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100% ditto on your analysis ZincFinger!
Someone (I can't recall who) posted on this board Dr. Seymour's e-mail/statement, and I am paraphrasing, "...is difficult to find staff with the necessary qualifications in Biomedical Engineering,...requiring a minimum of hand holding...". Then we read this...
Also, with this additional capital the company anticipates being able to hire necessary staff to accommodate the expanded workload as it gears several of its drug candidates towards IND filings over the near future. In addition, the company will be able to continue its R&D programmes, such as nanoviricides against Rabies and Ebola/Marburg viruses.
source: https://www.menafn.com/d91ccaa5-24e0-4559-aa10-d19cdbd7834a/NanoViricides-raises-USD20m-in-a-registered-direct-offering?src=MWHEAD
NanoViricides, Inc. is making human capital investments and I for one expect this year, and those that will follow, to be nothing short from spectacular!
It is as noretreat and/or puffer says, 60% pop to the upside and $15pps, if not more. Take your pick or pick both. It is going to be a year filled with leaps and bounds to the upside. Raising nearly $20MM in direct offering...?, out of the way for this year!
Simultaneously testing of the FluCide drug candidates at New Mexico-based Lovelace and the UK Public Health Agency sites should result in a dataset yielding a "high degree of confidence". The FluCide drug has the potential to wipe out virtually all strains of the influenza A virus.
source: http://www.proactiveinvestors.co.uk/companies/news/57646/nanoviricides-flucide-a-potential-cure-for-the-flu-drug-to-enter-human-trials-next-year-57646.html
The year of 2014 should be the year of the "green HULK"...$200 - $1000. We are fast approaching the end of the week, Friday and then..."good news" Monday.
I really don't know. I am hoping they have and if so we should soon find out by means of a company PR. For example, we found out about non-GLP KARD Scientific test with FluCide candidate by means of a PR about a month after the tests with it had begun.
It comes from onemedplace, see link...
http://www.onemedplace.com/blog/archives/13522
The article is less that a year old and to me it means that Australian Biologics Pty. Ltd. is successfully managing all projects, to this end,...or better, to that beginning!
WEST HAVEN, Conn.--(BUSINESS WIRE)--Jul 23, 2012 - NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company's broad-spectrum anti-influenza drug. Australian Biologics will also facilitate clinical trial site(s) selection and development of the clinical trials agreements.
Dr. Jim Ackland, the Manager of Australian Biologics Pty, Ltd, has extensive experience in this field. Prior to becoming managing director of this company, he was Vice-President, West Coast and Asia Pacific operations for the Biologics Consulting Group, the Company's US FDA regulatory affairs consulting group. In the 1990's, he was the Head of Regulatory Affairs, Vaccines, for the CSL Group in Australia. The CSL Group is a global, specialty biopharmaceutical company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions.
“We are very pleased to engage Jim and his staff because of their extensive experience in both the regulatory and operational aspects of the clinical trials landscape in Australia,” stated Eugene Seymour, MD, MPH, Chief Executive Officer of the Company.
Data, Upcoming Trials, and Optimism
The company also believes that by moving away from a vaccine-type approach, treatment can also become far more cost efficient. In an extended trial, FluCide was shown to be 1,500 times more effective than TamiFlu in a lethal animal model.
Dr. Seymour said that further trials of FluCide will take place in Australia because the Australian government reimburses 45 percent of research and development expenses, and also favorable conditions for certifying their drug manufacturing facilities.
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.”
source: http://www.onemedplace.com/blog/archives/13522
"Given the potential magnitude of what they are doing, a quarter or 2 difference on the timeline is really immaterial. Except of course the potential impact on Weedie's party planning activities." ~ weedhopper
Echo, can't wait to hear PRs on preliminary results from efficacy studies (LRRI and UK PHE)as well as tox studies from BASi.
H5N8 is a subtype of Influenza A virus. I agree, FluCide should work on that subtype as well.
That's right, I was unable to find anything wrong with that statement. All is good.
According to a company statement issued earlier in the week, NanoViricides believes that simultaneously testing of the drug candidates at these two sites should result in a dataset yielding a "high degree of confidence". Its FluCide drug has the potential to wipe out virtually all strains of the influenza A virus. Toxicology studies are expected to be wrapped up before mid-2014.
source: http://www.proactiveinvestors.com/companies/news/46906/nanoviricides-stock-up-almost-20-hits-new-52-week-high-on-back-of-nda-46906.html
Can you find anything wrong with the statement above?
In addition to FluCide, New Mexico-based Lovelace will be allowed to test the company's candidate for MERS (Middle East Respiratory Syndrome) – an ailment named as a potential threat to public health and national security by the Obama administration in June.
About Telomere...
source: http://www.news-medical.net/health/Telomere-What-are-Telomeres.aspx
The state health department is not required to report flu deaths of people over age 65, Chavez said.
source: http://albany.patch.com/groups/politics-and-elections/p/at-least-23-flurelated-deaths-in-bay-area-reported
Thanks Puffer for your detailed explanation. I chopped my ideas at the end of my post because I realized it would be a quite tight schedule.
