aside from the threat from poaching and loss of habitat, the virus poses an added threat to endangered gorillas and chimpanzees in Africa.

The Ebola virus is deadly in humans and apes
From monkeys to gorillas
The vaccine consists of a coat protein that surrounds the Ebola virus. It is not a functional virus, so it cannot cause infection.
"We knew it was safe before we even used it," Walsh says. "The need to do the vaccine trial was just to show people who are afraid of vaccination."
The downside of the vaccine is that the virus protein does not replicate in the body as the live virus does. It would take several shots before an chimp could acquire enough protection - which complicates things for vaccinating in the wild.
Walsh expects that the vaccine would also work on gorillas, but that has yet to be tested.
"It protected monkeys against Ebola infection. The immune response the chimpanzees had was very similar to the immune response the monkeys had. So my guess is it wouldn't cause any health problems in gorillas and it would also have a similar immune response."
According to Walsh, chances are it would also work on humans.
Human trials too expensive
And for vaccinating humans, you need a license.
To acquire a license, you need extensive human clinical trials - and they can be very expensive.
Quite often, large pharmaceutical companies often put up the cash for clinical trials.
But that is also part of the problem.
"No pharmaceutical company is going to make a profit by developing a vaccine against Ebola which is mainly affecting African villagers."

Governments can finance vaccine development in the lab - but clinical trials are expensive
Walsh says several Ebola vaccine candidates work well in monkeys. But none of them is currently being tested in human trials.
"If this was a disease in developed countries where there was a commercial market for the product, one of these vaccines would now be licensed on the market, there is no doubt. The money would be there."
According the research database Pharmprojects, no pharmaceutical company is currently working on clinical Ebola vaccine trials. However, it does show that several US and European companies are running Ebola vaccine projects - all in preclinical trials, which tend to be much less expensive.
"The US government will pay for vaccine research, especially for vaccines against terror threats - and Ebola is a bioterror threat," Walsh says. But the government won't finance clinical trials because of the enormous costs.
Vaccinating a non-licensed vaccine
There is, though, at least one vaccine which we know of, which could be used in humans. It has only ever been tested in monkeys - officially. But it has also proved to be effective in humans.
In 2009, a researcher at the Bernhard Nocht Institute in Hamburg accidentally pricked herself with an Ebola-infected syringe.
She was treated with a vaccine brought in from the US. The substance unlicensed as it had only been tested on monkeys.
It consisted of a weakened vesicular stomatitis virus that infects cattle, horses and pigs. It was genetically engineered to contain a portion of an Ebola virus protein.
And the researcher recovered.

Walsh wants to vaccinate chimpanzees in the wild
An end for trials with chimps?
One other thing will make Ebola vaccine development even harder in the future.
"To our knowledge, our study was the first conservation-related vaccine trial on captive chimpanzees," the authors write in "PNAS". "It may be the last."
The US is the only country that allows biomedical testing on captive chimpanzees. It is banned everywhere else. US legislation is now heading towards an end to this kind of research, so trials on captive chimpanzees may become illegal there as well.
Walsh says that would be a big mistake - not only for human patients needing drugs and vaccines, but also for conservation.
"You try to do something good for captive chimpanzees but in the process you are doing something really bad for wild chimpanzees."
To develop vaccines to protect wild apes from illnesses, researchers have to test them first on captive apes. Park rangers would never allow using a substance on protected wildlife if the substance hasn't been tested on apes in captivity, Walsh says.
But Walsh still hopes to raise the money to vaccinate African chimpanzees and gorillas against Ebola. Chances are he will manage - long before we ever see human clinical trials for the same vaccine.

http://www.dw.de/secret-serum-liberia-e ... a-17654230

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PostPosted: Tue Aug 05, 2014 11:23 am 
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San Diego Biotech Firm to Ramp Up Production of Ebola Treatment
By Joe Kloc
Filed: 8/5/14 at 10:47 AM | Updated: 8/5/14 at 10:50 AM

As the Ebola virus continues to spread through West Africa—where the death toll has now reached almost 900—an experimental drug previously untested in humans may offer a cure. The treatment, known as ZMapp, was developed by Mapp Biopharmaceutical in San Diego. The company has recently hinted that it may be ramping up production of the "secret serum."

