NanoViricides Inc. (NNVC)

[changes_iv]

The facts were presented at the 3rd Annual Influenza Research and Development.

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 has pre-clinical data for a highly effective and broad-spectrum anti-influenza drugs. 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 6000 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



Chemists at the University of Illinois, led by chemistry professor and medical doctor Martin D. Burke, built the machine to assemble complex small molecules at the click of a mouse, like a 3-D printer at the molecular level. The automated process has the potential to greatly speed up and enable new drug development and other technologies that rely on small molecules.

“We wanted to take a very complex process, chemical synthesis, and make it simple,” said Burke, a Howard Hughes Medical Institute Early Career Scientist. “Simplicity enables automation, which, in turn, can broadly enable discovery and bring the substantial power of making molecules to nonspecialists.”

The researchers described the technology in a paper featured on the cover of the March 13 issue of Science.

“Small molecules” are a specific class of complex, compact chemical structures found throughout nature. They are very important in medicine – most medications available now are small molecules – as well as in biology as probes to uncover the inner workings of cells and tissues. Small molecules also are key elements in technologies like solar cells and LEDs.

However, small molecules are notoriously difficult to make in a lab. Traditionally, a highly trained chemist spends years trying to figure out how to make each one before its function can even be explored, a slowdown that hinders development of small-molecule-based medications and technologies.

“Up to now, the bottleneck has been synthesis,” Burke said. “There are many areas where progress is being slowed, and many molecules that pharmaceutical companies aren’t even working on, because the barrier to synthesis is so high.”

The main question that Burke’s group seeks to answer: How do you take something very complex and make it as simple as possible?

The group’s strategy has been to break down the complex molecules into smaller building blocks that can be easily assembled. The chemical building blocks all have the same connector piece and can be stitched together with one simple reaction, the way that a child’s interconnecting plastic blocks can have different shapes but all snap together. Many of the building blocks Burke’s lab has developed are available commercially.

Read more: http://news.illinois.edu/news/15/0312molecule_machine_MartyBurke.html

A Molecule-Making Machine

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NanoViricides, Inc. Announces It Has Commenced Action Against Seeking Alpha to Obtain Identity of the Anonymous Short Seller

WEST HAVEN, CONNECTICUT -- Wednesday, March 5th, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) announces that it has filed a special proceeding in the Supreme Court of the State of New York to compel Seeking Alpha to disclose the identity of the person who wrote and published a defamatory, malicious, and libelous article about the Company on February 11, 2014, on the Seeking Alpha website. The writer identified self as a short seller in the article. The Company believes that the writer and/or others with whom the writer was in contact, had established and maintained a significant short position in the Company's common stock, and that these parties in collusion profited from the drop in the Company's share price that occurred subsequent to the posting of the article, at the expense of the Company's shareholders and the Company's position.

The said article published on the "Seeking Alpha" website by the anonymous write who called self "Pump Terminator"contained patently false, malicious, and defamatory statements, and constituted a premeditated, unsupported attack on the Company with the intent to injure and disparage the Company and its shareholders, and manipulate the market for the Company's stock and the Company's financial position.

The Company intends to commence an action against Pump Terminator, and anyone else that we discover to be responsible in connection with the article, to recover the damages caused to the Company and its shareholders. The Company also intends to provide the information it discovers to the relevant regulatory authorities for potential criminal investigation into the activities of the short seller and associates. The Company has already filed a complaint with the regulatory authorities regarding this matter. In addition, the New York Stock Exchange ("NYSE") has notified the Financial Regulatory Authority ("FINRA") of potential market manipulation and unusual activity in the market for the Company's stock.

The Company previously requested that the website "Seeking Alpha" immediately remove the article from their site. As of today's date, Seeking Alpha has failed to comply with this simple request, thereby becoming a complicit agent in the criminal act(s) perpetrated by the article author and collaborators-in-action.

"Many investors were panicked into selling their positions or were forced out by market limit orders," said Eugene Seymour, MD, MPH, CEO of NanoViricides. "We noted a very suspicious and rapid rise in short selling activity in the days preceding the publication of the article. This suggested to us that there was collusion between the writer and others, or possibly that the writer alone was responsible for the entire short selling. This information has been forwarded to the appropriate regulatory authorities. We will aggressively pursue all available remedies against anyone responsible for such blatant market manipulation."
http://www.nanoviricides.com/press%20releases/2014/NanoViricides,%20Inc.%20Announces%20It%20Has%20Commenced%20Action%20Against%20Seeking%20Alpha%20to%20Obtain%20Identity%20of%20the%20Anonymous%20Short%20Seller.html

[The anonymous short seller (or group) "Pump Terminator" never showed up at a New York court of law to face the damaged party, NanoViricides, Inc.. So much for their claims or so-called facts!]

The problem is that they are really hard to make. Even though they are small [molecules] they are very complex and it usually takes a highly trained specialist and a long time ~ Dr. Martin Burke...[but not anymore...a 3d printer-like molecule-making machine is here, now, and that is a fact!]