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Good morning Ms. “the Whale”/All! The only “ultimate public private partnership” I know of, beyond first phase of FDA clinical trials, is Relief Therapeutics (public) and NeuroRx (private). Does anyone know of any other public private partnership beyond first phase FDA clinical trials?
“...this ultimate public private partnership...”~ Rep Andy Harris, Md, Data Monitoring Comittee
You’ve got it badger (mc67). New eyes out there are reading...and when is our partner, Neuro Rx, going public? But, first things ($RLFTF) first!
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Quote ~
Well you know it’s like one of those extraordinary accidents, but some people say chance favors the prepared mind. And believe it or not vasoactive intestinal peptide, which is the active ingredient we’re working with, is a neuro endocrine peptide.~ Dr. Jonathan, Neuro Rx CEO
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158252687
Vasoactive intestinal peptide (VIP) is a basic 28 amino acid peptide that binds to a member of the class II family of G protein-coupled receptors (GPCRs). It is widely expressed throughout the body and plays an important role in numerous biological functions. VIP acts via three different GPCRs: VPAC1, VPAC2, and PAC1, which have been identified in various tissues, including brain, lung, kidney, gastrointestinal tract, tongue, and also on immunocompetent cells such as macrophages and lymphocytes. There is mounting evidence that VIP expression and signaling is altered in numerous neurological disorders, and it is becoming apparent that VIP and its receptors could be therapeutic loci for the treatment of several pathological conditions of the central nervous system. In this review, we describe the pathology of several major neurological disorders and discuss the potential pharmacotherapeutic role of VIP and its receptors for the treatment of disorders such as Alzheimer’s disease, Parkinson’s disease, and Autism Spectrum Disorders. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2967653/
No worries, as long as there is freedom of expression and posters are not violating iHub rules, I will continue to post the $RLFTF positives, “The Searchers “ will post their findings, the “well wishers” will post their best wishes/prayers, and analytical minds will post their analysis.
What part of $RLFTF recent history you don’t like? This part?>>>>>>>>>>>>>>>>>>>>>>>>>>>
NeuroRx CEO Jonathan Javitt commented, “Now that we know VIP suppresses replication of the SARS-CoV-2 virus in human lung cells, based on the outstanding work of the Oswaldo Cruz Institute (Rio de Janeiro). We are optimistic that treatment with VIP will not only help patients on ventilators, but will help to stop the advancement of the virus in patients with earlier stages of COVID-19. By blocking cytokine synthesis in the lung cells and increasing the production of surfactant, which is key to the lung’s ability to transmit oxygen, we are hopeful that inhaled VIP will prove to be of clinical benefit across a wider array of patients suffering respiratory complications from COVID-19 infection.” https://www.oindpnews.com/2020/08/neurorx-gets-clearance-for-clinical-trial-of-inhaled-aviptadil-for-covid-19/
Bought me some more today...
NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that aviptadil can prevent replication of the SARS-CoV-2 virus in human lung cells.
NeuroRx is developing aviptadil for COVID-19 in partnership with Relief Therapeutics, which is also developing RLF-100 for the treatment of pulmonary sarcoidosis and pulmonary hypertension. RLF-100, a synthetic human vasoactive intestinal polypeptide (VIP), has been designated as a Material Threat Medical Countermeasure and has also received Fast Track designation.
According to the companies, the trial will begin around September 1 in hospitalized COVID-19 patients who have severe disease that has not yet progressed to respiratory failure. Depending on the results of that portion of the study, the trial would be expanded to include mild and moderate COVID-19 patients outside of the hospital setting.
NeuroRx CEO Jonathan Javitt commented, “Now that we know VIP suppresses replication of the SARS-CoV-2 virus in human lung cells, based on the outstanding work of the Oswaldo Cruz Institute (Rio de Janeiro). We are optimistic that treatment with VIP will not only help patients on ventilators, but will help to stop the advancement of the virus in patients with earlier stages of COVID-19. By blocking cytokine synthesis in the lung cells and increasing the production of surfactant, which is key to the lung’s ability to transmit oxygen, we are hopeful that inhaled VIP will prove to be of clinical benefit across a wider array of patients suffering respiratory complications from COVID-19 infection.”
https://www.oindpnews.com/2020/08/neurorx-gets-clearance-for-clinical-trial-of-inhaled-aviptadil-for-covid-19/
Facts salad!
VIP has a half life of about 2 minutes in the bloodstream...ok.
Your body has about 5.6 liters (6 quarts) of blood. This 5.6 liters of blood circulates through the body three times every minute. In one day, the blood travels a total of 19,000 km (12,000 miles)—that's four times the distance across the US from coast to coast. ~ PBS, heartfacts
CDC Study Puts Economic Burden of Asthma at More Than $80 Billion Per Year. Asthma costs the U.S. economy more than $80 billion annually in medical expenses, days missed from work and school, and deaths, according to research published online in the Annals of the American Thoracic Society.
~AJMC
Acquisition?? Possible this early??
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4 little words that mean so much! When Dr. Javitt said, "So, you know, we’re wondering, are we seeing the world’s biggest placebo effect, or are we really on to something", I took it to be a statement more so than a question. In other words, "world's biggest placebo effect" tells me everything I need to know about what he believes is true and that really is "THE" 64 million-dollar question for all of us longs. Either this trial is going to set the Guinness world record for placebo effect after all of these amazing patient improvements or they actually have an effective therapeutic for covid and just need to prove it further for the FDA.
Which do you think is more likely? This sets a new world record out of all the hundreds of thousands of trials or it gets approved?
My $ stays on RLFTF.~ from Pcilliterate post
A growing body of experimental evidence indicates that surfactant dysfunction may contribute to the airway obstruction of asthma. In fact, guinea pigs sensitized with ovalbumin and then challenged by aerosol exhibit altered performance of surfactant (2). Similarly, lung lavage fluid and sputum of patients with allergic asthma contain a surfactant with decreased surface activity (3, 4). Leakage of plasma proteins into the airways appears to play a fundamental role in surfactant inactivation (3, 5). Other invoked mechanisms include increased hydrolysis of surfactant phospholipids (6) and decreased synthesis of hydrophobic surfactant proteins (7).
https://www.atsjournals.org/doi/full/10.1164/rccm.2312019
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Surfactant and allergic airway inflammation
https://smw.ch/article/doi/smw.2013.13818
Besides the disease burden, COPD is also associated with substantial economic costs. In the European Union, the total direct costs for COPD are estimated to be about 3% (€38.6 billion) of the total health care budget
https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-019-1179-7
Cigarette smoke is an important risk factor for COPD and it is known to adversely affect surfactant. In a series of 20 smoker, non-asthmatic COPD patients compared with 5 nonsmoker healthy controls we found a marked decrease (about 6-7 times) of total phospholipids in bronchoalveolar lavage fluids.
https://www.karger.com/Article/PDF/196100
Think that RLFTF will help alleviate this condition?
The study is posted at https://clinicaltrials.gov/ct2/show/NCT04360096 . The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure. If promising results are seen in the inpatient setting, the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the need for hospital admission.
https://news.yahoo.com/fda-grants-inhaled-ind-rlf-053000458.html
The ACE2 expression in human heart indicates new potential mechanism of heart injury among patients infected with SARS-CoV-2
Liang Chen, Xiangjie Li, Mingquan Chen, Yi Feng, Chenglong Xiong Author Notes>>>>>>>>>>>>>>>>>>
Cardiovascular Research, Volume 116, Issue 6, 1 May 2020, Pages 1097–1100, https://doi.org/10.1093/cvr/cvaa078
Published: 30 March 2020>>>>>>>>
Abstract>>>>>>>>>>>>>>>>>>>>>>
A new type of pneumonia caused by a novel coronavirus SARS-CoV-2 outbreaks recently in China and spreads into many other countries. This disease, named as COVID-19, is similar to patients infected by SARS-CoV and MERS-CoV, and nearly 20% of patients developed severe condition. Cardiac injury is a prevalent complication of severe patients, exacerbating the disease severity in coronavirus disease 2019 (COVID-19) patients. Angiotensin-converting enzyme 2 (ACE2), the key host cellular receptor of SARS-CoV-2, has been identified in multiple organs, but its cellular distribution in human heart is not illuminated clearly. This study performed the first state-of-art single cell atlas of adult human heart, and revealed that pericytes with high expression of ACE2 might act as the target cardiac cell of SARS-CoV-2. The pericytes injury due to virus infection may result in capillary endothelial cells dysfunction, inducing microvascular dysfunction. And patients with basic heart failure disease showed increased ACE2 expression at both mRNA and protein levels, meaning that if infected by the virus these patients may have higher risk of heart attack and critically ill condition. The finding of this study explains the high rate of severe cases among COVID-19 patients with basic cardiovascular disease; and these results also perhaps provide important reference to clinical treatment of cardiac injury among severe patients infected by SARS-CoV-2. https://academic.oup.com/cardiovascres/article/116/6/1097/5813131
BUDAPEST, Hungary (AP) — The number of new confirmed coronavirus cases spiked Friday in parts of eastern Europe, with Hungary and the Czech Republic registering all-time daily highs. Signs of the pandemic's resurgence were also evident in Britain and the Netherlands.
