Is constantly trying to figure out what the h#ll he is doing.
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Agreed about the signing on of Ergomed - they are already up to speed with the drug and the test protocols.
I wonder if they are going to demand payment up front? Or if they will agree to a piece of the later revenue as payment for their running this trial?
And Diwan self deals yet again. Moving potential future money from one of his pockets and back into another - likely at the expense of NNVC shareholders - yet again.
Nothing good here happens for current shareholders until - or unless - Diwan finds a partnership and gets the drug into an actual Phase II trail against an actual disease/virus.
NanoViricides Executes an Agreement Encompassing All Antiviral Drug Treatments With Theracour, Including “Trojan Horse” Drugs
SHELTON, CONNECTICUT – Thursday, September 26, 2024 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it has now obtained a right of first refusal (ROFR) for all antiviral drug developments from the R&D firm TheraCour Pharma, Inc. (“TheraCour”).
NanoViricides has signed a broad Memorandum of Understanding Agreement (MoU) with TheraCour encompassing all antiviral drugs developments on September 23, 2024, an important step that provides the Company certain intellectual property rights for developing treatments against any viral infections.
NV-387, the Company’s lead drug, is proving to be a revolutionary drug that has demonstrated strong effectiveness, surpassing existing drugs, against a number of distinctly different types of viruses in animal studies. With this MoU in place, the increasing number of antiviral indications of a broad-spectrum drug such as NV-387 can be quickly and easily discovered and added by the Company to its portfolio of drugs in its development pipeline.
In addition to NV-387, certain “Trojan Horse” drugs that can completely cure most viral infections by attacking the virus lifecycle in multiple ways have been developed by the Company. This MoU expands NanoViricides Inc’s abilities to opportunistically and rapidly develop such drugs to treat viral infections of public health importance, even for those viruses that don’t exist today and cannot be predicted.
The new MoU provides NanoViricides with the ability to rapidly progress in such new endeavors and provides the important intellectual property rights to further develop multiple drug candidates towards a multitude of antiviral applications, many of which may have been previously considered to be intractable.
The MoU also codifies the process by which the two parties negotiate licenses to specific antiviral fields. As in the past, a license would not be restricted to a single drug, but rather would encompass all drugs that can be conceivably applicable with the R&D performed against the licensed field of antiviral application.
The revolutionary nanoviricide technology resulting in host-mimetic, direct-acting antiviral drugs is opening up a new era of treating viral infections just as penicillin opened up a new era and revolutionized the treatment of bacterial infections, enabling “one drug - many bugs” model instead of the current “one bug - one drug” model. NV-387, an example of the capabilities of nanoviricide technology, was developed in 2020 in response to the COVID pandemic and has completed a Phase I human clinical trial successfully. The Company is now planning for NV-387 to enter into Phase II clinical trials for evaluation of its efficacy against several viral diseases that include RSV, Influenza, Bird Flu, COVID, as well as MPOX/Smallpox infections.
What is a “nanoviricide”?
A “nanoviricide” is a uniform polymer that self-assembles into nanoscale droplets called “micelles”, that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus “looks like” a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called “lipid-lipid mixing.” We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.
What are “Trojan Horse” nanoviricide drugs?
A nanoviricide can hide in its “belly” (i.e. encapsulates) one or more drugs that can attack the virus in other ways. The nanoviricide holding the drugs is expected to attack the virus particle itself and thus block the virus from infecting cells. We call this “Re-Infection Inhibition”. The encapsulated drug can be protected from host’s metabolism and delivered into infected cells to block the virus from replicating inside the cell. If both of these parts of the virus lifecycle are blocked, the viral infection would be cured, except in the case of viruses that create latency. A different encapsulated drug can also be delivered to attack the virus in its latent or dormant phase, although this has been a topic of scientific research rather than drug development as of now. Thus the “Trojan Horse” capability of a naoviricide enables developing drug that can cure most virus infections, and can be developed in the future to cure even viruses that cause latency such as herpesviruses and HIV/AIDS that are non-curable at present.
TheraCour is founded by and substantially owned by Dr. Anil R. Diwan, who is also the Company’s
co-founder. Dr. Diwan recused himself from the MoU discussions that were led by the Company’s Board of Directors in conjunction with legal advice from the Company’s counsel.
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 and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. 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-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) 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-387 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® 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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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”. WHO is the World Health Organization. R&D refers to Research and Development.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
Source: NanoViricides, Inc.
Continued good news - but when will that confirmatory study finally get underway?
CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation
https://www.stocktitan.net/news/CVM/cel-sci-s-multikine-r-increased-5-year-survival-rate-to-82-6-in-9xbf37sch81c.html
CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).
These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.
