Viruses are constantly mutating, taking on new and daunting
characteristics which make it more and more difficult for medical science to
thwart them, especially when the only tools available are based on centuries
old technology. The growing concern over the Zika virus, for instance, with
nearly 4,500 confirmed cases in Brazil (http://dtn.fm/80KgF) and cases cropping
up here in the U.S. (http://dtn.fm/iJe94), has lit a fire under the biotech
sector, but a hoped-for vaccine could only be partially effective at fighting
the spread. President Barack Obama recently asked Congress for $1.8 billion in
emergency funding that would, in part, help expedite the development of a Zika
vaccine. While Inovio Pharmaceuticals (NASDAQ: INO) has shown positive signs
(http://dtn.fm/dngJ3) with its nascent vaccine, human trials won’t see the
light of day until the end of this year.
The real kicker, though, is that, even if a vaccine is
developed, it may be only marginally effective at stopping something like Zika,
which is now even more readily asserted to be sexually transmissible
(http://dtn.fm/7KlhH), directly linked to microcephaly (http://dtn.fm/0zI3B) in
the newborn infants of infected women and even the paralyzing Guillain-Barre
syndrome (http://dtn.fm/IP1kw). As is the case with seasonal influenza (flu)
vaccines, overall efficacy is the real bottom line, and the CDC’s own numbers
(http://dtn.fm/Czzi9) indicate that for the 2014 to 2015 season, adjusted
overall efficacy was a mere 23 percent.
What we really need here is something new – a new and more
agile weapon system based on truly 21st century technology. Development-stage
NanoViricides (NYSE MKT: NNVC), with its nanotechnology-based biomimetic
anti-viral medicines called nanoviricides® looks to be the answer to a question
that, sadly, many in the medical community aren’t even asking yet. This
technology could rightly be considered a “penicillin” for viruses due to the
breadth of application, speed with which new indications can be developed, and
show-stopping efficacy potential, and the company’s proprietary nanoviricides
are also able to be administered orally (as well as through injection) in
certain cases. Oral FluCide™, for instance, which NNVC proudly proclaims to be
the first ever oral nanomedicine, has been shown to be substantially superior
(http://dtn.fm/Ef7RD) to Roche’s (OTC: RHHBY) TamiFlu® (Oseltamivir) in animal
models (Totally Lethal Infection Study) and exhibited broad-spectrum efficacy
(Influenza A H1N1 and H3N2). Oral Flucide has also shown clear indication that
a full clinical recovery is possible, even in high path, severe influenzas.
NanoViricides has received the IAIR AWARD as Best North
American Company for Leadership in the Nanomedicine Sector from the prestigious
IAIR® Group, the Milan-headquartered research institute and independent
publishing house with major shareholders from Europe and Asia which has over a
decade in global economy and sustainability publishing. This revolutionary
company has developed a simple, yet powerful, antiviral platform technology
employing the combination of a nanomicelle polymer that engulfs the target cell
(http://dtn.fm/L2pcG), and mimic receptor proteins known as ligands, which lure
the targeted virus to attack the nanoviricide. This platform’s key advantage of
being able to trick the targeted virus into thinking the nanoviricide is a
normal human cell via the ligands, which do not substantially change even when
a virus mutates to a new form that may be resistant to other measures, is
reinforced ably by NNVC’s proprietary method for quickly creating the unique
ligands which are used. Because of this sweeping unification of efficacy and
developmental capabilities, nanoviricides are not only suitable for attacking
otherwise impossible to defeat viral agents on a commercial scale, they can
also be rapidly developed in the field as a frontline measure to combat
fast-mutating viruses using the company’s ADIF™ (Accurate-Drug-In-Field)
technology.
Because the technique for field developing targeted
therapeutics using ADIF involves the same tried and tested methodology as for
any other nanoviricide – deriving the virus-binding ligand from the binding
site of the virus cell surface receptor – the capacity to create an effective,
targeted therapeutic in the midst of an outbreak, with only a small lab setup,
is an advantage moving forward for NNVC that represents a tremendous value
proposition to investors. Additionally, since the ADIF technology does not
require any specific identification of the actual virus or difficult to obtain
understanding of the specific molecular biology of the pathogen in question, a
rapid-deployment nanoviricide, made using nanomicelles that have been
stockpiled beforehand, effectively constitutes a field-ready smart weapon that
is as adaptable as the most daunting viruses in existence, such as H5N1, SARS,
and Ebola.
The combined market size for injectable and oral FluCide is
likely over $30 billion, and because the company’s antivirals are so completely
focused by design on the target virus, there is virtually no impact to the
host, marking another clear advantage of this technology over antiquated
vaccine technology. These nanoviricides can be created in weeks, instead of the
years often required to develop a vaccine, and the company already has a robust
pipeline of six potential blockbusters that have been tested in over 6,000
animals. FluCide has produced some amazing results thus far in animal model
work, such as a greater than 1,000-fold lung viral load reduction, compared to
less than two-fold in TamiFlu and the control group, or 100 percent survival
rate at 22 plus days seen in the Totally Lethal Infection Study, compared to a
100 percent death rate after only eight days with extended TamiFlu treatment
(100 percent death rate after five days with control group).
