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True Echo20. Thanks for the reminder!
This looks/sounds familiar but, just who holds the patent(s)?
Fine-tuning Nanotech to Target Cancer
Programmable nanoparticles have shown promise in early cancer trials, and may finally fulfill the promise of nanomedicine.
THURSDAY, MAY 3, 2012BY SUSAN YOUNG
Programmable particle: Bind's drug-delivery nanoparticle (artist's rendering).
Model & image by Digizyme, Inc.
The results of the human trials are startling.Even at a lower-than-usual dose, multiple lung metastases shrank or even disappeared after one patient received only two-hour-long intravenous infusions of an experimental cancer drug. Another patient saw her cervical tumor reduce by nearly 60 percent after six months of treatment. Though the drug trial—by Bind Biosciences in Cambridge, Massachusetts—of an experimental nanotechnology-based technique was designed simply to show whether the technology is safe, the encouraging results revive hopes that nanomedicine could realize its elusive promise.
For more than a decade, researchers have been trying to develop nanoparticles that would deliver drugs more effectively and safely. The idea is that a nanoparticle containing a drug compound could selectively target tumor cells or otherwise diseased cells, and avoid healthy ones. Antibodies or other molecules can be attached to the nanoparticle and used to precisely identify target cells. "One of the largest advantages of nanotechnology is you can engineer things in particle form so that chemotherapeutics can be targeted to tumor cells, protecting the healthy cells of the body and protecting patients from side effects," says Sara Hook, nanotechnology development projects manager with the National Cancer Institute.
"We make hundreds of combinations to evaluate in order to optimize the performance of each drug," says Jeff Hrkach, senior vice president of technology research and development.
But executing this vision has been difficult. One challenge: a drug's behavior in the body can change dramatically when it's combined with nanoparticles. A nanoparticle can change a drug's solubility, toxicity, speed of action, and more—sometimes beneficially, sometimes not. If a drug's main problem is that it's toxic to off-target organs, then nanotechnology can ensure that it's delivered to diseased cells instead of healthy cells. But if a drug depends on being absorbed quickly by diseased cells to be effective, a nanoparticle may slow the process and turn an optimal therapeutic into second best.
Bind, which was launched in 2007, has attempted to overcome this problem by building its drug-targeting nanoparticles in a way that allows the company to systematically vary their structures and composition. Typically, targeted drug nanoparticles are produced in two steps: first, a drug is encapsulated in a nanoparticle, and second, the external surface of the particle is bound with targeting molecules that will steer the therapeutic ferry to diseased cells. Generating such nanoparticles can be difficult to control and replicate, which limits a researcher's ability to fine-tune the nanoparticle's surface properties. To avoid this pitfall, Bind synthesizes its drug-carrying nanoparticles using self-assembly.
Under the right conditions, the subunits of its nanoparticles—some of which already contain targeting molecules—assemble on their own. No complex and variable chemical reactions are needed to produce the nanoparticles, and the properties of each subunit can be tweaked. This also allows the company's researchers to test a variety of nanoparticle-drug combinations and identify the best candidates for a particular task. "We make hundreds of combinations to evaluate in order to optimize the performance of each drug," says Jeff Hrkach, senior vice president of technology research and development.
Bind cofounder Omid Farokhzad, associate professor at Brigham Women's Hospital and Harvard Medical School, came up with the novel method for building nanoparticles while he was a postdoctoral researcher in the lab of Robert Langer, an MIT chemical engineering professor. Langer's group had already developed nanoparticles capable of releasing drugs in a controlled manner, but the particles did not yet seek out cancer cells specifically. Farokhzad's first challenge was to create nanoparticles whose molecular instructions would bring them to cancer cells, but which remained anonymous within the bloodstream so that the immune system wouldn't destroy them. The second was coming up with a robust and reproducible manufacturing process.
Instead, Farokhzad and Langer devised a method by which the building blocks of the nanoparticle and the drug self-assemble into a final product. Two types of polymer combine to form the tangled mesh of Bind's drug-laden spherical nanoparticle. One of these polymers has two chemically and structurally distinct regions, or "blocks": a water-insoluble block that forms part of the mesh that encapsulates the drug, and a water-soluble block that gives the final product a stealthy corona to evade the immune system. The other type of polymer has three blocks: the same two as the first, as well as a third region that contains a targeting molecule—the signal that will ensure the final particles attach to the desired cell types. The drug-carrying nanoparticles are formed by simply mixing these polymers together with the drug in the appropriate conditions.
The self-assembling polymers can be produced in a repeatable and scalable fashion. But the method has an additional benefit, one that may be the real key to Bind's success. The method by which the nanoparticles are built—from individual preparations of the two-block and three-block polymers—would also let researchers use high-throughput screening approaches, akin to how medicinal chemists design and test new drug compounds. Each block could be tweaked—extend one block, change the charge on another—and the relative amounts of each polymer could be varied. With so many parameters for tinkering, Bind's scientists can screen many combinations.
Its first drug in clinical trials, Bind-014, carries a widely used chemotherapeutic called docetaxel through the bloodstream to cancer cells. The drug is packaged inside a ball-like nanostructure made of biodegradable polymers that protect the drug and shield it from the body's immune system. The external surface of each nanoparticle is dotted with molecules that target cancerous cells. Once the nanoparticle has reached its target, it sticks to the outside of the cell, which triggers the cell to engulf the particle. The drug diffuses out of the particle at a controlled rate and is released into the deranged cell.
Mark Davis, a professor of chemical engineering at Caltech, is hopeful that the few ongoing trials of targeted nanoparticle therapeutics, which include one developed in his lab as well as Bind-014, will demonstrate the technology's potential. "The medical community isn't going to get excited until there is [an advanced human trial] where we can show what these targeted nanoparticles actually do for patients in a statistically significant way." For now, the results from the 17 patients enrolled in the phase I trial of Bind-014 look promising, but a real test of efficacy will have to wait until phase II trials, which are likely to start later this year.
The "programmable" design used by Bind may be key to bringing more nanoparticle-targeted drugs to trial. The company's methods could be applied to any existing drugs or compounds, including those that may have been shelved by pharmaceutical companies because they proved too toxic to the whole body. "We believe we can have a very broad platform of drugs that we can develop," says Hrkach.
source: http://www.siliconinvestor.com/readmsgs.aspx?subjectid=55797&msgnum=2301&batchsize=10&batchtype=Next
BIND BIOSCIENCES
Accurins™BIND is discovering and developing AccurinsTM, proprietary new best-in-class therapeutics with superior target selectivity, and an improved therapeutic index.
