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NNVC - features
NNVC - 11/13/2023 catalysts
$NNVC
__________________
NV-387 IS HIGHLY ACTIVE AGAINST TESTED CORONAVIRUSES INCLUDING SARS-COV-2 IN PRE-CLINICAL STUDIES
THE ENTIRE FLOAT ON NNVC IS JUST 11.2 MILL ACCORDING TO FINVIZ!
******NanoViricides, Inc. is possibly one of the few laboratories in the world to have developed an orally effective nanomedicine.
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$NNVC *** $NNVC *** $NNVC *** $NNVC *** $NNVC *** $NNVC *** NNVC
NNVC - 11/13/2023 catalysts
$NNVC
__________________VIRAL THERAPEUTICS_______________
NOTEWORTHY CATALYSTS
1. Broad-Spectrum, Pan-Coronavirus Drug NV-CoV-2 (API NV-387) for COVID, certain cases of long COVID, Seasonal Coronaviruses, MERS is in Clinical Trials. Two formulaJons are in clinical trials at present: Oral Syrup which can be titrated for body weight and is therefore preferable in pediatric seeng, and Oral Gummies, a fixed strength dosage form generally preferable for adults. We believe they would be highly effecJve for mild-to-moderate (non-hospitalized) cases of COVID. AddiJonally, NV-CoV-2 Solu=on for Injec=on, Infusion, and Inhala=on is developed for hospitalized COVID patients with severe disease; direct lung inhalaJon should provide significantly superior benefits by providing high pulmonary local concentration of the drug. NV-CoV-2 (NV-387) was found to have strong effectiveness in mulJple coronaviruses in vitro, and also strong effectiveness even when compared to remdesivir in animal studies of lethal lung infecJon. We believe the human clinical trial results should be consistent with these pre-clinical studies, and if so, would establish NV-CoV-2 as perhaps the most effecJve COVID treatment. There is no safe and effecJve COVID drug that covers all the paJent populaJons and disease severiJes at present, indicating significant unmet medical needs.
2. NV-387 Expanded Indications Program. We are elucidating the breadth of the anJviral spectrum of NV-387 at present. NV-387 is based on mimicking sulfated proteoglycans to a_ack the virus parJcle. A large number of viruses bind to such structures before gaining cell entry, including RSV, human MetaPneumoVirus (hMPV), certain Adenoviruses, other respiratory pathogens, as well as a number of systemic viruses such as Dengue viruses, Chickengunya, among others. Successful addiJonal indicaJons against any such viruses, if any, would significantly improve the return on investment, while fulfilling unmet medical needs.
3. Such additional indications would be eligible for Phase II/III studies with NV-387 having completed Phase I studies already.
4. Additonally, NV-387-R Could Result in Potential Cure Against a Number of Non-Latency Viruses.
HerpeCideTM Program. Variants of NV-HHV-101 are expected to become clinical drug candidates for topical treatment of HSV-2 “genital ulcers”, and HSV-1 “cold sores” soon aqer NV-HHV-101 goes into clinical studies. NV-HHV-101 is anJcipated to further expand into additional indications against chickenpox – a possibly orphan drug in the USA – and PHN (a morbidity of shingles persistent pain that may last for six months or longer, aqer the rash resolves).
We are also developing drugs against HIV.
******NanoViricides, Inc. is possibly the first in the world to have developed an orally effective nanomedicine.
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$NNVC - 11/13/2023 update
$NNVC
_____________________________
NEW ERA IN TARGETED ANTI-VIRAL THERAPEUTICS
NanoViricides, Inc. is a globally leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
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And then a significant bounce-back,.... This stock isn't going to go anywhere steadily upward until after we see some results from the ongoing Phase I trial come out AND have those results look positive for the future of the 'Cide.
Wow, this POS is could become one of the longest-running biowreck scams in history.
How long have the same saps been pumping this now? 20 years?
Nobody knows the future, correct. Nobody knows if their investments will do well in the future, but I'm pretty sure all investors hope they make a good return on their investment, so not sure what you are trying to say.
About being wrong or not, certainly your prediction that they can't make cides reliably enough to go into a trial was wrong. As was the claim Diwan never intended and never would run a trial.
So yeah, your predictions sure were wrong. Did you hope you would be right? Sorry. Just shows how unreliable is your information and predictions. And correct, you and your creator know if you are telling the truth or playing odd games, because you are Bored Member of internet stock chat platforms, or other issues.
Hope is not a good investment strategy.
Though I do appreciate that you identify the clear and obvious signs that this is a scam, even if you then go onto rationalize and justify them.
I know, I know, I’m a liar and can’t be trusted.
But that doesn’t make me wrong.
On the positive side, at least he is trying to give the appearance of independence from third parties, at least in word if not in deed.
But yeah: slippery, loose, imprecise, (outright false?), overly promotional, and self-dealing as ever.
Leopard. Spots.
Still will be interesting to see how the science plays out. Great concept. Terrible execution by slippery, self-dealing management.
But we may eventually see some clinical results that could be noteworthy. They might be able to drum up a partner for RSV trial? or they will hit the ATM (with EF Hutton now as placement agent) to maybe try to run a trial themselves, which they claim could be done for $1.5M - phase II for RSV?
They now split up their drugs into 4 types: (1) broad-spectrum S-PG or sialic acid mimic cides, (2) more specific viral (e.g. against HHV) cides, (3) cides plus encapsulation of an antiviral drug that stops replication or release from the cell, and now (4) somehow going after cells with latent viral infection / DNA ... seems a bit much to promote.
