Exclusive: NewLink says Ebola vaccine trial could start in weeks

[Buster's Uncle]

Exclusive: NewLink says Ebola vaccine trial could start in weeks
Reuters
By Sharon Begley  48 minutes ago



(Reuters) - NewLink Genetics Corp, which licensed an Ebola vaccine developed by Canadian government scientists, has enough doses on hand to launch the first human safety trial of an Ebola vaccine this summer, its chief executive said on Wednesday.

The company has also lined up two contract manufacturing companies and possibly a third and will be able to produce tens of thousands of vaccine doses within "the next month or two," Dr Charles Link said in an interview.

The largest Ebola outbreak in history, which has killed more than 1,000 people in West Africa, has lent an unprecedented urgency to efforts to develop vaccines and treatments, which for years had largely languished.

Last week, the Ames, Iowa-based company's wholly owned subsidiary, BioProtection Systems Corp, received $1 million from the United States Defense Threat Reduction Agency (DTRA) for more pre-clinical toxicology studies, including stepped-up manufacturing, to allow human trials to begin quickly. The vaccine was developed by scientists at the Public Health Agency of Canada.

"DTRA said, 'we want this to move quickly,'" Link said. "Before that, I'd have said it would take eight to 10 months before we could launch human studies, but now it's a matter of weeks."

Only one treatment, made by Tekmira Pharmaceuticals, had even begun human safety trials, while the others had been tested only in non-human primates.

In addition to NewLink, pharmaceutical giant GlaxoSmithKline is awaiting approval from the U.S. Food and Drug Administration (FDA) to begin a human safety trial of an experimental vaccine, possibly as soon as next month.

The World Health Organization said on Tuesday that two experimental Ebola vaccines were set to enter clinical trials in the coming weeks and that there could be enough early-stage data to consider their emergency use late this year.

"There is a way to fast-track clinical trials," WHO Assistant Director-General Marie-Paule Kieny said.

WHO's interest has acted like a starter's pistol in the race to get Ebola drugs or vaccines into the field. On Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, wrote in an essay in the New England Journal of Medicine that "production scale-up" of ZMapp is under way but will take time.

ZMapp is the cocktail of antibodies, produced by Mapp Biopharmaceutical of San Diego, given to two American medical workers who contracted Ebola and were evacuated to Atlanta.

Also on Wednesday, Canada's Tekmira Pharmaceuticals said it was discussing options for its experimental Ebola treatment with governments and other agencies, including the WHO.


DISCUSSIONS WITH GOVERNMENT

NewLink is attempting to fast-track its clinical trials.

Link said the company does not have to wait for manufacturing to ramp up before launching a safety trial of its vaccine: "We reserved plenty of doses" from ongoing studies in lab animals "to do the first human studies."

The company is in discussions with the U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health and Walter Reed Army Medical Center about where to conduct that trial and how to recruit volunteers. To get robust data, Link said, the vaccine should be given to between 20 and 100 healthy volunteers, all of whom would give informed consent.

Members of the military as well as medical workers on the front lines of the Ebola outbreak are the most likely participants, Link said. Before the trial can go forward, it needs FDA approval, which he expects to come quickly: "I have never seen the FDA so supportive," he said.

FDA spokeswoman Erica Jefferson said she could not confirm that the agency is in discussions with NewLink. "The FDA is generally not allowed to disclose information about any medical product under development," she added.

At least one site for the human safety trial will be in the United States, Link said. But the possibility of conducting a trial in Africa recruiting medical workers has also been raised in frequent conversations between his company and the CDC, WHO and other agencies.

Recruiting volunteers from the U.S. military is also "a distinct possibility," Link said, given the DTRA support and Walter Reed discussions: "From what I'm hearing, I'm not worried about finding volunteers."

