drkazmd65
4 days ago
Oh goody - another animal model PR - this time for influenza,.... How about actually starting a Phase II trial where you actually generate clinical data from actual sick human beings DIwan?
A Novel Broad-Spectrum Antiviral Against Influenza A Viruses, NV-387, Is Effective in Protecting Lungs from Damage in Lethally Infected AnimalModel, Says NanoViricides
SHELTON, CONNECTICUT – Thursday, June 20, 2024 -- NanoViricides, Inc. (NYSEAmer.: NNVC) (the "Company"), a clinical stage company and global leader in broad-spectrumantiviral nanomedicines, reports that the ultra-broad-spectrum antiviral NV-387, a clinicalPhase II stage drug candidate, was found to be effective in protecting lungs from damage in alethally infected Influenza A H3N2 mouse model.
"We believe that the lung protection afforded by NV-387 is a very important result. The mostsevere cases that lead to hospitalization and fatalities in respiratory viral infections involve lungdamage as an important factor," said Anil R. Diwan, PhD, President and Executive Chairman ofthe Company, adding, "This was starkly evidenced during COVID-19 pandemic wherein theDelta variant that caused severe lung damage also caused the largest number of hospitalizationsand fatalities. Influenzas, RSV, COVID can all cause severe lung damage resulting in fatalities."1. NV-387 Treatment Resulted in Significant Reduction in Lung Infiltration and Lung Cell DeathLungs of infected animals treated with NV-387, orally or intravenously, showed very limitedpresence of infiltrating cell-killing immune cells that are known to be an important cause of lungdamage, in addition to the direct lung damage from infected cell death caused by the virus itself.Further, the overall lung damage was significantly reduced upon NV-387 treatment.On day 7 post-infection, NV-387 oral treatment resulted in only about 31% lung infiltration byimmune system cells, and NV-387 intravenous treatment resulted in an even lower, about 22%,infiltration rate, whereas the lungs of infected untreated animals had a very high 68% infiltrationrate (smaller is better), as determined by micro-histopathology of lung tissues using specificstaining techniques.
2. NV-387 Treatment Resulted in Significant Reduction in Mucus Load in the LungsAdditionally, the extent of mucus in the lung tissue was substantially reduced in the case of oralas well as intravenous NV-387 treatment. The mucus index value in the case of NV-387 oraltreatment was about 53, and for intravenous NV-387 treatment it was about 32, as compared tothe infected untreated animals that had a mucus index value of 138 (smaller is better).Mucus is secreted by secretory cells in response to viral infection in an attempt to clear the virus,but it results in reduced lung capacity and eventually can lead to pneumonia. Thus reduction inmucus load is an important sign that the progress of the viral infection is arrested,...
drkazmd65
1 month ago
NanoViricides Bolsters Partnership Efforts - Engages Aagami Inc.
8:34 AM ET 5/23/24 | Dow Jones
This is an interesting twist - actually trying to actively push their potential treatment forward,...
SHELTON, CT / ACCESSWIRE / May 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports that it has engaged Aagami, Inc. for business development, specifically to seek licensing and partnering opportunities for our assets and platform technology.
The Company is currently seeking licensing and partnering opportunities for its key asset, NV-387, and its key nanoviricides(TM) platform technology. The Company has engaged Aagami, a small boutique firm, to help with these efforts for the regions of India and Japan, noting the firm's strength and specialty in these regions for licensing and partnering endeavors.
NV-387 has successfully completed a Phase I human clinical trial in healthy subjects in India.
No adverse events were reported even at the highest dose levels tested in the single-ascending dose or the multiple-ascending dose cohorts in the clinical trial. Two oral formulations of NV-387, (i) Oral Syrup, and (ii) Oral Gummies were tested in this clinical trial, which has been described in more details in prior press releases.
NV-387 is now ready for Phase II clinical trials in any of its multiple indications.
NV-387 is a unique host-mimetic, direct-acting, ultra-broad-spectrum antiviral nanomedicine based on our nanoviricides platform technology. NV-387 is a first-in-class drug that acts by a novel mechanism of action.
Viruses would not be able to escape NV-387 even as new variants develop in the field, because any new variant continues to use the same host-side features for infection that NV-387 presents, we believe. In contrast, viruses escape vaccines, antibodies and small chemical drugs readily as they change in the field.
