SHELTON, CT / ACCESSWIRE / February 10, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, reports that Dr. Anil Diwan, the Company's President and Executive Chairman of the Board, was interviewed on the Stuart Varney show on Fox Business News (FBN), on January 28, 2020. The Company has licensed a copy of the video excerpt from FBN and it is available on the Company's website (www.nanoviricides.com), home page, under the heading "Dr. Anil Diwan on Fox Business - 01/28/2020".
When Mr. Varney asked about the Company's efforts at developing a drug candidate against the novel coronavirus pneumonia (NCP, or 2019-nCoV, also known as the Wuhan coronavirus), Dr. Diwan explained the steps in the process. He explained that in the best case scenario, it would take 4-6 weeks to get a viable candidate in hand, and another four weeks or so to produce it in quantity in the Company's cGMP capable manufacturing facility. He explained that the first drug based on the Company's platform technology has gone through a suite of safety/toxicology studies and is ready for filing an IND application. So it will be up to the authorities to determine how to take this exploratory drug candidate to the patients, if the Company is successful.
Mr. Varney further inquired if the nanoviricide drug would become ineffective when the virus mutates. Dr. Diwan explained that the magic of our technology is that we copy the human cell surface receptor to which the virus binds. No matter how much a virus mutates, it continues to bind to the same receptor at the same site, as has been established in numerous studies. Thus, it is highly unlikely that the virus mutations would lead to the nanoviricide drug becoming ineffective. Dr. Diwan also explained how the nanoviricide polymer with multiple virus-binding ligands attached to it would act like a "Venus-fly-trap" for the virus particle. Dr. Diwan explained that the 2019-nCoV is known to bind to ACE2 protein on human cell surface in much the same way as the 2002-2003 SARS coronavirus did. The structures of these interactions have been solved. This made it possible for us to be able to develop ACE2-mimetic virus-binding ligands. Instead of blocking ACE2, we are developing a nanomachine that is designed to attack the virus particle itself.
Mr. Varney asked about the recent movement in the Company's stock price. Dr. Diwan said that we cannot comment on the stock price. However, he added that, at one time the Company's stock price was about $140 a few years ago. He conjectured that it was during the time of high excitement of early results of novel technology demonstrating safety and effectiveness in animal models. Dr. Diwan further explained that thereafter the Company entered into what is called the "valley of death" in the pharmaceutical industry; a time period when the Company has to perform years of elaborate work to get to an IND filing stage; work which generally does not catch investor interest in the same way as the initial safety and effectiveness demonstrations.
The Company believes that with the major milestone of the IND filing of its first drug around the corner, it should be poised for an upward momentum, as has generally been seen in the biopharma sector.
An unapproved exploratory drug, namely, remdesivir, (Gilead, CA), in the class of nucleotide analog prodrugs, has entered into exploratory clinical studies for the 2019 novel coronavirus in China already. Nucleotide analogs are drugs that viruses have been generally able to escape by mutations. Therefore, the Company believes that a pathway would become available if the Company can produce the drug candidate soon enough and if it proves effective in cell culture studies against coronaviruses related to the 2019-nCoV that are available for such testing.
As of today, reports suggest that the NCP new infection rate, i.e. the increase in number of proven new cases per day, are stabilizing. The total mortality currently stands at about 900+, with confirmed infections in 40,171 patients and additional 187,518 people under medical observation, in China, as reported by BBC news (https://apple.news/AKBIYmjkSSTqnFYzwa98nog). The virus has spread to at least 28 countries, but the number of cases in other locales are relatively small. The outbreak was declared a global emergency by the WHO on 30 January. Fox News has reported in an opinion piece that Dr. Robert Siegel, M.D., Ph.D., Professor in the Department of Microbiology and Immunology at Stanford University, suggests that Coronavirus epidemic could be contained in months and that global pandemic is unlikely (https://apple.news/AvF6yeY6sQ76V-F9KgCUFkg). Dr. Siegel suggests that a possible scenario is that this coronavirus will be contained, and be gone, or that it will continue to reemerge frequently afterwards, as is seen with MERS (Middle East Respiratory Syndrome) coronavirus, or with Ebola. A third less likely scenario, he said, is that NCP may not be contained, and may remain as an ongoing source of human infection, as we have seen with Zika and West Nile viruses.
Several coronaviruses have become endemic human pathogens, such as HCoV- 229E, NL63, OC43, and HKU1. These continually circulate in the human population and cause respiratory infections in adults and children world-wide. In contrast, SARS-CoV has caused only one well-known epidemic, with a mortality rate of about 9%, and MERS-CoV has caused repeated outbreaks, with mortality rates approaching 35%.
The Company's top priority remains working on its first IND application for NV-HHV-101. The Company intends to solicit interest and financing from government agencies in order to accelerate its work on the coronaviruses and novel pathogens.
The Company is preparing an IND application for its first clinical drug candidate to go into human clinical trials. This drug candidate, NV-HHV-101, is a skin cream with the treatment of shingles rash as its first indication. It has shown broad-spectrum activity against HSV-1 (cause of "cold sores"), HSV-2 (cause of "genital ulcers"), and VZV (the varicella-zoster virus, that causes chickenpox in children and immune-compromised humans, and shingles in adults).
NV-HHV-101 has already gone through standard battery of safety-toxicological testing, which provides confidence that our platform is capable of creating safe drugs.
The Company has its own cGMP-capable drug manufacturing facility where it intends to produce the drugs for clinical supply.
The market size for the treatment of shingles is estimated at approximately 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 at 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.
The Company develops its class of drugs, that we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
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. The Company does not currently have a license for coronaviruses, and did not seek a license when it worked on MERS in 2014. TheraCour has not previously denied any licenses requested by the Company. NanoViricides has in the past initiated new projects and has licensed certain areas after achieving positive results. 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. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".
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