Despite the last reverse split I see that NNVC has been well below 2 clams for some time now.
I expect to see another reverse split eventually, followed by a reduction to 2 clams again.
No matter how many reverse stock splits are done, 2 clams is always in the future.
Remember this?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171612555
I'm resisting the temptation to copy and paste the whole thing...it's that interesting...but I will quote the first sentence of the paragraph that you quoted which NO LONGER APPEARS on the Karveer "About Us" web page that you linked (https://www.karveermeditech.com/about-us.php):
"The founder of Kaveer Meditech is Dr. Anil Diwan, Karveer Meditech is working under the guidance of American Company AllExcel Inc. USA which is 100 % owned by Dr. Anil Diwan. Dr. Anil Diwan is the Chairman of Karveer Meditech"
https://www.karveermeditech.com/about-us.php
Why the reminiscence?
The late 10-K was filed today. It makes reference to the Karveer/Diwan relationship a few times:
"Karveer is owned by the Diwan family, consisting of four siblings and their immediate families. Dr. Diwan has an undivided share in the Diwan family interest in Karveer. The number of shares is not currently available. Consequent to and subsequent to the Karveer COVID License, Karveer is deemed to be a related party."
and
" Diwan, our Founder, President and Executive Chairman, is a passive investor in Karveer. His ownership interest does not provide him with control or significant influence over Karveer.
The highlight in the last sentence was added by me. To say that you own a business but do not have control or significant influence over it is just plain goofy and the kind of thing that one might expect from a Company that says "The Company currently has no registered trademarks" in a 10K that includes the following seven times: "nanoviricides®", falsely indicating that "nanoviricides" is, in fact, registered.
A small thing perhaps, but indicative of this Company's reliability.
NanoViricides, Inc.
Thu, October 12, 2023 at 6:45 AM EDT·10 min read
https://finance.yahoo.com/news/nanoviricides-inc-present-partnership-opportunities-104500220.html
SHELTON, CT / ACCESSWIRE / October 12, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), announces that the Company's President, Dr. Anil Diwan, will be presenting a talk in person at the Partnership Opportunities in Drug Delivery (PODD) Conference in Boston, MA, on October 16, 2023 at 6:07pm ET in Track 2B.
Dr. Diwan will present a talk entitled "Revolutionizing Antiviral Treatments - Orally Available Nanomedicines that Can Also Deliver Difficult APIs and Improve Their PK." His talk will focus on the following topics:
NanoViricides Flexible, Site-Targeting, Platform Technology is in Phase I
Orally Available, Broad-Spectrum Antivirals Platform Goes Beyond Immunotherapeutics
Escape of Virus is Not Likely
Curing Viral Infections is Within Reach
The NanoViricides technology platform has produced a highly effective, broad-spectrum antiviral drug candidate for the treatment of RSV, COVID-19, MERS, SARS, and many other viral infections. This drug, NV-387, is formulated into three different drug products, called (i) NV-CoV-2 Oral Gummies, (ii) NV-CoV-2 Oral Syrup, and (iii) NV-CoV-2 Solution for Injection, Infusion, and Inhalation.
The two oral formulations of NV-CoV-2 are in Phase 1a/1b clinical trial in India, sponsored by the Company's licensee and collaborator, Karveer Meditech Pvt. Ltd. The clinical trial includes single-ascending-dose (1a) and multiple-ascending dose (1b) arms in healthy subjects to evaluate the safety and pharmacokinetics in humans. In addition, the clinical trial also includes COVID-19 patient treatment arms in the multiple-ascending dose part (1b-COVID) that is designed to evaluate safety in COVID patients and to obtain efficacy parameters for dose regimen selection for Phase II/III clinical trials.
To date, 26 of 36 subjects have completed the study in the healthy subjects portion. No adverse events or severe adverse events were found and the drug was well tolerated even at the highest dosage tested. These results are consistent with the strong safety observed in pre-clinical studies.
Event
NanoViricides Presentation at the PODD 2023 Conference
Day & Date
Monday, October 16, 2023
Time, Track & Room
6:07pm ET, Track 2B, Room Independence AB, 4th Floor
Location
PODD, The Westin Copley Place, Boston, MA, USA.
Website
https://theconferenceforum.org/conferences/partners-in-drug-delivery/2023-2/#day-110364-tab
In addition to its strong effectiveness in pre-clinical studies against multiple coronaviruses,
NV-387 was also found to be highly effective as a treatment of RSV infection in a Lethal Lung Infection (ARDS/Pneumonia) Animal Model of the disease as previously reported. In this study, animals treated with oral NV-387 survived 15 days, almost matching the 16 days survival when treated with the highly toxic drug ribavirin. There is no treatment for RSV infection, other than ribavirin which is conditionally approved only for patients with high risk of progressively severe RSV disease, due to its significant side effects including hemolytic anemia and kidney failure.
We anticipate that NV-387 for treatment of RSV infection can enter into Phase II/III human clinical trials upon completion of its on-going Phase I human clinical trial.
The strong effectiveness as well as excellent safety of NV-387 observed in pre-clinical studies for multiple indications bodes well for the entire NanoViricides Technology Platform.
