Novavax Reports Positive Pre-Clinical Study Results from Live Virus Challenge to Pandemic Flu VaccineFerret Study to be Part of Data Package Required to Begin Clinical Trials
ROCKVILLE, Md., May 03, 2007 /PRNewswire-FirstCall/ -- Novavax Inc. said today that it has received positive study results from a live virus challenge to ferrets inoculated with its pandemic influenza vaccine, paving the way for clinical trials to begin on schedule later this year.
In the study, ferrets were inoculated with the company's virus-like particle (VLP) vaccine made from an Indonesian strain of H5N1 avian influenza. The ferrets, which represent the most relevant influenza animal model for humans, were then challenged with live H5N1 virus. All ferrets that received the Novavax vaccine survived, even those that received the lowest dose.
"These are our most important data to date," said Dr. Rick Bright, Novavax's Vice President of Global Influenza Programs. "We are looking forward to beginning our first clinical trial, which will be a major milestone for Novavax."
According to the study, ferrets that received Novavax's H5N1 vaccine were protected not only against the Indonesian strain of avian flu but also were cross-protected against a separate strain originating in Vietnam. Again, all ferrets that received the Novavax vaccine survived.
The ferret study was conducted in collaboration with the Southern Research Institute of Birmingham, Ala., a facility approved for handling highly lethal avian influenza viruses, and the University of Pittsburgh.
"We are on target to file our first vaccine investigational new drug ("IND") application by mid-year," said Novavax President and Chief Executive Officer Dr. Rahul Singhvi. "Given the robust results we have now received from the ferret challenge study, we are enthusiastic that we have a valuable new vaccine candidate to take into clinic trials."
Ferrets infected with influenza experience symptoms similar to humans, including runny noses, fevers, lethargy and weepy eyes. The ferret has proved to be the most predictive rodent model for success in human clinical trials for influenza.
"Novavax's proprietary vaccine may be the very first VLP vaccine for influenza to enter human clinical trials," Dr. Singhvi said. VLPs mimic the three-dimensional structure of a virus but do not contain genetic material, so they cannot replicate or cause infection. As VLPs maintain functional properties of both influenza surface proteins (hemagglutinin and neuraminidase), they likely trigger multiple arms of the immune system to generate a broadly protective immune response.
About Novavax Inc.
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 preventive 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 flu 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 global public health needs.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, 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.
CONTACT: Mariann Caprino of Novavax Inc., +1-240-268-2029
Web site: http://www.novavax.com/
Ticker Symbol: (NASDAQ-NMS:NVAX)
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Posted: May 2007