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No "problemo". Here is my rendition of what the "nano-machine" (nano-Cide), or as I also call it "nano-Terminator", does.
1- A person (host) that is unwell goes to the clinic/physician
2- He/She is diagnosed as being a host to a life-threatening virus
3- The virus is attacking host target-cells, replicating and continuing the attack
4- The host's immune system is mounting an offensive but it is being overwhelmed by the high number of virus "replicants"; it needs help and quick
5- The physician prescribes a dose (or two) of the necessary "nano-Cide" to do combat with the replicating virus (replicants)
6- One dose of the "nano-Cide" has approximately 75 trillion bio-mimetic "nano-Terminators" (imitate virus target cells) and it is injected into, or orally taken by, the host. They are also anphiphilic (water-loving) so they go to 50-75% of your body, depending on how hydrated the host is.
7- The "nano-Terminators" start to circulate in the host's blood stream at the speed of heart beats.
8- The virus (replicant) bumps into and engages one of trillions of "nano-Terminators" in the host. The "nano-Terminator" asks the replicant, who is your daddy and what does it do?, as it proceeds to engulf the "replicant". The "nano-Terminator" defeats the virus "replicant".
9- At the speed of heartbeats more virus "replicants" bump and engage other "nano-Terminators" and as expected the virus "replicants" come to their end, in the trillions, in a matter of hours.
10- The odds for the host's immune system are now better and continues to do battle against whatever is left of the virus "replicant" army, if any, and finish it.
11- The host grabs a tissue to wipe his/her nose clean. He/she is feeling a lot better and ready to go about their daily business.
Puffer, you replied to a message that was deleted in relation to FDA granting DengueCide Orphan status. You wrote, "Add 60 days for actual filing". In specific, what are you referring to? Thank you.
Excerpt from 2009 Jain Report: Structure and function of nanoviricides
source: http://allallan.blogspot.com/2009/04/nnvc-why-so-special.html
NanoViricides are polymeric micelles, which bind to multiple virus-surface-receptors as antiviral agents.They are different from any of the other micellar nanotechnologies as there are no metal particles attached and the micelles can penetrate the virus and bind to multiple sites for effective destruction of the virus.
Mechanism of action of NanoViricides
For a virus to infect a cell, it needs to bind to more than one site. For example, binding of HIV only to CD4 on T cells is insufficient to cause sustained disease; it needs HIV binding to at least two and possibly three different sites on the T cell and that too, at multiple points. For an antiviral to be effective, it should match the strategy to bind to more than one site on the virus. Ideally it should block all of these to prevent virus from infecting the cell and multiplying. Most of the current antiviral drugs have a single mechanism of action and block a single receptor. Drug combinations from different categories are required to increase the number of receptors blocked. Still this is not fully effective.
In contrast to other approaches, a NanoViricide™ micelle can recognize and bind to more than one type of binding site on the virus. The NanoViricide™ system enables design of a drug that binds to more than one type of site - currently as many as three different sites, on the virus - for a highly effective attack. NanoViricides Inc terms this as "multi-specific targeting".
A NanoViricide™ drug goes much further than just blocking all of the binding sites of the virus. The base material of a NanoViricide™ is a specially designed polymeric micelle material. It has the ability to disassemble an HIV particle by itself. Thus, after coating the virus particle, the NanoViricide™ loosens the virus particle, and weakens it. Some virus particles will even fall apart (uncoat). This provides a further therapeutic benefit. NanoViricides plans to enhance the viral disassembly capabilities of the NanoViricides™ by attaching specially designed "molecular chisels" to the NanoViricide™. Once the NanoViricide™ micelles coat the virus particle, the attached "molecular chisels" will go to work. They literally insert themselves into the virus coat at specific vulnerable points and pry apart the coat proteins so that the virus particle falls apart readily. The mechanism of action of NanoViricide is depicted schematically in Figure 4-1.
This description is a simplification. There is no fully adequate explanation of the observed efficacy because the mechanisms of action of nanomaterials as drugs and particularly, NanoViricides in vivo, are multiple and somewhat complex. Targets for this approach include influenzas, HIV, HCV, rabies and other viruses.
Advantages of NanoViricides
NanoViricides have been compared to current approaches to viral diseases, which are seldom curative and some of the advantages include the following:
§ Specific targeting of the virus with no metabolic adverse effects on the host.
§ The biological efficacy of NanoViricides drugs may be several orders of magnitude better than that of of usual chemical drugs. This in itself may limit the potential for mutant generation.
§ There are also other key aspects of the design of NanoViricides that are expected to lead to minimizing mutant generation.
§ Nanoviricides are safe because of their unique design and the fact that they are designed to be biodegradable within the body.
§ The new technology enables rapid drug development against an emerging virus, which would be important for global bio-security against natural as well as man-made (bio-terrorism) situations. It is possible to develop a research drug against a novel life-threatening viral disease within 3-6 weeks after the infection is found, i.e. as soon as an antibody from any animal source is available.
§ It is possible to make a single NanoViricide drug that responds to a large number of viral threats by using targeting ligands against the desired set of viruses in the construction of the drug.It is possible to “tune” the specificity and range (spectrum) of a NanoViricide drug within a virus type, subtype, or strain, by appropriate choices of the targeting ligand(s).
§ The safety of NanoViricide drugs is proven now as they specifically attack the virus and not the host.
§ A variety of formulations, release profiles and routes of administration are possible.
§ Low cost of drug development, manufacture, distribution.
NanoViricide drug candidates are currently in preclinical studies. Clinical trials are planned. Initially injectable products are considered to be most effective but alternative routes of administrations such as nasal sprays and bronchial aerosols can also be developed. Various Nanoviricide products will be described further along with relevant viral diseases.