NV-387 is a nanomachine designed to complete the task of dismantling the virus particle without requiring the host immune system involvement. This is important because the host immune system is dysregulated by any virus that causes significant pathology. In contrast, vaccines and antibodies require a functioning immune system.
NV-387 is active when given orally. The oral gummy formulation, in particular, overcomes the problem of swallowing issues present in many adults and children with severe respiratory diseases, as it dissolves in the mouth slowly.
Additionally, we have developed a formulation, Solution for Injection, Infusion, and Inhalation, for the treatment of severe, hospitalized cases.
NV-387 is inherently designed to be safe, and the non-clinical data support its safety. NV-387 is non-mutagenic, non-genotoxic, non-immunogenic, and there were no signs of any allergenicity. The recently completed Phase I clinical trial evaluating its safety in humans corrobaorates our non-clinical findings; there were no adverse effects reported in this clinical trial.
NV-387 could be a single drug to treat all of the "tripledemic" viruses, a "holy grail" of development of antiviral therapeutics. Its observed antiviral spectrum in cell culture and animal studies includes the Coronavirus family, including SARS-CoV-2 (COVID, Long COVID), RSV, Influenza A (potentially including H5N1 "Bird Flu"), as well as Smallpox/Mpox.
This ultra-broad-spectrum of NV-387 is, we believe, the result of its host-mimcry. NV-387 is designed to mimic the key virus-binding features of sulfated proteoglycans. A large pool of human pathogenic viruses may be susceptible to NV-387 because more than 90% of human pathogenic viruses are known to use one or more of the sulfated proteoglycans as attachment receptors.
Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ a sulfated proteoglycan for gaining access to human cells to infect and cause disease.
NV-387 mechanism is designed to attack the virus particle by mimicking the host-side attachment receptor(s) used by the virus particle, followed by engulfing the virus particle via the lipid-lipid-fusion with the virus surface, thereby rendering the virus incapable of infecting cells.
We believe that NV-387 is a revolutionary ultra-broad-spectrum antiviral drug with a strong potential to transform treatment of viral infections just as the broad-spectrum antibiotic, penicillin, transformed the treatment of bacterial diseases.
"Engaging Aagami gives a significant boost to our licensing and partnering efforts, while at the same time substantially freeing up our executives and staff to focus more strongly on further development of our multiple drugs and the nanoviricides platform through clinical trials," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.
About Aagami
Aagami, Inc. is a life sciences consulting firm based in the suburbs of Chicago which offers, Strategic Consulting Services, Business Development support in regions where the client is unable to reach out due to bandwidth, Technology Licensing Services, and Business Research & Market Intelligence Services.
For Global companies in Pharma, Biotech, Medical Devices & Technology, Consumer Healthcare, CROs, CDMOs, Aagami brings: Deep Experience of overcoming business and socio-cultural differences of various countries; Extensive 'C' level network nurtured for 21+ years; Global Deal making skills, honed for decades; Partners having combined experience of 250+ years; Supplementing the client's bandwidth to save time, effort & cost. Aagami has served 110+ clients in 180+ Assignments globally.
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(TM) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". 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 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(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 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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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.
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 which are, in some cases, beyond the Company's control and which 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
(MORE TO FOLLOW) Dow Jones Newswires
May 23, 2024 08:34 ET (12:34 GMT)
drkazmd65
1 month ago
And another pump,.... Diwan's pulling out all the stops this month.
A Novel Broad-Spectrum Antiviral with Activity Against RSV
6:36 AM ET 5/14/24 | Dow Jones
Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral Treatment
SHELTON, CT / ACCESSWIRE / May 14, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, says that antiviral activity of NV-387 against RSV/A2 is strong enough to have resulted in full survival of lethally infected animals was achieved.
In this study, extended dosing of NV-387 given orally was compared with a high dose of ribavirin given orally for the same duration. Two doses were given on first day of dosing followed by one daily dose for next 9 days (for a total of 11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21 days study period, with no signs of pathology (disease) apparent on the last day of observation. In contrast, ribavirin led to death of all animals by 14 days.
