SHELTON, Conn., Aug. 5, 2019 /PRNewswire/ -- NanoViricides, Inc.
(NYSE Amer.: NNVC) (the "Company"), a leader in developing novel
nanomedicines to treat viral diseases, based on the nanoviricdes®
platform, announces that its first drug candidate, NV-HHV-101, is
on track with required preclinical GLP Safety and Toxicology
studies moving towards human clinical trials. The Company reports
that NV-HHV-101 has been found to be safe and well tolerated in the
clinical observation portion of the GLP Safety/Toxicology study of
NV-HHV-101 as a dermal treatment.
The in-life stage of the first part of the GLP studies is
complete, allowing assessment of clinical observations. The Company
is waiting on the full histology studies to assess the effects on
all primary organs. The study was conducted by BASi, Evansville, IN, a Contract Research
Organization that is specialized in IND-enabling safety/toxicology
studies.
The first of these GLP studies, a GLP safety and tolerability
study following dermal treatment, was conducted using minipigs, who
received twice daily skin treatment for 28 days, at different
dosage levels. The animals were evaluated daily for general signs
of toxicity including body weight, detailed clinical physical
observations as well as the specific evaluation of the skin
treatment areas. Topical treatment of the skin at all doses was
well tolerated in all animals and all measured
parameters remained within normal range in the study.
The Company has previously found that NV-HHV-101 was safe and
well tolerated in non-GLP safety/toxicology studies. The GLP
studies are an expanded version of the non-GLP studies, with
extended treatment, larger number of subjects, and stringent
operational requirements as specified by the current Good
Laboratory Practices guidelines for such studies.
Additional studies required for the Safety and Toxicology
datasets for filing an IND are in progress.
The Company anticipates advancing NV-HHV-101 into human clinical
trials for topical dermal treatment of the shingles rash as the
initial indication, assuming that these studies are successful. The
Company also continues to evaluate this broad-spectrum drug
candidate as well as certain variations based on the same
candidate, for the treatment of other herpesviruses, namely HSV-1
cold sores and HSV-2 genital herpes. The market size for our
immediate target drugs in the HerpeCide™ program is variously
estimated into billions to 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.
The GLP Safety/Toxicology studies phase began in June, 2019. The
Company produced approximately 1kg of the NV-HHV-101 drug substance
under strict quality controlled operations at its cGMP-capable
manufacturing facility in Shelton,
CT, for these studies.
NanoViricides is a unique company in that it has its own cGMP
manufacturing capability for its complex nanomedicine drugs. This
has enabled the Company to minimize production time to a safety/tox
study quality drug product, as well as to minimize the associated
costs. The Company has the capacity and intends to perform cGMP
manufacture of its drug candidates as needed for human clinical
trials at this facility, allowing rapid progress to clinical
trials. We intend to file an IND with the US FDA soon after
completion of the GLP Safety/Toxicology studies and receipt of the
final reports from the performing agencies.
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's lead drug candidate
is NV-HHV-101, formulated as a skin cream for topical treatment of
shingles rash (caused by VZV). The Company is also evaluating this
broad-spectrum drug candidate and its variants for topical
treatment of HSV-1 "cold sores" and HSV-2 "genital ulcers". 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. Please refer to our quarterly and annual
reports for additional information. 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 new drug application.
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SOURCE NanoViricides, Inc.