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I am leery of these vaccines. Some have done good and others...
June 10, 2013 Janssen, Johnson & Johnson Innovation, Announce Collaboration With Belgian Scientists To Pursue New Research In Neurodegenerative Diseases
Janssen Research & Development will collaborate initially with KU Leuven, University Hospitals Leuven and VIB( Vlaams Instituut voor Biotechnologie) to create opportunities for collaborative research, and will invite other academic institutions to join the project as its next phase begins later this year.
Today Sep 03, 2013
Interest in a treatment for dengue fever in Europe was confirmed today by the announcement that J&J has signed a collaboration with the Wellcome Trust and the University of Leuven in Belgium. http://www.wellcome.ac.uk/News/Media-office/Press-releases/2013/WTP053792.htm
No doubt tha Big Pharma seeks creative and mutually beneficial pharmaceutical collaborations that as they say, "provide the best value in medicines to patients and to the healthcare industry".
The approach of some includes early stage option-based deals, late stage licensing deals, and acquisitions.
Geographically speaking they may be talking, dealing, collaborating on the other side of the world. However, it could also be a diversion while talks are going on closer to home. Just speculating.
DengueCide is "the only game in town" ~ Dr. Anil Diwan. Other Dengue drugs have failed in clinical trials. Once DengueCide is US FDA approved it will gain extension for patent life (7 years) and be a candidate to earn a Priority Review Voucher (minimum $200 million).
The world is watching the government agencies that will give "green light", to Nanoviricides, Inc., to market.
Nanovircides, Inc.(NNVC) is "laying down tracks for a railway" to market.
Nanoviricides, Inc. is a pioneering company in bio-nanotechnology. They have a "design platform technology" or mechanism, to plug-in ligands/receptors on the small surface of a micelle, and these components, plugged together, are the most lethal to a human-killing virus. The nanoviricide mimics a host's cell and fools the virus structure into binding with it. The virus particle is then encapsulated and destroyed. The "design platform technology" employed by Nanoviricides, Inc. is unique and is patented.
Thanks. It's work in progress on everything that is good about Nanoviricides, Inc.. I'm glad I could help.
Thanks Leifsmith,...trying to to draw a picture based on existing information. The New Tang Dinasty video was found with keywords: H7N9_ nanoviricides. The link is
New Tang Dynasty (NTD) Television is a television broadcaster based in New York City, with correspondents in over 70 cities worldwide. The company was founded by Falun Gong practitioners. Its stated mission is to bring truthful and uncensored information into and out of China; to restore and promote traditional Chinese culture; and to facilitate mutual understanding between the East and West.
ntdtv.com
The news anchor briefly goes over:
Public Health Agency of Canada > Fight Flu - www.publichealth.gc.ca
The StarPhoenix newspaper headline > Canada's National Lab to work on H7N9 flu virus; sample likely arrives next week --- Apr 2013
Press Release --- Nanoviricides Anticipates FluCide(TM) Drug Candidates to be Effective Against H7N9 --- headline likely from WSJ.com
Flucide kit (Solace Biotech)
Nanovircides, Inc.(NNVC) is "laying down tracks for a railway" to market.
Nanoviricides, Inc. is a pioneering company in bio-nanotechnology. They have a "design platform technology" or mechanism, to plug-in ligands/receptors on the small surface of a micelle, and these components put together are the most lethal to a human-killing virus. The "design platform technology" employed by Nanoviricides, Inc. is unique and is patented.
FluCide and DengueCide are two of the most developed drugs that Nanoviricides, Inc. is employing as engine thrusters to human trials (2014) and to the market.
They have signed contracts/agreements (2012 - 2013), in preparation for Investigational New Drug (IND) submission to the FDA and human trials (2014), with:
1) Id3A, LLC as the architect for its lab and cGMP pilot production facility
2) MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
3) BASi for Toxicology and Safety studies (initiate GLP Safety/Toxicology studies)
4) Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus
5) Public Health England to Test Nanoviricides Against H7N9, MERS
Nanoviricides, Inc. has been "laying down the tracks of the railway", path that will lead to the human trials (2014).
