SHELTON, CONNECTICUT -- Tuesday, January 9th, 2020 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a company with novel platform technology to treat difficult and life-threatening viral diseases, announces that it has successfully completed genetic toxicology testing required to support the IND application for NV-HHV-101 moving towards human clinical trials.
NV-HHV-101 was found to be safe in terms of potential genotoxicity in the suite of tests that were performed by an independent laboratory. The drug did not induce mutations in bacteria and did not cause chromosomal damage in human cells.
In the Ames test, NV-HHV-101 was negative for the ability to induce mutations in genes of several strains of Salmonella typhimurium and of Escherichia coli, both in the presence and absence of an exogenous metabolic activation system. The Ames test is used to assess the direct ability of a drug to cause mutations in DNA or genes, using bacterial cells.
Similarly, in the standard "Micronucleus" test NV-HHV-101 was negative at all doses tested for the induction of chromosomal damage in the human TK6 cell line, both in the presence and absence of the exogenous metabolic activation system. The Micronucleus test is used to assess the potential of a drug candidate to cause chromosomal damage in human cells.
These tests, taken together, are conducted to identify potential carcinogens. These tests are conducted in the presence and absence of metabolic activation system. This is because metabolism of a drug can cause the formation of potential carcinogens. A high, but not complete, correlation has been found between carcinogenicity in animals and mutagenicity in the Ames test or chromosomal damage in the micronucleus test. NV-HHV-101 was found to have no DNA, gene, or chromosome damaging activity in these tests.
The US FDA and other international regulatory authorities require these genetic toxicological studies to support the Investigational New Drug (IND) Applications for entering human clinical trials. Upon completion of all of the required IND-enabling studies, and receiving the relevant reports from our external collaborators, 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 at about one billion dollars by various estimates. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1million 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.
About NanoViricidesFDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.