NanoViricides Inc. (NNVC)

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Nanovircides, Inc.(NNVC) is "laying down tracks for a railway" to market.

Nanoviricides, Inc. is a pioneering company in bio-nanotechnology. They have a "design platform technology" or mechanism, to plug-in ligands/receptors on the small surface of a micelle, and these components put together are the most lethal to a human-killing virus. The "design platform technology" employed by Nanoviricides, Inc. is unique and is patented.

FluCide and DengueCide are two of the most developed drugs that Nanoviricides, Inc. is employing as engine thrusters to human trials (2014) and to the market.

They have signed contracts/agreements (2012 - 2013), in preparation for Investigational New Drug (IND) submission to the FDA and human trials (2014), with:
1) Id3A, LLC as the architect for its lab and cGMP pilot production facility
2) MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
3) BASi for Toxicology and Safety studies (initiate GLP Safety/Toxicology studies)
4) Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus
5) Public Health England to Test Nanoviricides Against H7N9, MERS

Nanoviricides, Inc. has been "laying down the tracks of the railway", path that will lead to the human trials (2014).

Nanoviricide, Inc. has also started sub-kg scale production of the injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of the injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from the in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of the injectable FluCide drug when the requisite large amount of drug substance is produced.

It is likely that MPH Engineering, LLC (“MPH”) was involved in making this sub-kg scale production, at the current lab facilities, possible and the experience should prove helpful when the process to produce (3) identical batches (kg scale), at the newly integrated cGMP plant (1H 2014), gets underway. The well seasoned MPH Engineering, LLC will be present when the cGMP pilot plant gets commisioned.

The injectable and oral FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. This indicates that the FluCide drug candidates are “broad-spectrum”, i.e., they should work against most, if not all, influenza viruses. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The oral FluCide is also dramatically more effective than TamiFlu in these animal studies. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth. The Company believes that these animal model results of both injectable and oral FluCide drug candidates should translate readily into humans.

Nanoviricides, Inc. "has the money" for human trials Phases I/IIa. As Dr. Seymour has stated, "...we are on a path, it's like being on a track...".

Nanoviricides, Inc.(NNVC) projected Milestones (2013)
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013

FluCide will be the first nanomedicine in the world that is orally active. Oral FluCide will open up a very large market. DengueCide is "the only game in town".

Other Dengue drugs have failed in clinical trials. DengueCide will gain extension for patent life (7 years) and be a candidate to earn a Priority Review Voucher (minimum $200 million).