ZMapp was first identified as a potential cure back in January but, according to the company, has not yet completed the first phase of safety testing. However, last week, when two Americans working in Liberia, Dr. Kent Brantley and Nancy Writebol, came down with the disease, they were offered the experimental treatment, CNN reported.

According to the National Institutes of Health (NIH), Samaritan's Purse—the nonprofit aid agency for whom Brantley and Writebol had been volunteering—contacted U.S. Centers for Disease Control and Prevention (CDC) officials in Liberia to ask about experimental treatments they had read about in the scientific literature. The CDC referred them to an NIH scientist on the ground in West Africa, who "informally answer[ed] some questions and referred them to appropriate company contacts to pursue their interest in obtaining experimental product." According to the NIH, this scientist was "not officially representing NIH and NIH did not have an official role in procuring, transporting, approving or administering the experimental products."

Newsweek Magazine is Back In Print

Three frozen vials of the drug were flown to Liberia, arriving on July 31; it is still unclear why, but initially, only one dose had thawed and Brantley reportedly offered it to Writebol. But when Brantley took a turn for the worse—"I'm going to die," he said—his doctors decided to administer the drug to him.

Though Brantly and Writebol are still ill, the early signs indicate that the drug may be working. Reportedly, Brantly was improving within hours of receiving the experimental treatment and has now made a "near complete recovery" Writebol did not react immediately to the first dose of the drug, but after a second dose also began to improve.

Mapp Biopharmaceutical declined Newsweek’s interview request but said via email it was “in the midst of an intense effort” to address the Ebola outbreak in West Africa. According to Mapp’s website, ZMapp is funded by the U.S. Army Medical Research Institute of Infectious Disease and the Defense Threat Reduction Agency. Last week, the DTRA announced that it would put more money behind ZMapp in order to produce sufficient quantity “to perform a Phase 1 clinical safety study.”

The goal, it seems, is to quickly get enough of the drug to bring it through the Food and Drug Administration (FDA) approval process. The FDA does, on rare, life-threating occassion, allow experimental drugs to be distrubeted without prior approval, under "compassionate use" conditions. The regulator has not yet stated whether this case fit that definition.

According to an information sheet provided by Mapp, ZMapp is composed of three antibodies “manufactured in plants;" specifically, plants from the Nicotiana genus—the same group of plants used in cigarette tobacco. The company described it as “an optimized cocktail” that combines two other compounds known as MB-003 and ZMAb.

The latter of the two, ZMAb, was the subject of several recent studies on macaques. The first study, published in 2012, evaluated the drug’s effectiveness when given to the animals either 24 or 48 hours after infection. All four of the macaques who began their treatment within 24 hours survived “with no apparent side effects,” and two of the four who began after two days fully recovered. In a second study, published in November of 2013, the six surviving macaques were then again infected with Ebola ten weeks after the first test in order to evaluate whether they had built up a resistance to the virus. All six survived.

These results, despite being in animal models, offer hope for the hundreds who are still fighting a disease that in some cases can have a 90 percent mortality rate.

More Ebola treatments are certainly needed in West Africa, but they may be required in the U.S. as well. According to WABC-TV in New York, a patient at Mount Sinai Hospital in Manhattan is currently being screened for a Ebola. The man, who had recently visited West Africa, came into the emergency room with “high fever and gastrointestinal systems,” ABC reported. Mapp Biopharmaceutical has not said whether or not the man will be given ZMapp if he does, in fact, have the virus.

http://www.newsweek.com/possible-ebola- ... als-263063

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PostPosted: Tue Aug 05, 2014 1:46 pm 
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Nigeria Considers U.S. Experimental Ebola Drug for Sick Doctor

By Yinka Ibukun Aug 5, 2014 11:14 AM ET

Aug. 5 -- Bloomberg’s Yang Yang reports on U.S. Ebola patients treated with Zmapp experimental drug from Mapp Pharmaceuticals in San Diego. She speaks with Betty Liu on “In The Loop.” (Source: Bloomberg)

Nigeria is considering applying for a dose of the experimental Ebola therapy given to two Americans to treat a Nigerian doctor who contracted the virus.

The female doctor who treated a Liberian victim of Ebola before he was diagnosed is receiving care in a hospital in Nigeria’s commercial capital of Lagos, Jide Idris, the state’s commissioner for health, told reporters today in the city.

