NanoViricides Inc. (NNVC)

[changes_iv]

Flu shot only 19% effective this winter
Liz Szabo, USA TODAY 5:03 p.m. EDT June 4, 2015

Flu vaccines were only 19% effective in preventing doctor visits for influenza this season, one of the lowest rates in the past decade, the Centers for Disease Control and Prevention said Thursday.

Health officials had predicted flu shots would be less protective than usual this year. That's because the viruses used to make the flu shots weren't a good match for the dominant strains of influenza in circulation, said Brendan Flannery, an epidemiologist in the CDC's influenza division.

Scientists face a difficult challenge each year when selecting the virus strains to be included in seasonal flu shots, said Andrew Pekosz, an associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. That's because flu viruses, unlike the measles or polio viruses, undergo significant genetic changes each year. So the vaccine needs to change every year, too.

Scientists from the CDC and Food and Drug Administration survey the dominant flu strains annually and make their selections in February, Flannery said. That gives manufacturers about six months to produce the vaccines, which ship out to clinics the following fall. Last year, however, flu viruses began mutating almost as soon as companies began production.
Read more: http://www.usatoday.com/story/news/2015/06/04/flu-shot-effective/28465601/

NanoViricides, Inc. - FluCide(TM) - About FluCide(TM) Data presented at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11

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
...
The data indicates that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.

Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html
...
No failures in 5000 plus animals and...

"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.

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.

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

=============================================

Optimizing the discovery and clinical translation of nanoparticles: could microfluidics hold the key? (2014)

...
Use of nanoprecipitation for commercial production of NPs still needs additional development; although high-throughput micro/millifluidic devices are available for rapid nanoprecipitation, some properties (e.g., drug loading and stealth layer coverage) of NPs prepared by nanoprecipitation methods may be suboptimal. There is still ample room for further development of microfluidic processes for NP synthesis, and the potential of microfluidics to create complex, multifunctional NPs for nanomedicine remains largely unexplored. Microfluidics-enabled combinatorial synthesis and screening for optimizing NPs has already been undertaken by several research groups. Here, issues of scalability are of less concern and the output is primarily in the form of research knowledge regarding behavior of different types of NPs. Microfluidic approaches will likely continue to be adopted and applied to understanding and optimization of NPs for diverse applications. However, the impact of better in vitro screening may be more substantial in the long run. If organ-on-a-chip technology indeed proves to be able to reduce the time and costs associated with in vivo studies, it will revolutionize the development process for therapeutics including NP drug carriers. So, coming back to the question – does microfluidics hold the key? Although microfluidics may not be indispensable for progress in nanomedicine, all indicators point to a future where microfluidics will play a major role in facilitating each step in the discovery and translation of NPs to clinical impact.
http://www.futuremedicine.com/doi/full/10.2217/nnm.14.73