Nanoviricide, Inc. has also started sub-kg scale production of the injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of the injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from the in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of the injectable FluCide drug when the requisite large amount of drug substance is produced.
It is likely that MPH Engineering, LLC (“MPH”) was involved in making this sub-kg scale production, at the current lab facilities, possible and the experience should prove helpful when the process to produce (3) identical batches (kg scale), at the newly integrated cGMP plant (1H 2014), gets underway. The well seasoned MPH Engineering, LLC will be present when the cGMP pilot plant gets commisioned.
The injectable and oral FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. This indicates that the FluCide drug candidates are “broad-spectrum”, i.e., they should work against most, if not all, influenza viruses. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The oral FluCide is also dramatically more effective than TamiFlu in these animal studies. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth. The Company believes that these animal model results of both injectable and oral FluCide drug candidates should translate readily into humans.
Nanoviricides, Inc. "has the money" for human trials Phases I/IIa. As Dr. Seymour has stated, "...we are on a path, it's like being on a track...".
It is quite a coincidence that yesterday I was corresponding with other interested/potential investors and JNJ, Merck and others were mentioned and the news come out:
J&J hunts for dengue fever drugs in tie-up with academia
http://www.reuters.com/article/2013/08/29/jj-dengue-idUSL6N0GU0TE20130829?type=companyNews&feedType=RSS&feedName=companyNews&rpc=43
DengueCide is a nanoviricide® that has shown very high effectiveness in an animal model of dengue virus infection. These animal studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Professor Harris has developed a mouse model simulating antibody-dependent-enhancement (ADE) of dengue infection using a special laboratory mouse strain called AG129. ADE in humans is thought to lead to dengue hemorrhagic fever and is associated with a high fatality rate. In this model, infection with a dengue virus when the mice are left untreated is 100% fatal. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. Tremendous efforts have been made for dengue vaccine development but, to date, no vaccine candidate has succeeded in clinical trials towards approval.
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.
NanoViricides Announces that DengueCide™ Has Received Orphan Drug Designation From the US FDA --- http://www.nanoviricides.com/press%20releases/NanoViricides%20Announces%20that%20DengueCide%E2%84%A2%20Has%20Received%20Orphan%20Drug%20Designation%20From%20the%20US%20FDA.html
The efficacy of DengueCide™ *** is unprecedented ~ Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley.
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%).
Once you approve one of many of the same "design platform technology" we will see many FDA "approvals to market" follow.
“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”
This construct, construct like LEGO pieces, boggles my mind! Watch the animation of the micelle. Do you see the referenced "hidden tails", a cross section view of the micelle, in the video animation?
Thank you Dr. Kaz. I liked that "onward!" part, most of all. Confidence is high on Nanoviricides, Inc.!
The following may help shed some light on the current topic:
The Role of GLP in Preclinical Research
The role of GLP studies in drug discovery is confusing to many scientists. The confusion has two causes.
Semantic
GLP is an acronym for "Good Laboratory Practices." Hence, many scientists infer that GLP studies must therefore be "good" and non-GLP studies are of questionable quality. Actually, the "good" is more about good documentation than good science.
Regulatory Requirements
The regulatory bodies require GLP for far fewer types of studies than many scientists think. GLP requirements are for safety studies, not other types of studies.
The consequences of this confusion are that many drug-discovery organizations end up wasting time and resources on unnecessary and premature GLP studies when their objectives would be better achieved without the burden of GLP.
What Is GLP?
GLP certification was established by the regulatory bodies to ensure that research submitted to them is not only properly executed, but is also documented thoroughly enough so that any scientist skilled in the art can follow the documentation and replicate the results. The level of detail required to achieve this level of documentation is substantial — so much so that the cost of generating the documentation exceeds the cost of the research itself.
