The Fort Worth Press - NanoViricides President Dr. Diwan Interviewed by Mission Matters' Adam Torres

Mr. Torres began with asking what is the mission of NanoViricides. Dr. Diwan responded that NanoViricides was founded to revolutionize treatment of antiviral diseases the way penicillin revolutionized the treatment of bacterial infections.

Dr. Diwan explained the technology behind navoviricides drugs, and its completely different approach as compared to traditional antiviral drug development approaches.

Dr. Diwan explained the technology behind navoviricides drugs, and its completely different approach as compared to traditional antiviral drug development approaches. Dr. Diwan explained that this different approach provides several important benefits -

• Viruses cannot escape a nanoviricide drug - because the nanoviricide copies the essential host-side features that the virus uses to cause cell infection, and these do not change no matter how much the virus changes. This is unlike vaccines, antibodies, and traditional small chemical drugs that are all escaped by viruses as they change under pressure.

• Irrespective of patient immune status, a nanoviricide drug is expected to work, because a nanoviricide does not depend upon the patient's immune system. In contrast, vaccines require competent immune system to produce effect. Antibodies also require competent immune system that must recognize the virus-antibody complexes and act upon them. In a severe viral infection, the patient's immune system is often derailed by the virus. Additionally, immunoicompromised patient population is increasing due to increase in chronic diseases such as obesity, diabetes, allergies, as well as infectious diseases such as HIV, EBV and others.

• All of the patient population, potentially from infants to adults to geriatrics, would be eligible for treatment with NV-387, because of its excellent safety and tolerability profile resulting from design using biocompatible, biodegradable components.

Dr. Diwan explained that the Company's drug candidate NV-387 has demonstrated efficacy against a number of unrelated viruses in animal models. Thus the goal of developing an emperic therapy for the treatment of acute respiratory infections is now within reach, with continuing clinical advancement.

Dr. Diwan explained that NV-387 had shown excellent effectiveness in lethal animal models of infections of viruses including Influenza, RSV, Coronaviruses, MPox, Smallpox as well as Measles. In fact NV-387 treatment led to complete cure of RSV infection in lethally infected animals. Additionally, NV-387 was found to be substantially superior to existing influenza therapeutics, namely Tamiflu (oselatmivir) and Xofluza (baloxavir) in a lethal infection animal model.

There is no approved therapy for MPox. Two drugs approved under the US FDA "Animal Rule" process, namely tecovirimat and brincidofovir were put into clinical trials for treatment of MPox. Tecovirimat failed to show improvement over the standard of care. Brincidofovir was dosed in an initial cohort in January, 2025 but no data can be found about its effects, and the clinical trial does not appear to have advanced further. Previously, in three MPox cases treated in the UK under emergency use protocols, brincidofovir led to significant elevation of liver enzymes and the drug was discontinued. No efficacy signal was found in these three cases.

There is no approved therapy for treatment of RSV infection, other than the toxic ribavirin as a last resort. Three antibodies have been approved for treatment of newborns so that they would not come down with RSV infection. A vaccine has been approved for treatment of expectant mothers despite risk of early/preterm births. These approvals indicate the severity of the problem and the need for an actual treatment of RSV infection.

There is no approved treatment for Measles virus infection.

Dr. Diwan advised that NV-387 has completed Phase I clinical trial in healthy subjects with no reported adverse events. He further stated that a Phase II clinical trial to test NV-387 for efficacy against Mpox (Monkeypox) virus is ready to begin soon. The ACOREP regulatory agency of the Democratic Republic of Congo (DRC) has already given permission for the clinical trial. The clinical trial application process has been completed. The trial is expected to begin with dosing of the first cohort of patients once the clinical site preparations are completed.

NV-387 is estimated to address a market potential of over $17 Billion by 2030 if approved, based on its broad spectrum and multiple indications.

Mr. Torres closed with advising the audience that Anil will be presenting and will be available for meetings at the Dealflow Discovery Conference at the Borgata Hotel in New Jersey on January 28th and 29th. Subsequent to the Conference, Dr. Diwan now happily notes that he had several successful meetings at this Conference.

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ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide^™ class of drug candidates and the nanoviricide^™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

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.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

A.Williams--TFWP