It’s pretty hard to hit an increasingly agile moving target
like the rapidly-evolving viruses that medical science is forced to contend
with these days, especially when medical professionals are handicapped by using
drugs that rely on somewhat antiquated approaches and technologies, many of
which were initially developed over a century ago. If you think about how
quickly a virus strain adapts and evolves, it is no wonder that medical science
has a difficult time keeping up.
Even the more sophisticated antiviral technologies in use
today often amount to little more than variations on existing approaches. The
Vesicular Stomatitis Virus-Ebola Virus vaccine (VSV-EBOV) deployed in frontline
clinical trials last year to combat the spread of Ebola throughout West Africa
is a prime example. Given that this recombinant, replication-competent vaccine
is basically just a genetically engineered virus from the same family as
rabies, which has been weaponized to express Ebola glycoproteins and thus
provoke an immune response in the host, the threat of the virus mutating around
existing (only marginally effective) solutions and escaping containment is a
persistent threat which looms large on the horizon.
More importantly, because the lion’s share of existing
antiviral agents typically use a method of action that takes place within the cell,
such indications are plagued by a host of unwanted side effects that can impair
the host’s immune system, as well as healthy cells. Currently in the process of
transitioning from a preclinical R&D company to a clinical biotech company
sometime within the next 15 months, NanoViricides, Inc. (NYSE MKT: NNVC) may
have the answer to this “one step forward, two steps back” problem, which is
inherent among rapidly evolving viruses, as well as a comprehensive platform
solution for difficult to treat viruses that have gone dangerously underserved.
NanoViricides is a unique biotechnology company focused on
nanomedicine and has developed a truly revolutionary, tailorable delivery
platform designed to destroy viruses both in and on the body. The company’s
wholly novel nanoviricide® class of drug candidates employs a combination of
cutting-edge nanotechnology and knowledge of the substantial lack of variance
in the receptor site for virus-binding ligands on a virus cell’s surface, even
after numerous mutations. This combination of a chemically attached
virus-binding ligand (a mimic of the receptor cell surface protein) derived
from the virus’s own binding site with a flexible “nanomicelle” polymer allows
nanoviricides to seek out and attach to a specific virus particle in bodily
fluids and then fully engulf it, using the polymer as a containment vessel.
This process, using targeted, stealth ligands designed to fool the virus into
thinking the nanoviricide looks biochemically like a superb infection target,
ultimately renders the virus cell incapable of infecting other cells and,
subsequently, dismantles it with no collateral damage to healthy cells.
As amazing as this method of action may sound when compared
to existing vaccine technologies and antivirals, the real beauty of NNVC’s
nanoviricide technology is its rapid-prototyping capability. The unique ability
of this platform to be used for quickly developing highly optimized,
virus-specific drug candidates, which can be tailored for premium
pharmacokinetic characteristics, such as sustained effect and diverse routes of
administration, is something which grants the company’s nanoviricide technology
an enviably disruptive profile. Moreover, the platform also possesses the
capacity to be utilized for broad-spectrum indications that can aggress up to
95 percent of known viruses in a cost-effective manner, including historically
neglected tropical diseases like Dengue fever and Ebola/Marburg.
With the recent outbreak of the Zika virus across Latin
America and the Caribbean (now considered to be pandemic), which has been
linked to birth defects such as microcephaly in fetuses born to women who
contract the virus, the CDC has issued a travel warning (which was echoed by
the agency’s EU equivalent) focused on pregnant women and women who may soon
become pregnant. Just this week a mother on Hawaii’s third largest island,
Oahu, who was infected with the Zika virus when she was residing in Brazil last
year, gave birth to a microcephalic child, echoing the patterns observed in Brazil.
An alarming incident rate increase for Zika of over 2,200 percent in Brazil
from 2014 to 2015, with over 3,500 cases last year and 46 infant casualties,
has prompted growing concern from health officials worldwide, and with the
Florida Department of Health reporting that, as of January 19, two cases of
Zika have been identified in Miami-Dade, the three- to five-year window
currently proposed by Brazilian authorities for the development of a vaccine
(in record time) paints an astoundingly clear picture of the inherent potential
value of NNVC’s highly-adaptable platform technology.