When to Use GLP
GLP is unnecessary until the final stage of preclinical development, at which point GLP documentation is needed for obtaining regulatory approval for further development.
Many researchers are under the mistaken impression that at the IND (Investigational New Drug) stage all studies must have GLP documentation. Actually, the FDA requires GLP documentation for only safety studies. This includes animal toxicity, genotoxicity, supporting toxicokinetic studies,1 and safety pharmacology.
GLP is NOT required for:
Efficacy studies, whether in vitro or in vivo.2 In fact, the IND application has no requirement at all for mechanism of action or efficacy studies.
In vitro studies, including:
Pharmacokinetic analyses that support the in vivo efficacy and toxicity studies
Drug-drug interaction studies3
In vitro ADME studies
The reasons for this are easy to understand. At the IND stage the regulators' key concern is about toxicity from exposure to the New Chemical Entity (NCE). Their goal is to ensure safety for human subjects. Other risks, such as whether the NCE is efficacious or has drug-like ADME properties are essentially commercial risks that are the responsibility of the filer. In fact, safety is core to the definition of GLP:
Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.4
for more info, source: http://www.apredica.com/glp.php
The ligands/receptors get plugged on to the micelle. That part is not shown on the video. Read about the density of ligands/receptors plugged in. The ligands and the micelle plug together like "LEGO pieces". The inward facing yellow lines are the deadly tails.
Here is the link on micelle...
Here is the link...
“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”
This construct, construct like LEGO pieces, boggles the mind! Watch the animation of the micelle. Do you see the referenced "hidden tails", in the video animation? Those are the deadly "tails" to a virus structure. Once the virus latches on to the ligands on the "small surface" of the micelle (as described above), the hidden tails will snap out and merge into the viral surface lipid coat. Mind boggling! It is the mechanism unique to Nanoviricides, Inc. and it is patented. I have seen mechanisms for drug delivery to cancer tumor cells but Nanoviricides, Inc. employed mechanism is unique.
“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”
Like "LEGO pieces" you plug-in the nano-micelle and bio-mimetic receptor protein (mimics "host's" cells - target cells of the virus) together to produce the most lethal enemy to a human-killing virus.
The lengthy visit to the hospital will be replaced by a short visit to the clinic:
An individual, feeling sick, goes to a clinic. The individual is diagnosed as being the host to a human-killing virus. The patient is prescribed a Cide for the indicated virus. Trillions of Cide particles quickly start circulating in the host's bloodstream. The virus structures are drawn to the Cide particles, the virus attacks/connects to the Cide micelle via ligands/receptors, the Cide envelopes the virus structure and destroys it. This event happens in the trillions and in a matter of hours. In a matter of hours, after arriving at the clinic sick, the individual is feeling better and he/she has averted a lengthy and financially crushing stay at the hospital.
The mechanism employed by Nanoviricides, Inc. to envelope the virus is patented. There are over 100 countries to approve "first in class" patent applications ~ 4Q 2013.
NanoViricides Signs a Non-Disclosure Agreement with the Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus
WEST HAVEN, Conn.--(BUSINESS WIRE)--
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") said it has signed a non-disclosure agreement (NDA) with the Lovelace Respiratory Research Institute (“LRRI”). The Company intends to enter into a Master Services Agreement with LRRI for the IND-enabling efficacy studies of both its broad-spectrum injectable and oral FluCide® drug candidates. These studies will employ multiple unrelated subtypes and strains of Influenza A, including the novel H7N9 strain, the subtype which is currently circulating in China. The Company has already shown that the injectable and oral FluCide drug candidates are substantially more effective than oseltamivir (Tamiflu®) in controlling influenza A virus infections in a highly lethal animal model using two unrelated subtypes of influenza A, namely H1N1 and H3N2. In addition to FluCide, LRRI will also be able to evaluate the Company’s anti-MERS drug candidates in cell culture and animal models when available. The NDA enables the scientists at the Company and LRRI to exchange confidential and proprietary information in preparation for the intended studies.