Leveraging our proprietary Medicinal Nanoengineering® platform, we develop Accurins that outperform conventional systemic drugs by selectively accumulating in diseased tissues and cells. The result is higher drug concentrations at the site of action with minimal off-target exposure, leading to markedly better efficacy and safety.
Accurin Components
BIND's targeted Accurins consist of the following components that facilitate selective targeting of diseased cells and tissues:
Targeting ligand: The ability to attach targeting ligands to nanoparticles is a unique and valuable aspect of our technology. We develop targeting ligands that recognize specific disease-associated cell-surface proteins or receptors, enabling Accurins to preferentially accumulate at their intended site of action.
Stealth and protective layer: Engineered using proprietary methods for precisely controlling the Accurin surface characteristics, the stealth and protective layer shields targeted nanoparticles from immune surveillance, while providing attachment sites for the targeting ligand through proprietary linking chemistries.
Therapeutic payload (API): We can incorporate a broad range of active pharmaceutical ingredients into our targeted nanoparticles, including small molecules, peptides, proteins, and nucleic acids, such as siRNA.
Controlled-release polymers: The API payload is encapsulated in a matrix of clinically validated, biodegradable, and biocompatible polymers that mediate the release of the payload at the site of disease at an optimal rate.
Comment:
"The patents are being issued to the inventors Anil R. Diwan, PhD, Jayant G. Tatake, PhD, and Ann L. Onton, all of who are among the founders of NanoViricides, Inc. The patents have been assigned to AllExcel, Inc., the Company at which the ground-breaking work was performed. AllExcel, Inc. has contractually transferred this intellectual property to TheraCour Pharma, Inc.
NanoViricides, Inc. holds exclusive worldwide licenses to these technologies for a broad range of antiviral applications and diseases......"
source: http://www.siliconinvestor.com/readmsgs.aspx?subjectid=55797&msgnum=2301&batchsize=10&batchtype=Next
United States Patent 8,173,764 - Diwan , et al May 8, 2012
Abstract
There are provided amphiphilic biodegradable copolymers comprising a hydrophilic backbone with pendant aliphatic groups as the hydrophobic component. The polymers form nanoscale molecular aggregates in aqueous environments, which have hydrophobic interiors that are capable of solubilizing insoluble organic compounds such as drugs, vitamins, dyes, and imaging agents. The polymers optionally feature reactive functional groups that provide attachment points for antibodies, ligands, and other targeting moieties useful for the targeted delivery of drugs and imaging agents.
Inventors: Diwan; Anil (West Haven, CT), Onton; Ann Louise (Fairfield, CT), Tatake; Jayant G. (Sandy Hook, CT)
Assignee: AllExcel Inc. (West Haven, CT)
Appl. No.: 12/223,052
Filed: January 19, 2006
PCT Filed: January 19, 2006
PCT No.: PCT/US2006/001820
371(c)(1),(2),(4) Date: June 17, 2010
PCT Pub. No.: WO2007/084126
PCT Pub. Date: July 26, 2007
source: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8,173,764.PN.&OS=PN/8,173,764&RS=PN/8,173,764
Does Diwan hold a 2nd generation NanoViricide(R)patent? I know Dr. E. Seymour weeks ago.
Now we are "back to the future" with NanoViricides, Inc.!
Don't get entangled with semantics. Watch the video, it is self explanatory.
A hundred tiny hands
When I make my first set of slave "hands" at one-fourth scale, I am going to make ten sets. I make ten sets of "hands," and I wire them to my original levers so they each do exactly the same thing at the same time in parallel. Now, when I am making my new devices one-quarter again as small, I let each one manufacture ten copies, so that I would have a hundred "hands" at the 1/16th size.
Where am I going to put the million lathes that I am going to have? Why, there is nothing to it; the volume is much less than that of even one full-scale lathe. For instance, if I made a billion little lathes, each 1/4000 of the scale of a regular lathe, there are plenty of materials and space available because in the billion little ones there is less than 2 percent of the materials in one big lathe.
It doesn't cost anything for materials, you see. So I want to build a billion tiny factories, models of each other, which are manufacturing simultaneously, drilling holes, stamping parts, and so on.
As we go down in size, there are a number of interesting problems that arise. All things do not simply scale down in proportion. There is the problem that materials stick together by the molecular (Van der Waals) attractions. It would be like this: After you have made a part and you unscrew the nut from a bolt, it isn't going to fall down because the gravity isn't appreciable; it would even be hard to get it off the bolt. It would be like those old movies of a man with his hands full of molasses, trying to get rid of a glass of water. There will be several problems of this nature that we will have to be ready to design for.
noretreat, we (investors/traders) know about NNVC, about specifics on Clinical Trial durations and guidelines, as much as competitors of NNVC. Because competitors (loaded mules, ahem) don't need to know more than we do, we along with competitors will know more when the time is right. Yes, competitors have the money and they may know more but NanoViricides, Inc. is a small company (few employees) with a marquee team of project managing companies, with well guarded secrets/patented technology. After so many years (nine?) we are finally near or on the final stretch to the Clinical Trials. Then it all begins!
There is a marquee team of project managing companies, along with Dr. Jim Ackland, the Manager of Australian Biologics Pty, Ltd are working to successfully manage all projects to the Clinical Trials (Q4 2014 or Q1 2015). It has been written that Australia will be the site for the Clinical Trials. But, three sites are under consideration. The competition are scratching their heads. All is well, we are on track, until the company says we are not.
NanoViricides, Inc. Reports Excellent Safety Profile of Its Broad-Spectrum anti-Influenza Drug Candidate, FluCide™ , in a Non-GLP Study
WEST HAVEN, CONNECTICUT -- Monday, December 2, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that it has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide™. No overt adverse safety and toxicology effects were observed in this study of the Company's optimized FluCide broad-spectrum anti-influenza drug candidate, even at the maximum feasible dose level. These results are consistent with the preliminary findings of this study that the Company has previously reported, and provide greater details of the safety of FluCide.
