New Host-Mimetic Technology Platform to Kill Viruses
SHELTON, CT / ACCESSWIRE / May 29, 2024 /NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), a global clinical-stage leader in broad-spectrum antiviral nanomedicines, highlights its progression of a world-class online broad-spectrum antiviral agent that can revolutionize the treatment of viral infections, adding RSV, COVID, influenza, and other viruses.
“Resistance is useless”: host mimetic generation to solve the greatest of antiviral drugs: virus evasion
No matter how tight a virus is in the field, it uses the same “landing sites” in the host framework to access, bind, and then fuse with cells, i. e. , an infection. A drug occupies the same landing sites and acts as a “decoy. “It would still be effective against the virus even if the virus changes, because the appearance of the host does not change.
NV-387 is designed to use such a complex “host mimetic” technology, incorporated with nanoviricidal™ nanomedicine, that it is designed to “look like a cell” to the virus.
Conversely, vaccines, antibodies, and small chemical drugs lose their effectiveness as the virus evolves in the field. The virus is constantly evolving due to herbal mechanisms such as mutations, recombinations, and/or rearrangements inherent in the life cycle of the virus. .
The incredibly broad antiviral spectrum of NV-387 is due to the fact that many different viruses use common landing sites on the hostside.
More than 90% of human pathogenic viruses are known to use one or more “landing sites” that belong to the sulfated proteoglycan (“SPG”) family. to attack most, if not all, of those viruses.
NV-387 is designed to mimic SPG and attack the virus like a cell-mimicking decoy. We’ve accumulated really extensive evidence that, in animal studies of fatal viral infections, NV-387 demonstrated antiviral activity unlike a diversity of other virus families. , surpassing or equaling the activity of known approved pharmacological agents.
NV-387 was particularly good at remdesivir in coronavirus infections, employing a design for the SARS-CoV-2 (COVID) virus, as previously reported. We know that NV-387 remains one of the most active antiviral drugs against various coronaviruses and is a viable clinical candidate for drug progression to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections.
NV-387 was particularly surprising for the three approved drugs, namely Tamiflu®, Rapivab® and Xofluza®, unlike a study of fatal lung viral infection with the H3N2 influenza virus, as reported in the past. It is also expected to possess strong antiviral activity opposite to the H5N1 “avian flu,” given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and is based on the observed broad-spectrum activity of NV-387.
NV-387 was found to be at least as effective as TPOXX® in an animal model study for smallpox/smallpox drug progression, of two other ways of contracting the infection, as previously reported.
In addition, we found that NV-387 is capable of absolutely curing a deadly RSV lung virus infection in animals, leading to the indefinite survival of the animals, as recently reported. There is no cure for RSV or any approved medication to remedy it. RSV infection other than the poisonous drug of last resort, ribavirin.
In addition, even novel viruses, whether from herbal resources or bioengineered, are expected to be vulnerable to NV-387 if they use SPG in human cells to infect and cause disease. Therefore, NV-387 can be very useful for preparedness against new viral epidemics and pandemics.
Therefore, NV-387 could be a single drug to treat all “tripledemic” viruses, and more, once approved.
The protection of NV-387 has been effectively studied in human clinical trials without adverse events.
NV-387 is inherently designed to be safe, thanks to careful selection of parts of the nanovirucidal polymer, and this has been proven through our studies.
Upon conducting the human clinical trials, we found that the protection of NV-387 was demonstrated through the maximum NOAEL rate of 1200 mg/Kg and the BAT rate of 1500 mg/Kg in rats. We also found that NV-387 is non-mutagenic, non-genotoxic, non-immunogenic and studies imply that allergenicity is not an issue; all the parameters that imply fair security.
A Phase I clinical trial of NV-387 oral syrup and NV-387 oral gummies was effectively completed with no adverse events reported. We are awaiting reports from the ORC to detail the findings.
“An antiviral agent with an extremely broad spectrum of antiviral activity, coupled with maximum safety, is the ‘holy grail’ of antiviral drugs,” said Anil R. Diwan, Ph. D. , the company’s president and chief executive officer, adding, “We believe that our direct-acting host-mimetic nanoviricide™ generation platform, capable of destroying viral particles, He has made this possible. NV-387 is now in a position to conduct Phase II studies with a view to obtaining regulatory approvals worldwide. He added: “If approved, NV-387 could be as revolutionary an antiviral agent as penicillin as an antibacterial agent. “
About Nanoviricides
NanoViricides, Inc. (the “Company”) (www. nanoviricides. com) is a development-stage company that creates special-purpose nanomaterials for antiviral therapy. The company’s new range of nanoviricidal® drug applicants is designed to target enveloped viruses in particular. debris and dismantle it. In addition, nanoviricides mimic host characteristics that viruses continue to crave despite mutations, and viruses are highly unlikely to evade nanvoricide drugs.