The injectable FluCide drug is intended for severely ill hospitalized patients while the follow-on oral drug is intended for use in out-patients. Following advice from the Company’s pre-IND meeting with the FDA, the Company intends to evaluate both drugs against multiple unrelated subtypes of influenza A in animal models and in cell culture studies.
H7N9 is a novel subtype currently circulating in China. Recent studies have indicated that it is a potential pandemic threat. H7N9 was found to be less sensitive to approved drugs than the H1N1/2009 pandemic strain. See New studies on H7N9 raise pandemic concerns | CIDRAP (http://www.cidrap.umn.edu/news-perspective/2013/07/new-studies-h7n9-raise-pandemic-concerns).
The Company has recently developed drug candidates for evaluation against the novel MERS h-CoV (“Middle East Respiratory Syndrome human Coronavirus”). The Obama administration has designated MERS as a potential threat to public health and national security, on June 4, 2013. Administration declares Mideast flu a potential public health emergency - The Hill's Healthwatch (http://thehill.com/blogs/healthwatch/public-global-health/303441-administration-declares-mideast-flu-a-potential-public-health-emergency). No drugs or vaccines are available against MERS h-CoV.
The Company has recently executed a NDA with the UK Public Health Agency that is intended to lead to a Master Service Agreement for the evaluation of FluCide against the novel A/H7N9 influenza strain as well as evaluation of the Company’s novel drug candidates against the newly emerging MERS human Coronavirus. The Company believes that independent testing of our drug candidates at these two sites should result in a dataset providing a high degree of confidence.
Efficacy
Definition: Whether a drug or other treatment works under the best possible conditions. In a research study about efficacy, the study participants are carefully selected, and the researchers can make sure the drug is taken properly and stored properly. The study participants may differ from other people in the general public who have the disease. A treatment that has efficacy under the best conditions may not work as well in a different group of people with the same disease.
Example: For example, a recent clinical trial compared people treated with insulin to people treated with oral medicine for diabetes. Only people with no other medical problems were enrolled in the study, and most were under age 65. The people treated with insulin had better improvement in their blood glucose than the people treated with oral medicines. This study is considered an efficacy study, because only younger people without any other health problems were included. Many people who have diabetes are over age 65 and have other problems such as heart disease. It is not known whether the same results would be found in these people.
=================================================================================================================
“The need for an effective, broad-spectrum, anti-influenza drug cannot be overstated,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “The current 2012 influenza season is already considered to be an epidemic. The current vaccine did not work well even though the same strain of H3N2 that is causing serious cases, was included in the vaccine mix. Vaccine effectiveness is only around 60%. In the previous 2009 epidemic, the virus swept the world long before a vaccine could become available. The 2009 virus was a novel strain, even though it was a subtype of H1N1. Vaccines are highly specific (narrow-spectrum) because they elicit antibodies in the human host, and antibodies are by nature very specific to their target.”
“We have clearly demonstrated that the design platform technology for nanoviricides allows development of powerful broad-spectrum antiviral drugs,” said Anil R. Diwan, PhD, President and Chairman of the Company, “We have developed a small chemical ligand that mimics both the mammalian (or a-2,6-) and avian (or a-2,3) forms of the native sialic acid receptor of influenza viruses. We can design a nanoviricide to exhibit several ligands at a single point, and each nanomicelle may exhibit several hundred ligands on its small surface. The ligands are designed to look very much like (mimic) the sialic acid to the influenza viruses, and the high density of the ligands would force the virus to land onto the nanoviricide and get destroyed by the hidden ‘tails’ of the nanomicelle that snap out and merge into the viral surface lipid coat.”
Binding to sialic acid on the cell surface is a completely conserved property of all influenza viruses. The avian influenza viruses tend to prefer binding to the a-2,3- variant of sialic acid, whereas those causing disease in humans tend to prefer binding to the a-2,6 variant. Pigs and some other species serve as “mixing species” where both the avian and mammalian viruses can grow, and further, avian viruses can mutate to mammalian viruses.