Detailed laboratory analyses of samples from this non-GLP safety and toxicology study showed no overall systemic effects and no direct effects on the primary organs. This includes liver and kidney tissues as well as liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity. In addition, FluCide showed no adverse effects on the lungs from the treated animals. This is very important because the respiratory system is a primary site of influenza virus infection and tissue damage. These strong safety findings were seen at all doses tested, even at the maximum feasible dose (MFD). MFD was much higher than the therapeutic dose range used to treat influenza virus infections in our animal model efficacy studies. FluCide was administered intravenously by tail-vein injections or by infusion in this study. The non-GLP safety/toxicology study was conducted at KARD Scientific in Massachusetts.
These results support the Company's positive findings in animals that were infected with different influenza A virus strains. In those studies, no safety or toxicology concerns were observed. The Company has previously reported that its FluCide candidate demonstrated extremely high anti-influenza activity in lethal infection animal models using multiple influenza A subtypes. The extremely high anti-influenza activity coupled with the strong safety data were the basis for the selection of this FluCide candidate for further drug development.
In addition, the Company is developing a flexible, multi-product, pilot manufacturing facility capable of manufacturing any of its drug candidates in c-GMP compliant manner. This facility will be able to provide the cGMP clinical drug substances for its future human clinical studies. (“c-GMP”= current Good Manufacturing Practices, a set of guidelines developed by the US FDA that the manufacture of a drug must adhere to for human clinical trials and future sales. Internationally, there are similar guidelines promoted by local regulatory agencies, and ICH harmonization guidelines promoted by the WHO). A group of private financiers that includes our founder Dr. Anil Diwan has acquired an 18,000 sq.ft. building on 4 acres with possibilities of expansion, in Shelton, CT, via Inno-Haven, LLC, a company formed specifically for that purpose. This building is now undergoing a total renovation to facilitate setting up a modern cGMP drug substance manufacturing facility with injectable drugs capability, as well as supporting analytical and chemistry laboratory facilities.The Company reported that the renovation of the facilities at 1 Controls Drive, Shelton, CT is now in Construction phase, and is expected to be completed in the first calendar quarter of 2014.
“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” said Eugene Seymour, MD, MPH, adding, “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”
"...He [Dr. E.Seymour] presented an extremely bullish picture, answered many questions - and so I bought some more, of course! It was hard not to become more excited due to his great enthusiasm, especially when he talks about cures and predicts this year's progress will "blow away" last year's impressive work..."~ KMBJN
NanoViricides, Inc. (the "Company"), is a nano-biopharmaceutical (nanomedicine) company whose business goals are to discover, develop and commercialize therapeutics to advance the care of patients suffering from life-threatening viral infections. We are a development stage company with several drugs in various stages of early development. The Company's drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. ("TheraCour®"), to which the Company has exclusive licenses in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. On February 15, 2010, the Company entered into an Additional License Agreement with TheraCour granting the Company the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types of Dengue viruses (DENV), Japanese Encephalitis (JEV), West Nile Virus (WNV), viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses.
source: http://www.nanoviricides.com/corporateinformation.html
Correct. They are licensed patents in perpetuity. Diwan, Allexcel, and TheraCour own the patents. The exclusive rights to those patents are owned by NanoViricides.
Now, before someone makes the bogus argument that the licenses can be revoked at anytime, the licensing agreement is very specific about the conditions under which the license can be rescinded: for non-payment of licensing fees or royalty payments or failure to develop antiviral drugs. All payments are current and NNVC has already fully complied with the second.
Breach of the agreement can be remedied simply by making payment within 90 days of receipt of the written notice.
Also, before the second bogus claim is made that there are no patents, there have been patent applications filed and are pending. The rest I will leave to the resident expert on patents, Nanopatent. ~ BigKahuna
Indeed! NNVC has an EXLCUSIVE license in perpetuity under the viral disease directed patents/filings.
Ref:
The Company's drugs are based on several patents, patent applications, provisional patent applications, and other property held by TheraCour Pharma, Inc. (TheraCou), to which the Company has exclusive licenses in perpetuity for the treatment of human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. ~ nanopatent
TheraCour Pharma, Inc.
On May 12, 2005, the Company entered into an Material License Agreement, amended as of January 8, 2007 (the "License") we entered into with TheraCour Pharma, Inc., ("TheraCour"), our largest shareholder. As of the present, TheraCour granted the Company an exclusive license in perpetuity for technologies developed by TheraCour for six virus types: HIV, HCV, Herpes, Rabies, Asian (bird) flu and Influenza. In consideration for obtaining this exclusive license, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) to pay $25,000 per month for usage of lab supplies and chemicals from existing stock held by TheraCour; (3) to pay the greater of $2,000 or actual costs, for other general and administrative expenses incurred by TheraCour on our behalf (4) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour; (5) that TheraCour Pharma, Inc. shall retain the exclusive right to develop and synthesize nanomicelle(s), a small (approximately twenty nanometers in size) long chain polymer based chemical structure, as component elements of the Licensed Products. TheraCour agreed that it will develop and synthesize such nanomicelle exclusively for NanoViricides, and unless such license is terminated, will not develop or synthesize such nanomicelle for its own sake or for others; and (6) to pay an advance payment equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses.
Development costs charged by and paid to TheraCour Pharma, Inc. was $1,484,323 since inception through September 30, 2007; and $143,653 and $184,885 for the three months ended September 30, 2007 and 2006, respectively. No royalties are due or have been paid from inception through September 30, 2007.
TheraCour may terminate the License upon a material breach by us as specified in the agreement. However, the Company has the opportunity to cure the breach within 90 days of receipt of notice to terminate the License.
TheraCour also permits the Company to use the nanomaterial we license to develop a treatment for Filovirus in accordance with a Cooperative Research and Development Agreement the Company executed with the U.S. Army Research Institute of Infectious Diseases on October 15, 2007. While the Company and TheraCour are negotiating an amendment to the licensing agreement to include Filovirus, there can be no assurance that an agreement may be reached, in which case TheraCour may revoke its exclusive license.
As of January 3, 2008, TheraCour owns 35,370,000 shares of the Company's outstanding common stock.
