NanoViricides Inc. (NNVC)

[changes_iv]

[Does anyone know of a company that is at the stage NanoViricides, Inc. is, just about ready to accelerate/produce large quantities of their most advanced Flucide(TM) candidate?]

Influenza
We are currently working to increase the production of FluCide™, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (BASI).

We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.

We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.

Drug Pipeline
The Company has six commercially important drug development programs in its rich pipeline. These include (i) Injectable FluCide for hospitalized patients, (ii) Oral FluCide™ for out-patients with Influenza, (iii) broad spectrum HerpeCide™ for various forms of herpes virus infections that cause oral and genital herpes, herpes keratitis (eye disease), and possibly also chickenpox, and shingles, (iv) a broad-spectrum antiviral ophthalmic solution for viral diseases of the eye such as epidemic kerato-conjunctivitis (EKC, caused usually by adenoviruses), and herpes keratitis, (v) DengueCide™, a broad-spectrum drug against all four types of dengue viruses, and (vi) HIVCide™, a broad-spectrum anti-HIV drug candidate that may be a "functional cure" against HIV/AIDS. In addition, we are engaged in research programs for the development of broad-spectrum drug candidates against a number of other viruses. These include filoviruses such as Ebola and Marburg, Rabies, and many others. We continue to advance these programs as opportunities become available. In the past, we have been constrained by the limitation of our small laboratory R&D facility in West Haven, CT. We now have a 18,000 sq. ft. state of the art cGMP-capable manufacturing facility for clinical scale production of any of our nanomedicine dug candidates including injectables, located in Shelton, CT. We are now working to bring the facility into full-scale operation. We anticipate that this facility will dramatically expand our ability to move our drug candidates into a clinical stage pipeline.

The Company has previously announced that it had approximately $36.4 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2014. The Company's operating expenditure is approximately $2M per quarter. We believe that we have sufficient funding available to perform initial human clinical studies on at least one of our drug candidates, and possibly to bring at least one other drug candidate into IND stage.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Provides%20an%20Update%20on%20Its%20Progress%20over%20the%20Last%20Quarter.html

[What is that company drug that directly competes with broad spectrum, low toxicity and effective Flucide(TM)? Tamiflu???...]

Different bird flu strain detected in Indiana backyard flock
Originally published May 11, 2015 at 1:10 pm

It is a different strain than the virus that has led to the loss of more than 30 million chickens, turkeys and other birds since March in 13 states.
The Associated Press

COLUMBIA CITY, Ind. (AP) — Bird flu has been found in a backyard poultry flock in northeastern Indiana, and it’s the first time the specific strain in question has been detected in the central U.S., animal health officials said Monday.

The H5N8 virus found in Whitley County is different from the H5N2 virus that has led to the loss of more than 30 million chickens, turkeys and other birds since March in 13 states, including Minnesota and Wisconsin, the U.S. Department of Agriculture said.

Some birds in the Whitley County flock of 77 ducks, geese, chickens, turkeys and other species have died, the agency said. The remaining birds were removed, the Indiana State Board of Animal Health said.

The board said it was checking with nearby poultry owners to see if the disease has spread. The board said it is coordinating with the USDA, the Indiana State Poultry Association and the Indiana Animal Disease Diagnostic Laboratory in responding to the disease.

Indiana is a leading poultry-producing state, nationally ranked first in the production of ducks and fourth in turkeys.

The board encourages backyard poultry owners to watch for signs of bird flu and report illnesses and deaths to the U.S. Department of Agriculture. Signs include sudden death, lack of energy or appetite, decreased and misshapen egg production; nasal discharge, coughing, sneezing and diarrhea.

Bird flu doesn’t affect the safety of eating eggs or poultry and poses little risk to humans. No human infections with the virus have been detected, the USDA said.

Bird flu can be carried by free-flying waterfowl such as ducks, geese and shorebirds. The occurrence in Whitley County west of Fort Wayne is the first time the H5N8 strain has been detected in the Mississippi flyway for migrating birds over the central U.S. The H5N8 strain previously had only been confirmed in the Pacific flyway after being detected in Oregon and Washington.
The Associated Press
http://www.seattletimes.com/seattle-news/health/different-bird-flu-strain-detected-in-indiana-backyard-flock/

H5N8 is a subtype of the Influenza A virus (sometimes called bird flu virus). Although H5N8 is considered one of the lower pathogenic subtypes, it is beginning to become more so. Many times, H5N8 is used as an incubator for the highly pathogenic H1N1. [1]
http://www.seattletimes.com/seattle-news/health/different-bird-flu-strain-detected-in-indiana-backyard-flock/

Influenza A virus subtype H5N8
http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H5N8

NanoViricides, Inc. Reports Oral FluCide™ Is Highly Effective Against H3N2 Influenza A Virus and Superior to Tamiflu® based on Increased Survival in a Lethal Influenza Animal Model
...
The Company has recently established oral effectiveness of its anti-influenza drug candidates in an H1N1 influenza A lethal infection mouse model. The Company believes that this may be the first ever targeted nanomedicine that is orally effective.

The Company intends to develop data about effectiveness of its drug candidates against certain unrelated influenza A viruses using both cell culture studies and animal models in a reasonable manner. These data will be needed as part of the IND application that the Company is working on. An IND application will be required for the Company to enter into human clinical trials.

H3N2 influenza virus is one of the multiple sub-types of influenza A that cause seasonal epidemics. According to the CDC, influenza causes approximately 36,000 deaths every year in the U.S. alone. The Hong Kong Flu pandemic of 1968-1969, which killed an estimated one million people worldwide, was caused by a variant strain of H3N2. The Company believes an orally administered nanoviricide that protect against multiple influenza virus sub-types would be effective in season after season of influenza epidemics. Such a highly effective, broad-spectrum anti-influenza drug is widely anticipated to be highly successful.

The Company believes that the anti-influenza drug candidates it has developed are broad-spectrum, i.e. they should work against most if not all of influenza viruses. This is because, in spite of mutations and antigenic drift, all influenza viruses bind to the same cell surface receptor called sialic acid, and the Company has developed small chemical ligands that mimic this receptor, to attack the influenza viruses. These ligands are chemically attached to the Company’s polymeric micelle backbones that mimic the cell membrane, to create the nanoviricides. The Company has previously shown effectiveness of its very early anti-influenza drug candidates against two different strains of H5N1 Bird Flu virus in cell culture studies. The Company has since then improved the ligands as well as the chemistries as reported from time to time.
http://www.businesswire.com/news/home/20120924005450/en/NanoViricides-Reports-Oral-FluCide%E2%84%A2-Highly-Effective-H3N2#.VVHuG_DSMSU

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