ROCKVILLE, Md., Nov. 30 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today it has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine candidate in healthy adults 60 years of age or older (older adults). This randomized, double-blind, active-controlled study is comparing the safety, tolerability and immunogenicity of two different doses (15 mcg and 60 mcg) of Novavax's trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone®).
This study enrolled 467 older adults in a three-arm study at six different sites located within the United States. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses are also being examined. Previous studies have shown that VLP-based flu vaccines drive strong neuraminidase inhibition (NAI) antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.
"With the rapid completion of enrollment in this clinical trial as well as the first part of our H1N1 vaccine study in Mexico announced previously, we are on track to report results from our two most advanced clinical programs during the first quarter of next year," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "If results from the seasonal flu vaccine study are positive, we will be able to advance this program into Phase III clinical testing as early as 2010."
Seasonal influenza infects between 5 percent and 20 percent of the world's population and kills between 250,000 and 500,000 people each year. In the United States, the Centers for Disease Control and Prevention estimates that 15 to 60 million people contract influenza each year leading to over 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices (ACIP) currently recommends seasonal influenza vaccination for children six months through 18 years of age, pregnant women, and adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.
Virus-like particles (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. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical trials and development of the seasonal influenza vaccine and other anticipated milestones 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 clinical trial results, which may not be sufficient for regulatory approval or may indicate safety concerns not yet encountered; even if the results of the planned clinical trials are positive, the data may not be accepted by regulatory bodies or the seasonal influenza vaccine may not be approved by the United States government or additional clinical trials may be required; the Company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; competition from already approved vaccines for seasonal influenza; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Company's ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the Company's ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; the cost, timing and success of regulatory filings and approvals; the Company's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. 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 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.
|SOURCE Novavax, Inc.|
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