I stand corrected - SEC not FDA.
The primary point of my statement remains correct.
Multikine works. At least we know that now. But this lead-in to getting the confirmatory trial set up is painfully slow.
And again - you harp on over, and over, and over, and over, and over, and over, with those same partial truths and your projections/assumptions.
Anger is not becoming and is pointless on a message board dude.
You remain incorrect - if quite adamant about it.
Assuming that NNVC's CRO/associates did not fudge the data - given an possibility I would not entirely put beyond Diwan or somebody he would hire - there was no toxicity shown in any of the dosing types that were tested in the Phase I trial in India. I met the guy about 9 years ago and he seems smart - but he's slippery in getting a straight answer from.
The fact remains - yes - the FDA hasn't agreed with the results and signed off on them as of yet. The FDA hasn't seen any of the finalized results yet. A technicality at this point, but a significant technicality. And I will agree with you on this point.
So NNVC making official claims that there was no toxicity observed at the tested levels of their drug candidate in public statements is - indeed - something that they should be careful about stating until after FDA review and approval. The FDA emphasized that point in the letter than you cite.
That also doesn't change the fact that - again unless the Indian doctors have lied or Diwan is lying (again a possibility I don't completely rule out) - the drugs have shown no toxicity at the dosing levels that NNVC is recommending. And since the drug candidate has shown no apparent toxicity in their animal model studies to date, there is little reason to think that it's going to start showing significant toxicity in humans vs other mammals.
I DO my due diligence. Perhaps you should be more honest about your motivations here. Harping on, and on, and on, and on, and on,... About the same flippin' nonsense daily gets old dude.
This all is why I want Diwan to pull his head out of his behind and get that data finalized so that the company can get it in front of the FDA and so that the FDA can do its thing.
Yes. That Phase I study did demonstrate safety under the planned dosing schemes. You are incorrect and apparently are not ashamed to let any with intelligence know that you are incorrect.
What that Phase I study did not demonstrate was efficacy in any of the planned dosing schemes against any actual human ailment. That's the problem currently.
What will tell the tale in the end - will Diwan EVER get a Phase II trial launched anywhere? India, China, at one point the old CEO talked about clinical trials to be held in Australia.
The only thing that will move this company up, and up to stay, is a partnership that leads to a successful clinical trail that actually treats sick people. Yes, the Phase I did further demonstrate that the drug is generally safe. But it wasn't used to treat anybody with symptoms of COVID or of anything else.
From today's cheesy PR - Diwan has pushed back the goalposts yet again,.... end of Calendar Year 2025?
Simultaneously, we are preparing for a Phase II clinical trial with the objective of evaluation of effectiveness of NV-387 as an antiviral in humans. We have initiated the required non-clinical GLP animal studies already, and anticipate the reports on these studies by the end of CY 2025.
Yet another 'paid for' pump by Diwan,..... How about actually lining up a partner Mr. CEO?
https://www.investorideas.com/News/2024/nanotech/08020Better-Solutions-for-Viruses.asp#google_vignette
OK - so now we're up to a float of ~58 Million shares. Still not bad IF they can get the confirmatory study rolling in the next quarter or two.
Made for an interesting day - that's for certain. Doesn't really change my long-term position here - but I am guessing it aggravated the H_ll out of a lot of folks who got sucked into the buying rush early in the day when it tanked back down to a realistic trading price again.
Yep - Found the trigger - New study out looking to see if there was bias in the old Phase III study - short answer is - they found no bias in either the larger study population, or in the smaller subpopulation that they intend to target in the confirmatory study. Good news, but not the news that we were really waiting for.
https://www.investing.com/news/assorted/celsci-corp-phase-3-population-analysis-for-upcoming-confirmatory-registration-study-in-head--neck-cancer-demonstrates-well-balanced-patient-population-confidence-in-clinical-results-432SI-3539209
About 6.5 million shares traded in the first 15 minutes? Share price currently a shade over $2? Somebody thinks that something is up this morning. No news posted on the Cel-Sci website though.
Interesting move up this morning - volume is kind of light though for it to seem like anything 'real' is up.
And back up again for no good reason today,...
Change in management - New Chairman - Guy with experience in raising money.
https://feeds.issuerdirect.com/news-release.html?newsid=5946140769547282
July 8, 2024 9:15 AM
CEL-SCI Appoints Robert Watson as Chairperson of the Board
CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.
Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.
“I have greatly appreciated Bob’s guidance as a Director of CEL-SCI. His recent retirement from an active CEO role created the bandwidth for him to assume additional responsibilities as our Chairperson. The team and I are excited to have Bob involved at this level where his capital markets expertise will be highly valuable,” stated CEL-SCI CEO Geert Kersten.
Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually.
Bob Watson commented, “Having been on the path with CEL-SCI toward FDA approval of Multikine, it is my honor to be able to stand side by side with the management team as we complete the final leg of this amazing journey to bring a pre-surgical immunotherapy to patients with head and neck cancer. As stated previously, we are very confident that the Registration Study will confirm the excellent safety and efficacy results demonstrated in prior studies.”
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240708501317/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
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,...
I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.
And yes - the tumor shrinkage and disease regression data will be available, if not collated and easily analyzable within weeks for each patient. Anecdotal data will be available, but getting the data organized enough to critically analyze is going to take time. If whatever CRO or deep pockets supporter is on the ball and organized, that is still likely to take months post the trial being filled. Again - it's going to take somebody organized and that will have money to throw at the problem to speed things up more than that.
I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.
It's going to be an interesting ride here in the meantime.
Have a good weekend folks.
There was nothing concrete holding that gain up - not surprisingly we're back down again.
There won't be any long-term change, one way up or down, until we know what Diwan's next move is going to look like. If he sells shares enough to fund a Phase II without some supporting partnership - then **splat** again.
If by some miracle - Diwan does find a legitimate partnership, sponsorship, and less dilutive funding - then we might see some sustained gains up.
In the meantime - enjoy your weekend all.
Diwan keeps on beating that PR drum,...
https://www.stocktitan.net/news/NNVC/the-sustained-slow-declining-blood-concentration-profile-of-nv-387-4syfrx9nibyb.html
The Sustained, Slow Declining, Blood Concentration Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect,...
Probably not quite that long of a timeline I would guess.
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)
At last some good news on the catheter treatment,....
https://finance.yahoo.com/news/citius-pharmaceuticals-achieves-primary-secondary-110000306.html
Agreed - there will need to be some money raised in some way. I'm waiting to see how they chose to do that as well.
I'm hoping that they can find a big-pharma partner who can help underwrite the costs for starting up the trial - in exchange (of course) for some part of the company or some cut from the eventual profits.
Or better yet - a buyout offer. Not just selling more shares at anywhere near the current share prices.
You might be a bit optimistic on the 'before the fall' comment for getting full enrollment. Otherwise I agree with your point here.
Back in late 2015, they were enrolling a steadily climbing 25-35 patients per month for the main Phase III trial. They did enroll a total of 340 patients during the whole of 2015 though. Assuming they push as hard as their CRO did in that year, I could see enrollment by end of Q1 of 2025 though. Once enrollment is filled - they should have data for an initial phase 1 (lower case intended) readout of their confirmatory trial by (I would guess) the next quarter.
Also, keep in mind, that the confirmatory trial has a more limited pool of patients than did the world-wide trial BECAUSE they are going to focus in on a subset of the potential patients with their confirmatory trail. I was tracking enrollment fairly closely back in 2015 when I still occasionally wrote summaries on Seeking Alpha. Part of how quickly they can fill a new trial is going to depend on how much human and financial capital they have available to throw at the problem.
https://seekingalpha.com/instablog/1033940-just-one-lab-nerd/4684406-cel-sci-company-cvm-continues-to-slog-forward-in-populating-phase-iii-trial-for-multikine
From a quick reading of the new Benzinga summary of the most recent corporate report:
The mortgage on their facility could be good, or could be bad - as that is one asset that the company does have that is not something specifically belonging to Diwan's privately held companies.
A partnership would be an excellent thing to get in place. However, Diwan might have to give up some control in order to get somebody outside to buy in.
Either way - I'm not adding 'yet' - but I am not selling anything I do hold either.
https://www.benzinga.com/pressreleases/24/05/ac38838071/nanoviricides-has-filed-its-quarterly-report
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)
It's never a bad sign when the CEO buys a block of shares.
Not a clue - but I am guessing it can't hurt.
Yeah - that's not entirely spelled out in the new Cel-Sci report document. However, I am guessing that they can get enrollment done much more efficiently than they did with that previous trial. Man that was a train-wreck last time with the CRO issues that they had. n
They should be able to get the tumor shrinkage and biomarker data under their belt rapidly. I suspect that they should be able to get enrollment relatively rapidly now as well with the existing supporting data. But survivorship data is just going to take the time to get it done.
They might go fishing for a partnership with a big pharma - or perhaps get a buyout offer on the table? As de-risked as Multikine is at this stage, some big oncology pharma might make 'us' an offer.
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.
Only the fact that they had enough product to get through toxicity testing, and to get a Phase I test done.
Agreed
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)
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.
That would appear to be the case Sir!
Apparently Mr. Market is very much NOT impressed by this addition to the BOD.
Has been for quite a while,... Not exactly a noteworthy point.