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This is the #1 place to discuss Nanoviricides. I'm a professional investor. I can't find people where I work (Wall Street community) who know anything about this company. So I move Mohammed to the mountain. Here to trade, learn, and then trade some more.
So you're helping prove my point, which is mice were never used and even today are very rarely thought of as useful for antiviral development. This is not a controversial topic.
Anyone can find one paper from a company no one has ever heard of. I'm talking about the last 5 decades of antiviral development. There is a difference. There is someone out there who thinks antihistamines work for Alzheimer's disease and has published experiments to prove so. It doesn't mean they do. A sucker is born every...?
Thanks. After all that you can admit your error. You might as well apologize for being insulting while you're at it.
Mice just aren't suitable vehicles to test antivirals. Merck didn't use mice in their development
http://pubs.acs.org/doi/abs/10.1021/jm800245z
You may think that nanoviricides are special and can be tested in any assay... but I think that's wishful thinking. Considering the product has been tested in mice, we should be ready for an IND any day now, right?
Or could it be that delivery, that special acronym, ADME, isn't quite the same in humans as it is in mice?
RT and nanoviricide's purported mechanism of action are not related. The point is HAART was developed without mice because they lack RT. You seemed to indicate otherwise when you said:
You do know that the entire HAART cocktail was developed by testing on mice? You do know this, yes?
Sorry?
Yep they're about $500 but if you want to keep them under observation, humans run you more.
That's the point. Why are you laughing? Like I said, no one is attacking you. It was literally the first way HAART was developed like you were wondering. HAART was not developed with mice.
In fact, no antiviral will be developed with mice. This is common knowledge. The SCID mice are not widely used. There are no relevant enzymes in these mice that will mimic human infection. Notice how I won't stoop to making fun of you.
Let me repeat. Mice are lacking important enzymes that make them useful for preclinical antiviral studies. The SCID mouse is no different. It's been this way since 1950, including in 1987 when HAART was developed. That's why I picked that paper. Folks developing antivirals STILL don't use mice.
You have a very poor attitude about you. I'm not trying to attack you.
Mice don't have reverse transcriptase. This makes them EXTREMELY POOR candidates for studying viral diseases. Wildly, terribly poor candidates. All of the data generated thus far with our Nanoviricides has been non-human. Without human data we can't rely too much on mice data or in vitro since there is such a poor correlation to success. Unlike other diseases where animal models are reliable, virology is a bit of a crap shoot since ADME/tox is pretty much all you can predict. Design a good drug that will be absorbed and circulated, and hope you got the metabolism right.
There hasn't been a new NRTI in a decade because once the crystal strucutre is solved you simply only have a few avenues to go down.
I'm only talking about antivirals, not vaccines.
Mice were not used in the development of NRTIs, NNRTIs and protease inhibitors.
http://www.ncbi.nlm.nih.gov/pubmed/2886549
HAART was done the way I suggested it was done. Your links are nothing more than fringe experimental work. The standard protocol excludes mice for obvious reasons.
For hepatitis C they're commonly used. Abbott Novartis and others use chimps all the time preclinically. Replicon is the standard after chimps, for reliability. Mice just don't apply in hep c/HIV.
The thing is when they do get used, chimps are by far the best surrogate. Talk to companies like VPHM, ANDS, VICL, AVII, ACHN and you learn these things. The funny part is using chimps is just as expensive as going straight to humans. Chimp clinical trials require paying for healthcare for the chimp for its lifetime.
If you spent time talking to the rest of the industry you'd know all this. I'm sure you can dig up a paper or two on attempts at getting mouse models accurate but your standard procedure is to skip it because there is no 'mouse HIV'. It's not homologous, etc. By the time you change the mouse's immune system to the point where it's somewhat human you've really missed the point. I'm sure it's someone life's work, so I'll pass on commenting on it, but as of now it's just not a part of the industry.
They just don't work. Talk to a pharmaceutical company. Just because they've been used doesn't mean they're valuable or indicative.
It's sort of like saying, well, no one wears Gap Jeans on a red carpet. I'm sure someone has done it. It's not quite protocol. The standard protocol for developing an antiviral is using SAR to derive the best efficacy and then animal models to get ADME/tox. Then the human phase 1/2 is the real crapshoot. It's a very unpredictable space if you know anything about drug dev.
