NanoViricides Has Shipped Drug Products for Impending Clinical Trials of NV-CoV-2, Its COVID Drug Candidate
SHELTON, CT / ACCESSWIRE / April 17, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in nanomedicines against viruses, announced today that it has shipped the drug products for impending clinical trials of NV-CoV-2, its COVID drug candidate, to its collaborator, Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer").
Karveer has already successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 as a COVID treatment in India. It has retained a well-regarded local Clinical Research Organization to conduct the NV-CoV-2 human clinical trials.
Even as U.S. President Joe Biden recently signed a resolution to end the COVID-19 emergency, SARS-CoV-2 continues to claim over 1,700 lives per week in the USA alone, in what is currently a "non-wave" period, claiming five times the number of lives taken by Influenza viruses. The SARS-CoV-2 virus with its continually evolving variants is now a continuously recurring phenomenon, like other seasonal viruses such as Influenzas.
The Company targets NV-CoV-2 to fulfill an important medical need that remains unmet even today. There is no antiviral COVID drug available yet that can be used for the treatment of all segments of patient population. Equally noteworthy, there is no antiviral COVID drug available yet that can be expected to continue to work even as new variants of the SARS-CoV-2 keep evolving and spreading in the field.
NV-CoV-2 is a broad-spectrum, pan-coronavirus drug that is unlikely to be overcome by SARS-CoV-2 variants, because of the very nature of how NV-CoV-2 is designed. It has been found to work against many unrelated coronaviruses in pre-clinical studies, supporting this expectation.
Additionally, the observed strong pre-clinical safety of NV-CoV-2 indicates that the drug would be applicable to treat disease in all populations from pediatrics to otherwise healthy adults to patients with co-morbidities. NV-CoV-2 has shown extremely strong safety in multiple pre-clinical animal models in both GLP and non-GLP studies. In particular, its extremely strong safety is seen in its NOAEL* value of 1,200 mg/Kg and MTD* value of 1,500 mg/Kg in rats. The drug was also found to be non-immunogenic and non-mutagenic. Further, there were no indications of possible allergy or injection-site reactions in any of the studies across multiple animal models.
NV-CoV-2 is expected to be available for the treatment of mild to moderate disease in two orally available forms, oral syrup and oral gummies to suit patients from pediatrics to healthy adults to patients with co-morbidities. It is expected to be available in an injectable form for the treatment of out-patients (i.e. non-hospitalized) with severe disease. It is also expected to be available in an infusion form as well as a direct lung inhalation form for the treatment of hospitalized patients with severe disease.
In contrast, currently approved antiviral drugs against SARS-CoV-2 have significant limitations on the segment of population in which they can be useful, severely restricting their applicability.
The NV-CoV-2 oral syrup and oral gummies drug products were shipped in preparation of impending human clinical trials. The human clinical trials are expected to commence soon in India with the drug being sponsored by the Company's licensee and collaborator, Karveer. NanoViricides recently announced that it executed a license agreement with Karveer giving it certain rights for the development, clinical evaluation, and commercialization of NV-CoV-2 and NV-CoV-2-R in India. NanoViricides would receive significant royalties upon commercialization.
* NOAEL = The no-observed-adverse-effect level (NOAEL) denotes the level of dose at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects compared to appropriate control. MTD = The maximum tolerated dose, is defined as the highest dose of a drug that does not cause unacceptable side effects or overt toxicity in a specific period of time.
About Karveer Meditech Private Limited
Karveer Meditech Private Limited is a small and aspiring dynamic pharmaceutical company in India. It has developed and commercialized in local markets more than a dozen different generic and semi-branded pharmaceutical drugs as well as Ayurvedic medicines and vitaminized nutritional supplement protein powder products. It was co-founded by Dr. Anil Diwan, who serves as a Director and is a passive investor. Dr. Diwan is also co-founder of and President and Executive Chairman of the Board of NanoViricides. Karveer Meditech is independently managed by its Managing Director in India
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical 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-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. 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 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, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.
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 NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
ICH refers to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient".
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SOURCE: NanoViricides, Inc.
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