Advantages of Nanoviricides over vaccines are
§ Nanoviricides work where vaccines fail and are effective even when the immune system is impaired such as in AIDS.
§ Nanoviricides work where effective vaccines are unavailable
§ Sufficient short term protection for an individual outbreak cluster-
§ Treatment can be started after infection
§ No need to vaccinate whole world population for control of a viral epidemic
Advantages of Nanoviricides over immunoglobulin therapies are
§ Fully chemical, room-temperature stable NanoViricides can be made against many diseases.
§ Nanoviricides based on antibody fragment conjugates do not require humanized antibodies. Antibodies from virtually any source can be used for developing NanoViricides, thus significantly reducing time and cost of development.
Immunoglobulin therapies require the patient's immune system (complement system) to function well, which is often not the case in advanced disease states. NanoViricides function completely independently of the human immune system while accomplishing the same goal of reduction in viremia.z
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Rejoice, the "good science" of tomorrow is here, today, thanks to the knowledge, the will, the efforts of "the good people" at Nanoviricides, Inc.
Thank you NNVCbob! You bring us all great news! Milestones on-track to completion 4Q 2013!
Nanopatent, once the Cides start to get fast tracked to the market, the era of antiviral "host enhancing" vaccines will come to a close. Big Pharma will have to adapt to the new "good science". Nanoviricides, Inc. footprint in the world, both healthwise and economic, will be greatly aclaimed by the people, the beneficiaries. "...Billions of dollars of stress on personal savings, Social Security, and Medicare each year. And the “cost” of illness — both in dollars and pain — only grows with age…" ~ Patrick Cox.
As you well know, Nanoviricides, Inc. has prestigious universities, institutions, collaborators. From the BigKahuna/Dr. Seymour " ...However, that being said, we are trying to hit the June 30th mark for sending in the request to the FDA for a meeting. Unfortunately, whether we can or cannot meet that date is not up to us and is predicated on getting back the additional data we need from our collaborators for the initial request. We also have other drugs that we can submit to the FDA..." We are on-track and moving forward towards the Milestones 4Q 2013.
Nanoviricides, Inc. will also have strong IP protection; well over 100 countries expected to approve patent applications by 4Q 2013; patents issued as "first in class" with no prior art.
Any idea if the next PR will be related to Nanoviricides/DengueCide application for Priority Review? Maybe next Friday or Monday? Confidence is high on NNVC!
If Nanoviricides, Inc. builds it, many will come...?
From the information that is widely available, About Nanoviricides, Inc. cGMP pilot plant...at the end are my observations and questions/speculation.
Nanoviricides, Inc. Retains AES Clean Technology, Inc. for Design, Engineering and Construction of the Cleanroom Suite in its previously announced cGMP Production and Laboratory Facility -- WEST HAVEN, CONNECTICUT -- January 14th, 2013
AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems (www.aesclean.com). Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is the leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries.
The Company has previously reported about the Shelton light industrial building that will house the cGMP pilot production plant, research laboratories, and offices. The cGMP pilot plant is being designed for the production of sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.
The light industrial building at 1 Controls Drive, Shelton CT was purchased by Inno-Haven, LLC. Inno-Haven is a private company that was founded by Dr. Anil R. Diwan, the Company’s CEO, and financed by himself and certain of his friends and associates, with the specific purpose of enabling clinical cGMP manufacturing capabilities for NanoViricides, Inc. drug substances. Acquisition of this 18,000 sqft building on 4.2 acres of land was previously announced by NanoViricides, Inc. in September, 2011. Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes. The drug substance produced in this facility will then be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready. NanoViricides, Inc. expects to lease this facility. No lease has been signed yet and no terms of lease have been finalized as of now.
WHAT IS A PILOT PLANT
A pilot plant is a small industrial system which is operated to generate information about the behavior of the system for use in design of larger facilities.
Pilot plants are used to reduce the risk associated with construction of large process plants. They do this in two ways:
--> They are substantially less expensive to build than full-scale plants. The business does not put as much capital at risk on a project that may be inefficient or unfeasible. Further, design changes can be made more cheaply at the pilot scale and kinks in the process can be worked out before the large plant is constructed.
--> They provide valuable data for design of the full-scale plant. Scientific data about reactions, material properties, corrosiveness, for instance, may be available, but it is difficult to predict the behavior of a process of any complexity. Engineering data from other process may be available, but this data can not always be clearly applied to the process of interest. Designers use data from the pilot plant to refine their design of the production scale facility.
If a system is well defined and the engineering parameters are known, pilot plants are not used. For instance, a business that wants to expand production capacity by building a new plant that does the same thing as an existing plant may choose to not use a pilot plant.
Additionally, advances in process simulation on Mcomputers have increased the confidence of process designers and reduced the need for pilot plants. However, they are still used as even state-of-the-art simulation cannot accurately predict the behavior of complex systems.
Pilot plant is a relative term in the sense that plants are typically smaller than full-scale production plants, but are built in a range of sizes. Some pilot plants are built in laboratories using stock lab equipment. Others are constructed of fabricated metal on dedicated concrete slabs and cost millions of dollars.
After data is collected from operation of a pilot plant, a larger production scale facility may be built. Alternatively, a demonstration plant, which is bigger than a pilot plant, but smaller than the full-scale production plant, may be built to demonstrate the commercial feasibility of the process. Businesses sometimes continue to operate the pilot plant in order to test ideas for new products, new feedstocks, or different operating conditions. Alternatively, they may be operated as production facilities, augmenting production from the main plant.