Survival Lifespan of Lethally Infected Mice - Lung
Infection with RSV A2
Survival, Increase in Survival,
Treatment Days Days Increase in Survival, %
------------ ----------- ------------------------ -------------------------
22+
NV-387, Oral (Complete) > 14 > 175%
------------ ----------- ----------- ----------- ---- -------------------
Ribavirin,
Oral 14 6 75%
------------ ----------- ------------------------ -------------------------
Vehicle 8 0 0%
------------ ----------- ------------------------ -------------------------
Thus we believe NV-387 oral treatment is capable of curing RSV infection. There is currently no approved treatment for RSV other than ribavirin. A safe and effective treatment remains an unmet medical need.
"This is an extremely significant result. To date, in our lethal infection animal models, we have not observed uniform survival with any of the treatments, including approved drugs, against viruses that include Influenza A, Smallpox/Mpox, and Coronaviruses," said Anil R. Diwan, PhD, President and Chairman of the Company, adding, "Our studies are designed to be so lethal that the survival lifetime itself can be used as the ranking parameter to evaluate the effectiveness of a treatment. Complete survival is not expected in such studies, unless the drug is extremely effective."
Previously, in July 2023, we reported that NV-387 treatment led to survival in lethally RSV infected animals equal to that observed with ribavirin treatment. In this study, we extended the dosing regimens of both ribavirin and NV-387, to determine if that improves survival.
Ribavirin is the only currently approved drug for RSV infection, that can be used only as a last resort because of its extensive toxicity that limits its effectiveness.
RSV is an important disease in infants and children less than 5 years old, as well as in older persons over 65 years old. According to the CDC, each year in the United States, RSV leads to approximately:
-- 58,000-80,000 hospitalizations among children younger than 5 years old;
-- 60,000-160,000 hospitalizations among adults 65 years and older;
-- 6,000-10,000 deaths among adults 65 years and older; and
-- 100-300 deaths in children younger than 5 years old.
Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy(R), GSK, and Abrysvo(R), Pfizer). Abrysvo was recently approved for use in pregnant women for protection of infants. Synagis (palivizumab), an antibody, as well as a new antibody, nirsevimab (Beyfortus(R)) have been approved by the US FDA for protection of newborn children at risk of RSV disease, but not for treatment of RSV infection and disease.
About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development 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. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". 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 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(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 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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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.
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 which are, in some cases, beyond the Company's control and which 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.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
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". API means active pharmaceutical ingredient.
Contact:
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
(MORE TO FOLLOW) Dow Jones Newswires
May 14, 2024 06:36 ET (10:36 GMT)
drkazmd65
2 months ago
And now,.... A Smallpox PR: Diwan is probably planning a capital raise,...
https://www.accesswire.com/860752/a-novel-broad-spectrum-antiviral-with-activity-against-smallpoxmpox
A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox
Wednesday, 08 May 2024 06:30 AM
NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricides
SHELTON, CT / ACCESSWIRE / May 8, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes activity against orthopoxvirus family (Smallpox/Mpox), with both inhalation and skin abrasion (sexual) modes of infection acquisition. Ectromelia virus infection of mice is a model for Smallpox infection in humans, and also serves as a surrogate for MPox infection in humans. All three viruses belong to the orthopoxvirus family.
NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.
This lung infection study substantiates the results of the previously reported intradigital footpad infection study that: (i) NV-387 has comparable antiviral activity as tecovirimat, and
(ii) NV-387 plus tecovirimat has much stronger antiviral activity than either drug alone.
We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly. In this study, we found that NV-387 alone treated animals survived 15 days, tecovirimat alone treated animals survived 16 days, and NV-387 plus tecovirimat treated animals survived 19 days, whereas vehicle-treated animals died in 8 days.
This lung-infection study emulates infection from aerosolized dispersion of the virus, as may be expected in a bioterrorism scenario.
Survival Lifespan of Lethally Infected Mice - Lung Infection with Ectromelia Virus
Treatment
Survival, Days
Increase in Survival, Days
Increase in Survival, %
NV-387, Oral
15
7
88%
Tecovirimat, Oral
16
8
100%
NV-387 + Tecovirimat, Oral
19
11
138%
Vehicle
8
0
0%
Previously, on November 14, 2023, we have reported that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment, with both treatments resulting in 14 days survival, whereas vehicle treated animals died in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat resulted in a significantly improved survival of 17 days in this study.
