FDA approves AVI BioPharma's study for Marburg vaccine
The FDA approved AVI BioPharma to begin safety and efficacy studies of the single oligomer vaccine, called AVI-6003, in both humans and non-human primates, according to MSNBC.
In previous trials, AVI BioPharma showed that the drug's efficacy can be attributed to a single component, while a second component, called AVI-7287, does not appear to contribute to the drug's ability to fight Marburg infection.
The studies are to be conducted under a contract provided by the U.S. Department of Defense and managed by the DOD's Joint Project Manager Transformational Medical Technologies Project Management Office, which is a component of the Joint Program Executive Office for Chemical and Biological Defense.
"While we have not seen any toxicity in humans to date with AVI-6003, by removing AVI-7287 we have a simpler development path and may improve the therapeutic window by evaluating a single action agent," AVI BioPharma's President and CEO Chris Garabedian said, MSNBC reports. "We are pleased to be able to explore this single oligomer as a potentially safe and effective treatment against this lethal hemorrhagic fever virus."