SHELTON, CONNECTICUT -- Friday, December 6th, 2019 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a global leader in nanomedicines against viruses, informs that the annual meeting of shareholders of the Company will be held on Saturday, December 7th, 2019 at 10:00 a.m., Eastern Daylight Time. The meeting will be held at the Sheraton Stamford Hotel, 700 East Main Street, Stamford, Connecticut 06901.
The Company is advancing its lead drug candidate, NV-HHV-101, towards filing its first IND application for the topical dermal treatment of singles rash as its first indication.
The Company's first drug candidate, NV-HHV-101, under the HerpeCide™ program is progressing towards human clinical trials satisfactorily. In light of the successful results that have become available so far in the IND-enabling pre-clinical development studies as reported by the Company in its press releases, the Company has been in the process of interviewing Contract Research Organizations (CRO's) that can perform human clinical trials of the NV-HHV-101 skin cream towards approval for the dermal topical treatment of shingles rash, as our first indication.
The Company has previously filed a pre-IND application for NV-HHV-101 for the dermal topical treatment of shingles rash with the US FDA and has received favorable responses on our potential study designs.
About 500,000 to 1 million episodes of herpes zoster (shingles) occur annually in the United States alone. In spite of the new Shingrix™ vaccine, the market size for a therapeutic for shingles is estimated to be in excess of $1 billion dollars. There is currently no approved drug against shingles, PHN, or chickenpox, indicating an unmet medical need.
In a human skin organ culture model of VZV infection, this drug candidate, NV-HHV-101, has been shown to be highly effective against VZV. This work was performed by Professor Jennifer Moffat at the SUNY Upstate Medical University, Syracuse, NY.
Since these efficacy studies were performed using human skin, and additionally were complemented with histological observations regarding safety, the Company believes that this work has laid the foundation towards success in human clinical trials.
The Company is working on developing drugs against several indications in our HerpeCide™ program. 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 NanoViricidesFDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.