NanoViricides, Inc. (OTC BB: NNVC)
(the "Company") announced today that the European associates of the
consulting firm Cote´ Orphan Consulting, on behalf of NanoViricides,
have submitted an Orphan Drug Application to the European Medicines
Agency (EMA) for DengueCide™, a drug candidate for the treatment of
dengue and dengue hemorrhagic fever.
The Company previously engaged the consulting firm Cote´ Orphan
Consulting (COC), headed by Dr. Tim Cote´, to assist with the DengueCide
orphan drug applications. The Company, in consultation with COC, has
determined that its current lead DengueCide drug candidate is eligible
for orphan drug status application in the European Union. The Company
has recently received Orphan Drug Designation for DengueCide from the US
FDA.
DengueCide is a nanoviricide® that has shown very high effectiveness in
an animal model of dengue virus infection. These animal studies were
conducted in the laboratory of Dr. Eva Harris, Professor of Public
Health and Infectious Diseases at the University of California,
Berkeley. Professor Harris has developed a mouse model simulating
antibody-dependent-enhancement (ADE) of dengue infection using a special
laboratory mouse strain called AG129. ADE in humans is thought to lead
to dengue hemorrhagic fever, and is associated with a high fatality
rate. In this model, infection with a dengue virus, when the mice are
left untreated, is 100% fatal. In contrast, in the same study, animals
treated with NanoViricides' DengueCide achieved an unprecedented 50%
survival rate.
Interest in a treatment for dengue fever in Europe was confirmed today
by the announcement that J&J has signed a collaboration with the
Wellcome Trust and the University of Leuven in Belgium. http://www.wellcome.ac.uk/News/Media-office/Press-releases/2013/WTP053792.htm
Recently, thirteen European countries have reported 82 imported dengue
cases including a major outbreak on the Portuguese island of Madeira. http://ecdc.europa.eu/en/publications/publications/communicable-disease-threats-report-31-may-2013.pdf.
Dengue fever is considered an “orphan” disease by the EMA.
There is currently neither an effective drug treatment nor a vaccine for
dengue virus infection. Tremendous efforts have been made for dengue
vaccine development but, to date, no vaccine candidate has succeeded in
clinical trials towards approval.
About Dengue and Dengue Hemorrhagic Fever
Dengue fever, a very old disease, has reemerged in the past 20 years
with an expanded geographic distribution of both the viruses and the
mosquito vectors, increased epidemic activity, the development of
hyper-endemicity (the co-circulation of multiple serotypes), and the
emergence of dengue hemorrhagic fever in new geographic regions. In
2013, this mosquito-borne disease is one of the most important tropical
infectious diseases globally, with an estimated 400 million cases of
dengue fever, over one million cases of dengue hemorrhagic fever, and
50,000-100,000 deaths annually. Dengue virus occurs in four primary
serotypes. Although the disease is endemic in many tropical parts of the
world, it is considered an orphan disease in the USA and Europe. (From
Clinical Microbiology Reviews).
NanoViricides Pipeline
NanoViricides is developing broad-spectrum anti-influenza drugs as part
of its rich drug pipeline. The Company believes that its FluCide™ drug
candidates will be effective against most if not all influenza viruses,
including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird
flu, seasonal influenzas, as well as novel influenza viruses. This is
because FluCide is based on the Company’s biomimetic technology,
mimicking the natural sialic acid receptors for the influenza virus on
the surface of a nanoviricide® polymeric micelle. It is important to
note that all influenza viruses bind to the sialic acid receptors, even
if they rapidly mutate. The FluCide drug candidates have already shown
strong effectiveness against H1N1 and H3N2 influenza viruses in highly
lethal animal models. The injectable FluCide drug candidates have shown
1,000X greater viral load reduction as compared to oseltamivir
(Tamiflu®), the current standard of care, in a highly lethal influenza
infection animal model. The Company believes that these animal model
results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against
influenza. This oral version is also dramatically more effective than
TamiFlu in the animals given a lethal influenza virus infection. This
oral FluCide may be the very first nanomedicine that is effective when
taken by mouth.
In addition, NanoViricides has developed drug candidates against Dengue,
HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong
effectiveness in relevant animal and/or cell culture models.
About
NanoViricides:
NanoViricides,
Inc. (www.nanoviricides.com)
is a development stage company that is creating special purpose
nanomaterials for viral 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.
FDA refers to US Food and Drug Administration. EMA refers to the
European Union’s office of European Medical Agency.
Copyright Business Wire 2013