NanoViricides (OTC:NNVC) is a company that holds more than one promising clinical development programs under its belt, with its most advanced - FluCide - set to undergo FDA scrutiny in an upcoming pre-investigational new drug (IND) application meeting in March.
The company's stock has gone up 13.7 percent year-to-date, currently changing hands at around 70.5 cents.
The drug development company makes anti-viral therapies using
nanomaterials for a number of viral diseases including seasonal
influenza, HIV/AIDS, oral and genital herpes, and the Dengue virus,
among many others.
has five drug development programs within its pipeline, including
FluCide, a drug that works against all forms of influenza such as
seasonal and epidemic flus, and HIVCide, a drug that works against the
HIV/AIDS virus, which the company says could become a "functional cure"
for the disease.
FluCide, which has the most clinical data of all of the company's
potential drugs and is therefore being advanced through the FDA process
first, works on the same principles as the rest of NanoViricides' platform.
CEO Eugene Seymour said that FluCide will encounter the most scrutiny
from the company's drug platform, as it represents a new class of
drugs, and is "essentially the only real treatment for patients
hospitalized for the flu including the immunocompromised like
post-transplant and cancer patients".
Indeed, when elderly patients or immuno-suppressed people pick up the
flu bug, they often become critically ill, leading to hospitalization
in most cases, particularly if the virus is of a pandemic nature like
the H1N1 swine flu, explained Seymour.
The drug candidate has been tested in animals against a number of
different strains of influenza A, which comprises the majority of flu
infections, as well as against H1N1 swine flu, H5N1 bird flu, and other
FluCide's ability to work against a host of flu virus strains is a
major consideration, added Seymour, as every year there are many
different mutations of the flu. In the US alone, there are approximately
250,000 severe influenza cases that require hospitalization every year,
resulting in approximately 40,000 deaths.
"Both vaccines and prior immunity look at a very narrow spectrum. If
the virus in question of the season is different even in a small way,
circulating antibodies from the prior strain will not recognize the new
"The yearly preventative vaccine often doesn't reflect the nature of
the circulating virus. Health professionals can estimate what the
strains will be, but they were wrong last year with the two strains that
were put into vaccine," said Seymour.
FluCide is not a vaccine, but rather a therapeutic drug, as it
actually destroys the virus as opposed to improving immunity to a
Seymour said that the world is expecting a flu pandemic, and though
it is not known when this will happen or what the specific strain will
be, it will pay off to be prepared.
In a pandemic emergency in the US, the government has a program
called "emergency use authorization", which means that if a drug has
completed Phase I/IIa safety and efficacy trials, and it is manufactured
under current good manufacturing practice (cGMP) conditions, then the
government is eligible to buy the product to treat people with the
current circulating strain of the flu virus.
"That is why we are pushing now to get FluCide into human trials as quickly as possible," added Seymour.
To fight the flu, the company uses NanoViricides,
an agent designed to fool a virus into attaching to this antiviral
nanomachine, in the same way that the virus normally attaches to the
receptor proteins on a cell surface. Once attached, the flexible
nanoviricide wraps around the virus and entraps it, and in the process,
the virus has its protective envelope breached. The virus is therefore
neutralized and effectively destroyed.
Seymour explained that every virus needs a target cell to enter and
replicate within the body, with the small attachment peptide on the
surface of the virus attaching to the cell's receptor protein.
But the company creates a nanomicelle comprised of polymers used for
many years in the body, and then a peptide, or a protein, is added that
mimics what is expressed in the target cell - creating a nanoviricide.
The body is flooded with many more of these nanoviricide cells than
target virus cells, helping to trick the virus.
The company's CEO said he believes that one infusion of the drug over
a period of a few hours should do the trick, but this has yet to be
tested in humans. So far, the drug has been tested in thousands of
animals, without having a failure, he continued. Results have showed
effectiveness in inhibiting the cycle of infection, and the spread of
the virus, as well as long-lasting effects after drug use was stopped.
