SHELTON, CT / ACCESS Newswire / March 4, 2025 / The HHS Department Secretary Robert F. Kennedy Jr. wrote an Opinion piece in the FoxNews entitled "Measles outbreak is call to action for all of us". He identifies an important issue that, "…there is no approved antiviral for those who may be infected…"[1].
Parents of children who are suffering, and the doctors who are treating them, are frustrated with the lack of any treatment. Mr. Kennedy clearly understands that the plight of suffering patients cannot be relieved without a drug to treat measles.
"We applaud Secretary Kennedy for recognizing the urgency of the situation and taking all possible steps including promoting vaccination in response to this outbreak, while clearly recognizing the deficiency in the response to be the lack of an effective treatment for measles viral disease," said Anil R. Diwan, PhD., President of NanoViricides, Inc.
NanoViricides believes that NV-387, the Company's flagship broad-spectrum antiviral, would be a potentially effective treatment for measles, and is worth evaluating during the current emergency situation created by the spreading outbreak. This belief has a strong rationale as explained below.
NV-387 is a broad-spectrum antiviral drug that has been found to be effective against many distinctly different virus families that use heparan sulfate proteoglycans (HSPG) during attachment to infect cells, including RSV, Influenza, COVID/Coronaviruses and Mpox/Smallpox[2].
We believe it is highly likely that NV-387 should work against measles based on our studies that clearly indicate measles virus also uses HSPG during attachment to infect cells[3].
Further, Measles virus belongs to the same family of paramyxoviruses that RSV belongs to[4]. Treatment with NV-387 was found to cure RSV infection in a lethal animal model study. Therefore, it is reasonable to anticípate that NV-387 could be effective against the measles virus.
"We would love to support the HHS Secretary's efforts and supplement those of the public health professionals in this time of crisis," said Anil R. Diwan, PhD, President of the Company, adding, "We believe that an investigator-initiated clinical-trial to evaluate NV-387 as a treatment for measles within the current US FDA regulatory framework is warranted. If successful, NV-387 could be used to treat additional patients within an emergency outbreak regulatory framework, and thereby significantly help in augmenting the response to the current situation."
We note that the current efforts at containment with case-tracking, contact-tracing and isolation, face daunting challenges to be effective because measles is far more contagious than SARS-CoV-2 that caused the global COVID pandemic. In fact, measles is the most contagious disease known to humans. Also, a person may be contagious several days before any obvious rash symptoms appear, and remains contagious for several days afterwards. A COVID-era-style lockup certainly is not warranted, but spread of the disease could continue until the outbreak extinguishes itself as has generally happened in recent measles outbreaks.
The fact that even vaccinated children are being hospitalized with the current measles virus should not be taken lightly, even though their percentage remains relatively small[5]. The vaccine strain of measles virus is derived from genotype A, whereas the current infection in Texas is driven by genotype D.8. The standard measles live attenuated virus vaccine since circa 1968 has continued to remain highly effective because the measles virus has undergone very few mutations over centuries, and because this virus only infects humans and does not have any other animal reservoirs to sustain it. However, this situation appears to be changing. Over the last decade, several genotypes arose and only a few have survived in the last few years, indicating a gain in fitness, as well as divergence from the original genotype A, which is still the only vaccine strain. It is not unlikely that the historically known 95-97% effectiveness of the standard measles vaccine may have begun to wane as new virus variants arise under the selective pressure of the current vaccine.
Further, vaccination during a growing outbreak does not necessarily protect the newly vaccinated since the vaccine takes several weeks to become effective in the vaccinated individual, as is well known. Vaccination, while laudable for its future effects, is insufficient as a response to the current outbreak.
Not having a drug to treat measles has resulted in a critical gap in the outbreak response.
On Friday, February 28th, the Secretary of HHS Robert F. Kennedy Jr. Posted on X that "Ending the measles outbreak is a top priority for me and my extraordinary team at HHS," and listed the steps being taken by his administration, including vaccination. (https://x.com/SecKennedy/status/1895585297351799198?mod=ANLink ). He further elaborated on the situation in the FoxNews opinion piece cited earlier.