Is it possible FDA has streamlined this process to the clinical trials? After all, FluCide (nanoviricides) is not just effective but has proven its low-toxicity.
Is it possible that this vehicle to the clinical trials has more than one speed? What if early on the efficacy and toxicology studies there are provision(s) (just like the clinical trials) to stop studies (for good and exceptional reasons)and go to report. That once reports are received by NanoViricides, Inc., Australian Biologics consulting firm jumps into action to coordinate the regulatory review and approval for the first human trials in Australia for Flucide. All this for good reasons. That FDA will follow suit and further accelerate approval to clinical trials, all in all, before December 2014.
Perhaps the provisions are not there yet but if not this time with FluCide they will be there for the other nanoviricides that will follow FluCide.
Regardless of all my speculation, we are finally moving with certainty, at a fast pace and NanoViricides, Inc. CEO, Dr. Seymour can unequivocally state that we will be awaiting for permission to start human trials this year, 2014.
Puffer, it was late September 2013 when the KARD Scientific non-GLP efficacy studies started (unannounced) and it was late October 2013 when it was reported.
------------------------------------------------------------------
NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reports that its optimized injectable FluCide® drug candidate was found to be well tolerated in a non-GLP small animal safety/toxicology study. This study is an important step in the drug development pathway for FluCide. This study will provide guidance for the IND-enabling GLP safety and toxicology study. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway. This non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts.
Dr. Krishna Menon, VMD, PhD, CEO of KARD Scientific, advised the Company after the completion of this short study, that mice treated with the maximum feasible dose of FluCide in a one hour infusion protocol remained healthy throughout the course of the study. No overt behavioral or clinical signs of any toxicity were observable, even at this highest possible dose level. The Company expects to receive a complete report of all laboratory and clinical data including blood chemistry and histopathology analysis soon.
These preliminary results support the Company's positive findings in efficacy studies using animal models of different influenza A virus strains wherein no safety or toxicology concerns were observed. The Company has previously reported that our injectable FluCide drug candidate was highly effective in animal models of different influenza A virus strains.
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From hereon forward, most of what I type is pure speculation on my part.
I believe that by mid to late October 2013 NanoViricides, Inc. knew their FluCide candidate. It is possible that it was mid to late October when the lab was cranked-up to start producing the necessary quantities (reproducible) of the FluCide candidate to start shipping to BASi, Lovelace IRRI , UK PHE.
Toxicology studies are expected to be wrapped up before mid-2014.
source: http://www.proactiveinvestors.com/companies/news/46906/nanoviricides-stock-up-almost-20-hits-new-52-week-high-on-back-of-nda-46906.html
How soon before mid-2014 will Toxicology studies be wrapped up? I figure Efficacy Studies will not be far apart from wrapping up their studies as well. These will strengthen the possibility of beginning clinical trials Q4 2014 and for everyone to get a huge Christmas present, not to mention those that are afflicted with a life-threatening Influenza that will benefit from having it sooner than later.
We also know that Dr. Seymour expects the cGMP Pilot Plant to be ready in a month or so. I take that statement to mean February 2014. I also take that to mean ready to produce the (3) batches in order for it to be certified by the FDA. How long will it take for the (3) identical batches to be produced? They would have approximately (3) months for that important step? Perhaps a month? I don't know this but time will tell. Definitely before mid-2014.
Next year's plans (2014) include: finishing the plant, completing toxicology studies and submitting paperwork to FDA, while awaiting for permission to start human trials.
source: http://online.wsj.com/article/PR-CO-20131223-905949.html
I agree, it would have to be a very aggressive pace to start clinical trials on Q4 2014. It is very likely we will wait for FDA decision (2014) to start clinical trials Q1 2015.
Clinical Trials in Q4 2014 means it is as early as nine months away. If you take another look to a "worth remembering" list of events and/or PRs, by robi-1-kenobi, (11)PRs that could involve additional PRs perhaps to bring up the list of events/PRs to nearly double...all in nine months to October 2014!!! What do you think is all that exposure in the printed media, radio and tv is going to do to the pps from now to October 2014?
NanoViricides, Inc. has established, and build upon, associations with prestigious institutions/collaborators in the past, all with successful results, on the testing of nanoviricides.
Examples of those results/relationships:
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTCBB: NNVC.OB) (the "Company") reports that post-infection treatment with its optimized FluCide™ drug candidates achieved 1,000-fold reduction in the levels of infectious virus in the lungs of animals with a lethal level of influenza virus infection. These findings corroborate the previously reported findings of both increased animal survival and protection of the lungs from influenza virus tissue damage in FluCide-treated animals in the most recent H1N1 influenza study.
Read more: Treatment with NanoViricides FluCide™ Drug Candidates Resulted in a 1000-fold Reduction of Viral Load in the Lungs of Animals - FiercePharma http://www.fiercepharma.com/press-releases/treatment-nanoviricides-flucide-drug-candidates-resulted-1000-fold-reductio#ixzz2qlrPPmcB
another example:
WEST HAVEN, Conn.--(BUSINESS WIRE)--Nov. 4, 2013-- NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company"), announced today that theDengueCide evaluation contract has been renewed with Dr. Eva Harris’ Laboratory at the University of California, Berkeley, School of Public Health, Division of Infectious Diseases and Vaccinology.
