NanoViricides Inc. (NNVC)

[changes_iv]

Company blames heat for why nasal spray flu vaccine didn't work well in kids against swine flu
4/21/2015 - A live virus nasal flu vaccine known as FluMist (made by AstraZeneca) is failing to provide protection to children, and its manufacturer is blaming the vaccine's total inefficacy on high temperatures rather than exaggerated quack science. When the supposedly "fragile" shot is set out at room temperature...
http://www.edmontonjournal.com/health/Company+blames+heat+nasal+spray+vaccine+didnt+work+well+kids/10845059/story.html

Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
4/20/2015 - The swine flu vaccine caused severe brain damage in over 800 children across Europe, and the UK government has now agreed to pay $90 million in compensation to those victims as part of a vaccine injury settlement. This is the same swine flu vaccine that the entire mainstream media ridiculously insists...
http://www.ibtimes.co.uk/brain-damaged-uk-victims-swine-flu-vaccine-get-60-million-compensation-1438572

"Canadian Flu vaccine paradox" Admits vaccines are causing more illness
3/5/2015 - The conventional medical system is literally grasping at straws trying to maintain the illusion that vaccines work, with new reports now admitting that flu vaccines are an utter failure while still pushing people to get them. The latest nonsensical narrative, at least from the Canadian government, attributes...
See more at: http://www.thedailysheeple.com/canadian-flu-vaccine-paradox-admits-vaccines-are-causing-more-illness_012015#sthash.eKmnlsK6.dpuf

Government pays compensation to 80 flu vaccine injuries and deaths
1/7/2015 - (Republished from VaccineImpact.com) The December 2014 report from the Department of Justice on damages paid by the U.S. Government to vaccine victims was recently published by the U.S. Department of Health and Human Resources. There were 180 cases of vaccine injuries decided. 134 cases received compensation,...
http://www.VaccineImpact.com

Flu cases spiking across US following CDC admission that this year's flu vaccine doesn't work
1/2/2015 - The vaccine industry is once again pimping the mainstream media to be its marketing mouthpiece for this year's flu "season," with the latest reports claiming that more than half of the country is now seeing a major uptick in flu cases. This year's influenza vaccine admittedly doesn't work against...
http://www.cbsnews.com/news/flu-outbreak-spreading-rapidly-in-us/

[Is there any chance that "Pump Terminator" or other bogeymen ever did risk assesment for any of them vaccine/drug companies, the competition for our small company, NanoViricides, Inc.? Of course, we are now reading about the aftermath, about damaged or ended lives, not your family but, what about these companies before they went to market? Any risk assesment on them companies? What is the risk assesment on your investment for any drug/vaccine company that gets "juiced up" and afforded shortcuts by a government? Ask "Pump Terminator" and good luck with that. Ask Zincy and good luck with that too! I'm sure the lives of some good folks have been hurt or ended by them "Great Society" governments "juiced up" companies. It is all about good intentions, right? And the latest, trust but verify! Verify, when again? And there's winners and there's losers - But they ain't no big deal -
'Cause the simple man, baby - Pays for thrills - The bills the pills that kill...

You vs. Big Government and Big Pharma

Big Pharma is a huge, out of control special interest group that derives its power and influence from its partner, Big Government. You see, government bureaucrats profit from promoting Big Pharma, because of the legions of lobbyists employed to help write the laws, the regulators who intensely review and follow every drug development and the politicians who are always looking for a big campaign donor.

On the far left, folks like Michael Moore attack this arrangement as capitalism, but really it is socialist corporatism-a partnership between Big Government and Big Pharma to promote the interests of each other at the costs of anyone who gets in the way.
http://www.offthegridnews.com/alternative-health/you-vs-big-government-and-big-pharma/

[Yes, Big Pharma and other smaller favorites of Big Government types. Greased skids or shortcuts, anyone? So easy to trade stocks with "greased skids"]

Big Pharma

Big Pharma is the nickname given to the world's vast and influential pharmaceutical industry and its trade and lobbying group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars a year by selling drugs and medical devices.
....
The industry demonstrates its power, political might and social influence over the nation’s governments and agencies, its health care systems, its doctors and hospitals, as well as the psyche of the American people. With the help of staggering profits and 1,100-plus paid lobbyists, the industry has gained powerful leverage on Capitol Hill.