“We will exploit the possibility of getting some,” Idris said. “There are protocols involved.”

San Diego-based Mapp Biopharmaceutical Inc.’s experimental ZMapp drug had only been tested on infected animals before it was given to Kent Brantly and Nancy Writebol, U.S. health workers who were infected with the virus in Liberia.

The Nigerian doctor is the country’s only confirmed case of Ebola, which has sickened 1,603 people in West Africa, killing 887, according to the World Health Organization. Most of the cases are in Guinea, Liberia and Sierra Leone.

Nigeria is monitoring another seven other people who came into contact with Patrick Sawyer, a Liberian government worker who died in a Lagos hospital on July 25, five days after flying into the country.

Nigeria is Africa’s biggest economy and its most populous nation of about 170 million people.

To contact the reporter on this story: Yinka Ibukun in Lagos at yibukun@bloomberg.net

To contact the editors responsible for this story: Antony Sguazzin at asguazzin@bloomberg.net Sarah McGregor, Dulue Mbachu
http://www.bloomberg.com/news/2014-08-0 ... cmpid=yhoo

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PostPosted: Tue Aug 05, 2014 2:42 pm 
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niman wrote:
Ebola outbreak and ZMapp will be discussed tonight at 10 PM EDT.

http://rense.gsradio.net:8080/rense/spe ... 080414.mp3

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PostPosted: Tue Aug 05, 2014 5:41 pm 
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It took more than 15 years of tireless research and millions upon millions of U.S. government dollars to produce a few grams of the experimental Ebola drug that may have saved the lives of two U.S. missionaries stricken by the virus in West Africa.

The news of Kent Brantly’s and Nancy Writebol’s improved conditions is wonderful. But it leads inevitably to the next question: How fast can we get some to the people dying in Liberia, Sierra Leone, Guinea and Nigeria?

The answer, at least from the information I’ve been able to gather so far, is: Yes, this can be done. It would be expensive. It would take a few months to produce. It would be complicated. No one could even remotely guarantee it would work.

But there’s little doubt it’s possible.

“Two months,” said Charles Arntzen, Regents’ professor at the Biodesign Institute at Arizona State University, who has collaborated for the past 15 years with Mapp Biopharmaceutical, the tiny San Diego company that produced the experimental serum given to the two Americans. “Maybe they could do it in a month. If they were [already] planning on it, I’m sure they could produce 10,000 doses in a month.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, was more cautious in an interview on CNN Tuesday. “It is not easy to make this serum,” he said. “The number of doses that are available right now, today…is less than a handful.

“It really is going to be a supply problem,” Fauci added. “It would take months to produce a significant amount more.”


There is only one place approved by the U.S. government to produce ZMapp, the cocktail of antibodies injected into Brantly and Writebol, the two U.S. missionaries who contracted the deadly disease in Liberia. That is Kentucky Bioprocessing in Owensboro, Ky., where the antibodies are produced in specially modified tobacco plants, which are then harvested, ground up into a green liquid, purified and turned into tiny doses — perhaps half a gram or a gram — of the ZMapp that was administered to the two missionaries.

A spokeswoman, Maura Payne, said in an e-mail Tuesday that “KBP is working closely with Mapp, various government agencies and other parties to increase production of ZMapp, but this process will take several months.”

And that is only the beginning of the litany of issues that would have to be addressed if, hypothetically, one of the West African governments wanted to try the drug as a last-ditch effort to stem the Ebola outbreak, which has sickened more than 1,600 and killed 887 in four countries. For starters, let’s remember that ZMapp had never been tried on a human being when Brantly and Writebol — and their physicians — opted to try it. That means years of safety testing and clinical trials were skipped, presumably because the two had few other options as they tried to survive Ebola.

“The fact that somebody had the risk-taking mentality to actually do this just blows me away,” Arntzen marveled in an interview Tuesday. “I’m just delighted…T0 me, it’s absolutely flabbergasting. But I love it. It restores my faith in government.”


Fair enough, but as Fauci is quick to note whenever he speaks, even if the drug helped the two Americans, there is no guarantee it will work on others. And no guarantee it wouldn’t have some harmful side effects.

We simply don’t know.


Experts told me they expect a lot of research to be done on Brantley and Writebol when they recover, in an effort to determine why the drug may have helped them.

