SHELTON, CT / ACCESSWIRE / April 17, 2023 /NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), a global clinical-stage leader in viral nanomedicines, announced that it has shipped pharmaceutical products for imminent clinical trials of NV-CoV-2, its COVID drug candidate, to its collaborator, Karveer Meditech Pvt. Ltd. , Kolhapur, India (“Karveer”).
Karveer has already effectively received the regulatory approvals required to conduct a clinical evaluation of NV-CoV-2 as a COVID remedy in India. Retained the facilities of a local clinical trials organization accredited to conduct human clinical trials of NV-CoV-2.
Even as US President Joe Biden recently signed a solution to end the COVID-19 emergency, SARS-CoV-2 continues to claim more than 1700 lives per week in the US alone. In the U. S. , in what is ultimately a “wave-free” period, taking five times the number of lives claimed by influenza viruses. The SARS-CoV-2 virus with its ever-changing variants is now a recurring phenomenon, as are other seasonal viruses such as influenza.
The company is targeting NV-CoV-2 to address a significant medical need that has yet to be met. There is still no COVID antiviral drug available that can be used for the treatment of all segments of the patient population. It is also valuable in pointing out that there is still no antiviral drug for COVID that can be expected to continue working even as new variants of SARS-CoV-2 continue to evolve and spread in the field.
In addition, the maximum observed preclinical protection of NV-CoV-2 indicates that the drug would be applicable to treat the disease in all populations, from pediatrics to, differently, healthy adults and patients with comorbidities. NV-CoV-2 has demonstrated incredibly superior protection in several preclinical animal models in GLP and non-GLP studies. In particular, its incredibly superior protection is reflected in its NOAEL* price of 1 200 mg/kg and its BAT price of 1 500 mg/kg in rats The drug was also found to be neither immunogenic nor mutagenic. In addition, there was no indication of imaginable allergic or injection site reactions in any of the studies in various animal models.
NV-CoV-2 deserves to be available for the treatment of mild to moderate diseases in two orally available forms, oral syrup and oral gums, to be suitable for patients from pediatric to healthy adults and patients with comorbidities. It deserves to be administered in injectable form for the treatment of outpatients (i. e. , outpatients) with serious illnesses. It should also be administered as an infusion and direct pulmonary inhalation for the treatment of hospitalized patients with severe illness.
In contrast, antiviral drugs recently approved for SARS-CoV-2 have significant limitations on the segment of the population in which they would possibly be useful, particularly limiting their applicability.
NV-CoV-2 oral syrup and oral gummy prescription drugs have been shipped in preparation for imminent human clinical trials. Human clinical trials are expected to begin soon in India, with the drug sponsored through the company’s licensee and collaborator, Karveer. NanoViricides recently announced that it has signed a license agreement with Karveer that grants it secure rights for the development, clinical evaluation and commercialization of NV-CoV-2 and NV-CoV-2-R in India. NanoVirucides would earn significant royalties upon commercialization.
About Karveer Meditech Private Limited
Karveer Meditech Private Limited is a small, dynamic and aspirational pharmaceutical company in India. It has evolved and advertised in local markets more than a dozen other generic and partial brand drugs, as well as Ayurvedic drugs and vitamin nutritional supplements in protein powders. -founded through Dr. Anil Diwan, who is a director and passive investor. Diwan is also co-founder and chairman and executive chairman of the board of directors of NanoViricides. Karveer Meditech is independently controlled through its managing director in India.
About nanoviricides
NanoViricides, Inc. (the “Company”) (www. nanoviricidas. com) is a clinical-stage company that introduces special target nanomaterials for antiviral therapy. The Company’s new elegance of nanoviricidal drug applicants is designed to target and dismantle enveloped particle viruses. Our lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by the SARS-CoV-2 coronavirus. Our other complex candidate is NV-HHV-1 for the treatment of shingles. We are waiting for precise dates for regulatory activities to move its drug applicants forward due to the company’s heavy reliance on external collaborators and consultants. The company is ultimately aiming to advance NV-CoV-2 in Phase I/II human clinical trials.
The Company is also launching a broad portfolio of medicines against a number of viruses, with preclinical successes in terms of protection and efficacy already achieved in many cases. The NanoViricides platform generation and systems are based on TheraCour’s TheraCour® nanomedicine generation, licensed by TheraCour to AllExcel. NanoViricides holds an exclusive and perpetual international license in this generation for several drugs with express addressing mechanisms for the remedy of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV) hepatitis C (HCV), rabies, herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), influenza and Asian avian influenza viruses, dengue virus, encephalitis virus Japanese, West Nile virus, Ebola/Marburg virus, and some coronaviruses. The Company intends to license poxviruses, enteroviruses and other viruses for which it conducts studies, if initial studies are successful. TheraCour has not denied any license requested through the Company to date. The company’s business style is based on TheraCour Pharma Inc. ‘s generation of licenses to rapid virus rapid vertical programs, as established when it was founded in 2005.
Disclosure Statement
This press release includes forward-looking statements that reflect the Company’s existing expectations regarding long-term events. Actual occasions can also differ drapingly and extensively from those projected here and count on a number of things. Certain statements contained in this release and other written or oral statements made through 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. Not to place undue reliance on forward-looking statements, as they involve known and unknown threats, uncertainties, and other things that, in some cases, are beyond the control of the Company and that also may only, and most likely will, have , a shades have an effect on actual effects, activity levels, functionality, or achievements. The Company does not assume any legal responsibility to publicly update or revise those forward-looking statements for any reason, nor to update the reasons why actual effects may also differ slightly from those expected in those forward-looking statements, even if new data becomes be held in the long run Important things that may also cause actual effects to differ slightly from company expectations come with, but are not limited to, things disclosed in “Risk Factors” and elsewhere in corporate filings. business from time to time with the United States. Securities and Exchange Commission and other regulatory authorities. While it’s not possible to expect or identify all of those things, they may come with the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; the successful progression of our product applicants; our ability to search and download regulatory approvals, aggregating with respect to the indications we seek; the successful marketing of our applicant products; and acceptance of the market position of our products. In particular, as usual, the Company will have to disclose the threat that the typical drug progression process for any pharmaceutical product is incredibly long and requires some really extensive capital. As with any drug development effort through a corporation, there is currently no guarantee that any of the Company’s drug applicants will show sufficient efficacy and protection in human clinical trials to result in a successful pharmaceutical product. adding our coronavirus drug progression program.
ICH refers to the International Council for the Harmonization of Technical Requirements for Human Pharmaceuticals. FDA refers to the U. S. Food and Drug Administration. UU. La IND application refers to the application for an “investigational new drug”. a “Chemistry, Manufacturing and Control”. The CHMP refers to the Committee for Medicinal Products for Human Use, which is the committee of the European Medicines Agency (EMA) responsible for medicinal products for human use. API stands for “Active Pharmaceutical Ingredient”.
PR Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir. com
SOURCE: NanoViricidas, Inc.