The Centers for Disease Control (CDC) remains vigilant against the increased spread or return of COVID because there are still close to 20,000 hospitalizations with as many as 2,300 deaths weekly directly from COVID infections in the USA as of March 5, 2023.
Yet, effective treatments for COVID still remain elusive. Even so-called “hybrid immunity,” a combination of immunity derived from vaccines and from natural infections, offers full or partial protection against reinfection only for around eight months. All the antibodies that were developed to fight the virus are essentially useless by now as the virus keeps on changing its cloak. Therefore, the world continues to need an effective treatment for COVID.
However, exciting news exists in that there is a company, NanoViricides Inc. (NYSE: NNVC), that has rapidly developed a novel drug against COVID and most coronaviruses.
Significant problems with the remaining antivirals currently on the market for COVID are known: Molnupiravir (Merck, MRK), a pill that prevents replication of the viral RNA genome, is potentially mutagenic, which can bring the risk of cancer and other diseases; Paxlovid (Pfizer, PFZ), an oral COVID antiviral, shows little effect on patients under 65 and the World Health Organization has recommendations against the use of Remdesivir (Gilead, GILD), a treatment only available intravenously and only for hospitalized patients.
Meanwhile, COVID is not gone. Rather, it is now everywhere, with the potential of breaking out into severe pandemics every few years.
Therefore, developing effective antivirals remains the only viable long-term strategy against COVID. Antivirals help the patient recover, help the immune system prevent the disease from causing serious harm, and importantly, effective antivirals also stop the virus from spreading.
NanoViricides, a leading nano-pharmaceutical drug development and commercialization company, is directly addressing this very important unmet need in healthcare. The company has rapidly developed a novel drug that works against most coronaviruses including SARS-CoV-2.
NanoViricides is now getting ready to start clinical trials outside the US for its lead clinical drug candidate, NV-CoV-2, an antiviral to treat almost all important human coronaviruses. These coronaviruses include SARS-CoV-2 and its variants which cause COVID, the seasonal coronaviruses that cause common colds such as OC-43, H229E, including the more severe ones that cause acute respiratory syndromes similar to COVID like NL63, and also the deadly ones like SARS-CoV-1 and MERS.
These coronaviruses are important because while SARS-CoV-2 became a major pandemic, other endemic coronaviruses have been causing loss of productivity, human suffering, and deaths every year, along with causing minor epidemics with different types erupting around the globe. And all of these viruses have the potential to generate variants that can result in major pandemics.
There are four known currently circulating globally endemic human coronaviruses, namely, hCoV-229E, hCoV-OC43, hCoV-HKU1, and hCoV-NL63. Of these, NL63 causes symptoms similar to the Delta SARS-CoV-2, with lower-lung disease and breathlessness, but with less severity and lower fatality rates. In addition, the deadly SARS-CoV-1 caused a small global epidemic around 2002-2004; and the even more deadly MERS, which survives in camels, continues to be a threat for travelers and residents of Middle Eastern countries. SARS-CoV-1 is presumed to be extinct because of its overall high case fatality rate of around 10%. MERS is sporadic because it has a very poor ability for human-to-human transmission, but its case fatality rate is approximately 35%, rivaling Ebola and Marburg viruses.
NanoViricides, Inc says NV-CoV-2 is a “broad-spectrum” drug, which means that no matter how much the coronavirus changes, this drug will continue to be effective. The Company believes this drug will be substantially more effective than other therapies and treatments already on the market. Also, it believes that NV-CoV-2 can be added to other therapy regimens to achieve greater effectiveness because it works by a mechanism different from that of the other available COVID drugs.
The Company has three formulations of the NV-CoV-2 drug – as oral gummies, oral syrup, and as a solution for injection, infusion, and inhalation. These multiple formulations make the drug applicable to a wide range of patients: both with or without comorbidities; to out-patients with mild to moderate COVID infection; as well as to severe hospitalized cases.
NanoViricides is excited to move forward with its potential treatment for COVID and help facilitate the healthcare industry’s efforts to deal with the ever-existing threat of coronavirus pandemics and to serve the market for COVID therapies and treatments which is currently worth more than $11 billion globally.
NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus.
The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it.
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 intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
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 poxviruses if the initial research is successful. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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