Hungarian Prime Minister Viktor Orban said his government was drafting a “war plan” to defend against the second wave of the pandemic. The plan's aim was “not for everyone to stay at home and bring the country to a halt ... but to defend Hungary’s functionality," Orban said.
The prime minister said measures meant to protect the economy and spur growth would be introduced in the coming weeks. In the second quarter of the year, Hungary's gross domestic product fell 13.6%, the worst drop in the region.
Orban reiterated the need to protect the elderly, one of the group's most at-risk during the pandemic, and authorities have banned most visits to retirement homes and hospitals to stem the spread of the virus.
Expanded access, sometimes called "compassionate use," is the use of an investigational medicine (i.e., one that has not been approved by Food and Drug Administration (FDA)) by a patient who cannot be enrolled in a clinical trial.
https://www.boehringer-ingelheim.us/innovation/clinical-trials/expanded-access-program
The fireman’s event was outside clinical trial (act of compassion) and not part of the clinical trial data deemed so important by Guilles Della Corte, MD and Relief Therapeutics Holding SA.
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Multinational Randomized Clinical Trials (MRCTs) are challenging
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But, despite the challenge, the need to conduct clinical research internationally is stronger than ever
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The increasing shift from expert opinion towards evidence-based medicine enhances the importance of MRCTs
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In addition, the demand of Health Authorities (HAs) for high quality data is also increasing, leading to favor MRCTs
https://www.academia.edu/33494364/PITFALLS_in_MULTINATIONAL_CLINICAL_TRIALS_pptx
PennyWorld, I posted this tip to get the ball rolling. Hopefully someone on this board is more savvy and can post a better tip than mine. Have a good day!
——-
There are high float and low float stocks. That can and does affect the price movement of a stock. If you're learning how to invest in the stock market with little money than float can be highly effective.
My preference is low float stocks (sub 10 million) for scalping stocks using hotkeys. I typically only hold for a few candle's because the bid ask spread is usually wide and I need to get in and out quick. I watch the volume and the price action and trade quickly.
Again, the price of the stock can change .40 cents in a few seconds, so you need to be quick. I use hotkeys on CMEG to day trade which is a customized version of DAS Trader and has no PDT rule.
Penny stocks are well known for doing this. Go and check a penny stock chart after a public offering. Here's another example below of OTlK's offering.
https://bullishbears.com/what-does-float-mean-in-stocks/
Benzinga Pro offers a Screener tool to find float. You can set parameters and filter for what you’re looking for such as:
-Specific dollar amount
-Float
-Float percentage
-Volume
-Shares outstanding
And so much more
There is an option to save the parameters you’ve chosen so it’s easily accessible for the next time.
https://pro.benzinga.com/blog/how-to-find-low-float-stocks/
Extracorporeal membrane oxygenation (ECMO) is a life support technique used in patients with respiratory and/or cardiac failure. The ECMO circuit consists of vascular cannulae, a pump and an artificial lung. Infections are among the most common complications associated with ECMO and have a significant impact on the mortality rate. Here we present a narrative literature review regarding the epidemiology, risk factors, pathogenesis and prevention of infectious complications during ECMO support. The prevalence of hospital-acquired infections during ECMO is 10-12% and their occurrence is likely to be more frequent compared with other critically ill patients. Coagulase-negative staphylococci, Candida spp., Enterobacteriaceae and Pseudomonas aeruginosa are the most frequently involved pathogens.
https://pubmed.ncbi.nlm.nih.gov/28528989/
Who picked that winner without mortality benefit at the tune of $70 million? Can we name him, her, them?
A clinical trial sponsored by the National Institutes of Health found that the drug shortens recovery times for many Covid-19 patients. However, remdesivir has not yet been proven to reduce mortality—to save lives. While the NIH trial found a numerical improvement in survival, the difference did not reach conventional thresholds of statistical significance or certainty; and a smaller study published in the Lancet also did not find an improvement in mortality. If remdesivir does not offer a mortality benefit, then the Institute for Clinical and Economic Review—an independent drug-pricing watchdog—puts the “value-based price benchmark” for the drug at $310 per treatment course. That’s about one-tenth its current price. Even if a mortality benefit from remdesivir were eventually confirmed, ICER pegs its value-based price at $2,500 to $2,800 per course, still 10 to 20 percent lower than what we pay right now.
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What about the cost of investment—does Gilead need to charge $3,120 for remdesivir to make up for all the time and money that the firm put into it? Even if it were appropriate to set a price based on a sunk cost—and most economists would argue that it’s not—remdesivir’s development has been buoyed by incredible amounts of government investment. The 2015 paper detailing the discovery of remdesivir was the product of a public-private partnership between scientists from Gilead, the US Army Medical Research Institute of Infectious Diseases, and the US Centers of Disease Control and Prevention; yet government employees were excluded from the molecule’s patent. Financially, remdesivir’s development has been directly supported by at least $70 million of taxpayer money—including funding for its initial discovery, studies of its effects on coronaviruses, and its Covid-19 clinical trials. Investment in remdesivir hasn’t been Gilead’s alone, and the drug’s price should accordingly reflect the contributions of taxpayer funds that offset the costs of its development and commercialization.~Wired
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Wired on Remdesivir...
<p>Remdesivir certainly has value, but the data right now supports a price lower than what its maker, Gilead Sciences, Inc., is charging. A clinical trial sponsored by the National Institutes of Health found that the drug shortens recovery times for many Covid-19 patients. However, remdesivir has not yet been proven to reduce mortality—to save lives. While the NIH trial found a numerical improvement in survival, the difference did not reach conventional thresholds of statistical significance or certainty; and a smaller study published in the Lancet also did not find an improvement in mortality. If remdesivir does not offer a mortality benefit, then the Institute for Clinical and Economic Review—an independent drug-pricing watchdog—puts the “value-based price benchmark” for the drug at $310 per treatment course. That’s about one-tenth its current price. Even if a mortality benefit from remdesivir were eventually confirmed, ICER pegs its value-based price at $2,500 to $2,800 per course, still 10 to 20 percent lower than what we pay right now.</p>
https://www.wired.com/story/the-us-is-paying-way-too-much-for-remdesivir/
EMCO
The ECMO team can decrease support even more or take away ECMO for minutes or hours to see if the patient needs to stay on ECMO.
You will hear the ECMO team talk about a “trial off.” The nursing staff will draw frequent labs to see how your loved one is doing. If everything looks good, the ECMO team will talk about removing ECMO.
If the test shows us the patient needs more time on ECMO, we can put them back on ECMO support. The medical team taking care of your loved one will walk you through what they are looking for each day.
Having issues with laptop and network device(s). Will reply asap. I do enjoy opportunities to speculate.
Thanks for the "How to" article. Ironically it is the musings of the CEO himself that are finding their way here, so I don't think complaining about them to him would accomplish much.
Besides, the NNVC CEO's words are frequently very interesting and he has provided much entertainment while occasionally finding a way to be his own worst enemy. Ain't no way I'm gonna complain about that, especially since I'm only here for the entertainment value.
If there's actually an "NNVC insider posting on the NNVC board", I don't know who it is. Do you know of one?
Influenza is among the nine deadliest viruses in the world.
During a typical flu season, up to 500,000 people worldwide will die from the illness, according to WHO. But occasionally, when a new flu strain emerges, a pandemic results with a faster spread of disease and, often, higher mortality rates.
The most deadly flu pandemic, sometimes called the Spanish flu, began in 1918 and sickened up to 40 percent of the world's population, killing an estimated 50 million people.
"I think that it is possible that something like the 1918 flu outbreak could occur again," Muhlberger said. "If a new influenza strain found its way in the human population,and could be transmitted easily between humans, and caused severe illness, we would have a big problem."
http://www.livescience.com/48386-deadliest-viruses-on-earth.html
NanoViricides President Dr. Diwan Presented FluCide Data at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
WEST HAVEN, CONNECTICUT -- Monday, July 14, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company's first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company's current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicate that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company's new facility capable of cGMP production of all of the Company's nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and "bird flu" such as H5N1.