Anil Diwan, the Company's President and Chairman, also serves as the CEO and Director of TheraCour and owns approximately 65% of the outstanding capital stock of TheraCour. Leo Ehrlich, the Company's former Chief Financial Officer, serves as TheraCour's Director and owns approximately 10% of the outstanding capital stock of TheraCour.~ nanopatent
More about NanoViricides, Inc. transformational technology...
Life-threatening viral diseases affecting mankind is the targeted, near future, multi-billion dollar business of NanoViricides, Inc.. NanoViricides, Inc. has identified a nanoviricides product pipeline: H1N1 "Swine Flu" seasonal influenzas (injectables), H1N1 "Swine Flu" seasonal influenzas (Oral), EKC causing Adenovirus, "Cold sores" Herpes, HIVCide (TM) potentially functional cure, MERS Coronovirus (R&D), Rabies (R&D), Ebola-Marburg-hemorrhagic viruses (R&D), Hepatitis C.
How many times have you heard about NanoViricides, Inc. misspending shareholders wealth for nearly nine years? or, heard about possible Big Pharma partnerships that would make all NanoViricides, Inc. investors newly minted millionaires!
Big Pharma "loaded mules" are exactly that, mules that are back in the 20th century manufacturing chemical compounds while NanoViricides, Inc. is "Back to the Future" in the 21st Century, seeking to commercialize their low-toxicity, effective and life-saving novel polymers.
Read and heed the message embedded in the PR. We are "going it" alone with our transformational technology!
“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” said Eugene Seymour, MD, MPH, adding, “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”
I have no reason whatsoever to think that KMBJN misunderstood the following in his fairly recent exchange with Dr. E. Seymour:
"...He [Dr. E. Seymour] presented an extremely bullish picture, answered many questions - and so I bought some more, of course! It was hard not to become more excited due to his great enthusiasm, especially when he talks about cures and predicts this year's [2014]progress will "blow away" last year's [2013] impressive work..."~ KMBJN
GLP is NOT required for:
Efficacy studies, whether in vitro or in vivo. 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 studies
- In vitro ADME 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.~ Kally-Cell
All we are waiting for is the first step, "every step", that will get us closer to the clinical trials (2014- 2015). We are waiting for preliminary information on GLP Tox studies, to be conducted by BASi in Indiana, and the cGMP Pilot Plant validation by the FDA.
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
H10N8 death in China; H5N1 in Cambodia, Vietnam;H7N3 vaccine trial; Rapid flu tests; Self-vaccination with patches
Health officials in China's Jiangxi province today reported their third recent human case of H10N8 avian flu, which proved fatal, according to a provincial statement in Chinese translated and posted by FluTrackers, an infectious disease news message board.
The patient, a 75-year-old man from the capital city of Nanchang, got sick on Feb 4 and was hospitalized with severe pneumonia. He died on Feb 8.
The two other recent cases include the first detection in the middle of December, in a 73-year-old woman who died from her infection, and a nonfatal case in a 55-year-old woman whose illness was reported in late January.
The virus is low pathogenic in birds but, like the H7N9 virus, appears to cause severe disease in people. A recent study in The Lancet urged health officials not to underestimate the pandemic potential of H10N8.
Feb 13 FluTrackers thread
Feb 4 CIDRAP News story "Study: H10N8 virus in first human case is novel strain"
H5N1 strikes flocks in Cambodia, Vietnam
Cambodia has reported an H5N1 avian flu outbreak at a village in Kampong Cham province, according to a report today from the World Organization for Animal Health (OIE).
The virus was detected by animal health officials who were called to investigate sickness and death in the village's duck flocks. The outbreak began on Feb 7. Of 5,250 susceptible birds, 4,466 deaths were reported, and the remaining 784 ducks were destroyed to curb the spread of the virus.
The outbreak was Cambodia's first since August 2013. The country has reported three H5N1 illnesses in humans so far this year, all in children. Two of the cases, reported yesterday, were in siblings who died from their infections, but one was not tested. The siblings lived in Kampong Cham province.
Feb 13 OIE report on Cambodia outbreak
Elsewhere, Vietnam's agriculture ministry today reported six H5N1 outbreaks from six different provinces, according to a separate OIE report. They range from Nam Dinh, located in the more northern part of the country, to more southern provinces, including Tay Ninh, Khanh Hoa, Quang Ngai, Kon Tum, and Ca Mau.
The outbreak dates range from Feb 7 to Feb 11, affecting village flocks. Of 18,981 susceptible birds, 9,181 died, and the remaining 9,800 were destroyed to control disease spread.
Feb 13 OIE report on Vietnam outbreaks
H7N3 vaccine trial shows promise, potential for use against H7N9
A phase 1 clinical trial of a candidate H7N3 live-attenuated influenza vaccine (LAIV) developed in Russia found that two doses were immunogenic and produced antibodies that were reactive not only to wild-type avian H7N3, but also to the new H7N9 virus that is infecting humans in China, according to a study yesterday in PLoS One.
A Russian and US team administered two doses of the vaccine to 30 of 40 randomly divided subjects, 10 of them receiving placebo. Among patients who got the LAIV doses, researchers found the majority (86.2%) of vaccine recipients developed serum and local antibody responses and generated antigen-specific CD4 and CD8 memory T cells. They also found that the vaccine was safe and well tolerated.
In addition, they found that sera from some of the vaccinated patients prompted an antibody response that was able to neutralize the new H7N9 virus. The team also found clues that most B cells and cytotoxic T cells induced by the H7N3 virus are likely to recognize the H7N9 virus.
They concluded that the H7N3 LAIV strain could be used in a priming vaccine strategy in the event of a pandemic until specific H7N9 vaccines are available.
Feb 12 PLoS One study
Rapid flu tests appear to guide antiviral decisions for outpatients
Clinicians in outpatient facilities often use the results of rapid influenza diagnostic tests (RIDTs) in making decisions regarding the use of antivirals, but these decisions are not always in line with treatment guidelines from the US Centers for Disease Control and Prevention (CDC), according to a study yesterday in the Journal of Clinical Virology.
The authors sent surveys to randomly selected physicians' offices, emergency departments, and community clinics in 2008 (pre–2009 H1N1 pandemic) and 2010 (post-pandemic) to assess RIDT testing practices; 5,064 surveys were sent in 2008 and 5,063 in 2010. In the post-pandemic survey, questions were included to evaluate any changes in RIDT practices in various risk groups.