Transmitted by the same species of mosquito that carries
Dengue fever (as well as now being thought to be sexually transmissible), Zika
virus, whose symptoms are relatively mild, was initially not considered to be a
major threat, even as the number of cases quickly shot up in Brazil. However,
an increasingly apparent correlation with birth defects like microcephaly and
possibly even the paralytic central nervous system malady, Guillain–Barré
syndrome, has turned a lot of heads in the medical community, especially
considering the lifelong impairment for children born with such birth defects.
NanoViricides’ development pipeline currently boasts a
number of promising primary candidates, from an injectable, as well as
orally-administered Influenza candidate (FluCide) aimed at the $33 billion plus
vaccine market, to indications for HIV/AIDS, and Herpes. FluCide is quite
interesting given the CDC’s own recent acknowledgment that the 2014 to 2015 flu
vaccine set record efficacy lows, with a paltry 23 percent reduction to risk of
getting the flu. The recent presentation by the CEO of NNVC, Eugene Seymour MD,
MPH at Biotech Showcase 2016, illustrated how the company is currently moving
full speed ahead with human trials for its lead virucidal herpes (of the
eye/cornea) keratitis (inflammation of the cornea) treatment, HerpeCide™. Human
clinical trials are currently on-track to begin late this year or in early
2017, and commercially-available HerpeCide would be a most welcome addition to
the healthcare system’s existing biomedical arsenal, as ocular herpetic disease
in general is a serious challenge for both optometrists and patients.
Herpes keratitis is the leading cause of infectious
blindness in the Western world and ultimately requires a corneal transplant
when it has progressed to the stage of blindness. Corneal transplant is a
difficult procedure that can often fail and the procedure can cost as much as
$24,400 on average, according to actuarial intelligence giant Milliman. The
major herpes viruses that cause ocular disease (simplex and zoster) quite often
bring about immunologic reactions in the host that outlive any active infection
as well, meaning that the latent demand for a real solution is considerably
larger than the baseline market metrics would indicate.
There are a variety of topical (as well as oral) treatments
available, such as GlaxoSmithKline’s (NYSE: GSK) Viroptic (trifluridine), which
carries significant toxicity risk, or Pfizer’s (NYSE: PFE) Vira-A (vidarabine),
although it has been largely displaced by Aciclovir, due to the former
indication’s administration via IV being cumbersome. Oral Aciclovir is
available under many different generic brand names, such as GSK’s Zovirax and
Eli Lilly’s (NYSE: LLY) Lovir, but side effects like dizziness, nausea, and
vomiting, as well as more severe problems such as neurotoxicity in dialysis
patients, has continued to daunt this segment of the broader $2 billion plus
annual market for herpes simplex virus treatments.
NanoViricides recently completed a transition to its new
c-GMP-capable, state-of-the-art production and testing facilities in
Connecticut, and has thus graduated into a select handful of small biopharma
developers with its own in-house, clinical-quality drug manufacturing
footprint. With the capacity to see candidates from design through to scaling
up of production for IND submissions and human clinical trials, NNVC now also
has the muscle to handle commercial-scale manufacturing when (and if) its
candidates are eventually licensed. This logistical capacity, combined with the
company’s smart weapon nanoviricide platform, means that NNVC’s most advanced
candidates, like HerpeCide and FluCide, stand an excellent chance of seeing
eventual commercialization.
This is great news considering that NNVC’s anti-Herpes
candidate has shown such great progress in HSV-1 animal model studies thus far,
with an over 85 percent survival rate (compared to zero for untreated animals),
as well as a marked ability to reduce virus production in cell cultures. Shown
to be superior to topical treatment with an Aciclovir formulation, the
company’s HerpeCide candidates could emerge as not only a leading treatment in
the space, but a real solution for patients dealing with the disease and
potentially facing blindness.
For more information, visit www.nanoviricides.com
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