Wednesday, biopharmaceutical company Novavax, Inc. (NVAX) reported positive results for the first stage of its two-stage pivotal Phase II study on its H1N1 virus-like particle or VLP pandemic influenza vaccine.
Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and other countries.
In the first stage of phase-II study, 1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of Novavax's 2009 H1N1 pandemic influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine.
The Data and Safety Monitoring Board or DSMB reviewed preliminary safety and immunogenicity data 14 days after the first dose administered to 500 subjects and found the vaccine well tolerated at all three dose levels, exhibiting no systemic side effects with mild local site reactions. In this subset, the hemagglutinin inhibition or HAI antibody titers 14 days after the first dose in the 15 and 45 mcg arms met the seroconversion and seroprotection criteria recommended by U.S. and European regulatory authorities.
Based on these findings, the DSMB recommended that the study proceed to second stage or Stage B of testing in which vaccine safety will be evaluated in 3,000 subjects with a 15 mcg single dose regimen. The company said, safety and immunogenicity data from all 1,000 subjects in Stage A will be available in January, 2010.
Rahul Singhvi, President and CEO, Novavax, said, "The trial's speedy turnaround from start of enrollment on October 19, 2009 to data review in less than six weeks is a testament to the enormous dedication of the Mexican-U.S. team. The DSMB's decision will enable us to begin enrollment in the second stage of this trial immediately."
VLPs mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology.
NVAX is currently trading at $3.40, up $0.19 or 5.92%, on the Nasdaq.
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