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NanoViricides Submits Pre-IND Briefing Documents to the US FDA

SHELTON, Conn., April 16, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to meet unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has submitted the required pre-IND Briefing Documents for its lead drug candidate NV-HHV-101 to the US FDA, ahead of schedule.

The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.

There is a significant unmet need for the topical treatment of shingles rash. An effective therapy has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine.

The pre-IND briefing documents included the current data on our drug development. This included a description of the drug and its potential benefits, summary of the rationale, a brief CMC section ("Chemistry, Manufacture, and Consistency") regarding production and quality assurance, summaries of the in vitro (cell culture) and ex vivo (human skin organ culture model) studies of effectiveness, and summaries of non-GLP safety/toxicology studies regarding safety. In addition, the briefing documents also included a general description of the GLP safety/toxicology study plan, as well as a plan of Phase I/Phase II human clinical trials for evaluating the safety and effectiveness of the drug in humans subsequent to filing an IND.

Consultants from the Biologics Consulting Group, Inc., Alexandria, VA, helped the Company develop the briefing documents including the presented clinical studies plan.

The non-GLP Safety/Toxicology studies were conducted by BASi, Evansville, IN, a Contract Research Organization that is specialized in IND-enabling safety/toxicology studies. BASi is now continuing to perform the GLP Safety/Toxicology studies subsequent to the successful completion of planned non-GLP studies.

The ex vivo human skin organ culture model has been developed by Professor Jennifer Moffat, Upstate Medical Center, SUNY Syracuse, NY. Evaluation of NV-HHV-101 continues to be performed in her lab. There is no animal model available for the evaluation of topical drugs against VZV infection. VZV only infects humans.

NanoViricides has previously shown that the NV-HHV-101 drug candidate as well as several related candidates in the pre-clinical optimization phase were highly effective against the shingles virus, VZV (Varicella-Zoster-Virus), in human skin organ culture ex vivo model of the disease. Further, the non-GLP Safety/Toxicology studies of NV-HHV-101 have shown an excellent safety profile, with no adverse events at the highest dosages tested in the safety/tox studies.

The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications as of now.

The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into several 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.

Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, VZV does not have an effective TK enzyme that is required for producing active forms from the acyclovir class of drugs, requiring frequent administration of large doses. While shingles presents with a debilitating "pins-and-needles" pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries. Limiting initial viral load is expected to minimize the occurrence of  such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia ("PHN"), which is defined as persistent pain six months or longer after the initial rash has subsided. Shingles occurs when the immune system weakens due to age, stress or other factors such as other immune-compromising diseases (such as HIV or other viral infections) or conditions (such as organ transplant or anti-immune therapeutics against auto-immune diseases). The epidemiological incidence rate of shingles suggests that almost every person will have shingles at least once in lifetime if he/she reaches an age of 85. Thus there is a significant unmet medical need for new, effective, therapeutics against shingles.

The FDA previously responded to our pre-IND meeting request letter and asked for the briefing documents to be submitted by April 19th (Our previous press release of April 6th had a typo error, and stated this date incorrectly as 29th). In addition, consistent with current protocol, the FDA has stated that they will provide a written response to the Company's submission. This written response will guide the Company's IND submission for this drug candidate and indication.

The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases. 

NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.

About NanoViricides 
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.  Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

FDA refers to US Food and Drug Administration. IND refers to investigational drug application. API refers to active pharmaceutical ingredient.

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SOURCE NanoViricides, Inc.