Latest news with #AnilR.Diwan
Miami Herald
3 days 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@
Miami Herald
5 days ago
- Business
- Miami Herald
Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides
SHELTON, CT / ACCESS Newswire / July 14, 2025 / 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 the design of the adaptive clinical trial protocol for the treatment of MPox Virus Clade Ia and Ib infections and disease is nearly complete. The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial: safe and effective dosing regimen in patients,safety and tolerability of the drug in patients, andantiviral effectiveness of the drug in patients. The overall clinical trial will enroll approximately 80 patients. "This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease." Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease. NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus. If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions. MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits. Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] . The adaptive, randomized, SOC controlled clinical trial will proceed in two parts: In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease. There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results. In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy. The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region. The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This 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. Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial. Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found. 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 [3] . 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, Public Relations Contact:ir@
Miami Herald
04-06-2025
- Business
- Miami Herald
NanoViricides Measles Drug Development Animal Study is Imminent
SHELTON, CT / ACCESS Newswire / June 4, 2025 / 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 its Measles drug development program. The Company has commissioned an animal trial to evaluate certain drug candidates in a lethal animal infection model. The Company has secured specially modified mice that bear the human form of CD150/SLAM protein that the Measles virus requires to enter cells. The Company will initiate the study as soon as the animals arrive and are acclimatized at the animal study laboratory. "NV-387 actually cured lethal RSV infection in animals, and Measles is a cousin of RSV," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "This gives us confidence that NV-387 will have strong activity against Measles virus as well." NV-387 is a clinical stage broad-spectrum antiviral drug that is designed to act as a decoy of a cell, attacking the virus by presenting to it the very features that the virus requires for binding to the cell, and upon binding, destroying the virus particle so it cannot infect. Over 90-95% of human pathogenic viruses require the sulfated proteoglycan feature that NV-387 presents to the virus. There is no approved drug for the treatment of Measles virus infection. Recently, CDC included Vitamin A as part of the standard of care for Measles infection. Vitamin A is known to help malnourished children with Measles, but its role as supplementary addition to non-deficient patients is not known. CDC also recommended use of ribavirin in extreme cases as a last resort. Ribavirin is a toxic nucleoside analog and is not approved for treatment of Measles. Thus there is a clear unmet need for a Measles drug. NV-387, a clinical stage drug can be rapidly developed to meet this need. The animal study of effectiveness of NV-387 in h-SLAM-modified mice will provide important information regarding potential human effectiveness of NV-387 to treat Measles virus infection. Measles outbreaks have continued to expand in the US, reaching a record 1,088 confirmed cases across 33 jurisdictions from January 1 through May 29, 2025 according to CDC ( Europe has witnessed a dramatic ten-fold increase in measles cases last year, i.e. 2024, over 2023. Measles vaccination rates have been declining in the USA since the COVID pandemic, according to a June 3, 2025 Johns Hopkins University news report ( The average county-level MMR vaccination rate in the USA fell from 93.92% pre-pandemic to 91.26% post-pandemic, moving well below the 95% herd immunity threshold that is generally regarded as providing community or herd immunity. Additionally, Measles vaccine failure cases have also been increasing according to the European data, which is an important cause for concern. It is likely that the increase in vaccine failure rate may be due to the increase in a new genotype, D8 of the Measles virus, replacing the previous dominant B3 genotype. The B3 genotype is closer to the Measles vaccine live attenuated Enders-Edmonton "Moraten" strain that has been used in the USA since 1968. The changing genotypes suggest that the Measles virus is likely drifting away from the current vaccine. In this global scenario, NV-387, the clinical stage broad-spectrum, host-mimetic antiviral nanomedicine drug could perhaps be the only currently available drug candidate to combat the Measles virus and disease. Measles cases in Europe were over 35,000 in 2024, an almost ten-fold increase from 2023, according to the annual report of European Center for Disease Prevention and Control (ECDC). Only approximately 87% of cases were in unvaccinated persons, and 13% of the cases were of vaccine failure, out of the cases with known vaccination status. The significant Measles vaccine failure rate observed in Europe is alarming, considering that the two-dose vaccine is supposed to be 97% effective. Overall, childhood vaccination in Europe was about 94% and declining. This rate is below the 95% considered the threshold for achieving "herd" or community immunity. Given the various causes of vaccine failure, and of vaccine hesitancy, attaining 95% vaccine coverage cannot be considered a very probable solution for combating the Measles epidemic. An effective drug is needed to combat the epidemic. ABOUT NANOVIRICIDESNanoViricides, 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
