SHELTON, CONNECTICUT -- Monday, April, 9, 2018 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reports that its drug candidates in the HerpeCide™ program have been found to be safe based on multiple parameters in the recently completed initial non-GLP safety/toxicology study.
No clinically observable adverse safety and toxicology effects were seen in this study of the Company's optimized topical dermal drug candidates.
These drug candidates will now advance towards the full battery of GLP safety and toxicology studies that are needed for filing an Investigational New Drug (IND) application with the US FDA, prior to beginning human clinical trials.
The drug candidates tested in this safety/toxicology study have previously shown broad-spectrum effectiveness against alphaherpesviruses, i.e. HSV-1, HSV-2, and VZV.
These candidates are being developed for multiple indications in the HerpeCide™ program. The overall market size for our targeted indications is in tens of billions of dollars.
There were no adverse effects on the skin at the treatment sites. Equally importantly, the results of the non-GLP safety and toxicology study showed that there were no overall observable systemic effects either. There were no observable direct effects on the primary organ function whether the drug was administered to the skin or administered systemically. This includes liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity.
These results are consistent with the positive findings in a model of VZV (the shingles virus) infection of human skin in which no safety or toxicology concerns have been observed, further demonstrating the safety of these drug candidates. The drug candidates have shown strong effectiveness in these shingles virus studies as well, as previously reported. Further, these candidates have demonstrated strong anti-viral activities against HSV-1, HSV-2, and VZV in cell culture studies using multiple cell lines.
Dermal topical treatment of rats with formulated drug candidates was evaluated in this study as a primary objective, since skin is the primary breakout site of HSV-1, HSV-2, and VZV infections. Additionally, the same drug candidates as formulated for systemic delivery were employed to evaluate potential systemic safety/toxicological effects.
The Company's drug candidates in HerpeCide™ program are being developed for direct topical application on the affected areas to control the infections. Direct topical application enables delivery of the highest possible concentrations of the active substance directly at the site of infection. This allows for maximal clinical effectiveness, while at the same time minimizing side effects that are seen with systemic therapy (such as oral drugs or injectables).
The Company expects to report additional data on the effects on the tissue structure (i.e. histopathology) when available. The study was conducted by AR Biosystems of Beverly, MA.
Anil R. Diwan, PhD, President of the Company, will present these data and the current state of development of the Company at the 2018 MicroCap Conference in New York City today. His presentation is scheduled for 10am today in Track 1. The Microcap Conference is being held at the Essex House in New York City (https://microcapconf.com).About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.