Survival Lifespan of Lethally Infected Mice - Intradigital Footpad Infection with Ectromelia Virus
Treatment
Survival, Days
Increase in Survival, Days
Increase in Survival, %
NV-387, Oral
14
6
75%
Tecovirimat, Oral
14
6
75%
NV-387 + Tecovirimat, Oral
17
9
113%
Vehicle
8
0
0%
This intradigital footpad infection study emulates the skin-to-skin transfer of the virus as in sexual transmission, such as that in the case of current Clade 1 MPox virus epidemic in the DR Congo; Clade 1 MPox is more deadly than the Clade 2 MPox; the latter had caused a small pandemic recently with sexual mode of transmission (https://www.sciencefocus.com/news/monkey-pox-new-strain , May 5, 2024).
Tecovirimat is the drug approved for smallpox under "animal rule" and is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA). It was mobilized from the stockpile during the recent MPox Clade 2 pandemic. BARDA is interested in development of additional poxvirus therapeutics as per a recent Broad-Agency Announcement (BAA). There is significant interest in the development of a smallpox therapeutic that works well by itself, as well as in combination with the known drug, tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.
Therefore we believe that NV-387 is a viable clinical candidate to be developed by itself for the treatment of poxvirus infections under the US FDA "Animal Rule". In addition, we believe that the combination of NV-387 and tecovirimat could reduce the potential for escape resistant generation against tecovirimat, as is known with other drug combination studies against viruses.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development 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-387 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores", and HSV-2 "genital ulcers". 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.
NV-387 has successfully completed a Phase 1a/1b clinical trial in which no adverse events were reported indicating excellent safety. Karveer Meditech Pvt. Ltd., our licensee and collaborator in India sponsored the drug for this clinical trial.
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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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.
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 which are, in some cases, beyond the Company's control and which 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.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
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".
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn, TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
drkazmd65
2 months ago
A Novel Broad-Spectrum Antiviral with Activity Against Influenza A
More fluff - try demonstrating efficacy in some sort of actual human trial Diwan,....
6:31 AM ET 5/6/24 | Dow Jones
NV-387 Possesses Strong Anti-Influenza-A Virus Activity, and May Have Activity Against H5N1 Bird Flu Virus, Says NanoViricides
SHELTON, CT / ACCESSWIRE / May 6, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes Influenza A viruses, possibly including Bird Flu H5N1 virus as well.
NanoViricides reports that in a lethal animal model of lung infection by Influenza A /H3N2 virus, NV-387 was found to have substantially superior antiviral effects compared to three approved anti-influenza drugs.
We have recently performed a lethal lung infection study of mice infected with Influenza A/H3N2 that were treated with NV-387 or one of the three approved drugs for direct comparison: Oseltamivir (Tamiflu(R), Roche), Peramivir (Rapivab(R), Biocryst), and Baloxivir (Xofluza(R), Shionogi, Roche). In this study, NV-387 Oral treatment led to a survival lifespan of 15 days, compared to 10 days with Oseltamivir Oral treatment, 11 days with Peramivir I.V. treatment, and 11 days with Baloxivir Oral treatment, while the vehicle-treated and untreated (infected) animals survived only 8 days.
Thus the anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs, namely Tamiflu, Rapivab, and Xofluza.
Survival Lifespan of Lethally Infected Mice
- Lung Infection with Influenza A H3N2
Increase in Increase in
Survival, Survival, Survival,
Treatment Days Days %
------------- --------- ----------- -----------
NV-387, Oral 15 7 88%
------------- --------- ----------- -----------
Oseltamivir,
Oral 10 2 25%
------------- --------- ----------- -----------
Peramivir,
I.V. 11 3 38%
------------- --------- ----------- -----------
Baloxivir,
Oral 11 3 38%
------------- --------- ----------- -----------
Vehicle 8 0 0%
------------- --------- ----------- -----------
Given the broad-spectrum of antiviral activity of NV-387 against viruses in many different virus families, we believe that its effectiveness against Influenza A/H3N2 is indicative of potential antiviral activity against most if not all Influenza A viruses.
In particular, we believe, based on structural information, that the H5 hemagglutinin of H5N1 bird flu virus may be even more susceptible to NV-387 attack than the H3 hemagglutinin of the H3N2 virus. This is because H5 contains a long polybasic site sequence, which has biochemical affinity from electrostatic interactions with the antiviral ligand used in NV-387. This antiviral ligand is a sulfated proteoglycan mimetic.