The Nanoviricides Platform also enables delivery of difficult active pharmaceutical ingredients (APIs) and improves their pharmacokinetic properties as demonstrated by the pre-clinical studies of NV-387-g-R (Remdesivir as a guest encapsulated within NV-387 polymeric micelles), and NV-387-g-Ribvp (a Ribavirin prodrug as a guest encapsulated within NV-387 polymeric micelles).
Viral infections can be cured by drugs utilizing power of the NanoViricides Platform that enables (a) "Re-Infection Inhibition", and (b) "Replication Inhibition" in a single drug, thereby blocking the virus lifecycle completely. The NanoViricides Platform also enables additional approaches towards potentially curing latent viral infections such as those caused by herpes family viruses (HSV-1, HSV-2, VZV, EBV, CMV, HHV-6A/B, HHV-7, KSHV), HIV and others.
Further applications of the Nanoviricides Technology Platform would be evident to researchers in their own unique fields to tackle other diseases.
In addition to the conference presentation, Dr. Diwan has scheduled several meetings at the Conference.
Dr. Diwan will present the Company's Assets and current development stage:
NV-CoV-2 (API NV-387): Clinical Stage. Treatment of COVID and certain cases of long COVID. Broad-Spectrum, Pan-coronavirus Drug "(viral) Resistance is Futile". Highly Effective and Extremely Safe in pre-clinical models. Excellent PK in monkey and rodent animal models.
NV-CoV-2-R: Encapsulates remdesivir within NV-CoV-2 substantially improving its PK profile and enabling synergistic drug action. Expect complete cure of coronaviruses by blocking both the re-infection cycle and replication cycle.
NV-HHV-1: Skin cream for treatment of Shingles rash. IND-enabling studies completed.
NanoViricides Technology Platform for Drug Encapsulation: The nanoviricides technology platform is proven to be capable of encapsulating and thus protecting a number of APIs improving their PK/PD and bioactivity. Enables long acting acute timeframe (~ 24 - 72 hours). Has enabled Oral, Transdermal, I.V. Injection, I.V. Infusion, and Lung Inhalation routes for drug delivery. Rescue drug candidates.
NanoViricides Technology Platform for Drug Development: Specific site-directed ligands for bind to viral surface glycoproteins enable blocking of re-infection and engulfment of the virus particle within the nanoviricide™ micelle. Expected to deliver encapsulated APIs to virally infected cells projecting viral glycoproteins, sparing normal cells from toxic antiviral APIs.
About PODD (from their website, https://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/)
Pharma, biotech and the drug delivery industries gather annually at PODD to assess delivery needs, latest trends and information on deals and learn about a wide range of innovative drug delivery technologies that could improve the delivery of various types of drugs. This can include proteins, peptides, oligonucleotides, biologics, and small molecules and more. PODD provides business development opportunities through organized networking and a partnering tool for new, emerging and established collaborations.
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-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced 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 factors including external collaborators and consultants. The NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.
NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain 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 RSV, 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 human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, 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.
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". "Prodrug" means a chemical that is readily converted into the referenced drug in the body.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
It will be interesting to see what the 10-K has to say about the trial(s) if and when it is filed. They say they will file it by next Friday.
I was going to comment on 'why' NNVC was up almost $0.10 for the day,.... but then I realized that trading was almost non-existent today. And of course it's back down most of that gain already.
Nothing interesting is going to happen until there are some Phase 1b results to talk about.
"The Registrant could not complete the required financial statements and accompanying notes for the filing of its Annual Report on Form 10-K for the year ended June 30, 2023 without unreasonable effort and expense. The registrant anticipates it will file such report no later than the fifteenth calendar day following the prescribed due date"
Formulaic hooey.
Will there be a subsequent event report regarding the Indian trial in the 10-K when they finally get around to publishing it?
But of course there's something going on. For the first time ever there's a set of clinical trials going on. Alas there hasn't been an update on the scientific status of them, just a notification that a $1.5M note issuance has somehow been triggered by the trial start even though NNVC itself isn't running the trial.
There's always something going on at NNVC that inures to the benefit of Anil Diwan.
"And still a lot of nothing going on here" describing activities that might be beneficial to non-affiliate shareholders.
And still a lot of nothing going on here.
In case this is behind a paywall I'll paste an excerpt or two. It's an OPINION piece from today's NY Times and the excerpts may show my own personal bias. I can post the entire piece if requested.
https://www.nytimes.com/2023/09/11/opinion/india-medicine-safety.html
"Over the past two decades, India emerged as the “pharmacy of the developing world,” the leading manufacturer of generic drugs and medicines, producing more than 20 percent of the world’s supply. This has helped to make a range of medicines available to poor patients around the world who previously had to do without.
Today, however, India stands accused of distributing death, as its regulators fail to prevent the manufacture and export of substandard medicines. But this isn’t entirely a made-in-India problem. There is a dirty secret in global health: Rich countries get quality medicines, the poor sometimes get poison."
"Last month, a Gambian government task force recommended suing the Indian government over deadly cough syrup. Yet the administration of Prime Minister Narendra Modi of India last month pushed a bill through Parliament that features lighter punishments for manufacturing substandard medicines, highlighting why individual nations cannot be relied on to address the problem.
India needs to clean up its act for its own good — its growth into a powerhouse of generic drug production has polluted its rivers with antibiotic waste, spawned dangerous superbugs and made it a global hot spot for drug-resistant tuberculosis. For the rest of the world, the main benefit of India becoming the pharmacy of the poor was to break Big Pharma’s control of lifesaving medicines. More cases involving deadly Indian-made medicines could undo that positive achievement by causing irreparable harm to the global reputation of cheap generics."
