"We believe that the start of the Phase 1a/1b safety and efficacy clinical trial is an important milestone not only for NanoViricides and Karveer Meditech, India, but for the whole world," said Dr. Anil Diwan, Ph.D., President and Executive Chairman of the Company, explaining, "NV-CoV-2 is aimed at satisfying the as-yet-unmet medical need for a highly effective broad-spectrum, pan-coronavirus drug that can be used for all patient populations. Further, we believe the nanoviricides technology adds a valuable tool to the basket of worldwide preparedness and response strategies for future viral pandemics."
The Company is a clinical-stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, called "nanoviricides". NV-CoV-2, the Company's lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, has now entered Phase 1a/1b human clinical trials that are sponsored by Karveer Meditech Pvt. Ltd. India, the Company's Licensee and co-developer in India (see below).
The Clinical Trial Will Evaluate Both Safety and Initial Efficacy Indications in COVID patients:
Phase 1a will assess the safety and tolerability of a new molecule (drug product NV-CoV-2 containing API NV-387) in healthy subjects. In Phase 1b, patients with mild to moderate COVID-19 will be enrolled to assess indication of efficacy.
The Single Dosing of Healthy Volunteers portion of the Phase 1a began with the dosing of a first set of volunteers on June 17, 2023. This set of volunteers was successfully discharged after a 48 hours in-hospital stay for observation, and will be further assessed in a final out-person visit as per the protocol. Further recruitments and dosings are scheduled as per the protocol.
NV-387 Is a First-in-Class Chemical Nanomachine that Acts by a Novel Mechanism of Action:
The Company calls the antiviral mechanism of NV-387 "Re-Infection Blocker." The drug is designed to directly attack the virus particle with a multi-pronged attack and thereby disable the virus completely so that it cannot further infect human cells and the infection cannot progress. The Company believes that this novel antiviral mechanism can become an important new tool for worldwide pandemic preparedness and response strategies to combat future viral pandemics.
NV-387 has demonstrated strong pan-coronavirus effectiveness as well as excellent safety in pre-clinical studies. Both our oral drug products: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies are formulations of the same active pharmaceutical ingredient (API), NV-387.
The Team Behind the Clinical Trials:
The Company previously announced that it has executed a License Agreement with Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer"). Under this Agreement, Karveer has the right to commercialize the Company's COVID drugs, NV-CoV-2 and NV-CoV-2-R, in India. To enable commercialization, Karveer has undertaken Clinical Development and Evaluation and is sponsoring these two drugs in India for this purpose.
Karveer Meditech has retained the Clinical Trials Organization, PristynCR Solutions, Pvt. Ltd., Aurangabad, Maharashtra, India, to develop and prosecute the clinical trials applications and conduct the clinical trials.
The Phase 1a/1b clinical trial labeled KM-NVCoV2-001 is being conducted at a single site, Clinical Research Unit in the Department of Clinical Pharmacology, Mahatma Gandhi Mission's Medical College and Hospital, Aurangabad, India.
The clinical trial protocol and information can be found in India's official clinical trials registry, https://ctri.nic.in/Clinicaltrials/pubview.php by entering the sponsor's name "Karveer Meditech" and selecting the search criterion "Sponsor."
About Mahatma Gandhi Mission's Medical College and Hospital, Aurangabad, India
Mahatma Gandhi Mission's Medical College and Hospital is a private, "NABH accredited" medical college hospital (A++ grade). The hospital has 700 beds, including 85 beds of Intensive care units. The hospital provides health care services through various charity schemes that enable free healthcare services to the eligible public. Additionally, the hospital also provides fee-paid specialty services and medical care. The hospital provides medical and surgical services along with super-speciality services such as Cardiology, Nephrology, Plastic Surgery, Neurosurgery, and Urology.
The hospital is well-supported with state of the art diagnostic laboratories which includes a NABL accredited Central Pathology Laboratory, Radiology and other services.
The hospital treats over 4,000 patients including out-patients and in-patients daily. The hospital has treated well over 20,000 mild, another 20,000+ moderate, and at least 12,000+ severe cases of COVID-19.
The Clinical Trial Unit at the Hospital has conducted multiple clinical trials for COVID drugs in different clinical phases.
About PristynCR Solutions Pvt. Ltd.
PristynCR Solutions Pvt. Ltd. is a contract research organization helping global enterprises to advance their regulatory and clinical research. Apart from Pharmaceutical trials services PristynCR also provides Medical Writing, Data Management, Pharmacovigilance and Regulatory Insight services; in short, a full-service stack from drug discovery to approval including tech transfer requirements.
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 Chairman of the Board of NanoViricides. Karveer Meditech is independently managed by its Managing Director in India.
About NanoViricides
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(R) 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 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 through 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(R) 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.
Disclosure Statement
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.
Contact:
NanoViricides, Inc.
[email protected]
Public Relations Contact:
MJ Clyburn
TraDigital IR
[email protected]
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