“Our relationship with Dr. Harris and her colleagues is critically important to our development program for DengueCide,” said Eugene Seymour, MD, MPH, CEO of NanoViricides. Dr. Harris has an excellent mouse model of dengue virus infection and disease that the Company used previously to evaluate its anti-dengue agents. In those studies, the nanoviricides® have shown high effectiveness. In Prof. Harris’ model of dengue vascular leak, dengue virus infection of the laboratory mouse strain, AG129, is 100% fatal when the mice are untreated. In contrast, in the same study, animals treated with one of NanoViricides' anti-dengue agents achieved an unprecedented 50% survival rate.
More steps to the upside are here now, and more are coming imho, so if you were thinking of advising friends/family to invest (not trade because that is for the well trained, armed with "tools" and experienced) now is the time because later this year, it is my fervent belief it will become harder for the small investor to accumulate significantly!
I see leifsmith's post. More news are coming!!!
From this point forward, we should see PRs that confirm progress towards Clinical Trials on 4Q 2014. Those PRs will build confidence on investors. Anticipation will build on this road to the Clinical Trials driving the pps higher, in my honest opinion.
Simultaneously testing of the FluCide drug candidates at New Mexico-based Lovelace and the UK Public Health Agency sites should result in a dataset yielding a "high degree of confidence". The FluCide drug has the potential to wipe out virtually all strains of the influenza A virus.
source: http://www.proactiveinvestors.co.uk/companies/news/57646/nanoviricides-flucide-a-potential-cure-for-the-flu-drug-to-enter-human-trials-next-year-57646.html
The BigKahuna at one time alluded to the need to see positive results on PD/PK and the LRRI, as well as UK PHE, will provide those results.
Testing for Influenza at UK PHE
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"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.
NanoViricides’ FluCide: a potential cure for the flu, drug to enter human trials next year
By Deborah Sterescu
June 04 2013, 6:21pm
source: http://www.proactiveinvestors.co.uk/companies/news/57646/nanoviricides-flucide-a-potential-cure-for-the-flu-drug-to-enter-human-trials-next-year-57646.html
The plan is to get the injectable version for critically-ill hospitalized patients through to the FDA drug process first, and then follow up with an application for its oral version – expected to be a much simpler process once the first approval is in hand.
Development-stage NanoViricides (OTCBB:NNVC) has everything it needs to drive shareholder value, with a potential money-maker in its hands in the form of a cure for the common flu. The company is now preparing for toxicology studies for its first FluCide candidate, expected to be wrapped up before the middle of next year.
The drug candidate has the potential to wipe out virtually all strains of the pesky influenza A virus, including the recent H7N9 avian strain that has been plaguing China.
FluCide, which is based on a completely new mechanism of action, is based on the company's nanoviricide technology, the combination of a nanomicelle - a biodegradable, non-toxic polymeric-based structure - that is then attached to a "ligand".
These ligands are designed to mimic the sialic acid receptors, which exist on the surface of the target cell of the virus, to the flu virus. The nanoviricide is then charged with its task of first binding to the virus particle and then spreading onto and over the viral surface, finally encapsulating the entire virus particle.
Once this happens, the virus is incapable of inserting its genetic material into its target cell, meaning it cannot replicate.
Unlike antibodies, the company's nanoviricide agents are designed to perform their antiviral effect even if the immune system is compromised, and can be designed to have as many as 20 or even larger numbers of virus-binding ligands.
NanoViricides, which based on this technology has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, has two FluCide candidates in hand – an injectable and oral version.
The plan is to get the injectable version for critically-ill hospitalized patients through to the FDA drug process first, and then follow up with an application for its oral version – expected to be a much simpler process once the first approval is in hand.
Currently, NanoViricides is working on constructing a production facility in Connecticut, where it can produce its drug candidates under current good manufacturing practice (cGMP) standards. Construction is anticipated to be wrapped up by the end of this year, after which the company will look to commission the plant, and make three batches of material under cGMP conditions.
Once the data from the toxicology and pre-IND studies are in hand as well, the drug developer will then be able to file its investigational new drug (IND) application for the move to the clinical stage.
Talks are underway with different facilities for the clinical trials, with NanoViricides having already inspected three facilities in the U.K., U.S. and in Belgium. The decision will be made on a series of factors including cost of the facility, availability and the cooperation of local governments.
“We’re excited about creating lots of potential cures for different viruses, but we’re focused first on FluCide. Once this is done, a path just opens,” says chief executive Dr. Eugene Seymour, who began practicing medicine in Los Angeles in the 1960s and founded Stat-Sure, which oversaw the development of a rapid HIV antibody blood test in the 1980s. “We have an almost infinite number of viral targets. As fast as Mother Nature throws us the viruses, we can make the drugs,” he adds.
