Replies to post #71929 on NanoViricides Inc. (NNVC)

[leifsmith]

Great work! I love trying to understand all this, and you are helping.

A simple thing we need to get across by conversation, email, social media: A nanoviricide is not a vaccine. A nanoviricide is better than a vaccine. The mental reflex that goes from "virus" to "vaccine" in one quick step, skipping over other possible solutions, has to be interrupted to allow a new thought to enter.

The Venus Flytrap image is especially useful. It's something everyone "gets."

Most of us are way beyond that and now we want to know more. Thanks!

[changes_iv]

NanoViricides reports it has successfully improved HIVCide drug candidate in cell culture studies (NNVC) 3.60 : Co reported that it has successfully improved upon its previous lead anti-HIV drug candidate, based on cell culture studies. An improved broad-spectrum anti-HIV nanoviricide that inhibited two distinctly different types of HIV-1 viruses equally well has been identified. This drug candidate also exhibited a very large therapeutic index. The co has previously reported that it is optimizing the anti-HIV drug candidate. The co reported that it has identified an improved broad-spectrum anti-HIV ligand, based on the previous best ligand from the 2011 study. Also, both of these broad-spectrum ligands, when connected to a different backbone polymer than in the 2011 study, have shown substantially improved inhibition of two different types of HIV-1 virus in a standard cell culture study of virus neutralization and inhibition. HIV-1 Ba-L, a CCR5-using strain as well as HIV-1 IIIB, a CXCR4-using strain, were both inhibited equally well by these two different nanoviricide drug candidates in the standard MAGI HIV Antiviral Assay. The present cell culture data also showed that the two nanoviricides under study were safe to cells at far greater levels than the level needed for therapeutic effects.

Now that FluCide and DengueCide are on parallel tracks to the Human Trials (2014), as previously projected, there is time to work on optimization of the next drug candidates, one of the leading candidates is HIVCide. Good management, anticipating! Very good news! More PRs are coming our way!

“We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.” ~ Dr. Anil R. Diwan, PhD, President and Chairman Nanoviricides, Inc.

[changes_iv]

NanoViricides Signs Agreement with Public Health England for Testing of Various NanoViricides Against Specific Viruses of Current Concern

NanoViricides, Inc. (the "Company") has signed a “confidential disclosure agreement” with Public Health England, the British government’s equivalent of the U.S. Centers for Disease Control. The agreement will allow the scientists at Public Health England to develop a specific proposal for the testing of different nanoviricides, such as FluCide®, against viruses of “mutual interest” to both organizations. More specifically, the first two viruses of mutual interest are H7N9, the influenza virus now circulating in China as well as the latest version of the coronavirus, now circulating in the Middle East. It is now referred to as the MERS virus.

This virus is similar to the SARS virus that infected 8000 people and killed approximately 800 people 10 years ago. Both H7N9 and the MERS CoV (coronavirus) have extremely high case fatality rates. Testing of nanoviricides antiviral drug candidates will be performed in a BSL3/4 facility at PHE. BSL3/4 facilities are designed to contain and enable the safe handling of organisms that can pose a significant threat to health.

[changes_iv]

NanoViricides, Inc. is advancing its oral broad-spectrum anti-influenza drug candidate, NV-INF-2, towards IND-enabling studies. This may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

In addition, the Company continues to develop its injectable anti-influenza drug, NV-INF-1, towards IND-enabling studies. This drug candidate has much greater activity than the oral drug, and is intended for use in hospitalized patients with influenza or potentially influenza-like illness. The Company believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication. Both of these drugs in the anti-influenza FluCide™ program have demonstrated very high effectiveness in a lethal influenza animal model, routinely showing substantial superiority to oseltamivir (Tamiflu®), the current standard of care. The Company believes that these drugs will be useable against most if not all types of influenza viruses, including seasonal (such as H1N1, H3N2), epidemic (such as H1N1/2009 “swine flu”, H3N2/2012), novel strains such as H7N9 that is currently circulating in China, and bird flu (such as H5N1, various clades). In addition, both of these drugs have shown extremely good safety profile in all of the animal studies that have been performed to date. This strong safety profile has necessitated a substantial scale-up in the Company’s current synthesis capabilities prior to commissioning a formal GLP safety and toxicology (“Tox Package”) study. The Company is in the process of developing the necessary scale-up synthesis laboratory.
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A cGMP manufacturing capability is projected to be soon complete/integrated (4Q 2013) for these and other nanoviricides drug candidates.
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The Company previously held a pre-IND meeting with the US FDA for its anti-influenza drug candidate, NV-INF-1, in the FluCide program on March 29, 2012. The Company believes it has received valuable input from the US FDA, applicable to the development of its anti-influenza drug candidates.

