SHELTON, CONNECTICUT -- Monday, December 2nd, 2019 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that it has initiated the Safety Pharmacology studies involving CNS, Cardiovascular, and Respiratory systems, that are required to support the IND application for NV-HHV-101 moving towards human clinical trials.
The Company believes that the likelihood of adverse effects on the central nervous, cardiovascular or respiratory systems is very low because our lead drug candidate, NV-HHV-101, is developed to be administered as a topical formulation to the skin in humans and is not expected to result in bodily systemic exposure.
Safety Pharmacology studies are designed to determine the potential undesirable effects of a drug on the central nervous, cardiovascular and respiratory systems. The Company has entered into an agreement with CorDynamics, Inc., Chicago, IL, to conduct Safety Pharmacology studies to assess the effects of NV-HHV-101 on the cardiovascular and respiratory systems. The Company has previously agreed to assess the central nervous system effects of NV-HHV-101 as part of its general safety and toxicology studies conducted by BASi, Evansville, IN. The draft report of the studies performed by BASi is being prepared by BASi.
For a drug to progress to clinical trials in humans, Safety Pharmacology must conclude that a drug has a sufficiently low potential to evoke adverse effects in patients during clinical trials. The FDA and other international regulatory authorities require Safety Pharmacology assessment to support the support Investigational New Drug (IND) submissions for entering clinical trials. Additional IND-enabling studies are in progress. Upon completion of all of these required studies, the Company anticipates filing an IND with the US FDA to advance NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication.
The market size for the treatment of shingles is estimated at about a billion dollars by various estimates. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur in the USA alone every year.
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. These additional candidates are based on NV-HHV-101, thereby maximizing return on investments and shareholder value.
About CorDynamics
CorDynamics, located in the city of Chicago, is a nonclinical contract research organization and consulting group focused on examining the cardiovascular effects of emerging drug candidates. The company is an industry leader in cardiovascular research and provides support with discovery and safety pharmacology studies for more than 500 international biopharmaceutical clients.
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.