NanoViricides Inc. (NNVC)

[changes_iv]

Nanovircides, Inc.(NNVC) is "laying down tracks for a railway" to market. There is currently a temporary delay in the construction of the "railway to market". The reason,

What's been misinterpreted as a problem is actually a very major accomplishment for the technology: the toxicity is SO low that they need much larger amounts for testing. In tox studies you test until you get some indications of toxicity because you have to know what the symptoms and effects of toxicity are, otherwise you don't know what to watch for. ~ ZincFinger

Since toxicity of the broad-spectrum FluCide is key in toxicology and safety sudies this is very important and greater quantities are needed, but the pace at which Nanoviricides, Inc. advances will soon resume and continue very close to schedule to deliver on projected Milestones.

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.

The company has signed contracts/agreements (2011 - 2013), in preparation for Investigational New Drug (IND) submission to the FDA and human trials (2014). The following are the companies directly involved in "laying down the tracks of a railway" to the human trials and FDA review to market:

1) Biologics Consulting Group, Inc. (BCG) for the preparation and submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases.
2) Id3A, LLC as the architect for its lab and cGMP pilot production facility
3) MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
4) BASi for Toxicology and Safety studies (initiate GLP Safety/Toxicology studies)
5) 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
6) Public Health England to Test Nanoviricides Against H7N9, MERS

As has been reported in recent past, Nanoviricides, 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.

Is it possible that broad-spectrum injectable Flucide is as toxic as the water you drink at home? If yes, BCG and BASi may have indicated they will need more of the injectable FluCide than previously estimated.

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 identical batches (kg scale), at the newly integrated cGMP plant(2014), gets underway. The experience will prove very useful when the integration of the plant is complete and the process to get it commissioned begins in 2014.

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 - 2014)
-cGMP/R&D Center Shelton CT integration completes (equipment moved in) ~ 4Q 2013
-Commision new cGMP plant (identical batches of FluCide produced) ~ 2014
-Receive initial results toxicology studies FluCide ~ 4Q 2013 or 1Q 2014
-Prepare IND for submission to regulatory authorities ~ 4Q 2013 or 1Q 2014

Once injectable Flucide "train rolls down the railway" (2014) others will follow. For example, 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, anywhere between $200 - $600 million.

Merck also said it will develop some of those candidates by investing in strengthening its pipeline through new licensing and business development activities with external partners; as well as concentrate in 10 "prioritized" national markets that account for most of its pharmaceutical and vaccine revenues – the U.S., Brazil, Canada, China, France, Germany, Japan, Korea, Russia, and the U.K. ~ nanopatent post

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Remember, once the "railway to the human trials" is completed with the first candidate, injectable FluCide, the other candidates will roll down those tracks with greater ease and speed, through the human trials and FDA review to market. Confidence is high on Nanoviricides, Inc.!

"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.

"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.