Novavax Inc. (Nasdaq: NVAX) today announced positive results from its immunogenicity study in ferrets inoculated with the company’s seasonal influenza vaccine candidate. The results allow Novavax to complete its new investigational drug application in support of Phase II clinical trials in the third quarter of this year.
“Novavax’ influenza programs are moving forward rapidly as planned,” Dr. Penny Heaton, Novavax’ Chief Medical Officer and vice president of Development stated in the press release. “In addition to the positive results from our seasonal influenza vaccine candidate announced today, the dose-ranging study of our H5N1 pandemic flu vaccine is enrolling as projected based on the favorable interim safety and immunogenicity analyses conducted last December. We plan to have the final doses selected for late stage development for both the pandemic and seasonal flu vaccine programs by the second half of this year.”
In the study, ferrets were administered the company’s trivalent vaccine, which contains a combination of three virus-like particles (VLPs) representing the H3N1, H1N1 and B virus strains. The vaccine induced protective antibody levels against each strain represented in the vaccine in 100 percent of the ferrets. The vaccine also induced protective antibody titers against a drifted strain in 50 percent of the ferrets.
“These results support on-going development of our trivalent seasonal influenza vaccine and keeps us on track to commence human trials of this vaccine candidate in the third quarter of 2008,” Rahul Singhvi, president and CEO of Novavax stated. “We will have two vaccines in Phase II development by the second half of this year.”
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