"Walking away with 60%+ gains after less than a month's time doesn't happen that often"
Did you really do that? If so, during what month?
Force of habit....and it's very lucrative.
Only one variable in the routine: "a pretty nifty way to both transfer some cash out of a US entity into _____"
The blank gets filled in with the AD owned entity du jour.
Looks like a pretty nifty way to both transfer some cash out of a US entity into India, and much else besides.
Why would AD want to do such a thing?
8-K filed explaining $1.5M left pocket to right pocket milestone payment....
except it's a note, not a payment, and it carries 12% interest.
Recap as I understand it:
NNVC signs new License agreement with TheraCour to cover Covid drug development.
AD goes to India and hires a company in which he is a principal to develop and run a Phase 1 for NNVC's covid drug.
NNVC issues note to Theracour for milestone payment amount of $1.5M.
So many other researchers using the same viral cell receptor decoy concept as NNVC:
https://www.science.org/doi/10.1126/scitranslmed.adi2623
Abstract
The Omicron variant continuously evolves under the humoral immune pressure exerted by vaccination and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and the resulting Omicron subvariants display further immune evasion and antibody escape. An engineered angiotensin-converting enzyme 2 (ACE2) decoy composed of high-affinity ACE2 and an IgG1 Fc domain could offer an alternative modality to neutralize SARS-CoV-2. We previously reported its broad spectrum and therapeutic potential in rodent models. Here, we demonstrate that the engineered ACE2 decoy retains neutralization activity against Omicron subvariants, including the currently emerging XBB and BQ.1 strains, which completely evade antibodies currently in clinical use. SARS-CoV-2, under the suboptimal concentration of neutralizing drugs, generated SARS-CoV-2 mutants escaping wild-type ACE2 decoy and monoclonal antibodies, whereas no escape mutant emerged against the engineered ACE2 decoy. Furthermore, inhalation of aerosolized decoys improved the outcomes of rodents infected with SARS-CoV-2 at a 20-fold lower dose than that of intravenous administration. Last, the engineered ACE2 decoy exhibited therapeutic efficacy for cynomolgus macaques infected with SARS-CoV-2. These results indicate that this engineered ACE2 decoy represents a promising therapeutic strategy to overcome immune-evading SARS-CoV-2 variants and that liquid aerosol inhalation could be considered as a noninvasive approach to enhance the efficacy of COVID-19 treatments.
And up another 20% so far today. Apparently that news out of India is going over well. Who would have guessed that getting a clinical trial running might actually make the needle move?
Up 10% today. Interesting. Its good to see something like a progress report from NNVC.
https://finance.yahoo.com/news/phase-1a-1b-human-clinical-104500663.html?guccounter=1&guce_referrer=aHR0cHM6Ly9zdG9ja3R3aXRzLmNvbS8&guce_referrer_sig=AQAAAFZhs8tVWBO-UvRR7WHmg8W32AOwnsV-XPX6YGrnDvhsvPWdYFzpZynRJ4dm7fvK8549RYl-9BPhw32eoYgQ14X7JLkaMYQl2z_j3Ogr4fHq5vH9sehuLIJM3wM6b7RrJYC-NWUqGLU_U4thXNcfNuizTk4jlSaLrjNYcVJLfnRc
Agreed. A lack of follow-up is kind of irritating. Even a quick note stating - Hey, we are starting the Phase 1b portion on (fill in the date). All needed resources to do so have been put into place.
That would be appreciated.
A month has now passed without an update to:
https://ih.advfn.com/stock-market/AMEX/nanoviricides-NNVC/stock-news/91519098/clinical-trial-of-broad-spectrum-antiviral-drug-nv
"We are pleased with the success of the clinical trial so far and look forward to the start of the Phase 1b portion soon," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, explaining, "This clinical trial we believe will be a springboard for NV-CoV-2 to launch into multiple antiviral indications in the near future. NV-387 is designed as a bio-mimetic that can possibly be an effective drug against many viruses including the coronaviruses. If successful, it is poised to satisfy many as yet unmet medical needs for the global population, not just limited to COVID."
And it begins.....NV-387, there's not a thing it can't fix.
Reminds me of what Soupy Sales got in trouble for: Now kids, I want you to go into your Dad's pants, find his wallet and take out the pieces of paper with the dead President's pictures on them and put them in an envelope and write Soupy sales show on it and put it in your mailbox.
C'mon Kids. It'll be fun!!!
I'm NOT really complaining - but this statement near the end of that article is more than a bit 'rich' after this company bounced from disease, to disease, to disease, to disease for the last decade+
Company’s Broad-Spectrum Antiviral NV-387 Has Demonstrated Excellent Effectiveness in RSV in a Lethal Lung Disease Animal Model, Reports NanoViricides
https://finance.yahoo.com/news/company-broad-spectrum-antiviral-nv-104500702.html
SHELTON, CT / ACCESSWIRE / July 11, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the strong effectiveness of its broad-spectrum antiviral clinical drug candidate NV-387 in an animal model of lethal lung infection with RSV (Respiratory Syncytial Virus).
