NanoViricides Inc. (NNVC)

[changes_iv]

Unlike the dishonorable actions of sociopaths like John Dillinger and Pump Terminator...

In two days NNVC rose from $1.02 to a $1.55, that is a 50% move to the upside, on no material news! As we all know, NNVC is a small float stock. Just imagine what will happen on positive material news!

"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch

NanoViricides Reports that its Director, Milton Boniuk, MD, has invested a Total of $7M in the Company this year

WEST HAVEN, CONNECTICUT -- Tuesday, September 17th, 2013 -- NanoViricides, Inc. (OTC BB: NNVCD) (the "Company") reported today that Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, and a Director of the Company has invested a total of $7 Million in the Company during the 2013 calendar year. Dr. Boniuk was the single largest investor with $3 Million in the recently concluded registered direct offering. Previously, he had invested $4 Million in the Company’s convertible debenture financing concluded in February, 2013. Professor Boniuk has also invested in the Company in earlier rounds of financing. He made these investments both personally as well as from his charitable foundation and other interests. Professor Boniuk joined the Company’s Board as an independent director in May, 2013, at the request of the Company’s executives. He says that his confidence in the Company has only continued to grow as he sees the Company’s management and execution now from a closer perspective.

When asked why he has made these investments, he explained that “As I became familiar with the technology and the various on-going programs that the Company has, it became apparent that the potential was nothing short of amazing. Dr. Diwan explained to me how it would be possible to create a novel drug against a previously unknown virus in a matter of weeks. The NanoViricides team has demonstrated this capability by creating potential drug candidates for the MERS human Coronavirus in just a few weeks. I was impressed by the business acumen of the senior management as demonstrated by their ability to bring in six commercially important drug candidates in the Company’s pipeline, in a relatively short time frame. I was also impressed by their receiving orphan drug designation for the dengue/dengue hemorrhagic fever drug candidate, the interest shown by the British Government Agency in a collaboration on MERS and H7N9, as well as the progress they’ve made in the construction of the new R&D and cGMP pilot production facility. Although I have known Dr. Seymour professionally for many years, I was introduced to the Company by my sister, Vivien Boniuk, MD, also an ophthalmologist, who had performed the animal studies on the Company’s drug candidates for adenovirus and herpes virus infections of the eye.”

The Company further reports that Dr. Vivien Boniuk was the very first investor in the Company, and has continued to be a major investor all along.

http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Reports%20that%20its%20Director,%20Milton%20Boniuk,%20MD,%20has%20invested%20a%20Total%20of%20$7M%20in%20the%20Company%20this%20year.html

Honorable people associate themselves with honorable endeavors.
http://ih.advfn.com/p.php?pid=nmona&article=68529003
http://ih.advfn.com/p.php?pid=nmona&article=68325023
http://ih.advfn.com/p.php?pid=nmona&article=68296181

The United States of America chose to go to the moon to engage in ongoing discovery, the ongoing exploration of celestial structures in outer space by means of continuously evolving and growing space technology.

Dr. Anil R. Diwan, his associates/directors and investors chose NanoViricides, Inc. to engage in the ongoing discovery of antivirals, medicines in a nanoscale universe, enabled by means of continuously evolving and growing special instruments/equipment/technology.

Cox also highlights some of the reasons why NNVC's moving forward to date has been such a seemingly long, slow, slog. Mostly Cox attributes this to the fact that the nano-medicine platform that NNVC is using is extremely novel, and because of that, each step forward is basically breaking new ground. ~ drkazmd65

Nanomedicines is upgrading the means, but does not change the primary goal, of medicine, which remains the care of patients. Nanomedicine may grant us the ability to conquer some diseases and for others reduce more effectively their human injury. Some problems will be solved; some new problems will be created. The most efficient nanorobots, however, can neither conquer the curse of human frailty, nor compel physicians to care. Once that is acknowledged, we will have much for which to be thankful and much to which to look forward. ~ Nanoscale: Issues and Perspectives for the Nano Century edited by Nigel Cameron, M. Ellen Mitchell

And the last great lesson is humility before the unsolved problems of the universe. ~ Sir William Osler

https://books.google.com/books?id=jA_vxKxF3iUC&pg=PA948&lpg=PA948&dq=and+the+last+great+lesson+universe+william+osler&source=bl&ots=-7-9rVWYvw&sig=hieEaHV-rr7IeCu6FG1qfoDEUBg&hl=en&sa=X&ved=0CB0Q6AEwAGoVChMIoqf6x7ODyAIVxpyACh1K8QZy#v=onepage&q=and%20the%20last%20great%20lesson%20universe%20william%20osler&f=false

The production of FluCide(TM) material, for the third and final phase of tox studies, continues...

