ROCKVILLE, Md., July 31 /PRNewswire-FirstCall/ -- Novavax, Inc. announced today that it has begun vaccinating healthy volunteers in the first human clinical trial of its virus-like particle (“VLP”) based pandemic influenza vaccine. The Phase I/IIa randomized, placebo-controlled clinical trial will evaluate the safety and immunogenicity of different doses of the H5N1 clade 2 VLP influenza vaccine in up to 230 healthy adults. The goals of the study are to demonstrate safety and to select a dose for evaluation in a Phase IIb immunogenicity study. The first subject was enrolled at Healthcare Discoveries in San Antonio, Texas, one of two U.S. clinical sites participating in the study.
Novavax is developing vaccines to treat influenza and other viral diseases based upon VLP technology. The technology creates vaccine particles in cell culture that mimic the three-dimensional structure of the virus, but do not contain genetic material and cannot replicate. The flu VLPs are designed to have a favorable safety profile and potentially be more immunogenic than current pandemic vaccines, without the use of an adjuvant. Recent preclinical studies have supported this hypothesis by showing that Novavax’s influenza VLPs induced a robust immune response.
“The start of this clinical study represents a major milestone in the company’s strategy to develop novel and improved vaccines for the 21st Century,” stated Penny Heaton, M.D., Novavax Vice President and Chief Medical Officer. “The pandemic influenza vaccine is the first application of our proprietary VLP technology against a looming public health problem.”
“To create a novel vaccine clinical candidate within two years of focusing Novavax into a vaccine company is testament to our employees’ diligence and belief in our mission. The value of this clinical trial is far reaching since it will help us better understand the broad potential of the Company’s novel VLP vaccine technology platform with key human data,” stated Rahul Singhvi, Chief Executive Officer.
About Novavax
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 preventative 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 influenza, 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 public health needs.
Forward-Looking Statements
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.
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Rick Bright http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=63841 Penny Heaton http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=63842 Gale Smith http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=63840
Novavax, Inc.
CONTACT: Tricia J. Richardson of Novavax, Inc., +1-240-268-2031
Web site: http://www.novavax.com/
