ROCKVILLE, Md., May 03, 2007 /PRNewswire-FirstCall/ -- Novavax Inc. said today that it has received positive study results from a live virus challenge to ferrets inoculated with its pandemic influenza vaccine, paving the way for clinical trials to begin on schedule later this year.
In the study, ferrets were inoculated with the company's virus-like particle (VLP) vaccine made from an Indonesian strain of H5N1 avian influenza. The ferrets, which represent the most relevant influenza animal model for humans, were then challenged with live H5N1 virus. All ferrets that received the Novavax vaccine survived, even those that received the lowest dose.
"These are our most important data to date," said Dr. Rick Bright, Novavax's Vice President of Global Influenza Programs. "We are looking forward to beginning our first clinical trial, which will be a major milestone for Novavax."
According to the study, ferrets that received Novavax's H5N1 vaccine were protected not only against the Indonesian strain of avian flu but also were cross-protected against a separate strain originating in Vietnam. Again, all ferrets that received the Novavax vaccine survived.
The ferret study was conducted in collaboration with the Southern Research Institute of Birmingham, Ala., a facility approved for handling highly lethal avian influenza viruses, and the University of Pittsburgh.
"We are on target to file our first vaccine investigational new drug ("IND") application by mid-year," said Novavax President and Chief Executive Officer Dr. Rahul Singhvi. "Given the robust results we have now received from the ferret challenge study, we are enthusiastic that we have a valuable new vaccine candidate to take into clinic trials."
Ferrets infected with influenza experience symptoms similar to
humans, including runny noses, fevers, let