SHELTON, Conn., Aug. 17, 2015 /PRNewswire/ -- NanoViricides,
Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company
developing anti-viral drugs, reports that it is accelerating its
HerpeCide™ drug development program.
The Company will continue to develop its anti-herpesvirus
franchise in parallel with the development of FluCide™, its
anti-influenza drug candidate. The Company believes that drug
development of the external treatments for the different herpes
virus infections, such as topical skin creams or lotions for the
treatment of herpes lesions, or shingles rash, as well as eye drops
or gels for the treatment of herpes keratitis, are likely to
require significantly less development work compared to the
development of an injectable drug.
Biologics Consulting Group, Inc., a leading FDA regulatory
consultant, is advising the Company on drug approval pathways and
regulatory strategy.
Both the total amount of drug needed and the total amount of
time needed for the pre-IND studies for any of the topical
anti-herpes drug indications is expected to be much less than the
corresponding projections for our injectable FluCide™ drug
candidate for hospitalized patients with severe influenza.
The Company will continue the drug candidate and formulation
optimization studies towards identification of the developmental
drug candidates for IND applications. These studies will be
performed to develop eye drops and gels for the treatment of HSV-1
herpes keratitis, as well as for skin cream and lotion formulations
for the topical treatment of HSV-1 cold sores, HHV-3 shingles
as well as HSV-2 genital lesions. The Company will then determine
which indication it will follow first towards an IND. Unlike
influenza, the herpesvirus efficacy studies are expected to need to
be done with a very few HSV viral strains.
The Company has already successfully scaled up its drug
production processes to 200g+ scale. The Company anticipates that
this production scale may be sufficient for the tox package and
other pre-IND studies for any one of the anti-herpes topical
indications, whether for dermal application or for ocular
therapy.
In addition, the Company is also continuing to scale up the
production level of its different drug candidates to 1kg/batch, in
order to enable production of the large amount of injectable
FluCide needed for the Tox Package studies. The total amount needed
for FluCide Tox Package studies was estimated at about 2~2.5kg,
because of the extremely strong safety observed in preliminary
safety toxicology studies in two different animal species.
The Company believes that it has sufficient financing available
for IND filings and initial clinical trials of its drug candidates
for at least two indications. The Company anticipates multiple
indications to result from the HerpeCide and FluCide programs.
The Company recently disclosed that its anti-herpes drug
candidates have demonstrated excellent efficacy in repeated
experiments in a dermal infection model of zosteriform herpes in
mice in two different laboratories.
The market size for herpes simplex virus treatments is in excess
of $2 billion annually. The Company
believes that a drug that is superior to existing therapies could
result in significantly expanded market size.
Existing therapies against HSV include acyclovir, famciclovir
and chemically related drugs These drugs must be taken orally
or by injection and are not very effective as topical agents.
Other drugs are largely ineffective. Currently, there is no cure
for any of the herpesvirus infections.
About Biologics Consulting Group
Biologics Consulting
Group, Inc., a leading regulatory consulting firm in product
development and regulatory strategy for biologics, drugs, and
medical devices. For over 20 years, Biologics Consulting Group has
supported clients in the preparation and review of CBER, CDER and
CDRH regulatory applications, product development strategies,
quality (or CMC) requirements, pre-clinical and clinical study
designs, GLP/GCP/GMP audits, and strategic business planning.
The Biologics Consulting Group team is comprised of over 40
consultants with experience as FDA reviewers and senior
supervisors, certified FDA inspectors, and senior leaders from the
biotechnology industry.
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 pre-clinical 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.
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SOURCE NanoViricides, Inc.