From 1998 to 2013, Big Pharma spent nearly $2.7 billion on lobbying expenses — more than any other industry and 42 percent more than the second highest paying industry: insurance. And since 1990, individuals, lobbyists and political action committees affiliated with the industry have doled out $150 million in campaign contributions.
http://www.drugwatch.com/manufacturer/

[Of course they have to spend a lot of money to buy lawmakers influence! After all, many human lives will be destroyed. How does Big Government, the largest investment organization in the history of mankind (investment, hah!) with US $18+ trillion (or is it $28 trillion, or is it $38 trillion, or is it...???) in the hole and counting at the speed of compound interest on the debt!!!...How does Big Government - DoD tells a company here is $140 million "hot check"; go do some Ebola drug research/development? Another display of "Yes we can" socialist/democrat corporatism? Or how does the DoD spends $400 million on smallpox vaccine that God help us no one wants to be in a situation where they become the guinea pig to test a drug that theoretically should work!?! Where is the sense of proportionality? We are talking about a small company with a safe drug vs a juiced up company or juiced up Big Pharma? Just what is the criteria employed to select these drug companies? This is why Dr. Seymour is correct in saying, "...there are no shortcuts", definitely not for our small drug company and its disruptive technology. First of all, it has been found to be safe time and time again...]
http://www.fiercebiotech.com/press-releases/tekmira-awarded-140-million-u-s-government-contract-develop-rnai-therapeutic-against-is
http://www.forbes.com/sites/rickungar/2011/11/13/is-bizarre-smallpox-drug-deal-obama-administrations-next-solyndra/

...NNVC's FluCide is composed of : 1. A backbone of PEG that provides the polar outer shell of the micelle and makes it soluble 2. Pendant (branched chains) of fatty acids that provide the non-polar core (and likely disrupt the viral coat - my conjecture) 3. Sialic acid and other receptor (ligand) mimics that act as decoys to attract and bind the viral particles. Of these, only PEG is not naturally occurring, which is why we've been discussing its potential toxicity here. And as indicated in Winstreak's post, it is used extensively in drug products (and consumer products). And it has an excellent safety profile with an extremely wide band of tolerance.~ Robi-1-Kenobi and Winstreak

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=97610175

PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.

Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.

The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.

Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible.
http://dmd.aspetjournals.org/content/35/1/9.full

[Bets on margin need to be concerned with facts that were presented at the 3rd Annual Influenza Research and Development. FluCide(TM) is not only safe, it is effective as well!]

West Haven, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).

Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company’s first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. 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.

Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that 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. He also presented the data on NV-INF-2, the Company’s current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.

The data indicates that both NV-INF-1 and NV-INF-2 are 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.

Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.

The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.

This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and “bird flu” such as H5N1.

The total market size addressed by the Company’s current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA. Read more: http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html

[And today those are the undisputed F-A-C-T-S. Currently there is no company out there, none, that is on equal footing with our small company, one that has pre-clinical data for a highly effective and broad-spectrum anti-influenza drug. Moreover, our anti-influenza drugs are independent from the host's immune system. Our drugs are only targeting the life-threatening virus in the host.]

No failures in 5000 plus animals and...

"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.

We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.

http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html

NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.

... We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time. http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html [And if the nanoviricides(R) are bioequivalent, once you get the 500g and/or 1kg scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they? But for now we are only concerned with the first cGLP 1kg batch of FluCide(TM) to be shipped to BASi followed by another 1kg identical batch and finally a 500g batch. Why not?]

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DARPA invests (hah!) on pharma and then some...