Indeed, the company says it has promising drug candidates for not only the flu, but also against HIV, viral eye diseases, Herpes and Dengue viruses.
According to recent company statements, both drugs in its FluCide program have shown “very high effectiveness” in preclinical animal studies of three "distinctly different" influenza A virus infections, routinely showing superiority to Tamiflu, the current standard of care. Flucide drugs showed complete survival, or 22 plus days, while Tamiflu resulted in only 8 to 9 days of survival, the company has said. Untreated animals died within five days.
“We could have made a drug for the SARS virus in a few weeks using our technology. All I needed was the antibody. Essentially, it’s using the nanomicelle as a missile with the receptor mimic as the “guidance” system," the chief explains.
“We should be able to plug in one mimic after another once our first drug hopefully gets approved by the FDA, with one drug expected to move into the approval stage every six months after the first one is completed.”
He says there has been tremendous activity in the field of nanomedicine recently, specifically in cancer, and as a result anticipates the FDA is cognizant of what the technology entails.
“Everybody is focused on cancer because that’s where the big money is, but I expect the new economic realities of medicine will lean more towards what we’re doing with viruses.”
The company had current assets, including cash, equivalents, collateral advance, and prepaid expenses, of $16.9 million at the end of the first quarter, which it estimates is sufficient to support operations for at least two years as well as the initial human clinical trials of its first FluCide drug candidate.
Finding support for its drug pipeline has so far not been challenging given the current state of capital markets. It raised $6 million from three family offices and a charitable foundation in February, and announced the full retirement of its Series C convertible preferred stock held by Seaside 88.
“We have been quite frugal. As we progress along our path, the value of the company will increase so securing additional financing should not be that difficult . With additional capital, we can advance more drugs into the FDA in a shorter period of time,” says Dr. Seymour.
He makes the point that the materials the company uses are dissolvable and biodegradable unlike other nano-materials that are toxic. “We haven’t had a problem in all the animals we have tested and we have autopsied many of them.
“We’ve got the capital, the people, the facility and the scientific advisory board. Something catastrophic would have to happen to derail us.”
Last week, the company appointed Baylor College of Medicine professor Dr. Milton Boniuk to its board of directors, and recently added Meeta Vyas, credited as being the first Indian woman to be named CEO of a publicly listed U.S. corporation, as its interim CFO.
We are finally on year 2014 and we are headed for the clinical trials 4Q 2014. Have they announced location for Clinical Trials yet? If not, that is a coming PR that demonstrates progress and confidence towards the 4Q 2014 clinical trials.
Simultaneously testing of the FluCide drug candidates at New Mexico-based Lovelace and the UK Public Health Agency sites should result in a dataset yielding a "high degree of confidence". The FluCide drug has the potential to wipe out virtually all strains of the influenza A virus.
Testing for Influenza at UK PHE
"In frenzied excitement he eats up the ground; he paws fiercely, rejoicing in his strength, and charges into the fray, afraid of nothing, when the trumpet sounds." (Job 39: 21-24, New International Version).
NanoViricides, Inc. is not afraid, and neither are we...we are conditioning a FAST TRACK for our "FAST" and rising bionanotech!!!
Sometime ago the BigKahuna said the following:
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.~ BigKahuna
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"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.
Once again, correction...
...look if you are successful you are going to be more than a hundred million dollar market cap ~ Dave Gentry, Red Chip Money Report
Next year's plans include: finishing the plant, completing toxicology studies and submitting paperwork to FDA, while awaiting for permission to start human trials.
source: http://www.marketwired.com/press-release/recap-nanoviricides-inc-ceo-dr-eugene-seymour-clear-channel-business-talk-radio-interview-nyse-mkt-nnvc-1865069.htm
Next year (2014) is now here. Permission from the FDA to start clinical trials should be swift. All we are waiting for now is:
1- Preliminary and final report(s) on BASi's Toxicology and Safety studies (employing Culex Automated In Vivo Sampling System with minimal human intervention. Perform automated blood sampling, automated dosing, microdialysis collection, and more in awake and freely moving animals.)
...look if you are successful you are going to be more than a hundred billion dollar market cap ~ Dave Gentry, Red Chip Money Report
Lets post, lets congratulate those investors vested on sky-rocketing biotechs and then lets invite them to take a look at NanoViricides, Inc. (NNVC). Get their attention, they will come to know and see why we have held to it for so long. There is far more to be realized this year and the next, and the next...if we build that cGMP Pilot Plant (and we have), they will come!!! Clinical Trials 4Q 2014 or 1Q 2015?...Just in time for the next flu season!!!
Many potential catalysts lining up for NNVC SP increase now, I think.
Week of JP Morgan Healthcare conference in San Fran usually causes run up in SP of BioTech stocks.
Dr. Seymour to present at EBD BioTech Showcase conference in San Fran with potential announcements of one or more of the following.
Could announce start of GLP Tox study
- if so, greatly betters chance of FluCide clinical studies this year.
Could announce progress on cGMP pilot manufacturing for clinical study materials.
- if so, checks off one more item for FluCide clinical studies this year.
