NanoViricides Inc. (NNVC)

[changes_iv]

Perhaps if we look at how it worked out for Mapp Bio's ZMapp it will help understand how it could work for NanoViricides, Inc. as well. Getting the efficacy testing for EbolaCide started is the first step, just a few weeks ahead (IMO).

ZMapp

A 2014 paper described how Mapp and its collaborators at Public Health Agency of Canada, Kentucky BioProcessing, and the National Institute of Allergy and Infectious Diseases first humanized the three antibodies comprising ZMab, then tested combinations of MB-003 and the humanized ZMAb antibodies in guinea pigs and then primates to determine the best combination, which turned out to be c13C6 from MB-003 and two humanized mAbs from ZMab, c2G4 and c4G7. This is ZMapp.[7]

In an experiment also published in the 2014 paper, 21 rhesus macaque primates were infected with the Kikwit Congolese variant of EBOV. Three primates in the control arm were given a non-functional antibody, and the 18 in the treatment arm were divided into three groups of six. All primates in the treatment arm received three doses of ZMapp, spaced 3 days apart. The first treatment group received its first dose on 3rd day after being infected; the second group on the 4th day after being infected, and the third group, on the 5th day after being infected. All three primates in the control group died; all 18 primates in the treatment arm survived.[7] Mapp then went on to show that ZMapp inhibits replication of a Guinean strain of EBOV in cell cultures.[14]

Use in humans

In the US, the FDA's Animal Efficacy Rule can be used, often in combination with a Phase I clinical trial, to demonstrate reasonable safety for a drug, to obtain permission to treat urgently sick people with the drug under the FDA's Expanded access program. The Animal Efficacy Rule exists because the normal path for testing the safety and efficacy of drugs is not possible for diseases caused by dangerous pathogens or toxins.[17][19] The FDA has allowed two drugs, ZMapp and an RNA interference drug called "TKM-Ebola", to be used in Americans suffering from Ebola virus disease under these programs.[20] Other countries have similar programs to allow early access through named patient programs.

Individual treatments

In 2014, Samaritan's Purse worked with the FDA and Mapp Biopharmaceutical to make the drug available to two of its health workers who were infected by Ebola virus during their work in Liberia, under the Expanded access program.[17] At the time, there were only a few doses of ZMapp in existence.[17] Both workers received the drug and were transported to the US, where they recovered and were then released from the hospital.[21][22][23] A 75-year-old Spanish priest who was infected with Ebola virus in Liberia received ZMapp in cooperation with Spanish health authorities, and died shortly thereafter.[24][25]

The west African nation of Liberia secured enough ZMapp to treat three Liberians with the disease, one of whom died.[26][27]

A British nurse who contracted Ebola virus disease while working in Sierra Leone, was transported to the UK and treated with ZMapp, and recovered.[28][29] All of the cases mentioned above occured in August 2014.

A Norwegian aid worker at Doctors Without Borders in Sierra Leone who contracted Ebola was flown to Oslo on October 6th were she is reported to recieve ZMAb (see above), containing to two of the three active antibodies in ZMapp.[30][31]

Mapp announced on August 11, 2014 that its supplies of ZMapp had been exhausted.[32]

Approval

The lack of drugs and unavailability of experimental treatment in the most affected regions has spurred some controversy.[17]

On August 6, 2014, Peter Piot, who co-discovered Ebola virus, and other scientists, including the director of the Wellcome Trust, called for the release of ZMapp for affected African nations.[33] The fact that the drug has been given to Americans and a European and not to Africans has, according to the Los Angeles Times, "provoked outrage, feeding into African perceptions of Western insensitivity and arrogance, with a deep sense of mistrust and betrayal still lingering over the exploitation and abuses of the colonial era."[33]

However, in light of the history of exploitation and abuses, Dr. Salim S. Abdool Karim (director of an AIDS research center in South Africa), responding to a question on how people may have reacted if ZMapp and other drugs would have been used first in Africans, said, “It would have been the front-page screaming headline: 'Africans used as guinea pigs for American drug company’s medicine.'"[17]

Regarding whether ZMapp should be fast-tracked for approval or be made available to sick patients outside of the United States, U.S. President Barack Obama stated on August 6, 2014, “I think we have to let the science guide us."[34]

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

Mapp Bio doses of the ZMapp drug were exhausted and the company did not have capacity to produce more doses of its drug in order to continue aiding sick patients while it advanced in clinical trials and pre clinical studies.

Mapp Bio's ZMapp today...

Feds Provide Funding, Expertise to Advance ZMapp Drug for Ebola

In a statement today, the federal health agency said it would provide $24.9 million to Mapp Bio through an initial, 18-month contract. The company will make a small amount of ZMapp for early stage clinical safety studies and for non-clinical animal studies needed to demonstrate its safety and effectiveness.

The effort is intended to advance ZMapp toward FDA approval, and includes subject-matter expertise and technical support to accelerate drug manufacturing and to address regulatory and other non-clinical concerns. The health agency’s assistant secretary for preparedness and response can extend the contract up to a total of $42.3 million.