No one uses mouse models for virology. Period, the end.
Is there a reliable preclinical model for hepatitis, HIV or herpes? I think the answer is no. So are these results worth the paper they're written on? This whole conversation is a hypothetical dependent on a hypothetical.
Pharma tests possible antivirals in chimps. I wouldn't believe much until we get chimp/human results. You can put pretty much anything in a cell culture and see what you want. Try it on a monkey.
I guess the way I interpret "that's a whole 'nother project" is that curing herpes (or HIV for that matter), is not simple and straightforward because of the facts he mentioned. The notion that he's working on a simpler, more accessible type of herpes is in-line with this thinking. He states very plainly in the beginning "we do not work in cells as far as we know", which means that he can't penetrate the Herpes hiding in nerve cells (or HIV hiding in T-cells). I think I'm giving a very fair interpretation of what he said.
Sure, you're welcome. I have a lot of experienced with viruses - the target of Nanoviricide's platform.
The problem with studying viruses preclinically, is there is almost no human surrogate. Humans have complex immune systems. The only good surrogates are chimps, and even those are not perfect. One chimp can cost hundreds of thousands, unfortunately--these research tools are only available to the largest pharmaceutical companies. Things like viral kinetics, antibody response, adaptive immunity - they're not well replicated in mice.
Witness the confusion in the hepatitis world (NNVC is notably absent from this disease). There is a preclinical assay, "Replicon", which drug companies use to determine efficacy without running expensive chimp studies. Replicon isn't that useful because drugs are metabolized in humans differently from in vivo experiments. This is where ADME comes to play.
Anyway, the point is preclinical virus development is a waste of time until you see human results. NNVC still hasn't filed an IND so, so much for that. It is possible that something likes rabies or dengue has an applicable model since it is a fast killing virus. Having said that, I just realized these treatments are likely going to be intravenous only, so some part of ADME argument is moot--but then so is some of the commercial oppportunity (most antivirals are oral).
Don't forget there are almost no good preclinical assays for HIV. You really need to prove human efficacy. So without a lead candidate nomination with GMP/GLP pharmatox, etc followed by an IND submission - we're just guessing on the HIV results and their ability to translate to humans.
Let's see some viral log curves. HAART has no delivery issue with respect to ADME. For humans, we've reached the final frontier for HIV therapy - clearing the virus from the blood is easily achievable with one pill (Atripla) - we need something that will clear it from the reservoirs where the antivirals can't reach.
From Seymour's comments ("we don't work inside cells") and his comment at 8:00 where he notes "that's a whole other project" with respect to tackling herpes virus which is hidden latent in nerve cells, I suspect NNVC does not have the technology to tackle HIV. The facts are simple.
Rabies? That seems interesting.
I'd go head over heels for a published study or even a press release that had animal group vs. animal group for HIV or Herpes. Don't think they've done it yet?
These issues aren't insurmountable - it's just fun to talk about every company's successes and failures. Even IBM almost went bankrupt. So with HIV, Herpes and Dengue seemingly not so attractive, maybe Rabies is the hot ticket for NNVC?
Exactly at 8:00 he begins to talk about how herpes is not curable because it hides out in nerve cells. HIV does something very similar in 'sanctuary' sites. Because these viruses will never ONLY be in the circulation and some virus will be in tissue, the NNVC approach will not work for HIV and Herpes - Seymour to understand this if you listen to 8:00-8:30 or so.
Give me the link and I'll point it out. I think talking about the limitations of herpes and referring to topical being the only applicable area was what I meant.
Just trying to keep a balanced perspective which has helped me with investing before. Unfortunately I can't change my screen name every time new data comes in. Dengue has been talked about by a half a dozen biotech companies as their cash cow. Without some guidance from the company on when we might have a drug a little further a long, I think the enthusiasm here is premature. Maybe one of the other cides will excite me more.
Praying for ASAP. Of course INDs when it comes to 'bioterror' and diseases where you have a limited human population to study have different rules. Commonly cited is the "two species" rule. Of course any 'cide' for a mass market disease like HIV, Herpes, etc would have to go through a traditional IND process. Carcinogenicity, tox panels, ADME, the whole lot of it costs $1m+ if you want to do it fast. I have no idea where NNVC is in the process because they don't really talk about getting from point A to point B (rather, they focus on point B). I'll try to think about it a little more intelligently and get back to you.
