Home Tags Posts tagged with "zmapp"
zmapp
The first human trials for an Ebola vaccine have begun in Maryland.
Researchers are studying how human immune systems respond to the vaccine.
Twenty healthy adult volunteers are being tested at the National Institutes of Health (NIH) in Maryland.
The trial has been brought forward amid an outbreak of the Ebola disease in West Africa that has killed at least 1,500.
No volunteers will be infected with the Ebola virus but the vaccine has performed well in primate trials.
There is no cure for Ebola but a separate experimental drug, ZMapp, was 100% effective in studies on monkeys, according to researchers who published their data in Nature last week.
The first human trials for an Ebola vaccine have begun in Maryland
ZMapp has not been officially studied in humans, but it was used on seven people infected with Ebola in West Africa, mostly health workers.
Two of them later died and it is unclear if the drug helped the others to recover. The fatality rate during this outbreak has been about 50%, according to the World Health Organization (WHO).
At least 3,000 people have been infected with the virus. On August 29, a fifth country, Senegal, had its first confirmed case.
WHO has warned it could get much worse and infect more than 20,000 people.
“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped develop the drug.
Researchers in Bethesda, Maryland, will be looking for any adverse reactions and how each volunteer’s immune system responds to the vaccine.
NIH is also partnering internationally with the Wellcome Trust and others for a similar trial in the UK, the Gambia and Mali.
The experimental Ebola drug ZMapp shows it is 100% effective in monkey studies, even in later stages of the infection, the only clinical trial data showed.
The study’s findings have been published in Nature.
Yet the limited supplies will not help the 20,000 people predicted to be infected during the outbreak in West Africa.
Two out of seven people given the drug, have later died from the disease.
ZMapp has been dubbed the “secret serum” as it is still in the experimental stages of drug development with, until now, no public data on effectiveness.
Doctors have turned to it as there is no cure for Ebola, which has killed more than 1,500 people since it started in Guinea.
Researchers have been investigating different combinations of antibodies, a part of the immune system which binds to viruses, as a therapy.
ZMapp shows it is 100 percent effective in monkey studies, even in later stages of the Ebola infection
Previous combinations have shown some effectiveness in animal studies. ZMapp is the latest cocktail and contains three antibodies.
Trials on 18 rhesus macaques infected with Ebola showed 100% survival.
This included animals given the drug up to five days after infection. For the monkeys this would be a relatively late stage in the infection, around three days before it becomes fatal.
Scientists say this is significant as previous therapies needed to be given before symptoms even appeared.
One of the researchers, Dr. Gary Kobinger from the Public Health Agency of Canada, said this was a huge step up from previous antibody combinations.
“The level of improvement was beyond my own expectation, I was quite surprised that the best combination would rescue animals as far as day five, it was fantastic news.
“What was very exceptional is that we could rescue some of the animals that had advanced disease.”
However, there is always caution when interpreting the implications for humans from animal data.
A Liberian doctor, one of three taking the drug in the country, and a Spanish priest both died from the infection despite ZMapp treatment.
The course of the infection is slower in humans than macaques so it has been cautiously estimated that ZMapp may be effective as late as day nine or 11 after infection.
But Dr. Gary Kobinger said: “We know there is a point of no return where there is too much damage to major organs, so there’s a limit.”
The group wants to start clinical trials in people to truly assess the effectiveness of the drug.
Liberian doctor Abraham Borbor has died despite taking experimental anti-Ebola drug ZMapp, Liberia’s information minister says.
Abraham Borbor was one of three doctors in Liberia who had been given ZMapp and were showing signs of recovery.
ZMapp has been credited with helping several patients recover, including two US doctors.
More than 1,400 people have died from Ebola this year in four West African countries – Guinea, Liberia, Nigeria and Sierra Leone.
Dr. Abraham Borbor “was showing signs of improvement but yesterday (Sunday) he took a turn for the worse,” Liberian Information Minister Lewis Brown told the BBC.
“What this means for the drugs, I don’t know,” the minister added, without giving further details.
It is believed Dr. Abraham Borbor died in the capital Monrovia. He was the deputy chief medical doctor at the country’s largest hospital.
ZMapp has been credited with helping several Ebola patients recover
Liberia has recently imposed a quarantine in parts of Monrovia to try to stop the spread of the virus.
Last Thursday, police fired live rounds and tear gas during protests among residents of the city’s West Point slum.
Liberia has seen the most deaths – more than 570 – in what is now the worst Ebola outbreak in history.
Meanwhile, Japan said it was ready to allow shipments of an experimental anti-viral drug to help combat the Ebola outbreak.