NV-387 Can Advance Directly into Phase II Human Clinical Trials for RSV Treatment:
NV-387 is the active ingredient of NV-CoV-2, the Company's drug for the treatment of COVID and possibly long COVID. It is already in Phase 1a/1b human clinical trials for the evaluation of safety in healthy volunteers and of safety and preliminary efficacy in COVID patients as previously reported.
It is expected that NV-387 can be advanced into Phase II studies against RSV once the current Phase I studies of NV-CoV-2 are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments (ROI).
"We are very pleased with the extremely high effectiveness of NV-387 in combating RSV", said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Importantly, both oral administration and intravenous injection of NV-387 were highly effective. This study further establishes the broad-spectrum antiviral effectiveness of NV-387, and further solidifies our novel nanoviricides platform technology."
RSV is an Important Acute Lower Respiratory Infection (ALRI; includes Pneumonia)[1]:
Each year in the United States, an estimated 58,000-80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood ALRI and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3·2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
There are No Effective Treatments for RSV:
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.
However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for treatment of RSV infection.
Market Size of RSV Therapeutics is Expected to Hit US$ 8.73 Billion by 2031[2]:
GrowthPlus Reports, in June 2023, says the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
NV-387 Injection was Found to be Highly Effective Against a Lethal Direct-Lung RSV infection in a Mouse Model:
Animals treated with injection vehicle solution alone survived 7 days. Ribavirin, a toxic drug, was used as a positive control. Animals treated with injections of ribavirin survived 16 days, whereas animals treated with injectable NV-387 survived 15 days, almost matching the efficacy of ribavirin treatment.
NV-387 Administered by Oral Gavage was also Found to be Highly Effective in the Same Lethal Direct-Lung RSV Infection Study:
Animals treated with oral drug vehicle alone survived 7 days. Orally administered Ribavirin, a toxic drug, was used only as a positive control. Animals treated with oral ribavirin survived 16 days, whereas animals treated with oral NV-387 survived 15 days, again almost matching the efficacy of ribavirin treatment.
Unlike ribavirin, NV-387 has been found to be extremely safe in preclinical studies. Therefore, it would be possible to increase the dose level or frequency of NV-387 to increase its effectiveness. Thus this study demonstrates that NV-387 is a highly effective drug candidate for the treatment of RSV infection with significant patient benefits.
NV-387 Demonstrated Very High Oral Bioavailability in This Study:
The dosing of NV-387 orally given was twice as much as that given by I.V. injection to compensate for oral bioavailability. The apparent oral bioavailability of NV-387 based on efficacy parameters appears to be of the order of almost 50% in this study, a very high value.
NV-387 Acts by a Novel Mechanism:
The Company developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It was designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering it incapable of infecting another cell.
The Company calls this novel antiviral mechanism "Re-Infection Blocker".
Expanding Indications of NV-387:
NV-387 employs mimics of well known attachment sites on the cells commonly used by viruses called sulfated proteoglycans. Since these attachment receptors are used by over 90% of human pathogenic viruses, the Company anticipated that NV-387 may have effectiveness against many viruses beyond coronaviruses, our initial focus.
RSV is the first non-coronavirus that the Company has evaluated for susceptibility to NV-387.
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® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II human clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Disclosure Statement: This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. In particular, as is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
[1] Lancet 2017; 390: 946-58
[2] https://finance.yahoo.com/news/respiratory-syncytial-virus-rsv-therapeutics-093200835.html?guccounter=1&guce_referrer=aHR0cHM6Ly9kdWNrZHVja2dvLmNvbS8&guce_referrer_sig=AQAAAJXyjZT5Eielym71qZ0IBGYvgi3hzLSE58E-lHgXYBqe05twy3ZebjDbrt-UQegh3oVT7jvFPFYFIUfhjVwW0eguJwwbdSkRaOqkUrwAE38mmEqGdq_TJ1mwmBd95cGsHyvreIVtgdVm2RhQfzyUiQvFrjQKvale9YMdc5vLUTFc .
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
We're up almost to $1.60 (it was briefly up to $1.74) so far today. It appears that 'the market' liked that last PR about the RSV in animal models. It that's true - Diwan may have finally gotten this company moving forward with a useful product.
The self-dealing CEO will - of course - massively benefit while we at least start to get something for our time and patience.
Thanks for the thoughts.
re: "presumably 3 in each?"
That's what I presumed, which seemed to me to be too small from which to reach any valuable conclusions, especially in the sick cohorts where it was hoped some efficacy inklings could be gleaned.
Forever the skeptic you know, but I've seen this act before. Design a test that can only be inconclusive, look at the bright side of the scant results, and determine that further testing is justified.....and that more funds will need to be raised.
I'm not sure that this sample will even assure safety.
At least he's giving us stuff to consider.
A few other thoughts:
I have no interest in getting in the middle of this....
"So I guess that is 2 mega-oft-repeated opinions that have been proven wrong so far?"
....but I think some might expect the FDA to be more cautious than the Indian authorities and express opinions based on that thought and the Diwan established failure to have ever sought any FDA protocol approvals.
"So, playing it safe until they show safety, then can include kids, elderly, and sicker subjects."
Ethically that makes sense and you have to start somewhere, but it would require a second Phase 1 test to allow for treatment of those groups and Dingdong says he's gonna fix everybody:
"Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage."
We're gonna need a lotta popcorn for this one, even if "Phase 1a is Progressing Rapidly:" and "Phase 1b to Begin Shortly:".
