NanoViricides Inc. (NNVC)

[changes_iv]

Design, develop, and manufacture CIDES...is the goal...every day they get closer...will have done it for less money...in record time...and will control the process from A-Z.

Simply implying disaster...with implied inside information...character assassination of the docs, mischaracterization of course corrections NNVC had to make are all arguments of distraction.~ Magnus1

The touted NanoViricides, Inc. competition, a privately-held company with First-in-Class drug, juiced-up by a Federal Agency - NIH, fast-tracked, once found engaged in "grant fraud" of a Federal Agency...NexBio - Fludase(TM) was peer-reviewed when?

NexBio has recently completed a Phase IB trial with increasing single and multiple dose regimens of DAS181 in healthy subjects. The drug was well tolerated and there were no Serious Adverse Events. NexBio recently announced peer-reviewed publications describing antiviral activity of DAS181 in multiple non-clinical models for Pandemic Influenza A(H1N1) and for influenza resistant to Neuraminidase inhibitors (NAI) such as Tamiflu®.

http://www.prnewswire.com/news-releases/nexbio-initiates-phase-ii-trial-of-das181-fludaser-for-treatment-of-influenza-including-pandemic-influenza-ah1n1-80902792.html

Peer-reviewed articles are coming, in my opinion but, not thanks to the FDA and/or FDA partners.

If you feel squeamish commenting on NextBio - Fludase(TM) then provide another company/drug, one that also competes directly with NanoViricides, Inc. First-in-Class FluCide(TM), one that has been imposed with the mandate to find the Maximum Feasible Dose (MFD) or toxic dose?

Here is what we, and the FDA, should know about PEG, backbone of nanoviricides(R) amazing therapeutic drugs:

PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.

Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.

The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.

Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible.

http://dmd.aspetjournals.org/content/35/1/9.full

Once again, point the NNVC forum to the FDA criteria (or NIH criteria) employed in imposing NanoViricides, Inc. - FluCide(TM) , a First-in-Class therapeutic drug, with finding MFD or toxic dose? Where is that "fair is fair" criteria? or is it the "yes, we can"/Big Pharma/Pump Terminator/cabal criteria employed?!?

The pre-clinical GLP toxic studies will complete when BASi receives the 2Kg of FluCide(TM). But when?

1) NanoViricides, Inc. commissioned the new state-of-the-art multi-kilogram Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in early Jan 2015
2) On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. 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.
-We are now making the FluCide(TM) material for Phase III in large animals!

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals

MersCide

Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak

EbolaCide

Making more drug for continuation of the testing by USAMRIID

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

Between January 2015 to June 1st, 2015 (3) identical batches were produced...that is my estimation. That means (1)Kg of FluCide(TM)/GLP/CMC every (6) weeks. If the Pilot Plant started to make FluCide(TM) drug on June 1st, 2015 it will take (12) weeks to get the 2Kg to complete Phase III toxicology studies. It may take more FluCide(TM) material (~2 to 2.5Kg) but, what is the problem with that? We have the 100Kg and the 200g kg recipes!

The Company has already successfully scaled up its drug production processes to 200g+ scale. The Company anticipates that this production scale may be sufficient for the tox package and other pre-IND studies for any one of the anti-herpes topical indications, whether for dermal application or for ocular therapy.

In addition, the Company is also continuing to scale up the production level of its different drug candidates to 1kg/batch, in order to enable production of the large amount of injectable FluCide needed for the Tox Package studies. The total amount needed for FluCide Tox Package studies was estimated at about 2~2.5kg, because of the extremely strong safety observed in preliminary safety toxicology studies in two different animal species.

http://ih.advfn.com/p.php?pid=nmona&article=68192325