The total market size addressed by the Company's current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Do you know of an NNVC insider posting on the NNVC board? Write an open letter to the CEO! Do it from Seeking Alpha! Here are some guidelines to help you out!
How to Write an Effective Complaint Letter to a CEO
By Ruth Mayhew
The adage about the squeaky wheel is often true when you want to resolve an issue where you've received poor service or a defective product. If you attempted to resolve your dissatisfaction with the store manager or customer service representatives, consider writing a letter to the company's CEO -- the chief executive officer. Taking time to write a letter that states your concerns, along with information that substantiates your claim, can work to your advantage.
Other People Are Reading
Gather all the information possible about your complaint. That can include previous correspondence with customer service representatives, payment records and evidence of a deficient product, poor service or other proof that substantiates your claim. Assemble your documents and information in chronological order to illustrate the period from when you first experienced the deficiency to the present.
Draft a chronology of events. If necessary, begin your chronology from the time you first subscribed to the service or initially purchased the product. Include pertinent information such as dates of service, product description, model and serial numbers. Refine your draft with specific information that asserts your right to a replacement product or repair service. For example, if you have experienced poor home telephone service, gather information about when you previously reported the service as well as technicians who attempted to repair your telephone service.
Research the company, including the specific product or service. Access online resources for user-generated information about satisfied and dissatisfied customers. Review their complaints and the course of action they followed to resolve their issues. Obtain information about the company from business databases and clearinghouses such as the Better Business Bureau. Depending on the industry, contact government resources for information on how to lodge a complaint. For example, the Federal Trade Commission is a resource for individuals with complaints against businesses.
Write the body of your letter, beginning with an introduction. Explain that you're writing to the CEO because you did not receive a satisfactory response from your previous contact with customer service or another representative of the company. Compose a pleasant introduction, free from sarcasm and anger. The best way to resolve matters is through cooperation, but sarcastic wit or letters written in a condescending manner will not receive the positive response you're seeking.
Insert your chronology. If necessary, pare down the details in your letter to maintain just the essential points. Your letter should also indicate you have additional information that you will gladly share in a telephone conversation or subsequent communication. Express your interest in resolving the matter as quickly as possible so as not to take up unnecessary resources. Include contact information and your availability for a telephone call or face-to-face meeting. Dispatch your letter or e-mail and retain a copy for your personal files.
Read more : http://www.ehow.com/how_8147371_write-effective-complaint-letter-ceo.html
His buys are costing him nothing out of pocket. All he's doing is investing the interest payments he is getting as a result of the ridiculous sweetheart deal he got on his Debentures. So he may be watching the price dropping on the shares he's bought but it's virtually painless for him. ~ loanranger
Wednesday, 12/10/14 --- Those that proposed that the Doctor's recent purchase of 50,000 shares stood as a symbol of his confidence in the company now need to consider what his sale of a multiple of that amount might mean. Seriously, I think his recent purchase was meant to mitigate against any questions that these sales might raise. ~ loanranger
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
When insider(s)/investor(s) buy, buy, buy...yes, we should pay attention and join! Do you have information that supports the idea Dr. Milton Boniuk is just throwing good money after bad? Who, Pump Terminator and his minimum wage crew? A hunch? We know who Ben McClure is but, who is Pump Terminator? In my view, his/her/their blog provided the "go-ahead" signal for the "bear attack" NanoViricides, Inc. CEO referred to in his letter to shareholder but again, Dr. Milton Boniuk, an independent director/insider, an astute/highly successful businessman, an entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator, buys repeatedly and confidently.
http://ih.advfn.com/p.php?pid=nmona&article=68529003
http://ih.advfn.com/p.php?pid=nmona&article=68325023
http://ih.advfn.com/p.php?pid=nmona&article=68296181
Why is it you can give a positive opinion about the impartiality of the "loanranger" poster but never ask him about Dr. Boniuk's NNVC stock sale, a sale that never came to past!?!
Wednesday, 12/10/14 --- Those that proposed that the Doctor's recent purchase of 50,000 shares stood as a symbol of his confidence in the company now need to consider what his sale of a multiple of that amount might mean. Seriously, I think his recent purchase was meant to mitigate against any questions that these sales might raise. ~ loanranger
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
Red flag: Insiders aren't buying stocks
The stock market is having a terrific week. Momentum is giddy, except for this: the best informed people aren't buying stocks.
Smart investors keep an eye on what the so-called "insiders" are doing -- the CEOs, directors and company founders.
Typically, when the stock market tanks like it did in late August and September, top management will jump at the opportunity to buy cheap stock. It's the ultimate sign of confidence they believe better days are ahead.
But that's not what's happening.
"I've been very surprised," says David Santschi, CEO of TrimTabs Investment Research. "We were looking for a big pick up in insider buying. We didn't see it."
Enthusiasm from insiders has evaporated as the market dropped. It's a cautionary sign.
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http://money.cnn.com/2015/10/09/investing/insiders-are-not-buying-stocks/index.html
Enter Dr. Milton Boniuk, an independent director/insider, an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator...
NanoViricides Reports that its Director, Milton Boniuk, MD, Has Invested a Total of $7M in the Company this Year
By Business Wire |
September 17, 2013
NanoViricides Reports that its Director, Milton Boniuk, MD, Has Invested a Total of $7M in the Company this Year
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB:NNVCD) (the "Company") reported today that Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, and a Director of the Company has invested a total of $7 Million in the Company during the 2013 calendar year. Dr. Boniuk was the single largest investor with $3 Million in the recently concluded registered direct offering. Previously, he had invested $4 Million in the Company’s convertible debenture financing concluded in February, 2013. Professor Boniuk has also invested in the Company in earlier rounds of financing. He made these investments both personally as well as from his charitable foundation and other interests. Professor Boniuk joined the Company’s Board as an independent director in May, 2013, at the request of the Company’s executives. He says that his confidence in the Company has only continued to grow as he sees the Company’s management and execution now from a closer perspective.
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"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
If we have a similar platform technology (to destroy viruses) to that of BIND Therapeutics (for cancer), we may be using similar, if not the same source, for specialized/high tech equipment/instruments.
BIND Therapeutics has the patented Accurins(R) and NanoViricides Inc, has the patented nanoviricides(R).
BIND History
BIND Therapeutics was launched in 2007 as BIND Biosciences with the vision of revolutionizing the treatment of life-threatening diseases through the application of nanotechnology.
After two decades of research at MIT in the area of biomaterials and nanoparticle engineering, a number of critical technologies converged in the laboratory of Professor Robert Langer that would enable the development of therapeutic polymeric nanoparticles. Building on this convergence, Professor Omid Farokhzad of Harvard Medical School began collaborating with Professor Langer to apply combinatorial strategies to develop targeted nanoparticles for specific therapeutic applications.
This research, conducted in collaboration with the Koch Institute at MIT and Brigham and Women's Hospital-Harvard Medical School resulted in a the development of the Medicinal Nanoengineering platform, which enables the identification of the precise characteristics of an optimally engineered targeted nanoparticle for clinical applications. BIND Therapeutics was cofounded by Drs. Langer and Farokhzad for the purpose of developing and commercializing innovative and impactful pharmaceutical products based on the medicinal nanoengineering platform.
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www.bindtherapeutics.com/about/history.html
Microfluidic Platform for Combinatorial Synthesis and Optimization of Targeted Nanoparticles for Cancer Therapy (2013)
Taking a nanoparticle (NP) from discovery to clinical translation has been slow compared to small molecules, in part by the lack of systems that enable their precise engineering and rapid optimization. In this work we have developed a microfluidic platform for the rapid, combinatorial synthesis and optimization of NPs. The system takes in a number of NP precursors from which a library of NPs with varying size, surface charge, target ligand density, and drug load is produced in a reproducible manner. We rapidly synthesized 45 different formulations of poly(lactic-co-glycolic acid)-b-poly(ethylene glycol) NPs of different size and surface composition, and screened and ranked the NPs for their ability to evade macrophage uptake in vitro. Comparison of the results to pharmacokinetic studies in vivo in mice revealed a correlation between in vitro screen and in vivo behavior. Next, we selected NP synthesis parameters that resulted in longer blood half-life and used the microfluidic platform to synthesize targeted NPs with varying targeting ligand density (using a model targeting ligand against cancer cells). We screened NPs in vitro against prostate cancer cells as well as macrophages, identifying one formulation that exhibited high uptake by cancer cells yet similar macrophage uptake compared to non-targeted NPs. In vivo, the selected targeted NPs showed a 3.5-fold increase in tumor accumulation in mice compared to non-targeted NPs. The developed microfluidic platform in this work represents a tool that could potentially accelerate the discovery and clinical translation of NPs.