Could announce scheduling and date set for FluCide efficacy studies in PHE and/or Lovelace.
- if so, also increases odds for Flucide clinical studies this year.
Dr. Seymour and other officers presence at the BioTech Showcase also offers opportunities for networking for potential partnerships with larger companies attending the JPM HC conf - both in San Francisco at the same time.
So traders may just be looking at this as a time with better odds for a nice jump in share price over a short time period...~ robi-1-kenobi
KaBOOM!!! Why is this important?
The stock of a little-known biotech company, Intercept Pharmaceuticals Inc., ICPT +59.89% nearly quadrupled Thursday after the company's liver-disease drug performed well in a clinical trial, marking the biggest one-day stock leap among Nasdaq Composite companies of a similar size since at least 2012.
Shares of New York-based Intercept—which has 45 employees and no products on the market—closed Thursday at $275.87 on the Nasdaq Stock Market, valuing the company at $5.3 billion. On Wednesday, the stock closed at $72.39 with a market capitalization of $1.4 billion.
That's the largest one-day jump among Nasdaq Composite companies with market values of over $1 billion since at least 2012, according to FactSet Research Systems Inc.
The drug, called obeticholic acid, or OCA, mimics a naturally occurring human bile acid that Intercept believes has liver-protective properties. The National Institute of Diabetes and Digestive and Kidney Diseases sponsored a clinical trial of the drug in patients with a condition known as nonalcoholic steatohepatitis, which involves fat accumulation in the liver that can cause inflammation and lead to the more serious conditions of cirrhosis and liver failure. The disease progresses over many years and often has no symptoms in the early stages.
There are no specific therapies for the disease, which affects 2% to 5% of Americans, according to the National Institutes of Health. Instead, physicians often recommend patients lose weight if they are overweight, improve their diets, exercise, and avoid alcohol and unnecessary medications.
source: http://online.wsj.com/news/articles/SB10001424052702304347904579310212798133916
NanoViricides, Inc. is a very frugal company, has 5 employees on the payroll, and is on-track to clinical trials this year (2014) with their first broad-spectrum therapeutic drug for Influenza, FluCide. In the United States, each year on average 5% to 20% of the population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications. Antiviral medicines that are used to treat or prevent the flu include oseltamivir (Tamiflu®) and zanamivir (Relenza®) and they are 40% - 60% effective against the flu. Two other antiviral medicines, rimantadine (Flumadine®) and amantadine (Symmetrel®), were used in the past but are generally no longer effective because most flu viruses are now resistant to them.
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"...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.
KaBOOM!!! Why is this important? Please, consider this...
The stock of a little-known biotech company, Intercept Pharmaceuticals Inc., ICPT +59.89% nearly quadrupled Thursday after the company's liver-disease drug performed well in a clinical trial, marking the biggest one-day stock leap among Nasdaq Composite companies of a similar size since at least 2012.
Shares of New York-based Intercept—which has 45 employees and no products on the market—closed Thursday at $275.87 on the Nasdaq Stock Market, valuing the company at $5.3 billion. On Wednesday, the stock closed at $72.39 with a market capitalization of $1.4 billion.
That's the largest one-day jump among Nasdaq Composite companies with market values of over $1 billion since at least 2012, according to FactSet Research Systems Inc.
The drug, called obeticholic acid, or OCA, mimics a naturally occurring human bile acid that Intercept believes has liver-protective properties. The National Institute of Diabetes and Digestive and Kidney Diseases sponsored a clinical trial of the drug in patients with a condition known as nonalcoholic steatohepatitis, which involves fat accumulation in the liver that can cause inflammation and lead to the more serious conditions of cirrhosis and liver failure. The disease progresses over many years and often has no symptoms in the early stages.
There are no specific therapies for the disease, which affects 2% to 5% of Americans, according to the National Institutes of Health. Instead, physicians often recommend patients lose weight if they are overweight, improve their diets, exercise, and avoid alcohol and unnecessary medications.
source: http://online.wsj.com/news/articles/SB10001424052702304347904579310212798133916
NanoViricides, Inc. is a very frugal company, has 5 employees on the payroll, and is on-track to clinical trials this year (2014) with their first broad-spectrum therapeutic drug against Influenza, FluCide. In the United States, each year on average 5% to 20% of the population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications. Antiviral medicines that are used to treat or prevent the flu include oseltamivir (Tamiflu®) and zanamivir (Relenza®) and they are 40% - 60% effective against the flu. Two other antiviral medicines, rimantadine (Flumadine®) and amantadine (Symmetrel®), were used in the past but are generally no longer effective because most flu viruses are now resistant to them.
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"...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.
The fact that NanoViricides, Inc. has a control program in place at the lab to enable large scale synthesis of FluCide in a reproducible manner makes possible for the company to conduct the additional efficacy studies, as required for the IND application, in parallel with the safety/toxicology studies. Moving along...!!!