The response rate was lower in 2010 than in 2008 (18% vs 41%), but a higher percentage of respondents reported RIDT use in 2010 (73%) than in 2008 (20%) for all facility types.
In both survey years, antivirals were prescribed for more than two thirds of patients with flu-like symptoms who had a positive RIDT result within 48 hours of onset (69% pre-pandemic, 67% post-pandemic). An "H1N1 effect" was seen in 2010, meaning higher treatment levels in high-risk patients, but the numbers fell short of CDC recommendations (eg, 31% of children under 2 years of age, 23% of children 2 to 5, and 37% of pregnant patients).
Feb 12 J Clin Virol abstract
Study: Self-applied microneedle vaccine patches well tolerated
Most patients attempting self-vaccination with microneedle patches were successful, particularly when a snap-based device was used, and most would prefer to self-vaccinate given the choice, says a study in Vaccine that the authors claim is the first to assess usability and acceptability of the method.
The study group comprised 91 venue-recruited adults. They self-administered placebo-containing microneedle patches three times, had one placebo microneedle patch applied by an investigator, and had an intramuscular injection of saline.
Those in the first group, comprising 70 participants, were given patches that are applied with thumb pressure alone. Usability was evaluated by counting needle insertion sites after swabbing the skin with stain. They showed wide variability in the number of insertion points as well as a learning curve (more insertion points on the third attempt than the first).
The authors took this to mean that subjects needed a device to assist with correct needle insertion, so they repeated the regimen on 21 subjects with devices that snapped shut when the appropriate application pressure was reached.
The best usability was attained by those using the snap devices; over three repetitions, this group had a median success rate of 93% to 96% with little variability among individuals. All patch vaccinations were well tolerated.
Subjects' intent to be vaccinated in the next flu season increased from 44% before the trial to 65% afterward (confidence interval, 55% to 74%). Among those expressing an intent to be vaccinated, 76% preferred microneedle-patch vaccination over injection and 64% preferred self-vaccination over patches applied by a healthcare worker.
source: http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Inc%20Reports%20Excellent%20Safety%20Profile%20of%20Its%20Broad%20Spectrum%20anti%20Influenza%20Drug%20Candidate%20FluCide%20in%20a%20Non%20GLP%20Study.html
WEST HAVEN, CONNECTICUT -- Monday, December 2, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that it has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide™. No overt adverse safety and toxicology effects were observed in this study of the Company's optimized FluCide broad-spectrum anti-influenza drug candidate, even at the maximum feasible dose level. These results are consistent with the preliminary findings of this study that the Company has previously reported, and provide greater details of the safety of FluCide.
Your point is well taken. I kinda let go...
Haemorrhagic fevers, biological weapons and NanoViricides, Inc. ADIF(TM) Technology
Important for International Travel and Health
Haemorrhagic fevers are viral infections; important examples are Ebola and Marburg haemorrhagic fevers, Crimean–Congo haemorrhagic fever (CCHF), Rift Valley fever (RVF), Lassa fever, Hantavirus diseases, dengue and yellow fever.
Hantavirus diseases, dengue and yellow fever are described separately.
Cause
Viruses belonging to several families. Ebola and Marburg belong to the Filoviridae family; hantaviruses, CCHF and RVF belong to the Bunyaviridae family; Lassa fever virus belongs to the Arenaviridae family; and dengue and yellow fever belong to the Flaviviridae family.
Advanced Technologies : ADIF(™) Technologies
We believe that our technologies and capabilities for attacking different viruses are fairly well demonstrated. In addition, we have developed "Accurate-Drug-In-Field(™)" or ADIF(™) technologies that may show efficacy in treating epidemics like H5N1, SARS or Ebola by developing a targeted therapeutic in the field to prevent the spread of the disease.
ADIF technology does not require any knowledge of the molecular biology of the virus, or even its specific identification. An accurate drug, specifically targeted at the virus, can be developed in the field from nanomicelles stockpiled beforehand. This enables a rapid response timeframe as short as 3 weeks for initial drug doses, and potentially less than 3 months for sufficient doses to curb the spread of the virus outside the affected area. Thus ADIF technologies are applicable to novel, or engineered viruses, or emerging infections whether natural or man-made. This technology may have significant applications in the Biodefense area. We believe that this is the only technology that can enable humans to combat novel viruses before they spread disease.
We have already successfully demonstrated the ADIF technology capabilities.
I read somewhere there are 1 x 10 to the power of 23 viruses in the world. You ask, "Are they good for anything besides that?" We will have to wait and see.
As an entity they are surely successful but I don't get what their point is. Our immune system says 'bad news, kill!', and does so fairly successfully. The battle continues. If the viruses win we lose - game over.
Now, to engineer a virus to help man - I appreciate that and get the point. We need, up to this point, to use the ones we find in nature to do our bidding with a few tweaks here and there. Better to engineer a virus from the get go to do our bidding. How far away from that are we? Days, months, years?
The chicken came first.
I suppose they kinda developed together from the first moment of creation and have progressed (!!??) to the present time. ~ nanopatent
Find the pseudonymed poster...
"First we have the fair trial, then we hang him" ~ Judge Roy Bean
It may seem like a fairly fundamental question, but there is still debate over whether viruses should be considered a form of life.
The diversity of viral infections is immense. Viruses cause everything from common cold (rhinoviruses) to Ebola and warts (papillomavirus); from HIV/AIDS to influenza and smallpox. Many viruses can cause cancer: the hepatitis B virus is a known cause of liver cancer, and some types of human papillomavirus cause cervical cancer.
Adenovirus-36 (Adv36) May Cause Obesity
There IS a virus that causes obesity. Adenovirus-36 (Adv36) is a human “common cold” virus that is easily caught from an infected person who is coughing or sneezing, or if they do not wash their hands after having a bowel movement. At least one-third of people affected by obesity have been infected and multiple investigators all around the world have started to work on this virus.
Researchers at the University of Wisconsin began experimenting with Adv36 around 1995 and found that when they experimentally infected chickens and mice, the animals increased their body fat by 50 to 150 percent. Compared to uninfected animals, about 60 to 70 percent of infected animals became obese. The investigators then tested monkeys by squirting Adv36 up their nose. This was an important experiment because Adv36 is a human virus and monkeys are the closest animal model to humans. One hundred percent of the infected monkeys gained weight.
