NanoViricides Inc. (NNVC)

[changes_iv]

NanoViricides Announces Delivery of FluCide to BASi to Begin Toxicology Studies

Published on October 3, 2014 at 7:40 AM

NanoViricides, Inc. reports that it has shipped FluCide™ to BASi for the start of toxicology studies. NanoViricides has chosen BioAnalytical Systems Inc. Toxicology Services of West Lafayette, Indiana to perform our safety/toxicology studies as needed for an IND submission of the Injectable FluCide drug candidate.

In other news, NanoViricides reported that the synthesis of its anti-Ebola second generation drug candidates has started. We anticipate being able to evaluate these against Ebola virus with certain of our previous collaborators. The contracts to enable such evaluation are currently in progress. The Company’s nanomedicine technology enables development of drugs that directly attack the virus, in a manner that a virus may not be able to overcome despite mutational changes. This is very important for the current epidemic-causing Ebola virus strain, which has been shown to be mutating rapidly.

Injectable FluCide was found to be extremely safe in mice in a preliminary safety study. This study showed no evidence of any adverse events even at the maximum tolerable dose level. No significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.

With this information, and in consultation with BASi, we designed the safety/toxicology protocols for certain starting studies. We estimated that the total “Tox Package” studies would need as much as 2.5kg of the drug substance. Recently we broke up the study into parts and developed a starting study protocol that would require a 200g batch. Simultaneously, we have successfully scaled up our synthesis processes in the current Wood Street facilities, to be able to produce a 200g batch. The material we produced has gone through certain tests for its quality. We then prepared the samples as per the protocol design, and we have shipped them to BASi yesterday.

Nanoviricides Reports that the FluCide Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi
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

[About three months later...]

WEST HAVEN, CONNECTICUT -- Thursday, January 22, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCide® drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.

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.nanoviricides.com/press%20releases/2015/Nanoviricides%20Reports%20that%20the%20FluCide%20Candidate%20was%20found%20to%20be%20Very%20Safe%20in%20cGLP-like%20Safety%20and%20Toxicology%20Study%20in%20Rats%20Performed%20by%20BASi.html

[It took approximately 3 months for NanoViricides, Inc. to get the results from BASi for GLP Toxicology Study, Phases I and II. If GLP toxicological study (Phase 1, 2 and 3) take up to nine months(after commissioning the study), 3 of which are reporting on results, can we say Phase III will take 3 months and 2 months of reporting? And that is a "Puffer-like" conservative estimate.]

On Apr 6, 2015...

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 18th, 2015...

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.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html

[We have likely developed the 500g scale-up recipe for FluCide (TM), and now the 1kg scale-up recipe. Can we say we are now making material, the first 1kg of identical batches for the last phase of tox studies in large animals?]

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

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Miniaturized lab-on-a-chip methods are being deployed as labor-saving devices in biological research, through the advent of a suite of microfluidics technologies. Microfluidics enables large-scale studies that provide the means to better understand, prevent, and treat human disease. In his 2012 Midsummer Nights' Science lecture, Paul Blainey discusses the promise of using microfluidics to transform our industrial infrastructure to operate more efficiently, while protecting the natural environment.

New Alliance Between Microfluidics And Particle Sciences Expands Reach Of Microfluidizer® Technology

Microfluidics and Particle Sciences collaborate to extend the application, expertise and support of unique high shear fluid processors.

[4/06/2015] — Westwood, MA — Microfluidics, exclusive global creator of Microfluidizer® high shear fluid processors, is now partnering with Particle Sciences, Inc., a leading contract development and manufacturing organization (CDMO). This new alliance is designed to give the companies more ways to serve their clients with complex formulation development as well as lab support testing services in Pharmaceutical and Biopharmaceutical processing.

“Particle Sciences has been a good partner in the past, making our decision to work more closely with them an easy one,” said Brad Besse, Business Unit Director at Microfluidics. “They have shown themselves to be leaders in nanoparticle production, specifically with our technology.”

CEO at Particle Sciences, Dr. Mark Mitchnick, added, “Particle Sciences is the leading CDMO for nano-based products. We have worked with Microfluidics since before their acquisition by IDEX, and already have several machines installed. We are seeing an increasing need for the highly consistent performance Microfluidizer® technology is able to deliver. This, combined with Particle Sciences’ deep understanding of the technology and our base capabilities in characterization and sterile production is driving the relationship expansion. We have formulated multiple products with Microfluidizer® technology, recently manufacturing 120L of a sterile emulsion for a client using the equipment and have several more in the pipeline.”

Besse also said he believes “that by working together, both parties can expand their application expertise and support services to better serve our customer needs. In addition to formulation and clinical trial production, Particle Sciences affords our customers the ability to work with highly potent compounds under cGMP guidelines, in a purpose-built facility.”

Microfluidics is the exclusive producer of Microfluidizer® high shear fluid processors for uniform particle size reduction, robust cell disruption and nanoparticle creation. The innovative Microfluidics Technology Center, located at the Company’s headquarters outside Boston, Massachusetts, is staffed by expert engineers with a wide range of nanotechnology and application experience for proof-of-concept and process development support. Microfluidizer™ technology enables companies to create tiny particles that achieve big results. To learn more, please visit www.microfluidicscorp.com, email [e-mail] , or contact us at [phone].

Particle Sciences is an integrated provider of drug development services. Particle Sciences focuses on BCS II/III/IV molecules, biologics and highly potent compounds through a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others. Through a full range of formulation, analytic and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic. They also have an extensive history in government contracting alongside their customers...
http://www.microfluidicscorp.com/latest-news-a-events/200-new-alliance-between-microfluidics-and-particle-sciences-expands-reach-of-microfluidizerr-technology