Recent trends try to keep the size of the plant a small as possible to save costs. This approach is called miniplant technology. The flow chemistry takes up this trend and uses flow miniplant technology for small scale manufacturing.
source: http://en.wikipedia.org/wiki/Pilot_plant
A pilot plant can be used for:
Evaluating the results of laboratory studies and making product and process corrections and improvements.
Producing small quantities of product for sensory, chemical, microbiological evaluations, limited market testing or furnishing samples to potential customers, shelf-life and storage stability studies
Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant.
source: http://www.academia.edu/1745550/SCALEUP_TECHNIQUES_AND_PILOT_PLANT
The following called my attention:
1- The cGMP pilot plant is being designed for the production of sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.
2- Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes.
3- design changes can be made more cheaply at the pilot scale and kinks in the process can be worked out before the large plant is constructed.
4- Alternatively, they may be operated as production facilities, augmenting production from the main plant.
5- Recent trends try to keep the size of the plant a small as possible to save costs.
I speculate that Nanoviricides, Inc. will use the cGMP pilot plant to:
1- go from human trials (four phases...few short months), and after approval by FDA, to full production/commercial of FluCide and DengueCide from the cGMP pilot plant(~ 2H 2014) Possible?
2- DengueCide gets Priority Review Voucher (minimum $200 million) and sells it to another Pharma company (~ 2H 2014)
3- The PRV sale money is then used to finance a larger cGMP plant (~4Q 2014) -- see also --> http://www.bioprocessintl.com/journal/2008/February/Construction-and-Start-Up-Costs-for-Biomanufacturing-Plants-182238?pageNum=3
4- While the larger cGMP plant is under construction/integration, the PRV money is also used to take HIVCide-I and other Cides (perhaps two at a time), through parallel "fast tracks", tox studies, clinical trials and after FDA approval, market. (~3Q 2014)
5- The new larger cGMP plant is complete 4Q 2015
As we all know, Nanoviricides, Inc. has subcontracted several professional firms to perform key projects and then there is MPH Project Management Group/Engineering cost efficiently orchestrating/directing the cGMP plant to completion/integration/commission/validation/readiness.
Nanoviricides, Inc. has plans and they are on-track. Confidence is high on NNVC!
Thanks Leifsmith. I totally agree. There was a time when I thought of doing a video like this but, why re-invent the wheel? I cannot improve on this video. Someone has already done it.
This is the link (below) and I would respectfully suggest everyone adopt it and make it their private signature in every communication. The "Liberty" signature, the "we the people" signature.
Barring the meddlers, the world improvers, the Malthusians, (ahem) bureaucrats, the Cides will whisk through human trials and then the era of "host enhancing" vaccines, against virus threats, will come to a close in the western world.
Imagine coursing through the blood stream, chasing through the body (host), grabbing and destroying the offending virus particles. A nanoviricide®, as defined by the Company, is a nanomachine that is armed to destroy a particular kind of virus.
I recall, on one occasion, nanopatent posted and I'm paraphrasing, "how long does it take to infect mice with a deadly virus and how many hours does it take to cure them? Hours?
I believe FDA is realizing the breakthrough bio-nanotechnology drug delivery system before them, they see now what is involved here and how fast Nanoviricides, Inc. can turn around come up with a virus-destroyer drug.
Nanoviricides, Inc. has 9 anti-viral drugs in their current pipeline that have already undergone extensive testing in over 5000 animals. No evidence of toxicity. No side effects!
Dr. Seymour said, "...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." The FDA has probably come to realize that they need to streamline Priority Review from the normal six months to "a few short months". That means "Priority Review" could very well culminate 4Q 2013.
Nanoviricides, Inc. is not the only one making the case, before the FDA, for the breakthrough bio-nanotechnology drug delivery system that terminates viruses, threatens and kills people worldwide. It is all the prestigious universities, schools of medicine, and others that are Nanoviricides, Inc. collaborators. It is all those countries, countries that will add up to more that 100 worldwide before the end of 2013, that will be issuing patents to protect Nanoviricides, Inc. Intellectual Property. ---
"...Unlike these existing drugs, however, NanoViricides’ technology acts before the virus has had a chance to gain entry into a healthy cell. This is like defeating a besieging enemy army with withering fire before it’s forced the city gates or undermined the defensive walls. The alternative methods used today are the equivalent of a last-ditch house-to-house battle after the defenses have been breached..." ~ Patrick Cox
Nanoviricides, Inc. is not about just any drug making platform. It is about THE BREAKTHROUGH bionanotechnology platform for antiviral drug delivery. Like "LEGO pieces" the polymeric anphiphilic micelles come together to become a virus most lethal enemy.
There are about 100 trillion cells in a human body and there are approximately 70 trillion "water-loving" polymeric micelles in one dose of DengueCide™. A couple of doses of these "non-toxic" and "water-loving" polymeric micelles is like posting a sentinel at every house, a sentinel with the defensive/offensive skills of a "terminator". ---
The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation.
I'll go with a "...few short months..." as Dr. Seymour says...4Q 2014.
Are we "on-track" to get PRV from FDA? If yes, how soon? 1Q 2014?
---
What brought me to become an investor in NNVC?
Several years ago, when searching for a good stock to invest on, persuasive arguments flashed across my laptop screen, arguments that really caught my attention and captured my imagination. Demographics, science and Patrick Cox writings, all contributed to my selection of Nanoviricides, Inc.(NNVC) as the company to invest on. As Patrick Cox once wrote, "...Unlike these existing drugs, however, NanoViricides’ technology acts before the virus has had a chance to gain entry into a healthy cell. This is like defeating a besieging enemy army with withering fire before it’s forced the city gates or undermined the defensive walls. The alternative methods used today are the equivalent of a last-ditch house-to-house battle after the defenses have been breached.
