NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), reported today that it has signed a “Master Service Agreement” with the Southern Research Institute (“Southern Research”), Birmingham, AL. Southern Research is a well established, prestigious institution that has performed preclinical testing services for several vaccines and antivirals.
This agreement will allow Southern Research to perform testing of the Company’s anti-Influenza and anti-HIV drug candidates.
Anti-Influenza Testing
A panel of different influenza viruses including the current novel H1N1/2009 “Swine Flu” strain, H5N1, and other highly pathogenic strains as well as seasonal influenza strains will be used to evaluate effectiveness of the Company’s anti-influenza nanoviricides. Southern Research is registered with the CDC to receive and transfer “select agents” (certain extremely dangerous pathogens), including highly pathogenic avian influenza, and has received the current novel Influenza A/California/4/2009 H1N1 isolate ("swine flu") from the Centers for Disease Control (CDC).
Previously in preliminary studies the Company has successfully tested several anti-Influenza nanoviricides against H1N1 as well as two clades of H5N1. The Company has previously reported that FluCide™ was more than 10 times (1,000%) superior to oseltamivir (Tamiflu®, Roche) in a lethal animal model of H1N1 infection.
The Company is now developing a single pan-Influenza drug under the FluCide™ program. This is made possible by new ligands that we designed to be highly effective against all influenza A viruses. This development is based both on our previous studies and the use of molecular modeling and rational drug design methodologies. Previously, the Company had three different programs to tackle seasonal, highly pathogenic, and H5N1 avian influenza using separate, highly effective drugs. The Company has now consolidated these three programs in order to develop a single anti-Influenza drug without compromising the high levels of efficacy and safety of the previous three separate drug candidates. The new pan-Influenza nanoviricide drug candidates will be evaluated by Southern Research. In vitro cell culture evaluations will be performed initially, as is customary.
Anti-HIV Testing
The Company has already shown that several of its nanoviricide drug candidates were more than 25 times (2,500%) superior to a three-drug HAART cocktail in a standard SCID-hu Thy/Liv mouse model study of HIV-I infection. In particular, treatment with only 150mg/kg nanoviricides, as opposed to 4,200 mg/kg HAART drug cocktail (i.e. 28 times greater dosage of HAART cocktail) resulted in viral load decrease that was equal to or better than HAART, and double-positive CD4+/CD8+ T cell counts that were equal to or better than HAART. In addition, the nanoviricides were superior to the HAART cocktail in all parameters evaluated.
Significantly, the nanoviricide treatment was given only during the first week in this six-week anti-HIV study, whereas HAART treatment was continued daily. These anti-HIV nanoviricide drug candidates will be further evaluated in cell culture studies at Southern Research Institute, advancing towards our goal of filing pre-IND and later IND applications to the FDA.
Strategy to Maximize the Likelihood of Success in Drug Development
“We have a large number of highly active backup drug candidates for each of the viruses we are working on, unlike most other companies that have one or very few active drug candidates,” said Anil R. Diwan, PhD, President of the Company, explaining, “Nanoviricides technology enables us to develop novel, effective drug candidates in a very short time frame.”
“We maximize the likelihood of having a successful drug by advancing several candidates through the pipeline for each of our programs,” said Eugene Seymour, MD, MPH, CEO of the Company.
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