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, 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," Dr. Heaton said.
"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," said Rahul Singhvi, President and Chief Executive Officer of Novavax, Inc. "We will have two vaccines in Phase II development by the second half of this year."
The company is also preparing its seasonal VLP vaccine candidate for head-to-head human studies against a marketed flu vaccine beginning in the fourth quarter of 2008. Virus-like particles have been created for each of the three new flu vaccine strains recommended by the Centers for Disease Control and Prevention ("CDC") for the upcoming 2008-2009 season. Historically, it is not common for CDC to recommend changing all three strains of the seasonal influenza vaccine, however, even with this recommendation, Novavax has been able to construct the corresponding VLPs within six weeks of the announcement. We believe that the ability of Novavax to respond quickly to emerging flu strains using its proprietary recombinant VLP technology could significantly differentiate Novavax from other flu vaccine companies.
Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based highly potent, recombinant vaccines utilizing a new, efficient manufacturing solution.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; results of further animal and human testing may result in data inconsistent with previously announced data or with our expectations; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
|SOURCE Novavax, Inc.|
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