These current anti-viral drugs have other drawbacks. They are expensive and resistance develops as the virus mutates. There is also toxicity.
More than 99% of seasonal flu viruses have developed resistance to Tamiflu, according to the CDC. Unlike such drugs, NanoViricides has found no evidence of toxicity or resistance in animal trials. There is no mechanism by which resistance can develop against NanoViricides’ technology. If the surface proteins on the virus mutate away from the ability of the nano-micelle to attach to them, they have also mutated away from the ability to attach to the surface of a human cell. The viruses don’t have a chance. The Viral Equivalent of Penicillin.
These current anti-viral drugs have other drawbacks. They are expensive and resistance develops as the virus mutates. There is also toxicity...".
The Nano-Cides are agnostic to the host, but more than that... ---
I understand what you say, I did however write to the U.S. Congress just to add one more voice. Nanoviricides, Inc. is a start-up company, with great science, with great potential to solve health related economic problems as well as health threats to this country and abroad. It makes no sense to take away Orphan Drug Designation tax credit. If the U.S. takes the tax credit out, in essence they are taxing. Our government, our nation, is in great need of revenue to overcome the deficit and start to pay our national debt. There is a commonsensical solution, as Thomas Sowell puts it, "The real goal should be reduced government spending, rather than balanced budgets achieved by ever rising tax rates to cover ever rising spending."
The Orphan Drug designation tax credit is money that will not be collected by the tax agency if let alone while, at least in the case of Nanoviricides, Inc., billions of dollars of stress on personal savings, Social Security, and Medicare each year could be alleviated. And the “cost” of illness — both in dollars and pain? That as well.
Any good they tax, and we will get less of it. The U.S. Congress should hear from all of us, investors and any future beneficiaries of Nanoviricides, Inc. science.
I believe we, investors, should take a moment to write an email to our/your Representative/Senator in the U.S. Congress http://www.usa.gov/Contact/US-Congress.shtml
advocating for the Orphan Drug Designation. After all, we the people will benefit in more ways than one from this drug designation.
Follow the format for the email shown in the following link:
http://www.ala.org/aasl/sites/ala.org.aasl/files/content/aboutaasl/aaslcommunity/quicklinks/el/Sample_Letter_to_Elected_Officials.pdf
The benefits are summarized in your post and CDC
http://www.cdc.gov/dengue/epidemiology/local_dengue.html
From Motley Fool:
About Dengue and Dengue Hemorrhagic Fever
Dengue fever, a very old disease, has reemerged in the past 20 years with an expanded geographic distribution of both the viruses and the mosquito vectors, increased epidemic activity, the development of hyper-endemicity (the co-circulation of multiple serotypes), and the emergence of dengue hemorrhagic fever in new geographic regions. In 2013, this mosquito-borne disease is one of the most important tropical infectious diseases globally, with an estimated 400 million cases of dengue fever, over one million cases of dengue hemorrhagic fever, and 50,000-100,000 deaths annually. Dengue virus occurs in four primary serotypes.
A potentially life-threatening dengue disease due to “antibody-dependent enhancement of infection (ADE)” occurs when a patient is infected with a different serotype of dengue virus after the patient’s immune system was “primed” by a previous dengue virus infection. ADE increases the propensity to develop dengue hemorrhagic fever, or dengue shock syndrome, with a high fatality rate. Dengue viruses are carried by mosquitoes that serve as the vectors for the disease. The disease is endemic in many tropical parts of the world, although it is considered an orphan disease in the USA and Europe. (From Clinical Microbiology Reviews).
NanoViricides has also developed an oral drug candidate against influenza. This oral version is also dramatically more effective than TamiFlu in the animals given a lethal influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models.
An orphan designation for our dengue drug candidate, if granted, is expected to help the Company assign a higher priority to its dengue drug program, and undertake rapid development following the influenza drug candidates.
I get the reasoning behind your statement. The human trials will confirm that (2014) "...we are agnostic as to the host..." ~ Dr. Seymour.
On the other side of the pond another prestigious Institute of Public Health is collaborating.
WEST HAVEN, Conn., Jul 08, 2013 (BUSINESS WIRE) -- NanoViricides, Inc. NNVC -1.54% (the "Company") said it has signed a "confidential disclosure agreement" with Public Health England, the British government's equivalent of the U.S. Centers for Disease Control. The agreement will allow the scientists at Public Health England to develop a specific proposal for the testing of different nanoviricides, such as FluCide(R), against viruses of "mutual interest" to both organizations. More specifically, the first two viruses of mutual interest are H7N9, the influenza virus now circulating in China as well as the latest version of the coronavirus, now circulating in the Middle East. It is now referred to as the MERS virus. This virus is similar to the SARS virus that infected 8000 people and killed approximately 800 people 10 years ago. Both H7N9 and the MERS CoV (coronavirus) have extremely high case fatality rates. Testing of nanoviricides antiviral drug candidates will be performed in a BSL3/4 facility at PHE. BSL3/4 facilities are designed to contain and enable the safe handling of organisms that can pose a significant threat to health.
"...All the Lego pieces are already in the box, thanks to the genius of Dr. Anil Diwan, Dr. Eugene Seymour and a few others. If the NanoViricides team can cure dengue — and I believe they can — they can quickly go on to cure other orphan tropical diseases. West Nile, Rift Valley, Lassa, Ebola, Marburg, Bunya and Chikungunya are only the obvious targets. Believe me, the people running NanoViricides know about the priority voucher program and understand its implications. Once they have scaled up, I believe they could produce a new orphan tropical disease cure every two weeks..." ~ Patrick Cox
It's interesting how NNVC is moving to prepare the new FluCide (R) for MERS in order to proceed with tox studies. Like "Lego" pieces coming together. Thank you.
