NanoViricides, Inc. (OTC BB: NNVC) recently announced that a fundamental patent, on which the nanoviricides® technology is based was issued in the USA on May 8, 2012. The issuance notification was received from the US Patents and Trademarks Office last week.
NanoViricides, Inc. 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 US Patent is granted for “Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers.” The patent term is expected to last through October 1, 2026, including an anticipated extension, with the possibility of further extensions in compensation for time spent in clinical trials.
“We are very pleased with the validation of the novelty of our technologies,” said Dr. Diwan, President and Chairman of NanoViricides, Inc., adding, “This patent establishes a fundamentally new direction in developing biomimetic approaches.”
Commenting on the patent award, Dr. Eugene Seymour, MD, MPH, Chief Executive Officer of the company, stated, “We always knew that this is a ground-breaking technology. We believe, based on the tremendous effectiveness that our nanoviricides drugs have shown against a large number of viral diseases in several very stringent animal models, that this technology spells a fundamental change in how medicines will be developed in the future. For example, our anti-influenza clinical candidate, Flucide™, was developed using the nanoviricide® technology, and has exhibited surprisingly high levels of effectiveness in animal studies, far surpassing the existing drugs. Our expectation that FluCide will work well in humans is based upon the results of these animal studies that indicate (1) extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment even after the drug is discontinued.”
OneMedRadio interviewed CEO Dr. Eugene Seymour. Please click below to hear full audio interview and see full transcript that follows.
Brett Johnson: Welcome, Brett Johnson at OneMedRadio in New York City. Today, I am with Dr. Eugene Seymour who is the chief executive of NanoViricides, symbol NNVC traded on the bulletin board. The company has developed some innovative technology for the treatments of viruses. Thanks for joining us today, Dr. Seymour.
Dr. Eugene Seymour: Certainly, my pleasure.
BJ: So you had big news this past week, the issuance of a patent that had been in application since 2006. Can you talk about the significance of that?
Dr. Eugene Seymour: Certainly. I think this is really the biggest thing that’s ever happened to us because what it does is it really says that we now control the field of antivirals that are related to the use of polymers in the nanotechnology arena. So there was no prior art, Dr. Diwan, the inventor of the technology, has been working on this for the last 20 years, patent application was submitted some six years ago, and we submitted I think 31 claims and we got 31 claims approved. The patent application is extraordinarily complex, but essentially what it says is you have this degree of protection and this makes the company extremely valuable to a large pharmaceutical company because they really do like to have patent coverage.
BJ: So why don’t you tell us in layman’s term what does the technology do? In simple terms, how does it work?
ES: Okay. You know, in a sense, Brett, it’s very elegant and easily described. What happens of course happens at a level that is twenty thousandths of a meter in size so that is quite complex, but I can explain it rather simply. Every virus needs a target cell because viruses are different than bacteria. Bacteria are self-contained. They’re able to reproduce themselves, they have metabolism, and they don’t need a cell. A virus is nothing really but containing of computer code, RNA or DNA and what happens is the virus looks for the target cell, injects in the genetic material, and the genetic material hijacks the replication machinery of the cell to make copies of itself, one to a million copies.
So there are some antiviral drugs, they try to prohibit the entry of this genetic material into a cell and there are some that try to impede the exit of the newly formed virus created within that cell to the outside. We do things in a lot simpler way. What we have created is a nanoviricide. Nanoviricide is about 20, 30, 40 billions of a meter in size, extraordinarily small, much, much smaller than a virus. Now on the surface of the target cell is a protein and that protein is the signaling protein. We call it the receptor protein. On the surface of the virus is the attachment protein and when the two meet up with one another, they link. The virus is then pulled into the close approximation of its target cell and it injects in the genetic material, which then takes over and replicates within the cell.
What we do is we take that receptor molecule that’s sitting on the surface of the target cells and we make a very small copy of it. Just like to recognize you, Brett, I don’t need you whole, I don’t need your arms and your legs and all that other nonsense, I only need your eyes, your nose, your ears, your mouth and then I can recognize you. It’s the same thing with us. We make a very, very small mimic of what’s expressed on the surface of the target cell of the virus and we place that on the nanomicell. Now we have the nanoviricide and what happens is and we flood the body with trillions of these and there are many more of our nanoviricides than there are of the target cells and what happens is the virus attaches to our nanoviricide, which then opens up like a Venus fly trap and begins to encapsulate the virus. Sort of slimy, very much like Ghostbusters and as that happens, it completely encapsulates the virus and then through some complex physical chemical interactions between our nanoviricide and the envelope covering the virus, there’s breaching over the wall of the virus and out streams the genetic material where it’s picked off by the lowest level of immune system cells in the body and the it’s excreted and that’s the end of the game.
That’s why we’ve had such incredible success because we have this working, this system working and working very, very, very efficiently. By the way, we can build this for any virus.
BJ: So what do you see is the principal applications of this technology?
ES: Well, let’s look at some of the more common viral diseases that have market shares in the billions. Influenza and our nanoviricide for influenza will destroy any influenza A and we’ve tested many, many different ones. We even tested H5N1 the bird flu virus. We tested that in Vietnam when they were having an outbreak some years ago. HIV and we reported some very good results in animals with HIV. In fact, we reported a functional cure on two separate occasions, which means that we reduced the level of virus in the body to such a low level that you allow the antibody producing cells to recover and control the remainder of the cells and that way people can live a normal life often as we anticipate with only five days of treatment and maybe an additional treatment every three months for the next year and then after that nothing. They’re not contagious because the amount of virus that they have in the body is really so dramatically reduced. Then there’s herpes of the genitals, herpes of the eye.
