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More than 30,000confirmed or suspected cases of monkeypox have been reported across 93countries in the world. While those numbers are still small scientistsare now concerned that this sudden and unusual outbreak could lead tomonkeypox becoming endemic in these large numbers of new countrieswhere it was only seen sporadically before.
With no specifictreatment approved for the virus, doctors are turning to old smallpoxmedications — a disease that hasn’t had a reported case in nearly50 years — and off-label use of an antiviral approved for smallpoxthat was developed as a medical countermeasure for potentialbioterrorism, SIGA Technologies Inc. ’s (NASDAQ: SIGA) TPOXX.
TPOXX has anumber of shortcomings. Its injectable form requires each dosing to beinfused over 6 hours, twice daily for several days. The injectableform may be considered rapid-acting, for severe cases, but cannot begiven to patients with renal impairment (kidney damage). However,there is an oral capsule form. In terms of mechanism, TPOXX inhibitsorderly exit of a mature virion. However, most of the monkeypox virusparticles exit due to cell lysis, and are infectious even though notfully mature; this mode is not affected by TPOXX.
Most importantly, itsutility in humans has not been established, as it was approved underthe “Animal Rule” authority of the US FDA. It had showneffectiveness in monkeys to increase survival upon monkeypox virusinfection.
Importantly, TPOXX, during its development, has been known togive rise to resistant viruses or escape mutants. Something thatscientists fear can give rise to new monkeypox viruses that may beworse than the current ones, as has been happening with the SARS-CoV-2virus of COVID-19.
Thus there is a clear and immediate need for rapid new drugdevelopment against monkeypox virus and potential variants.
NanoViricides Inc. (NYSE American: NNVC ) reports that it may have a solutionthat would offer a more targeted treatment for the monkeypox virusthat the virus may not escape from by mutations.
The Strange And Sudden Outbreak OfMonkeypox
What’s unusual about the outbreak is that although the“Patient Zero” in UK was connected to travel to Nigeria, andinitial outbreaks occurred connected to raves in Europe, casespreceding to this outbreak have also been found to have occurredearlier, and not all the cases are linked to individuals who traveledto countries where the virus is usually found or have known contactwith infected animals. While researchers are still trying tounderstand how that’s possible, the worry is that it’s been spreadingsilently and undetected for some time.
And it can spreadsilently because an infected person is contagious even before theclassic rash is present. The current outbreak also has differentsymptoms. Usually, a fever and swollen lymph nodes would precede theclassic monkeypox rash and ulcers. However, with this virus, itappears that the rash can occur simultaneously with fever and swollenlymph nodes, or fever may even be absent. This is why possibly therash of this virus was mistaken to be from other viruses such asherpes or shingles, although the monkeypox rashes behave distinctlydifferently from herpes or shingles rashes once formed.
The Spread May Indicate Decreasing ImmunityTo Pox Viruses
The monkeypox virus is a member of the poxviridae family alongwith smallpox, molluscum contagiosum and a few others. During thesmallpox eradication program in the late 1960s, the vaccine used toprevent smallpox also helped curb monkeypox infections.
Since 1980, smallpox hasbeen declared to be entirely eradicated worldwide with successfulworldwide vaccination campaigns. Smallpox does not have any animalreservoirs, it infects only humans, which contributed to itselimination. Monkeypox outbreaks have been regular in the endemicregions of Western and Central Africa, with annually thousands ofcases. Many of these cases are deemed to be tied to transmission fromanimals rather than human to human transmission. But the recent uptickoutside these regions may be related to the fact that many people bornafter the smallpox programs of the 60s stopped in 1980 have never hadthe smallpox vaccine. Even in those who received the smallpox vaccine,it has been over forty to sixty years, and the vaccine was expected tobe effective for fifteen to twenty years only.
With the last naturalreported case of smallpox occurring in 1977 ,smallpox vaccines were seen as no longer necessary and widespreadvaccination campaigns disappeared. While smallpox hasn’t come back,that decline in vaccination rates slowly brewed a generation of peoplewho could be more vulnerable to other pox viruses in the family.
