SHELTON, CONNECTICUT -- Tuesday, March 5, 2019 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, announces that its first drug candidate has successfully completed the first of the Safety/Toxicology studies moving towards human clinical trials.
The Company is developing its broad-spectrum drug candidate in the HerpeCide™ program, namely, "NV-HHV-101", towards human clinical trials. The drug candidate is formulated as a dermal topical cream.The first part of the IND-enabling safety/toxicology studies comprised a non-GLP evaluation of safety and tolerability of the drug candidate in mini-pigs. The study was performed by BASi, Evansville, IN, an independent contract research organization that is specialized in IND-enabling safety/toxicology studies.
In this study, all dosage levels of the nanoviricide® drug product, including the maximum feasible dose, were well tolerated in all treated animals. All of the parameters evaluated in the study remained within normal ranges, and showed no adverse effects from the drug treatment.
These strong safety results are consistent with our previous studies on two related drug candidates during drug candidate optimization. The Company has previously tested two related development candidates in the HerpeCide™ program in non-GLP Safety and Tolerability study in rats for dermal exposure as well as systemic exposure by subcutaneous and intravenous routes of administration. The Company previously reported that those candidates were both found to be safe based on multiple parameters in the completed non-GLP Tolerability study.
Mini-pigs are considered to be a well correlated animal model for human dermal drug and cosmetics development. Pigs and mini-pigs are a much closer correlate of human clinical results as compared to rats for dermal topical applications.
The success of these studies forms the basis for progressing the drug candidate into more formal GLP Safety/Toxicology studies. The Company is negotiating with BASi for the earliest possible date for starting the GLP phase of these IND-enabling studies. Assuming that the GLP studies are also successful, the Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication.
In this non-GLP study, the drug skin cream was applied topically twice daily to approximately 10% of the total body surface area of each mini-pig in the group for seven days, as per a standard protocol for regulatory agencies including the US FDA. Each group of animals received a single dosage level (i.e. a given concentration of the API in the same amount of formulation vehicle). The dosage levels were varied from zero (vehicle alone) up to the maximum feasible dose in the study employing multiple groups.
The animals were evaluated daily for general signs of adverse effects and toxicity including body weight, detailed clinical physical observations as well as the specific evaluation of the skin treatment areas. Prior to treatment and one day after completion of dosing, blood samples were taken from each animal for hematology and clinical chemistry standard testing to assess systemic adverse effects, if any.
The seven days of treatment in this study began towards the end of December 2018, as previously reported by the Company.
Minipig size, anatomy, physiology, metabolism, and genetics are considered to correlate well to those of humans. Pig skin is anatomically, physiologically, biochemically, and immunologically similar to human skin. Also, pig skin is fixed or adherent like humans unlike the loose skin of rodents and dogs that are typically used in other safety and tolerability studies. The outer skin layer, the epidermis, of the minipig is also approximately the same thickness as that of human skin. Thus, minipigs are preferred by regulatory agencies for dermal treatment safety and tolerability studies.
The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.