drkazmd65
7 hours ago
And yet - again - Diwan blathers on but continues to do nothing useful.
NanoViricides Not Affected by Tariffs and Other Policies, Has Excellent Long Term Outlook, Stock-Price Decline Misguided, Explains the Company
Shelton, Connecticut – Tuesday March 11, 2025.
NanoViricides, Inc. (the “Company”, NYSE-Amer.: NNVC), a clinical-stage global leader developing revolutionary broad-spectrum antiviral drugs that the viruses cannot escape, declared today that its business is not affected by the tariff policies of the US government or corresponding retaliatory policies of other governments, nor is it affected by the spending cuts being implemented by the current White House administration.
Therefore, the Company believes that smart financial strategists would view the longer term strong prospects of the Company (explained below) as supporting the case of NNVC as an effective hedge against the current general stock market turmoil.
Additionally, the Company reports that it does not develop vaccines. On the contrary, the Company is developing antiviral treatments, that are for helping patients infected by viruses.
“We believe that the policies of the current Secretary of HHS, Mr. Robert F. Kennedy, would lead to focusing more strongly on development of broad-spectrum antiviral treatments such as our clinical-stage as well as earlier-stage antiviral pipeline drug products rather than the previous vaccine-focused strategy,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company.
The Company has recently suggested that its revolutionary broad-spectrum antiviral drug NV-387 could have strong potential for the treatment of measles.
NV-387 was found to cure a lethal RSV infection in an animal model. Both Measles virus and RSV belong to the same family of viruses called paramyxoviruses. This family of viruses use heparan sulfated proteoglycans as their first stop, congregating next to cells, before gaining entry into cells.
There is no treatment available for measles; the lack of treatment is fueling the spread of this highly contagious disease.
Only a treatment for measles can effectively limit transmission of the virus and spread of the contagion, the Company believes.
It is illogical and unscientific to believe that vaccination, which is being widely promoted, would have any immediate effect for controlling the current outbreak. This is because the vaccinated person will only become protected several weeks after receiving the vaccine dose. Additionally, immune-compromised subjects cannot be vaccinated.
Although measles is spreading primarily in unvaccinated children, a small proportion of vaccinated persons is also being infected, and could suggest a drift in the virus towards partial vaccine escape. The rapid spread of measles in West Texas is bleeding into nearby areas due to travel. Several other states have reported independently initiated measles cases as well. So far there were two deaths with measles.
NV-387 mimics host-side signature required by viruses that does not change even as the viruses keep changing. In particular, NV-387 mimics heparan-sulfate-like structures to which over 90% of human pathogenic viruses are known to bind. NV-387 is a polymeric nanomachine that “looks like” a cell to the virus, and the virus ends up being engulfed by the shape-shifting NV-387 polymeric micelles, and thereby the virus is blocked from infecting cells in the first place.
The Company is currently working on a clinical trial application for enabling a Phase II human clinical trial to assess effectiveness of NV-387 for the treatment of MPox infection in the Central African region. An MPox epidemic has been raging in this region since June, 2024.
NV-387 could readily be approved for the treatment of MPox if successful in the Phase II clinical trial. There is no treatment for MPox at present.
NV-387 was found to be highly effective against Influenza A lethal infection in an animal model, significantly surpassing the effectiveness of known approved drugs including Tamiflu® and Xofluza®. These data indicate that NV-387 should be readily approvable for influenza virus infections. NV-387 is expected to be effective against bird flu viruses H5N1, H5Nx etc. as well.
NV-387 was found to be highly effective in lethal virus infection animal models for COVID. As of today’s 5-year anniversary of WHO declaration of the global COVID-19 pandemic, COVID has continued in the global population as endemic infections that produce sporadic waves. The only drug available remains Paxlovid® that was found to have no benefits compared to placebo in otherwise healthy adults that became sick with SARS-CoV-2 infection in clinical trials.
“We believe NV-387 has a bright future,” said Dr. Diwan, adding, “And we are strategizing to bring this future closer to reality every day.”
The Company has also developed a herpesvirus family antiviral, NV-HHV-1, that has indications against HSV-1, HSV-2, as well as VZV (shingles). NV-HHV-1 has gone through IND-enabling studies as a skin cream formulation for topical treatment of shingles rash, HSV-1 cold sores, and HSV-2 ulcers. The Company is developing a systemic drug based on NV-HHV-1 for oral treatment of herpesvirus infections as well. NV-HHV-1 awaits behind NV-387 in the pipeline for clinical development.
Additionally, the Company has also developed a drug against HIV/AIDS, namely NV-HIV-1. The Company believes NV-HHV-1 in combination with some of the existing drugs could lead to achieving cures of HIV infection.
“With all of these developments in progress, we are not exposed to current macroeconomic factors such as wars, tariffs, export taxes, or spending cuts,” said Dr. Diwan, explaining, “In fact, we believe that smart financial strategists would be recommending NNVC with its strong long term potential to act as a hedge against the current turmoil in the stock markets.”
“Therefore, we believe that the recent decline in the Company’s stock price concomitant with the general market sell-off is misguided and smart investors are expected to avail this dip opportunity,” said Dr. Diwan.
ABOUT NANOVIRICIDES
NanoViricides, Inc. (the "Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.
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.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
Source: NanoViricides, Inc
drkazmd65
1 month ago
NanoViricides Engages CRO for Phase II Clinical Trial - Odd though that the press release here doesn't mention any CRO by name.
So - it appears that they plan to target monkeypox for a Phase II?
https://finance.yahoo.com/news/nanoviricides-engages-cro-phase-ii-113000925.html
SHELTON, CT / ACCESS Newswire / January 27, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that it has engaged a Clinical Research Organization (CRO) to conduct a Phase II clinical trial advancing its broad-spectrum antiviral drug NV-387 further into the regulatory pipeline.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., further commenting, "Our regulatory development strategy for this drug is now further advancing into a Phase II clinical trial stage."
The Company has previously stated that it is working towards a Phase II clinical trial to evaluate the effectiveness of NV-387 for the treatment of MPox patients. MPox disease, caused by the human Mpox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the African region, including the Democratic Republic of Congo (DRC), Uganda, and others. It led to the WHO declaring a Public Health Emergency of International Concern ("PHEIC") on August 14, 2024.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.
In July 2024, SIGA received a procurement order for $112.5 million of oral TPOXX from the U.S. Government under the 19C BARDA contract, for delivery to the U.S. Strategic National Stockpile (SNS), despite the clinical trial failure. Additionally, in August, 2024, SIGA received a procurement contract and related order from the U.S. Department of Defense for approximately $9 million of oral TPOXX, as well as a small amount of IV TPOXX, despite clinical trial failure.
"These desperate attempts by the Previous US Administration to acquire an ineffective drug with hundreds of millions of dollars of taxpayer money only go to show how sorely a truly effective antiviral drug that works against MPox/Smallpox is needed by the government agencies," commented Anil R. Diwan, PhD, President and Executive Chairman of the Company.
NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.
In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.
Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37.
In contrast, viruses are highly unlikely to escape NV-387 because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.
NV-387 is host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.
Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses wirth small changes that viruses undergo as they are faced with these challenges in the field.
Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.
NV-387 has already been found to be able to cure lethally RSV infected mice.
NV-387 was found to be significantly superior to oseltamivir (Tamiflu®), baloxavir (Xofluza®), and premivir (Rapivab®) in a lethal Influenza lung infection model designed to rank-order the effectiveness of these various drugs.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, as their limitations have become clearly evident during the COVID-19 pandemic.
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.
Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name.
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., info@nanoviricides.com
Public Relations Contact: ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
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