The NewLink vaccine uses an attenuated or weakened virus, a pathogen found in livestock called vesicular stomatitis virus (VSV). One of the virus's genes is replaced by a gene from the Ebola virus. The Ebola gene makes a harmless protein that sits on the virus's outer coat.

The idea is that after the VSV is injected, the body's immune system will recognize the Ebola protein as foreign and begin making antibodies that destroy Ebola viruses, all of which have the protein.

Link is confident in the vaccine's safety and efficacy, based on results in monkeys. Live, attenuated viruses can cause inflammation and other adverse reactions, but that may be deemed worth the risk given Ebola's high fatality rate.

"We're here to help and do whatever we can" in the disastrous Ebola outbreak, Link said. "My team has been told to get it done tomorrow."

(Additional reporting by Toni Clarke; Editing by Michele Gershberg and Jonathan Oatis)


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Scientists find how 'nefarious' Ebola disables immune response
Reuters
By Kate Kelland  7 hours ago



LONDON (Reuters) - Scientists studying the lethal Ebola virus say they have found how it blocks and disables the body's ability to battle infections in a discovery that should help the search for potential cures and vaccines.

In the largest and deadliest outbreak of the disease yet recorded, Ebola has killed more than 1,000 people in West Africa since March.

A group of scientists in the United States found that Ebola carries a protein called VP24 that interferes with a molecule called interferon, which is vital to the immune response.

"One of the key reasons that Ebola virus is so deadly is because it disrupts the body's immune response to the infection," said Chris Basler of the Icahn School of Medicine at Mount Sinai, New York, who worked on the study.

"Figuring out how VP24 promotes this disruption will suggest new ways to defeat the virus."

The team, lead by Gaya Amarasinghe from Washington University School of Medicine, found that VP24 works by stopping something called "transcription factor STAT1" - which carries interferon's antiviral message - from entering the nucleus of a cell and initiating an immune response.

"This study shows just how nefarious the Ebola virus can be," said Ben Neuman, a virologist at Britain's university of Reading who was not directly involved in this study.

"Ebola virus carries a small tool that intercepts the cell's distress signals, and when this happens, it disables some of the most useful machinery that our bodies have for fighting Ebola. That leaves the body with only crude defenses that are less effective at stopping the virus, and end up causing much of the damage that can eventually lead to death."

Ebola is one of the most deadly diseases known in humans and has a case fatality rate of up to 90 percent. In the current epidemic in West Africa, the virus has infected more than 1,800 people. So far, 1,013 of these have died, the vast majority in Guinea, Liberia and Sierra Leone.

There are no proven treatments or vaccines to prevent Ebola, although several biotech companies and research teams have potential drugs in development.

Amarasingh's team, whose work was published in the journal Cell on Wednesday, said understanding how Ebola disarms immune defenses will be crucial in the development of new treatments.

A World Health Organisation-convened panel of experts said on Tuesday that patients infected with Ebola in the West African outbreak could be offered experimental drugs.

The WHO's panel of medical ethicists said several drugs had passed the laboratory and animal study phases of development and should be fast-tracked into clinical trials and made available for compassionate use.


http://news.yahoo.com/scientists-nefarious-ebola-disables-immune-response-161408775.html

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Consignment of experimental Ebola drug arrives in Liberia
Reuters
By Clair MacDougall  4 hours ago



Liberian soldiers (C) check people travelling in Bomi County August 11, 2014. REUTERS/Stringer



MONROVIA (Reuters) - A consignment of experimental Ebola drugs arrived by plane in Liberia on Wednesday to treat two doctors suffering from the virus, which has killed more than 1,000 people across four West African countries.

The drug, ZMapp, arrived in two boxes on a commercial flight from the United States carried by Liberia's Minister of Foreign Affairs, Augustine Ngafuan, and was unloaded at the VIP terminal, a Reuters witness said.

It will be taken to a hospital in the capital and administered to Liberian doctors Zukunis Ireland and Abraham Borbor, who officials said contracted the disease while attending to patients, including a late colleague.