I can see it now: "Based on the end of the Covid pandemic and the recent increase in Malaria cases both in the US and worldwide we have decided that it is in the Company's interest to pivot away from".....etc.
He's pivoted away from EVERYTHING HE HAS EVER STARTED. A Phase 1 in India is only enough to hold him based on the way he structured the latest deal with himself. I hope you can keep me interested based on the science because based on business practices this is only worth watching for the fumbles.
It's impossible to know the exact details of the trial without seeing the protocol, but we can guess.
Apparently will have 12 healthy cohorts, as you suggested:
1A - healthy controls, single dose, syrup or gummy, 3 dose levels = 6 cohorts, presumably 3 in each?
Observe for 2 days.
1B - healthy controls, multiple daily doses x 5 days, syrup or gummy, 3 dose levels = 6 cohorts, presumably 3 in each? Observe for 7 days?
Presumably this would be N=36 here for healthy controls.
Then also after that, will include N=36:
1B - mild to moderate Covid, NOT expected to require hospitalization within 48 hours. Have no idea if will dose these by syrup or gummies, and which dose level(s) they will use. Maybe they will do the same thing they did for healthy controls, with 12 cohorts of 3 each, starting with single dose of syrup or gummies at lowest dose, and working up dose levels, then also try multiple doses the same way?
It's interesting that they specify that Covid patients will be expected NOT to require hospitalization for clinical purposes within 2 days. Does that mean they will admit them 7 days of observation still, or treat them at home / as an outpatient and have them come back only if they get worse? Probably admit them only for the study, and they don't want people they will actually need to treat for Covid so quickly.
Why exclude kids and elderly? Probably because too much hassle for kids (usually get to them after it's proven safe in adults) and don't want more frail elderly (want to minimize possibility of bad outcomes if they are more frail to start).
So, playing it safe until they show safety, then can include kids, elderly, and sicker subjects.
Ha, yes, Diwan continues to be inappropriately overly promotional in just about everything he says!
But at least he is finally running a trial.
The trial results will help start to sort out the truth from the Diwan BS.
Theoretically, the nanoviricides are independent of the host and safe for all hosts. But of course that needs to be proven in large trials.
BTW, apparently Diwan is able to manufacture enough nanoviricide material in a consistent way that satisfies the Indian medical regulatory authorities. It seems like they will use ~300g of NV-CoV-2 for this trial (assuming average subject ~70 kg).
So I guess that is 2 mega-oft-repeated opinions that have been proven wrong so far?
We still don't know if nanoviricides are safe (but they seem to be so far at doses studied) or effective in humans. We also don't know how much will be required for each dose. For Covid, it could be 20 mg/kg/day * 70 kg * 5 days = 7 g per course. Can they manufacture a 5-10 g / dose course at a good profit margin? What is their production capacity?
I guess this news explains your return from a 3 year hiatus to make a few points, some of which I agree with.
"Your start with relatively health people "
No, you start with HEALTHY people in the Phase 1a.
"Phase II will expand the demographics."
Not necessarily. If there is a Phase 2 it will recruit a much larger group of patients and they won't be healthy.
"Your questions will become OBE with all the positive outcomes."
OBE? Help me out here:
https://www.acronymfinder.com/OBE.html
My questions related to sample sizes, inclusion/exclusion criteria and fuzzy language. I thought they were decent questions and I know there's at least one person here who can either address them or tell me they're inconsequential. I think that would better be done BEFORE all the positive outcomes are revealed since the answers may have a bearing on how those outcomes are interpreted.
It's Phase I. Your start with relatively health people so that comorbidities won't play a role in the results. Its designed to be conservative as a first step into human trials. My understanding is efficacy is normally performed in Phase II, but they designed it to get some efficacy data in phase I in this case. Phase II will expand the demographics. Your questions will become OBE with all the positive outcomes.
Just a few questions based on some of the info received to date:
1. How will the patient population be allocated between the cohorts in 1a and 1b?
Total Sample Size="72"
Intervention A. NV-CoV-2 Oral Gummy (Chewable gel):
Single dose(Phase 1a) once only in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route
Multi-dose (phase1b) once every alternate day for five dosing days once in day in three cohorts of 500mg, 1000mg and 2000mg for oral administration via sub lingual route
Intervention B. NV-CoV-2 Oral Syrup
Single dose (phase 1a) once only for oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg.
Multi dose (phase 1b) once every alternate day for five dosing days by oral administration in three cohorts of 10mg/kg; 20mg/kg and 40mg/kg.
IF I understand the process (a big IF) each cohort will involve dosing at least one unique individual ( in other words the Single dose 1a requires at least 3 individuals, 1 for each dosage). There are 12 total cohorts in the two trials.
If one were to assume that the cohorts include an equal number of individuals the total sample size of 72 would include 6 patients in each cohort. Is that adequate to "Evaluate Both Safety and Initial Efficacy Indications in COVID patients" (as described in the Company's press release) to any degree of medical certainty?
2. Exactly how is the mild to moderate/severe population defined?
"Phase 1b to Begin Shortly:
In Phase 1b, healthy persons will be dosed with multiple doses of the Oral Syrup and separately, Oral Gummies to study Safety and Tolerability.
Additionally, in Phase 1b, in separate cohorts, patients with mild to moderate/severe COVID-19 shall be enrolled to assess indication of efficacy. Patients deemed by the physician to be likely to require hospitalization within 48 hrs of screening will be excluded."