Associated Press
04-06-2025
- Business
- Associated Press
NanoViricides Measles Drug Development Animal Study is Imminent
SHELTON, CT / ACCESS Newswire / June 4, 2025 / 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 its Measles drug development program. The Company has commissioned an animal trial to evaluate certain drug candidates in a lethal animal infection model. The Company has secured specially modified mice that bear the human form of CD150/SLAM protein that the Measles virus requires to enter cells. The Company will initiate the study as soon as the animals arrive and are acclimatized at the animal study laboratory. 'NV-387 actually cured lethal RSV infection in animals, and Measles is a cousin of RSV,' said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, 'This gives us confidence that NV-387 will have strong activity against Measles virus as well.' NV-387 is a clinical stage broad-spectrum antiviral drug that is designed to act as a decoy of a cell, attacking the virus by presenting to it the very features that the virus requires for binding to the cell, and upon binding, destroying the virus particle so it cannot infect. Over 90-95% of human pathogenic viruses require the sulfated proteoglycan feature that NV-387 presents to the virus. There is no approved drug for the treatment of Measles virus infection. Recently, CDC included Vitamin A as part of the standard of care for Measles infection. Vitamin A is known to help malnourished children with Measles, but its role as supplementary addition to non-deficient patients is not known. CDC also recommended use of ribavirin in extreme cases as a last resort. Ribavirin is a toxic nucleoside analog and is not approved for treatment of Measles. Thus there is a clear unmet need for a Measles drug. NV-387, a clinical stage drug can be rapidly developed to meet this need. The animal study of effectiveness of NV-387 in h-SLAM-modified mice will provide important information regarding potential human effectiveness of NV-387 to treat Measles virus infection. Measles outbreaks have continued to expand in the US, reaching a record 1,088 confirmed cases across 33 jurisdictions from January 1 through May 29, 2025 according to CDC ( ). Europe has witnessed a dramatic ten-fold increase in measles cases last year, i.e. 2024, over 2023. Measles vaccination rates have been declining in the USA since the COVID pandemic, according to a June 3, 2025 Johns Hopkins University news report ( ). The average county-level MMR vaccination rate in the USA fell from 93.92% pre-pandemic to 91.26% post-pandemic, moving well below the 95% herd immunity threshold that is generally regarded as providing community or herd immunity. Additionally, Measles vaccine failure cases have also been increasing according to the European data, which is an important cause for concern. It is likely that the increase in vaccine failure rate may be due to the increase in a new genotype, D8 of the Measles virus, replacing the previous dominant B3 genotype. The B3 genotype is closer to the Measles vaccine live attenuated Enders-Edmonton 'Moraten' strain that has been used in the USA since 1968. The changing genotypes suggest that the Measles virus is likely drifting away from the current vaccine. In this global scenario, NV-387, the clinical stage broad-spectrum, host-mimetic antiviral nanomedicine drug could perhaps be the only currently available drug candidate to combat the Measles virus and disease. Measles cases in Europe were over 35,000 in 2024, an almost ten-fold increase from 2023, according to the annual report of European Center for Disease Prevention and Control (ECDC). Only approximately 87% of cases were in unvaccinated persons, and 13% of the cases were of vaccine failure, out of the cases with known vaccination status. The significant Measles vaccine failure rate observed in Europe is alarming, considering that the two-dose vaccine is supposed to be 97% effective. Overall, childhood vaccination in Europe was about 94% and declining. This rate is below the 95% considered the threshold for achieving 'herd' or community immunity. Given the various causes of vaccine failure, and of vaccine hesitancy, attaining 95% vaccine coverage cannot be considered a very probable solution for combating the Measles epidemic. An effective drug is needed to combat the epidemic. 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. [email protected] Public Relations Contact: [email protected] SOURCE: NanoViricides press release
Associated Press
02-06-2025
- Business
- Associated Press
NanoViricides (NNVC) to Unveil ‘Escape-Proof' Antiviral Platform at Major Biotech Convention
