ROCKVILLE, Md., Dec. 17 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today favorable results from preclinical studies of its recombinant trivalent seasonal influenza virus-like particle (VLP) vaccine. The trivalent seasonal influenza vaccine is the second of two influenza vaccine programs that Novavax is developing using its recombinant VLP technology. The Company's pandemic influenza vaccine candidate is currently in Phase I/IIa clinical trials.
In a study using mice, two injections of Novavax's trivalent seasonal flu vaccine without an adjuvant induced strong HAI antibody responses against all 3 influenza subtypes contained in the vaccine including H3N2, H1N1, and B. The study showed that when all three seasonal influenza VLPs were given as a single trivalent vaccine, the immune response to each subtype was comparable to that observed when the VLPs were given in a monovalent formulation. Three different dosages of the trivalent vaccine were given; the anti-hemagglutinin (HI) antibody titer increased with dosage and protective levels of HI antibody titers were observed against each subtype at a dose of 3 g of hemagglutinin.
This preclinical study will be included in an Investigational New Drug ("IND") submission for the seasonal influenza vaccine currently targeted for the second quarter of 2008, with human trials to follow after clearance by the Food & Drug Administration ("FDA"). A toxicology study for the seasonal influenza vaccine has also been initiated as planned.
"We are pleased that the results from this seasonal influenza vaccine preclinical study are in line with our expectations. We are aggressively moving this program forward to file an IND as planned in the second quarter of 2008. If filed as anticipated, this would be our second vaccine IND within 12 months of our first vaccine IND, which we filed in June 2007 for our Pandemic influenza VLP vaccine," said Dr. Rahul Singhvi, Novavax's President and CEO.
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding product sales, 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 forward-looking statements or historical experience include risks and uncertainties, including 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; 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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