Glaxo's Ebola vaccine to start human trials

A vaccine candidate to be tested in the upcoming Ebola drug trials.
A vaccine candidate to be tested in the upcoming Ebola drug trials. (NIAID/GSK)
Posted: August 30, 2014

With the Ebola epidemic growing in West Africa, drugmaker GlaxoSmithKline and the National Institutes of Health said Thursday that they would begin next week the first human trials of a potential vaccine that might help prevent the spread of the virus, which has killed more than 1,500 people.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, a division of NIH, said the epidemic was now "uncontrolled" and requires an "all-hands-on-deck" response.

Fauci stressed that other public-health measures - isolating patients and increasing the supply of and proper use of protective clothing, for example - are essential because even accelerated vaccine testing and production will take months and years, if the vaccines work at all.

The World Health Organization's assistant director general, Bruce Aylward, told reporters in Geneva, Switzerland, Thursday that the number of infected people could be two to four times higher than the WHO's current figure of 3,069 cases, and could eventually reach 20,000.

"Three weeks ago, the WHO came back to us and said, 'We don't see an end in sight with this epidemic. What can we do to make this go faster?' " Rip Ballou, vice president of clinical research and translational science at GSK Biologicals, said by phone from Belgium. "We got together with NIH and came up with this accelerated plan."

GlaxoSmithKline is based in London, but about 300 of its Philadelphia-area employees are involved in this effort, according to Donna Altenpohl, GSK vice president for U.S. public policy, who works from the Navy Yard.

Chief executive officer Andrew Witty has increased GSK's investment in vaccines because, he says, drugmakers, wherever they are based, will need to work around the globe and because Africa is the next Asia in terms of economic development.

Altenpohl helps lead one slice of that effort, which is GSK's biosecurity work with NIH and the Departments of Defense and Health and Human Services. The Pentagon's Defense Threat Reduction Agency and Defense Advanced Research Projects Agency have biological and chemical divisions.

"The fact that we're able to accelerate this is driven and helped by almost 15 years of research work, largely through the NIH and the Department of Defense," said Ballou, who spent 20 years in the Army, researching infectious diseases, then worked for MedImmune (now owned by AstraZeneca) and the Gates Foundation.

The GSK vaccine candidate in this case came from its 2013 acquisition of the Swiss-Italian company Okairos A.G. for about $325 million, and the testing will be conducted at NIH facilities in Bethesda, Md.

The Wellcome Trust, a UK-based foundation with roots that connect to GSK, donated money for eventual production if the GSK vaccine is found to be safe and effective, and it will help sponsor another set of tests run through Oxford University, the University of Maryland, and the Mali Ministry of Health. Mali has enough health-care infrastructure to conduct proper clinical trials, and it can attract clinical trial volunteers with similar ethnicity to the people now in danger in Liberia, Sierra Leone, Nigeria, and Guinea.

Altenpohl said she was excited by the multi-pronged partnerships forming to address the crisis. "That is good public policy," she said.

Still, she works at a for-profit company in an industry previously accused of unethical drug-testing.

"The proper protocols," she said, "are being expedited, but not shortchanged."


dsell@phillynews.com

215-854-4506 @phillypharma

www.inquirer.com/phillypharma

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