ROCKVILLE, Md., May 9, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that it has begun enrollment in a second Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu"). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of this trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant ("Adjuvant 2").
This Phase I trial is identical in design to the Phase I study launched on May 1, 2012; it will enroll healthy subjects, each of whom will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 2, or a placebo. The trial is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.
Gregory Glenn, M.D., Novavax's Senior Vice President and Chief Medical Officer, stated: "This second clinical trial is supporting our efforts to determine the most appropriate dose of our VLP A/H5N1 avian influenza vaccine candidate and which adjuvant, if any, will be used in our future clinical trials. Like the first A/H5N1 trial we initiated on May 1, we believe this trial will provide the data to determine whether our vaccine will fulfill the criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA'sCenter for Biologics Evaluation and Research. Once again, we extend our thanks for HHS BARDA's support for these trials and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year."
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 nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel 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.
Statements herein relating to the future of Novavax and its ongoing development of its VLP vaccine products 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, 2011, 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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