NanoViricides Inc. (NNVC)

[changes_iv]

USA (HPAI H5N2)

The World Organization for Animal Health (OIE)'s Director General Bernard Vallat said that the avian influenza epidemic is likely to be under control within a few months as the United States has increased measures to contain the disease and the summer heat weakens it. The virus has led to the death or culling of more than 40 million birds from commercial farms and backyard flocks in 16 states. The epidemic was particularly severe in the U.S. because farmers were not prepared, and because of the large size of the nation's farms.
http://www.nwhc.usgs.gov/disease_information/avian_influenza/

Bird Flu Virus H5N2 Spreading Across U.S.; CDC Warns Doctors to Be Vigilant

Doctors and state health officials should be on the lookout for people infected with the H5N2 bird flu virus, which has spread to at least 20 states this year, the Centers for Disease Control and Prevention said Tuesday.

While no humans have been diagnosed with either H5N2 or H5N8 avian influenza, the virus' expansion across the country has caused more than 200 outbreaks among chickens, turkeys and other birds. It's killed or forced the slaughter of more than 45 million birds, the U.S. Department of Agriculture said.

"While these recently identified HPAI H5 viruses are not known to have caused disease in humans, their appearance in North American birds may increase the likelihood of human infection in the United States," the CDC said.

People can get avian influenza — both H5N1 and H7N9 have infected and killed people. H7N9 avian influenza has infected 622 people since 2013 and killed 227 of them.

H5N1 was the first strain of bird flu to really worry experts — and it still does.

It's infected 784 people in 16 countries since 2003, and killed 429 of them. "Previous human infections with other avian viruses have most often occurred after unprotected direct physical contact with infected birds or surfaces contaminated by avian influenza viruses, being in close proximity to infected birds, or visiting a live poultry market," the CDC added.
http://www.nbcnews.com/health/health-news/keep-look-out-h5n2-bird-flu-cdc-tells-doctors-n368686

Study: New H5N1 strain in Egypt may be tied to rise in human cases

A new strain of H5N1 avian influenza virus that has apparently gained predominance in Egypt in recent months may be associated with the sharp increase in human H5N1 cases there during that same time frame, an international team of scientists reported yesterday in Eurosurveillance.

The researchers said the new strain has spread widely in Egypt's poultry and that two recent H5N1 isolates from human patients fall into the same group. It's too early to tell if the strain has gained a greater ability to jump from birds to humans, they wrote, and further studies are needed to find out if that's the case.
http://www.cidrap.umn.edu/news-perspective/2015/04/study-new-h5n1-strain-egypt-may-be-tied-rise-human-cases

About NanoViricides, Inc. - FluCide(TM)

The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.

NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.

Read more:

http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html

http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html

NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.

... We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time. http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html

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High-Throughput Microfluidic Preparation (2 yrs ago)

Much improved robustness allows parallelization (40 or more nozzles operating simultaneously)

Nanofluidics is the study of the behavior, manipulation, and control of fluids that are confined to structures of nanometer (typically 1-100 nm) characteristic dimensions (1 nm = 10-9 m).

Advanced Materials - Synthesis of Size-Tunable Polymeric Nanoparticles Enabled by 3D Hydrodynamic Flow Focusing in Single-Layer Microchannels† (22 February 2011)
http://onlinelibrary.wiley.com/doi/10.1002/adma.201004333/abstract