The world's worst outbreak of Ebola has claimed the lives of 1,069 people and there are 1,975 probable and suspected cases, the vast majority in Guinea, Liberia and Sierra Leone, according to new figures from the World Health Organisation.

Three people have died in Nigeria.

The U.N. health agency said only around 10 to 12 doses of the drug have been made and this raises difficult ethical questions about who should get priority access.

The doctors will be the first Africans to receive it, though it has been given to a Spanish priest who later died and two U.S. aid workers who are reported to have shown signs of recovery.

Authorities are also concerned that ZMapp's unproven status could leave them open to the charge that humans are being used as guinea pigs.

"This is not the panacea to the problem. It is at the risk of the patient," Liberia's Assistant Health Minister Tolbert Nyenswah told journalists at Monrovia's main airport.

Information Minister Lewis Brown told Reuters the drug merely offered a "glimmer of hope" and its use was little more than a gamble.

Even so, the clamor for it is strong given that the contagious hemorrhagic disease is killing more than half of its victims and there is no known cure or vaccine.

"I welcome it. It is very good. Our nurses are dying. If you bring them the medication it will make them stronger to fight Ebola," said stationery seller James Liburd, in Monrovia.


ANOTHER DOCTOR DIES

In evidence of the ethical dilemma, Melvin Korkor, the first Liberian doctor to survive Ebola, said he would not have used ZMapp when he was fighting for his life because U.S. authorities said they were not responsible for any adverse effects.

"Any drug that has not been approved by FDA should not be administered," he told Reuters.

One of the epidemic's most tragic consequences is the toll on health care workers who rushed in as first responders only to become infected themselves due to inadequate protection measures or diagnoses of patients that came too late or were inaccurate.

The World Health Organization said this week that 170 health care workers had been infected and at least 81 had died.

Sierra Leonean doctor Modupeh Cole became the latest medical practitioner to die of Ebola, a health ministry spokesman said on Tuesday.

He contracted the disease after treating a patient who later proved to have the virus and died. The country's leading Ebola doctor, Shek Umar Khan, also died last month.

Eight Chinese health workers are in quarantine in Sierra Leone because they may have contracted Ebola, according to the spokesman for the Chinese embassy in Freetown, Xu Zhou.

The seven doctors and one nurse treated patients at two Chinese-run hospitals in Freetown who later died from Ebola. One of the doctors has emerged from quarantine after a 21-day observation period, Zhou told Reuters.


GUINEA CLOSES BORDER

Despite the stir caused by ZMapp, preventive public health measures will be crucial to containing the outbreak, according to the U.N. health agency.

As a result, West African and other governments, including some which have seen no cases of the virus, have taken measures intended to prevent the spread of the disease.

Guinea-Bissau has decided to close its frontier with eastern neighbor Guinea, Prime Minister Domingos Simoes Pereira told a news conference. Germany on Wednesday urged its nationals to leave Liberia, Guinea and Sierra Leone, though the request did not apply to medical workers or German diplomatic staff, a foreign ministry spokesman said.

The outbreak has brought fresh attention to efforts to find a cure. Scientists in the United States studying Ebola say they have found how it blocks and disables the body's ability to battle infections in a discovery that should help the search for potential cures and vaccines.

The scientists found that Ebola carries a protein called VP24 that interferes with a molecule called interferon, which is vital to the immune response.

"One of the key reasons that Ebola virus is so deadly is because it disrupts the body's immune response to the infection," said Chris Basler of the Icahn School of Medicine at Mount Sinai, New York, who worked on the study.

(Additional reporting by Emma Farge in Dakar, Umaru Fofana in Freetown, Stephanie Nebehay in Geneva, Albert Dabo in Bissau, Alexandra Hudson and Madeline Chambers in Berlin and Kate Kelland in London; Writing by Matthew Mpoke Bigg; Editing by Ruth Pitchford)


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