...In addition, we continue to perform step-wise scale up of production to enable multi-kg batches of our injectable anti-Influenza drug candidate for IND-enabling “Tox Package” studies. These studies are estimated to require up to 2.5 kg of the drug substance. We plan on scaling up from the 200g scale to 500g scale and then to 1kg scale. We may be able to combine several batches at either the 500g scale or at the 1 kg scale, provided that they are sufficiently equivalent in the characterization studies, in order to prepare a single master batch for further Tox Package studies. In the meantime, we have already performed preliminary safety/toxicology studies in rats using 200g material produced in our older R&D facilities in West Haven, CT. These studies have demonstrated excellent safety of FluCide. Previously, we have performed preliminary safety studies in mice as well. Those studies demonstrated excellent safety of FluCide. This led to the calculation of a very large quantity for our ensuing “Tox Package” studies for this drug candidate.

http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Annual%20Report.html

June 1, 2015, 9:47 PM
FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals
.
.
.
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

We are making the FluCide(TM) material for the third and final phase of the Safery/Tox studies. Once we've reached the 2~2.5kg needed, it will be shipped to BASi and soon enough Phase III of Safety/Tox studies will begin and complete with the expected excellent results we've observed in the past. This goes to prove, once again, what many in the scientific community already knew...

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

PEG is the backbone of all nanoviricides(R) drugs and this is very important because...

Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna

Once the third and final phase of FluCide(TM) candidate completes the likely second nanoviricide(R) candidate to quickly advance to clinical trials will be HerpesCide(TM).

SHELTON, Conn., Aug. 10, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions ("TransPharm"), a pre-clinical services company in Jackson, MI.

All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading. All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
.
.
.
Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.

.
.
.

http://www.prnewswire.com/news-releases/nanoviricides-reports-that-the-dramatic-effects-of-its-topical-anti-herpes-treatment-were-reproduced-once-again-in-an-animal-model-in-a-different-laboratory-300125886.html

Because HerpesCide(TM) is a topical drug (external to the host) it can move faster, through the regulatory process, to market approval. The market for this drug is potentially from $2 billion to $4 billion.

Two of our drug programs, namely Injectable FluCide, and HerpeCide skin cream, are now in the late pre-clinical or IND-enabling studies stage. We anticipate that these drug candidates will move forward into IND or equivalent regulatory filings, and ensuing human clinical trials. As these drug candidates are advancing into the clinic, we believe that our additional drug candidates will also move forward into IND-enabling studies. The HerpeCide program is likely to expand into multiple indications that include skin cream or lotion for treatment of cold sores, skin cream for the treatment of genital herpes lesions, skin cream or lotion for the treatment of shingles breakouts, and ocular herpes keratitis, to name a few. We are thus poised for strong growth with a number of drug candidates in a number of disease indications.

http://uk.reuters.com/article/2015/09/16/nanoviricides-report-idUKnPn90NRtJ+8d+PRN20150916

In particular, Ocular Herpes Keratitis is a nasty virus...

Eye Herpes (Ocular Herpes)
By Jessica Hill

Caused by the type 1 herpes simplex virus, eye herpes (ocular herpes) is a common, recurrent viral infection affecting the eyes. This type of herpes virus can cause inflammation and scarring of the cornea that sometimes is referred to as a cold sore on the eye. Herpes of the eye can be transmitted through close contact with an infected person whose virus is active.

The National Eye Institute (NEI) says an estimated 400,000 Americans have experienced some form of ocular herpes, with close to 50,000 new and recurring cases occurring each year.

http://www.allaboutvision.com/conditions/ocular-herpes.htm

Honorable investors of NNVC, first Dr. Vivien Boniuk followed by her brother Dr. Milton Boniuk ...When asked why he has made these investments, he explained that “As I became familiar with the technology and the various on-going programs that the Company has, it became apparent that the potential was nothing short of amazing

"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.

===========================================

About Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study.

Abstract

Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.

FROM THE CLINICAL EDITOR:

Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness.
http://www.ncbi.nlm.nih.gov/pubmed/23969105