A sign of a (stock)tsunami is that the water(stock nav) rushes away from the shore, then comes back to higher levels...That is the first indication and then, the water begins rising fast taking out everything in its path. Stay short and ignore the signs of the coming tsunami, at to your own peril.
Your fact is only half of a fact! I have owned-up to the following:
April 16, 2014: "The Company also reported that it is producing Injectable FluCide(TM), our most advanced drug candidate, at its existing facilities, in the large quantity needed for the Safety and Toxicology ("Tox Package") study. The strong safety observed in preliminary safety studies resulted in requirement of a very large quantity for the Tox Package study. Notably, the drug candidate was found to be safe even at the maximum feasible dosage level in a small animal study. The Company reports that it has successfully scaled up the production of injectable FluCide at its current facility."
Why dwell on the Apr 6, 2014 PR? Is that your job? More PRs came after that one, consistent with scale-up studies! Why? Our small company will not be afforded any shortcuts by the Federal Agencies that impose rules/requirements on small companies like NanoViricides, Inc., with First-in-Class drugs. In addition, before the Apr 16, 2014 PR, we read Mar 2014 CEO letter...
In the calendar year 2013 we have successfully achieved several important milestones. We completed the non-GLP toxicology studies for FluCide with an excellent safety demonstration. In spite of being given the MFD (maximum feasible dose based on volume and concentration), in small animals, we found absolutely no evidence of adverse events. The MFD was estimated to be hundreds of times the therapeutic dose. We started the scale-up and characterization studies for FluCide in our existing laboratories while waiting for the new facility to come online, and this process is progressing satisfactorily.
The CEO letter 2014, the Apr 6, 2014 and following PRs clearly state that 2014 was practically all about scale-up studies, and it all started at the old lab/existing facilities. You can thank the FDA for that.
Your referenced "juiced-up" competition, Ansun BioPharma (NexBio) Fludase is a First-in-Class drug, is it not? (Note: More than half (51%) of the NMEs approved in CY 2012 (20 of 39) were identified by FDA as First-in-Class, meaning drugs which, for example, use a new and unique mechanism of action for treating a medical condition.) Point this forum to the FDA pre clinical tox studies for NexBio - Fludase requirement to find the Maximum Feasible Dose or Toxic Dose. You should know this, should you not? Why not ask "Pumpy Terminator"/cabal, they should know about this.
NanoViricides, Inc. FluCide(TM), a First-in-Class drug as well, was required by the FDA to find the Maximum Feasible Dose, was it not? Knowing what we know about PEG + ligands, etc., where is the sense of proportionality in the FDA - U.S. Federal Agency requirements? Is it a "Yes we can" criteria? Moreover, the NIH has being funding NexBio, since its founding in 2003, to the tune of $73 million!!!
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
Here is what we and the FDA should know about PEG :
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.
Where again is FDA's requirement for Ansun BioPharma (NexBio) Fludase, a First-in-Class drug, to conduct toxicology studies using MFD or to find the toxic dose? Why did your referenced "juiced up" competition defrauded de American Taxpayer funded NIH - U.S. Federal Agency?
Is NanoViricides, Inc. drug FluCide(TM) delayed? Compared to what other company with the same technology??? We have First-in-Class drugs.
There are those who complain that the tox studies are delayed. I don’t believe that it is the case at all. Had our drug system not produced such amazing initial tox results, we would be well into the BASi studies at this time. The FDA mandates that we find the toxic dose. To do that requires an inordinate amount of material. When the amount of material needed is produced, the studies will start. I feel that it will be quite soon but I cannot, in good conscience, give a hard date.
Reiterating, what everyone should know about your "juiced-up" competition...
-A small-biotech that is privately-held -with Fludase a first-in-class Influenza drug -skids begin to get greased, for the small-biotech, Aug 8, 2005 -a 50m contract with the NIH, fast-tracked -Why would a privately-held company, that seems to have 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.
-If they had gone public in 2003 (or 2004) they would have likely taken off at the news they were funded by the NIH and crashed at the news that Ansun Biopharma had to pay $2 million for grant fraud and later on dismiss the CEO and his entire board of directors.
What do I take from all these news on Ansun Biopharma (NexBio) competition? NanoViricides, Inc. should receive north of $73 million from the NIH after Phase I clinical trials because, fair is fair! or better than that, poster "looneyforms - Dr Boniuk is selling NNVC shares???" will explain in detail, what criteria is employed by a Federal Agency like the National Institutes of Health (NIH) to award grants to any given company? Is that the "Yes we can" criteria or where is it written/printed?
Here is the FluCide(TM) preclinical data to help out:
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.
NanoViricides, Inc. is no longer releasing news about "scale-up studies" and it is because... -we are done with scale-up studies, we have the 1Kg scale-up recipe for FluCide(TM) -we commissioned the new state-of-the-art multi-kilogram Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in early Jan 2015 -Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide, 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. -We are now making the FluCide(TM) material for Phase III in large animals!
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
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
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The beleaguered United States of America/taxpayers have an $18+ trillion dollar national debt, growing at the speed of compound interest on the debt, with federal unfunded liabilities exceeding $127 trillion and some still feel the urge to defraud?!?
