Novavax Initiates First Phase 1 Clinical Trial of Its A(H7N9) Influenza Vaccine Candidate
ROCKVILLE, Md., July 8, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a Phase 1 clinical trial of its monovalent virus-like particle (VLP) vaccine candidate for the prevention of disease due to A/Anhui/1/13-like A(H7N9) avian influenza viruses (A(H7N9) vaccine).
This Phase 1, randomized, observer-blinded, placebo-controlled trial will enroll up to 280 eligible adults. Each subject will be randomized into one of seven treatment groups, including placebo, or varying doses of the A(H7N9) vaccine, with or without an adjuvant. Each subject will receive two identical intramuscular doses at Day 0 and Day 21 and undergo study follow-up for approximately one year after the second dose. All subjects will be evaluated for safety and immunogenicity.
"Novavax has moved our program rapidly from the A/Anhui/1/13-like
(H7N9) viral gene sequence, to vaccine candidate, into multiple animal studies, and now, exactly three months after the gene sequence was obtained, into a clinical trial," said Stan Erck, President and Chief Executive Officer of Novavax. "We expect to report top-line results from this clinical trial later this year. This level of performance is a testament to the Novavax technology and the hard-work and commitment of its people. It serves as a powerful example of the Company's ability to respond rapidly to any future pandemic event."
About A(H7N9) Influenza
In March 2013, avian-origin A(H7N9) viruses emerged as human pathogens in Southeastern China. As of 4 July 2013, 133 human cases had been reported to the WHO from China, including 43 deaths. The majority of these patients were hospitalized with severe pneumonia, acute respiratory distress syndrome and multi-organ dysfunction. Immunologic experience with these A(H7N9) viruses had not been observed previously in the general population. In the event these viruses gain the ability for efficient and sustained human-to-human transmission, an influenza pandemic could result, with the potential for high rates of illness and mortality worldwide. Although it appears that the first A(H7N9) epidemic has subsided, the presence of a natural reservoir, the lack of antibodies to A(H7N9) in the general population, the severity of the disease and the potential for a second wave epidemic suggest an urgent need for A(H7N9) vaccine development. Vaccines are widely considered to be the first line of defense for protecting populations in advance of an influenza pandemic.
About VLPs and Novavax' Vaccine Program
VLPs are self-assembling protein structures that resemble the external structure of viruses, and when used as antigen in a vaccine, elicit broad and strong antibody and cellular immune responses, but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major virus proteins that are important targets for fighting influenza: hemagglutinin stimulates the body to produce antibodies that prevent binding of the influenza virus; neuraminadase induces immunity that prevents viral spread through the cells in the respiratory tract; and matrix 1 stimulates cytotoxic T lymphocytes to kill infected cells. VLPs have been and can be designed quickly to match novel viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces 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, LG Life Sciences of Korea and PATH.
Together, these organizations support Novavax' worldwide commercialization strategy and have 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.
Forward Looking Statements
Statements herein relating to the future of Novavax and its ongoing development of its 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, 2012, 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.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Posted: July 2013