SHELTON, Conn., April 16,
2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the
"Company") a company with novel platform technology to meet unmet
medical needs in treating difficult and life-threatening viral
diseases, reports that it has submitted the required pre-IND
Briefing Documents for its lead drug candidate NV-HHV-101 to the US
FDA, ahead of schedule.
The Company is developing NV-HHV-101 as a broad-spectrum drug
against a number of herpes viruses. The Company has chosen shingles
rash as the first indication for this drug candidate. It is being
developed as a dermal topical cream. It is designed to reduce the
local viral load, thereby minimizing rash progression and further
nerve damage.
There is a significant unmet need for the topical treatment of
shingles rash. An effective therapy has been estimated to have a
market size into several billions of dollars, if it reduces PHN
incidence. An effective therapy against shingles rash reduction
alone is estimated to have a market size of several hundred million
dollars to low billion dollars. These market size estimates have
taken into account the potential impact of the new Shingrix® GSK
vaccine and the impact of the existing Zostavax® vaccine.
The pre-IND briefing documents included the current data on our
drug development. This included a description of the drug and its
potential benefits, summary of the rationale, a brief CMC section
("Chemistry, Manufacture, and Consistency") regarding production
and quality assurance, summaries of the in vitro (cell
culture) and ex vivo (human skin organ culture model)
studies of effectiveness, and summaries of non-GLP
safety/toxicology studies regarding safety. In addition, the
briefing documents also included a general description of the GLP
safety/toxicology study plan, as well as a plan of Phase I/Phase II
human clinical trials for evaluating the safety and effectiveness
of the drug in humans subsequent to filing an IND.
Consultants from the Biologics Consulting Group, Inc.,
Alexandria, VA, helped the Company
develop the briefing documents including the presented clinical
studies plan.
The non-GLP Safety/Toxicology studies were conducted by BASi,
Evansville, IN, a Contract
Research Organization that is specialized in IND-enabling
safety/toxicology studies. BASi is now continuing to perform the
GLP Safety/Toxicology studies subsequent to the successful
completion of planned non-GLP studies.
The ex vivo human skin organ culture model has been
developed by Professor Jennifer
Moffat, Upstate Medical Center, SUNY
Syracuse, NY. Evaluation of NV-HHV-101 continues to be
performed in her lab. There is no animal model available for the
evaluation of topical drugs against VZV infection. VZV only infects
humans.
NanoViricides has previously shown that the NV-HHV-101 drug
candidate as well as several related candidates in the pre-clinical
optimization phase were highly effective against the shingles
virus, VZV (Varicella-Zoster-Virus), in human skin organ culture
ex vivo model of the disease. Further, the non-GLP
Safety/Toxicology studies of NV-HHV-101 have shown an excellent
safety profile, with no adverse events at the highest dosages
tested in the safety/tox studies.
The Company is also developing drugs against HSV-1 "cold sores"
and HSV-2 "genital ulcers", both based on this same drug candidate,
although final clinical candidates are in pre-clinical optimization
stage for both of these indications as of now.
The market size for our immediate target drugs in the HerpeCide™
program is variously estimated into several tens of billions of
dollars. The Company believes that its dermal topical cream for the
treatment of shingles rash will be its first drug heading into
clinical trials. The Company believes that additional topical
treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold
sores" treatment, and HSV-2 "genital ulcers" treatment are expected
to follow the shingles candidate into IND-enabling development and
then into human clinical trials.
Existing drugs given systemically may not reach required
concentrations at the site of shingles outbreak, limiting
effectiveness. In addition, VZV does not have an effective TK
enzyme that is required for producing active forms from the
acyclovir class of drugs, requiring frequent administration of
large doses. While shingles presents with a debilitating
"pins-and-needles" pain associated with the characteristic rash
that is self-limiting within 2-3 weeks in most patients, in a
substantial percentage of patients, it presents as a severe,
debilitating disease that leads to complications including
hospitalization(s) and in some cases may result in extended
treatments including subsequent surgeries. Limiting initial viral
load is expected to minimize the occurrence of such
complications, and is also expected to reduce the incidence of
post-herpetic-neuralgia ("PHN"), which is defined as persistent
pain six months or longer after the initial rash has subsided.
