NanoViricides Inc. (NNVC)

[changes_iv]

From NanoViricides, Inc. - October 7, 2013 Press Release,

...the Company announced that in this small animal non-GLP safety/toxicology study of NV-INF-1 drug candidate, even at maximum feasible dosage, the drug was well tolerated and that no adverse events were found at study completion. The Company is awaiting a full report on the chemistry and histology data from this study. These results are consistent with our findings during efficacy studies of this drug candidate in lethally infected mouse models. The Company is currently performing scale up studies on its FluCide drug candidate in its existing facilities. Upon scale-up, we will be able to produce the quantities of materials we need for the GLP Safety/Toxicology study of the injectable FluCide drug. We intend to begin the GLP Safety/Toxicology study as soon as feasible.

http://www.nanoviricides.com/press%20releases/2013/NanoViricides,%20Inc.%20Files%20Quarterly%20Report%20-%20Reports%20a%20Strong%20Cash%20Position%20Sufficient%20for%20Clinical%20Trials%20of%20its%20First%20Drug%20Candidate.html

We anticipate that our facility will be the only anti-viral nanomedicine cGMP production facility in the world (or the US for sure) ~ Eugene Seymour, MD, MPH, CEO of NanoViricides, Inc.

Nanoviricide, Inc. has also started sub-kg scale production of the injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of the injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from the in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of the injectable FluCide drug when the requisite large amount of drug substance is produced.

[We shipped FluCide(TM) to BASi in October 2014 and about 3 months later we received expected excellent results for Phase I and II of Toxicology Studies]

FACTS: No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed. There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.

The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.
http://www.prnewswire.com/news-releases/nanoviricides-reports-that-the-flucide-candidate-was-found-to-be-very-safe-in-cglp-like-safety-and-toxicology-study-in-rats-performed-by-basi-300024776.html

[By January 23, 2015 we were into the process of commissioning operations to perform scale up studies needed for making the large cGLP quantities of FluCide(TM) material for the final Phase III]

The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of 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.
http://www.prnewswire.com/news-releases/nanoviricides-reports-that-the-flucide-candidate-was-found-to-be-very-safe-in-cglp-like-safety-and-toxicology-study-in-rats-performed-by-basi-300024776.html

[On April 6, 2015, about (3) months later after the January 23, 2015 PR, the complete Characterization Group was moved to the new, one of a kind, Shelton Pilot Plant. Seems to me (3) identical batches have been produced, processes have been validated, and commissioning of the Pilot Plant, to produce cGLP 1Kg material of FluCide(TM), will be complete.]

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

[On May 18,2015...]

The Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analytics Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility. We implemented a phased program for commissioning the new facility. This has enabled us to continue to progress in all of our existing programs, without interruptions.

The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate. Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters
...
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.

[Scale-up? What, no more Scale-up "studies"? Is the scale-up process already validated? But at the time of the PR in May 18 they were still doing CMC studies and that relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. Then on Jun 1, 2015 Dr. Seymour emails, "...we are making FluCide(TM) material."]

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals

MersCide

Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak

EbolaCide

Making more drug for continuation of the testing by USAMRIID

Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!

Eugene Seymour MD MPH
Chief Executive Officer NanoViricides, Inc [e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114356690

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[It would add to certainty if companies in the field of nanomaterials manufacturing could claim production scale-up is guaranteed within a year but we are talking scale-up of "breakthrough technology" nanomaterials. Easier said than done. Continuous manufaturing of Nanomaterials...does that mean day and night manufacturing? Hmmm.]

Microfluidics Establishes PureNano™ Group (PNG) to Advance Continuous Manufacturing of Nanomaterials
Nanotechnology-Based Drugs, Fine Chemicals and Materials for Energy Applications to Be Targeted

Newton, MA (PRWEB) June 13, 2011

Microfluidics, the exclusive global provider of Microfluidizer® high shear fluid processors, today launched a dedicated, internal PureNano Group (PNG) to develop go-to-market strategies for PureNano. This is an exclusive, award-winning, processing technology used to create tailored nanomaterials through crystallization, chemical reaction and nano-encapsulation. Applications of the technology include nanotechnology- based novel pharmaceuticals, functional foods and catalysts.

“Our PureNano Technology is a leap forward for materials engineering in producing the purest, most uniform nano-sized substances available anywhere,” said Thomai (Mimi) Panagiotou, Ph.D., Microfluidics Chief Technology Officer. “The PNG has the passion and commitment to advance PureNano’s technology, process consulting, training and implementations. I am confident that we will achieve new levels of product quality and process efficiency for the pharmaceutical market, the energy industry and beyond.”

Dr. Panagiotou will head the group. The PNG team will also include: MIT Chemical Engineering senior faculty member Robert J. Fisher, Ph.D., PureNano Engineering Manager Ken Chomistek and Microfluidics Global Sales Support Manager Tom Speed.

Over the next six months PNG’s business objectives will include:

-Establishing PureNano customer interactions, services and implementation
-Assuring that each PureNano unit is implemented successfully
-Creating market knowledge about the technology’s capabilities
-Developing and integrating a comprehensive sales training module

PureNano Technology
PureNano Technology, a cutting-edge platform for continuous manufacturing, combines a unique, high shear fluid processor with expert process development. It is a revolutionary technology for bottom-up nanoparticle creation offering:

-Continuous crystallization for production of highly crystalline drug nanoparticles
-Multi-phase chemical reactions
-Nanoencapsulation of actives
-Process intensification

With the goal of reducing the time and cost of commercial drug formulation, PureNano enables companies to transform their batch manufacturing efforts into continuous production processes. Through the bottom–up creation of nanoparticles, as well as the ability to control their growth, PureNano enables research teams to develop stable and consistent nanoemulsions of previously unattainable sizes and narrow distributions (such as Azithromycin with a z-average particle size of 82 nm).

About Microfluidics

Microfluidics, an IDEX company, is the exclusive producer of Microfluidizer® high shear fluid processors for uniform particle size reduction, robust cell disruption and bottom-up nanoparticle creation. Used primarily by pharmaceutical, biotechnology, chemical, cosmetic, nutraceutical/food and energy companies to research, develop and improve products with efficient processes, more than 3,000 Microfluidizer processors are installed at customer sites in 50 countries around the world. The innovative Microfluidics Technology Center, located at the company’s headquarters outside Boston, Mass., is staffed by expert engineers with a wide range of nanotechnology and application experience for Proof of Concept and Process Development services.

By producing smaller particle sizes and a more narrow distribution than other technologies, with scaleup from lab to production guaranteed, Microfluidics enables companies to create tiny particles that achieve big results. To learn more, visit http://www.microfluidicscorp.com.

http://www.prweb.com/releases/nanotechnology/nanomanufacturing/prweb8562325.htm

http://www.manufacturingchemist.com/news/article_page/Microfluidics_sets_up_PureNano_Group/61726