drkazmd65
3 months ago
Safety in Multiple-Ascending-Dose Healthy Subjects Clinical Trial Part Successfully Established for the NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2 with No Adverse Events Found
6:31 AM ET 1/29/24 | Dow Jones
SHELTON, CT / ACCESSWIRE / January 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the healthy subjects part of the Phase 1a/1b Clinical Trial of NV-CoV-2 was completed successfully. No adverse events were reported in any of the multiple ascending dose cohorts, confirming the excellent safety of NV-387, the active ingredient in NV-CoV-2.
NV-387 is highly active against many respiratory viruses; all tested Coronaviruses and RSV among them. NV-387 was designed to mimic the host-side feature called "sulfated proteoglycans" ("S-PG"), presenting a biomimetic of S-PG on the surface of the nanoviricide that mimics a biological cell membrane. Over 90% of human pathogenic viruses use S-PG receptors to cause infection, and many of them are expected to be susceptible to NV-387.
NV-387 is designed to attack the viral surface and disable the virus from being able to infect cells. This is reminiscent of how antibiotics such as penicillins attack bacterial surface and dismantle the bacteria.
This ultra-broad-spectrum, cross-virus-families, antiviral activity of NV-387 is expected to revolutionize not only the treatment of viral infections but also how we respond to potential pandemics in a significantly more rapid fashion than what happened with COVID-19.
Viral variants are unlikely to escape the nanoviricide drug (i) because even as the virus mutates it still binds to the same host-side features, that the nanoviricide copies; and (ii) such escape is not expected based on the extremely wide spectrum of activity of NV-387, across multiple viruses in each family and across distinct virus families.
All clinical trial subjects were held in the hospital during treatment period. All of them have been discharged and all of them have also gone through the final post-discharge follow-up visit. There were no adverse events reported during treatment or through the follow-up visit. Clinical observations during the in-hospital sequestration did not show any adverse events. No adverse events were reported from lab reports of the subjects for various blood tests, organ function tests, or ECG (heart). There were no dropouts.
These results are indicative of an excellent safety profile of NV-387. These results are consistent with the excellent safety characteristics observed for NV-387 in the pre-clinical studies.
NV-387 has been found to be non-immunogenic, non-allergenic, non-mutagenic, as well as non-genotoxic in various pre-clinical animal model studies leading to the clinical trials. No adverse effects were reported in GLP Safety-Toxicology studies in multiple animal models including non-human primates (NHP, Cynomolgus monkeys). The NOAEL (No-Observed-Adverse-Events-Level) was 1,200 mg/Kg and MTD (Maximum Tolerable Dose) was 1,500 mg/Kg in rats, which indicate excellent safety.
In contrast, most known antiviral drugs have significant dose-limiting toxicities.
The human subject pharmacokinetic (PK) plasma samples have been duly received at the GLP bioanalytical lab in the USA and will be analyzed shortly.
Two different drug products, (i) NV-CoV-2 Oral Syrup, 100mg/mL, and (ii) NV-CoV-2 Oral Gummies, strengths of 500mg and 1,000 mg were in the study. There were three dosing cohorts for each of the drug products.
The Phase1a-Healthy Subjects part was a Single-Ascending-Dose trial, that was successfully completed with no adverse events found, as reported previously in a press release on November 28, 2023.
The Phase1b-Healthy Subjects part was a Multiple-Ascending-Dose trial. The dosing of NV-CoV-2 Oral Syrup was at nominal 10mg/Kg, 20mg/Kg and 40mg/Kg levels, with the first dose being double the nominal amount (a "loading dose"). The dosing of NV-CoV-2 Oral Gummies was at nominal 500mg, 1,000mg, and 2,000mg levels, with the first dose being double the nominal amount (a "loading dose"). In all cohorts, there was a double dose on first day, followed by single doses every 48 hours for a total of five dosing instances (i.e. 6 total nominal doses) over a period of 9 days.
The clinical trial will now undergo data-lock procedures and thereafter biostatistical analyses will be conducted. The final report will become available afterwards.
The Phase 1a/1b clinical trial is being managed by our collaborator and licensee in India, Karveer Meditech Pvt. Ltd., Kolhapur, India, who is also the drug sponsor in India. The trial is being conducted by the clinical research organization (CRO) Pristyn CR Solutions Pvt. Ltd., Aurangabad, India at the Mahatma Gandhi Mission's Medical College & Hospital, Aurangabad, India, as previously described.
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, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients.
The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.