...NanoViricides, Inc.'s achievements this past year was, receiving orphan drug designation from the European Union and the US FDA for DengueCide, their drug for Dengue Hemorrhagic Fever, and Dengue. Also starting construction of their high tech, state of the art nano-medicine anti-viral drug manufacturing plant, the only one in the US and possibly the entire world. Next year's plans include: finishing the plant, completing toxicology studies and submitting paperwork to FDA, while awaiting for permission to start human trials.
source: http://www.marketwired.com/press-release/recap-nanoviricides-inc-ceo-dr-eugene-seymour-clear-channel-business-talk-radio-interview-nyse-mkt-nnvc-1865069.htm
Finishing the plant:
NanoViricides, Inc. has assembled a marquee team of experienced personnel to help us with the design, architecture, and engineering of this facility. Mr. Andrew Hahn continues to provide overall stewardship for this project. He was formerly Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his firm, MPH Engineering, LLC (“MPH”), continue to help with the overall project management and design engineering of the laboratory and cGMP pilot production facility. Prior to founding MPH, from 2000 to 2007, Phil Mader served as the Senior Capital Project Manager at Bristol-Myers Squibb Company in Wallingford, CT (“BMS”). He was involved in the design, implementation, and commissioning of various biology and chemistry laboratory projects within budget and in a timely manner. Ms. Kathyann Cowles of ID3A, LLC, serves as the Principal Architect. Ms. Cowles, co-founder of Id3A, has over thirty years of experience as a licensed Architect and Senior Project Manager for diverse and complex design and construction projects in the academic, science, technology, corporate and research sectors.
Completing toxicology studies:
November 13, 2012 07:00 AM Eastern Standard Time
WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTCBB: NNVC) (the "Company") announced today that it has entered into an agreement with Bioanalytical Systems, Inc. (NASDAQ: BASI) to conduct drug development studies required for submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases.
The Company 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.
NNVC might eventually make it standard to have two versions of each Nanoviricide drug: a general use one not targeted to pass the BBB and one that's the same, except targeted to pass the BBB when there were any indications or suspicions that it was needed.~ ZincFinger
Drug Transport to Brain with Targeted Nanoparticles
Nanoparticles are solid colloidal matrix-like particles made of polymers1 or lipids.2 Generally administered by the intravenous route like liposomes, they have been developed for the targeted delivery of therapeutic or imaging agents. Their main advantages over liposomes are the low number of excipients used in their formulations, the simple procedures for preparation, a high physical stability, and the possibility of sustained drug release that may be suitable in the treatment of chronic diseases. Until the mid 1990s, their development as drug carriers was seriously limited by the lack of long-circulating properties.
3 Therefore, in contrast to liposomes and despite the abundance of experimental works and achievements in the field of nanoparticle technology, no nanoparticle-based drug formulation has been marketed so far. Due to their size ranging from 10 to 1000 nm (generally 50–300 nm), and like liposomes, they are unable to diffuse through the blood-brain barrier (BBB) to reach the brain parenchyma. Based on general parenteral formulation considerations and specific BBB features, Table Table 1 summarizes the ideal nanoparticle properties required for drug brain delivery.
4 One particularly interesting application of nanoparticule could be the drug brain delivery, accompanied with the local sustained release, of the new large molecule therapeutics now available to treat the CNS: peptides, proteins, genes, antisense drugs. Due to their poor stability in biological fluids, rapid enzymatic degradation, unfavorable pharmacokinetic properties, and lack of diffusion toward the CNS, they may be advantageously formulated in brain-targeted protective nanocontainers.
5 Compared with conventional drugs, they possess a high intrinsic pharmacological activity. The small dose requested for therapeutic efficiency could easily fit the loading capacity of nanoparticles and would not require the administration of large amount of potentially toxic nanoparticle excipient. Because of the large variety of the nanoparticles developed so far, this review will focus on nanoparticles investigated for brain delivery. Nanoparticles made of polybutylcyanoacrylate (PBCA, FIG. 1) have been intensely investigated since the first papers in 1995 showing that when coated with the nonionic surfactant polysorbate 80 they permitted to deliver drugs to the brain.
6,7 Despite interesting results, PBCA nanoparticles have limitations, discussed in this review, that may preclude, or at least limit, their potential clinical applications. Nanoparticles made of polylactide homopolymers (PLA) or poly(lactide-co-glycolide) heteropolymers (PLGA) may be a promising alternative. In the mid 1990s, long-circulating pegylated PLA or PLGA nanoparticles have been made available that opened great opportunities for drug targeting.3 Pegylated nanoparticles are made of methoxypoly(ethylene glycol)-PLA/PLGA (mPEG-PLA/PLGA, FIG. 1), i.e., esters of PLA or PLGA with PEG of various molecular weights. More recently, the synthesis of functionalized pegylated PLA/PLGA nanoparticles opened new perspectives for targeted drug delivery in general, and for drug brain targeting in particular. This review will present their general properties and will propose preparation methods of brain-targeted pegylated nanoparticles...
TABLE 1.