If you are no "dr" and you are no "md", then you are no "dottore"! No problem, it is a title, no insult implied. Not a funny, I am just upbeat on NNVC. Rejoice, the "Nano-Cides Special" is on track. --
Excellent. I knew I had see this before. Thank you.
Yes, I stand corrected "dottore" kazmd65. Thank you. I meant to state once again that the application submitted by Nanoviricides (Jun 10, 2013) to the FDA, for designation of DengueCide TM with Orphan Drug status, should be approved by FDA soon, before Sep 10 2013. Drugs designated with Orphan Drug status are promising developmental drugs and are "fast tracked" to the next "station", Phase I/II. That cGMP pilot plant in Shelton, CT will soon be complete (4Q 2013), commissioned, lit, and humming. Time is money! Dr. Seymour and NNVC's management understand this well.
Dr Seymour (Nanoviricides CEO) answers question (March 2103) after presentation UCLA University School of Medicine:
"This is one of the most prestigious Nanotechnology Institutes in the world. I've been talking to them for the past 4 years. I think they have finally understood the scope and magnitude of the work that he has done. He and I will be meeting with people from a number of different departments such as Chemistry, BioChemistry, Physics, Biophysics etc. I know some of these people from my prior faculty position at the UCLA School of Medicine. The Institute is rich with distinguished scientists and graduate students, some with Master's degrees and many with PhD's. They have expressed a serious interest in collaborating with us on a number of basic science projects that will yield information that the FDA will require. The amount of time and money that we will save is truly incalculable. Whenever you present a new technology to the FDA, having a prestigious Institute and University behind you is extremely valuable. They will also begin to publish papers that will get us the attention we need in the lay press.More information will be forthcoming over the next few months as we continue to move forward."
We have collaborators which are listed about sixteen minutes into the recent NNVC - RedChip video presentation ---
I believe was DrFeelgood once made this assertion about polymer nano-particles or micelles,
"...Polymer nano-particles or nanomicelles are used as carriers for the delivery of drug. It has been one of the most attractive areas because of its scientific value and potential of application. The nano-micelles are constructed from very low toxicity substances. They have roughly the same toxicity as water. Drink too much water and it's toxic; the same with NanoViricides materials. NanoViricide micelles are constructed from materials found normally in the metabolic process. So, the nano-micelle is broken down in much the same way. The targeting ligand does not attack human cells or animal cells. It binds to sites on virus cells that the virus uses to bind with human cells..."
A nanoviricide is constructed by chemically attaching virus-binding ligands to a polymeric (water-loving) micelle.
http://online.wsj.com/article/PR-CO-20130422-911033.html
There you have it! This is the answer to "1)pharmacokinetics" from the DengueCide TM -FDA requirements I listed on my previous post. The Cides do end the virus and then its channeled out of the body, with other waste material, through the colon and kidneys.
I still don't know, with any greater degree of certainty, the answer to the remaining two, however:
3)dosing - generally applies to feeding chemicals or medicines in small quantities into a process fluid or to a living being at intervals or to atmosphere at intervals to give sufficient time for the chemical or medicine to react or show the results
*** I could not find info on this; however it may very well be the same dosage as FluCide TM. There are about 100 trillion cells in the human body and about 70 trillion nanomicelles in one dose of FluCide TM. No dose-limiting side effects have been seen for our FluCide TM candidates as yet, indicating that in a severely ill patient, the dosage of FluCide TM can be increased even further.
4)stability - A drug must remain potent and safe long after it leaves a manufacturing facility. Ensuring this safety requires a range of technologies and applications.
*** I could not find info on this; although I am sure it has been answered in the past by companies in the pharmaceutical industry.
DengueCide TM is to be approved by the FDA, likely before Sep 2013 and then it will be on a controlled fast track to the market (2014 - 2015).
Good one! LOL, however, I must go back to work.
If we are going to get cheap shares of NNVC, the time is now. Have management, have money, will travel! The "Nano-Cides Special" has tracks and each will soon be carrying valued cargo, in a controlled race to the market (2014 - 2015).---
What happens after NanoViricides Submits (Jun 10, 2013) DengueCide™ Orphan Drug Designation Application to the US FDA for dengue and dengue hemorrhagic fever?
from Orphan Drug Designation
by Jeff Fritsch Debra Lewis Erica McNeilly Henry (Chip) Startzman
FDA Office of Orphan Products Development
NNVC is sent a letter acknowledging receipt of the application.
Reviewed by reviewer - designation Team Leader - OOPD director.
Expect less than 90 days to decision (for DengueCide® that is September 2013). A negative decision can always be readdressed.
Roughly 60-70% of applications result in granting orphan drug designation status.
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The Orphan Drug Designation program provides orphan status to drugs and biologics[1] which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on:
1)pharmacokinetics - discover the fate of a drug from the moment that it is administered up to the point at which it is completely eliminated from the body
*** I could not find info on this
2)pharmacodynamics - study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect
A nanoviricide is constructed by chemically attaching virus-binding ligands to a polymeric micelle. The biomimetic ligands tend to have poor energies of interaction with the virus particle per ligand, yet a large number of ligands enable a successful interaction with the virus particle. Additionally, the nanoviricide competes with cells for binding to the virus particle, and must provide a substantially more efficient interaction than the cell-virus interaction, in order to achieve a therapeutic effect.