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We reported a new microfluidic platform for the rapid, combinatorial synthesis of targeted polymeric NPs. It was first demonstrated that NPs with a wide range of properties can be generated by making a small library comprised of NPs with size from 25-200 nm, zeta potential from -20 to +20 mV, ligand density from 0 to ~105 ligands/µm2, and drug loading from 0 to 5%. Subsequently, we showed the rapid NP development capabilities of the system by synthesizing 45 NP formulations of different sizes and PEG coverage, and screened them against macrophage uptake in vitro. Finally we investigated the relation between in vitro macrophage uptake and in vivo pharmacokinetics, where low macrophage uptake correlated with longer circulation time. Building upon the in vitro macrophage uptake screen, we synthesized and screened targeted NPs to identify a formulation that maximized specific uptake in vitro while minimizing macrophage uptake. We also investigated the tumor accumulation of TNPs versus NT-NPs of essentially identical biophysicochemical properties, where the TNPs showed 3.5-fold accumulation in tumor versus non-targeted ones. Three key advantages of our system over existing bulk synthesis include (i) from a small set of NP precursors one can rapidly synthesize a NP library with a wide range of distinct physicochemical properties; (ii) the NPs prepared have high batch-to-batch reproducibility; (iii) NPs can be prepared at different scales (e.g. microgram versus milligram) without varying substantially the NP properties. These advantages allow for both in vitro and in vivo screening with the goals of either accelerating the clinical translation of a specific formulation or obtaining deeper fundamental understanding on the correlation of NP properties and biological behavior.
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www.ncbi.nlm.nih.gov/pmc/articles/PMC3963607/
April 22, 2015
BIND Therapeutics Presents Data Highlighting Ability of Accurins to Control Biodistribution and Accumulate in Target Tissue at AACR Annual Meeting 2015
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CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, today announced that clinical and preclinical data from its oncology pipeline, including proprietary and collaboration programs, were presented at the American Association of Cancer Research (AACR) Annual Meeting 2015. The presentations include data from the Company's lead proprietary Accurin drug candidate, BIND-014, and the Accurin drug candidate AZD2811, which is being developed in collaboration with AstraZeneca.
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In a poster entitled, "Imaging Accurin-AZD1152 hQPA nanoparticle accumulation in pre-clinical tumours," data were presented that show the Accurin nanoparticle AZD2811 accumulates in tumors and achieves prolonged tumor drug exposure. This is the first time distribution of nanoparticles in tumors has been demonstrated.
-Imaging mass spectrometry analysis demonstrated that Accurin nanoparticle AZD2811 accumulates in preclinical tumor models and confirmed that the Accurin accesses the tumor and provides prolonged drug exposure and retention in the target tissue.
-Multiple imaging techniques demonstrated Accurin nanoparticle AZD2811 is still detected at nine days after nanoparticle administration, while no drug was detected 24 hours after the prodrug AZD1152 was administered.
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http://ir.bindtherapeutics.com/releasedetail.cfm?ReleaseID=907878
...about two months later...
June 23, 2015
BIND Therapeutics Announces FDA Authorization of First-in-Human Clinical Trial with AstraZeneca's Aurora B Kinase Inhibitor Accurin AZD2811
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- Collaboration with AstraZeneca results in second Accurin candidate to enter clinical development -
- Promising AZD2811 Data Demonstrating Tumor Growth Inhibition and Prolonged Drug Exposure Recently Presented at 2015 American Association of Cancer Research (AACR) Annual Meeting -
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called Accurins™, today announced that the U.S. Food and Drug Administration (FDA) has authorized the use of AstraZeneca's Accurin AZD2811 in clinical trials under an investigational new drug (IND) application. BIND is collaborating with AstraZeneca on the development of AZD2811, an Aurora B Kinase inhibitor that has been shown to be active in both solid and hematological tumors in preclinical models, and the companies anticipate enrolling patients in a phase 1 clinical trial with AZD2811 in the fourth quarter of this year. BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD2811.
Preclinical data on AZD2811 were presented at the 2015 American Association of Cancer Research (AACR) annual meeting in April 2015, including data demonstrating promising in vivo and in vitro tumor growth inhibition as monotherapy in models of diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC). Additional data showed that AZD2811 delivers prolonged exposure to active drug while having the potential to adapt the dosing regimen, potentially achieving an improved therapeutic index. In addition, using mass spectrometric imaging, AZD2811 was shown to accumulate in tumors and achieve prolonged tumor drug exposure. This represents the first time distribution of nanoparticles in tumors has been demonstrated. Previously, preclinical tumor model data were presented showing that AZD2811 minimizes the bone marrow toxicity seen with the parent compound, which has limited the clinical utility of Aurora B kinase inhibitors as a class.
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BIND and AstraZeneca expect to enroll the first patient in a phase 1 clinical trial with AZD2811 in the fourth quarter of 2015. Under terms of the collaboration, AstraZeneca is responsible for clinical development and commercialization and BIND is responsible for conducting clinical manufacturing through at least the end of phase 2 clinical trials.
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ir.bindtherapeutics.com/releasedetail.cfm?ReleaseID=919006
About BIND Therapeutics factsheet:
»We design combinatorial libraries of targeted nanoparticles with precise and systematically varied biophysicochemical properties such as particle size, surface properties, ligand density, API load and release profile, using a unique self-assembly nanoparticle fabrication process to optimize each product-for example, to balance circulation time with effective targeting and binding for a
particular cell or tissue target.
»We engineer product candidates with optimal performance properties using an iterative process that includes in vitro drug release and cell binding along with in vivo PK, tolerability, biodistribution, targeting, and efficacy studies.
»We manufacture candidate Accurins from gram-scale laboratory experiments through kilogram-scale GMP clinical batches using robust, reproducible, and scalable processes
www.bindtherapeutics.com/pdfs/BINDfactsheet.pdf
Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study.(2014)
Abstract
Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.
FROM THE CLINICAL EDITOR:
Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness.
www.ncbi.nlm.nih.gov/pubmed/23969105
Optimizing the discovery and clinical translation of nanoparticles: could microfluidics hold the key?
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Since the first demonstration of a liposomal drug carrier in 1970s [1], tremendous efforts have been directed at developing nanoparticle (NP) platforms for therapy and diagnosis of major diseases. A few US FDA-approved NPs have emerged, including liposome-based Doxil and albumin-based Abraxane for chemotherapy, and iron oxide NPs Feridex and Resovist for MRI [2,3]. Several other NP platforms are in clinical trials, including a targeted polymeric NP for treatment of prostate cancer [2–4]. Yet, there exist major bottlenecks that retard discovery and clinical translation of NPs [2–3,5]. First, rational design of NPs is nontrivial because of limited knowledge of how the physicochemical properties of NPs correlate with in vivo behavior. Therefore, current technology for optimization of NPs requires intensive in vitro and in vivo screening. Second, conventional batch-type bulk reactors are limited in their ability to reproducibly prepare high-quality NPs while tuning their physicochemical properties. Third, in vitro screens do not adequately model in vivo environments, considerably increasing the cost of in vivo screening.
In the past decade, the intersection of nanomedicine and the rapidly growing field of microfluidics – the science and technology of manipulating nanoliter to picoliter volumes of fluids in microscale channels [6] – has provided fresh approaches to tackle these challenges [5]. Microfluidic systems enable precise control of microscale environments, which finds use in chemical synthesis, chemical and biomolecular analysis, tissue engineering, and other applications. Now, microfluidics is playing a key role in synthesis and screening of NPs and in elucidating the interaction of NPs with cells and tissues, promising to accelerate the clinical translation of NPs [5].
