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   Biotech / MedicalNanoViricides - Nanobiotechnology


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From: donpat3/26/2019 11:59:54 AM
of 1214
 
NanoViricides has Requested a Pre-IND Meeting with the US FDA

Published: Mar 26, 2019 7:00 a.m. ET

SHELTON, Conn., March 26, 2019 /PRNewswire/ -- NanoViricides, Inc. (nyse mkt:NNVC) (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, announces that it has requested a pre-IND meeting with the US FDA, as it progresses its lead drug candidate towards human clinical trials.

The Company recently reported that its first broad-spectrum drug candidate in the HerpeCide™ program, namely, NV-HHV-101, has successfully completed the non-GLP portion of the Safety/Toxicology studies that are required for filing an IND in order to initiate human clinical trials. The Company is now in the process of manufacturing a large batch of the drug as needed for the GLP portion of the Safety/Toxicology studies. Our IND-enabling non-GLP as well as GLP Safety/Toxicology studies are being conducted by BASi, Evansville, Indiana, a well known CRO specializing in these studies.

NanoViricides has now submitted a request for a "Type B" Pre-IND Meeting with the US FDA for this drug candidate. The Company believes that the resulting pre-IND meeting will provide valuable information for designing the Company's clinical program for this drug candidate. The initial indication of this drug candidate will be for the treatment of shingles rash. The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications as of now.

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.

The Company is developing its clinical program for NV-HHV-101, formulated as a skin cream for topical application, with the help of regulatory affairs experts from the Biologics Consulting Group, Inc., Alexandria, VA.

Until our own antiviral cell culture studies, it was not known whether such a drug would be able to attack the Varicella Zoster Virus (VZV). VZV causes chickenpox in children and shingles in adults. Upon primary infection in childhood, VZV becomes dormant in the nerve ganglia as the patient recovers from chickenpox (or from the attenuated viral vaccine "ZostaVax®"), and then the virus reactivates in adulthood when immune surveillance weakens to present as shingles.

The Company has conducted a drug candidate optimization program using an ex vivo human skin organ culture ("SOC") model of VZV infection, together with cell culture based VZV infection studies, to arrive at NV-HHV-101. The SOC model of VZV infection has been developed by Professor Jennifer Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. It is the only pre-clinical model suitable for evaluating a topical therapy against shingles because VZV infects only humans. There is no animal model available for the evaluation of topical drugs against VZV infection.

NV-HHV-101 is formulated as a dermal cream to be applied topically on the rash. It is expected to reduce viral load at the site, thereby arresting the progress of the shingles rash, and minimizing damage to nerve endings in the area. It is generally believed that the damage to nerve endings caused by VZV that is replicated locally after it is released from the nerves initially leads to the severe "pins-and-needles" debilitating pain of shingles. Thus NV-HHV-101 is expected to minimize the entire pathology of shingles, including the rash, skin damage, nerve damage, and associated pain. The Company intends to focus the initial clinical studies to evaluate the effect of application of NV-HHV-101 on the shingles rash.

Existing antivirals against VZV include oral derivatives of acyclovir. These drugs requires activation by a viral enzyme, thymidilate kinase (vTK), for further cellular conversion to the active triphosphate form that interferes with the viral DNA polymerase. However, the vTK encoded by VZV has an extremely poor activity (compared to vTK from HSV-1 or HSV-2), and thus these drugs have very poor activity against VZV, and large oral dosages over extended periods are needed to be given for relatively small clinical benefit. Additionally, a dermal topical cream formulation of cidofovir is employed in very severe cases of shingles. Cidofovir is highly toxic, particularly towards kidneys. A safer, effective, drug is thus an unmet medical need for VZV.

Zostavax and other attenuated VZV (Oka strain) vaccines for chickenpox are available, but not widely adopted. These vaccines may lead to a less severe form of shingles in adulthood or at a later age, compared to the "wild type" chickenpox virus. A new vaccine, Shingrix® has been introduced by GSK recently, based on subunits or protein fragments of the virus, which cannot lead to rebound shingles, but suffers from a very severe side effects profile. Shingrix is not yet widely available, potentially due to difficulties in manufacturing.

