SHELTON, Conn., May 13, 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 successfully
completed manufacture of the drug for the upcoming GLP
Safety/Toxicology study of its lead candidate in several kilogram
quantities.
The Company has successfully completed production of
kilogram-scale quantities of the drug substance, NV-HHV-101.
Additionally, the Company has also successfully completed its
formulation into the skin cream drug product at several kilograms
scale, as is anticipated for the upcoming GLP Safety/Toxicology
study.
The Company has achieved an extremely important milestone with
this accomplishment. The manufacture of the drug substance and its
formulation into drug product were both accomplished under cGMP
conditions, at our own facility in Shelton, CT.
The Company believes it has de-risked the cGMP manufacture of
not just NV-HHV-101, but that it has also substantially de-risked
the entire nanoviricide® platform regarding cGMP manufacturing
capability. It is well known that cGMP manufacture of nanomedicines
is a challenging aspect in nanomedicines drug development.
The Company further provides an update that it is awaiting
comments from the US FDA on its pre-IND application for NV-HHV-101.
Those comments, when received, will inform further studies towards
IND filing. Once the GLP Tox Package studies are complete, and
associated analyses are complete, the Company expects to receive
reports from relevant external parties. These reports and a plan of
the clinical studies will then be developed into an IND application
for NV-HHV-101.
Thus, the Company is successfully executing rapidly on all
fronts towards the goal of filing an IND as soon as possible.
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 medical 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.
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 a 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 even 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 at present.
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 drug from the
acyclovir class of pro-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, as highlighted in
NBC-News recently in the article Chickenpox is a lifelong herpes
virus that comes with a serious side effect.
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. The available Zostavax® and other live attenuated virus
vaccines often lead to "rebound shingles", a less severe form of
the disease. The new Shingrix® GSK vaccine does not contain live
virus, but is reported to have debilitating side reactions in as
many as 20-25% of persons that receive it. Such side reactions may
be expected to limit the vaccination rate since shingles is not a
life-threatening disease. Besides, Shingrix is not yet widely
available, due to limited production capacity. Thus there continues
to be a significant unmet medical need for new, effective,
therapeutics against shingles.
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.