Business Wire - September 21, 2009
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 FluCideÖ 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 FluCideÖ 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.
About Southern Research Institute Infectious Diseases Research Contract Services
The Infectious Disease Research Department at Southern Research Institute provides a wide range of research services that include anti-infective drug and vaccine discovery, preclinical drug development, and basic research initiatives in microbiology, virology, molecular virology, viral immunology, flow cytometry and tissue culture. Our primary focus is to quickly and efficiently provide drug discovery and development services that address all of the guidelines suggested by the Food and Drug Administration for preclinical drug and vaccine development.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricideÖ class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital herpes, viral diseases of the eye including EKC and herpes simplex; Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
Contacts
NanoViricides, Inc.
Amanda Schuon, 310-550-7200
info@nanoviricides.com
090921
BW090929
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