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Now Improved Substantially And Vastly Superior To Current Treatment
NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), announced that Dr. Eugene Seymour, MD MPH, CEO of the Company, presented lifetime data from the recent FluCide™ animal study on November 19th at the Influenza Congress USA 2009 in Washington, DC.
These data clearly established that the new version of FluCide™ is superior to the older version. The data also showed extremely large survival lifetime improvement compared to an extended therapy using oseltamivir (Tamiflu® Roche).
Separately, Dr. Anil R. Diwan, President of the Company, presented a talk on November 18th at the Nano and Clean Tech 2009 Conference (www.chemshow.com/includes/nano.pdf) in New York City, held in conjunction and partnership with the Chem Show 2009.
Dr. Diwan gave a description of the nanomedicine technology on which the Company's product platform is based. He then went on to discuss the successful development of several drug candidates in a relatively short timeframe and with very small R&D expenditures that NanoViricides Inc. has been able to achieve. "Our achievements have clearly demonstrated that we can develop drug candidates against new virus targets very quickly," he said. He explained that the multi-point binding of a nanoviricide™, enabled by the underlying TheraCour® polymer, results in a nanoscale "velcro" or zipper-like effect. This allows the Company to employ virus-binding ligands with relatively low affinities successfully. "Other drug development approaches require discovery of antibodies or chemicals with very high affinities, sub-micromolar or better, which takes a lot of time and money," he said, adding, "In contrast, our technology allows us to use mimics of the natural and conserved binding sites of the viruses. This allows rapid development. Also, it means that a virus is far less likely to escape a nanoviricide compared to its escape rate against a highly specific drug discovered using a conventional methodology."
The recent animal study of FluCide was conducted using the same total lethality protocol employed in previous influenza studies by the Company. The new version of FluCide drug candidate extended the lifespan of lethally infected mice to 334±11 hrs (or 14 days) on average. In contrast, mice treated with an extended oseltamivir protocol survived for 193±3 hrs (or 8 days) on average. Control infected mice survived for only 121±2 hrs (or 5 days). FluCide was given as an IV injection, on alternate days, for five treatments. Oseltamivir was given as oral, twice daily, each at 20mg/kg through life (or 14 treatments). Previously, oseltamivir given using the customary protocol of oral, twice daily, each at 20mg/kg for 4 days (8 treatments), has produced a survival time of 151±1 hrs (or 6.3 days) in this model. Several additional parameters have been evaluated in this study. The Company expects to analyze the data from these additional parameters as they are received in the near future.
The Company believes that the lifetime data demonstrate an unquestionable superiority of the FluCide drug candidate compared to current drugs, and establish it as a viable therapy against influenza. We believe that FluCide is likely the most effective drug candidate in development against influenza, based on these results.
The studies were conducted by Dr. Krishna Menon, PhD, VMD, MRCS, at KARD Scientific, MA. One million virus particles of Influenza A Strain A/WS/33 (H1N1) were aspirated directly into the lungs of mice. A repeat "booster" infection was performed at 22 hrs. This is a highly lethal model, allowing the survival lifetimes to be directly used for rank ordering of efficacy of drug candidates.
The Company has previously shown that a previous version of the FluCide drug candidate was highly effective against two different clades of the H5N1 bird flu virus, in addition to being highly effective against H1N1 in the mouse model. The Company has recently improved the FluCide drug candidate, creating what it believes to be a single drug candidate against all forms of influenza. The Company believes that the data we presented at the Influenza Conference establish this pan-influenza drug candidate as a leading anti-influenza drug in development.
We have assembled a world class team to lead us to success. We have brought together highly experienced individuals with strong expertise in their respective areas. Our team possesses the combined expertise of having performed research, development, and regulatory processing for over 25 drugs, of which 10 are approved and the rest are at various advanced clinical stages, at the team members' previous affiliations. Our team is also highly innovative, and boasts pioneering research in varied areas that are at the fore-fronts of medical science and pharmaceutical technology such as polymeric micelles, multi-specific multi-targeting, anti-sense DNA, siRNA, ribozymes, and gene therapy.
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