The market size for a highly effective drug against shingles is projected to be in several billions of dollars, if it leads to substantial reduction in the advanced manifestation of the disease, namely PHN, by independent consultants. These market size estimates account for the effect of ZostaVax and the newly introduced Shingrix vaccine on the patient population size. PHN or "post-herpetic neuralgia" is the continuation of the debilitating pain of shingles well after the patient has recovered from the shingles rash episode itself. PHN is believed to be due to extensive damage to nerve endings in the area of the shingles rash, and is expected to be correlated with the severity of the shingles presentation (or viral load). A less effective drug that minimizes the pathology of the shingles rash alone is also projected to have a market size into a billion dollar range.

The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.

NanoVircides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour Pharma, Inc. NanoViricides holds licenses for developing drugs against several different viruses from TheraCour, including HSV-1 and HSV-2. A license for drugs against VZV is in progress. The Company recently announced that it has entered into a non-binding letter of intent with TheraCour with respect to the terms of a license for use in all therapeutic indications caused by the shingles virus (VZV), including shingles, chickenpox, PHN, ARN (acute retinal necrosis), and other clinical manifestations where attacking the VZV virus would be of clinical benefit. TheraCour is owned substantially by the Company's President and Executive Chairman of the Board, Anil R. Diwan, PhD. A final license agreement is in progress.

About NanoViricides
NanoViricides, Inc. ( 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. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. 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.

FDA refers to US Food and Drug Administration. IND refers to investigational drug application. API refers to active pharmaceutical ingredient.

View original content to download multimedia:http://www.prnewswire.com/news-releases/nanoviricides-has-requested-a-pre-ind-meeting-with-the-us-fda-300818336.html

SOURCE NanoViricides, Inc.

Copyright (C) 2019 PR Newswire. All rights reserved

marketwatch.com

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From: Savant4/6/2019 10:47:25 AM
of 1214
 
Global Pandemic...only a matter of time>>>if not this, then another<<
msn.com

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From: Savant4/8/2019 11:39:06 AM
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sciencealert.com

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From: donpat4/9/2019 9:51:31 AM
of 1214
 
NanoViricides Provides Update on Pre-IND Meeting with the US FDA, GLP Safety/Toxicology Studies to Begin Soon, Multiple Kg Scale Drug Production Accomplished at Its Own Facility

Published: Apr 9, 2019 9:00 a.m. ET

SHELTON, Conn., April 9, 2019 /PRNewswire/ -- NanoViricides, Inc. NNVC, +2.96% (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that US FDA has responded to its request for a pre-IND meeting. In addition, the Company reports that it has completed production of the drug product for the ensuing GLP Safety/Toxicology studies of its lead drug candidate in the HerpeCide™ program.

The Company reports that it has successfully completed the scale-up of the chemistries and production of kg-scale quantities of the drug substance or API, NV-HHV-101. The Company further reports that it has successfully scaled up and manufactured about 10kg of the drug product, as required for the ensuing GLP Safety/Toxicology ("Tox Package") studies. The production of the drug product, a dermal topical skin cream formulation of the API was at different API concentrations as required for the study. All of the production, including that of the API and of the drug products at various API concentrations, was performed under stringent conditions meeting regulatory requirements for the GLP Tox Package study.

The entire production was accomplished at the Company's own cGMP-capable manufacturing facility at Shelton, CT. The Company has now demonstrated that it has multi-kilogram per batch drug production capability.

The GLP Safety/Toxicology study is scheduled to begin in the second week of May at BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies.

The Company also reports that it is preparing the pre-IND Meeting Submission Documents as required by the US FDA. The Company is developing its clinical program and these submission documents, for NV-HHV-101, formulated as a skin cream for topical application, with the help of regulatory affairs experts from the Biologics Consulting Group, Inc., Alexandria, VA.

The FDA has responded to our pre-IND meeting request letter and has asked for the documents to be submitted by April 29th. In addition, consistent with current protocol, the FDA has stated that they will provide a written response to the Company's submission. This written response will guide the Company's IND submission for this drug candidate and indication.

The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases.

The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications as of now.

