NanoViricides Signs Agreement with St. Jude Children's Research Hospital for further Influenza Drug Development
SHELTON, CONNECTICUT -- May 31, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") announced today that it has entered into an agreement with St. Jude Children's Research Hospital, Memphis, TN, for further drug development in its anti-influenza program.
NanoViricides, Inc. has previously held a pre-IND meeting with the US FDA on its anti-influenza drug development program, and obtained valuable guidance. Since then, the Company has been performing necessary CMC (chemistry, manufacture, and control) studies and production scale-up for the identified development candidate, namely, FluCide™-I. The Company has also continued further anti-influenza drug development that is anticipated to result in additional candidates superior to FluCide-I.
The testing of these candidates for anti-influenza activity will be performed in the laboratory of Dr. Elena Govorkova in collaboration with Dr. Robert G. Webster and will include both in vitro and in vivo studies. They have extensive experience in influenza virus infections with a large number of different influenza strains, and in anti-viral agents discovery. The overall objective of these studies will be to help select clinical drug development candidates for the treatment of influenza virus in humans, using both the injectable and oral administration routes. Injectable administration is preferable for hospitalized patients that are extremely sick, while oral administration is preferred for out-patients.
The in vitro studies will evaluate the efficacy and potency of the Company's nanoviricides anti-viral agents against a panel of influenza A and B virus infection of different types of cells, including human bronchial epithelial cells. The in vivo studies in small animals will evaluate the safety and efficacy of the Company's nanoviricides to protect against severe H1N1 influenza infection.
The St. Jude influenza research program began in 1968 under the leadership of renowned virologist Robert G. Webster, PhD. The research program has provided important breakthroughs in several major influenza outbreaks over the years, leading to the designation of St Jude Influenza Program as a World Health Organization Collaborating Center for Influenza and a NIH Center of Excellence for Influenza Research and Surveillance.
(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
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 Medical Agency.
Anil R. Diwan