�Novavax, Inc. (NASDAQ: NVAX) announced favourable results from the second stage of the Phase I/IIa human clinical trial of its pandemic grippe virus-like speck (VLP) vaccine candidate. The vaccine, which does not contain an adjuvant, induced robust neutralizing antibody responses. Novavax's VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain. Avian flu emerged in humans in Indonesia in 2005 and has caused 135 documented human cases, 81% of which birth been fateful.
In this study, the vaccine demonstrated strong neutralizing antibody titers across all three doses tested, exhibiting increasing antibody titers with the escalation of the dose. The study evaluated individuals world Health Organization received deuce injections of 15 micrograms (mcg), 45 mcg, 90 mcg or placebo. Among those individuals in the 15 mcg arm, 72% had a neutralizing antibody titer of 1:20 or greater (four-fold climb from baseline) against the H5N1 A/Indonesia strain as did 73% of subjects in the 45 microgram arm and 94% of subjects in the 90 mcg arm. All subjects tested negative for neutralizing antibodies to the H5N1 A/Indonesia strain before vaccination and no responses were observed among individuals wHO received a placebo. Novavax's proprietary VLPs contain the surface proteins (hemagglutinin [HA] and neuraminidase [NA]) and matrix protein (M1) of the H5N1 A/Indonesia nisus. Additional immunological responses induced by each of the components of the vaccinum are being evaluated including responses against HA, NA and the M1 proteins.
Although the safety information are noneffervescent blinded pending complete base hit follow-up, on that point have been no serious adverse events reported. An independent external Data and Safety Monitoring Board fully supported continuation of the study including expansion to the 90 mcg dose.
VLPs ar recombinant structures mimicking the size and shape of the virus but deficiency genetic real and ar therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to make a virile immune reply. The HA and NA are included to induce neutralizing antibody responses, whereas the M1 may induce cell-mediated immune responses that provide trade protection against drifted (i.e., mutated) strains.
Addressing the Gaps in the System
"These data ar exciting because they march that recombinant VLPs ar a valid and powerful vaccine plan of attack against flu. Combined with our advanced manufacturing approach, our VLP vaccine candidate has the potential to address an unmet need in pandemic influenza preparation efforts being planned by health regime around the world," aforesaid Dr. Rahul Singhvi, President and CEO of Novavax.
Novavax's fabrication process makes it possible to potentially produce and distribute a vaccine matched to a pandemic strain in clip to interrupt and/or halt a pandemic. Novavax's grippe VLPs are produced in insect cell culture, utilizing a fabrication process that consists exclusively of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than that of traditional egg-based or mammalian cell culture manufacture. Because the Novavax work on involves recombinant technology and does not require a live flu virus, vaccine can be manufactured within 10 to 12 weeks of identification of a pandemic form, approximately 50% of the time continuance required to manufacture egg-based vaccines. As a key fruit commercialization opening move, Novavax has collaborated with GE Healthcare, a whole of General Electric Company (NYSE: GE), to develop processes victimization disposable systems as its manufacturing approach. This fabrication approach permits rapid commission at a fraction of the toll of traditional, egg-based manufacture facilities. The VLP vaccine may be an efficient and affordable component of a pandemic solution for countries that do non currently have in-border pandemic vaccine production.
"This data milestone simon Marks good progress in the viability of Novavax's vaccine which, combined with GE Healthcare's ready-to-use bioprocessing technologies, signals the promise of a solution to problems countries face in preparing for the inevitability of pandemic influenza," said Peter Ehrenheim, President and CEO, Life Sciences, GE Healthcare.
"In the face of a global health menace, innovations are required that can render safe and effective vaccines quickly and reliably," aforesaid Robert B. Belshe, M.D., Dianna and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology at the Saint Louis University School of Medicine, who served on the Data and Safety Monitoring Board for the study. "Two doses of this novel vaccinum - which is designed to keep bird grippe - gave strong immune responses.
The data ar encouraging that this unexampled vaccine approach can help oneself prevent pandemic influenza."
Support for VLP Seasonal Influenza Vaccine Candidate
These data ar also supportive for moving forward with development of another Novavax vaccine candidate: against seasonal influenza. Seasonal influenza causes over five hundred,000 deaths worldwide and over 36,000 deaths in the U.S. each year, most of which occur in adults 65 years of age and older, a population in which currently licensed vaccines have only when modest efficaciousness. Novavax has developed a vaccine candidate against seasonal worker (human) grippe strains. While current seasonal worker vaccines consist almost whole of HA, the Novavax VLP contains HA, NA, and M1 with the potential of inducing neutralizing antibody to prevent infection and bring down the rigour of grippe illnesses. Dose ranging studies in healthy young adults and adults 65 years of age and older are scheduled to start later this year.
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a all-inclusive range of infectious diseases worldwide exploitation advanced proprietary virus-like subatomic particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information roughly Novavax is available at http://www.novavax.com and in the Company's various filings with the Securities and Exchange Commission. http://www.novavax.com
Forward Looking Statement
Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments are forward-looking statements inside the substance 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 genuine results to differ materially from the results discussed in the forward-looking statements or historic experience let in risks and uncertainties, including risks relating to the early stage of Novavax's product candidates under development; current results may not be prognosticative of next pandemic results, results of our seasonal worker influenza vaccine or any other vaccine that we may explicate; further testing is mandatory before regulative approval can buoy be applied for and the FDA may non approve the pandemic vaccinum even if further tribulation results ar similar to those disclosed herein; uncertainties relating to clinical trials; dependence on the efforts of third parties; contest for clinical resources and patient registration from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and approach to capital to fund our operations including further l trials. Further information on the factors and risks that could regard 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 advanced statements speak only as of the date of this exhort release, and Novavax assumes no duty to update forward-looking statements.
http://www.novavax.com
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Tuesday, 2 September 2008
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