The Company recently reported that its first broad-spectrum drug candidate in the HerpeCide™ program, namely, NV-HHV-101, has successfully completed the non-GLP portion of the Safety/Toxicology studies that are required for filing an IND in order to initiate human clinical trials.

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.

The Company has conducted a drug candidate optimization program using an ex vivo human skin organ culture ("SOC") model of VZV infection, together with cell culture based VZV infection studies, to arrive at NV-HHV-101. The SOC model of VZV infection has been developed by Professor Jennifer Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. It is the only pre-clinical model suitable for evaluating a topical therapy against shingles because VZV infects only humans. There is no animal model available for the evaluation of topical drugs against VZV infection.

NV-HHV-101 is formulated as a dermal cream to be applied topically on the rash. It is expected to reduce viral load at the site, thereby arresting the progress of the shingles rash, and minimizing damage to nerve endings in the area. It is generally believed that the damage to nerve endings caused by VZV that is replicated locally after it is released from the nerves initially leads to the severe "pins-and-needles" debilitating pain of shingles. Thus NV-HHV-101 is expected to minimize the entire pathology of shingles, including the rash, skin damage, nerve damage, and associated pain. The Company intends to focus the initial clinical studies to evaluate the effect of application of NV-HHV-101 on the shingles rash.

Existing antivirals against VZV include oral derivatives of acyclovir. These drugs requires activation by a viral enzyme, thymidilate kinase (vTK), for further cellular conversion to the active triphosphate form that interferes with the viral DNA polymerase. However, the vTK encoded by VZV has an extremely poor activity (compared to vTK from HSV-1 or HSV-2), and thus these drugs have very poor activity against VZV, and large oral dosages over extended periods are needed to be given for relatively small clinical benefit. Additionally, a dermal topical cream formulation of cidofovir is employed in very severe cases of shingles. Cidofovir is highly toxic, particularly towards kidneys. A safer, effective, drug is thus an unmet medical need for VZV.

Zostavax and other attenuated VZV (Oka strain) vaccines for chickenpox are available, but not widely adopted. These vaccines may lead to a less severe form of shingles in adulthood or at a later age ("rebound shingles"), compared to the "wild type" chickenpox virus. A new vaccine, Shingrix® has been introduced by GSK recently, based on subunits or protein fragments of the virus, which cannot lead to such rebound shingles, but suffers from a very severe side effects profile. Shingrix is not yet widely available, potentially due to difficulties in manufacturing.

The market size for a highly effective drug against shingles is projected to be in several billions of dollars, if it leads to substantial reduction in the advanced manifestation of the disease, namely PHN, by independent consultants. These market size estimates account for the effect of ZostaVax and the newly introduced Shingrix vaccine on the patient population size. PHN or "post-herpetic neuralgia" is the continuation of the debilitating pain of shingles well after the patient has recovered from the shingles rash episode itself. PHN is believed to be due to extensive damage to nerve endings in the area of the shingles rash, and is expected to be correlated with the severity of the shingles presentation (or viral load). A less effective drug that minimizes the pathology of the shingles rash alone is also projected to have a market size into a billion dollar range.

The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.

About NanoViricides
NanoViricides, Inc. ( 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. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. 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.

FDA refers to US Food and Drug Administration. IND refers to investigational drug application. API refers to active pharmaceutical ingredient.

View original content to download multimedia:http://www.prnewswire.com/news-releases/nanoviricides-provides-update-on-pre-ind-meeting-with-the-us-fda-glp-safetytoxicology-studies-to-begin-soon-multiple-kg-scale-drug-production-accomplished-at-its-own-facility-300827945.html

SOURCE NanoViricides, Inc.

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From: donpat4/16/2019 10:41:02 AM
of 1214
 
NanoViricides Submits Pre-IND Briefing Documents to the US FDA



NEWS PROVIDED BY

NanoViricides, Inc. Apr 16, 2019, 07:00 ET

SHELTON, Conn., April 16, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to meet unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has submitted the required pre-IND Briefing Documents for its lead drug candidate NV-HHV-101 to the US FDA, ahead of schedule.

The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.

There is a significant unmet need for the topical treatment of shingles rash. An effective therapy has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine.