The Company has previously reported that its anti-influenza drug candidates have reduced viral loads from tens to hundreds of times lower levels than oseltamivir (Tamiflu®), depending upon the particulars of the experiment. The FluCide™ oral and injectable drug candidates also protected the lungs of the animals much better than did oseltamivir, indicating a clear benefit. The protection from influenza virus was clearly reflected in the strong increase in survival time in the FluCide-treated animals as compared to oseltamivir. Mice serve only as a “test tube” in these studies, since our drugs are designed to attack the virus particles directly. Thus these positive results in animal studies are expected to correlate well with the human clinical trials.
“We are rapidly advancing towards our goal of filing an IND with the FDA for Influenza based on the guidance we received in our previous pre-IND meeting with the FDA,” said Anil R. Diwan, President of the Company.
Just think of the "true grit" of a housewife turned racehorse owner & breeder, that against all odds makes all the right decisions to build a company of five: Ms. Penny Chenery, Elizabeth Ham (secretary), Lucien Laurin (manager/trainer of Secretariat), Ron Turcotte (jockey of the "flying horse" Secretariat) and last, but not least, Secretariat...plus all other advisors/investors that took the risk and were handsomely rewarded. Nanoviricides, Inc. has very good odds to make it to market. Now we need many more investors with the vision to see it all through!
Echo20! I was not aware of this important detail. Thank you for bring it to my/our attention!
What Are Common Flu Complications?
The most common flu complications include viral or bacterial pneumonia, muscle inflammation (myositis), central nervous system disease, and heart problems including heart attacks, inflammation of the heart muscle (myocarditis), and inflammation of the sac around the heart (pericarditis).
Other flu complications may include ear infections and sinus infections, especially in children, dehydration, and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes.
Those at highest risk for flu complications include adults over 50, children ages 6 months to 4 years, nursing home residents, adults and children with heart or lung disease, people with compromised immune systems (including people with HIV/AIDS), and pregnant women.
(For in-depth information, see WebMD's Flu and Chronic Medical Conditions.)
source: http://www.webmd.com/cold-and-flu/flu-guide/flu-complications
The Inflammation-Heart Attack Connection: New Evidence
http://youtu.be/tP9vGs0Adzc
Thanks. I will take a look at keywords "tox studies" and "efficacy studies" it their proper context this evening. Making the distinction helps me. Have a great day!
Nanomachines: How Viruses Work, and How We Can Stop Them
Watch this 44 minutes long great lecture from Carolyn Bertozzi, director of Berkeley Lab's Molecular Foundry, a colleague 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.
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.
Dengue and dengue hemorrhagic fever have been designated as orphan drug status eligible diseases in the USA. Orphan Drug designation enables several benefits to promote drug development that include tax credits and an extended exclusive marketing period upon drug approval. These benefits provide significant financial incentives for developing orphan drugs. However, there can be no assurance that DengueCide will be granted an orphan drug designation. *** FDA has since designated DengueCide as Orphan Drug ***
In addition to the incentives related to orphan drug status, the Company may be eligible to receive a Priority Review Voucher (PRV) in the USA, upon approval of a drug against dengue viruses. A PRV can be applied by the Company to another drug candidate to obtain a “priority review” to speed up the regulatory process for that other drug. A PRV can also potentially be sold to another pharmaceutical company to obtain an immediate financial benefit. The value of a PRV has been variously estimated to be between $200M to $600M for such transactions.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. Tremendous efforts have been made for dengue vaccine development but, to date, no vaccine candidate has succeeded in clinical trials towards approval.
source: http://www.fool.com/investing/businesswire/2013/06/10/nanoviricides-submits-denguecide-orphan-drug-desig.aspx
http://youtu.be/dhE2LJTT0-o
You've said that Nanoviricides, Inc. has been doing toxicology studies for nearly eight years. I'll take you at your word on that. The part of those eight years toxicology studies that corresponds to FluCide, in my opinion, are now part of the IND upcoming submission to the FDA. I'm speculating here based in part on the following PR excerpt:
"We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1.
