SHELTON, CT / ACCESSWIRE / July 21, 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, today announced that Anil R. Diwan, PhD, President and Executive Chairman of the Company, will participate in the "B. Riley FBR Virtual Infectious Disease Summit - Therapeutics Day" on Tuesday, July 21, 2020. The Conference is organized by B. Riley FBR, Inc. (https://brileyfbr.com/).
Dr. Diwan is invited to participate in Panel #3 at 2020 at 2:10 p.m. ET, entitled "Taming the Severe Disease Presentations". He will briefly discuss the Company's novel nanomedicines platform and the Company's progress in the lead IND-ready candidate for the treatment of shingles rash, NV-HHV-101, as well as in developing a drug candidate against SARS-CoV-2, the cause of COVID-19 global pandemic.
The Company believes that it is close to selecting a clinical candidate worthy of advancing into human clinical trials for the treatment of SARS-CoV-2 infection, based on (i) cell culture effectiveness studies against multiple circulating coronaviruses that employ different cell surface receptors, (ii) a lethal lung infection animal model effectiveness study using hCoV-NL63 infection (a coronavirus that uses the same receptor, ACE2, as SARS-CoV-2, and produced similar disease in the animal model), and (iii) preliminary safety studies in animal model at maximum feasible dosage levels. The Company has disclosed its findings from these studies in previous press releases.
Prior to filing for human clinical trials, NanoViricides plans on conducting studies, towards clinical candidate selection, to further determine the effectiveness against SARS-CoV-2, perform additional drug development studies as may be necessary, and request a pre-IND Meeting with the US FDA for regulatory guidance.
The Company is also working with its regulatory consultants on completing an IND with the US FDA to advance its lead drug candidate NV-HHV-101 into human clinical trials for topical dermal treatment of Shingles rash as the initial indication. In particular, the Company is working on finalizing the clinical trials plan for the anticipated human clinical trials for shingles rash treatment. The Company is also in the process of finalizing clinical trial sites. This process has been adversely affected by the current global COVID-19 pandemic, and in particular, its effects across the USA.
Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the "Venus-fly-trap" flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients.
Additionally, it is well known that viruses escape antibody-drugs via mutations. The Company's "nanoviricide" drug candidates, in contrast, are designed to be broad-spectrum, and therefore virus escape by mutations is expected to be unlikely.
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 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 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 simultaneously (a) attacking extracellular virus to break the reinfection cycle, and (b) disrupting intracellular production of the virus, thus 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 in the process of completing an IND application to the US FDA for this drug candidate. The Company cannot project an exact date for filing an IND because of its dependence on a number of external collaborators and consultants, and the effects of recent COVID-19 restrictions.
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. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. 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's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
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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