The first major application of microfluidics for nanomedicine was for improving the quality of NPs though control of the reaction environment [5,7–8]. Microfluidic reactors enable rapid mixing of reagents, control of temperature, and precise spatiotemporal manipulation of reactions that are difficult, if not impossible, in larger reactors [7,9]. For example, amphiphilic molecules self-assemble into NPs by mixing with a nonsolvent in a process known as nanoprecipitation [2,5]. In this process, mixing time has a strong influence on the average NP size and the size distribution. In conventional bulk synthesis methods, mixing is heterogeneous and typically occurs on a time scale longer than the characteristic time scale for self-assembly, which results in large and polydisperse NPs. Controlled and homogeneous mixing in microfluidic synthesis methods results in smaller and uniform NPs [5,8]. Microfluidic control of reactions on the millisecond timescale has also enabled rapid nucleation followed by controlled growth and rapid quenching, leading to the synthesis of various inorganic NPs with improved spectral response for imaging applications [7,9]. This fine spatiotemporal control was achieved by using monodisperse droplets that serve as identical microscale reactors [9]. Droplets can be generated, combined, mixed and split in a controlled manner using microfluidic units. Since the reaction time of reagents directly correlates to residence time of the droplet in microchannel, it can be precisely controlled by tuning the residence time in a reaction area (e.g., heating zone) [10] or by adding a quenching agent at precise downstream locations [11]. Although microfluidics typically deals with small volumes, parallelized and high-throughput micro/millifluidic systems have also been developed to enable synthesis of high-quality NPs at larger scales [12–14]. Unlike batch reactors that require process optimization for scale-up, microfluidic devices typically operate in continuous process mode and do not require intensive process optimization for larger-scale production. These developments in synthesis and scale-up make a strong headway towards addressing the need for improved quality and consistency of NPs.
Microfluidics also enables precise and reproducible manipulation of the physicochemical properties of NPs, opening new avenues for high-throughput combinatorial NP synthesis and screening. For example, Chen et al. prepared a library of siRNA-containing lipid NPs with different chemical structures using a microchannel with groove structures for rapid and effective mixing of reagents [15]. This approach enabled in vitro and in vivo screening of lipid NP-mediated siRNA delivery to discover optimal lipids for silencing factor VII expression in mouse liver. Valencia et al. developed a microfluidic platform for rapid, combinatorial synthesis of a library of polymeric NPs by combining a multi-inlet micromixer for premixing NP precursors in a specified ratio and a downstream mixing unit for rapid nanoprecipitation [16]. Using high-throughput screening, this combinatorial synthesis method identified a targeted NP formulation that exhibited enhanced tumor accumulation in a mouse model of prostate cancer compared with an otherwise identical nontargeted NP. These results illustrate the potential of high-throughput microfluidic synthesis and screening to reduce costs by consuming smaller volumes of reagents while exploring a large parameter space of the physicochemical properties of NPs.
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http://www.futuremedicine.com/doi/full/10.2217/nnm.14.73
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NanoViricides President Dr. Diwan Presented FluCide Data at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
WEST HAVEN, CONNECTICUT -- Monday, July 14, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company's first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company's current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicate that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company's new facility capable of cGMP production of all of the Company's nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and "bird flu" such as H5N1.
The total market size addressed by the Company's current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
NanoViricides recently received an important international award, the "IAIR Award 2014 for Leadership in Nanomedicines in the North American Sector".
The Company currently has approximately $41 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
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"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 number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.
In Iowa, one of the largest U.S. egg processors has started to buy foreign supplies for the first time. Elsewhere in the Midwest, a free-range egg producer says it may build automatic car washes to scour vehicles accessing its 60 farms. And nationally, agricultural workers are being urged to get flu shots.
Less than six months after the country’s worst-ever outbreak of avian influenza killed 48 million birds and cost taxpayers almost $1 billion, the American poultry industry is remaking itself to prepare for the likely return of the disease. The virus thrives in chilly weather and is carried across the country by wild birds that are just now beginning to migrate south.
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http://www.claimsjournal.com/news/national/2015/10/05/266119.htm
Report finds $1.2 billion in Iowa avian flu damage
Iowa took an economic hit of about $1.2 billion stemming from the death of more than 30 million hens and 1.5 million turkeys because of avian flu this past spring, according to a report commissioned by the Iowa Farm Bureau Federation (IFBF) released yesterday.
In addition, H5 avian flu affected thousands of poultry in multiple outbreaks in both Palestine and Nigeria.
Iowa study: 8,400 jobs lost
The Iowa study, conducted by Decision Innovation Solutions of Urbandale, Iowa, found that the avian flu outbreaks around the state—mostly caused by H5N2—resulted in 8,444 lost jobs, many of which will not be recovered.
It also noted an impact of $427 million in lost wages in addition to the jobs lost, as well as about $145 million in lost taxes. The firm estimated the total economic loss at $1.2 billion. The outbreaks affected the egg, chicken, and turkey industries in the state.
In May, Minnesota and Iowa experts put the total loss for the two states at around $1 billion, but several H5N2 outbreaks occurred in both states after that. Minnesota lost more than 9 million poultry to the virus, mostly turkeys. Nationwide, about 50 million birds died because of the outbreaks.
"Many layer operations affected by the outbreak expect to take 18-24 months before reaching pre-outbreak production levels," the report said. "Egg producers able to sell eggs, as well as consumers, can expect to be in an elevated price environment for at least the next 6-9 months. Turkey producers are predicted to be out of production for approximately 30 weeks."
"It's really astounding that we could lose half of our poultry flock in a couple of months," said Dave Miller, the IFBF's director of research and commodity services, according to a Des Moines Register story yesterday. "Recovery from this outbreak, which devastated Iowa egg and poultry farms, will not be swift."
The report concludes, "In addition to the lost revenue to producers, [highly pathogenic avian flu] also has many other adverse consequences on economic activity up and downstream such as lost business for feed suppliers, veterinarians, transportation, financial institutions, and decreases in government tax revenues."
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http://www.cidrap.umn.edu/news-perspective/2015/08/report-finds-12-billion-iowa-avian-flu-damage
Bird flu vaccine, under development, divides U.S. poultry industry
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Many countries have a strict policy of refusing to accept meat from nations using a vaccine because it can be difficult to discern through testing whether birds were infected with an active virus or were vaccinated, said James Sumner, president of the USA Poultry & Egg Export Council.
Even during the current outbreak which affected 15 states, about 10 trade partners banned poultry imports from the entire U.S., Sumner said.
Vilsack said it's uncertain when a vaccine would be ready for large-scale production. Even once stockpiled, a vaccination program would not begin until the USDA, consulting with affected states, decided it was necessary to control an outbreak.
http://www.cbsnews.com/news/bird-flu-vaccine-developed-for-chickens/
About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. 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...
"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 number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.
Hold your horses "Wild Bill",...news flash!
This technology works and has been proven over and over!
NanoViricides Reports that the Dramatic Effects of Its Topical Anti-Herpes Treatment were Reproduced Once Again in an Animal Model in a Different Laboratory
SHELTON, CONNECTICUT -- Monday, August 10, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions ("TransPharm"), a pre-clinical services company in Jackson, MI.
All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading. All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
Some of the nanoviricides found effective in the previous study were tested in this study for the confirmation of efficacy in a dermal animal model in Balb-c mice using the same highly aggressive and neurotropic HSV-1 strain H129c, which was used previously.
The earlier studies were performed in the laboratory of Dr. Ken S. Rosenthal at Northeast Ohio Medical University where Dr. Rosenthal continued as a Professor Emeritus. He is a leading researcher in herpes virus anti-viral agents and vaccines.
In the previous study, two of the anti-Herpes nanoviricides® reduced the extent of disease (morbidity) and mortality of the HSV-1 infected animals that were treated. These nanoviricides also reduced virus production in cell culture. Importantly, topical dermal treatment with these nanoviricides led to almost complete (>85%) survival of the infected mice in this animal model whereas all untreated animals died of the disease. Further, these nanoviricides were superior to topical treatment with an acyclovir formulation employed as a positive control. The Company reported on these studies in April, 2015.
Professor Rosenthal consulted with NanoViricides and TransPharm for the establishment of the animal model for dermal HSV-1 infection using the HSV-1 strain H129c at the TransPharm laboratories.
Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.
About Dr. Rosenthal
Dr. Rosenthal is now Professor at the Roseman University of Health Sciences College of Medicine, NV. He continues as Professor Emeritus at Northeast Ohio Medical University (NEOMED), after retiring in December 2014. He is a leading researcher in the field of herpes viruses, antiviral drugs and vaccines. His research interests encompass several aspects of how herpes simplex virus (HSV) interacts with the host to cause disease. His research has addressed how HSV infects skin cells and examined viral properties that facilitate its virulence and ability to cause encephalitis. He is also researching how the human host immune response works against HSV for the development of protective and therapeutic vaccines.
About TransPharm
Transpharm Preclinical Solutions offer numerous types of studies for testing antimicrobials, antivirals, antifungals, antiparasitics, along with newer therapies using antibodies. TransPharm's scientists' skill set covers a broad range of Research and Development. This allows us to offer numerous services upon request. We have many strategic alliances along the Biotechnology Corridor which allows us to offer a wide variety of services.
