NanoViricides Inc. (NNVC)

[changes_iv]

Successful scale up to me means they have done it in a reproducible manner or batches (GMP-like).

The Company also reported that it is producing Injectable FluCide™, our most advanced drug candidate, at its existing facilities, in the large quantity needed for the Safety and Toxicology ("Tox Package") study. The strong safety observed in preliminary safety studies resulted in requirement of a very large quantity for the Tox Package study. Notably, the drug candidate was found to be safe even at the maximum feasible dosage level in a small animal study. The Company reports that it has successfully scaled up the production of injectable FluCide at its current facility.

source: http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20won%20the%20IAIR%20AWARD%20as%20Best%20North%20American%20Company%20for%20Leadership%20in%20the%20Nanomedicine%20Sector.html

It is possible that GLP Toxicology and Safety studies may have already started(IMO)in which case we are waiting for news like those from non-GLP tox-studies at KARD Scientific Massachusetts:

Detailed laboratory analyses of samples from this non-GLP safety and toxicology study showed no overall systemic effects and no direct effects on the primary organs. This includes liver and kidney tissues as well as liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity. In addition, FluCide showed no adverse effects on the lungs from the treated animals. This is very important because the respiratory system is a primary site of influenza virus infection and tissue damage. These strong safety findings were seen at all doses tested, even at the maximum feasible dose (MFD). MFD was much higher than the therapeutic dose range used to treat influenza virus infections in our animal model efficacy studies. FluCide was administered intravenously by tail-vein injections or by infusion in this study. The non-GLP safety/toxicology study was conducted at KARD Scientific in Massachusetts.

These results support the Company's positive findings in animals that were infected with different influenza A virus strains. In those studies, no safety or toxicology concerns were observed. The Company has previously reported that its FluCide candidate demonstrated extremely high anti-influenza activity in lethal infection animal models using multiple influenza A subtypes. The extremely high anti-influenza activity coupled with the strong safety data were the basis for the selection of this FluCide candidate for further drug development.

As previously reported, the results of this study will provide both the basis and focus for the GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These GLP studies will be performed on both large and small animals at the BASi facility in Indiana.

source: http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Inc%20Reports%20Excellent%20Safety%20Profile%20of%20Its%20Broad%20Spectrum%20anti%20Influenza%20Drug%20Candidate%20FluCide%20in%20a%20Non%20GLP%20Study.html

BASi Launches Culex NxT Next Generation In Vivo Automated Sampling System --- Dec 2012
...
Developed by BASi to collect pharmacokinetic and pharmacodynamic data, the Culex system can automatically collect blood, bile, metabolites, dialysates and more from awake and freely moving animals as small as mice and as large as swine. The system is used by nine of the world's top ten pharmaceutical companies, universities, and contract research organizations.

"Scientists choose Culex over manual sampling because it delivers better data, which leads to better decision-making," said Candace Rohde-Johnson, director of BASi's Instruments Division. "Incorporating innovative hardware and software improvements, the new Culex NxT has the same small footprint, robust design and ease of use of the original, providing its users peace of mind when away from the lab. Culex's ability to run experiments around the clock versus just during business hours significantly increases our clients' efficiency and productivity in the early stages of drug discovery, including safety pharmacology."