Ideal Properties of Nanoparticles for Drug Brain Delivery
-Nontoxic, biodegradable, and biocompatible
-Particle diameter < 100 nm
-Physical stability in blood (no aggregation)
-Avoidance of the MPS (no opsonization), prolonged blood circulation time
-BBB-targeted and brain delivery (receptor-mediated transcytosis across brain capillary endothelial cells)
-Scalable and cost-effective manufacturing process
-Amenable to small molecules, peptides, proteins, or nucleic acids
-Minimal nanoparticle excipient-induced drug alteration (chemical degradation/alteration, protein denaturation)
-Possible modulation of drug release profiles
source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC539329/
Yes! In the United States, each year on average 5% to 20% of the population gets the flu and more than 200,000 people are hospitalized from seasonal flu-related complications, this according to CDC stats.
We have read many times on this board that antiviral medicines that are used to treat or prevent the flu include oseltamivir (Tamiflu®) and zanamivir (Relenza®)and they are about 40% - 60% effective. Two other antiviral medicines, rimantadine (Flumadine®) and amantadine (Symmetrel®), were used in the past but are generally no longer effective because most flu viruses are now resistant to them.
Question for the board: Once we move in high-tech computers, and the interfacing equipment/instrumentation, inside the cGMP Pilot Plant, is it possible to get certification by the FDA without producing the (3) identical batches of the FluCide candidate?
I don't doubt at all that today the high-tech computers/software/instrumentation/equipment can produce the (3) identical batches. But, was this capability available 9 years ago, or five years ago? I don't think so, but then, I could be wrong. People talk about slowdowns, maybe that is one reason.
Organized US medicine, and some doctors, will toss aside alternative medicine. Below is the weblink to an excerpt from Eugene D. Weinberg (another Eugene) on "Iron Loading and Disease Surveillance" which I failed linking to previous post.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640766/pdf/10341171.pdf
Today, there is more than one way to protect an important organ like the liver and ZincFinger's described backup plan, if not primary, is a good one.
Correction: We will see an explosion in pps to the upside, or KaBOOM, around first quarter of 2015!!!
About US organized medicine (ahem) and ICPT and NNVC...it is another Puffer-like example (among others) on how these breakthrough technologies can skyrocket in pps with no products in the market!
The stock of a little-known biotech company, Intercept Pharmaceuticals Inc., ICPT +59.89% nearly quadrupled Thursday after the company's liver-disease drug performed well in a clinical trial, marking the biggest one-day stock leap among Nasdaq Composite companies of a similar size since at least 2012.
Shares of New York-based Intercept—which has 45 employees and no products on the market—closed Thursday at $275.87 on the Nasdaq Stock Market, valuing the company at $5.3 billion. On Wednesday, the stock closed at $72.39 with a market capitalization of $1.4 billion.
That's the largest one-day jump among Nasdaq Composite companies with market values of over $1 billion since at least 2012, according to FactSet Research Systems Inc.
The drug, called obeticholic acid, or OCA, mimics a naturally occurring human bile acid that Intercept believes has insert-text-here. The National Institute of Diabetes and Digestive and Kidney Diseases sponsored a clinical trial of the drug in patients with a condition known as nonalcoholic steatohepatitis, which involves fat accumulation in the liver that can cause inflammation and lead to the more serious conditions of cirrhosis and liver failure. The disease progresses over many years and often has no symptoms in the early stages.
There are no specific therapies for the disease, which affects 2% to 5% of Americans, according to the National Institutes of Health. Instead, physicians often recommend patients lose weight if they are overweight, improve their diets, exercise, and avoid alcohol and unnecessary medications.
source: http://online.wsj.com/news/articles/SB10001424052702304347904579310212798133916
NanoViricides, Inc. is being thorough and is on the move!!!
WEST HAVEN, Conn.--(BUSINESS WIRE)--Jul 23, 2012 - NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company's broad-spectrum anti-influenza drug. Australian Biologics will also facilitate clinical trial site(s) selection and development of the clinical trials agreements.
source: http://www.drugs.com/clinical_trials/nanoviricides-retains-consulting-firm-expedite-first-flucide-human-trials-australia-14091.html
Nothing is static in economies and markets. As NanoViricides, Inc. progresses on-track to clinical trials, and progress is communicated via PRs, pps will climb higher. Just like ICPT, first $30 pps and higher, around $70 pps, sounds good, IMHO. We should be given breakthrough technology FAST TRACK (good for flying horses) once the GLP evidence is presented by BASi, in Indiana. We will see an explosion in pps, or KaBOOM. around first quarter of 2014!!! You ain't seen nothing yet!!!...but we will this year and next...and the following years!!!
Many Flu Victims Are Young, Healthy and Vaccinated: Doctors?
http://www.nbcdfw.com/news/health/Many-Flu-Victims-Are-Young-Healthy-and-Vaccinated-Doctors-239311381.html
So that's how it happens...
Intercept stock triples on liver disease study
AP
ICPT - Intercept Pharmaceuticals Inc
Sym Last Chg Pct Volume
ICPT 281.26 +208.87 +288.53% 4,971,892
NEW YORK (AP) — Shares of Intercept Pharmaceuticals more than tripled in value Thursday morning after the company stopped a clinical trial of a liver disease drug early, saying there was clear evidence the treatment worked.
