WEST HAVEN, CONNECTICUT -- August 15, 2011 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") reports that its lead anti-HIV candidate achieved a long term anti-HIV effect with a much shorter dosing regimen and a markedly lower total drug dose than that of the HAART Drug Cocktail therapy. Treatment with the lead anti-HIV nanoviricide reduced HIV levels and protected the human T cells (CD4+,CD8+) to the same extent as treatment with the HAART cocktail in the SCID/hu Thy/Liv mouse model. The three drug HAART cocktail used for comparison in this study is one of the combination therapies recommended for initial therapy in humans, AZT, 3TC and Efavirenz. Other specific results of this study were recently announced by the Company.
The nanoviricide agent was dosed 8 times in the first 20 days after HIV infection whereas the HAART cocktail was dosed daily for the 48 day study duration. The nanoviricide total dose was 1,200 mg/kg while the HAART cocktail dose was 4,800 mg/kg. At both 24 and 48 days after HIV infection, the HIV viral load was markedly reduced to the same extent in both the NNVC-treated mice and the HAART-treated mice and the “double positive”, CD4+,CD8+, human T cells were similarly protected in both treatment groups. Thus, 28 days, roughly 1 month, after stopping nanoviricide dosing, the clinical benefit on HIV viral load and T cells was sustained.
The Company believes that achieving this sustained clinical benefit after stopping nanoviricide treatment is highly significant. In a previous influenza virus study, a similar sustained reduction in viral load was observed. This supports the NanoViricides anti-viral mechanisms. It is important to emphasize that mouse drug metabolism is much faster than human metabolism. Thus, if nanoviricide therapy is effective in HIV-infected humans, a sustained clinical benefit can be envisioned with intermittent nanoviricide treatment.
"It's been more than 30 years since I saw my first patient who turned out to have HIV/AIDS," said Eugene Seymour, MD, MPH, CEO, "since then I've always dreamt of the day a drug like ours would come along. Studies using our current HIVCide™ candidate in the standard HIV drug test model resulted in extensive destruction of the virus, defined as a "functional cure." Human testing must be done to confirm our hypothesis that this drug can be administered infrequently to maintain a functional cure. I feel this could be as infrequently as monthly or every other month. If confirmed, this would be the biggest advance in HIV/AIDS therapy since the advent of protease inhibitors fifteen years ago."
The study was performed at KARD Scientific, Inc., Beverly, MA, in a Bio-Safety Level 3 (BSL-3) facility under the guidance of Dr. Krishna Menon who has extensive experience in pre-clinical evaluation of drug candidates in disease-relevant animal models.