In May of last year, the viral drug company reported that its FluCide
drug candidate reduced flu virus levels by 1,000-fold in an animal
study with mice, as compared to the infected untreated control animals,
the company said.
Mice treated with Tamiflu, the standard method of treatment, showed
less than a two-fold reduction in lung viral load, a measure of the
amount of infectious flu virus, at the same time point.
More importantly, two of the three FluCide drug candidates tested
maintained the reduced viral load at 7, 13, and 19 days after virus
infection in the 21-day long study.
For the study, a fatal quantity of virus particles of influenza A
strain was aspirated directly into the lungs of mice. Treatment with
either FluCide or Tamiflu began 24 hours after infection.
Previously, the company also reported that the same three FluCide
drug candidates achieved significantly increased survival rates of
between 20 to 22 days, and more than 95% reduction in lung inflammation.
NanoViricides said it still has to perform toxicology studies for FluCide, required for the FDA to move forward.
Seymour said that the company expects to start these trials just
after the pre-IND FDA meeting takes place, which is expected in the next
four to six weeks.
The FDA is anticipated to give guidance on the types of species to be
used in the study, and how many animals are necessary within each
species group, said NanoViricides' CEO. The preliminary meeting will also review the company's plan for conducting human clinical trials needed for approval.
Once FluCide is on its targeted FDA path, NanoViricides expects its other nanoviricide drugs in the pipeline to follow, with one expected "every six months or so".
Just this year alone, the company is awaiting results of new animal
studies testing its drug for genital herpes, as well as animal trial
results for herpes of the eye, and the Dengue virus.
Its HIVCide program, which is again based on the nanoviricide
platform, is also creating buzz, with a potential $21 billion
addressable market based on 2013 estimates. NanoViricides
has said that its drug has proven to be a "functional cure" in two
large studies, meaning that although there may be some residual virus
left, the amount of virus is not enough to make it contagious or cause
illness, Seymour said.
The company used animals with a “humanized” immune system for the HIV
trials as embryonic human thymus cells were implanted into the target
animals. Effects of the HIVCide lasted at least 30 days after therapy
Last July, NanoViricides
reported that HIVCide achieved an efficacy level equivalent to a highly
active anti-retroviral triple (HAART) drug cocktail in an animal study.
The three drug-combination used for comparison is one of the current
therapies recommended for patients with HIV.
Although a functional cure is not a complete cure, it would allow an
infected person to continue normal life even after discontinuation of
therapy, maintaining undetectable viral load until a recurrence.
Seymour said that the worse case for this program is to treat
patients with HIVCide for a few days, and then give them a booster
"every few months", with the best case enabling antibodies from the
recovering immune system to knock out the residual virus.
Indeed, by knocking the amount of virus down so low both in blood
circulation and in the lymph nodes, immune system cells could
potentially be allowed to recover, and make antibodies to destroy the
remaining amount of virus.
"An outright cure would be everybody's dream," insisted Seymour.
The company still has to test the HIV drug in human trials, which is a "complex and expensive issue", said NanoViricides' CEO, meaning it will likely need a partner.
"That is why we are going for the low-hanging fruit at the moment, so
to speak - such as herpes, dengue and flu - which the world definitely
New cGMP Manufacturing Facility
which has a cash position of around $14 million, has also taken steps
to ensure cGMP manufacturing of drug candidates, with limited capital
costs to the company. It is planning to begin the refurbishment of a new
18,000 foot square facility in 2012 in Connecticut, where the company
will design, order and install a cGMP manufacturing plant.
The drug developer has already announced that a colleague will
guarantee all the loans necessary for the refurbishment and the
construction of the plant, as well as the necessary equipment, allowing
it to start producing samples of its drugs and ensuring consistent
Human trials for FluCide are expected to start next year, depending
on how fast the manufacturing facility can be ready, Seymour concluded.