It is not clear whether T-705 (or Avigan) will actually work against Ebola, and no monkey or human trials of the drug have been done.
T-705 was developed by Japan’s Toyama Chemicals company for use against new strains of influenza. It was approved by the Japanese government earlier this year.
A company spokesman says the firm believes the similarity between flu viruses and Ebola means Avigan could be effective.
Japan says it is ready to ship Avigan even without approval by the World Health Organization (WHO).
Ebola is spread between humans through direct contact with infected body fluids and several doctors and health workers have died.
It is one of the world’s deadliest diseases, with up to 90% of cases resulting in death, although in the current outbreak the rate is about 55%.
The speed and extent of the outbreak was “unprecedented”, the WHO said last week.
An estimated 2,615 people in West Africa have been infected with Ebola since March.
On Saturday, Sierra Leone’s parliament passed a new law making it a criminal offence to hide Ebola patients.
If the law is approved by the president, those caught face up to two years in prison.
[youtube MrhiHilYxv4 650]
Dr. Kent Brantly, one of the US aid workers who recovered from an Ebola infection, is “thrilled to be alive” as he is discharged from hospital.
Dr. Kent Brantly, 33, thanked supporters for their prayers at a news conference in Atlanta.
Nurse Nancy Writebol, 59, was discharged on August 19.
The two were brought to the US for treatment three weeks ago.
The outbreak has killed more than 1,300 people in West Africa, with many of the deaths occurring in Liberia.
“Today is a miraculous day,” said Dr. Kent Brantly, who appeared healthy if pallid as he addressed reporters on Thursday at Emory University hospital.
“I am thrilled to be alive, to be well, and to be reunited with my family. As a medical missionary, I never imagined myself in this position.”
Dr. Kent Brantly contracted the Ebola virus in Liberia, where he and his family moved in October 2013 (photo AP)
Dr. Kent Brantly said Ebola “was not on the radar” when he and his family moved to Liberia in October.
After his family returned to the US as the Ebola outbreak tore through West Africa, Kent Brantly continued to treat Ebola patients and woke up on July 23 feeling “under the weather”.
Dr. Kent Brantly said he lay in bed for nine days, getting progressively sicker and weaker.
On August 1, he was flown to Atlanta for treatment at Emory unit.
Emory infectious disease specialist Dr. Bruce Ribner said after rigorous treatment and testing officials were confident Dr. Kent Brantly had recovered “and he can return to his family, his community and his life without public health concerns”.
The group for which Dr. Kent Brantly was working in Liberia, Samaritan’s Purse, said they were celebrating his recovery.
“Today I join all of our Samaritan’s Purse team around the world in giving thanks to God as we celebrate Dr. Kent Brantly’s recovery from Ebola and release from the hospital,” Franklin Graham said in a statement.
Nancy Writebol’s husband David said in a statement that she was free of the virus but was significantly weakened.
Her family decided to leave the hospital privately in order to allow her to rest and recuperate.
Meanwhile, South Africa on Thursday said non-citizens arriving from Ebola-affected areas of West Africa – the countries of Guinea, Liberia and Sierra Leone – would not be allowed into the country.
There is no cure for Ebola, one of the deadliest diseases known to humans, with a fatality rate in this outbreak of 50-60%.
But both Dr. Kent Brantly and Nancy Writebol received an experimental treatment known as ZMapp.
The drug, which has only been made in extremely limited quantities, had never been tested on humans and it remains unclear if it is responsible for their recovery.
ZMapp was also given to a Spanish priest, who died, and three Liberian health workers, who are showing signs of improvement.
[youtube ftAoelTlKLs 650]
Liberia’s information ministry has announced that 17 suspected Ebola patients who went missing after a Monrovia quarantine centre was attacked have been found.
The government had previously denied they were missing.
New UN figures show that 1,229 people have now died since the beginning of this year in the outbreak that has also hit Sierra Leone, Guinea and Nigeria.
The World Health Organization (WHO) says there were 84 deaths reported between August 14 and 16.
Ebola has no known cure, but the WHO has ruled that untested drugs can be used to treat patients in light of the scale of the current outbreak – the deadliest to date.
The virus is transmitted by direct contact with the body fluids of an infected person. Initial flu-like symptoms can lead to external hemorrhaging from areas such as eyes and gums, and internal bleeding which can cause organ failure.
The Liberian information minister said the missing patients were now at the newly expanded treatment unit opened over the weekend at the John F. Kennedy Memorial Medical Center in the capital, Monrovia.
He also said the health of three Liberian doctors infected with Ebola had improved after they receiving the experimental drug ZMapp.
