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Friday, 08/22/2014 1:32:49 PM

Friday, August 22, 2014 1:32:49 PM

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Excerpt from Scott Gotliebb article on Ebola experimental drugs --- Forbes magazine

...The World Health Organization said last Thursday that the scope of the Ebola outbreak may be vastly underestimated, and will grow worse before they are able to get the epidemic under control.

Amid these dire warnings, and facing a virus with no proven remedies, treatments, or vaccines, a panel of WHO ethicists approved the use of experimental therapies in stricken patients.

It was the right decision for a host of reasons. In fact, it shouldn’t have been ethicists who reached such a conclusion. Drug regulators should have taken this decision.

Patients facing a deadly virus with no proven treatments deserve access to experimental drugs, so long as they provide informed consent to receive them. Such forward deployed drugs should already have established basic proof of safety, and there should be a plausible reason to believe that these agents could also prove effective.

But there’s another reason to forward deploy these experimental treatments. It’s the only way we are ever going to find out if they work, and put them to wider use.

In fact, regulatory policies in the U.S. allow for drugs to be approved on the basis of studies in animals alone when there is no ethical way to test a medicine in sick patients. In the case of Ebola, you can’t purposely infect someone with the virus so that you have a subject to test a treatment on. You need to wait for an outbreak.

The only way we’re going to find out for sure if these experimental Ebola drugs are effective is to use them in sick patients. Given the state of science, this initial use is going to based on little more than information about their effectiveness in animals.

FDA issued a so-called “animal rule” almost a decade ago (amid fears of bioterrorism after the deadly anthrax attacks) outlining how a drug could be approved on the basis of only efficacy studies in animals. It was rightly acknowledged that animal testing alone would have to form the basis of approval when we were dealing with therapeutics that targeted rare and deadly diseases that could be used as weapons.


http://www.forbes.com/sites/scottgottlieb/2014/08/18/as-the-ebola-outbreak-expands-these-experimental-drugs-could-see-action/

So, knowing that a decade old FDA rule existed, why is it that some of taxpayers money has not been allocated to try out once more our intelligent technology? When will NanoViricides, Inc. get a few million, of taxpayers money, to show that we have an effective EbolaCide candidate to destroy the Ebola virus? Not only that, we also have a new cGMP Pilot Plant ready to produce enough quantities to protect the Ebola plague fighters and restore their credibility in that part of the world, by saving the lives of thousands. All we need is enough funding to test EbolaCide's efficacy at a BSL-4 lab first and once successful, enough funding to produce quantities to eradicate Ebola from West Africa. That is not to much to ask considering hundreds of millions, of taxpayers money, have been spent with handpicked companies other than ours. Once we are funded, lets see who wins the race to eradicate the Ebola virus.

"Some of these drugs look great in the test tube and in mice and primates," says Erica Saphire, a molecular biologist at Scripps Research Institute whose lab is studying the effectiveness of ZMapp. The drug is a cocktail of antibodies that attach to the virus or infected human cells, flagging them for destruction by the immune system and "locking" Ebola's viral machinery so that the virus can no longer invade healthy cells.


http://www.motherjones.com/politics/2014/08/new-drugs-and-vaccines-cant-stop-ebola-outbreak

EbolaCide are trillions of nanoviricides in one dose that will target/attach to the Ebola virus structures, "locking" Ebola's viral machinery and destroy them in the trillions, in a matter of hours.

Dr. Eugene Seymour, CEO NanoViricides, Inc., describes the "modus operandi" of the Ebola virus which is key to the design of the EbolaCide candidate:

Ebola virus infects a wide variety of human cell types, by using various attachment receptors to enter endosome structures inside cells. Upon entry, the virus binds to its cognate receptor, the Niemann-Pick C1 cholesterol transporter protein inside the late endosomes, fuses with the endosomal membrane, and thus enters the cytoplasm. It replicates, buds out of the cell, and the cycle repeats itself. The virus shuts down several of the host's immune system defenses, and thus gains an upper hand.



Now, the following is news on a vaccine that has been in the works for years, with government-taxpayers greased skids and all...

Researchers at the National Institutes of Health are accelerating human clinical trials for what scientists hope is a promising new vaccine to combat the deadly Ebola virus.

Phase 1 of the clinical trials, which were previously not expected to begin until the end of September, will start early next month in response to the Ebola outbreak in West Africa, said Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases. Fauci said researchers hoped to finish Phase 1 by the end of November rather than January 2015, as originally planned.

“We’re dealing with an urgent situation,” Fauci said. “We want to respond as safely as we can but also as quickly as we can.”

The NIH’s Vaccine Research Center has been working on the vaccine for years with Okairos, a Swiss-Italian biopharmaceutical company now owned by British drug maker GlaxoSmithKline. The experimental vaccine has shown promising results in nonhuman primates, Fauci said. The vaccine will be tested on 20 healthy adults at the NIH Clinical Center in Bethesda, Md.

Known as a chimpanzee adenovirus vector vaccine, the experimental vaccine contains no infectious Ebola virus material. According to Fauci, the chimpanzee adenovirus is a “dead virus,” meaning it cannot replicate once it enters the body. The dead virus is intended to trigger the body to make antibodies, which would reproduce if a person was exposed to Ebola.

Researchers will compare the human immune response to the vaccine to previous tests on monkeys to determine whether the vaccine is effective.

It remained unclear when the vaccine would be ready, but Fauci said it MAY BE available sometime in 2015, depending on Food and Drug Administration approval.



How experimental, as the governments claim, is experimental? Shouldn't we be testing the experimental vaccine in West Africa before it spreads any further? Can the government chew (clinical trials) and walk (administer the vaccine around regions of infection) at the same time? And how about the WHO and Nanosilver? in what stage of development is that other drug? Are taxpayers paying for that as well?
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