The last sentence alters the terms of the study to be patients with mild to moderate/severe COVID-19 that aren't likely to be hospitalized in the next 48 hours, eliminating a chunk of the moderate/severe population. It also differs slightly from the actual exclusion criteria, which says:
"Likely need for hospital admission within 24 to 48 hrs of randomization as per the assessment of the physician. (SpO2- <94%)"
3. Inclusion criteria:
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Obviously a decision was made to exclude the over 60 group, which is known to be the high risk age group. Why?
It may be a reasonable criteria to include, but it seems as if the trial wasn't exactly designed in a way that is consistent with the Diwan promotional effort.
From the press release:
"Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage.
In contrast, existing COVID therapeutics are limited in the treatable segment(s) of population; thus, Remdesivir is indicated for hospitalized patients only; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are not taking other drugs that would cause interactions. This leaves a large patient population that is unserved. "
What a pair of balls. He excludes the same or similar groups from the current 1a and 1b tests that he accuses existing treatments of failing to serve while saying "we believe that NV-CoV-2 will be useable in all segments of patient populations".
Read the underlined passage above and compare it to the following Inclusion and Exclusion Criteria from the current trial:
Inclusions: Age From 18.00 Year(s)/Age To 60.00 Year(s)
Exclusions: 1-Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood-forming organs.
2-History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
3-History of severe infection or major surgery in the past 6 months.
I'm not saying that the trial inclusion/exclusion criteria are unreasonable....they aren't. What is unreasonable is the promotion of a treatment as being "useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage" in a press release about a clinical trial that has been designed to avoid those issues without any mention of that fact while at the same time taking note of the failures of existing treatments.
It's shady and it's no surprise.
edit: Please consider adding the Clinical Trial registry as a Sticky: https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=67454&EncHid=&userName=Karveer Meditech
Clinical Trial of Broad-Spectrum Antiviral Drug NV-CoV-2 is Progressing Well, Says NanoViricides - NV-CoV-2 is Positioned to Fulfill Many Unmet Medical Needs
6:45 AM ET 7/6/23 | Dow Jones
SHELTON, CO / ACCESSWIRE / July 6, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") reports that the clinical trial of its broad-spectrum antiviral drug NV-CoV-2 is progressing satisfactorily.
NanoViricides is a clinical-stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform. NV-CoV-2 (API NV-387), our lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, is in Phase1a/1b Safety and Preliminary Efficacy Human Clinical Trials initiated by the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Company's Licensee and co-developer in India.
Following safety and tolerability evaluation in healthy persons for a single escalating dose of NV-CoV-2 Oral Syrup or NV-CoV-2 Oral Gummies in the Part 1a, the clinical trial will continue into Part 1b if there are no serious adverse events.
Phase 1a is Progressing Rapidly:
Enrollment in the third and highest single dose level of 40mg/Kg NV-CoV-2 Oral Syrup, and separately, 2,000mg NV-CoV-2 Oral Gummy has already begun. The lowest dose cohorts in the clinical trial (10mg/Kg Oral Syrup, and separately, 500mg Gummy) have completed, and the middle dose cohorts (20mg/Kg Oral Syrup, and separately, 1000mg Gummy) have been substantially completed allowing the highest dose cohorts to begin. Each person after dosing is under observation (in-hospital stay) for 48 hrs, followed by a scheduled follow-up visit.
There were no adverse events to date at any of the dose levels including the highest dosages.
Phase 1b to Begin Shortly:
In Phase 1b, healthy persons will be dosed with multiple doses of the Oral Syrup and separately, Oral Gummies to study Safety and Tolerability.
Additionally, in Phase 1b, in separate cohorts, patients with mild to moderate/severe COVID-19 shall be enrolled to assess indication of efficacy. Patients deemed by the physician to be likely to require hospitalization within 48 hrs of screening will be excluded.
"We are pleased with the success of the clinical trial so far and look forward to the start of the Phase 1b portion soon," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, explaining, "This clinical trial we believe will be a springboard for NV-CoV-2 to launch into multiple antiviral indications in the near future. NV-387 is designed as a bio-mimetic that can possibly be an effective drug against many viruses including the coronaviruses. If successful, it is poised to satisfy many as yet unmet medical needs for the global population, not just limited to COVID."
"Resistance is Futile": NV-387, the active pharmaceutical ingredient of NV-CoV-2 is designed to mimic a cell membrane with a number of so called "attachment receptor sites" chemically covalently connected to each polymer chain in the nanomicelle. No matter how much a virus changes, it still binds to the same attachment receptor(s), and therefore, it is unlikely to escape the nanoviricide drug.
This design we believe solves the major issue of small molecule as well as antibody therapeutics, namely, development of resistant virus variants.
NV-CoV-2 is Aimed at Satisfying Many Unmet medical Needs in COVID: NV-CoV-2 was shown to be extremely safe in pre-clinical animal studies. It was also found to be extremely effective in lethal infection animal model studies.
Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage.
In contrast, existing COVID therapeutics are limited in the treatable segment(s) of population; thus, Remdesivir is indicated for hospitalized patients only; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are not taking other drugs that would cause interactions. This leaves a large patient population that is unserved.
Further, we believe that NV-387 may become an important drug for the treatment of certain cases of long COVID wherein residual virus is known to be present.
