SHELTON, CO -- July 6, 2023 -- InvestorsHub NewsWire
-- NanoViricides, Inc. (NYSE
American:NNVC) (the
"Company") reports that the clinical trial of its broad-spectrum
antiviral drug NV-CoV-2 is progressing satisfactorily.
NanoViricides is a clinical-stage global leader in the
development of highly effective antiviral therapies based on a
novel nanomedicines platform. NV-CoV-2 (API NV-387), our lead drug
candidate for the treatment of coronavirus infections including
COVID and potentially many cases of long COVID, is in Phase1a/1b
Safety and Preliminary Efficacy Human Clinical Trials initiated by
the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Company's
Licensee and co-developer in India.
Following safety and tolerability evaluation in healthy persons
for a single escalating dose of NV-CoV-2 Oral Syrup or NV-CoV-2
Oral Gummies in the Part 1a, the clinical trial will continue into
Part 1b if there are no serious adverse events.
Phase 1a is Progressing
Rapidly:
Enrollment in the third and highest single dose level of 40mg/Kg
NV-CoV-2 Oral Syrup, and separately, 2,000mg NV-CoV-2 Oral Gummy
has already begun. The lowest dose cohorts in the clinical trial
(10mg/Kg Oral Syrup, and separately, 500mg Gummy) have completed,
and the middle dose cohorts (20mg/Kg Oral Syrup, and separately,
1000mg Gummy) have been substantially completed allowing the
highest dose cohorts to begin. Each person after dosing is under
observation (in-hospital stay) for 48 hrs, followed by a scheduled
follow-up visit.
There were no adverse
events to date at any of the dose levels including the highest
dosages.
Phase 1b to Begin
Shortly:
In Phase 1b, healthy persons will be dosed with multiple doses of
the Oral Syrup and separately, Oral Gummies to study Safety and
Tolerability.
Additionally, in Phase 1b, in separate cohorts, patients with
mild to moderate/severe COVID-19 shall be enrolled to assess
indication of efficacy. Patients deemed by the physician to be
likely to require hospitalization within 48 hrs of screening will
be excluded.
"We are pleased with the success of the clinical trial so far
and look forward to the start of the Phase 1b portion soon," said
Anil R. Diwan, Ph.D., President and Executive Chairman of the
Company, explaining, "This clinical trial we believe will be a
springboard for NV-CoV-2 to launch into multiple antiviral
indications in the near future. NV-387 is designed as a bio-mimetic
that can possibly be an effective drug against many viruses
including the coronaviruses. If successful, it is poised to satisfy
many as yet unmet medical needs for the global population, not just
limited to COVID."
"Resistance is
Futile": NV-387, the active pharmaceutical ingredient of
NV-CoV-2 is designed to mimic a cell membrane with a number of so
called "attachment receptor sites" chemically covalently connected
to each polymer chain in the nanomicelle. No matter how much a
virus changes, it still binds to the same attachment receptor(s),
and therefore, it is unlikely to escape the nanoviricide drug.
This design we believe solves the major issue of small molecule
as well as antibody therapeutics, namely, development of resistant
virus variants.
NV-CoV-2 is Aimed at Satisfying Many Unmet
medical Needs in COVID: NV-CoV-2 was shown to be extremely
safe in pre-clinical animal studies. It was also found to be
extremely effective in lethal infection animal model studies.
Thus we believe that NV-CoV-2 will be useable in all segments of
patient populations, (i) in age from pediatric to geriatric, with
otherwise healthy adults included; (ii) with or without
co-morbidities; (iii) with disease manifestation from mild,
moderate, severe to hospitalized stage.
In contrast, existing COVID therapeutics are limited in the
treatable segment(s) of population; thus, Remdesivir is indicated
for hospitalized patients only; Molnupiravir and Paxlovid are both
indicated for patients over 65 years of age with co-morbidities
that are not taking other drugs that would cause interactions. This
leaves a large patient population that is unserved.
Further, we believe that NV-387 may become an important drug for
the treatment of certain cases of long COVID wherein residual virus
is known to be present.
NV-387 May Have a Very
Large Range of Indications, because Over 90% of All Human Viruses
Use the Attachment Receptor(s) Mimicked by NV-387:
NV-387, the active pharmaceutical ingredient of NV-CoV-2, mimics a
family of attachment receptors called sulfated proteoglycans
(S-PG), or glycosaminoglycans (GAGs). This family includes heparan
sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate
(CSPG), and keratan sulfate (CSPG). Over 90% of known pathogenic
viruses bind to one or more of these attachment receptors. These
viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory
Syncytial Virus, and HMPV- human MetaPneumoVirus), Dengue Viruses,
HerpesViruses, Human PapillomaViruses (HPV), HIV, Hendra and Nipah
Viruses, Ebola and Marburg Viruses, among others.
NV-387 is likely to be effective as a clinically viable drug
candidate against at least some of these viruses, we believe. Many
of these viruses have no available antivirals or have antivirals
with limited applicability.
We have already undertaken a program to expand the potential
indications of NV-387. Success in any of these studies would enable
direct entry into Phase II/III clinical trials for that
indication.
Such expansion of use of NV-387 would significantly expand the
market size and substantially improve the return on investments
(ROI).
On June 29, 2023, we reported that the Phase 1a/1b human
clinical trials referenced above began on June
17,, 2023. The team behind the clinical trials was
also described therein.
About
NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical 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. Our lead drug candidate is NV-CoV-2 for the
treatment of COVID caused by SARS-CoV-2 coronavirus. Our other
advanced candidate is NV-HHV-1 for the treatment of Shingles. The
Company cannot project exact dates for the regulatory activities in
progressing its drug candidates because of the Company's
significant dependence on external collaborators and consultants.
The Company is currently focused on advancing NV-CoV-2 through
Phase I/II human clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID.
NV-CoV-2-R is another drug candidate for COVID that is made up of
NV-CoV-2 with Remdesivir, an already approved drug, encapsulated
within its polymeric micelles. Remdesivir is developed by Gilead.
The Company has developed both of its own drug candidates NV-CoV-2
and NV-CoV-2-R independently.
The Company is also developing a broad pipeline of drugs against
a number of viruses, with preclinical safety and effectiveness
successes achieved already in many cases. NanoViricides' platform
technology and programs are based on the TheraCour® nanomedicine
technology of TheraCour, which TheraCour licenses from AllExcel.
NanoViricides holds a worldwide exclusive perpetual license to this
technology for several drugs with specific targeting mechanisms for
the treatment of the following human viral diseases: Human
Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and
HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu
Virus, Dengue viruses, Japanese Encephalitis virus, West Nile
Virus, Ebola/Marburg viruses, and certain Coronaviruses. The
Company intends to obtain a license for poxviruses, enteroviruses,
and other viruses that it engages into research for, if the initial
research is successful. TheraCour has not denied any licenses
requested by the Company to date. The Company's business model is
based on licensing technology from TheraCour Pharma Inc. for
specific application verticals of specific viruses, as established
at its foundation in 2005.
Disclosure
Statement
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
that are, in some cases, beyond the Company's control and that
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. In
particular, as is customary, the Company must state the risk factor
that the path to typical drug development of any pharmaceutical
product is extremely lengthy and requires substantial capital. As
with any drug development efforts by any company, there can be no
assurance at this time that any of the Company's pharmaceutical
candidates would show sufficient effectiveness and safety in human
clinical trials to lead to a successful pharmaceutical product,
including our coronavirus drug development program.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Oct 2024 to Nov 2024
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Nov 2023 to Nov 2024