Our lead drug candidate is NV-387 (NV-CoV-2 pharmaceutical) for the treatment of RSV, COVID-19, long COVID, influenza, H5N1 avian influenza, and other respiratory viral infections. NV-387 has effectively completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse effects, even at repeated higher and maximum doses. This trial was conducted through the drug’s sponsor, Karveer Meditech Pvt. Ltd. , our licensee and collaborator in India.
Currently, the company has focused on advancing NV-387 to phase II human clinical trials for the treatment of RSV infection.
Our other complex candidate is NV-HHV-1 for the treatment of shingles rashes, HSV-1 “cold sores” and HSV-2 “genital ulcers”. The company cannot wait for a precise date for the submission of an IND for any of its drugs due to its reliance on various external collaborators and consultants.
The company is also developing drugs for a number of viral diseases, adding oral and genital herpes, viral eye diseases adding EKC and herpetic keratitis, H1N1 swine flu, H5N1 bird flu, seasonal flu, HIV, hepatitis C, rabies, dengue and Ebola, among others. The NanoViricides platform generation and systems are based on TheraCour’s TheraCour® nanomedicine generation, which TheraCour licenses to AllExcel. NanoViricides holds an exclusive international perpetual license for this generation of various drugs with express targeting mechanisms in perpetuity for the remedy 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 avian influenza viruses, dengue virus, Japanese encephalitis virus, West Nile, Ebola/Marburg virus and some coronaviruses. The Company intends to license poxviruses and/or enteroviruses if initial studies are successful. The Company’s generation is based on broad, exclusive and sublicensable cash licenses for drugs developed in those spaces through TheraCour Pharma, Inc. The Company’s business style is based on TheraCour Pharma Inc. ‘s generation of licenses for express virus express vertical programs, as stated at its founding in 2005.
As usual, the company mentions the threat factor, which is that the path to typical progression for a pharmaceutical product is incredibly long and requires significant capital. As with any drug progression effort from any company, there can be no guarantee in this regard. at which point any of the company’s pharmaceutical applicants would demonstrate sufficient efficacy and protection for clinical progression in humans. In addition, there is no guarantee at this time that the positive effects of the coronavirus in our laboratory will lead to successful clinical trials or a successful pharmaceutical product.
This press release includes forward-looking statements that reflect the Company’s existing expectations regarding long-term events. Actual events may also differ materially and materially from those projected here and have a number of points. Certain statements contained in this release and other written or oral statements made through 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. 1934. We should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other matters which, in some cases, are beyond the control of the Company and which may also have, and probably will have, material effects on the effects real. , degrees of activity and performance. or achievements. The Company undertakes no legal responsibility to publicly update or revise such forward-looking statements for any reason, nor to update the reasons why actual effects may also differ materially from those anticipated in such forward-looking statements, even if new data is released. be achieved in the long term. Important points that may also cause actual effects to differ materially from the Company’s expectations come with, among others, the points disclosed under the heading “Risk Factors” and elsewhere in the Company’s filings from time to time. . another from the United States. Securities and Exchange Commission and other regulatory authorities. Although it is not possible to expect or identify all of these details, they are likely to include the following: demonstration and evidence-in-principle in preclinical trials that a nanoviricide is safe and effective; a successful progression of our product candidates; our ability to seek and download regulatory approvals, aggregated with respect to the indications we seek; the successful commercialization of our product candidates; and acceptance of the market position of our products.
The terms “protection,” “efficacy,” and expressions used in this press release refer to study results, including clinical trials, as commonly used in studies and do not imply an evaluation of protection or efficacy by the U. S. FDA. U. S.
“NOAEL” stands for “Unobserved adevrese event level,” which is the dose used at which no adverse events have been found in animal studies.
“BAT” stands for “maximum tolerated dose”, which is the maximum dose used that does compromise the survival of the animals.
FDA refers to the U. S. Food and Drug Administration. The IND application refers to the “investigational new drug” application. cGMP refers to existing good manufacturing practices. CMC stands for “Chemistry, Manufacturing, and Controls. “CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee for medicinal products for human use. API stands for “Active Pharmaceutical Ingredient”. API stands for Active Pharmaceutical Ingredient.
Contact:
NanoViricides, Inc. info@nanoviricides. com
PR Contact: MJ Clyburn, TraDigital IR clyburn@tradigitalir. com
SOURCE: NanoViricides, Inc.
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