The combined estimated market size for the company’s
antiviral eye drops designed to fight conjunctivitis/keratitis, its HerpeCide™
indication for shingles, as well as ocular and genital herpes (note that HSV-1
has also been linked to Alzheimer’s), and its DengueCide™ indication to combat
Dengue arboviruses (West Nile, Yellow Fever, Japanese B Encephalitis), are in
the neighborhood of $17 billion. The market size for NNVC’s HivCide™, which
could be the first ever broad-spectrum weapon to stop the spread of HIV/AIDS,
is estimated to be around $22 billion. The company’s DengueCide indication for
Dengue fever and Dengue hemorrhagic fever is of particular note here, as that
virus is in the same family as Zika.
The company already has multiple pre-clinical studies
underway at various universities, HerpeCide is on track for human trials as
early as this year, FluCide is slated for human trials shortly thereafter, and
both the FDA and EMA have granted DengueCide orphan drug status. To understand
the full story of NNVC, though, it is important to look at the company’s
visionary management, including its chairman and president, Anil R. Diwan, PhD,
as well as its CEO, Eugene Seymour MD, MPH, and CSO, Randall W. Barton, PhD.
Dr. Diwan, a prolific inventor and serial entrepreneur,
pioneered polymeric micelle-based nanomedicine technologies with his invention
of them back in 1991, but he is also the driving force behind keeping the
company’s administrative and R&D costs at extremely low levels – despite the
fact that the company has been aggressively expanding its pipeline each year.
This administrative acumen is due in large part to his considerable wealth of
experience, having founded nanomedicine and cell-targeted drug delivery, as
well as small chemical, device technology and informatics-focused operations
such as TheraCour Pharma and AllExcel, prior to co-founding NNVC. Dr. Diwan is
a patent holder, with three more applications filed internationally resulting
in numerous nation-level patents abroad. He has received numerous NIH small
business innovation research grant awards and has several patent applications
in various stages.
Dr. Seymour has a similarly eminent history of research and
work under his belt, having cut his teeth back in the 1960’s in LA and Beverly
Hills during the rise of the HIV/AIDS epidemic and having been tapped by the
U.S. government to create a testing laboratory, as well as run a large-scale
data generation operation examining HIV prevalence in LA’s Hispanic population.
Dr. Seymour founded the company now known as Stat-Sure because of his foresight
about the importance of prevention in lieu of a cure for HIV, and he went on to
run a large non-profit after leaving the company in the late 1990’s,
spearheading testing and training efforts in Asia and Africa before going on to
be a UN Global Program on AIDS consultant who was deployed in several other
countries. A holder of eight patents whose first love was chemistry and who
initially trained to be a clinical investigator, Dr. Seymour got his master’s
degree in the epidemiology of infectious diseases from UCLA before going on to
do internal medicine work, and later becoming a member of the USC faculty as an
Associate Professor. Dr. Seymour is also a Vietnam vet, having served in the U.S.
Army Reserve Medical Corps during the Vietnam era, attaining the rank of Major.
Last, but certainly not least, is NNVC chief science officer
Dr. Barton. Dr. Barton, former VP of drug discovery at personalized oncology
innovators A&G Pharmaceuticals, has a rich history of drug discovery and
development on both the small molecule and biological drug candidate ends of
the spectrum, spanning multiple focus areas from virology and immunology to
inflammation. Dr. Barton also possesses a great deal of experience in
cardiovascular disease-related discovery and development from his collective
pharmaceutical/biotech industry work, and he was a director for two decades at
the U.S. pharmaceuticals division of German pharma giant Boehringer Ingelheim,
where he helped do the pre-clinical development on the important HIV inhibitor
drug Viramune (Nevirapine). This is a man with over 80 scientific publication
to his name who has an abundance of academic and teaching experience behind him
and who was the principal investigator in the development of five patents. Dr.
Barton received his PhD in biochemistry from the University of Tennessee at Oak
Ridge National Laboratory and was a faculty member at the University of
Connecticut Medical School when he was awarded the NIH’s Career Development
Award for his work doing research and education in the field of immunology.
Needless to say, NNVC has an esteemed, deep bench of upper
management talent that has continued to produce bottom line results and
mounting shareholder value in the form of its candidate portfolio. The immense
potential of the company’s rapidly developing pipeline and nanoviricide/ADIF
platform technologies themselves cannot really be properly estimated. Investors
need to take a closer look here before the rest of the world realizes what NNVC
has its hands on.
Get ahead of the curve, visit www.nanoviricides.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
