GAITHERSBURG, Md., Oct. 14, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy elderly subjects.
The trial is a randomized, observer-blinded, placebo-controlled Phase 2 study scheduled to enroll 1,600 elderly subjects (>60 years of age) at ten sites in the United States. The trial will evaluate the incidence of all respiratory illnesses due to RSV, including medically-attended respiratory illnesses due to RSV, and hospitalizations for respiratory illness due to RSV in community-living elderly adults who have been treated with placebo. The study will also evaluate the safety and immunogenicity of a 135µg dose of the RSV F Vaccine compared with placebo. The trial will also estimate the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illnesses due to RSV.
"The initiation of this elderly clinical trial, shortly after the initiation of our Phase 2 maternal immunization trial last month, demonstrates our commitment to the strategy of building an RSV franchise. The goal of that strategy is to maximize the value of this product candidate for susceptible populations, the medical community, and our shareholders," said Stanley C. Erck, President and CEO of Novavax, Inc. "Today there is a significant unmet medical need for an RSV vaccine for the approximately 57 million individuals over the age of 60 in the US. This suggests that the elderly market may be the largest value driver in our RSV franchise."
"RSV is increasingly recognized by the medical and scientific community as a pathogen of great importance in the elderly population. This key study will evaluate RSV respiratory illness incidence rates in the elderly population in a prospective manner, further develop our safety and immunogenicity database in older adults and provide an estimate of the RSV F Vaccine's efficacy. Answers to these questions will inform the design of our projected Phase 3 pivotal study," said Greg Glenn, SVP, Research and Development at Novavax, Inc. "It is our goal to commence three RSV clinical trials in the fourth quarter, furthering the development of our RSV F Vaccine in each of the three key target populations: young infants via maternal immunization, children beyond infancy, and the elderly. We look forward to initiation of our Phase 1 Pediatric RSV study later this quarter."
RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection or its complications annually in the U.S., and up to 180,000 are hospitalized for serious respiratory symptoms. Currently, there is no approved RSV vaccine available for any of these populations.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant 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, 2013, filed with the Securities and Exchange Commission (SEC). 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 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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