A New Way To Predict Outbreaks: Replikin Peptide Concentration In H5N1 Influenza Virus Genome As A Marker For Lethal Outbreaks

WHO and CDC have stated that the
predictive accuracy of their annual formulations for human influenza
vaccines is "suboptimal" -- often correct less than 50% of the time,
especially for seniors. Perhaps in part because we are not yet accurate in
our predictions of upcoming influenza strains, approximately 36,000 people
die each year of flu in the United States alone.



As in the case of hurricanes, early warning of the location and
intensity of virus outbreaks would allow us more rapidly and effectively to
defend ourselves with strain-specific vaccines. This is now possible.



To provide this vital knowledge, Drs. Samuel and Elenore Bogoch of the
Foundation for Research on the Nervous System and Replikins Ltd. of Boston
("Replikins") are presenting new technology at the 7th International Bird
Flu Summit in Las Vegas November 13-14, 2008 that can accurately predict
which viral strains are poised to attack human populations, and reveal the
location from which this viral strain is going to strike. This service is
being offered to WHO and CDC.



The key to this predictive technology is a new class of structural
virus peptides that have been shown to be involved in the chemistry of
rapid replication. The Drs. Bogoch called them "Replikins," and they are
strictly defined by the concentration of lysine and histidine residues and
the spacing between them. To demonstrate the correlation between the
concentration of replikins and the lethality of influenza virus outbreaks,
Replikins Ltd. has developed software called FluForecast(R), which counts
the number of replikins in the sequences of each strain of flu virus across
the years -- and thanks to the data in public databases like PubMed, we now
can track as far as 90 years back.



What Replikins have found is that there's a strong correlation between
the concentration of replikins and the lethality of an influenza virus
outbreak. This allows us to determine in advance, using newly designed
software, which viruses have the highest replikin concentrations -- and are
thus poised to become the most lethal outbreak.



Replikin peptides are not distributed equally throughout the virus
genome, but are concentrated in a specific area of the genome designated
the Replikin Peak Gene (RPGene). When the replikin counts for certain viral
strains are elevated, we see pandemics -- in which one to 50 million people
die. Note that the replikins, like the pandemics, are strain-specific.



From its observations Replikins were able to predict an impending
increase in human H5N1 mortality rate. In each host group -- goose, duck,
chicken and human -- levels stayed low through 2004. But then Replikins saw
a sudden spike in replikins particularly in chicken and human populations
in 2005-06, which corresponded with increased epidemics in Asian countries.
Which countries? Here again, Replikins looked at H5N1 replikin counts per
country. Low levels - - below 4 -- were observed in each country until
2005-06, when it spiked most dramatically in Indonesia. Replikins thus
predicted that Indonesia would be the first country to experience an H5N1
outbreak with higher human mortality, and this was proven to be correct in
2006-07.
















So Replikins have demonstrated that tracking replikin counts not only
works historically, but it can predict impending human mortality. Sequence
the virus and you can tell whether it's relatively benign or likely to
cause a pandemic -- the first time this has been possible.



Replikins is offering its FluForecast(R) service to WHO and CDC as a
powerful new tool for tracking the appearance and lethality of new flu
strains. By performing prompt replikin analysis of all human influenza
sequences as they emerge, we can have advance warning of the intensity and
location of future human influenza outbreaks. This will increase the
accuracy of annual formulations for influenza vaccines, and will thereby
hopefully reduce annual human influenza mortality rates. It is hoped that
tracking replikins will save lives.



Beyond prediction, this new replikin-based technology also can be
applied to combat influenza -- and to develop new vaccines that are more
accurate and effective than current technology provides. Replikins have
successfully demonstrated this capability when used against a virus in
shrimp, which are susceptible to several devastating viral diseases. The
replikin-based vaccine developed by Replikins to combat Taura Syndrome
virus had a stunning result on the test population, protecting 91% of the
shrimp against this deadly virus. Replikin vaccines work orally -- and can
be synthesized far more quickly than conventional viral vaccines. The
vaccine used to save the shrimp was manufactured in seven days. You can
imagine what this type of rapid lead time would allow for making on-demand
strain-specific influenza vaccines, which with traditional methods must be
prepared nine months up to a year in advance.



Replikins is working to expand the capabilities of this vaccine
technology and looks forward to making significant inroads to control H5N1
and other influenza populations.



Replikins are the viral tool of the future -- making accurate
predictions in humans and animals now, through the FluForecast(R) service,
and hopefully becoming a front-line weapon to stop viral pandemics in the
future.



Contact: John McKenney, Replikins Ltd., 617-536-0220. An expanded
version of this press release, with charts and additional data, will be
posted on Replikins' website -- Replikins -- on November
13th.



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Replikins Ltd.

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