Latest news with #NanoViricides
Miami Herald
3 hours ago
- Health
- Miami Herald
WHO Extended Global Emergency Status of MPox Epidemic - Development of Treatment for MPox with NV-387 is Timely, Says NanoViricides
SHELTON, CONNECTICUT / ACCESS Newswire / July 16, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, comments on the extension of the MPox Public Health Emergency of International Concern (PHEIC) by WHO. The Director General of WHO has extended the PHEIC declaration for MPox epidemic according to a WHO news release dated July 10, 2025, following continuing upsurge of the MPox virus (MPXV) epidemics in the African region[1]. Sporadic travel related cases of MPXV Clade I have occurred outside Africa, including in the USA, but so far have not resulted in further transmission. The threat of such sustained transmission continues, and is part of the decision to continue the PHEIC status. "Our development of NV-387 towards Phase II clinical trial for treatment of MPOX is timely for responding to the continuing threat of a global spread of MPox, and for meeting the need for treatment of MPox patients in Africa, in light of the continuing spread of MPox," said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides, Inc., adding, "If successful, this NV-387 clinical trial will also open up a multi-billion-dollar global market of preparedness for poxvirus bioterrorism to us." At present, there is no drug approved, that is actually safe and effective in humans, for the treatment of the MPox disease, which is caused by MPXV infection. Tecovirimat (SIGA) has failed to show any effectiveness over standard of care in a clinical trial for treatment of MPXV infections. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"[2], [3]. In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial[4]. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles[5]. The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. In contrast to the small chemical drugs, vaccines, antibodies, that viruses escape readily, NV-387, the novel broad-spectrum antiviral developed by the Company, is designed such that viruses would not escape the drug. This is because NV-387 mimics the cell-side feature called heparan sulfate proteoglycans (HSPG) to which the viruses bind and concentrate next to the cell before they can attack the cell and cause infection. No matter how much a human pathogenic virus mutates, it continues to bind to HSPG. Over 90% of human pathogenic viruses are known to bind to HSPG. Additionally, NV-387 has been found to be extremely safe and well tolerated in a Phase I human clinical trial. There were no reported adverse events or serious adverse events in this clinical trial. In animal studies, NV-387 was found to be extremely safe, with a No-Observed-Adverse-Event Level (NOAEL) of the drug at 1,200 mg/kg, and the Maximum Tolerated Dose (MTD) at 1,500 mg/kg in intravenous injection in rats. The Phase I clinical trial results for NV-387 were consistent with the safety observations in animal model studies. NV-387 is orally available and is formulated as oral gummies that are soft solids that do not require swallowing, and are designed to dissolve in the oral cavity itself. This is important because MPox patients may not have the ability to swallow pills or capsules because of viral lesions in the oral cavity. The Company recently announced that it has completed the development of a clinical trial protocol for the impending Phase II study of NV-387 for the treatment of MPox disease in the African Region. This will be a randomized clinical trial comparing NV-387 treatment with the Standard of Care, to evaluate the dosing regimen for NV-387, the safety and tolerability of the dosing regimen in MPox patients, and effectiveness of NV-387 on the MPXV virus and the MPox disease that it causes. Of note, both tecovirimat and brincidofovir were approved by the US FDA for smallpox virus, based on the "Animal Rule", which avoids the use of human efficacy clinical trials that would be unethical to conduct with a smallpox challenge study in humans. We also note that smallpox is a more severe disease than even the most severe form of MPox disease, and both of these drugs have been found to be inadequate for the treatment of MPox according to currently available datasets (although definitive data from the brincidofovir clinical trial has not been released yet). These two drugs (tecovirimat and brincidofovir) have been acquired in the US Strategic National Stockpile for bioterrorism preparedness to the tune of around billion dollars. The overall global market for bioterrorism preparedness against smallpox variants is estimated to be several billions of dollars. The Company anticipates that a successful Phase II clinical trial of NV-387 for the treatment of MPox would open up the US Government SNS market and similar global markets to our drug and benefit the Company's other programs as well. MPXV Clade Ib strain is dominant in major parts of Africa and continues to spread, whereas the less virulent MPXV Clade IIb strain is dominant in Sierra Leone, with cases increasing at present. While vaccination has started, overall, the uptake of available vaccines has remained lower than anticipated due to logistical, operational, and financial barriers, according to the report of the International Health Regulations (2005) (IHR) Emergency Committee for MPox of the WHO on June 5, 2025. MPXV Clade II has become epidemic, within limited population demographics, in the Western world including the USA since a 2022 epidemic it caused, driven by travel-related transfer from Western Africa. The PHEIC regarding MPox 2024 was first declared on August 14, 2024, and was extended in February 2025. It has been extended again now as the MPXV continues to spread in neighboring countries in Africa threatening further global spread and sustained transmission. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( 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, Public Relations Contact:ir@
Associated Press
07-07-2025
- Business
- Associated Press
NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development. NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387's Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID. Strategic Advantages of the MPox Focus The company believes its focus on MPox offers significant advantages: Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there's a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial. Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget. Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company's use of lethal challenge animal models. This is a critical point, as NanoViricides' animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections. Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the 'FDA Animal Rule,' have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts. Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides' host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness. Innovative Drug Delivery Adding to its strategic advantages, NV-387 will be administered as 'NV-387 Oral Gummies.' This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult. Addressing the Broader MPox Threat The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security. NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc. Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM). Source: Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of BURU or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated fifteen hundred dollars by a 3rd party EDM Media Consulting Group for content distribution services on nnvc or July 6th, 2025. is neither an investment advisor nor a registered broker. No current owner, employee, or independent contractor of is registered as a securities broker-dealer, broker, investment advisor, or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. This article may contain forward-looking statements as defined under Section 27A of the Securities Act of 1933 and 21E of the Exchange Act of 1934. These statements, often incorporating terms like 'believes,' 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' or similar expressions about future performance or conduct, are based on present expectations, estimates, and projections, and are not historical facts. They carry various risks and uncertainties that may result in significant deviation from the anticipated results or events. Past performance does not guarantee future does not commit to updating forward-looking statements based on new information or future events. Readers are encouraged to review all public SEC filings made by the profiled companies at It is always important to conduct thorough due diligence and exercise caution in is not managed by a licensed broker, a dealer, or a registered investment adviser. The content here is purely informational and should not be taken as investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor regarding forward-looking statements. Any statement that projects, foresees, expects, anticipates, estimates, believes, or understands certain actions to possibly occur are not historical facts and may be forward-looking statements. These statements are based on expectations, estimates, and projections that could cause actual results to differ greatly from those anticipated. Investing in micro-cap and growth securities is speculative and entails a high degree of risk, potentially leading to a total or substantial loss of investment. Please note that no content published here constitutes a recommendation to buy or sell a security. It is solely informational, and you should not construe it as legal, tax, investment, financial, or other advice. No content in this article constitutes an offer or solicitation by or any third-party service provider to buy or sell securities or other financial instruments. The content in this article does not address the circumstances of any specific individual or entity and does not constitute professional and/or financial advice. is not a fiduciary by virtue of any person's use of or access to this content. This article is for informational purposes only and does not constitute investment advice. Always conduct your own research before making investment decisions. This analysis represents the opinion of the author based on publicly available information and should not be considered investment advice. Investors should conduct their own due diligence before making investment decisions. Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: [email protected] City: Frisco State: Texas Country: United States Website: Press Release Distributed by To view the original version on ABNewswire visit: NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
Globe and Mail
07-07-2025
- Business
- Globe and Mail
NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development. NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387's Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID. Strategic Advantages of the MPox Focus The company believes its focus on MPox offers significant advantages: Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there's a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial. Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget. Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company's use of lethal challenge animal models. This is a critical point, as NanoViricides' animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections. Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the "FDA Animal Rule," have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts. Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides' host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness. Innovative Drug Delivery Adding to its strategic advantages, NV-387 will be administered as "NV-387 Oral Gummies." This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult. Addressing the Broader MPox Threat The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security. NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc. Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM). Source: Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of BURU or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated fifteen hundred dollars by a 3rd party EDM Media Consulting Group for content distribution services on nnvc or July 6th, 2025. is neither an investment advisor nor a registered broker. No current owner, employee, or independent contractor of is registered as a securities broker-dealer, broker, investment advisor, or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. This article may contain forward-looking statements as defined under Section 27A of the Securities Act of 1933 and 21E of the Exchange Act of 1934. These statements, often incorporating terms like 'believes,' 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' or similar expressions about future performance or conduct, are based on present expectations, estimates, and projections, and are not historical facts. They carry various risks and uncertainties that may result in significant deviation from the anticipated