NanoViricides Inc. (NNVC)

[changes_iv]

It is common knowledge...

PEGylation, by increasing the molecular weight of a molecule, can impart several significant pharmacological advantages over the unmodified form, such as:

-Improved drug solubility
-Reduced dosage frequency, without diminished efficacy with potentially reduced toxicity
-Extended circulating life
-Increased drug stability
-Enhanced protection from proteolytic degradation

PEGylated drugs also have the following commercial advantages:

-Opportunities for new delivery formats and dosing regimens
-Extended patent life of previously approved drugs

PEG is a particularly attractive polymer for conjugation. The specific characteristics of PEG moieties relevant to pharmaceutical applications are:

-Water solubility
-High mobility in solution
-Lack of toxicity and low immunogenicity
-Ready clearance from the body
-Altered distribution in the body

http://en.wikipedia.org/wiki/PEGylation

U.S. Ebola "Patient zero" Thomas Duncan is in critical condition and is being administered an experimental drug, and according to the media, one that could kill him but at the same time, one that could save his life. Does anyone know what drug is being used? If given the choice between the unknown drug and second generation EbolaCide, which one would you pick?

The pre-clinical safety profile for FluCide (a bioequivalent of EbolaCide)is, as Dr. Milton Boniuk would put it, "...nothing short from amaizing."

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.

In as early as just a few weeks we should be testing EbolaCide II for efficacy. How long will it take to rescue the animal subjects from the jaws of death? Hours? Can we rescue from death > 90% of animal subjects?

Ebola virus (EBOV) remains one of the most lethal transmissible infections and is responsible for high fatality rates and substantial morbidity during sporadic outbreaks. With increasing human incursions into endemic regions and the reported possibility of airborne transmission, EBOV is a high-priority public health threat for which no preventive or therapeutic options are currently available. Recent studies have demonstrated that cocktails of monoclonal antibodies are effective at preventing morbidity and mortality in nonhuman primates (NHPs) when administered as a post-exposure prophylactic within 1 or 2 days of challenge. To test whether one of these cocktails (MB-003) demonstrates efficacy as a therapeutic (after the onset of symptoms), we challenged NHPs with EBOV and initiated treatment upon confirmation of infection according to a diagnostic protocol for U.S. Food and Drug Administration Emergency Use Authorization and observation of a documented fever. Of the treated animals, 43% survived challenge, whereas both the controls and all historical controls with the same challenge stock succumbed to infection. These results represent successful therapy of EBOV infection in NHPs.

Read full text: http://stm.sciencemag.org/content/5/199/199ra113

What are we faced with?

..."It's the single greatest concern I've ever had in my 40-year public health career," said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "I can't imagine anything in my career - and this includes HIV - that would be more devastating to the world than a respiratory transmissible Ebola virus."

As the virus spreads and mutates, Osterhold and other experts warn, the likelihood increases.

Osterholm calls it "genetic roulette."

One thing is for certain: We have to be prepared if the problem escalates. And if it does, there's a very high chance U.S. technology will ultimately save the day.
...
The U.S. government is so motivated to prevent a widespread crisis that they've imposed what's called the "Animal Rule."

"The Animal Rule," says Paul Mampilly, editor of FDA Trader, "allows the FDA to give conditional approval to drugs if they work in animal studies."

Why, Paul explains to us, is "because we're going to need more than one drug to make sure, because the virus is adapting to us as we're adapting to it. It mutates into different forms."

Besides, we all have different DNA, and therefore different ways of reacting to certain drugs. Some drugs that work on one person may not work on another, and vice versa.

".we're going to need every single Ebola drug that we have to try to help these patients."

"That means we're going to need every single Ebola drug that we have to try to help these patients," Paul goes on. "And then pray that they work."

Another bioequivalent of EbolaCide II is the HIVCide candidate. How has that performed in the past?

...The antiviral effect of the anti-HIV nanoviricide ("HIVCideT") continued throughout the 48 days of study even though HIVCide dosing was discontinued after only 20 days.

The clinical benefit of HIVCide was found to be sustained for at least four weeks after the last drug dose. Treatment with the lead anti-HIV nanoviricide both (1) reduced the HIV viral load and (2) also protected the human T cells (CD4+,CD8+), equally well as compared to treatment with the three-drug HAART cocktail, at 24-days as well as at 48-days, even though the HIVCide treatment was stopped at 20 days.

The Company believes that achieving this sustained clinical benefit after stopping nanoviricide treatment is highly significant. A similar sustained reduction in viral load even after discontinuation of the drug was also observed for the Company's previously reported anti-influenza FluCideT lead drug candidate. Such sustained, prolonged clinical effects can be expected on the basis of the design of nanoviricides. A nanoviricide is made from a polymeric micelle structure that is designed to provide long circulating half-life in the body that should enable sustained therapeutic effectiveness.

If given the choice between an experimental drug that could kill you in the process of saving you or simply a fast-acting drug that could save you, which one would you pick?

We are going to read soon...

1- our BSL-4 partner/collaborator for second generation EbolaCide efficacy testing
2- synthesis completion of second generation EbolaCide candidates

In as early as just a few weeks we may very well be reading that efficacy testing for EbolaCide II has begun.

If, God forbid, you were to be infected with the Ebola virus, don't let them feed you any experimental drug that may kill you and/or save you! Ask for second generation EbolaCide that could very well save you. JMHO!

Currently, while the Ebola virus "genetic roulette continues", the scientists are racing inside the state-of-the-art few kilograms cGMP Pilot Plant in order to get it validated.

As part of the advanced IND–enabling development of our Injectable FluCide drug candidate, we have continued to scale up our production processes for both the backbone polymer and the ligands. We have been able to make up to 200g batches in our existing facility. We believe that we will be able to make as much as a few kilograms in a single batch in the new cGMP-capable facility. If the course of treatment of a successful Ebola drug candidate is assumed to be a few grams, we would be able to make as many as a thousand courses of treatment per batch. Our production capacity would thus be responsive to the current requirements for the containment of the Ebola epidemic in West Africa.