Unlike Mapp Bio, NanoViricides, Inc. does have capability of producing sufficient quantities of second generation EbolaCide (scale up).

NanoViricides, Inc. now has the capability of producing sufficient quantities of an anti-Ebola drug, after it is developed, for combating current and future Ebola epidemics. The highly customizable nanomedicine cGMP capable pilot scale manufacturing facility in Shelton, CT, will be able to supply all of the nanoviricides drug candidates in quantities needed for human clinical trials.

As of October 1, 2014, the World Health Organization (WHO) and the Centers for Disease Control (CDC) reported a total of approximately 7,493 suspected cases and 3,439 deaths, with the Case Fatality Rate (CFR) standing at 70%, derived using data from patients with definitive clinical outcomes, according to Wikipedia (en.wikipedia.org/wiki/Ebola_virus_epidemic_in_West_Africa). Unfortunately, this Ebola outbreak has continued to expand at an exponential rate in spite of significant efforts to contain it. It has also continued to spread geographically. A first case of Ebola infection detected in the USA occurred in Dallas, TX, recently, with the patient who flew in from Liberia while having no symptoms. The first confirmed case of Ebola infection contracted outside of Africa has occurred in Spain in a nurse, who was taking care of two volunteer priests that became infected with Ebola virus and were brought back from Africa, at the Hospital Carlos III in Madrid.

Currently, there are no approved drugs or vaccines against Ebola, , although some vaccines as well as some drug candidates have entered clinical trials. Recently, WHO has announced a policy for use of experimental drugs against Ebola to expedite drug availability.

http://ih.advfn.com/p.php?pid=nmona&article=63943022

Thanks to Dr. Anil R. Diwan, President of NanoViricides, Inc., and associates, the state-of-the-art cGMP Pilot Plant was made possible in Shelton, CT.

The Company has reported that an 18,000 square foot facility in Shelton, CT has been acquired by Inno-Haven, LLC, a special purpose entity formed for the project. When completely renovated, the new facility is anticipated to house administrative, R&D and cGMP or “current Good Manufacturing Practice” manufacturing functions for the Company.
...
NanoViricides, Inc. did not incur any capital costs, as Inno-Haven, LLC financed the acquisition of the building. The financing was derived from Dr. Diwan’s personal funds and from private mortgage loans that were personally guaranteed by him. Dr. Diwan is a controlling Member of Inno-Haven, LLC.

“Conserving capital is very important for NanoViricides,” said Dr. Eugene Seymour, MD,MPH, CEO of the Company, adding, “Dr. Diwan’s commitment and personal risk-taking has allowed us to minimize capital expenditures even as we endeavor to enable cGMP manufacturing capability for our drug candidates. We are further pleased that he has agreed to end the programmed sale, as soon as there was sufficient funding available.”
...
The Company will be required to have cGMP manufactured drug products available for clinical trials when it files an Investigational New Drug application to the FDA. cGMP is a set of guidelines that address the manufacturing processes, equipment, and facility, among other aspects, that must be adhered to when producing drugs for human use...

http://www.businesswire.com/news/home/20111017006997/en/NanoViricides-Announces-President-Dr.-Diwan-Completed-Stock



A superior and dramatically effective second generation EbolaCide could have sharp repercussions throughout our economy, Market Futures, and the world economy.

And that ultimately could have serious economic consequences. Nothing of course is more tragic than the human cost of the Ebola outbreak. But as the crisis persists, economists are beginning to look at what the toll might be for the global economy as well. In a world still climbing out of the financial meltdown of six years ago, we can hardly afford any new disruptions to investment and consumer spending that could further drag down growth.

That, however, is exactly what a sustained Ebola epidemic could do. We can get a pretty good idea of what can happen from looking at the impact of SARS in East Asia in 2003. Wherever the disease went, people stopped doing what they would normally do, in order to protect themselves, and that had an immediate effect on demand. Restaurants that would usually be jam-packed in central Hong Kong appeared abandoned; flights almost always crammed took off nearly empty; hotels emptied. Though the overall economic damage from SARS was in the end minimal, since it was contained relatively quickly, if the disease had spread more widely or become more entrenched, the cost would have risen precipitously.

We can already see that happening in West Africa. A recent World Bank study estimated that if the epidemic is not contained quickly, it would cost Liberia 12% of its GDP by the end of 2015, and Sierra Leone 8.9% — a loss these poor nations can ill afford. If the outbreak spreads more widely to neighboring countries with larger populations and economies, the World Bank figures the two-year financial cost could reach $32.6 billion. Travel to the region has already plummeted. John Grant, executive vice president of aviation-information provider OAG, recently calculated that the number of scheduled flights out of the worst-hit countries have dropped by 64% since May. Major carriers including British Airways and Delta Air Lines have suspended flights. The president of Dubai-based Emirates noted that the Ebola outbreak has dampened demand in Asia for flights to Africa."

http://time.com/3488874/ebola-economic-cost/