results or events. Past performance does not guarantee future does not commit to updating forward-looking statements based on new information or future events. Readers are encouraged to review all public SEC filings made by the profiled companies at It is always important to conduct thorough due diligence and exercise caution in is not managed by a licensed broker, a dealer, or a registered investment adviser. The content here is purely informational and should not be taken as investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor regarding forward-looking statements. Any statement that projects, foresees, expects, anticipates, estimates, believes, or understands certain actions to possibly occur are not historical facts and may be forward-looking statements. These statements are based on expectations, estimates, and projections that could cause actual results to differ greatly from those anticipated. Investing in micro-cap and growth securities is speculative and entails a high degree of risk, potentially leading to a total or substantial loss of investment. Please note that no content published here constitutes a recommendation to buy or sell a security. It is solely informational, and you should not construe it as legal, tax, investment, financial, or other advice. No content in this article constitutes an offer or solicitation by or any third-party service provider to buy or sell securities or other financial instruments. The content in this article does not address the circumstances of any specific individual or entity and does not constitute professional and/or financial advice. is not a fiduciary by virtue of any person's use of or access to this content. This article is for informational purposes only and does not constitute investment advice. Always conduct your own research before making investment decisions. This analysis represents the opinion of the author based on publicly available information and should not be considered investment advice. Investors should conduct their own due diligence before making investment decisions. Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: editor@ City: Frisco State: Texas Country: United States Website:
USA Today
01-07-2025
- Business
- USA Today
There is a Strong Business Case for Phase II Clinical Program for Treatment of MPox Infection Using NV-387, an Industry-Leading Broad-Spectrum Antiviral Drug Candidate
NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC ) (the 'Company'), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that it is forging ahead with advancing its lead candidate NV-387 into Phase II clinical drug development. NanoViricides has chosen MPox as the first indication to advance NV-387 into Phase II clinical trials out of the four indications for which the Company has substantial efficacy data in animal studies, namely RSV, Influenza, COVID, and Orthopoxviruses (MPox/Smallpox). The MPox program enables advancing its pipeline towards revenue in the fastest possible manner, the Company believes. The Company intends to advance NV-387 against respiratory infections soon after the Phase II clinical trial of NV-387 for the treatment of MPox infection gets under way. NanoViricides has already added one Clinical trial Site to the MPox Phase II Program. A Phase II Clinical Trial Protocol has been developed with the Principal Investigator at this site in the Democratic Republic of Congo (DRC), and this Protocol is undergoing final refinements. A Clinical Trial Application is in development with many parts having been substantially completed. NanoViricides has engaged a Clinical Research Organization (CRO) to organize and conduct this Phase II clinical trial for the treatment of MPox with NV-387, as previously stated, and this CRO has organized the Clinical Trial Site and is preparing the CTA with the Company's inputs. The manufacture of the drug substance NV-387 is substantially completed at the Company's own facility. The manufacture of the drug product 'NV-387 Oral Gummies' is in progress. MPox as the first indication has several strategic benefits for the Company. Firstly, because of the continuing epidemic in the African Region there is a strong need for the drug and also there is the ability to recruit patients and complete the clinical trial in a timely manner. Additionally, running clinical trials in the African Region is substantially less expensive than clinical trials in USA or Europe that the Company has planned for RSV, a commercially important indication with multi-billion dollar potential market. Secondly, a proof of efficacy in humans of NV-387 against MPox would validate our use of lethal challenge animal models and would establish that our animal model data are predictive of human outcomes. This would have huge implications since our animal model data against every infection we have tested to date has demonstrated NV-387 to be substantially superior to existing drugs, viz. RSV, Influenza, COVID, and of course, MPox/Smallpox. Thirdly, there is a strong financial case for choosing MPox as the indication. This business case has become even stronger with the failure of tecovirimat (Tpoxx) in clinical trial against MPox. Tecovirimat and brincidofovir (Tembexa) are the only two drugs approved by the US FDA for the treatment of Smallpox, a virus of bioterrorism concern. Both of these drugs were approved under the 'FDA Animal Rule', which eliminates the need for demonstration of efficacy in humans. The 'FDA Animal Rule' is applicable for diseases such as Smallpox and others where clinical trials in human patients are not feasible or would be unethical. These FDA approvals have led to the acquisition of these two drugs into the US Strategic National Stockpile (SNS) to the tune of billions of dollars. And now, there is a clear need for replacing these non-performing drugs with a drug that actually works against MPox and Smallpox (see further down below). We believe NV-387 would become the choice for addition to the SNS if our proposed Phase II clinical trial against MPox demonstrates benefits of the NV-387 treatment. The most recent acquisition contracts with BARDA for tecovirimat, which were for drug replenishments, have been valued at over $150million. An initial stocking contract for NV-387 is likely to be substantially larger, as was the case with the initial acquisition of several drugs into the SNS. Brincidofovir failed an early clinical trial against MPox due to liver toxicity. Tecovirimat failed a recent clinical trial against MPox since it demonstrated no superiority in efficacy over the standard of care. Importantly, both of these drug candidates are small chemicals that the viruses can readily escape by mutations. Smallpox, if it ever becomes fielded as a bio-terrorism agent, is unlikely to be in the 'original' form of the virus, and could be explicitly manipulated to breed resistance to such small chemical drugs by onerous entities. Of note, MPox is in the same family as the Smallpox virus; MPox causes a much weaker form of disease than the Smallpox virus. Thus there is a strong case for HHS to support NV-387 drug development for Bioterrorism Readiness. The 'NV-387 Oral Gummies' drug product is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash. The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC ( ). Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve. ABOUT NANOVIRICIDES NanoViricides, Inc. (the 'Company') ( ) 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@ Public Relations Contact: ir@ SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire
Miami Herald
18-06-2025
- Health
- Miami Herald
With Rising Variants of COVID and Bird Flu, the Single Broad-Spectrum Antiviral NV-387 Would be the Best Partner for Preparedness, Says NanoViricides' Dr. Diwan
SHELTON, CT / ACCESS Newswire / June 18, 2025 / Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE Amer.: NNVC ) (the "Company"), asserts that with new rising variants of COVID and Bird Flu, the single broad-spectrum antiviral drug NV-387 is well-positioned to support preparedness efforts and to combat potential pandemics. Nimbus, a new COVID variant, officially NB1.8.1, is displacing the LP8.1 variant that was dominant until a few weeks ago in the USA ( Nimbus has been rising globally since Spring according to WHO ( Nimbus causes "razor-sharp" sore throat in some individuals, which is extremely painful and lingering for some time, in addition to the usual COVID symptoms. Nimbus is more resistant to antibodies generated from previous vaccines, although prior vaccination or natural COVID infection is expected to still be protective in terms reduced severity compared to without such immunity according to CDC. Nimbus is likely to be more transmissible than the previous variants. It belongs to the JN.1 subfamily of the Omicron family of SARS-CoV-2 virus. Recently, the Influenza A H5N1 virus from a dairy worker in Michigan was found to be capable of airborne transmission in a ferret animal model [1] ( This genotype B3.13 (clade clade 2.3.4.4b) virus in dairy cattle causes moderate severity disease in humans. In contrast, a highly pathogenic genotype D1.1 that is circulating in birds birds has led to one critical month-long illness in Canada and one death in the US signifying the potential for high morbidity and mortality from this genotype if it spreads in humans. Additionally, a new genotype of H5N1 in Cambodia has caused four fatalities and fifth severe infection as of today ( NV-387, the broad-spectrum antiviral drug is expected to be effective against all of these bird flu viruses. NV-387 was found to be substantially superior to Tamiflu® (Roche, Oseltamivir), Rapivab® (Biocryst, Peramivir), as well as Xofluza (Shionogi/Roche, baloxavir) in lethal lung infection animal model of Influenza infection. All three of these existing anti-influenza drugs are known to be escaped by Influenza viruses by single point mutations in H or PB2 genes. NV-387 was found to be substantially superior to the approved drug Remdesivir in a lethal coronavirus lung infection animal model for SARS-CoV-2. Thus the single drug NV-387 alone can combat H5N1, Influenza as well as COVID infections. NV-387 has completed Phase I clinical trial in healthy human subjects with no reported adverse events. COVID as well as Influenza viruses readily escape vaccines, antibodies as they change in the field during an epidemic wave. They are also likely to escape small molecule drugs by such changes. NV-387 takes advantage of the invariant features that these viruses use for causing infection, by mimicking heparan sulfate-like structures. No matter how much these viruses change in the field, they continue to use the heparan sulfate attachment receptors in order to cause infection. Thus it is practically impossible that the viruses may be able escape NV-387 without losing their ability infect and transmit across humans, the Company believes. NV-387 is orally available, formulated as oral gummies that dissolve in the mouth, thus avoiding issues of inability to swallow which occurs related to sore throat, old age, as well as in young children. NV-387, as a treatment, is designed to help actually patients with disease recover rapidly, thus limiting the viral spread as well as providing for natural infection-based immunity in the recovered patient. "NV-387 is thus the best current choice available for a highly cost-effective pandemic preparedness development," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "We have US-based cGMP manufacturing capabilities already set up as well." Of note, natural immunity, as induced by recovery from infection, is known to be superior to immunity from subunit and mRNA vaccines. One of the important reasons is that in natural infection, the immune system is subjected to all possible antigens from the entire virus, unlike just the selected antigens or antigen fragments that are present in subunit or mRNA vaccines. Also, NV-387 can be manufactured in the USA and stockpiled readily at room temperature or refrigeration (for longer periods of time). Unlike NV-387, vaccines or antibodies would require to be created after the virus takes hold, and they would suffer substantial loss of effectiveness within months after deployment due to changes in the virus. Additionally, vaccines require a cold chain handling. Vaccines also need to be administered to a large proportion of healthy population. There are significant logistical problems with vaccines. There is also the issue of vaccine reluctance, which is a personal choice, as it should be in a free country like the USA. The broad-spectrum antiviral drug NV-387 was developed specifically to overcome all of these problems. In case of further spread of a severe COVID variant and also a Bird Flu variant in human populations, it will be possible to move NV-387 rapidly into Phase II clinical trial for these diseases, and then prepare for deployment early in the potential pandemic, curtailing its spread. About NanoViricides NanoViricides, Inc. (the "Company") ( 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, Public Relations Contact:ir@ SOURCE: NanoViricides, Inc.
