NanoViricides (OTCBB:NNVC) said Monday that the US FDA has confirmed March 29 as the date for the initial meeting with the company's scientists regarding the clinical development of its FluCide program.
Investors cheered the news, with shares rising nearly 15 percent to 81 cents as of 3:01pm ET.
The pre-investigational new drug (IND) meeting will focus on FluCide, designated as NV-INF-1, NanoViricides anti-influenza drug.
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.
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
The company said it continues to work with the Biologics Consulting
Group, Inc., Alexandria, VA (BCG), to prepare for pre-IND meeting with
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 initial indications for the drug are anticipated to be a
“piggy-back” solution for delivery through the customary IV infusion
for hospitalized patients presenting with Influenza-Like-Illness (ILI),
and out-patient influenza. The out-patient treatment is planned as a
single injection that a medical office can easily administer when the
patient goes for a clinical visit, with no expected follow-up treatment.
It has also planned a strategy for a future second generation oral
anti-influenza drug for out-patient influenza cases, based on
discussions with BCG, it said, but has not yet begun the necessary
development work for this.
It therefore continues to work on development of its injectable drug against influenza towards US and International approvals.
In the USA alone, there are approximately 300,000 severe influenza
cases that require hospitalization every year, with approximately 40,000
According to NanoViricides,
expert physician advice suggests that the dosage form for the drug
should be a high strength solution suitable for “piggy-back”
incorporation into the standard IV fluid supplement system that is
typically used in hospitalized patients.
So far, FluCide has been tested in thousands of animals, without
having a failure. 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.
The clinical drug candidate is expected to be effective against a
majority of strains and types of influenzas including swine flu,
seasonal flu such as H1N1, H3N2, highly pathogenic types such as H7N and
H9N, as well as the highly lethal bird flu, or H5N1.
All flu viruses use the same common receptor to bind to human cells,
and the company said it therefore believes that its drug candidate
should work against most of these viruses.
The market size for anti-influenza drugs is currently estimated to be approximately $4 to $7 billion worldwide.