The NanoViricides Platform May OfferA Rapidly Deployable Solution
NanoViricides is a developmental-stage companyworking on an antiviralplatform that a virus theoretically can’t outsmart. Bychemically attaching a binding ligand to a nano-sized polymer, thecompany has created an antiviral that can attach to a virus’sbinding site, which doesn’t mutate even as a virus evolves and lookssimilar across most viruses. Once attached, the nanoviricide engulfsthe viral cell, blocking it from reproducing or infecting healthycells.
Thecompany states that the broad-spectrum antiviral can be tailored to awide range of viruses with the goal of providing a treatment thatremains effective against just about any species and strain of virusthat threatens the human population.
With clinical candidates for COVID-19 and Shingleshaving successfully completed the full battery of IND-enablingstudies, and preclinical research underway for a pipeline of additional treatments tailored to Herpesviruses, HIV, and more, thecompany has already found ways to adapt the platform to a broad rangeof difficult to treat viral infections. The company hopes to tailor anantiviral based on this platform to the recent and worrying resurgenceof monkeypox cases. The Company has recently announced in its pressreleases that it is about to begin testing on its drug candidates formonkeypox virus treatment. The Company also said that it is followinga two-pronged strategy: (a) The first one being to develop a quickdrug to deploy rapidly that improves upon the existing drugtecovirimat so that it can be used widely including in patients thatTPOXX is contraindicated; and (b) The second one being continueddevelopment of highly effective drugs against poxviruses and other DNAviruses that can add a strong drug to the current one-drug repertoireof poxvirus treatments.
AboutNanoViricides
NanoViricides, Inc. (the "Company")(www.nanoviricides.com) is a development stage company that iscreating special purpose nanomaterials for antiviral therapy. TheCompany's novel nanoviricide® class of drug candidates aredesigned to specifically attack enveloped virus particles and todismantle them. Our lead drug candidate is NV-HHV-101 with its firstindication as dermal topical cream for the treatment of shingles rash.In addition, we are developing a clinical candidate for the treatmentof COVID-19 disease caused by SARS-CoV-2 coronavirus. The Companycannot project an exact date for filing an IND for this drug becauseof its dependence on a number of external collaborators andconsultants.The Company is now working on tasks for completing an INDapplication. The Company is currently pursuing two separate drugcandidates for the treatment of COVID-19 patients. NV-CoV-2 is ournanoviricide drug candidate that does not encapsulate Remdesivir.NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2with Remdesivir encapsulated in it. The Company believes that sinceRemdesivir is already US FDA approved, our drug candidateencapsulating Remdesivir is likely to be an approvable drug, if safetyis comparable. Remdesivir is developed by Gilead. The Company hasdeveloped both of its own drug candidates NV-CoV-2 and NV-CoV-2-Rindependently.The Company intends to re-engage into an IND applicationto the US FDA for NV-HHV-101 drug candidate for the treatment ofshingles once its COVID-19 project moves into clinical trials, basedon resources availability. The NV-HHV-101 program was slowed downbecause of the effects of recent COVID-19 restrictions, andre-prioritization for COVID-19 drug development work.The Company isalso developing drugs against a number of viral diseases includingoral and genital Herpes, viral diseases of the eye including EKC andherpes 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 theTheraCour® nanomedicine technology of TheraCour, which TheraCourlicenses from AllExcel. NanoViricides holds a worldwide exclusiveperpetual license to this technology for several drugs with specifictargeting mechanisms in perpetuity for the treatment of the followinghuman viral diseases: Human Immunodeficiency Virus (HIV/AIDS),Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, HerpesSimplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),Influenza and Asian Bird Flu Virus, Dengue viruses, JapaneseEncephalitis virus, West Nile Virus, Ebola/Marburg viruses, andcertain Coronaviruses. The Company intends to obtain a license forpoxviruses if the initial research is successful. The Company'stechnology is based on broad, exclusive, sub-licensable, fieldlicenses to drugs developed in these areas from TheraCour Pharma, Inc.The Company's business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specificviruses, as established at its foundation in 2005.
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