ROCKVILLE, Md., March 1, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has begun enrollment in a Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. This randomized, observer-blind, comparator-controlled study is being conducted in multiple centers in Australia under the company's contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) to develop recombinant vaccines for the prevention of seasonal and pandemic influenza. The trial will evaluate the immunogenicity and safety of three dose levels of Novavax's quadrivalent seasonal recombinant VLP influenza vaccine in healthy adults between the ages of 18 and 64.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "The start of this clinical trial is a significant milestone that reflects the progress we have made in our seasonal influenza vaccine program. We believe that most seasonal vaccines in the future will contain a second B strain and thus consist of a quadrivalent, or four-strain, composition. This trial allows us to transition from a trivalent to a quadrivalent seasonal vaccine candidate. The data will help establish the immunogenicity, safety and tolerability of our quadrivalent seasonal influenza VLP vaccine and determine the most effective and appropriate dose for later evaluation in young adults in our upcoming Phase III trial. This trial is being conducted in Australia so that we can evaluate our VLP vaccine candidate prior to the start of the influenza season in the southern hemisphere, and without waiting for the end of influenza transmission in the northern hemisphere. I commend my colleagues and our clinical investigators on their success in launching this important study."
The Phase II trial will enroll up to 500 eligible subjects who will be randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants will receive a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax vaccine or a standard dose of a licensed trivalent vaccine. Study participants will be evaluated at day 21 for hemagglutination inhibition (HAI) response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.
Novavax expects to evaluate the top-line data from this Phase II trial in the third quarter of 2012.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant vaccine nanoparticle (RVN) technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Forward Looking Statements
Statements herein relating to the future of Novavax and its ongoing clinical development of its influenza VLP vaccine candidates are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2010, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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