Intercept said a data monitoring board recommended it stop the trial because patients who were being treated with its experimental drug, obeticholic acid, were faring better than patients who took a placebo. Intercept is studying the drug as a treatment for nonalcoholic steatohepatitis.
Nonalcoholic steatohepatitis is a type of chronic liver disease caused by excessive fat accumulation in the liver. It causes inflammation that can cause scarring. The scarring can lead to cirrhosis, liver failure, and death.
Shares of Intercept Pharmaceuticals Inc. surged $190.22 to $262.61 in morning trading and reached a high of $305. The stock closed at $72.39 on Wednesday.
The data monitoring board (I pressume FDA) stopped the clinical trial, saying there was clear evidence the treatment worked...kaboom , ICPT goes "hillbilly"!
FN, daBoze's thought popped into my mind as well when I read the news on ICPT. This is good to keep the health until NanoViricides, Inc. comes out with HCVCide. Also, heed ZincFinger's advice. Find it here...http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93516604
Echo, take a look at daBoze and robi-1-kenobi posts...
In the past NNVC has stated that its viricides have a very long shelf life and can be stored at ambient temperatures.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90422045
2. FluCide will not likely require refrigeration (based on the chemistry and the Jain BioPharma report, below, which I am sure NNVC contributed to).
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93128606
Hi FORZANANO, I hope this new treatment for HCV turns out to be a successful one for your father. Best to you, and your family this 2014, the year of the transformational-technology of NanoViricides, Inc.!
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation,cosmetics, emitting devices (ERED), and veterinary products.
source: wikipedia
There is a lengthy/expensive Development and Approval process for drugs.
Thank you! Just pointing out, again and again, the obvious,we are getting started on the track to FDA review and the market. We moving forward in several fronts and soon enough we will hear good news from several sources.
We are paying expert companies to help us navigate the FDA Development and Approval process. I would not be surprised if identical batches of the FluCide candidate have been shipped to BASi for tox and safety studies. We will soon hear good preliminary results on "tox studies" that once again confirm results from KARD Scientific results on the FluCide candidate.
If toxic Marijuana can bypass all this expensive/lengthy scrutiny by the FDA (pigs are flying), with the blessings of the DOJ, we certainly should request and be given breakthrough technology fast track on the grounds of efficacy, safety and low-toxicity!
What are the long-term effects of weed?
NanoViricides, Inc. is just getting started in its race to market!
NanoViricides Announces Initiation of Toxicology Study of FluCide®
By Business Wire | More Articles
October 7, 2013 | Comments (0)
NanoViricides Announces Initiation of Toxicology Study of FluCide®
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reports that it has initiated the initial non-GLP toxicology evaluation of its optimized injectable FluCide® drug candidate. This study is an important step in the drug development pathway for FluCide. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway.
The non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These IND-enabling GLP safety and toxicology studies will be performed by BASi Toxicology Services in West Lafayette, IN. The Company has previously reported that its FluCide candidate was highly effective in animal models of different influenza A virus strains. In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress.
The Company is considering two separate indications for this injectable FluCide drug. The first is hospitalized patients with severe influenza. In the USA, there are approximately 300,000 severe influenza cases that require hospitalization every year resulting in approximately 40,000 to 50,000 deaths. A pandemic would increase those numbers by an order of magnitude.
There is a well known unmet medical need for treatment of these hospitalized patients as current influenza treatments have limited effectiveness because of the severity of the infection. A highly effective drug should receive rapid widespread acceptance.
The second planned indication would be for outpatients with influenza. The Company is hopeful that the outpatient treatment will likely be a single, small injection, at the first clinical visit with no follow-on treatment needed. During the 2009 H1N1 “swine flu” pandemic, there were approximately 61 million cases of out-patient influenza in the USA alone. A single course treatment for out-patients is a highly sought after goal in influenza therapeutics.
The Company is also developing an oral version of FluCide. The oral FluCide development will follow and benefit from the development of injectable FluCide. When approved, the oral FluCide would replace the injection of FluCide in out-patient cases.
The market size for anti-influenza drugs is currently estimated to be in several billions of dollars worldwide. The Company believes that if its FluCide® drug becomes available, the influenza drug market size could become substantially higher. The market size for over the counter (OTC) medications for control of influenza symptoms alone is approximately $2.1 billion dollars annually in the USA, and about £0.5 billion (about $1 billion) in the UK (source: http://www.mintel.com/press-centre/press-releases/410/consumers-cough-up-for-remedies-as-flu-season-starts-early). Similar large market sizes are reported for other countries across the globe. It is well known that when an effective treatment for a disease becomes available, the market size explodes and the novel effective treatment captures a substantial portion of the market.
About NanoViricides :
NanoViricides, Inc. ( www.nanoviricides.com ) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
source: http://www.fool.com/investing/businesswire/2013/10/07/nanoviricides-announces-initiation-of-toxicology-s.aspx#.Us2E1vutY1c
We are no longer a penny stock and good news, IMHO, are forthcoming!