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NanoViricides President Dr. Diwan Presented FluCide Data at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
WEST HAVEN, CONNECTICUT -- Monday, July 14, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company's first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company's current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicate that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company's new facility capable of cGMP production of all of the Company's nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and "bird flu" such as H5N1.
The total market size addressed by the Company's current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
NanoViricides recently received an important international award, the "IAIR Award 2014 for Leadership in Nanomedicines in the North American Sector".
The Company currently has approximately $41 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
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Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
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Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
Enter Dr. Milton Boniuk (2013)...
NanoViricides Appoints Baylor Professor Dr. Milton Boniuk as an Independent Board Member
WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has appointed Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, as an independent member of the Company’s Board of Directors.
Dr. Boniuk is an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator. Currently, he is the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX. He conducts a busy clinical practice in orbital surgery, eyelid reconstruction, ocular oncology and comprehensive ophthalmology. Additionally, he plays a major role in Baylor’s resident and fellow medical doctor education programs.
Dr. Boniuk has been a long term investor and strong supporter of NanoViricides, Inc.
“Milton’s strong business acumen, integrity, and professional expertise will be of great help in strengthening our corporate governance as well as fostering our drug development activities,” said Eugene Seymour, MD, MPH, CEO of the Company.
Dr. Boniuk has made significant contributions in cataract surgery, glaucoma, corneal dystrophies, retinal diseases and surgery. He is a nationally and internationally recognized expert in the pathology and surgical management of orbital and intra-ocular tumors. His description of the ocular pathology of the congenital rubella syndrome in 1967 was a landmark publication. Of note, Dr. Boniuk has made substantial medical contributions in areas that are of great significance to the Company, such as ocular adenoviral infections, that cause epidemic kerato-conjunctivitis (EKC). The Company has developed a drug candidate for EKC infection that was successfully tested in rabbits. These animals serve as a surrogate for the viral disease in human eyes.
“Dr. Boniuk brings a unique set of skills to the Board of NanoViricides, Inc.,” said Anil R. Diwan, PhD, President of the Company, adding, “He shares our enthusiasm for the novel biomimetic nanoviricides® technologies and the resulting anti-viral drugs. In addition to strengthening our corporate governance, he will be of great value in progressing our drug development programs into the clinic.”
Dr. Boniuk is also well known for his philanthropic endeavors. He and his wife Laurie founded the National Society for Parent and Child Development in 1989. In 1994, he established the Lions Eye Bank Foundation’s Milton Boniuk, M.D., Endowment Fund to support resident research in the Ophthalmology Department at Baylor. In 2004, Milton and Laurie Boniuk contributed $5 million to Rice University to establish the Boniuk Center for the Study and Advancement of Religious Tolerance. In 2013, they gave an additional $28.5M to Rice University to upgrade this Center to The Boniuk Institute for the Study and Advancement of Religious Tolerance. The Boniuk Institute will conduct research, public outreach and educational programming. Its mission is to foster multidisciplinary research that leads to innovative ways to understand and achieve religious tolerance.
Dr. Boniuk earned his MD at the Dalhousie University, Halifax, Nova Scotia, Canada, followed by an internship at the Victoria General Hospital, Halifax, Nova Scotia, Canada, and Residency at the Center for Ophthalmology, Jefferson Medical College - Wills Eye Hospital, Philadelphia, PA. In addition, he served a Fellowship in Ophthalmic Pathology at the world-renowned Armed Forces Institute of Pathology, Washington, DC.
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Those that proposed that the Doctor's recent purchase of 50,000 shares stood as a symbol of his confidence in the company now need to consider what his sale of a multiple of that amount might mean. Seriously, I think his recent purchase was meant to mitigate against any questions that these sales might raise. ~ loanranger (2014)
All three of the above patents were granted during the last 9 months and assigned to Kineta, Inc. (Seattle, WA). Is Nanoviricide's FluCide™ the Binding Site Mimetic referred to in those patents or are they referring to some other FluCide ~ loanranger
"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
The NanoViricides, Inc. PR clearly indicates they follow advice from the company, at the time, Australian Biologics. I quickly researched and provided an article with a link. From the article I underlined the following:
...The Company has engaged Australian Biologics to study and develop a roadmap for conducting certain Phase 1 and Phase 2 human clinical studies in Australia....
NanoViricides Accelerates its Herpes Drug Development Program
SHELTON, CONNECTICUT -- Monday, August 17, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide™ drug development program.
The Company will continue to develop its anti-herpesvirus franchise in parallel with the development of FluCide™, its anti-influenza drug candidate. The Company believes that drug development of the external treatments for the different herpes virus infections, such as topical skin creams or lotions for the treatment of herpes lesions, or shingles rash, as well as eye drops or gels for the treatment of herpes keratitis, are likely to require significantly less development work compared to the development of an injectable drug.
Biologics Consulting Group, Inc., a leading FDA regulatory consultant, is advising the Company on drug approval pathways and regulatory strategy.
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
Opinion of an anonymous poster. What can I say,...weak? Just because other companies don't divide Safety/Tox Studies/GLP in phases does not mean it cannot be done? or do you have evidence to the contrary?
Here are the facts:
NanoViricides Retains a Consulting Firm to Expedite First FluCide™ Human Trials in Australia
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NanoViricides, Inc. (OTC BB:) (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.
The Company believes that it will have the capability for producing drugs suitable for human clinical trials when renovation of the new facility in Shelton is completed. In parallel, the Company continues to pursue appropriate human clinical study pathways for its highly effective anti-influenza drug candidate, NV-INF-1, in the FluCide™ program. The Company has engaged Australian Biologics to study and develop a roadmap for conducting certain Phase 1 and Phase 2 human clinical studies in Australia.
NV-INF-1 has been shown to be highly effective in controlling influenza viral infection in lethal infection mouse model. Animals survived for full duration of the study (21 days) when treated with NV-INF-1 on alternate days. In contrast, oseltamivir-treated animals (40mg/kg given every day) survived for only 8 days. Untreated animals survive only 5 days in this highly lethal influenza infection model. The Company has previously reported that depending upon the treatment protocol, NV-INF-1 has shown viral load reduction of 1.3 logs to 3 logs in these various studies. In contrast, oseltamivir (Tamiflu®) treatment in the same studies has resulted in viral load reductions of only about 0.2 logs to 0.8 logs. Further, the lung damage caused by the influenza virus infection is also substantially reduced upon FluCide treatment as compared to oseltamivir treatment. Our data indicate that NV-INF-1 is significantly more effective compared to the standard-of-care drug for influenza, viz. oseltamivir.
The Company believes, based on our animal studies data, that NV-INF-1 may be the most effective anti-influenza drug currently in development.
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.
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Since its founding in 2003, NexBio has received at least $73 million in grants and contracts from the National Institutes of Health to develop and test Fludase, according to agency records and a 2009 report from the San Diego industry group Biocom.
After operating solely with government funding, the company in recent years tried to raise money from investors. It isn't clear whether those efforts were successful.
Company officials did not respond to several telephone and email messages.
"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus [3].
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
...
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
NanoViricides Appoints Baylor Professor Dr. Milton Boniuk as an Independent Board Member
WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has appointed Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, as an independent member of the Company’s Board of Directors.
Dr. Boniuk is an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator. Currently, he is the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX. He conducts a busy clinical practice in orbital surgery, eyelid reconstruction, ocular oncology and comprehensive ophthalmology. Additionally, he plays a major role in Baylor’s resident and fellow medical doctor education programs.
Dr. Boniuk has been a long term investor and strong supporter of NanoViricides, Inc.
“Milton’s strong business acumen, integrity, and professional expertise will be of great help in strengthening our corporate governance as well as fostering our drug development activities,” said Eugene Seymour, MD, MPH, CEO of the Company.
Dr. Boniuk has made significant contributions in cataract surgery, glaucoma, corneal dystrophies, retinal diseases and surgery. He is a nationally and internationally recognized expert in the pathology and surgical management of orbital and intra-ocular tumors. His description of the ocular pathology of the congenital rubella syndrome in 1967 was a landmark publication. Of note, Dr. Boniuk has made substantial medical contributions in areas that are of great significance to the Company, such as ocular adenoviral infections, that cause epidemic kerato-conjunctivitis (EKC). The Company has developed a drug candidate for EKC infection that was successfully tested in rabbits. These animals serve as a surrogate for the viral disease in human eyes.
