NanoViricides, Inc. (NYSE: NNVC) 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.
NanoViricides, Inc. (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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. 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.