3)dosing - generally applies to feeding chemicals or medicines in small quantities into a process fluid or to a living being at intervals or to atmosphere at intervals to give sufficient time for the chemical or medicine to react or show the results
*** I could not find info on this
4)stability - A drug must remain potent and safe long after it leaves a manufacturing facility. Ensuring this safety requires a range of technologies and applications.
*** I could not find info on this
5)safety - companies must show evidence of their compound’s biological activity and provide data indicating that the drug is reasonably safe and effective before initial administration
from Dr. Diwan --- The nanoviricide also must be able to exercise its effect in the biological matrix, be it in the bloodstream, plasma, mucosa, or other extracellular spaces. Further, it should have minimal undesirable interaction with the matrix and host cells so that sufficient material is available for clearing out a fulminant viral infection from a patient's body. In addition, the nanoviricide needs to be able to distribute itself within the body, across various barriers, so that it can reach the spaces where the virus particles are present. NanoViricides, Inc. has demonstrated that highly effective antiviral treatments can be created against a large number of viruses, despite these design challenges.
6)efficacy - DengueCide has shown very high effectiveness in animal models of dengue virus infection and also in cell culture studies of dengue virus infection.
However, some statistical burdens are lessened in an effort to maintain development momentum. For example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease in question.
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THE SCIENCE OF HOPE:
The need, the challenges and three proven strategies
for successful orphan drug development - from Premier-Research
Advantages of Orphan Drug Development
Developmental drivers such as government incentives, shorter development timelines and high rates of regulatory approval are making orphan drug development as economically viable as non-orphan drug development, even though the patient pool is smaller.
The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation.
Once a compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%).
Of note, orphan designation for the drug in the orphan indication is maintained regardless of follow-on indications. As a result, one model for development is based on lead development of a compound with a relatively quick-to-market orphan indication, followed by consideration of expansion to other indications. Orphan drugs also experience significant competitive advantage in being first to market. Recent research suggests that the higher
pricing, increased market share, lower marketing costs, longer exclusivity period and faster uptake of orphan drugs offset the smaller patient pool. For example, Soliris® (Alexion Pharmaceuticals), indicated for treatment of paroxysmal nocturnal hemoglobinuria (PNH), generated $541 million in sales in 2010, despite the fact that there are only an estimated 4,000-6,000 patients in the U.S. with PNH.
In Puerto Rico, U.S. territory: The most recent island-wide epidemic occurred in 2007, when more than 10,000 cases were diagnosed
The revenue-generating potential of orphan drugs is compounded in cases where drugs have multiple orphan disease indications, or go on to gain approval for larger, non-orphan disease indications. In addition, a high number of orphan drugs are biologics[1], which
are less likely to have generic equivalents, prolonging their value to sponsors, even after patent expiration.
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WEST HAVEN, CONNECTICUT -- June 10, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has filed an Orphan Drug application with the Office of Orphan Product Development (OOPD) of the US FDA for DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic fever.
The Company previously engaged the consulting firm Cote´ Orphan Consulting (COC), headed by Dr. Tim Cote´, to assist with the orphan drug application. The Company, in consultation with COC, has determined that its current lead DengueCide™ drug candidate is eligible for orphan drug status application in the USA.
Tim Cote´, MD, MPH, was the Director of the Office of Orphan Product Development (OOPD) at the FDA, from 2007 to 2011. In this role heading OOPD at the Agency, he was responsible for the implementation of the Orphan Drug Act, a system of grants and drug development incentives designed to create therapies for 6,000+ rare diseases. After leaving the US FDA, Dr. Cote´ served as the Chief Medical Officer (CMO), National Organization for Rare Disorders (NORD), Washington, DC. He has held several other illustrious positions with increasing responsibilities during his career, including CDC Country Director for Rwanda, Senior Research Investigator in the Viral Epidemiology Branch of the National Cancer Institute, and Branch Chief, Therapeutics and Blood Safety, CBER, FDA. In addition to his role as the Principal at COC, Dr. Cote´ is currently Professor of Regulatory Practice at the Keck Graduate Center, Claremont, CA.
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I am confident we are going to get FDA approval. My reasons?
1)The Cides "...are agnostic as to the host.” and the efficacy of DengueCide* is unprecedented**. Feel free to add others, if you have the information.
* DengueCide™, our broad-spectrum drug candidate against all four types of dengue, has led to survival of 50% of mice in an ADE (antibody-dependent-enhancement) mouse model of dengue infection, clinically relevant for the high fatality rate dengue DHF/DSS manifestations.
Antibody-dependent enhancement (ADE) - occurs when non-neutralising antiviral antibodies enhance viral entry into host cells, leading to increased infectivity in the host cells. Some cells do not have the usual receptors on their surfaces that viruses use to gain entry. The antibodies bind to antibody Fc receptors that some of these cells have in their plasma membrane. The viruses bind to the antigen binding site at the other end of the antibody. ADE is common in cells cultured in the laboratory, but rarely occurs in vivo except for dengue virus. This virus can use this mechanism to infect human macrophages, causing a normally mild viral infection to become life threatening.