NV-387 May Have a Very Large Range of Indications, because Over 90% of All Human Viruses Use the Attachment Receptor(s) Mimicked by NV-387:
NV-387, the active pharmaceutical ingredient of NV-CoV-2, mimics a family of attachment receptors called sulfated proteoglycans (S-PG), or glycosaminoglycans (GAGs). This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (CSPG). Over 90% of known pathogenic viruses bind to one or more of these attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human MetaPneumoVirus), Dengue Viruses, HerpesViruses, Human PapillomaViruses (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others.
NV-387 is likely to be effective as a clinically viable drug candidate against at least some of these viruses, we believe. Many of these viruses have no available antivirals or have antivirals with limited applicability.
We have already undertaken a program to expand the potential indications of NV-387. Success in any of these studies would enable direct entry into Phase II/III clinical trials for that indication.
Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).
On June 29, 2023, we reported that the Phase 1a/1b human clinical trials referenced above began on June 17,(,) 2023. The team behind the clinical trials was also described therein.
About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II human clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Disclosure Statement
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product
(MORE TO FOLLOW) Dow Jones Newswires
July 06, 2023 06:45 ET (10:45 GMT)
Well said Sir!
NNVC has indeed received IND approval in India on 1/27/23 from DCGI.
https://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=67454&EncHid=&modid=&compid=%27,%2767454det%27
https://clinregs.niaid.nih.gov/country/india#
I'm not sure what this does to your hypothesis that you repeated over and over again here, something about "in all the history of ...., if someone hasn't gotten an IND in ... x ... years, they never have gotten one and never will," but I'd say it destroys it pretty well, in spite of the inane repetition of it. I guess someone had to be first biotech to be the longest one in preclinical development and a breaker of your "rule" / observation! I guess you were wrong with your prediction, despite dozens of repetitions of it over 7+ years. Being right for 7 years was pretty good, though!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=121988456
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170460706
Will see if they if they have any hint of decent results, if they will be able to attract a partner or raise funds to go it alone, and if they will be coming to the US and will get an IND here too.
P.S. Another company that raised over $100M and still in product development over ~2 decades plus is the private company, Brilliant Light Power. Will see if they start getting some traction this year too. They also have lots of doubters and detractors.
Good lord.
The delusional magical thinking continues.
What you said Sir!
If I had to guess, I imagine they will do the 1a part within a month or two at most. Probably dose all the low dose gummies and syrup controls in one day, then see results in a week or two. If all is well, go to mid dose and repeat, then finally high dose if no dose limiting toxicities.
Although they have no controls or placebo, they will at least have low, mid, and high dose groups for comparison for mild-moderate Covid subjects in part 1b. If they are looking at any efficacy, such as time to viral clearance, then they could see a dose-effect that supports efficacy (where lower dose is closer to placebo effect).
It will be good to see this drug class finally administered in humans after all this time. I hope it is safe.
Not completely worthless though. Mostly a Phase I is geared toward assessing general safety and dosage ranges. If they figure that out then it's done its job. An open label study can still get the data that they need here.
If they get some data from the 1b group indicating that viral load decreases, or that symptoms show some improvement, that sets up a potential Phase II and gives self-dealing Diwan something to try and sell in a partnership with some other, bigger pharma fish.
One bonus to a potential COVID treatment is that 'if' it works, 'then' its going to work quickly or not at all. It won't take forever to actually 'do' the Phase I, and a Phase II should be similarly quick to see results, or the lack of results.
"And as such, virtually worthless."
They can assess safety without a comparator, can't they?
“Randomized, no comparator....I take that to mean no placebo..”
Correct. It’s an open label study.
And as such, virtually worthless.
Assuming it actually is being conducted, which is at least debatable.
"OK,... sudden decent volume and up ~18%? What's up today?"
Looks like you have your answer....somebody got a heads up.
"Mr. Market - he was apparently not at all impressed that Anil finally got something started."
And I suspect that that same somebody flipped back out.
Not a lot of money either day. If Diwan had any credibility left there would have been. The smart money may recognize this to be what it is, another Diwan deal with Diwan.
That said, it's news and you're right about this: Mr. Market - he was apparently not at all impressed.
"Would be good to see the trial endpoints besides safety, plus the size of the study, duration, etc... I imagine this will be a small, short safety trial, possibly with ascending doses? Likely to be randomized and placebo controlled? "
https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=67454&EncHid=&userName=Karveer Meditech
Registered on: 18/04/2023
Date of First Enrollment (India) 01/05/2023
Estimated Duration of Trial Years="0"Months="1"Days="5"
Total Sample Size="72"
Randomized, no comparator....I take that to mean no placebo..
Secondary Outcome
To evaluate the Pharmacokinetic (for healthy subjects only) and Pharmacodynamic nature (for Covid-19 patients only) of NV-CoV-2.
- To obtain an early measurement of drug activity in mild/moderate COVID-19 patients.
From the press release:
"The Single Dosing of Healthy Volunteers portion of the Phase 1a began with the dosing of a first set of volunteers on June 17, 2023. This set of volunteers was successfully discharged after a 48 hours in-hospital stay for observation, and will be further assessed in a final out-person visit as per the protocol. Further recruitments and dosings are scheduled as per the protocol."
How long do you think it would take to assess safety before dosing the 1b patients?
Why did it apparently take 5 months to scrape together 36 healthy volunteers? Been a long time coming.....seems a little patience is finally justifiable but I'm itching to see where this goes.
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