'Resistance is Futile' - Host-Mimetic Technology To Solve the Greatest Pain for Antiviral Medicines, i.e. Virus Escape
No matter how much a virus changes in the field, it uses the same 'landing sites' in the host body to gain access to cells, attach to and then fuse into the cells, causing an infection. A drug using the same landing sites and acting as a 'decoy' would remain effective against the virus even as the virus changes, because the host side does not change.
NV-387 is designed to employ such advanced 'host-mimetic' technology, built into the nanoviricide nanomedicine that is further designed to 'look like a cell' to the virus.
In contrast, vaccines, antibodies and small chemical drugs all lose their effectiveness as the virus changes in the field. The virus is constantly changing due to various natural mechanisms such as mutations, recombinations, and/or re-assortments that are native to the virus lifecycle.
Extremely Broad Antiviral Spectrum of NV-387 Resulted Because Many Diverse Viruses Use Common Host-Side Landing Sites
Over 90% of human pathogenic viruses are known to use one or more 'landing sites' that are in the Sulfated Proteoglycans ('SPG') family. A successful host-mimetic nanoviricide drug using SPG as the key feature to attract viruses could theoretically be able to attack most if not all such viruses.
NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. We have accumulated substantial evidence that in lethal viral infection animal studies, NV-387 demonstrated strong antiviral activity against a range of different virus families, exceeding or matching the activity of known approved drug agents.
NV-387 was substantially superior to remdesivir in coronavirus infections, using a model for SARS-CoV-2 (COVID) virus, as reported earlier. We believe that NV-387 continues to be one of the most active antiviral drugs against multiple coronaviruses, and that it is a viable clinical candidate for drug development to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections.
NV-387 was substantially superior to the three approved drugs, namely Tamiflu, Rapivab, and Xofluza against an Influenza H3N2 lethal lung viral infection study, as previously reported. We believe that NV-387 is expected to possess strong antiviral activity against H5N1 'Bird Flu' as well, given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and based on the observed broad-spectrum activity of NV-387.
NV-387 was at least as good as TPOXX in a model animal study for the development of Smallpox/Mpox drugs, in two different ways of acquiring infection, as reported earlier.
Further, we found that NV-387 is capable of completely curing a lethal RSV lung virus infection in animals, leading to indefinite survival of the animals, as reported recently. There is no cure for RSV, and no approved drug for treatment of RSV infection other than the toxic last-resort drug ribavirin.
Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ SPG for gaining access to human cells to infect and cause disease.
NV-387 could thus be a single drug to treat all of the 'tripledemic' viruses, and more, when so approved.
Safety of NV-387 Studied Successfully in Phase I Human Clinical Trials with No Adverse Events
NV-387 is inherently designed to be safe, by careful choice of the components of the nanoviricide polymeric chemical, and this was borne out in our studies.
Leading to the human clinical trials, we had found that the safety of NV-387 was demonstrated by the very large NOAELvalue of 1,200mg/Kg and MTD value of 1,500mg/Kg in rats. We had also found that NV-387 was non-mutagenic, non-genotoxic, non-immunogenic, and studies indicated that allergenicity was not an issue; all parameters that indicate excellent safety.
A Phase I clinical trial of NV-387 Oral Syrup and NV-387 Oral Gummies was completed successfully with no adverse events reported. We are awaiting reports from the CRO to further elaborate on the findings.
'An antiviral agent with an extra-ordinarily broad spectrum of antiviral activity, coupled with strong safety, is a 'holy grail' of antiviral medicines,' said
About
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor,
The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 'cold sores' and HSV-2 'genital ulcers'. 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 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.
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
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
'NOAEL' means 'No-Observed-Adevrese-Event-Level', which is the maximum dosage employed at which there were no adverse events found in animal studies.
'MTD' means 'Maximum Tolerated Dose', which is the maximum dosage employed that does not compromise survival of the animals.
FDA refers to
Contact:
Email: info@nanoviricides.com
MJ Clyburn
Email: clyburn@tradigitalir.com
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