"We agree with the HHS Secretary's opinion piece that describes the current administration's robust implementation of standard public health response practices including vaccination, while identifying that the administration is working diligently in spite of a lack of effective treatment," said Dr. Diwan, adding, "In this emergency situation, we urge the Secretary to support NanoViricides, Inc.'s efforts to further develop and commercialize its revolutionary medicine NV-387, a broad-spectrum antiviral drug that is not only expected to treat the measles virus infection and help suffering patients, but also to serve as a robust platform addition for future outbreak and pandemic response against a multitude of viruses."
As discussed in prior press releases, NV-387 is expected to remain an effective treatment even as viruses mutate.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.
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[1] In this Opinion piece, Mr. Kennedy has identified the main pillars of the response to the outbreak. He states that "Vaccines not only protect individual children from measles, but also contribute to community immunity, protecting those who are unable to be vaccinated due to medical reasons," adding that "The decision to vaccinate is a personal one," promoting vaccination while educating the public regarding the safety and effectiveness of the MMR vaccine. He also states that while there is no approved antiviral for treatment, CDC is now recommending the Vitamin A treatment protocol for patients under physician supervision.
Regarding the use of Vitamin A, we note that the physician supervision is necessary because of liver toxicity of high doses of vitamin A and its metabolites. We further note that Vitamin A is found to reduce measles mortality in studies performed in nations where nutritional deficiencies are significant, and the relevance of these studies for USA is not known. Thus the Vitamin A treatment protocol only serves to highlight the issue that there is no effective treatment for measles.
[2] NV-387 has been found to be superior to existing drugs in treating lethal infections in animal models. It was substantially superior to Tamiflu®, Rapivab®, as well as Xofluza®, in treating lethal Influenza A infection. It was found to be superior to TPOXX® in treating lethal MPox infection in two different animal models, one for skin-to-skin infection, and another for direct lung infection. The same drug was found to be substantially superior to injectable Remdesivir in treating a lethal Coronavirus infection animal model of COVID. Additionally, the same drug was found to completely cure lethal RSV infection in an animal model. In pre-clinical animal studies, its safety indexes were extremely strong, as indicated by a NOAEL of 1,200 mg/kg and a MTD of 1,500 mg/kg. NV-387 was found to be safe and well tolerated in a Phase 1 clinical trial in healthy volunteers.
[3] We performed computer modeling based investigations of the known structures of both surface proteins of Measles virus, namely, the H protein, and the F protein. In the 3-dimensional structures of both of these proteins, we have found large regions of contiguous positive charges. This finding clearly indicates that both H and F coat proteins of Measles virus would attach to HSPG during the process of infecting cells. Thus, this structural study provides substantial rationale that NV-387 could be effective in the treatment of Measles virus infection.
[4] Most viruses interact with HSPG or other similar structures, called "Attachment Receptor(s)" first. This leads to many virus particles concentrating near the cell, ready to mount an attack. It enables the virus particles to come close to the cell, and thereafter bind to one of a few specific proteins that enable internalization of the virus into the cell, called "Cognate Receptor(s)". For example, SARS-CoV-2 uses HSPG for attachment, and then ACE2 as the cognate receptor. Measles virus uses CD150 (aka hSLAM) and Nectin-4 as cognate receptors. Our finding has shown that Measles virus uses HSPG as an attachment receptor. RSV also uses HSPG as an attachment receptor.
[5] The Secretary's Opinion piece (ibid) notes that "The current Texas outbreak has predominantly affected children, with 116 of the 146 cases occurring in individuals under 18 years of age. The DSHS reports that 79 of the confirmed cases involved individuals who had not received the measles, mumps, and rubella (MMR) vaccine, while 62 cases had unknown vaccine status. At least five had received an MMR vaccine."
From this, one can calculate that at least 3.5% of the confirmed cases were vaccinated, and this number could be possibly larger because nearly 42.5% of patients had unknown vaccine status. Only 54% of the cases occurred in truly unvaccinated persons.
SOURCE: NanoViricides
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