"The company will now plan and execute the studies identified based on this meeting."
source: http://www.proactiveinvestors.com/companies/news/27192/nanoviricides-says-pre-ind-meeting-with-fda-for-flucide-successful-27192.html
We read a post from the BigKahuna, "... -IMO, the biggest thing, Anil was able to develop the MERS solution in less than a week. Less than a week for the type that will be tested in EU is pretty amazing and beats the 3 weeks of the rapid in field technology they previously talked about..."
This week we read, "The Company has also started sub-kg scale production of our injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of our injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from our in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of our injectable FluCide drug when the requisite large amount of drug substance is produced."
NanoViricides Progressing on Schedule to Build New Clinical Scale cGMP Production Plant
Published on August 20, 2013 at 8:26 AM
NanoViricides, Inc. (the "Company") reported today that the renovation of the facility in Shelton, CT, to build its new clinical scale cGMP production plant is progressing on schedule.
The Company has recently signed confidentiality agreements with both Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI). Both of these institutions have the ability to perform further testing of our FluCide drug candidates against additional influenza viruses including H7N9. The Company intends to perform our remaining IND-enabling studies of FluCide at these institutions. Keyword here, "remaining".
Nanoviricides, Inc. will soon start/finish producing the quantities of injectable FluCide™ in sub-kg scale and ship them to the two key collaborators. The studies will begin in earnest with the injectable FluCide. Once injectable FluCide is shipped to key collaborators, production of the oral FluCide will be next to start, soon enough it will finish production and will be shipped to the key collaborators as well.
The two key collaborators, Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI), will progressively perform the remaining IND-enabling studies of FluCide and feed Nanoviricides, Inc. with initial tox studies results (4Q 2013) and that in turn will enable Nanoviricides, Inc. to prepare IND for submission to regulatory authorities (4Q 2013), all in the "nick of nano-time" to meet the projected Milestones.
Toxicology studies for FluCide, of key collaborators, continues and completes in 1Q 2014. The final tox studies results are fed to Nanoviricides, Inc. Subsequently, IND is finalized and submitted to the FDA 1Q or 2Q 2014. I am speculating here but this is how I believe these key events will pan out.
Projected Milestones -
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013
Who better than Dr. Eva Harris for a discussion about Viral and Immunological Determinants of Dengue Virus Fitness and Disease Severity --- http://youtu.be/-BqrhA--yFw ---
Watch the video and the projected Milestones again! They are not mine, they are Nanoviricides, Inc. Watch the video.
I did not say tox studies would complete 2013.
It would certainly be nice Echo20. I am basically extracting information from Nanoviricides, Inc. PRs and putting it into an e-mail. I am nevertheless confident preliminary Tox Studies will complete as Dr. Seymour indicated, 4Q 2013.
Thanks erdoc1958. I ate some of the words but it goes with the speed at which I type. I nevertheless will edit before I send e-mails to friends and family. I hope you are doing the same. Live and prosper.
Dr. Kaz, you know that is the way it is going to be, step by step,.... milestone by milestone,....positive thinking, we will continue to move forward. We've been several years in the wilderness but things are beginning to fall into place and click, all in a timely/controlled/efficient manner. I agree, it is nice to see.
I am doing the same, learning as much as I can from the doctors in the field in order to better communicate with people/friends/family about Nanoviricides, Inc.. I got two replies from friends, yesterday and today. I got one from a member of my family but I will continue the drill until they hopefully see exactly what I see. Good things to come.
Leifsmith, here are the links, embedded in post. I was unable to get to them yesterday. I will continue embedding them as suggested.
