Hello Everyone,
We are keeping a close eye on NNVC today.
If you read the report then you know that this one is a past winner that is sitting right at that support line in the 1.10 area.
This one has been drifting lower on light interest over the past month.
We are going to watch this one closely today and the rest of the week as we could see a potential rebound off of this level.
Publicly traded companies have a lot of incentive to stay above the all important 1 Buck level which.
It is a critical "psychological" level for traders as well. Some guys just won't cross that dollar threshold.
Make sure you read today's news and keep it at the top of your screen.
NanoViricides Engages CRO for Phase II Clinical Trial
SHELTON, CT / ACCESS Newswire / January 27, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that it has engaged a Clinical Research Organization (CRO) to conduct a Phase II clinical trial advancing its broad-spectrum antiviral drug NV-387 further into the regulatory pipeline.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., further commenting, "Our regulatory development strategy for this drug is now further advancing into a Phase II clinical trial stage."
The Company has previously stated that it is working towards a Phase II clinical trial to evaluate the effectiveness of NV-387 for the treatment of MPox patients. MPox disease, caused by the human Mpox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the African region, including the Democratic Republic of Congo (DRC), Uganda, and others. It led to the WHOdeclaring a Public Health Emergency of International Concern ("PHEIC") on August 14, 2024.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.
In July 2024, SIGA received a procurement order for $112.5 million of oral TPOXX from the U.S. Government under the 19C BARDA contract, for delivery to the U.S. Strategic National Stockpile (SNS), despite the clinical trial failure. Additionally, in August, 2024, SIGA received a procurement contract and related order from the U.S. Department of Defense for approximately $9 million of oral TPOXX, as well as a small amount of IV TPOXX, despite clinical trial failure.
"These desperate attempts by the Previous US Administration to acquire an ineffective drug with hundreds of millions of dollars of taxpayer money only go to show how sorely a truly effective antiviral drug that works against MPox/Smallpox is needed by the government agencies," commented Anil R. Diwan, PhD, President and Executive Chairman of the Company.
NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.
In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.
Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37.
In contrast, viruses are highly unlikely to escape NV-387 because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.
NV-387 is host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.
Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses wirth small changes that viruses undergo as they are faced with these challenges in the field.
Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.
NV-387 has already been found to be able to cure lethally RSV infected mice.
NV-387 was found to be significantly superior to oseltamivir (Tamiflu®), baloxavir (Xofluza®), and premivir (Rapivab®) in a lethal Influenza lung infection model designed to rank-order the effectiveness of these various drugs.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, as their limitations have become clearly evident during the COVID-19 pandemic.
About NanoViricides
NNVC is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. 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 currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.
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