Thus it is very likely that NV-387 may have strong antiviral activity against the bird flu H5N1 virus, although further work is needed in this regard.
"We are pleasantly surprised by this extremely broad and strong antiviral activity of NV-387," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "We are close to having a single drug NV-387 for the treatment of all of the tripledemic respiratory viruses - Coronaviruses, RSV, and Influenza A, which would be a revolutionary achievement."
We note that all three approved influenza drugs oseltamivir, peramivir and baloxivir are known to be prone to viral escape by mutations. In contrast, NV-387 as a host-mimetic is highly unlikely to be escaped by the susceptible viruses.
To date H5N1 bird flu virus has caused only sporadic infections in humans that have been zoonotic in origin, most previous ones being from poultry to humans, while recently cases from cattle to human transmission have occurred. H5N1 has caused increasing spread in wild bird and poultry populations, and now has taken hold in several herds of dairy cattle. Recent reports by CDC indicate that the current H5N1 dairy virus has not incorporated mutations necessary for successful human infection and for human-to-human transmission.
This H5N1 was also found to be sensitive to oseltamivir. However, the influenza viruses in particular are known to change rapidly by mutations, recombinations, as well as re-assortments; the last one enabled by the multi-segmented nature of the virus genome. Eight RNA segments together make up its genome, and in a co-infection of two different influenza A viruses, interchange i.e. reassortment of these segments can take place leading to new variants. Rightly, public health officials are closely watching H5N1.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development 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 RSV, COVID-19, Long COVID, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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-CoV-2 into Phase I/II human clinical trials.
NV-CoV-2 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-CoV-2 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(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 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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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.
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 which are, in some cases, beyond the Company's control and which 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
2024-05-06 10:31:00 GMT A Novel Broad-Spectrum Antiviral with Activity -2-
regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
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".
Contact:
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
> Dow Jones Newswires
May 06, 2024 06:31 ET (10:31 GMT)
drkazmd65
2 months ago
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon
https://finance.yahoo.com/news/nanoviricides-reports-phase-nv-387-103000253.html
NanoViricides, Inc.
Tue, Apr 30, 2024, 6:30 AM EDT
SHELTON, CT / ACCESSWIRE / April 30, 2024 / NanoViricides, Inc. (NYSE Amer:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that the Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon.
The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed and completed in April by the Drug Sponsor and our licensee, Karveer Meditech, Pvt. Ltd., and the CRO, PristynCR, in India. The decision to close the clinical trial with healthy subjects study completed was taken because diligent efforts to identify suitable COVID-19 participants for the clinical trials were met with a notable absence of positive cases at the designated clinical trial sites, despite addition of a second site during January/February 2024.
Both the single ascending dose part of this clinical trial (called Phase 1a), and the subsequent multiple ascending dose part (called Phase 1b) have been completed with healthy subjects. There were no reported adverse effects, indicating excellent safety of both of the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, at all of the dosage levels given to the subjects. The CRO is now in the process of completing database input of all of the subjects' clinical datasets to achieve datalock for further statistical analysis.
Phase II Clinical Protocol Discussion in Progress
As previously reported, NV-387, the active ingredient in the drug products in this clinical trial, has been demonstrated to possess an extremely broad effectiveness against multiple virus families in lethal animal studies evaluating NV-387 in comparison to available drugs. Thus, NV-387 has been found to be active against (i) Coronavirus infection, (ii) RSV infection, and (iii) Smallpox/Mpox related Ectromelia virus infection in animal models.
This ultra-broad-spectrum activity profile of NV-387 in animal models suggests that it could be a single drug effective against most if not all of the respiratory viral infections.
We have therefore initiated discussions with physicians, subject matter experts, and clinical site investigators in India, towards designing appropriate clinical trials for determining the dosing protocol and effectiveness of NV-387 towards the goal of clinically establishing the spectrum of effectiveness of NV-387. An antiviral drug such as NV-387 if found to be effective in human clinical studies would be a highly desirable drug globally. It would enable treatment of patient as soon as they present to the physician with a viral disease without waiting for a test for identifying which viral infection it is. This is reminiscent of how antibiotics are prescribed, without specific infectious agent identification, relying on the ultra-broad-spectrum of antibacterial activity.
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