SHELTON, Conn., Oct. 22, 2018 /PRNewswire/ -- NanoViricides,
Inc. (NYSE Amer.: NNVC) (the "Company"), reports that its new
CEO, Dr. Irach Taraporewala, has presented a letter to the
shareholders of the Company. The letter provides a Corporate Update
along with his assessment of where the Company stands today. Dr.
Taraporewala also explains his expertise in taking a novel drug
from pre-clinical development through human clinical trials in the
letter.
The CEO letter is available on the Company's website at
www.nanoviricides.com.
The text of the CEO letter is provided below:
Letter to Shareholders from CEO Irach B. Taraporewala, Ph.D.,
with Company Updates
It is a real pleasure for me to have come aboard as the new CEO
of NanoViricides, Inc. at the beginning of September, 2018. The
annual report, and charting the Company's course, became the
top priorities since I joined, and I am now happy to be able to
present to you where we are.
I was attracted to the novel nanomedicines platform technology
that NanoViricides is bringing to fruition. This technology which
holds great promise. Not only that, but the Company is currently at
a very exciting new phase of its evolution – almost ready to enter
the clinical development phase for its first drug candidate, having
successfully established efficacy and safety in pre-clinical
studies.
Previously I have successfully led a novel drug through FDA
regulatory stages, through Phase II clinical trials. Before
joining NanoViricides, I conducted substantial due diligence on the
Company, and after joining, I have been busy diving into the
intricacies of the technology and laboratory data on the drug
candidates, especially as it relates to Chemistry, Manufacture, and
Controls (CMC) and Safety/Toxicology studies that become part of an
Investigational New Drug (IND) Application filing. I am
happy to report that we are in a great shape and the Company is
moving rapidly towards filing its first Investigational New Drug
(IND) application with the FDA.
The FDA looks for indicators of both efficacy and safety in its
assessment of drug products. NanoViricides has obtained evidence
that the shingles virus (VZV) is cleared effectively when
virus-infected human skin is treated with the nanoviricides drug
formulations targeting VZV. Importantly, this validation came from
the laboratory of Dr. Jennifer
Moffat at the SUNY Upstate Medical
Center, an international expert. The nanoviricides drug
formulations were also shown to be non-toxic in these ex-vivo human
skin patch studies, using histological assessments. The drug
candidates were also shown to be effective and non-cytotoxic in
cell-culture studies. Preliminary animal toxicology studies
conducted by the company have shown that its nanomedicine products
are safe. All of these studies have paved the way for us to now
conduct the Good Laboratory Practice (GLP)-certified IND-enabling
safety/toxicology studies required to be filed with the IND
application that we will be submitting to the FDA.
I am knowledgeable about current Good Manufacturing Practices
(cGMP) required for drug product manufacture. The company has
built a state-of-the-art cGMP compatible manufacturing plant at its
Shelton, CT headquarters location,
capable of scaled-up manufacture of clinical trial materials.
The facility is currently gearing up to full cGMP compliance and
capability. In examining the facility, reviewing
manufacturing procedures, and interviewing the staff, based on
my own extensive cGMP manufacturing experience, I am confident that
the company has the full capability for manufacturing high quality
materials suitable for the IND-enabling safety/toxicology ("Tox
Package") studies as well as for early human clinical trials.
Therefore NanoViricides is now set for moving rapidly into the
regulatory clinical trials stage of drug development. The Company's
broad and deep pipeline will enable us to bring several drugs into
the clinical stage, one after another, once the first drug goes
forward.
With this steady progress, I believe that the Company has a
number of important milestones that it can be expected to achieve
relatively rapidly.
We have started reaching out to the investment community with a
refined message. The company has recently engaged a media relations
firm, The MoneyChannel-NYC to assist with the company's extended
investor outreach. In addition, we recently presented at
various investor conferences including the Rodman and Renshaw Conference, the LD MicroCap
event in New York City and the
MicroCap Conference, and we will continue to perform investor
outreach and get the word about the company through such
events.
I am now a new member of the NanoViricides team (I certainly do
view a CEO's role first and foremost as an active "hands-on" team
member as well as company leader). I believe my past
experience in running both the business/fundraising and
technical/regulatory realms in a small pharmaceutical company
setting will prove invaluable.
Having taken drug molecules from the lab bench through the FDA
regulatory process and into successful clinical trials has provided
me with the means to advance the goals of NanoViricides, Inc. to
drive up shareholder value. In my previous role as CEO of a
NASDAQ-listed start-up pharmaceutical company, I achieved
progressive rounds of corporate financing, each at a higher
valuation. I was involved in business development,
licensing, and M&A activities as well. That
experience, the corporate contacts, and knowledge base I have
progressively built up will serve NanoViricides well.
I look forward to getting to meet the shareholders of the
Company and keep open lines of communication with all of you.
The path of drug development seems long at times. But
NanoViricides has built up its highly promising technology and
infrastructure properly from the ground up through a staged,
pragmatic approach. The elements of success have now all been
put in place.
I anticipate your continued support of our Company to help us in
achieving success. NanoViricides' technologies hold real
promise to benefit humanity with innovative new therapies for viral
diseases. That has been the unwavering mission of
NanoViricides all along. I am very glad to now be a part of
the cCompany's team that strives tirelessly to make that a
reality.
Sincerely,
Irach Taraporewala, PhD
Chief Executive Officer.
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,
shingles and chickenpox, 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. EMA refers to the
European Union's office of European Medicines Agency.)
View original content to download
multimedia:http://www.prnewswire.com/news-releases/nanoviricides-ceo-dr-irach-taraporewala-presents-a-letter-to-shareholders-300735016.html
SOURCE NanoViricides, Inc.