** DengueCide is a nanoviricide® that has shown very high effectiveness in animal models of dengue virus infection and also in cell culture studies of dengue virus infection. These animal studies as well as cell culture studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Prof. Harris found that the special laboratory mouse strain AG129 infected with a dengue virus in a lethal challenge ADE-simulation protocol, when left untreated, suffered a 100% fatality rate. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
2)Barring influence of "Big Pharma" , over the FDA, against us, we should get approval. But why would they be against us? For example, according to Mayo Clinic, "No specific treatment for dengue fever exists. Your doctor may recommend that you drink plenty of fluids to avoid dehydration from vomiting and high fever. Acetaminophen (Tylenol, others) can alleviate pain and reduce fever. Avoid pain relievers that can increase bleeding complications — such as aspirin, ibuprofen (Advil, Motrin, others) and naproxen sodium (Aleve, others)." Of the four viruses of Dengue, Nanoviricides picked the two worse (DHF***/DSS***) and there is currently no drug or specific treatment for them. Therefore "Big Pharma" doesn't have a competing drug or vaccine and to me this eliminates the possibility of their involvement.
*** When a person is exposed to dengue for the first time, the disease usually is not severe. When the same person is later infected by a different dengue serotype, the body produces antibodies against the previous dengue serotype. The new dengue virus uses these antibodies to infect more cells, thus leading to severe dengue disease. Such a secondary infection may lead to dengue hemorrhagic fever or dengue shock syndrome with high fatality rates. The ADE phenomenon has made development of vaccines and antibody therapeutics against Dengue a tremendous challenge. A vaccine works by creating antibodies against the included serotypes.
3)A very competent and reputable group, Cote´ Orphan Consulting (COC), was in charge of gathering all data, results (there is info about DengueCide-FDA requirements I could not find but I feel confident they do have it) and putting it all together in order to submit the application for Dengue Orphan Status to the FDA.
We should get the FDA approval for DengueCide® Orphan Status by September 2013 and another controlled/tracked race to the market will have begun. --- http://youtu.be/n4-uoUpN1c4 ---
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[1] biologics is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein or living cells that are used as therapeutics to treat diseases. Biologics are created by biological processes, rather than being chemically synthesized.
It's the Nano-Cides Special?, Bringin' us mo'mo-ney back...
Good to know you are in.
Projected Milestones for 2013
From the NNVC - RedChip video, the following are events and the projected Milestones for 2013:
-Completion of new Company cGMP/R&D Center in Shelton, CT
-Commission new cGMP plant and begin production of cGMP drugs
-Receive initial results of toxicology studies on FluCide TM
-Prepare IND for submission to regulatory authorities
I'm sure the Project Management group as well as the company that designed the toxicology and safety pharmacology studies were on board with these projected Milestones for 2013. Their reputation is on the line. I believe they will deliver. Company’s survival is dependent on reaching milestones efficiently (in terms of time and money) to successfully raise additional funding. The company has enough money to take them through Phase I/II 2014. How can they achieve the important Phases I/II if the projected Milestones are delayed? Yes, these Milestones are very important and they know it. We know it. Every time we post these news we are holding them accountable and the company is fully aware of that.
Other coming events in 2013:
Patents issued in Australia, Japan, China, the United States and in all of Africa. Twenty five countries thus far. Well over 100 countries should approve patent applications by the end of 2013. These patents were issued as "first in class" with no existing prior art.
I do expect application for DengueCide® orphan status will get approval from regulatory body ~ 2013
Having completed the expected 2013 projected Milestones and others, they will enter a controlled race to Phase I (2014). Anticipation will build and that will be good for all.
Uuuuh,...I think I've really struck a nerve!
I have been here for years, but silent. I just felt confidence was high, the NNVC presentations were good and that is why I started to post.
NNVC has being managed well. They have the money that will get them through Phase I/II next year. Yes, in recent past there have been delays, but now there is a well seasoned Project Management group in place, managing activities on a timeline. The catalysts/events/objectives are NNVC's objectives/goals that they have outlined in their NNVC-RedChip video. Have a little faith (not blind faith), their promises will be fulfilled according to their outlined plan (barring the meddlers, the world improvers, (ahem) bureaucrats)
You may be trading NNVC and that is good, it is your prerogative. Others, like myself, are patiently holding and confident on the science behind this NNVC "Express".
Nanotechnology, as far as we know, has its origins in 1959 when first discussed by renowned physicist Richard Feynman in his talk "There's Plenty of Room at the Bottom", in which he described the possibility of synthesis via direct manipulation of atoms.
http://www.popularmechanics.com/technology/engineering/extreme-machines/advanced-3d-printer-creates-nano-indycar-7358796
The advent of computers/microcomputers has made possible to turn raw data into usable information fast, tool/utilities have been developed and in turn they have accelerated all kinds of new discoveries and potential breakthroughs scientists are about to unveil.
Look, I feel the dated table of events I posted could be adjusted (those that I guesstimated, not explicitly shown in the video) but adjustments, if any, will be minor because the Project Management group is getting good input information from everyone else in the company and that is why they publish the outlined objectives we saw in the NNVC-RedChip video.
If you want, post yours out there and we will see in time which are more accurate. Information, specially good information that comes now from the NNVC CEO, will bring certainty, confidence and resistance/shorts will be out of the way, soon, very soon.
NNVC has a good Project Management steering NNVC's activities in a timeline. It has put the NNVC Express on track, and this train is moving up. ---
Nooo! But I figure Patrick Cox has a schedule of catalysts and I was trying to guesstimate what that schedule looked like. I have a few thousand shares and holding. I am not a trader, although in the near future I would like to become one.
I was also trying to draw attention to the NNVC-RedChip video because embedded in them is good information. Anyone can draw their own conclusions from them but I suspect they will not be far from mine. The information is there!
I condensed information that I sent on e-mail to friends and family, with the usual disclaimer of course. That is what I posted this morning.
I always keep reminding myself NNVC leadership is frugal. That is why the CEO, a physician/epidemiologist (not a sales/marketing specialist), is taking the initiative to do the conferences, the interviews, etc.. He does a good job.