Two US missionaries, who were flown home for treatment from Liberia, are reportedly recovering from the virus after taking doses of the same medicine.
ZMapp was also given to a 75-year-old Spanish priest who contracted Ebola in Liberia, but he died in Spain last week.
Seventeen suspected Ebola patients who went missing in Liberia after a Monrovia quarantine centre was attacked have been found
In Nigeria, which has had four fatal Ebola cases, health officials say five people have now recovered from the virus and been discharged from hospital in Lagos. Another three are still being treated.
The attack on Liberian quarantine centre, where 37 people were being held in Monrovia’s densely populated West Point township, took place on Saturday evening.
There are conflicting reports over what sparked the riot, in which medical supplies were also stolen.
Officials said the protesters were unhappy that patients were being taken there from other parts of the capital. Other reports suggested the protesters had believed Ebola was a hoax and wanted to force the centre to close.
There are also reports that the mattresses and linen being used by patients were taken during the attack.
In neighboring Sierra Leone, the agricultural minister has said the outbreak is also having a severe impact on the economy, as 66% of people were farmers and agriculture accounted for 46% of GDP and 25% of all exports.
Since the outbreak spread to Nigeria in July, when a person infected with Ebola flew from Liberia to Lagos, several airlines have stopped flights to the worst-affected countries.
Kenya’s ban on people from Guinea, Liberia and Sierra Leone entering the East African nation comes into force on Wednesday – and Cameroon has closed its land, sea and air borders with Nigeria.
Canada will donate up to 1,000 doses of an experimental Ebola vaccine to help battle the disease’s outbreak in West Africa.
The announcement comes after the World Health Organization (WHO) said it was ethical to use untested drugs on Ebola patients.
However, experts say supplies of both the vaccine, and experimental drug ZMapp are limited and it could take months to develop more supplies.
More than 1,000 people have been killed by the current outbreak.
Canada says between 800 and 1,000 doses of the vaccine, which has only been tested on animals, will be donated to the WHO for use in West Africa.
However, it will keep a small portion of the vaccine for research, and in case it is needed in Canada.
The current outbreak has infected people in Guinea, Sierra Leone, Liberia and Nigeria.
Canada will donate up to 1,000 doses of an experimental Ebola vaccine to help battle the disease’s outbreak in West Africa (photo WHO)
Dr. Gregory Taylor, deputy head of Canada’s Public Health Agency, said he saw the vaccines as a “global resource”.
He said he had been advised that it would make sense for health care workers to be given the vaccine, given their increased risk of contracting the disease.
Even if Canada releases most of its existing doses, experts warn it could take four to six months to make a quantity large enough to have any real impact at preventing the illness.
On Tuesday, the WHO said that in light of scale of the outbreak and high number of deaths, it was “ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
Last week the WHO declared the Ebola outbreak was a global health emergency.
Liberia says it is getting an experimental drug, ZMapp, after requests to the US government.
However, the WHO said there were only 12 doses.
ZMapp maker Mapp Biopharmaceutical said on Tuesday: “The available supply of ZMapp has been exhausted. We have complied with every request for ZMapp that had the necessary legal/regulatory authorization.
“Drug has been provided at no cost in all cases.”
ZMapp has been used on two US aid workers, Dr. Kent Brantly and Nancy Writebol, who have shown signs of improvement, although it is not certain what role the medication played in this.
A Roman Catholic priest, infected with Ebola in Liberia, who died after returning home to Spain is also thought to have been given the drug.
Ebola’s initial flu-like symptoms can lead to external hemorrhaging from areas like eyes and gums, and internal bleeding which can lead to organ failure. Patients have a better chance of survival if they receive early treatment.
[youtube 11B1NPvvYnE 650]
There a handful of Ebola drugs that have been shown to work well in animals.
One is ZMapp – the drug requested by the Liberian government to treat infected doctors. This contains a cocktail of antibodies that attack proteins on the surface of the virus.
Only one drug has moved onto early safety testing in humans. Known as TKM-Ebola this interrupts the genetic code of the virus and prevents it from making disease causing proteins.
There a handful of Ebola drugs that have been shown to work well in animals
TKM-Ebola was trialed in healthy volunteers at the beginning of 2014 but the American medicines regulator asked for further safety information. The manufacturer says human studies may soon resume.
Another option would be to use serum from individuals who have survived the virus – this is a part of the blood that may contain particles able to neutralize the virus.
Vaccines to protect against acquiring the Ebola disease have also been shown to work in primates.
The US authorities are considering fast-tracking their development and say they could be in use in 2016. Trials are likely to start soon, according to the World Health Organization.