As for cost, no one I’ve been able to talk to so far could even hazard a guess, other than to say it would probably be expensive. Liability issues might have to be addressed. But Arntzen said that any government, especially the Untied States, could afford it.

Arntzen said he spoke Monday night with Larry Zeitlin, one of the two founders of Mapp Biopharmaceutical, whom he described as a free spirit and “Renaissance man” who cares little for profit and has dedicated the past 15 years to finding an Ebola treatment that could be made widely available in the developing world.

Zeitlin and partner Kevin Whaley “were just happy as a clam,” Arntzen said. “Most of us in science…our greatest reward is we get to publish a scientific paper and other nerd scientists get excited and that’s the highlight of our life.

“And here he reads in the newspaper that his drug probably saved a life. That’s beyond anything I’d expect to hear in my life.”

Lenny Bernstein writes the To Your Health blog. He started as an editor on the Post’s National Desk in 2000 and has worked in Metro and Sports.

Brady Dennis is a national reporter for The Washington Post, focusing on food and drug issues.
http://www.washingtonpost.com/news/to-y ... n-victims/

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PostPosted: Tue Aug 05, 2014 7:40 pm 
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Experimental Ebola drug may have helped 2 US patients
Filed Under: Ebola
Robert Roos | News Editor | CIDRAP News | Aug 05, 2014

As the second of two Americans fighting Ebola virus disease (EVD) returned to the United States from Liberia today, reports suggested that an experimental drug they received may have helped them.

Nancy Writebol, a hygienist who was working at an Ebola hospital in Liberia, arrived at Emory University Hospital in Atlanta this afternoon, according to CBS News. She received two doses of the drug while in Liberia, and she can now walk with help and has regained her appetite, the story said.

The drug, a mixture of three monoclonal antibodies, has also been given to Keith Brantly, MD, of the Christian organization Samaritan's Purse, according to reports. He was flown back to the United States Aug 2 and is also being treated at Emory. Reports yesterday said Brantly's condition was improving.

In other developments, Ebola test results were being awaited for a patient in Columbus, Ohio, and one in Saudi Arabia, according to media and government reports. Also, the World Bank Group pledged to provide up to $200 million to help Liberia, Sierra Leone, and Guinea fight the virus, while British Airways said it is suspending service to Liberia and Sierra Leone because of the EVD epidemic.

Antibody cocktail
The decision to treat the two Americans with the experimental drug stemmed from an inquiry from Samaritan's Purse to the Centers for Disease Control and Prevention (CDC) about possible treatments, according to a Washington Post story. The CDC put the group in touch with National Institutes of Health (NIH) workers in Liberia who were aware of tests of the drug in monkeys.

Within a few days, doses of the drug were flown in from the United States and given to Brantly and Writebol, according to the Post. A spokesman for SIM, or Service in Mission, the Christian group that employs Writebol, told the newspaper that her condition seemed to stabilize after she was treated on Jul 31.

The drug is a mixture of three monoclonal antibodies that targets parts of the Ebola Zaire virus, according to a Canadian Press report today. Two of the antibodies were developed by the Public Health Agency of Canada and one is a product of the US Army Medical Research Institute of Infectious Diseases, the story said.

The drug is called ZMapp and is made by Mapp Biopharmaceutical of San Diego, according to the Canadian Press. It said ZMapp has not been tested in humans, but tests in monkeys look promising. Genetically engineered tobacco plants are used to produce the antibodies.

A spokesman for Reynolds American, parent of a Kentucky company that developed the tobacco plants, said the Food and Drug Administration permitted use of the product under "investigational new drug" rules.

Potential cases in Saudi Arabia, US
Meanwhile, an ABC News report today said the CDC has tested six people for Ebola, one of whom is a 46-year-old woman in Columbus, Ohio, who was hospitalized several days ago after a trip to one of the affected African countries. The story said she is doing well now. It provided no details on the other patients.

There was no word yet on the Ebola test results for a patient at Mount Sinai Hospital in New York City, but the city's health department said in a statement that the diagnosis was unlikely.

In Saudi Arabia, the Ministry of Health reported that a 40-year-old man who got sick after a trip to Sierra Leone is being bested for Ebola. The ministry said he presented at a Jeddah hospital last night with symptoms of a viral hemorrhagic fever and is now in isolation in a tertiary care center. A preliminary test for dengue virus was negative.