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 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, Inc., which TheraCour licenses from AllExcel, Inc. 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV 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:
2024-01-29 11:31:00 GMT Safety in Multiple-Ascending-Dose Healthy -2-
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View the original press release on accesswire.com
loanranger
4 months ago
Notice of Annual Meeting of Stockholders
To Be Held on Saturday, January 13, 2024
To Our Stockholders:
NOTICE IS HEREBY GIVEN, that the Annual Meeting of Stockholders (the “Annual Meeting”), of NanoViricides, Inc. (the “Company” or “NanoViricides”) will be held on Saturday, January 13, 2024, at 10:00 a.m., Eastern Daylight Time, at Hampton Inn & Suites Stamford, 26 Mill River Street, Stamford, CT 06902, for the following purposes:
1. To re-elect Anil Diwan as a Class I director for a two-year term expiring at the 2025 annual meeting of stockholders and until his successor is duly elected and qualified or until their earlier resignation or removal (Proposal 1);
2. To conduct an advisory vote on the compensation of the Company’s named Executive Officers (Proposal 2);
3. To approve an award of 10,204 shares of Series A Convertible Preferred Stock to Anil Diwan in connection with the extension of his employment as the Company’s President (Proposal 3);
4. To ratify the appointment of EisnerAmper, LLP, the Company’s independent registered accounting firm for the fiscal year ending June 30, 2024 (Proposal 4); and
5. To transact such other business as may properly come before the Annual Meeting, including to consider any procedural matters incident to the conduct of the Annual Meeting, such as the postponement of the Annual Meeting in order to solicit additional proxies to vote in favor of the matters presented at the Annual Meeting.
"The Company’s Board of Directors (the “Board of Directors”) has fixed the close of business on November 13, 2023, as the record date for the determination of holders of record of the Company’s common stock entitled to notice of, and to vote at, the Annual Meeting. A list of shareholders of record of the Company as of the record date will remain open for inspection during the Annual Meeting until the closing of the polls thereat."
drkazmd65
5 months ago
The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides
6:41 AM ET 11/28/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / November 28, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully. Recruitment for the Multiple-Ascending Dose part was also completed. The drug NV-CoV-2 contains the Company's nanoviricide active agent, NV-387, which has shown strong broad-spectrum antiviral activity not only against multiple coronaviruses, but also against RSV and in a model for Smallpox therapeutics.
The Phase 1a Clinical Trial Part, namely Single-Ascending-Dose in Healthy Volunteers, Was Completed Successfully:
The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that all 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose ("SAD") clinical trial have now completed the study. Follow-up visit was also concluded for all of the Phase 1a volunteers. Previously, we reported on August 21, 2023 that 26 of the 36 healthy volunteers had completed the Phase 1a study.
No Adverse Events Found in the Healthy Volunteers Cohorts to Date:
No adverse events or serious adverse events were found at any of the three dose levels studied, in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the completed Phase 1a (Single Ascending Dose) part of the study.
To note, we have previously reported that no adverse events or serious adverse events were found in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the 26 out of 36 healthy volunteers that had completed the Phase 1b part (Multiple-Ascending Dose) of the study.
Recruitment for Multiple-Ascending-Dose Clinical Trial (Phase 1b) in Healthy Volunteers Was Completed:
Additionally, the remaining 10 healthy volunteers have been recruited into the Multiple-Ascending Dose part of the Phase 1b study, completing the targeted 36 volunteers recruitment.
"The excellent safety of NV-CoV-2 formulations is expected to enable use of the drug across all patient population, from young children, otherwise healthy persons, to immune-compromised persons, persons with advanced age with or without co-morbidities," said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, "We await completion of the multiple-ascending dose portion of this trial in healthy volunteers which is expected soon. Thereafter we plan on advancing NV-387 for the treatment of several different viruses that this drug has shown strong activity against."
NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families:
NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.
There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity.
The market size for RSV therapeutics has been estimated to be approximately $2 Billion rising to $8 Billion.
Additionally, we recently reported that NV-387 was as effective as the approved drug tecovitrimat (TPOXX(R), SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism.
Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic. It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.
NV-387 Acts by a Novel Mechanism:
We developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell.
We call this novel antiviral mechanism "Re-Infection Blocker".
NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria:
In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, we anticipate that NV-387 may have effectiveness against many other viruses. We plan on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications.
NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.
NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats:
There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.
We believe that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.
NV-387 Addresses Large Market Sizes:
In addition to the well-known strong and continuing market size for COVID drugs, GrowthPlus Reports, in June 2023, has said that the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
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, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients.
The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.
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 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, Inc., which TheraCour licenses from AllExcel, Inc. 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV 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
2023-11-28 11:41:00 GMT The Phase 1a/1b Human Clinical Trial of NV-CoV-2, -2-
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.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View source version on accesswire.com:
https://www.accesswire.com/810675/the-phase-1a1b-human-clinical-trial-of-nv-cov-2-the-companys-broad-spectrum-antiviral-drug-has-successfully-completed-the-first-part-phase-1a-reports-nanoviricides
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