The pre-IND briefing documents included the current data on our drug development. This included a description of the drug and its potential benefits, summary of the rationale, a brief CMC section ("Chemistry, Manufacture, and Consistency") regarding production and quality assurance, summaries of the in vitro (cell culture) and ex vivo (human skin organ culture model) studies of effectiveness, and summaries of non-GLP safety/toxicology studies regarding safety. In addition, the briefing documents also included a general description of the GLP safety/toxicology study plan, as well as a plan of Phase I/Phase II human clinical trials for evaluating the safety and effectiveness of the drug in humans subsequent to filing an IND.

Consultants from the Biologics Consulting Group, Inc., Alexandria, VA, helped the Company develop the briefing documents including the presented clinical studies plan.

The non-GLP Safety/Toxicology studies were conducted by BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies. BASi is now continuing to perform the GLP Safety/Toxicology studies subsequent to the successful completion of planned non-GLP studies.

The ex vivo human skin organ culture model has been developed by Professor Jennifer Moffat, Upstate Medical Center, SUNY Syracuse, NY. Evaluation of NV-HHV-101 continues to be performed in her lab. There is no animal model available for the evaluation of topical drugs against VZV infection. VZV only infects humans.

NanoViricides has previously shown that the NV-HHV-101 drug candidate as well as several related candidates in the pre-clinical optimization phase were highly effective against the shingles virus, VZV (Varicella-Zoster-Virus), in human skin organ culture ex vivo model of the disease. Further, the non-GLP Safety/Toxicology studies of NV-HHV-101 have shown an excellent safety profile, with no adverse events at the highest dosages tested in the safety/tox studies.

The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications as of now.

The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into several tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.

Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, VZV does not have an effective TK enzyme that is required for producing active forms from the acyclovir class of drugs, requiring frequent administration of large doses. While shingles presents with a debilitating "pins-and-needles" pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries. Limiting initial viral load is expected to minimize the occurrence of such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia ("PHN"), which is defined as persistent pain six months or longer after the initial rash has subsided. Shingles occurs when the immune system weakens due to age, stress or other factors such as other immune-compromising diseases (such as HIV or other viral infections) or conditions (such as organ transplant or anti-immune therapeutics against auto-immune diseases). The epidemiological incidence rate of shingles suggests that almost every person will have shingles at least once in lifetime if he/she reaches an age of 85. Thus there is a significant unmet medical need for new, effective, therapeutics against shingles.

The FDA previously responded to our pre-IND meeting request letter and asked for the briefing documents to be submitted by April 19th (Our previous press release of April 6th had a typo error, and stated this date incorrectly as 29th). In addition, consistent with current protocol, the FDA has stated that they will provide a written response to the Company's submission. This written response will guide the Company's IND submission for this drug candidate and indication.

The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases.

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.

About NanoViricides
NanoViricides, Inc. ( 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. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. 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.

FDA refers to US Food and Drug Administration. IND refers to investigational drug application. API refers to active pharmaceutical ingredient.

SOURCE NanoViricides, Inc.

Related Links

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From: Savant4/22/2019 8:06:13 PM
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AC-44 a new miracle compound...they say..works against 'Mexican blood flu' and everything else, it seems

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From: Savant4/27/2019 9:02:22 PM
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Tiny robots powered by magnetic fields could help drug-delivery nanoparticles reach their targets

phys.org

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From: Savant5/4/2019 6:56:08 PM
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Here's a chance to try cides on pigs...another diversion?
msn.com

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From: Internship7/26/2019 2:44:41 PM
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They say NanoViricide is a sell, Not too sure, how high did it ever get, looks kind of stable to me, and affordable. Kind of a similar line to nanoconductors. Some of those nano bots use nickel, apparently, to make them magnetic. Which means that this could benefit some Ontario mines( wasn't one of them called Nickel Center?til it got merged with sudbury?) as far as I know. There is a test here surveymonkey.ca that I found there : minescanada.ca which mentions that Nickel is also used in beer making. Kind of made me not ever want to have a beer again, even more than usual.
[yt]CzrJ2gvuZWA?t=3[/yt]

williamsbusinessreview.com

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From: Savant8/7/2019 9:06:00 PM
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cheap cure for cancer? This man says so...hope it works, but, if not, will rid you of worms

msn.com

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