SHELTON, CONNECTICUT -- Thursday, October 31st, 2019 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that it has initiated dermal sensitization and ocular irritation studies that are required to support the IND application of NV-HHV-101 moving towards human clinical trials.
The Company has contracted MB Research Labs, Spinnerstown, PA, to conduct the studies to assess the dermal sensitization and ocular irritation potential of the drug candidate. These initial studies involve two separate types of studies: 1) Assess the direct potential of the drug candidate to induce skin sensitization after repeated treatment of the skin (contact dermal sensitization); and 2) Assess the potential of the drug candidate to cause ocular irritation following potential exposure. The ocular irritation test (EpiOcularTM Eye Irritation Test, EIT) is a non-animal test in compliance with multi-national regulatory guidelines. Additional IND-enabling studies are in progress. Upon completion of all of these required studies, the Company anticipates filing an IND with the US FDA to advance NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication.
The market size for the treatment of shingles is estimated in the billion dollars range by various estimates. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur in the USA alone every year.
The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials. These additional candidates are based on NV-HHV-101, thereby maximizing return on investments and shareholder value.
Contact dermal sensitization is an immunological response in which repeated skin exposure induces specific skin sensitivity (reactivity). Eye irritation testing is required because of the potential for accidental eye exposure of NV-HHV-101, which is designed to be applied to affected skin by spreading.
About MB Research Labs
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.
MB Research Labs, Spinnerstown, PA, is a GLP contract research laboratory that provides industry-leading safety and toxicology services for the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies. With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive capabilities in full compliance with OECD, FDA, and EPA.
About NanoViricides
NanoViricides, Inc.
Anil R. Diwan
info@nanoviricides.com