Supply constraints for vaccines are caused by cumbersome manufacturing. We still make these things in chicken cells. Increasingly cell-based manufacturing has sped the process up. These products weren't nearly as profitable as their pharmaceutical counterparts... new targets and diseases were in endless supply until the 90s/00s. Increasingly, the impact of generic drugs and fewer medical problems to solve pharmacologically helped the pharmaceutical world realize vaccines are a valuable, high-margin asset. I don't think the legal environment means much. Companies love making flu vaccines--SNY has been doing it for 100 years. MRK NVS GSK Solvay Crucell BAX and many others find it very profitable.
I am a pharmaceutical investor for a living. Ask me anything!
The vaccine will take 5 years to get global use. Meanwhile we've been waiting 5 years for an IND. That is threading the needle given that we haven't optimized a lead candidate for promotion to two species studies. Companies like AVII are a few years ahead. SIGA and others are also seemingly making progress. Hopefully this new funding will change something.
I know a lot about in vivo experimentation. I was dumbing this down because not everyone on the board can talk this talk. The point is Replicon assays, cell lines, etc become irrelevant until you're looking at human ADME. I wonder what the human ADME looks like for these 'cides'...
Resigned like there is no hope. Just listen to the first 5 minutes of the Rodman presentation. He hems and haws and notes that herpes and HIV are not going to be great targets.
I am beginning to suspect the entire technology makes sense in petri dishes but when put into actual animals/humans the world is a bit more complex. Micelle/surfactant/colloids - there are reasons there are no drugs based on these technologies (one exception is surfactants poured into infant lungs). For systemic circulation one needs a structure less physicially complex. Surfactants just dissociate/dissolve like in the body - can't build a drug off of that.
I think you're missing the point - starting a phase 3, whether it's first patient in today or next month, is pretty quick and threatening any hope of success for NNVC. If everyone is innoculated, the need for a therapy is limited.
Also did you notice that dengue is a flavivirus? That means most hep c drugs will probably work as antivirals, as Roche is testing. There are other companies on the hunt for dengue drugs - AVII, etc. I think given NNVC's slim resources its unlikely much will come from this. Too many players in this field and we have no idea when an IND is coming.
Shouldn't be too hard to just vaccinate folks traveling to Dengue areas and preclude anyone with prior infection from being vaccinated. This is mostly a non-for-profit endeavor, after all. Very few in the developed world care to be vaccinated or not know that they've had dengue in the past. Looks like dengue is a dead end.
Large phase IIIs ongoing. This is probably why the stock has been down. Without dengue not sure what is left. Reminds me of H1N1 where big pharma made all the money and small biotech was left with scraps. Also notice Roche just put a drug into the clinic (RO4588161). I wish we could move drugs into phase I to phase III this quickly.
http://www.sanofipasteur.com/sanofi-pasteur2/front/index.jsp?siteCode=SP_CORP&codeRubrique=34&codePage=PAG_34_PR12
http://clinicaltrials.gov/ct2/show/NCT01134263?term=dengue&rank=1
http://clinicaltrials.gov/ct2/show/NCT01064141?term=dengue&rank=2
http://clinicaltrials.gov/ct2/show/NCT00993447?term=dengue&rank=5
http://clinicaltrials.gov/ct2/show/NCT01187433?term=dengue&rank=7
http://clinicaltrials.gov/ct2/show/NCT01096576?term=dengue&lup_s=09%2F03%2F2010&lup_d=30
http://clinicaltrials.gov/ct2/show/NCT01134263?term=dengue&rank=1
It's actually in phase III. That means they're 5+ years ahead of NNVC.
Did anyone notice the Sanofi vaccine for dengue? I'm assuming everyone will get vaccinated and the market might shrink.
Listen to the Rodman replay - he seemed very resigned on HIV/Herpes.
I'd love to see some kind of presentation at a scientific conference, or event a publication like other companies do!
Is HIV still in play? - Rodman Conference Question
The CEO said that the Herpes drug they have is not a cure because it hides out in nerve cells. I think HIV does something similar. Does that mean we can't get a cure for HIV?
I guess that's okay - we can get enough cash from dengue and the others!
I had no idea they had an updated website at seymour.com. Thanks so much!