BJ: And this technology is effective on all these viruses?
ES: Yeah. All we do is change the receptor molecule. It’s a plug and play. It’s a Lego system. We just change the receptor molecule that’s attached to our nanomicell and now we’re set up for another virus.
BJ: So what’s the status of the company? I mean when will this be available?
ES: Well, that you’re going to have to ask the FDA. I suspect it’s going to be available sooner in other countries than in the US, which is not an atypical situation. However, the clinical trials are cheap, they’re quick because influenza for example is a self-limited disease and it’s over in ten days. We’re looking at very sick hospitalized patients, often those who are immune compromised, who have cancer, post renal transplant, lung transplant, bone marrow transplant or HIV. These people have really nothing that can be done for them and we feel that we can eradicate the influenza virus very quickly and effectuate a cure of influenza. Now obviously, this has to be tested in humans but from all the animal work, it certainly seems that way.
And remember, the most important thing is because you might say to me, well wait a minute, you work in animals, big deal, it’s the work in humans that counts. In a way that’s true, but on the other hand we’re independent of the host. We don’t care whether you’re a man, a mouse, or a whale, or a dinosaur. We only care about the virus and the virus is the virus and it’s the same in any of these animals. So we’re independent of the host and that’s what makes this so amazing.
BJ: So it does sound truly impressive. So are you in clinical trials now or what’s the —
ES: Oh, we’ve had our first meeting with the FDA and we’re doing the things that they want us to do to prepare to file what’s known as and IND, an Investigation New Drug Application. We’re building a manufacturing facility to make this in volume for our clinical trials. So we’re sort of gearing up, but I’m hoping that we can start work in another country much sooner, sometime next year, than we can in the United States. Because we don’t need material produced in a special plant, that gives us like a nine-month earlier window to go and do the work in another country. Remember, for example Australia has its flu season in our summer so that gives us an opportunity to start looking at Australia as a potential clinical trial site.
So we have the money in the bank to accomplish the task. We have the management. We have the drugs and we have the consultants needed to help us get the manufacturing going. So we’re in the best shape we’ve ever been.
BJ: Can you talk a little bit about the corporate side? You guys have been in public now for a number of years. I know your stock has traded as high as $2.50 or even $3 and recently it was down to 58, although it’s come back quite nicely this last week as a result of the patent. Would you be raising more capital? What’s the company’s capital situation and ability to get this product to the market?
ES: Well, you know, biotech companies always need capital. The difference between us and other biotech companies is that we’re extraordinarily frugal. We have the drugs. We don’t have to go through drug discovery and all we have to do really is finish our toxicology work and then go into human trails. So will we raise some more money? I don’t know at this juncture. I’m waiting to get some quotes and as soon as I get some quotes for these trials then I’ll know how much they’re going to cost. But the initial feeling is that we’re really not going to need very much. If we do, it will be a small amount.
We’ve been public as you say seven years. We had a high of $3.75, a low of about 10 cents and now we’re trading 84 cents giving us a value of I believe over $130M, $135M as a market cap.
BJ: So why is now a good time to get into the stock?
ES: Because we have this patent coverage, which is critical. We’ve had our first meeting with the FDA and they’ve been very encouraging because there really is no good treatment for influenza. You know, I’m a clinician, I’m a physician, I’ve used the various drugs over the years and unfortunately none of them work very well and they all have severe limitations. We’re looking towards a cure for influenza with our FluCide, our first drug.
BJ: Interesting. Can you take just a second and tell us a little bit about your background and how you got involved in the company?
ES: Yeah, sure. You know, I’m a physician, I practiced medicine for many years and this is my second public company and I was involved in the development of an AIDS test, a rapid AIDS test used now in many countries around the world. I met Dr. Diwan, the inventor, I think nine years ago and I thought, you know, he’s brilliant but this is just crazy because no one was talking nine years ago about nanotechnology. Over a two-year period, it, as I looked into it more and more, really became clear that this was the future. This was penicillin for viruses and I said to him okay, let’s form a company. We did seven years ago. We backed into a shell and like you mentioned we’ve traded as high as $3.75 and also low, very low right after we did that shell. But we’re very actively traded. I think we’ve traded, oh, in the last three days two, two and half million shares. So there is a serious interest in the company but they want to wait until they see human results and then they’ll start to talk to us seriously.
By the way, we have I think the last count is somewhere between 10,000 and 12,000 retail investors. We have no institutions involved and we really don’t do a lot of PR work. We go to conferences and we’re invited to conferences around the world and we participate in many of them, but we’ve really been sort of flying under the radar. I think it’s now time because nanotechnology is enjoying a real boom and people understand it. So when you say nanotechnology they say, oh, yeah, I’ve heard of that. So I think that the confluence of all of these events is going to continue to drive the value of the company plus the work we’re doing with one drug after another. The idea is as soon as we go into our IND with the first drug, the flu drug, we’re going to have another drug every six months going into the FDA because we’ve got them lined up. I mean I told you herpes, adenovirus of the eye, Dengue, HIV, and there’s some others that don’t have much commercial value, rabies, Ebola, things like that that we’ve also done work on. So that’s sort of the situation.
BJ: Well congratulations on the patent. It’s truly an exciting story and we’ll be very keen to follow your progress. So thanks so much for joining us today.
ES: My pleasure.
BJ: So that was Dr. Eugene Seymour who is the chief executive of NanoViricides traded NNVC. Brett Johnson, OneMedRadio in New York signing off. Good day.
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