Micelle Formation
Nanoviricides, Inc. reports that its project for enabling clinical scale drug product cGMP capability is now in the Construction phase. Design, engineering, and architecture for this facility were completed at the end of June, 2013. Subcontractors were retained at the end of June as well. The demolition plan was executed in July, 2013. Initial construction work began on schedule in August and is now being performed at full force. The construction is on schedule to be completed by the end of December, 2013. However, the schedule may be adversely affected if delivery of certain key pieces of equipment with relatively long lead times does not occur in a timely manner.
We must assume all is going according to plan, "...on a path, like being on a track...", because although those "key pieces of equipment" are not yet at 1 Control Dr., Shelton, CT there is no indication that they will not be. If they are delayed, I'm sure MPH Project Management Group/Engineering has taken this possibility into account. When the plant completes December 2013, it will be integrated and commissioned and if not commissioned on schedule time will likely be recouped 1Q 2014.
Otherwise the coming Milestones are-
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches begin)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013
The Company has also started sub-kg scale production of our injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of our injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from our in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of our injectable FluCide drug when the requisite large amount of drug substance is produced.
Here Nanoviricides, Inc. seems to be in control and Tox Studies will begin as scheduled. Bioanalytical Systems, Inc. (BASi) has designed the toxicology and safety pharmacology studies that will enable the IND submission and the first-in-human clinical trials of its FluCide® investigational anti-influenza product. BASi will conduct the cGLP and non-GLP studies as required (cGLP = current Good Laboratory Practices). These studies are designed to assess overall safety in animals receiving multiple doses of FluCide. Specific safety pharmacology studies will also be conducted to assess the effects of FluCide® on the cardiovascular, respiratory and central nervous systems. These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia. Nanoviricides President, Dr. Anil Diwan spoke more about plans for 2013 leading to 2014. --- www.youtube.com/watch?v=tLcEYfxDG84&feature=youtu.be ---
Yes, I thought so too. Try the following:
1- Notice the title on the top left corner of the video
2- Move your mouse pointer over the title and click on it
3- After you click on title it should open another tab/page with the video in Youtube website.
Once there you will also have the url to use and disseminate information. Let me know if that works for you or your comments, if any.
A nanoviricide is like lobbing the whole "mis-uhl" with the launching pad at the virus, destroying the virus, in the trillions and in hours! Agreed, is a guided missile!
Nano, the Next Dimension...that boggles the mind.
Uploaded on Mar 9, 2008
Nanosciences and nanotechnologies represent a formidable challenge for the research community and industry. World-class infrastructure, new fundamental knowledge, novel equipment for characterisation and manufacturing, multi-disciplinary education and training for innovative and creative engineering, and a responsible attitude to societal demands are required.
This short documentary film gives a glimpse of some of the many activities that are being carried out in Europe in these fast-growing fields of research and technological development.
As you well know the Public Health England will be testing Nanoviricides FluCide against H7N9, MERS and that would be a grand opportunity to solidify in practice that what Armstrong already knows in theory. Not only that but Armstrong could invest a couple of thousand dollars or more (GBP equivalent), further his education and pay for many other expenses. The opportunity of a lifetime. Who knows, he may already be at the Public Health of England doing an internship.
Living Polymerisation And Nanomedicines by Tom Armstrong
What if NNVC were to barrel through $1.41/sh in spectacular fashion? Just a "what if". After all, we never know exactly what next Monday "good news" will bring. People are beginning to understand better the science/bio-nanotechnology behind Nanoviricides, Inc.. It is like learning a new language. The sooner everyone understands it, learns it, the better we can communicate. Therefore, once we become experts like Dr. Seymour (see video signature) contact all friends, neighbors, family,...they will thank you for it.
Per the BigKahuna...Nanoviricides are currently binary: they either work in humans as they have in animals, or they don't. IMO, there is nothing in between. If they work in humans, then $10 billion will be leaving $40 billion on the table. Pharmassette went for $11 billion with one drug completing Phase 2 and ready for Phase 3. Do the math with that and 5 antiviral drugs plus 200 more in development.