$200 million donation
In Washington, DC, the World Bank Group announced yesterday it would provide up to $200 million to help Guinea, Liberia, and Sierra Leone control Ebola, cope with the disease's economic impact, and strengthen public health systems.

World Bank Group President Dr. Jim Yong Kim, a medical doctor experienced in treatment of infectious diseases, said the new pledge was in response to a plea for assistance from the three countries and the World Health Organization, according to a World Bank press release.

"I am very worried that many more lives are at risk unless we can stop this Ebola epidemic in its tracks," Kimsaid in the release.

And in another development, British Airways announced today it is suspending service to Liberia and Sierra Leone until Aug 31 "due to the deteriorating public health situation in both countries."

See also:

Aug 5 CBS News story

Aug 4 Washington Post story

Aug 5 Canadian Press story

Aug 5 ABC News story

Aug 5 Saudi Ministry of Health statement

Aug 4 World Bank Group press release

Aug 5 British Airways announcement (see "Summary" list)

http://www.cidrap.umn.edu/news-perspect ... s-patients

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PostPosted: Tue Aug 05, 2014 11:47 pm 
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Experts: Give new US Ebola drug to Africans
World's top Ebola specialists question why only US aid workers given experimental drug, but firm says little available.
Last updated: 06 Aug 2014 03:06

Almost 900 people in Guinea, Sierra Leone and Liberia have been killed and more than 1,600 infected [Reuters]
Three of the world's leading Ebola specialists have called for experimental drugs and vaccines to be offered to people in West Africa, where a vast outbreak of the deadly disease is raging in three countries.

Noting that American aid workers who contracted the disease in Liberia were given an unapproved medicine before being evacuated back to the United States, the specialists - including Peter Piot, who co-discovered Ebola in 1976 - said Africans affected by the same outbreak should get the same chance.

Piot, David Heymann and Jeremy Farrar, all influential infectious disease professors and respectively directors of the London School of Hygiene and Tropical Medicine, the Chatham House Centre on Global Health Security, and the Wellcome Trust, said there were several antiviral drugs, monoclonal antibodies and vaccines under study for possible use against Ebola.


Expert discusses experimental Ebola treatment
"African governments should be allowed to make informed decisions about whether or not to use these products - for example to protect and treat healthcare workers who run especially high risks of infection," they wrote in a joint statement.

The World Health Organization (WHO), "the only body with the necessary international authority" to allow such experimental treatments, "must take on this greater leadership role", they said.

"These dire circumstances call for a more robust international response," they added.

Almost 900 people in Guinea, Sierra Leone and Liberia have been killed by Ebola and more than 1,600 infected since the virus started spreading in Guinea in February.

Two American aid workers who fell sick with Ebola in Liberia saw their conditions improve by varying degrees in Liberia after they received an experimental drug called ZMapp, developed by San Diego-based private biotech firm Mapp Biopharmaceutical.

Piot, Farrar and Heymann questioned why Africans were not being given the same chance.

If the deadly virus was raging though wealthy countries, they said, medical agencies "would begin discussions with companies and labs developing these products and then make rapid decisions about which of them might be appropriate for compassionate use".

Little of drug available

"Experimental treatments shouldn't be rolled out generally without prior safety testing," they said in their statement, issued in London late on Tuesday.

"But in the face of the critical challenge in West Africa, the WHO and Western medical agencies should be helping countries weigh the risks and benefits of limited deployment of the best (drug and vaccine) candidates to those in the greatest need, while continuously monitoring safety and efficacy."



Biotech firm Mapp and its commercial partner Leaf Biopharmaceutical said the ZMapp drug was only identified as a potential treatment candidate in January and that, as a result, very little of it was currently available. The company said that the treatment was hard to produce and that it was working to scale up production as soon as possible.

The ZMapp serum consists of three antibodies manufactured in modified tobacco leaves, which take weeks to grow.

A spokesman for the Geneva-based WHO told Reuters news agency that the United Nations health agency "would not recommend any drug that has not gone through the normal process of licensing and clinical trials".

Treating patients with experimental drugs that have not been tested in humans to determine safety and efficacy is highly unusual.

http://www.aljazeera.com/news/africa/20 ... 16828.html

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