With the current strong cash position, the Company believes that it has sufficient funds available to perform the necessary IND enabling studies for its anti-influenza drug programs, to file an Investigational New Drug Application (“IND”) with the US FDA, and to conduct initial human clinical trials of its first anti-influenza drug.

Including the Flucide program, the Company currently has six commercially important drug candidates in its pipeline. These include the aforementioned drugs against all Influenzas, HIVCide™, HerpiCide™, DengiCide™, and a broad-spectrum nanoviricide eye drop formulation against viral infections of the eye. These programs are based on the Company’s platform technology that enables specifically targeting a particular type of virus with a novel mechanism of action. In addition, the Company continues its other research and development programs. These include (a) broad-spectrum nanoviricides against a number of Neglected Tropical Diseases, and (b) its novel ADIF™ (“Accurate Drug In Field”™) technologies which promise a way to attack novel viruses, whether man-made (bioterrorism) or natural (such as SARS), before they cause a pandemic.

source: http://www.nanoviricides.com/press%20releases/NanoViricides%20Files%20Quarterly%20Report%20-%20Reports%20Having%20Sufficient%20Funds%20and%20Satisfactory%20Progress%20in%20its%20Advancing%20Pipeline.html

[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

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92563558

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.

[changes_iv]

Just to follow-up on the idea of "cides" for animals here is a 2008 article on chicken and nanoparticles:

DATE: February 21, 2008

CONTACT: Jeremy Tzeng, [phone]
[e-mail]

WRITER: Peter Kent, [phone]
[e-mail]


Clemson researchers develop nanoparticle chicken feed

CLEMSON, S.C. — Poultry is big business in South Carolina and Clemson University scientists are using nanotechnology to keep the birds and consumers healthy.

Watch the videoThe researchers are developing drug-free ways to keep chickens and humans from contracting illnesses.

More than 200 million broilers and layers are raised in the Palmetto State. The industry has moved toward bigger broiler farms with flocks of between 150,000 and 300,000 birds becoming common.

Chickens are susceptible to disease. An illness in a handful of birds can spread throughout a facility housing thousands. Vaccines and medications can be effective but pose risks to growers and consumers. Each flock has particular health and immunity profiles, so chicks from different breeders do not respond to vaccines and diseases the same way. What’s more, bacteria can build up “antibiotic resistance” making the drugs less effective.

Researcher Jeremy Tzeng greets one of his test subjects.For consumers, poultry can harbor bacteria, viruses and fungi that do not affect them but do cause human illnesses, especially when poultry is undercooked or mishandled during food preparation.

Researchers are looking for drug-free alternatives. Clemson scientists have made a promising discovery using nanotechnology. Nanotechnology is tiny science — working with materials 1/100,000th the size of a human hair. Scientists are seeking to shrink materials down to the scale of atoms, creating particles that show promise for making better medicines, faster computers and safer foods.

Jeremy Tzeng and Clemson colleagues Fred Stutzenberger, Robert Latour Jr. and Ya-Ping Sun have built nanoparticles that mimic the host cell surface in poultry and locks to the targeted pathogens. The particles then bind together and are purged through the bowel. Tzeng calls it “intelligent chicken feed.”

"If we use this physical purging, physical removal, we are not using antibiotics so the chance of the microorganism becoming resistant to it is really small,” Tzeng said.

To protect the discovery, Clemson technology transfer officials are patenting it. Tzeng says that it will take more research and testing before the nanoparticle is ready to be used, but in the not-so-distant future, chickens and humans may live better lives due to intelligent chicken feed.

source: http://media-relations.www.clemson.edu/archive/newsroom/articles/top-stories/Nanotech_chicken_feed.php

Do they have the patent?