Rising Replikin Counts in E. Coli in Germany Since 2005 Preceded Current E. Coli Outbreak

LONDON, June 21, 2011 /PRNewswire/ --

- Synthetic Replikins Therapeutics for E. Coli Now Available for Testing

Scientists Drs. Samuel and Elenore Bogoch of BioRadar UK Ltd. announced that retrospective studies indicate that an increase in Replikin Counts of the EHEC lethal strains of E. Coli preceded the current E. Coli outbreak. These EHEC strains of E. Coli have been studied in laboratories in Germany and elsewhere since 1995, and genome sequences are consequently available in the public databases.  Replikins are subsequences of the genome of an infectious agent that have been correlated with virulence across a range of diseases. Just as the H1N1 pandemic of 2009 was predicted in 2008 because of Replikin Count increases, E. Coli Replikin Counts (number of replikins per 100 amino acids) increased from 1.9 (+/- 1.2) in 2005, to 3.7 (+/- 2.9) in 2009 and to 14.2 in 2011. Twenty-nine individual Replikin sequences identified so far, conserved in the genomes of these hemorrhagic E. Coli strains, have been traced back from 2011: twenty-five of them to 1999, and four to 1995. To date, no other structures of infectious organisms have been described that correlate quantitatively and temporally with epidemic outbreaks, course, and lethality, and permit early or advance strain-specific warning of such outbreaks.

Replikins are genomic structures related to rapid replication, defined by Replikins Ltd. and BioRadar's proprietary and patented algorithm as peptides 7 to 50 amino acids long, containing two or more lysines, six to ten amino acids apart, at least one histidine, and a lysine concentration of 6% or more. As Replikins increase in number, they have been observed by linear and three-dimensional x-ray diffraction studies to expand and spread on the surface of the hemagglutinin gene of the influenza virus.

How reliable a signal is an increase in Replikin Count? To date, the Replikins science team has studied over 30,000 genomic sequences from a period of 94 years as published in PubMed. Statistically significant increases in Replikin Count (p<0.001) are consistently followed by or co-temporal with outbreaks. In a recent confirmation of reliability, the increases in Replikin Count were submitted for independent examination for the years 2002 to 2008, the years on which the 2008 prediction of the outbreak of the 2009 H1N1 pandemic had been based. The Replikin Count increases were found to be highly significant, namely, p values a) by t-test = 1/10 to the 130th power, b) by linear regression = 1/10 to the 24th power and 1/10 to the 29th power, c) by Spearman correlation < 2/10 to the 16th power, d) by Wilcoxon rank sum<1/10 to the 16th power, and e) by multiple regression adjusting for correlation between consecutive years = 2/10 to the 22nd power .

E. Coli now joins the group of pathogens in which outbreaks and/or increased lethality were found to be preceded by significant Replikin Count increases (p<0.001) in the pathogen one year or more in advance (Replikins Press <replikins.com>). These pathogenic outbreaks include influenza H5N1 (1997-2011), the influenza H1N1 pandemic (2002-2009), and its recurrence (2010), West Nile Virus outbreaks (2000-2008), Foot and Mouth Disease outbreaks (2009-2011), and the SARS outbreak (2002-2003). Rising E. Coli Replikin Counts also preceded rising mortality rates. This relationship has been found previously in malaria (Pl. Falciparum), in Taura Syndrome shrimp virus, where it predicted lethality, in H1N1 influenza, and in H5N1, where together with the increased lethality, the geographic localization was correctly predicted to be Indonesia (2006-2008).

The clinical significance of having a replikin count advanced warning is that such advanced warning will give health authorities more time to organize public health efforts and formulate vaccines even under old vaccine technology methods.  Replikins vaccine and therapeutic technology (consisting of solid phase synthesis in seven days) dramatically reduce the time and cost of production and accelerate distribution to a larger percent of the world's population as the solid phase synthesis vaccines do not require refrigeration.

Before the outbreak, in the case of the 2009 H1N1 pandemic, one year advance warning was provided by the Replikin technology. The TransFlu™ Replikins Vaccine was synthesized in 7 days and successfully tested in animals.*  After the H1N1 outbreak occurred in April 2009, the Replikins Count of the virus, was determined every few days 'real-time' in the 12,806 sequences published on PubMed throughout the course of the pandemic (2009-2010). There are two Replikin genes, one for infectivity and one for lethality.  The virus Replikin Count indicated that while infectivity would persist, lethality was rapidly declining. If this information had been more broadly utilized, much concern and cost could have been averted. If the rising Replikin Count of E. Coli in Germany had been observed two years ago, specific preventive and therapeutic countermeasures could have been implemented at that time. Even now, after the current E. Coli outbreak has begun, the projected course can be better defined with BioRadar genomic sequence analysis and Replikin countermeasures are available for testing.

For information regarding the BioRadar Global Surveillance System™ and on synthetic Replikins vaccines and therapeutics now available for testing, contact aborsanyi@replikins.com.

*Jackwood MW, et al. Efficacy of a Replikin peptide Vaccine Against Low Pathogenicity Avian Influenza H5 Virus. Avian Diseases 53(4): 613-617, 2009.