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Novavax Announces Favorable Interim Results from Human Clinical Trial for Its Pandemic Influenza Vaccine Program
Date:12/20/2007

ROCKVILLE, Md., Dec. 20 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today favorable interim results from a Phase I/IIa human clinical trial of its non-adjuvanted pandemic influenza virus-like particle (VLP) vaccine candidate.

Penny Heaton, MD, Chief Medical Officer and Head of Clinical Development stated, "The initial results from our Phase I/IIa study are promising and support further development of our pandemic influenza vaccine through regulatory licensure. We are moving forward with a dose ranging study as anticipated. These data illustrate the potential of the VLP platform to provide well tolerated and effective vaccines against difficult viral targets, such as the H5N1 avian influenza strain."

In the initial stage of this study, seventy healthy adults 18 to 40 years of age received two doses of either 15 or 45 mcg of the H5N1 VLP vaccine candidate or a placebo. The goal was to evaluate safety and immunogenicity, including hemagglutinin inhibition (HAI) and neutralizating antibody responses.

The interim results indicate that the vaccine was well tolerated in all study groups. An independent Data and Safety Monitoring Board (DSMB) reviewed the safety data and recommended that Novavax proceed with the second stage of the study, in which the safety and immunogenicity of a range of doses up to 90 mcg will be evaluated.

The vaccine also induced good immune responses. Among those individuals in the 45 mcg arm (N=35), 83% had neutralizing antibody against the H5N1 A/Indonesia/05/2005 avian flu strain after the second vaccination. Sixty- three (63) percent had a 4-fold rise in neutralizing antibody from baseline. In regard to HAI responses, 48% had a 4-fold increase in titer from baseline. All
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SOURCE Novavax, Inc.
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