Nanoviricides Initiates a Safety/Toxicology Study of Its Leading Shingles Candidates
SHELTON, CONNECTICUT -- Wednesday, December, 6, 2017 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reports that it has begun initial safety and toxicology evaluation of its optimized nanoviricides® drug candidates developed against varicella-zoster virus (VZV), the shingles virus. This study is an important step in the drug development pathway for a treatment for shingles, a debilitating infection of human skin by VZV. The long term goal of this project is the development of nanoviricide drugs for topical dermal treatment of shingles, genital herpes and cold sores.
The non-GLP safety and toxicology study in rats is being conducted at AR Biosystems, Beverly, MA. The study will (i) evaluate the direct effects of topical delivery of the drug candidates on the skin, (ii) assess if the drugs attain detectable levels in the blood, and also (iii) evaluate whether there are any effects on the blood and primary organs, in uninfected animals. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies that are required for the IND submission to the U.S. FDA. As a result of the success of its drug lead optimization process, the Company has selected two clinical development candidates for further evaluation in this initial safety/toxicology study.
The Company has previously reported that the nanoviricides® drug candidates showed marked inhibition of VZV infection, replication and spread in human skin cultured ex vivo in experiments performed in the laboratory of Dr. Jennifer Moffat, SUNY Upstate Medical Center. Since VZV causes skin lesions, experimental VZV infection of human skin is considered to be representative of natural VZV infection. VZV is restricted to human tissue and only infects and replicates in human tissue. Dr. Moffat runs a leading laboratory studying disease-relevant models of VZV infection of human skin for evaluating effectiveness of potential drugs against the shingles virus.
The market size for anti-shingles drugs is currently estimated to be in the range of billions of dollars, even though shingles vaccines are available.
(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.
Eugene Seymour, MD, MPH.