NV-387 was found to be highly effective against the 'tripledemic' respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. In all of these cases, NV-387 was substantially superior to existing drugs. NanoViricides (NNVC) is presenting at the prestigious BIO International Convention on June 16th, showcasing their revolutionary broad-spectrum antiviral platform that could transform how we treat viral infections—potentially creating the first 'empiric antiviral therapy' similar to how antibiotics work for bacterial infections. A Major Platform for a Breakthrough Company NanoViricides, Inc. (NYSE American: NNVC) has announced it will be presenting on Monday, June 16th, at 2:30pm at the BIO International Convention 2025 in Boston, MA. This isn't just any conference—the BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with 20,000 industry leaders from across the globe. Event Details: When: Monday, June 16, 2025 at 2:30 PM Where: Room 153B, Boston Convention and Exhibition Center Presenter: Dr. Anil R. Diwan, PhD, President and Executive Chairman The Revolutionary Science Behind NNVC What makes NanoViricides particularly compelling is their unique approach to antiviral therapy. NV-387 is a revolutionary broad-spectrum drug candidate designed to mimic host-side features that the virus particle uses as the first landing site in order to mount a cellular infection. The implications are staggering: an estimated 90-95% of human pathogens utilize the same common landing feature that is mimicked by NV-387, giving the drug its extremely broad antiviral spectrum. Why This Matters: The 'Escape-Proof' Advantage Traditional antivirals face a critical weakness—viruses mutate and develop resistance. NNVC's approach is fundamentally different. The virus cannot escape NV-387 even as it changes in the field, because the virus continues to use the sulfated proteoglycan features for attachment despite all changes. This represents a paradigm shift from existing vaccines, antibodies, and small chemical anti-viral modalities that are all readily defeated by viruses by relatively small changes, often in single viral proteins. Game-Changing Clinical Results The company's lead drug candidate has already demonstrated remarkable efficacy. NV-387 was found to be highly effective against the 'tripledemic' respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. In all of these cases, NV-387 was substantially superior to existing drugs. The Path to 'Empiric Antiviral Therapy' Perhaps most exciting is NNVC's vision for the future of antiviral treatment. NV-387 is expected to become an 'emperic therapy' for viral infections, just as antibiotics such as amoxicillin are used as emperic therapies for bacterial infections. NV-387 would be the first ever drug enabling emperic antiviral therapy, and would be potentially as revolutionary to antiviral therapy as antibiotics have been to anti-bacterial therapy. This means doctors could prescribe antiviral treatment immediately upon seeing a patient with viral symptoms, without waiting for specific test results—a breakthrough that could save countless lives. Diverse Pipeline with Massive Market Potential NNVC isn't a one-trick pony. Their pipeline includes: NV-387: Targeting MPOX, moving toward Phase II trials in response to WHO's Public Health Emergency NV-HHV-1: A pan-herpesvirus drug candidate active against HSV-1, HSV-2, VZV, and potentially CMV, HHV-6, and HHV-8 NV-HIV-1: Showing strong efficacy in HIV infection models The overall market size of NV-387 indications is estimated to be well in excess of $10 billion. Beyond Antivirals: Platform Technology Opportunities The company's nanoviricide platform extends beyond just antiviral applications. The technology enables: Drug Rescue: Encapsulation of a difficult or failed drug within the nanoviricide polymeric micelle can enable rescue of the drug candidate turning it into a clinically viable drug candidate, saving hundreds of millions of dollars of development work Oral Drug Delivery: Including for peptides like GLP-1 obesity drugs Targeted Delivery: Zip-code-specific delivery to tissues, cells, or pathogens What to Watch at BIO Convention Dr. Diwan will be providing updates on the company's drug pipeline and discussing platform technologies available for licensing. Dr. Diwan will also be available for meetings in the BIO Partnering™ match-making platform during the Convention from June 16th through June 19th, 2025. This presents significant partnership and licensing opportunities, potentially accelerating development timelines and providing non-dilutive funding sources. The Bottom Line NanoViricides represents a potentially transformative approach to antiviral therapy. Their presentation at BIO Convention offers a crucial opportunity to showcase their technology to potential partners and investors. With their lead drug candidate moving toward Phase II trials and a platform technology with applications beyond antivirals, NNVC could be positioned at the forefront of a new era in viral disease treatment. The June 16th presentation will be a key catalyst to watch, potentially providing insights into partnership opportunities, development timelines, and the company's strategic direction. For investors interested in revolutionary biotech plays, NNVC deserves serious consideration—while keeping in mind the inherent risks of clinical-stage pharmaceutical development. Some of the other biotech stocks to keep on radar include Vertex Pharmaceuticals (NASDAQ: VRTX), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Summit Therapeutics Inc. (NASDAQ: SMMT) and Moderna, Inc. (NASDAQ: MRNA). Disclaimer: This analysis is for informational purposes only and should not be considered as investment advice. Always conduct your own research and consult with financial advisors before making investment decisions. Clinical-stage pharmaceutical companies carry significant risks, and there can be no assurance of successful drug development or regulatory approval. This blog post is for informational purposes only and does not constitute financial advice or an endorsement of COEP 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 one thousand five hundred dollars by a 3rd party EDM Media for content distribution services on NNVC for June 2nd, 2025. is neither an investment advisor nor a registered broker. 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Source: 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) to Unveil 'Escape-Proof' Antiviral Platform at Major Biotech Convention
