SHELTON, CONNECTICUT -- Wednesday, September 5, 2018 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a global leader in developing nanomedicines to attack viruses, announced today that it will be presenting at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held on September 4-6, 2018 at the St. Regis New York Hotel in New York City.
Dr. Anil Diwan, President and Chairman of the Board of NanoViricides, will present a corporate overview and discuss the Company's progress in taking its first drug candidate into human clinical trials. He will also introduce the Company's new CEO, Dr. Irach Taraporewala. The presentation is scheduled for 3:25pm ET on Thursday, September 6th, 2018.
The Company has updated its corporate "fact sheet", or brochure, and it is available on the Company's website at www.nanoviricides.com.
The Company has a broad and deep pipeline of drug candidates based on its unique, post-immunotherapeutic "bind-encapsulate-destroy" "nanoviricide®" technology platform, that addresses a market space of $40 Billion to $70 Billion. The Company is currently focused on developing topical skin creams and eye drops in the HerpeCide™ program to treat infections caused by VZV, HSV-1, and HSV-2 herpesviruses, towards regulatory approvals. These drug candidates leverage significant amounts of common technologies, thereby enabling the Company to maximize return on investments (ROI).
The Company has previously reported that its lead anti-VZV drug candidates in the HerpeCide™ program have been found to be highly effective against VZV infection of human skin patch organ culture studies. These candidates were also found to be highly effective in cell culture studies. In addition, these candidates were found to be effective in ameliorating pain sensations in an animal model of abnormal (neuropathic) pain. A characteristic excruciating pain is a debilitating pathology of shingles presentation. Thus a direct pain-reducing effect of the Company's anti-shingles drug candidates would be very important in ameliorating the pathology of shingles, in addition to the already demonstrated significant antiviral effect.
There are currently no approved treatments for shingles, PHN, or chickenpox, representing a commercially valuable unmet medical need. All of these are diseases caused by VZV. A highly effective treatment of shingles that would result in reduction in the duration and severity of PHN cases has been estimated to have a potential market size in the range of billions of dollars, even after the recent introduction of the new Shingrix vaccine. There are approximately 500,000 to 1 Million episodes of shingles hospitalization cases annually in the United States alone. Approximately 18% of patients overall, and as many as 30-50% of older patients with shingles, are estimated to have PHN. This represents more than 200,000 cases of PHN annually in the USA alone. Such VZV complications can cause extended hospitalization in about 4% of shingles patients overall, with an average estimated cost as high as $20,000 per hospitalized patient.
The Company has also found that these candidates were extremely safe in a preliminary rat safety/toxicology study. This has led to a redesign of the IND-enabling Safety/Toxicology study ("Tox Package") to be performed at the "maximum feasible dose" (MFD) level. This is estimated to require multi-kilogram quantities of the drug candidates. The Company has recently started production of the necessary quantities of the drug candidate at our cGMP-capable facility in Shelton, CT. The Company expects to begin "Tox Package" studies once the drug is manufactured in the multi-kg quantities needed and is already in negotiation with a CRO site for the study. The acute dermal safety/tox study is expected to be of a relatively short duration and we anticipate filing an IND once the report is available.
All of our drug candidates are based on broad and exclusive licenses in perpetuity from TheraCour Pharma, Inc. A license for VZV and the remaining herpesviruses is in progress. HSV-1 and HSV-2 are already licensed, as well as many other viruses including all influenzas, HIV, Dengue, Ebola/Marburg, among others. For further details, please refer to our quarterly and annual reports.
Shingles is caused by reactivation of the Varicella Zoster Virus (VZV, aka human herpesvirus-3 or HHV-3). A chickenpox (i.e. varicella) infection in childhood leads to the virus becoming latent in the nervous system. At an older age, or when immunity against this resident latent virus decreases, the virus replicates in the nerve cells, and bursts out of the nerve endings infecting neighboring skin cells, thus causing a typical shingles rash. The nerve injury caused by the virus leads to a characteristic excruciating and debilitating pain. The shingles rash may continue to expand for several days, and then subsides in about three weeks in an uncomplicated case. The VZV-associated neuropathic pain does not resolve quickly, and may continue even after the rash has resolved (hence called PHN), for several months to, in rare cases, years.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.