NanoViricides Inc. (NNVC)

[loanranger]

"A major problem in the field of nanomedicines has been that most nanomedicines have been found to be notoriously difficult to manufacture in a consistent manner from batch to batch. This is because of the complexity inherent in making large molecules, and the very nature of polymer and particle making processes.
The nanoviricide technology has been designed from the ground up to enable consistent manufacture and control."
https://www.sec.gov/Archives/edgar/data/1379006/000114420416124276/v447590_10k.htm


"Nanomedicine sales reached $16 billion in 2015"
"Current problems for nanomedicine involve understanding the issues related to toxicity and environmental impact of nanoscale materials (materials whose structure is on the scale of nanometers, i.e. billionths of a meter)."

Applications

Some nanotechnology-based drugs that are commercially available or in human clinical trials include:

Abraxane, approved by the U.S. Food and Drug Administration (FDA) to treat breast cancer,[28] non-small- cell lung cancer (NSCLC)[29] and pancreatic cancer,[30] is the nanoparticle albumin bound paclitaxel.
Doxil was originally approved by the FDA for the use on HIV-related Kaposi's sarcoma. It is now being used to also treat ovarian cancer and multiple myeloma. The drug is encased in liposomes, which helps to extend the life of the drug that is being distributed. Liposomes are self-assembling, spherical, closed colloidal structures that are composed of lipid bilayers that surround an aqueous space. The liposomes also help to increase the functionality and it helps to decrease the damage that the drug does to the heart muscles specifically.[31]
Onivyde, liposome encapsulated irinotecan to treat metastatic pancreatic cancer, was approved by FDA in October 2015.[32]
C-dots (Cornell dots) are the smallest silica-based nanoparticles with the size <10 nm. The particles are infused with organic dye which will light up with fluorescence. Clinical trial is underway since 2011 to use the C-dots as diagnostic tool to assist surgeons to identify the location of tumor cells.[33]
An early phase clinical trial using the platform of ‘Minicell’ nanoparticle for drug delivery have been tested on patients with advanced and untreatable cancer. Built from the membranes of mutant bacteria, the minicells were loaded with paclitaxel and coated with cetuximab, antibodies that bind the epidermal growth factor receptor (EGFR) which is often overexpressed in a number of cancers, as a 'homing' device to the tumor cells. The tumor cells recognize the bacteria from which the minicells have been derived, regard it as invading microorganism and engulf it. Once inside, the payload of anti-cancer drug kills the tumor cells. Measured at 400 nanometers, the minicell is bigger than synthetic particles developed for drug delivery. The researchers indicated that this larger size gives the minicells a better profile in side-effects because the minicells will preferentially leak out of the porous blood vessels around the tumor cells and do not reach the liver, digestive system and skin. This Phase 1 clinical trial demonstrated that this treatment is well tolerated by the patients. As a platform technology, the minicell drug delivery system can be used to treat a number of different cancers with different anti-cancer drugs with the benefit of lower dose and less side-effects.[34][35]
In 2014, a Phase 3 clinical trial for treating inflammation and pain after cataract surgery, and a Phase 2 trial for treating dry eye disease were initiated using nanoparticle loteprednol etabonate.[36] In 2015, the product, KPI-121 was found to produce statistically significant positive results for the post-surgery treatment.[37]"
https://en.wikipedia.org/wiki/Nanomedicine


CHALLENGES IN SCALE-UP PRODUCTION OF NANOMEDICINE

All the methods described above can be classified in bottom-up (i.e., starting from a dissolved molecule to a precipitate) and top-down processes (i.e., starting from a macro-size drug powder to be reduced to smaller one). The later one has been adopted by pharmaceutical industry at large. However, bottom-up approach is less popular at industrial level as this approach needs removal of the traces of the remaining solvent which is a difficult process (7). There are several components associated with scale-up of a nanomedicine product from bench to the market. For examples, nature of material and its generally regarded as safe (GRAS) status, toxicological features associated with size and shape of nanoparticle (44), in vivo biodegradability of nanocarriers, and balancing of multicomponent system at large scale are a few of them. One has to be careful before selection of materials, solvent, procedure of nanoparticle development, cost, and acceptability of finished product both by clinicians and patients. During scale-up of laboratory method, sometimes the desired features of nanoparticles are lost(highlight mine). For example, in a study of scale up of nanoparticle prepared using emulsion method, it was observed that increase in impeller speed and agitation time, particles size was decreased although entrapment efficiency was not altered (45). Selection of nanoparticle production method is also important to save time during pilot batch production from scale-up point of view. In a comparative study of ibuprofen-loaded nanoparticles, it was found that nanoprecipitation method took less time (about 2 h) than emulsion-based method (about 3 h) for nanoparticle production (25). After optimization of therapeutic need, market demand, research and development, production steps, scale-up feasibilities, clinical trials, and regulatory issues, a nanomedicine product reaches to market. Some of the commercially available nanomedicine products for the therapeutic purposes are Doxil® (Bridgewater, USA), Daunoxome (Gilead) Abraxane® (Abraxis Bioscience), Ambisome® (Gilead), Estrasorb (Novavax) Emend (Elan), MegaceES (Elan), Tricor (Elan), and Triglide (SkyPharma). In addition, nanoparticles-based formulations currently available for in vivo imaging include Resovist (Schering), Feridex (Advanced Magnetics), and Gastromark (Advanced Magnetics). The nanomedicine products no doubt are superior in therapeutic performances than conventional drug delivery systems and hence are highly demanded. The overall market for the nanomedicine product in the year 2012 was about 12 billion dollar (46).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4245446/


At my personal crude level of understanding:
1. It can be and has been done.
2. It ain't easy.
3. NNVC hasn't done it.

The question that can't be answered..."will they do it?"... has to do with the true intentions and abilities of NNVC's personnel, and the only reasoned opinion that can be expressed on that question must be based on what has been accomplished to date. I'll repeat the link:
https://www.sec.gov/Archives/edgar/data/1379006/000114420416124276/v447590_10k.htm
...and the history:
https://www.sec.gov/cgi-bin/browse-edgar?CIK=NNVC&action=getcompany&owner=exclude


ps. FWIW, this was the first return in my Google search for nanomedicine scalability:
http://www.mbmn.gatech.edu/en/top/research/
Obviously it's an issue that is getting a lot of attention.