NanoViricides Inc. (NNVC)

[changes_iv]

Phase I in a week?,...two weeks!!!

Here is how:

The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broad-spectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an "Investigational New Drug" application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced. However, certain international regulatory agencies do not require cGMP product, but rather cGMP-like product. The difference is subtle, but can make a difference of several months. We plan on taking advantage of this and try to request permission for human clinical trials abroad soon after we can make cGMP-compliant product in the new facility. The number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.

http://www.nanoviricides.com/2014-ceo-letter.pdf

The difference is subtle...

Facilities and Equipment. Although it generally is not necessary to fully qualify all equipment and validate all processes used in the manufacture of a product during its early development stages, it is important to document which equipment was utilized, why it was selected, and how it was used, cleaned, etc. If calibration of the equipment used to manufacture the product would typically be required in a GMP environment, a similar system is highly desirable at the research and development stage. In short, an intelligent evaluation of which pieces of equipment are critical to the operation should be made as soon as possible, and those critical pieces of equipment should be targeted to achieve compliance with "GMP-like" requirements by the time clinical-grade material is produced. Analogously, if the manufacturing process requires microbiologically-controlled facilities, it is prudent to measure and document the environmental control of these facilities to maintain product integrity and comparability.

Setting priorities for reaching compliance with GMP requirements is an integral part of product development planning. Once critical facilities and equipment have been identified, it is time to establish a schedule for generating compliance documentation. During product development, the move toward full compliance with Good Practice regulations is best regarded as a continuum, rather than a "now nothing, now everything" approach.
http://www.regulatory.com/forum/article/gdps.html

Nanoviricides are currently binary: they either work in humans as they have in animals, or they don't. IMO, there is nothing in between. If they work in humans, then $10 billion will be leaving $40 billion on the table. Pharmassette went for $11 billion with one drug completing Phase 2 and ready for Phase 3. Do the math with that and 5 antiviral drugs plus 200 more in development.~ BigKahuna

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=91019400

Today, that is a valuation of about $50 billion...

"...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.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116713354

You may say now, "Yes, we can! or counter by quoting/referencing your sources. Yes, we can!?!


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NanoViricides, Inc. - FluCide(TM) - About FluCide(TM) Data presented at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11

The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. 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 Company believes that these animal model results should translate readily into humans.

NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.

Read more:
finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html

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

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.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html

[Seems to me they have completed the 1kg scale-up recipe and about 1kg is all we will need for clinical trials.]

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals
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Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!

Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
[e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange