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More than 30,000 confirmed or suspected cases of monkeypox have been reported across 93 countries in the world. While those numbers are still small scientists are now concerned that this sudden and unusual outbreak could lead to monkeypox becoming endemic in these large numbers of new countries where it was only seen sporadically before.
With no specific treatment approved for the virus, doctors are turning to old smallpox medications - a disease that hasn't had a reported case in nearly 50 years - and off-label use of an antiviral approved for smallpox that was developed as a medical countermeasure for potential bioterrorism, SIGA Technologies Inc.'s (NASDAQ: SIGA) TPOXX.
TPOXX has a number of shortcomings. Its injectable form requires each dosing to be infused over 6 hours, twice daily for several days. The injectable form may be considered rapid-acting, for severe cases, but cannot be given to patients with renal impairment (kidney damage). However, there is an oral capsule form. In terms of mechanism, TPOXX inhibits orderly exit of a mature virion. However, most of the monkeypox virus particles exit due to cell lysis, and are infectious even though not fully mature; this mode is not affected by TPOXX.
Most importantly, its utility in humans has not been established, as it was approved under the "Animal Rule" authority of the US FDA. It had shown effectiveness in monkeys to increase survival upon monkeypox virus infection.
Importantly, TPOXX, during its development, has been known to give rise to resistant viruses or escape mutants. Something that scientists fear can give rise to new monkeypox viruses that may be worse than the current ones, as has been happening with the SARS-CoV-2 virus of COVID-19.
Thus there is a clear and immediate need for rapid new drug development against monkeypox virus and potential variants.
NanoViricides Inc. (NYSE American: NNVC) reports that it may have a solution that would offer a more targeted treatment for the monkeypox virus that the virus may not escape from by mutations.
The Strange And Sudden Outbreak Of Monkeypox
What's unusual about the outbreak is that although the "Patient Zero" in UK was connected to travel to Nigeria, and initial outbreaks occurred connected to raves in Europe, cases preceding to this outbreak have also been found to have occurred earlier, and not all the cases are linked to individuals who traveled to countries where the virus is usually found or have known contact with infected animals. While researchers are still trying to understand how that's possible, the worry is that it's been spreading silently and undetected for some time.
And it can spread silently because an infected person is contagious even before the classic rash is present. The current outbreak also has different symptoms. Usually, a fever and swollen lymph nodes would precede the classic monkeypox rash and ulcers. However, with this virus, it appears that the rash can occur simultaneously with fever and swollen lymph nodes, or fever may even be absent. This is why possibly the rash of this virus was mistaken to be from other viruses such as herpes or shingles, although the monkeypox rashes behave distinctly differently from herpes or shingles rashes once formed.
The Spread May Indicate Decreasing Immunity To Pox Viruses
The monkeypox virus is a member of the poxviridae family along with smallpox, molluscum contagiosum and a few others. During the smallpox eradication program in the late 1960s, the vaccine used to prevent smallpox also helped curb monkeypox infections.
Since 1980, smallpox has been declared to be entirely eradicated worldwide with successful worldwide vaccination campaigns. Smallpox does not have any animal reservoirs, it infects only humans, which contributed to its elimination. Monkeypox outbreaks have been regular in the endemic regions of Western and Central Africa, with annually thousands of cases. Many of these cases are deemed to be tied to transmission from animals rather than human to human transmission. But the recent uptick outside these regions may be related to the fact that many people born after the smallpox programs of the 60s stopped in 1980 have never had the smallpox vaccine. Even in those who received the smallpox vaccine, it has been over forty to sixty years, and the vaccine was expected to be effective for fifteen to twenty years only.
With the last natural reported case of smallpox occurring in 1977, smallpox vaccines were seen as no longer necessary and widespread vaccination campaigns disappeared. While smallpox hasn't come back, that decline in vaccination rates slowly brewed a generation of people who could be more vulnerable to other pox viruses in the family.
The NanoViricides Platform May Offer A Rapidly Deployable Solution
NanoViricides is a developmental-stage company working on an antiviral platform that a virus theoretically can't outsmart. By chemically attaching a binding ligand to a nano-sized polymer, the company has created an antiviral that can attach to a virus's binding site, which doesn't mutate even as a virus evolves and looks similar across most viruses. Once attached, the nanoviricide engulfs the viral cell, blocking it from reproducing or infecting healthy cells.
The company states that the broad-spectrum antiviral can be tailored to a wide range of viruses with the goal of providing a treatment that remains effective against just about any species and strain of virus that threatens the human population.
With clinical candidates for COVID-19 and Shingles having successfully completed the full battery of IND-enabling studies, and preclinical research underway for a pipeline of additional treatments tailored to Herpesviruses, HIV, and more, the company has already found ways to adapt the platform to a broad range of difficult to treat viral infections. The company hopes to tailor an antiviral based on this platform to the recent and worrying resurgence of monkeypox cases. The Company has recently announced in its press releases that it is about to begin testing on its drug candidates for monkeypox virus treatment. The Company also said that it is following a two-pronged strategy: (a) The first one being to develop a quick drug to deploy rapidly that improves upon the existing drug tecovirimat so that it can be used widely including in patients that TPOXX is contraindicated; and (b) The second one being continued development of highly effective drugs against poxviruses and other DNA viruses that can add a strong drug to the current one-drug repertoire of poxvirus treatments.
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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