Met with Dr. Seymour over lunch:
Some bullet points of things we discussed, none of which was not already public discussion from the company and officers:
-New site construction is ahead of schedule and should finish at the least on time. (This meeting was early Monday before this info was confirmed by NNVCbob onsite observations).
-Wants to move Dengue and flu simultaneously and has the money to do it.
-Because Dengue can't be tested through a challenge protocol with patients inoculated with the virus (made sick with Dengue then treated), it may be approved with only small phase 1/2a under orphan drug/breakthrough.
-In the coming months he will be reporting progress for EKC, HSV, HIV studies and general nanoviricide tweaking.
-IMO, the biggest thing, Anil was able to develop the MERS solution in less than a week. Less than a week for the type that will be tested in EU is pretty amazing and beats the 3 weeks of the rapid in field technology they previously talked about.
-Looking for an Aspire type deal for future money needs.
-Now looking to go it alone by a strategy of contract manufacturing and alternative avenues of distribution. At this point, he sees no reason to hand over a nanoviricide license after Anil and crew have done all the work, and that license in return for the smallest percentage. (I think this could change with the right deal, a partnership with 50/50 split and the partner picks up the remaining costs plus pays huge benchmarks. Those deals are out there.)
Some of the known Catalysts are:
Approval for DengueCide® orphan status ~ 3Q 2013
Well over 100 countries to approve "first in class" patent applications ~ 4Q 2013
Milestones -
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013
Excerpt from 2009 Jain Report: Structure and function of nanoviricides
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
I'm not a trader therefore I cannot help you there. Others here are and I am sure they can help you. For example, Lookatthesky has now a partial position at 1.05. If I were to bet, I would say tomorrow it opens at today's lowest point and it closes with a higher low or a solid white candle all the way to 1.20s or 1.30s in order to get ready for whatever good the new week will bring us. Again, I am all in and long.
So It Is Written...So It Shall Be Done!
I would say $100 is very good price. I'm sure Roche figured out it was a good price for their Tamiflu. Roche is not stupid and will see no point on continue with Tamiflu which means their market will become Nanoviricides, Inc. market and then some. It is possible that Nanoviricides, Inc. will conduct their own study (if they have not already) and price FluCide higher than Tamiflu.
Now, here is a funny that was e-mailed to me, while we wait for NNVC to reach $1.63/share soon, very soon:
A Harley biker is riding by the zoo in Washington , DC when he sees a little girl leaning into the lion's cage.
Suddenly, the lion grabs her by the cuff of her jacket and tries to pull her inside to slaughter her, under the eyes of her screaming parents. The biker jumps off his Harley, runs to the cage and hits the lion square on the nose with a powerful punch.
Whimpering from the pain the lion jumps back letting go of the girl, and the biker brings her to her terrified parents, who thank him endlessly.
A reporter has watched the whole event. The reporter addressing the Harley rider says, 'Sir, this was the most gallant and brave thing I've seen a man do in my whole life.' The Harley rider replies, 'Why, it was nothing, really, the lion was behind bars. I just saw this little kid in danger and acted as I felt right.'
The reporter says, 'Well, I'll make sure this won't go unnoticed. I'm a journalist, and tomorrow's paper will have this story on the front page...So, what do you do for a living and what political affiliation do you have?'The biker replies, 'I'm a U.S. Marine and a Republican.' The journalist leaves.
The following morning the biker buys the paper to see news of his actions, and reads, on the front page:
U.S. MARINE
ASSAULTS AFRICAN IMMIGRANT
AND STEALS HIS LUNCH
That pretty much sums up the media's approach to the news these days.
“A free press is the unsleeping guardian of every other men that free man prize; it is the most dangerous foe of tyranny. Where men have the habit of liberty the Press will continue to be the vigilant guardian of the rights of the ordinary citizen.“~ Sir Winston Churchill