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Appendix 92 REPLIKINS Applications of ReplikinsR and BioRadar Global Surveillance SystemTM in FMDV surveillance and vaccine production S. Bogoch 1, E. Bogoch1 and P. Willeberg2 1 Replikins, Ltd., 38 the Fenway, Boston, MA 02215, USA 2 Center for Animal Disease Modeling and Surveillance, School of Veterinary Medicine, University of California, Davis, CA 95616, USA No structures of infectious organisms have been known previously which correlate quantitatively and temporally with epidemic outbreaks, course, and lethality, and which permit early or advance warning and rapid specific response. Data from CDC‐Harvard and Scripps‐Crucell (4,5) confirms Replikins: ‐inhibitory antibody lands on and binds to Replikins as the specific epitopes in influenza viruses ‐conservation of Replikins back to 1918 ‐cross‐strain conservation of Replikins ‐all above make pan‐flu vaccines possible, as Bogoch and Bogoch previously showed (1‐3) References 1. Bogoch S and Bogoch ES. Replikins: the chemistry of rapid replication. Begell House, N.Y. 2005; 2. <replikins.com>, ‘Replikins Press’‐33 online reports, 2006‐2009; 3. www.uspto.gov. 2001‐2009; 4. Sui, J. et al. "Structural and functional bases for broad‐spectrum neutralization of avian and human influenza A viruses.", Nature Structural and Molecular Biology, published online:22 February,2009, doi:10.1038‐nsmb.1566. 5. Ekeirt, D.C. et al, "Antibody Recognition of a Highly Conserved Influenza Virus Epitope", Science DOI: 10.1126‐science.1171491, Science Published online, Feb. 26 2009 A biochemical key to rapid replication • A new group of peptides in viruses and other infectious organisms and proteins related to rapid replication • Named “Replikins” because of their close quantitative relationship to rapid replication and outbreaks • Discovered in the disease organism’s genome • Small peptides strictly defined by the presence and concentration of certain amino acids, and the spaces between them • Increase in the number of Replikin peptides per 100 amino acids (Replikin Count), in the overall genome correlates with rapid replication and disease outbreaks References 1. Bogoch S and Bogoch ES. Replikins: the chemistry of rapid replication. Begell House, N.Y. 2005; Library of Congress 2. <replikins.com>, ‘Replikins Press’‐33 online reports, 2006‐2009; 3. www.uspto.gov. 2001‐2009; THESE REFERENCES PRESENT EVIDENCE THAT ‐Replikins are specific epitopes in influenza viruses ‐increase in concentration of Replikins (Replikin Count) signals influenza outbreaks ‐conservation of Replikins occurs back to 1918 ‐cross‐strain conservation of Replikins occurs ‐all above make pan‐flu vaccines possible, FMD 14/14 correct predictions in influenza 2001-2010 H1N1 Pandemic of 2009 was correctly predicted and published one year earlier, in April 2008 (see refs) Foot and Mouth Disease Outbreaks in 2010 Were Predicted in 2009 by the Quantitative Increase of Replikins in Foot and Mouth Disease Virus Gene 2009: Highest Replikin Counts of FMD virus peak gene in 52 years; Completely Synthetic Replikins FMDV Vaccine based on conserved replikins now available “New tools and challenges for progressive control” Open Session of the EuFMD Research Group, Vienna (Austria) 29 September ‐ 1 October 2010 Appendix 92 EARLY WARNING RAPID RESPONSE By quantitatively analyzing Replikin sequences BIORADAR™ Predicts and Tracks: • outbreaks and epidemics • the geographical location of such outbreaks Measures: • infectivity TWO SEPARATE REPLIKINS GENES • lethality Applies to: • multiple diseases and strains of diseases e.g. influenza, SARS, Foot and Mouth Dis., HIV, malaria Found in: • multiple disease hosts (animals and humans) REPLIKINS VACCINES Biological Vaccines –Too Little, Too Late •There are over six billion people and countless animal species •Current production methods cannot meet world demand •Annual and ad hoc formulations are sub‐optimal •Production against the latest emerging strain takes too long •Contaminants and side effects are common problems Replikins Synthetic Vaccines – a Solution •Non‐biological, produced via solid‐phase chemical synthesis •No biological contaminants, no need for potentially toxic preservatives •Produced in as little as seven days •Can be rapidly mass produced to meet world pandemic needs •More cost‐effective to produce •Readily transported without refrigeration BioRadarTM services are available To national governments and public health groups, for surveillance and early warning efforts and to pharmaceutical companies, for increasing specificity and the time available for vaccine production and testing “New tools and challenges for progressive control” Open Session of the EuFMD Research Group, Vienna (Austria) 29 September ‐ 1 October 2010