However, experts warn ultimately the only way to be sure a drug or vaccine is effective is to see if it works in countries affected by Ebola.
[youtube MwT0aTnmal0 650]
The World Health Organization (WHO) has announced that untested drugs can be used to treat patients infected with the Ebola virus.
The WHO said it was ethical in light of the scale of the outbreak and high number of deaths – more than 1,000 people have died in West Africa.
The statement was made after its medical experts met in Switzerland on Monday to discuss the issue.
However, officials warned there were very limited supplies of potential treatments.
The WHO said where experimental treatments are used there must be informed consent and the results of the treatment collected and shared.
The WHO says it is ethical to use untested drugs to treat patients infected with the Ebola virus
In a statement, it said: “In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”
However, the organization conceded there were still many questions to be answered including how data could be gathered effectively while the focus remained on providing good medical care.
It was also unclear where the funding for the treatment would come from.
Last week the WHO declared the Ebola outbreak was a global health emergency.
The move came as Liberia said it was getting an experimental drug, ZMapp, after requests to the US government.
The WHO said there were only 12 doses.
ZMapp has been used on two US aid workers, Dr. Kent Brantly and Nancy Writebol, who have shown signs of improvement, although it is not certain what role the medication played in this.
A Roman Catholic priest, infected with Ebola in Liberia, who died after returning home to Spain is also thought to have been given the drug.
However, the drug has only been tested on monkeys and has not yet been evaluated for safety in humans.
There is no cure for Ebola, which has infected at least 1,779 people since the outbreak was first reported in Guinea in February.
The Liberian government said it was aware of the risks associated with ZMapp, but the alternative was to allow many more people to die.
[youtube KtScTYq4YKI 650]
ZMapp, the experimental drug given to Dr. Kent Brantly and Nancy Writebol to fight the Ebola virus, seems to be working, according to health specialists.
The untested drug was developed by San Diego-based Mapp Biopharmaceuticals.
What we need to know about ZMapp:
1. ZMapp is made from tobacco leaves
ZMapp is made from the leaves of modified tobacco plants, specifically, the Nicotiana benthamiana plant, Bloomberg reported. The tobacco leaves, which typically do more harm than good in regard to human health, help combat the Ebola virus because of the compound that’s created from their modification. The combination of compounds in ZMapp includes a compound called MB-003 and another called ZMAb. MB-003 protected 100% of monkeys exposed to the Ebola virus immediately after exposure. ZMAb provided 100% survival to monkeys one day after exposure. That number decreased to 50% after two days, according to NBC News. Erica Ollmann Saphire, a professor of immunology at the Scripps Research Institute in La Jolla, California, said that one of the antibodies in the serum helps alert the immune system to the presence of infected cells so they can be destroyed. The other two antibodies seem, “to neutralize the virus,” Prof. Erica Ollman Saphire told WebMD.
ZMapp, the experimental drug given to Dr. Kent Brantly and Nancy Writebol to fight the Ebola virus, seems to be working
2. ZMapp had never before been tested in humans
The drug had never been tried before in humans with Ebola, but had shown promise in monkeys with the disease. Both Dr. Kent Brantly and Nancy Writebol knew the drug had never been tested in humans before taking it. Their improving conditions have left researchers optimistic about the effectiveness of ZMapp. Thomas Geisbert, a professor of infectious disease at The University of Texas Galveston Medical Branch, told WebMD: “If we can prove that whatever the treatment was worked, that’s fantastic. That’s exciting. But I’m cautiously optimistic, because with this particular outbreak, almost 40 percent of patients survive without treatment. So we want to make sure that it wasn’t somebody that was going to survive anyway.”
3. ZMapp’s creation was a collaborative effort
ZMapp was the result of collaboration among Mapp Pharmaceuticals, San Diego-based LeafBio, Defyrus in Canada and the Public Health Agency of Canada, according to Times of San Diego.
Mapp Pharmaceuticals said in a statement: “ZMapp was first identified as a drug candidate in January 2014 and has not yet been evaluated for safety in humans. As such, very little of the drug is currently available. Mapp and its partners are cooperating with appropriate government agencies to increase production as quickly as possible.”
4. ZMapp’s use has raised ethical questions
The use of ZMapp has raised ethical questions regarding who has the right to experimental treatment, Bloomberg reported. Robert Garry, a virologist at Tulane University, told the publication: “There are a lot of Africans that are also dying. If we are going to do it for the Americans then we should certainly step up our game for the Africans.”
Liberia’s assistant health minister, Tolbert Nyenswah, told The Wall Street Journal health officials have become inundated with requests from the families of Ebola patients for ZMapp.
