SHELTON, CONNECTICUT -- Wednesday, October 9, 2019 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"),a leader in nanomedicines with novel platform technology to treat difficult and life-threatening viral diseases, announces that it has initiated bio-analytical studies as part of the required IND-enabling preclinical safety and toxicology studies of NV-HHV-101, moving towards human clinical trials.
The Company has contracted NorthEast BioLab, Hamden CT, to conduct the bio-analytical studies and facilitate the toxicokinetic analyses. These studies and analyses are part of the required general safety and toxicology studies that will go into an Investigational New Drug (IND) Application to the US FDA.
NorthEast BioLab has already performed the bio-analytical assay development and validation and is in the process of determining the concentrations of NV-HHV-101 in blood samples from the general safety and toxicology studies that are required for IND.
The Company has previously reported on the early results from the GLP safety and toxicology studies that were performed by BioAnalytical Systems, Inc., Evansville, IN ("BASi"). The first of these studies, a GLP safety and tolerability study following dermal treatment, was conducted using miniature pigs, called minipigs, that received twice daily skin treatment of NV-HHV-101 for 28 days. A second GLP study was conducted in rats treated with NV-HHV-101 for 28 days by subcutaneous administration to ensure systemic exposure and to determine effects of such systemic exposure. NV-HHV-101 is designed for administration as a dermal topical cream.
As previously reported, treatment of minipigs and rats with NV-HHV-101 for 28 days has been shown to be safe for the animals and well tolerated based on the in-life observations. The Company is awaiting more detailed clinical and histological reports from these GLP Safety/Toxicology studies.
The results of the bio-analytical assays on blood samples collected from the minipigs and rats will be used for toxicokinetic analyses as part of the safety profile of NV-HHV-101.
The Company is planning that the bio-analytical assays and pharmacokinetic analyses required for the human clinical trials also to be performed by NorthEast BioLab.
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 NorthEast BioLab
NorthEast BioAnalytical Laboratories LLC (NorthEast BioLab) has in-depth expertise in analytical testing laboratory services to perform in-vitro and in-vivo testing of chemicals and assessing their efficacy for intended therapeutic value. The company has 15+ years of experience as an analytical services laboratory committed to developing and validating robust bioanalytical methods per FDA guidance and has developed outstanding processes and standard operating procedures (SOPs) for streamlining drug testing and analysis with the primary objective of expedited FDA drug approval.
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.