NanoViricides Inc. (NNVC)

[changes_iv]

Bird Flu Vaccine Conditionally Approved, but Still Can’t Be Sold
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“U.S.D.A. has said no vaccine is to be used for highly pathenogenic avian influenza,” said Joel Harris, vice president for sales and marketing at Harrisvaccines, which was founded by his father, Dr. Hank Harris. “What this license does is that if they allow a vaccine to be used, we would immediately have a U.S.D.A.-licensed product available for producers.”

The H5N2 strain of avian influenza that did most of the damage in the spring is extremely virulent, moving from one or two birds to entire flocks within 24 to 48 hours. It is believed to have been spread by wild birds migrating north, and poultry and egg producers have been concerned that birds will bring it or another equally devastating strain back with them as they begin their migration south this winter.
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Harrisvaccines is continuing to test the efficacy of the vaccine, with one trial with turkeys underway and other planned for testing on adult hens and day-old chicks. Mr. Harris said the biggest drawback so far is that the vaccine must be injected, which is logistically complicated in operations involving tens and even hundreds of thousands of birds.
http://www.nytimes.com/2015/09/22/business/bird-flu-vaccine-conditionally-approved-but-still-cant-be-sold.html

It is possible that once NanoViricides, Inc. ships samples of FluCide(TM) to BASi for third and final phase of Safety/Toxicology Studies, the H5N2 strain may be among those used for additional efficacy studies, required to ascertain the broadspectrum nature of the drug candidate.

The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broadspectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an Investigational New Drug” application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced. However, certain international regulatory agencies do not require cGMP product, but rather cGMP-like product. The difference is subtle, but can make a difference of several months. We plan on taking advantage of this and try to request permission for human clinical trials abroad soon after we can make cGMP-compliant product in the new facility.
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http://www.nanoviricides.com/2014-ceo-letter.pdf

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About Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study

Abstract

Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.

FROM THE CLINICAL EDITOR:

Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness.
http://www.ncbi.nlm.nih.gov/pubmed/23969105