Shingles occurs when the immune system weakens due to age, stress
or other factors such as other immune-compromising diseases (such
as HIV or other viral infections) or conditions (such as organ
transplant or anti-immune therapeutics against auto-immune
diseases). The epidemiological incidence rate of shingles suggests
that almost every person will have shingles at least once in
lifetime if he/she reaches an age of 85. Thus there is a
significant unmet medical need for new, effective, therapeutics
against shingles.
The FDA previously responded to our pre-IND meeting request
letter and asked for the briefing documents to be submitted by
April 19th (Our previous press
release of April 6th had a typo
error, and stated this date incorrectly as 29th). In addition,
consistent with current protocol, the FDA has stated that they will
provide a written response to the Company's submission. This
written response will guide the Company's IND submission for this
drug candidate and indication.
The present indication for NV-HHV-101 is for the treatment of
shingles rash caused by reactivation of the shingles virus, VZV
(varicella-Zoster-Virus). VZV causes chickenpox in children as a
result of primary infection, and then becomes latent. Reactivation
occurs in adulthood when immune surveillance weakens, due to age,
stress, or other immune-compromising factors, including other
diseases.
NV-HHV-101 is a broad-spectrum nanomedicine designed to attack
herpesviruses that use the HVEM ("herpesvirus entry mediator")
receptor on human cells. This drug candidate is composed of a
flexible polymeric micelle "backbone" to which a number of small
chemical ligands are chemically attached. The ligands in this case
are designed to mimic the binding site of the herpesviruses on
HVEM, based on molecular modeling. NV-HHV-101 is expected to bind
to VZV via a number of binding sites (i.e. the ligands), thereby
encapsulating the virus particle and destroying its ability to
infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide®
strategy is distinctly different from the mechanism of action of
existing antiviral drugs against VZV.
About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development
stage company that is creating special purpose nanomaterials for
antiviral therapy. The Company's novel nanoviricide® class of drug
candidates are designed to specifically attack enveloped virus
particles and to dismantle them. The Company is developing drugs
against a number of viral diseases including H1N1 swine flu, H5N1
bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral
diseases of the eye including EKC and herpes keratitis, Hepatitis
C, Rabies, Dengue fever, and Ebola virus, among others. This press
release contains forward-looking statements that reflect the
Company's current expectation regarding future events. Actual
events could differ materially and substantially from those
projected herein and depend on a number of factors. Certain
statements in this release, and other written or oral statements
made by NanoViricides, Inc. are "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. You should not
place undue reliance on forward-looking statements since they
involve known and unknown risks, uncertainties and other factors
which are, in some cases, beyond the Company's control and which
could, and likely will, materially affect actual results, levels of
activity, performance or achievements. The Company assumes no
obligation to publicly update or revise these forward-looking
statements for any reason, or to update the reasons actual results
could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Important factors that could cause actual
results to differ materially from the company's expectations
include, but are not limited to, those factors that are disclosed
under the heading "Risk Factors" and elsewhere in documents filed
by the company from time to time with the United States Securities
and Exchange Commission and other regulatory authorities.
Although it is not possible to predict or identify all such
factors, they may include the following: demonstration and proof of
principle in preclinical trials that a nanoviricide is safe and
effective; successful development of our product candidates; our
ability to seek and obtain regulatory approvals, including with
respect to the indications we are seeking; the successful
commercialization of our product candidates; and market acceptance
of our products.
FDA refers to US Food and Drug Administration. IND refers to
investigational drug application. API refers to active
pharmaceutical ingredient.
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SOURCE NanoViricides, Inc.