“Dr. Boniuk brings a unique set of skills to the Board of NanoViricides, Inc.,” said Anil R. Diwan, PhD, President of the Company, adding, “He shares our enthusiasm for the novel biomimetic nanoviricides® technologies and the resulting anti-viral drugs. In addition to strengthening our corporate governance, he will be of great value in progressing our drug development programs into the clinic.”
Dr. Boniuk is also well known for his philanthropic endeavors. He and his wife Laurie founded the National Society for Parent and Child Development in 1989. In 1994, he established the Lions Eye Bank Foundation’s Milton Boniuk, M.D., Endowment Fund to support resident research in the Ophthalmology Department at Baylor. In 2004, Milton and Laurie Boniuk contributed $5 million to Rice University to establish the Boniuk Center for the Study and Advancement of Religious Tolerance. In 2013, they gave an additional $28.5M to Rice University to upgrade this Center to The Boniuk Institute for the Study and Advancement of Religious Tolerance. The Boniuk Institute will conduct research, public outreach and educational programming. Its mission is to foster multidisciplinary research that leads to innovative ways to understand and achieve religious tolerance.
Dr. Boniuk earned his MD at the Dalhousie University, Halifax, Nova Scotia, Canada, followed by an internship at the Victoria General Hospital, Halifax, Nova Scotia, Canada, and Residency at the Center for Ophthalmology, Jefferson Medical College - Wills Eye Hospital, Philadelphia, PA. In addition, he served a Fellowship in Ophthalmic Pathology at the world-renowned Armed Forces Institute of Pathology, Washington, DC.
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Dude...seriously, we have FluCide(TM)advancing from Phase 1 and Phase 2 of Safety/Toxicology Studies, there is no effective treatment out there for the shingles and we are accelerating development of topical HerpesCide(TM). Our nanomedicines go after the virus in the host, not to enhance the host's immune system which other drugs in the market are not very effective doing. Take a look at the Herpes video:
NanoViricides Reports that the Dramatic Effects of Its Topical Anti-Herpes Treatment were Reproduced Once Again in an Animal Model in a Different Laboratory
SHELTON, CONNECTICUT -- Monday, August 10, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions ("TransPharm"), a pre-clinical services company in Jackson, MI.
All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading.
All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
Some of the nanoviricides found effective in the previous study were tested in this study for the confirmation of efficacy in a dermal animal model in Balb-c mice using the same highly aggressive and neurotropic HSV-1 strain H129c, which was used previously.
The earlier studies were performed in the laboratory of Dr. Ken S. Rosenthal at Northeast Ohio Medical University where Dr. Rosenthal continued as a Professor Emeritus. He is a leading researcher in herpes virus anti-viral agents and vaccines.
In the previous study, two of the anti-Herpes nanoviricides® reduced the extent of disease (morbidity) and mortality of the HSV-1 infected animals that were treated. These nanoviricides also reduced virus production in cell culture. Importantly, topical dermal treatment with these nanoviricides led to almost complete (>85%) survival of the infected mice in this animal model whereas all untreated animals died of the disease. Further, these nanoviricides were superior to topical treatment with an acyclovir formulation employed as a positive control. The Company reported on these studies in April, 2015.
Professor Rosenthal consulted with NanoViricides and TransPharm for the establishment of the animal model for dermal HSV-1 infection using the HSV-1 strain H129c at the TransPharm laboratories.
Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.
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On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide(TM), and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch.
Drug substance is a pure material which exerts a pharmacological action while Drug product is a finished end product which may contain one or more drug substances in combination with excipients meant for use by humans and animals ~ posted by meghana
NanoViricides Accelerates its Herpes Drug Development Program
SHELTON, CONNECTICUT -- Monday, August 17, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide™ drug development program.
The Company will continue to develop its anti-herpesvirus franchise in parallel with the development of FluCide™, its anti-influenza drug candidate. The Company believes that drug development of the external treatments for the different herpes virus infections, such as topical skin creams or lotions for the treatment of herpes lesions, or shingles rash, as well as eye drops or gels for the treatment of herpes keratitis, are likely to require significantly less development work compared to the development of an injectable drug.
Biologics Consulting Group, Inc., a leading FDA regulatory consultant, is advising the Company on drug approval pathways and regulatory strategy.
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Bird Flu Vaccine Conditionally Approved, but Still Can’t Be Sold
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“U.S.D.A. has said no vaccine is to be used for highly pathenogenic avian influenza,” said Joel Harris, vice president for sales and marketing at Harrisvaccines, which was founded by his father, Dr. Hank Harris. “What this license does is that if they allow a vaccine to be used, we would immediately have a U.S.D.A.-licensed product available for producers.”
The H5N2 strain of avian influenza that did most of the damage in the spring is extremely virulent, moving from one or two birds to entire flocks within 24 to 48 hours. It is believed to have been spread by wild birds migrating north, and poultry and egg producers have been concerned that birds will bring it or another equally devastating strain back with them as they begin their migration south this winter.
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Harrisvaccines is continuing to test the efficacy of the vaccine, with one trial with turkeys underway and other planned for testing on adult hens and day-old chicks. Mr. Harris said the biggest drawback so far is that the vaccine must be injected, which is logistically complicated in operations involving tens and even hundreds of thousands of birds.
http://www.nytimes.com/2015/09/22/business/bird-flu-vaccine-conditionally-approved-but-still-cant-be-sold.html
It is possible that once NanoViricides, Inc. ships samples of FluCide(TM) to BASi for third and final phase of Safety/Toxicology Studies, the H5N2 strain may be among those used for additional efficacy studies, required to ascertain the broadspectrum nature of the drug candidate.
The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broadspectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an Investigational New Drug” application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced. However, certain international regulatory agencies do not require cGMP product, but rather cGMP-like product. The difference is subtle, but can make a difference of several months. We plan on taking advantage of this and try to request permission for human clinical trials abroad soon after we can make cGMP-compliant product in the new facility.
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Unlike the dishonorable actions of sociopaths like John Dillinger and Pump Terminator...
In two days NNVC rose from $1.02 to a $1.55, that is a 50% move to the upside, on no material news! As we all know, NNVC is a small float stock. Just imagine what will happen on positive material news!
"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
NanoViricides Reports that its Director, Milton Boniuk, MD, has invested a Total of $7M in the Company this year
WEST HAVEN, CONNECTICUT -- Tuesday, September 17th, 2013 -- NanoViricides, Inc. (OTC BB: NNVCD) (the "Company") reported today that Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, and a Director of the Company has invested a total of $7 Million in the Company during the 2013 calendar year. Dr. Boniuk was the single largest investor with $3 Million in the recently concluded registered direct offering. Previously, he had invested $4 Million in the Company’s convertible debenture financing concluded in February, 2013. Professor Boniuk has also invested in the Company in earlier rounds of financing. He made these investments both personally as well as from his charitable foundation and other interests. Professor Boniuk joined the Company’s Board as an independent director in May, 2013, at the request of the Company’s executives. He says that his confidence in the Company has only continued to grow as he sees the Company’s management and execution now from a closer perspective.
When asked why he has made these investments, he explained that “As I became familiar with the technology and the various on-going programs that the Company has, it became apparent that the potential was nothing short of amazing. Dr. Diwan explained to me how it would be possible to create a novel drug against a previously unknown virus in a matter of weeks. The NanoViricides team has demonstrated this capability by creating potential drug candidates for the MERS human Coronavirus in just a few weeks. I was impressed by the business acumen of the senior management as demonstrated by their ability to bring in six commercially important drug candidates in the Company’s pipeline, in a relatively short time frame. I was also impressed by their receiving orphan drug designation for the dengue/dengue hemorrhagic fever drug candidate, the interest shown by the British Government Agency in a collaboration on MERS and H7N9, as well as the progress they’ve made in the construction of the new R&D and cGMP pilot production facility. Although I have known Dr. Seymour professionally for many years, I was introduced to the Company by my sister, Vivien Boniuk, MD, also an ophthalmologist, who had performed the animal studies on the Company’s drug candidates for adenovirus and herpes virus infections of the eye.”
The Company further reports that Dr. Vivien Boniuk was the very first investor in the Company, and has continued to be a major investor all along.
