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 US 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 US 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 US 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."
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 US 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 US 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 US 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."
© Thomson Reuters 2014
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