I also have a brother and nephew; they were both bitten by the "Aedes Aegypti" mosquitoes in Puerto Rico and ended up in the hospital with Dengue and hemorrhagic fever. So when the good doc says "you feel like you want to die" I know first hand because that is what my brother told me it was like.
I read with great interest everyone's posts, some of them very funny,..that one on Kate giving birth,...funny. I hope NNVC goes forward to fulfill its promise and realize its great potential, soon.
GO NNVC!!!!
If NNVC builds it, they will come...
The Company reported in April 2013 that the engineering design of its cGMP manufacturing plus laboratory facility is substantially complete.
The important and rate-determining step towards the start of any clinical program for FluCide is the construction of the production plant in Connecticut
o NNVC hired contractors and builders who build the framework at their own plants, then deliver to site in a modular fashion and then integrate on-site
o This ex-location production is both cost- and time- efficient and could be completed 5 months from start date
Lets be conservative and say that assembly begins on this month, July 2013. NNVC should have the plant ready by December2013!...ready and validated.
o The pilot plant will likely be ready to begin producing FluCide test batches by YE2013 or 1Q2014
Indication from NNVC - FDA meeting is: toxicology studies will continue in parallel with the construction of the manufacturing plants. Both will likely conclude at the same time by YE2013 allowing for production of drug materials for the seamless start of the clinical program in 2014.
Puffer indicated that to be conservative, human trials are likely to start Q3 2014. From my perspective, conservative is good.
In the NNVC RedChip video Dr. Seymour indicated NNVC is on a path, a track, Project Managers are steering, key activities on a timeline, to completion. That video, and the demeanor of Dr. Seymour fills many voids in the big picture. It was good.
The potential of catastrophic event(s) that could delay are always present but the Project Management group steering is a seasoned one. The plant will be physically complete by the end of 2013 and the steady climb will begin.
Well lookie here, NNVC has disrespected resistance level! And a higher high on nearly 3 times the average volume!
Two events that precede the coming series of parallel events beginning this year:
->BASi for Toxicology and Safety Studies - agreement signed Nov 12, 2012; NNVC ANTICIPATES that it will need very large quantities of the drug candidate for these “tox package” studies.
->NNVC announced it has retained the services of Mr. Phil Mader and his firm, MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
According to your 6 month modeling, if the cGMP facility is physically completed by or before Sep - Oct 2013, it will be sometime between October 2013 and April 2014 when they start production of the test batches.
Events running in parallel for a year - beginning sometime between Sep - Oct 2013 when cGMP facility is physically complete:
-cGMP plant/facilities complete sometime in or before October 2013; transition to full production of TEST BATCHES begins sometime before Apr 2014;
-Human trials begin outside the U.S. (Australia) sometime during first half of 2014. Since it is outside the U.S. no FDA approval is necessary
-Sometime close to/before April 2014 FDA certifies cGMP plant/facilities; production test batches have begun; test batches can be employed in Human trials Australia as well as for Tox studies.
Puffer, you've said, "As a near term catalyst you've got potential Dengue approval for orphan status both here and in Europe. That should be forthcoming, possibly within a few weeks (due within 3 mos of 10 Jun in the U.S.). Beyond that I would encourage people to look at the big picture. We could be in or very close to human trials 1 yr hence. Phase I/IIa should only take about 6 weeks... positive results there and $1.00 will be a distant memory. I would also expect higher prices as we approach those trials."
I must say I like the big picture. Nanopatent recently brought to our attention Nanowerk news -- Cancer nanotechnology: Nanoparticles with protein 'passports' evade immune system. Others have alluded to a similar mechanism/passport employed by NNVC in the "human-like cells" or nanomicelles.
Download the "soaring to new highs" video --
I tend to agree with the moderator's assessment:
1)Tox studies slated for the near future, if not started already,
2)New production facility is now under construction, (likely to be complete by October 2013. How long does it take FDA to certify the facility? Lets say FDA certification by November 2013, IMO) Yeah?
3)Overseas first in Human studies scheduled for after the New Year,
4)H7N9 mutating into a human pathogen with a growing threat to Europe and Australia, and probably some other stuff in process to be announced.
As you like to say when you pound the table, pay up now or pay a lot more later.
Why doubt the nav of NNVC is going to climb higher and higher? Keep playing the "soar to new highs" tune --
NNVC will be taking some by surprise. As NNVC drills through resistance listen to LoLa, Lola video/tune
From Tomorrow in Review
Supply chain for your generic drugs tainted? No problem, use plant-based DNA. Labor costs too high? No problem, 3-D print your products instead. Money too controlled? No problem, buy Bitcoin anonymously. Google those in the science today journals.
As once stated by our moderator, "The nano-micelles are constructed from very low toxicity substances.They have roughly the same toxicity as water. Drink too much water and it's toxic; the same with NanoViricides materials. NanoViricide micelles are constructed from materials found normally in the metabolic process. So, the nanomicelle is broken down in much the same way. The targeting ligand does not attack human cells or animal cells. It binds to sites on virus cells that the virus uses to bind with human cells. So, in effect the nanoviricide acts as though it is a human cell and cannot bind or attack human cells."
No government entity wants to be caught by surprise in a Pandemic, not in Eurasia and not in the U.S.. Dr. Eugene Seymour asserted in Equities.com interview that "...in two weeks they can create a new drug. For example, the SARS virus...give me two weeks and I can have it..." http://www.equities.com/media-gallery/170-nanoviricides-inc?category_id=65
We are living in the "Age of Information"! Who do you know is going into this weekend without at least 10,000 shares of NNVC? I believe will be $8 by the end of this year and double digit for next, IMO.