NanoViricides Inc. (NNVC)

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The highest density of cannabinoid receptors is found in parts of the brain that influence pleasure, memory, thinking, concentration, sensory and time perception, and coordinated movement. Marijuana overactivates the endocannabinoid system, causing the “high” and other effects that users experience. These effects include altered perceptions and mood, impaired coordination, difficulty with thinking and problem solving, and disrupted learning and memory.

Marijuana also affects brain development, and when it is used heavily by young people, its effects on thinking and memory may last a long time or even be permanent. A recent study of marijuana users who began using in adolescence revealed substantially reduced connectivity among brain areas responsible for learning and memory. And a large long-term study in New Zealand showed that people who began smoking marijuana heavily in their teens lost an average of 8 points in IQ between age 13 and age 38. Importantly, the lost cognitive abilities were not fully restored in those who quit smoking marijuana as adults. Those who started smoking marijuana in adulthood did not show significant IQ declines.

http://www.drugabuse.gov/publications/drugfacts/marijuana

What if nanoviricides were also a recreational drug? DoJ would tell FDA to stand down and with just a democratic vote we could go to market!!! Our breakthrough technology drug producing pilot plant would not have to be validated by the FDA. What your government cares about is the youth of America, right?

Instead, life-saving FluCide had to be produced in an inordinate amount...

There are those who complain that the tox studies are delayed. I don’t believe that it is the case at all. Had our drug system not produced such amazing initial tox results, we would be well into the BASi studies at this time. The FDA mandates that we find the toxic dose. To do that requires an inordinate amount of material. When the amount of material needed is produced, the studies will start. I feel that it will be quite soon but I cannot, in good conscience, give a hard date. ~ Dr. E. Seymour, CEO of NanoViricides, Inc. --- Jul 20, 2014

The FluCide-BASi GLP tox studies have begun...

WEST HAVEN, CONNECTICUT -- Wednesday, October 1, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reports that it has shipped FluCide™ to BASi for the start of toxicology studies. NanoViricides has chosen BioAnalytical Systems Inc. Toxicology Services ("BASi") of West Lafayette, Indiana to perform our safety/toxicology studies as needed for an IND submission of the Injectable FluCide drug candidate.

In another news, NanoViricides reported that the synthesis of its anti-Ebola second generation drug candidates has started. We anticipate being able to evaluate these against Ebola virus with certain of our previous collaborators. The contracts to enable such evaluation are currently in progress. The Company's nanomedicine technology enables development of drugs that directly attack the virus, in a manner that a virus may not be able to overcome despite mutational changes. This is very important for the current epidemic-causing Ebola virus strain, which has been shown to be mutating rapidly.

Injectable FluCide was found to be extremely safe in mice in a preliminary safety study. This study showed no evidence of any adverse events even at the maximum tolerable dose level. No significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
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We have previously published the pre-clinical data on the Company's first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. FluCide has been built on the nanoviricides® technology platform. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4 that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.

The data indicate that NV-INF-1 is a highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.

http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20FluCide%20Samples%20Were%20Shipped%20To%20BASi%20For%20Start%20of%20Safety%20Toxicology%20Studies%20Also%20Reports%20That%20Ebola%20Drug%20Candidates%20are%20Being%20Synthesized.html