Patrick Cox: NanoViricides Demonstrates 15X Killing Power of Market-leading Flu Drug
This is huge, folks. In a rational world, the FDA would simply approve FluCide, the leading anti-influenza drug by NanoViricides, Inc. ( OTCBB: NNVC) right now and rush it to market. Further results of a third-party validation were made public Monday morning. They are stunning. Because they are written in "science speak," it may not be immediately obvious.
Previously, I've reported that new tests of NanoViricides' tweaked nanotech FluCide therapy had vastly increased the survival rate of mice given lethal infections of influenza. Roche's Tamiflu, the market leader, increased life spans to an average of 7.8 days. NanoViricides' FluCide increased it to 18.1 days.
The new information, however, confirms that FluCide works by killing viruses. Obviously, this is important because it reduces the stress that viruses put on the body. TamiFlu only halved the viral load. FluCide killed 15 times the viruses. This is critical because it means that you could kill more simply by increasing the dose of FluCide in the initial treatment or in subsequent doses. FluCide is, in fact, a cure for influenza.
Think about what this means. TamiFlu's sales have gone down somewhat recently as certain viruses have developed immunities and concern about side effects has grown. Still, however, Roche's sales of the drug this year are estimated at 1 billion Swiss Francs, which translates roughly into US$1 billion.
Let me review some of the high points of what makes NanoViricides' technology so uniquely amazing. First, these nano-sized particles do not act inside the cell and are not metabolized by the liver, which is the process that produces most of the unexpected side effects that derail promising drugs. Even in massive doses, they have never produced side effects.
This is because they are not drugs in the classical sense. They are a fusion of polymer nanoparticles with organic ligands. These ligands, found via in silico supercomputer 3D simulation, imitate the cellular locks that viruses have keys for. Viruses that encounter these nano/bio machines "think" they have found a cell and attack them. They enter these nanoparticles and then, they are harmlessly dismantled and disposed of.
Normally, a drug winding its way to market has one huge cloud casting doubt on its future. It is the consequences of human testing. Dr. Joseph Kim, the brilliant CEO of DNA vaccine company Inovio Pharmaceuticals (AMEX: INO) once told me a great biotech saying: Rats lie. Monkeys exaggerate.
This is true because most drugs interact with the entire human metabolism, which is vastly more complicated than most animals' metabolisms. Most people don't know it, but we've cured cancer completely in many of the animals used for medical tests. Those cures, however, have produced unexpected side effects in humans and are therefore unusable.
NanoViricides' technology doesn't interact with the metabolism. It doesn't enter human cells, which is why it may not work on the few virus that can hide in cells, such as hepatitis C. It is a tiny quasi-robot that fights one-on-one with viruses no matter where it encounters them. If it works in a test tube full of infected blood, and it does, it will work in a blood vessel. It is a true revolution in medicine that will be memorialized in medical texts just as Edward Jenner's discovery of vaccinations is today.
Am I saying I have a crystal ball and can tell you nothing will go wrong with this technology? Well, obviously I would be a liar if I were. Still, this is as close to a grossly-underpriced sure thing as I have ever seen. I have a few more pressing items on NanoViricides.
One is that the FDA's approval bar for TamiFlu was very low. If you feel like doing a little data mining to convince yourself this is true, go to the FDA's Website. Type Tamiflu in the search field and then click on the top drug type, "capsule."
If you dig around, you can access all the approval letters and internal FDA memos for approved drugs. They tell you a lot about the types of clinical and animal testing requirements that the FDA has for particular kinds of drug.
If you look at Tamiflu, using the link I included above, you find that Roche did 2 pivotal studies during flu season, one in the US (374 subjects) and one in South America (475 subjects) using people 18-65 years old. They did smaller studies later to increase the age range and look at high-risk group such as those suffering from chronic cardiac or pulmonary disease. They weren't asked to repeat any clinical studies, however.
They also performed about 15 studies in mice and rats. Various FDA memos describe the criteria they used to grant approval. The point, however, is that that Tamiflu only reduced the duration of influenza by 1.3 days, but the FDA still approved it. This is a very low bar and it bodes well for NanoViricides' FluCide.
It's possible, of course, that Roche could pressure the FDA to delay approval of FluCide, but another influenza epidemic is inevitable and NanoViricides is going to step up to the plate when it comes. Anybody who blocks them will have a big public relations Problem.
Dengue Serotypes that Cause Hemorrhagic Fever Found in Florida
The first case of "locally acquired" dengue has appeared an hour and a half east of me, in Miami. That means that mosquitoes carrying the dengue virus are breeding in the verdant South Florida wetlands. This is going to be a problem and NanoViricides has the cure. Remember, the mortality rate of reinfection from one of the other three dengue serotypes produces hemorrhagic fever with a 20 percent mortality rate.
We know, in fact, that these other strains have already popped up in Florida. Let me extract part of the Palm Beach Post story I've linked above.
"'This is a big deal,' said Lillian Rivera, administrator of the Miami-Dade Health Department.
"'We have not had a locally acquired case of dengue fever since the 1950s,' said Dr. Fermin Leguen, the department's chief epidemiologist.
"The victim, described only as a man who had not traveled outside Miami-Dade County for more than two weeks, was briefly hospitalized but has fully recovered, Rivera said. His case was confirmed by laboratory tests.
"Health officials said they don't know where the man acquired the disease. It was a different strain from the one that has caused 57 locally acquired cases in Key West and one in Broward County."
So we have multiple strains breeding in Florida. Storms blow mosquitoes around down here like living clouds. Dengue hemorrhagic fever is coming. NanoViricides already has the cure.