A second experiment in a group of monkeys who had been in the animal facilities, from whom blood had been drawn and stored every six months for seven years, had Adv36 testing done on their blood. These monkeys were not deliberately infected, but all 15 became “naturally” infected throughout the seven years. Body weight was stable before infection, but once they tested positive for Adv36, they started to gain weight. The investigators speculated that their human handlers became infected and brought in the virus.
A critically important finding surprised the researchers – infected animals did NOT eat more and did NOT do less exercise, but they still gained weight. This virus causes obesity without changes in diet and exercise by changing metabolic rate and efficiency of food utilization.
Testing Adv36 in Humans
The researchers then began to test humans, both affected by obesity as well as some not affected, in Wisconsin, New York and Florida. The test for Adv36 is a blood test that is highly specific – if you have antibodies against Adv36, you have been exposed. More than 500 individuals were tested and the investigators found that 30 percent of the individuals affected by obesity and 11 percent of the individuals not affected by obesity had been infected. The infected people weighed more than 50 pounds more than the uninfected.
Since these early studies, now more than 15,000 people in nine different countries have been tested for Adv36 infection. The frequency of infection varies in different countries and ranges from 6 percent in Belgium/Holland to 65 percent in Italy. All but one research group has found the prevalence of infection to be 20 percent or greater and the average is about 40 percent. Studies in adults vary, but in all six known studies in children, Adv36 was associated in some way with obesity (see chart below).
How Contagious is Adv36?
A question that invariably is asked is, “Can I catch obesity from a person affected by obesity?” The answer is that it is very unlikely to be able to catch obesity from a person who has become affected by obesity due to the virus. The difference in metabolic rate is small, so it takes quite some time to gain large amounts of weight. The animal studies have the advantage of being able to tell exactly when the animal was infected and they showed that the virus persists two months or less. It takes much longer than two months to become obese, so the virus will be gone before the person gains a lot of weight.
Scientists have determined how the ADV36 virus works
The DNA (genetic material) of the virus gets into the fat cells of the person or animal and causes them to bring in more fat and glucose from the blood and to make fat out of the glucose. The viral DNA also causes adult stem cells in the fat tissue to turn into fat cells, so the total fat cell number increases. Thus, an infected person will have bigger fat cells and more of them. Scientists have figured out the sequence of the DNA in Adv36, which gene in the virus causes the effect, and how this gene changes the chemistry inside fat cells to cause obesity.
What if I am Infected?
What can you do if you are infected? This is a critical question for most people, because who cares if you are infected if you cannot do anything about it? The bad news is that at the present time, there are no specific treatments for Adv36. If you are already affected by obesity, the usual problems of losing weight and keeping it off will apply.
The good news is that if you are currently not affected by obesity, it is a lot easier to prevent obesity than to treat it. Some of the anti-obesity drugs work very well to prevent weight gain. Policy changes in some states will be needed to allow Adv36 infected, non-obese people to go on obesity drugs to prevent weight gain.
More good news is that at least one paper shows that people who are infected with Adv36 lose weight better than uninfected people. So, it may be easier to lose weight; then, careful attention to diet, exercise and treatment with anti-obesity drugs may allow better weight maintenance. The bad news – people who are infected and lose weight may be more likely to gain it back more quickly if they do not pay attention to diet, activity and anti-obesity drugs.
Finally, some last good news – research is ongoing to identify antiviral agents that appear to work against Adv36 infection. And the best news of all, a vaccine has been developed that appears, in very early studies, to prevent infection with Adv36. More research is needed, but it appears that eventually we will be able to prevent Adv36-induced obesity in those who do not have it and to treat it in those who do.
Conclusion
How will this information alter the way people affected by obesity and the disease of obesity are treated? A great deal of advocacy work is ahead to convince politicians and third party payors to do the right thing; however, the knowledge that at least a portion of obesity is due to an infectious disease changes the entire debate.
About the Author:
Richard Atkinson, MD, has worked in obesity treatment and research for 40 years. He is past president of the former American Obesity Association and the North American Association for the Study of Obesity, and is the current editor of the International Journal of Obesity.
Comment about NanoViricides, Inc.,
The "good doctors" at NanoViricides, Inc. have the money and are continuing their work towards the Clinical Trials (2014 - 2015). NanoViricides, Inc. lawyers are also at work to protect the company's interests in court and with the Securities Exchange Commission. No short interest "hit job" to manipulate the stock price is going to be successful for very long, mainly because we are on-track with the FluCide candidate for 2014 and the scientific technology behind NanoViricides, Inc. is highly transformational.
On a larger scale...
The big picture with Jim Rogers ~ Market Manipulation
I think it is clear that all markets are manipulated as interest rates are set and money/credit created by central banks. I believe that the main reason Mr. Rogers does not pay serious attention to manipulation is due to his long-term investment strategy . In the long run, the markets always prevail and any short-term market manipulation should thus be viewed as an opportunity to accumulate/sell an asset that is artificially held down/up in the short-term.
"Everything should be made as simple as possible, but not simpler" ~ Albert Einstein
The plaintiff may have this week to make up their mind as to stay out or buy. Even if the plaintiff's lawsuit has legal standing they may have until Friday to make up their mind; stay out or buy with both hands. If, as they claim, they were blindsided to the downside, who is to say they will not be blindsided again, this time to the upside.
From a previous post from another_voice_2, in email exchange w/Dr. Seymour, "the length of time necessary to do the tox studies" instead of -- the length of time necessary to start tox studies -- or enough quantities of the FluCide candidate (reproducible) to start tox studies.
We are days away from Friday and that may be all the plaintiff has to make up their mind (if they have not already). As Lookathesky suggested, withdrawing their lawsuit/complaint may do wonders for their shares---if they are in.
We are on the road to the Clinical Trials (2014)and we don't have all our eggs in one basket. We have LRRI, UK PHE and ViroClinics Biosciences, BV nearly lined up for efficacy studies. An old rehashed complaint should not and will not derail NanoViricides, Inc.
A heartfelt congratulations to all that will buy at these low prices between today and Friday.
Here is the video...
