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Novavax Reports Positive Results from Preclinical Studies of its VLP-based Trivalent Seasonal Influenza Vaccine Candidate
Date:4/16/2008

Results Support Moving Forward with a planned IND Filing for Novavax's

Seasonal Influenza Vaccine Candidate

ROCKVILLE, Md., April 16 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) said today that it has received positive results from an immunogenicity study in ferrets inoculated with the company's trivalent seasonal influenza vaccine candidate. These findings will enable Novavax to complete its planned investigational new drug ("IND") application to support initiation of a Phase II clinical trial targeted to begin in the third quarter of this year.

In the study, ferrets were inoculated with the company's trivalent seasonal influenza vaccine containing a mixture of three virus-like particles (VLPs) representing the H3N1, H1N1, and B virus strains. The vaccine induced protective antibody levels against each of the three strains represented in the vaccine in 100% of ferrets receiving a dose of 15 mcg/strain which is the standard dose for currently licensed split and subunit influenza vaccines. The vaccine candidate also induced protective antibody titers against a drifted strain in approximately 50% of ferrets inoculated. A separate toxicology study conducted in rabbits showed the trivalent vaccine was well tolerated with no unexpected side effects. The ferret and toxicology studies were conducted in collaboration with Dr. Ted Ross at the University of Pittsburgh Center for Vaccine Research and Bridge Laboratories, Gaithersburg, Maryland, respectively.

"Novavax' influenza programs are moving forward rapidly as planned," said Dr. Penny Heaton, Novavax' Chief Medical Officer and VP of Development. "In addition to the positive results from our seasonal influenza vaccine candidate announced today
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SOURCE Novavax, Inc.
Copyright©2008 PR Newswire.
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