5. Mapp Biopharmaceuticals was part of a group awarded a $28 million grant to fight Ebola
Mapp Biopharmaceuticals was one of several companies and research to be selected for a five-year grant of up to $28 million awarded by the National Institutes of Health in order to fight Ebola, according to The Scripps Research Institute.
[youtube Zwl71kviptk 650]
Liberia will receive ZMapp, an untested experimental Ebola drug, to treat infected patients, the government announces.
The move came after a request to the US from Liberian President Ellen Johnson Sirleaf, the government said.
The news came as medical ethics specialists met in Geneva to explore the use of such new treatments.
The World Health Organization (WHO), which is hosting the meeting, says some 1,013 have died from Ebola in West Africa.
US government officials said their role had been to put Liberian officials in contact with ZMapp maker Mapp Biopharmaceutical.
The pharmaceutical company said its supply of the drug was exhausted after its supplies were sent to West Africa, AFP news agency reported.
Liberia will receive an untested experimental drug, Zmapp, to treat people infected with Ebola
The drug was “provided at no cost in all cases,” the company added.
ZMapp has been used in the US on two aid workers who have shown signs of improvement, and a Roman Catholic priest, infected with Ebola in Liberia, who is currently being treated in a hospital in Madrid.
However, the drug has only been tested on monkeys and has not been yet evaluatd for safety in humans.
The WHO will announce the outcome of its emergency meeting on the role of experimental drugs on Tuesday.
Earlier, Ivory Coast announced it had banned all passenger flights from the three countries hit the worst by the spread of Ebola: Guinea, Liberia and Sierra Leone.
It is the second country, after Saudi Arabia, to impose such a ban in a bid to prevent the spread of the deadly virus.
There is no cure for Ebola, which has infected at least 1,779 people since the outbreak was first reported in Guinea in February.
Ebola’s initial flu-like symptoms can lead to external haemorrhaging from areas like eyes and gums, and internal bleeding which can lead to organ failure. Patients have a better chance of survival if they receive early treatment.
Meanwhile, China has sent medical supplies worth 30 million yuan ($4.9 million) to Liberia, Sierra Leone and Guinea to help fight against the disease.
Separately, the Chinese ambassador to Sierra Leone said on Monday that eight Chinese medical workers who had been treating Ebola patients had been placed in quarantine for the past two weeks in the capital.
Nigeria, Africa’s most populous country, confirmed a 10th case of Ebola on August 11.
[youtube Zwl71kviptk 650]
The Ebola infected US aid workers, Dr. Kent Brantly and Nurse Nancy Writebol, appear to be improving after receiving an experimental drug, officials have said.
It is not clear if the ZMapp drug, which has only been tested on monkeys, can be credited with their improvement.
Dr. Kent Brantly was flown from Liberia to Atlanta for treatment on Saturday. His colleague Nancy Writebol arrived back in the city of Atlanta on Tuesday.
Since February, 887 people have died of Ebola in four West African countries.
The World Bank is allocating $200 million in emergency assistance for countries battling to contain the Ebola outbreak.
Dr. Kent Brantly and Nurse Nancy Writebol’s condition appear to be improving after receiving Ebola experimental serum ZMapp
It is the world’s deadliest outbreak to date and has centered on Guinea, Liberia and Sierra Leone. There have also been two cases in the Nigerian city of Lagos, where eight people are currently in quarantine.
British Airways has temporarily suspended flights to and from Liberia and Sierra Leone until August 31, 2014, because of the health crisis, the airline said in a statement. It follows a similar suspension by two regional air carriers last week.
The Ebola virus spreads by contact with infected blood and bodily fluids. The current outbreak is killing between 50% and 60% of people infected.
There is no cure or vaccine for Ebola – but patients have a better chance of survival if they receive early treatment.
Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, says clinical trials are to start in September on an Ebola vaccine that has shown promising results during tests on animals.
Dr. Kent Brantly and Nancy Writebol were treated with the ZMapp serum before their evacuation from Liberia.
According to a CNN report, quoting a doctor in Liberia, Dr. Kent Brantly’s condition improved dramatically within an hour of receiving the drug.
Service in Mission (SIM), the Christian aid group that employs Nancy Writebol, says she has had two doses of the drug and did not respond as well as Dr. Kent Brantly but she is showing “improvement”.
“She is walking with assistance… strength is better… has an appetite,” SIM spokesman Palmer Holt told the Washington Post newspaper in an email on Monday.
Nancy Writebol is on her way to a special isolation ward at Atlanta’s Emory University Hospital, where Dr. Kent Brantly is being treated by infectious disease specialists.