Thank you nanopatent! One of the highly important collaborators of NanoViricides, Inc. is the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) is the U.S Army’s main institution and facility for defensive research into countermeasures against biological warfare.
Advance the RedChip Emerging Growth Showcase (June 26-27, 2013)video to 16:26...
Agree! Borrowing from KMBJN post...
"...He [Dr. E.Seymour] presented an extremely bullish picture, answered many questions - and so I bought some more, of course! It was hard not to become more excited due to his great enthusiasm, especially when he talks about cures and predicts this year's progress will "blow away" last year's impressive work..."~ KMBJN"
NanoViricides, Inc. "transformational technology" could save countless lives as well as billions $$$ annually!
Borrowing again from quotes/posts...
Tox timing, animal species all communicated clearly, with supporting references below.
1. GLP Tox Study timing is expected to be about 6 months - not a change from recent NNVC communications.
2. Two animal species minimum required per FDA Guidance (3 planned for FluCide) - never was a new or unknown requirement.
TOX TIMING:
2014 Goals in Dr. Seymour's NNVC presentation from LD Micro Conf
- Initiate GLP FluCide toxicology studies (Q1)
- Report FluCide toxicology results (Q3)
Duration of Tox Studies from FDA/ICH (covers all Regulatory Regions WW)
LINK: FDA/ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
From Table 1 to get into single dose Clinical Trials - Tox Study durations of up to 2 weeks* required (for both rodent and non-rodent arms)
From Table 2 to market the drug - Tox Study durations of up to 1 month required (for both rodent and non-rodent arms)
* Note that for an injectable FluCide, Cmax is immediate at injection. The concentration only decreases from there. So monitoring is reduced and a 2 week study meets the Guidance, although this would have been negotiated with FDA in the Pre-IND meeting. For this novel drug, FDA may have asked for longer durations of FluCide Tox monitoring. Conservatively, consider up to 2-3 month duration of Tox Study with rodents and non-rodents tested mostly at the same time.
Per the NNVC schedule goals, ~ 6 months to report Tox results leaves at least 3 months to complete analytical testing and reporting. Very reasonable schedule.
ANIMAL SPECIES:
From the same FDA Guidance (M3(R2)), GLP Tox studies supporting initiation of clinical trials are ALWAYS done in at least 2 mammalian species (one non-rodent). This is NOT a new or unknown requirement and is reflected in the company's timelines. The company (from correspondence relayed from previous poster - sorry, can't remember who) will be using 3 species (mice, rats, dogs). I have posted this multiple species Tox testing requirement on this board a few times previously.
"...the duration of the animal toxicity studies conducted in two mammalian species (one non-rodent) should be equal to or exceed the duration of the human clinical trials up to the maximum recommended duration…" ~~~ robi-1-kenobi
How long it takes to ramp up production in the new plant, the length of time necessary to do the tox studies, timelines for our collaborators to complete and report their data, length of time necessary for the US FDA and the European Medicines Agency to approve the initiation of the human trials, length of time it takes for the patent offices to approve our patent applications (Brazil has been 5 years already) ~ Dr. E. Seymour
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
Borrowing quotes from the BigKahuna and idrocket2003...
Shelf Life ~ I asked Dr Seymour about this issue, and he answered with an interesting set of facts. 9 years ago Dr Diwan made a small batch of "goo" and put it in the glove compartment of his car. Each year since he has taken a small sample of the stuff and tested it for its effectiveness. In every sample tested it is still as good as the day it was made! The implications of this are mind-boggling! NO REFRIGERATION NECESSARY!~ Dave idrocket2003
I hope you all read post #79334 on the IH board. In doing so you will discover the serendipitous discovery of the "nanoviricide" but also how Dr Diwan named his first company TheraCour. It is short for "therapuetic courier". ~ idrocket2003
The discovery of the nanoviricide was indeed serendipitous. While testing the nanomicelle as a future therapeutic courier, Diwan and company ran a PoC against a massive virus particle, cytomegalovirus, biggest virus to give the nanomicelle a huge target. After applying the nanomicelles to the culture, they found no virus. Couldn't figure it out because there was not yet an API in the micelle. They ran a second test and found that the nanomicelle destroyed the virus all by itself. A few more times and they found that the nanomicelle destroyed virus particles every single time a particle came in contact. Voila the therapeutic courier (TheraCour) became a nanoviricide. ~ BigKahuna
So you are saying that in "cradle to grave, Big Government" countries (not the U.S., ahem), who constantly present themselves to be the caretakers/benefactors of the people, who constantly feel the pain of the people, that there is no social/welfare component in the decision making to approve a patent application?
"...This authoritative book provides a comprehensive critical overview of the basic IP paradigms, such as patents, trademarks and copyrights. Their intersection with competition law and their impacts on the exercise of social welfare are analysed from an evolutionary perspective.
The analyses and proposals presented encompass the features and rationales of a legal field in constant evolution, and relate them to increasingly rapid technological, economic, social and geo-political developments. Gustavo Ghidini highlights the emerging trends that challenge the traditional ‘all-exclusionary’ vision of IP law and its application. The author expertly combines holistic, evolutionary and constitutionally oriented approaches, with the search for a rebalancing of the IP rights holders’ positions with citizens’ and users’ rights..."
source: http://www.e-elgar.co.uk/bookentry_main.lasso?id=13190
Generosity, or being generous, is a good trait in others and in yourself. It is not a trait of any government, or as President Washington once characterized it, "force".
All in all, there are challenges to manage all activities/timelines mentioned in another_voice_2/Dr. Seymour's email exchange, but I feel confident that NanoViricides, Inc. marquee team of managing companies, along with Dr. Jim Ackland, the Manager of Australian Biologics Pty, Ltd will be successful in managing all to the Clinical Trials (2H 2014 - Q1 2015).
If Brazil is the country mentioned by name in the email, I am not going to ask a question about Zimbabwe. Would you? Thank you in advance for the list of the approved patents in other countries, other than Brazil.
I once lived in Brazil. If you think the US government is corrupt and sclerotic, try Brazil. ~ daBoze
Thank you on your posted email exchange! I particularly like, "...the length of time necessary to do the tox studies...". Have the tox and safety studies begun? This question likely falls under the "there are also competitive reasons not to do so!" category.
nanopatent, question on patents: If you read another_voice_2 email, why do you think the government of Brazil would take 5 years to accept NNVC's patent applications? NanoViricides, Inc. should have over 100 recognized by now assuming the governments are assigning priorities in doing their work. Is it because of a procedural maze? Duplication of Brazil's government efforts, if any? Is there any consideration of the people's welfare in assigning priority to patent applications?
