SHELTON, CONNECTICUT -- Tuesday, March 12, 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 another important step in its Safety/Toxicology studies moving towards human clinical trials.
The broad-spectrum anti-herpes clinical candidate in the HerpeCide™ program, namely NV-HHV-101, was tested in this study, formulated as a subcutaneous injection, to determine potential systemic safety and toxicological effects. While NV-HHV-101 is designed and developed as a dermal topical cream, it is important to determine if any systemically absorbed portion of the drug can have deleterious effects.
NV-HHV-101 administered subcutaneously was well tolerated and there were no NV-HHV-101-related findings in this escalating dose study at all dosages up to the maximum feasible dose in dogs. The success of this non-GLP study allows advancing the drug candidate into the GLP portion of the Safety/Toxicology studies that are required for filing an IND.
This study was conducted at BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies. The study was completed in February, 2019.
The Company is negotiating the earliest possible date for starting the IND-enabling GLP Safety and Pharmacology studies at BASi. Assuming that these studies are successful, the Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication as soon as possible.
This non-GLP safety and tolerability study in dogs, was a lead in to a planned GLP safety cardiovascular, and if necessary respiratory, study in dogs. The objective of this study was to evaluate the tolerability of NV-HHV-101 when administered as single escalating doses separated by at least three days. An increased level of dosage was given to the same animals after a washout period of at least three days, if there were no observed safety/toxicology issues. Four escalating levels of dosages up to the maximum feasible dose were administered in this manner. The animals were evaluated for clinical observations, body weights, and food consumption. Blood samples for systemic exposure were collected at specified time points, processed, and frozen for further planned tests.
These positive results help provide the basis for proceeding to IND-enabling GLP Safety Pharmacology studies. Safety Pharmacology studies are designed to investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In addition to separately conducted Toxicology assessments with new drug candidates, Safety Pharmacology studies provide important information to clinical investigators for potential acute adverse effects upon a number of body systems, such as the cardiovascular, respiratory and central nervous systems.
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.