Cox also highlights some of the reasons why NNVC's moving forward to date has been such a seemingly long, slow, slog. Mostly Cox attributes this to the fact that the nano-medicine platform that NNVC is using is extremely novel, and because of that, each step forward is basically breaking new ground. ~ drkazmd65
Nanomedicines is upgrading the means, but does not change the primary goal, of medicine, which remains the care of patients. Nanomedicine may grant us the ability to conquer some diseases and for others reduce more effectively their human injury. Some problems will be solved; some new problems will be created. The most efficient nanorobots, however, can neither conquer the curse of human frailty, nor compel physicians to care. Once that is acknowledged, we will have much for which to be thankful and much to which to look forward. ~ Nanoscale: Issues and Perspectives for the Nano Century edited by Nigel Cameron, M. Ellen Mitchell
And the last great lesson is humility before the unsolved problems of the universe. ~ Sir William Osler
...In addition, we continue to perform step-wise scale up of production to enable multi-kg batches of our injectable anti-Influenza drug candidate for IND-enabling “Tox Package” studies. These studies are estimated to require up to 2.5 kg of the drug substance. We plan on scaling up from the 200g scale to 500g scale and then to 1kg scale. We may be able to combine several batches at either the 500g scale or at the 1 kg scale, provided that they are sufficiently equivalent in the characterization studies, in order to prepare a single master batch for further Tox Package studies. In the meantime, we have already performed preliminary safety/toxicology studies in rats using 200g material produced in our older R&D facilities in West Haven, CT. These studies have demonstrated excellent safety of FluCide. Previously, we have performed preliminary safety studies in mice as well. Those studies demonstrated excellent safety of FluCide. This led to the calculation of a very large quantity for our ensuing “Tox Package” studies for this drug candidate.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
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Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.
Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.
The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.
Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible.
Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna
SHELTON, Conn., Aug. 10, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reports that the dramatic improvements in clinical symptoms associated with herpes simplex virus infection were reproduced in an animal model in a different laboratory. These studies were performed by TransPharm Preclinical Solutions ("TransPharm"), a pre-clinical services company in Jackson, MI.
All of the nanoviricides® tested improved clinical scores dramatically, with clinical presentation being arrested at redness or simply raised local lesions, and a complete absence of zosteriform spreading. All of the nanoviricides treated animals survived the lethal HSV-1 infection challenge for the duration of the study while untreated animals died towards the end of the study. These nanoviricides are designed as topical treatment for the breakout of herpes sores.
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Existing therapies against HSV include acyclovir and drugs chemically related to it. These drugs must be taken orally or by injection and are not very effective as topical agents. Other drugs are largely ineffective. Currently, there is no cure for any of the herpesvirus infections.
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Two of our drug programs, namely Injectable FluCide, and HerpeCide skin cream, are now in the late pre-clinical or IND-enabling studies stage. We anticipate that these drug candidates will move forward into IND or equivalent regulatory filings, and ensuing human clinical trials. As these drug candidates are advancing into the clinic, we believe that our additional drug candidates will also move forward into IND-enabling studies. The HerpeCide program is likely to expand into multiple indications that include skin cream or lotion for treatment of cold sores, skin cream for the treatment of genital herpes lesions, skin cream or lotion for the treatment of shingles breakouts, and ocular herpes keratitis, to name a few. We are thus poised for strong growth with a number of drug candidates in a number of disease indications.
Eye Herpes (Ocular Herpes)
By Jessica Hill
Caused by the type 1 herpes simplex virus, eye herpes (ocular herpes) is a common, recurrent viral infection affecting the eyes. This type of herpes virus can cause inflammation and scarring of the cornea that sometimes is referred to as a cold sore on the eye. Herpes of the eye can be transmitted through close contact with an infected person whose virus is active.
The National Eye Institute (NEI) says an estimated 400,000 Americans have experienced some form of ocular herpes, with close to 50,000 new and recurring cases occurring each year.
"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.
"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus [3].
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
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.
.
Eugene Seymour MD MPH
Chief Executive Officer NanoViricides, Inc eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
NanoViricides Appoints Baylor Professor Dr. Milton Boniuk as an Independent Board Member
WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has appointed Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, as an independent member of the Company’s Board of Directors.
Dr. Boniuk is an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator. Currently, he is the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX. He conducts a busy clinical practice in orbital surgery, eyelid reconstruction, ocular oncology and comprehensive ophthalmology. Additionally, he plays a major role in Baylor’s resident and fellow medical doctor education programs.
Dr. Boniuk has been a long term investor and strong supporter of NanoViricides, Inc.
“Milton’s strong business acumen, integrity, and professional expertise will be of great help in strengthening our corporate governance as well as fostering our drug development activities,” said Eugene Seymour, MD, MPH, CEO of the Company.
Dr. Boniuk has made significant contributions in cataract surgery, glaucoma, corneal dystrophies, retinal diseases and surgery. He is a nationally and internationally recognized expert in the pathology and surgical management of orbital and intra-ocular tumors. His description of the ocular pathology of the congenital rubella syndrome in 1967 was a landmark publication. Of note, Dr. Boniuk has made substantial medical contributions in areas that are of great significance to the Company, such as ocular adenoviral infections, that cause epidemic kerato-conjunctivitis (EKC). The Company has developed a drug candidate for EKC infection that was successfully tested in rabbits. These animals serve as a surrogate for the viral disease in human eyes.
“Dr. Boniuk brings a unique set of skills to the Board of NanoViricides, Inc.,” said Anil R. Diwan, PhD, President of the Company, adding, “He shares our enthusiasm for the novel biomimetic nanoviricides® technologies and the resulting anti-viral drugs. In addition to strengthening our corporate governance, he will be of great value in progressing our drug development programs into the clinic.”
Dr. Boniuk is also well known for his philanthropic endeavors. He and his wife Laurie founded the National Society for Parent and Child Development in 1989. In 1994, he established the Lions Eye Bank Foundation’s Milton Boniuk, M.D., Endowment Fund to support resident research in the Ophthalmology Department at Baylor. In 2004, Milton and Laurie Boniuk contributed $5 million to Rice University to establish the Boniuk Center for the Study and Advancement of Religious Tolerance. In 2013, they gave an additional $28.5M to Rice University to upgrade this Center to The Boniuk Institute for the Study and Advancement of Religious Tolerance. The Boniuk Institute will conduct research, public outreach and educational programming. Its mission is to foster multidisciplinary research that leads to innovative ways to understand and achieve religious tolerance.
Dr. Boniuk earned his MD at the Dalhousie University, Halifax, Nova Scotia, Canada, followed by an internship at the Victoria General Hospital, Halifax, Nova Scotia, Canada, and Residency at the Center for Ophthalmology, Jefferson Medical College - Wills Eye Hospital, Philadelphia, PA. In addition, he served a Fellowship in Ophthalmic Pathology at the world-renowned Armed Forces Institute of Pathology, Washington, DC. ...
PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.
Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.
The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.
Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible.
Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.
You mean like Rawnoc's touted marvel drug Fludase!?! Preclinical done quickly, in one fell swoop!
NexBio...
-A small-biotech that is privately-held
-with Fludase(TM) a first-in-class Influenza drug
-government begins to grease skids for the small-biotech, Aug 8, 2005?
-a 50m contract with the NIH, fast-tracked
Why would a privately-held company, that seemingly has everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?
Since its founding in 2003, NexBio has received at least $73 million in grants and contracts from the National Institutes of Health to develop and test Fludase, according to agency records and a 2009 report from the San Diego industry group Biocom.
After operating solely with government funding, the company in recent years tried to raise money from investors. It isn't clear whether those efforts were successful.
Company officials did not respond to several telephone and email messages.
NanoViricides Reports FluCide™ Samples Were Shipped To BASi For Start of Safety/Toxicology Studies
WEST HAVEN, CONNECTICUT -- Wednesday, October 1, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reports that it has shipped FluCide™ to BASi for the start of toxicology studies. NanoViricides has chosen BioAnalytical Systems Inc. Toxicology Services ("BASi") of West Lafayette, Indiana to perform our safety/toxicology studies as needed for an IND submission of the Injectable FluCide drug candidate.
...In addition, we continue to perform step-wise scale up of production to enable multi-kg batches of our injectable anti-Influenza drug candidate for IND-enabling “Tox Package” studies. These studies are estimated to require up to 2.5 kg of the drug substance. We plan on scaling up from the 200g scale to 500g scale and then to 1kg scale. We may be able to combine several batches at either the 500g scale or at the 1 kg scale, provided that they are sufficiently equivalent in the characterization studies, in order to prepare a single master batch for further Tox Package studies. In the meantime, we have already performed preliminary safety/toxicology studies in rats using 200g material produced in our older R&D facilities in West Haven, CT. These studies have demonstrated excellent safety of FluCide. Previously, we have performed preliminary safety studies in mice as well. Those studies demonstrated excellent safety of FluCide. This led to the calculation of a very large quantity for our ensuing “Tox Package” studies for this drug candidate.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
.
.
.
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Recent “Bear” Attack
As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.