NanoViricides Signs Agreement with Viroclinics Biosciences BV for Testing of Various NanoViricides Against Specific Viruses of Current Concern
WEST HAVEN, Conn.--(BUSINESS WIRE)--February 04, 2014--
Tuesday, February 4th, 2014 - NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reported today that it has signed a "confidential disclosure agreement" ("CDA") with Viroclinics Biosciences, BV ("Viroclinics"), a spinoff of the Department of Viroscience at the Erasmus Medical Centre ("Erasmus") in Rotterdam, the Netherlands. The agreement will allow the scientists at Viroclinics to develop a specific proposal for the testing of different nanoviricides(R) , such as FluCide(TM), against viruses of mutual interest to both organizations.
Viroclinics is a virology contract research organization serving the biopharmaceutical community (http://www.viroclinics.com/en-GB/). Viroclinics provides preclinical as well as clinical development services for vaccines and antivirals. The ongoing, intimate interaction between scientists at Erasmus and Viroclinics staff yields a strong, flourishing platform to create and implement assays at the forefront of viroscience. Viroclinics participated in the discovery and characterization of the Middle East Respiratory Syndrome (MERS) Coronavirus in 2013 and SARS Coronavirus in 2003, attesting to its leadership position in the field.
NanoViricides, Inc. anticipates that we will be able to test and develop our drug candidates against influenzas, dengue, MERS Coronavirus, as well as rabies, with the help of Viroclinics. In particular, NanoViricides is interested in the testing of its lead broad-spectrum anti-influenza drug candidate FluCide against various influenza A strains including the highly lethal H5N1 and H7N9 viruses that pose a strong global public health threat.
Testing of nanoviricides antiviral drug candidates will be performed in a BSL2 or BSL3 facility at Viroclinics, as applicable. These facilities are designed to contain and enable the safe handling of organisms that can pose a significant threat to health. Executives from NanoViricides plan to visit the Rotterdam facility later this month to conclude the final research agreement.
Regardless of who approached whom, it is an excellent association!
Great succession of quotes...
Luck is not a problem in science, it is a very valuable asset.
Serendipity is most generous to those that know how to handle her.
Read "Serendipity: Accidental Discoveries in Science" by Royston M. Roberts if you have a hard time wrapping your head around that one.
On the negative side, luck has very little to do with it. Science is all about controlling the variables and finding alternative approaches when something doesn't work. Stuff happens and it's not "luck" it's part of the game. Good people deal with it very effectively and it's not at all uncommon for a good person to turn "bad luck" into something very valuable, often more valuable than the thing they were originally after. (a major reason that large corporations and BPs are so poor at research is that don't know how to handle serendipity, usually mistaking it for a problem rather than an opportunity. ~ ZincFinger
The discovery of the nanoviricide was indeed serendipitous. While testing the nanomicelle as a future therapeutic courier, Diwan and company ran a PoC against a massive virus particle, cytomegalovirus, biggest virus to give the nanomicelle a huge target. After applying the nanomicelles to the culture, they found no virus. Couldn't figure it out because there was not yet an API in the micelle. They ran a second test and found that the nanomicelle destroyed the virus all by itself. A few more times and they found that the nanomicelle destroyed virus particles every single time a particle came in contact. Voila the therapeutic courier (TheraCour) became a nanoviricide. ~ BigKahuna
The Chart Looks Perfect.......
In many ways: a multi-year cup with handle, an extended flat base, and now a triple bottom at $4.57 within the base! I predict yesterday's close is the bottom. All we need is a significant company announcement and we will gap up and never close it again!
THIS STOCK IS A GIFT AT THESE LEVELS. As Zinc stated on 12-2-2013 in commenting on the toxicology studies of FluCide: "This stock has one of the best risk-reward ratios I've ever seen". I couldn't have said it better!~ Dave (idrocket2003)
Right on the money...that is the one!
idrocket2003,
made in another email by Dr Seymour:
"The bankers are predicting $500 in 3 years".
What I liked about yesterday's PR is what was not said.
Things like:
We have to to deviate from our plans
We have to pause or we won't be able to complete this or that
The PR gave us some detail of events past and forward. In other words, NanoViricides, Inc. continues to "lay down the tracks for a railway" to clinical trials and FDA review to market.
A Phase 1 and 2a trial is planned to commence in the fall of 2014, after construction work to expand a leased research lab in Shelton, Connecticut is completed. Dr. Seymour said the timeline on the trials is short: a Phase 1/2a trial involving 24 patients would take about four to six weeks, followed by a Phase 2b trial with 100 patients, which would take about another month, and then a Phase 3 trial with a sample size of about 500 patients would take two more months.
The company plans to seek approval abroad first. However, as Seymour noted, the recent “Pandemic and All-Hazards Preparedness Reauthorization Act of 2012” bill could mean that FluCide’s approval in Australia could lead to marketization in the United States in as little as two years.
“We could have material available in the U.S. for the 2014-2015 flu season.” Dr. Seymour said. “Definitely a year later, we would have a hell of a lot more.”
Some people think that the clinical trial will start in the middle of 2015.
I think that it will be much earlier but that's out of our control
A lot of us really believe in NNVC 's success , but the frustration is that the dates keep changing. ~ Forzanano
Actually, with all the money we have, things will go faster ~ Dr. Seymour
NanoViricides, Inc. "good news" Monday is here...
NanoViricides Reports Construction of its New Facility and cGMP Pilot Production Plant is Nearing Completion, also Provides Details of its $20 Million Registered Direct Offering
source: http://www.businesswire.com/news/rxtimes/20140127005622/en/NanoViricides-Reports-Construction-Facility-cGMP-Pilot-Production
FN, you really snagged a good article! Thank you! YEEEEH-HAAAAH!!!
nanopatent, that will be a good question for Dr.Anil Diwan (and associates) when he shows up at Oslo to claim Nobel Prize of Physiology or Medicine. Did you dream of nanoviricides before you went to work on the nano-structures?