SHELTON, Conn., June 3, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to fulfill unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has received favorable comments from the US FDA on the Company's pre-IND application for its lead drug candidate.
The Company reports that the US FDA (the Agency) has generally agreed in its pre-IND response that the plan of drug development presented by the Company to the FDA is generally adequate at this time. The Company received the response on May 23rd, 2019.
In particular, the Agency has agreed that the Company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has further agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate. The US FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time.
The FDA has made valuable suggestions in the pre-IND response. The additional non-clinical studies recommended by the Agency are generally consistent with the Company's planned IND-enabling non-clinical studies. The Company has discussed the Agency's comments and suggestions in detail with its regulatory consultants from Biologics Consulting Group, VA.
"This is an important milestone that takes our lead drug closer to an IND filing," commented Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "We are very pleased with the FDA response."
The Company is now proceeding with completing the IND-enabling studies, and is working towards engaging appropriate clinical study sites and developing concrete clinical study plans.
The Company has chosen NV-HHV-101, a broad-spectrum drug candidate in its HerpeCide™ program, as its lead candidate. This candidate is formulated as a skin cream for the treatment of shingles rash, the Company's first target indication. Shingles is caused in adults by varicella zoster virus (VZV), the same virus that causes chickenpox in children. The chickenpox virus remains latent in the nerve ganglia, and breaks out into shingles rash generally due to immune-compromised status. NV-HHV-101 is designed to mimic the herpesvirus binding site on the herpesvirus entry mediator (HVEM), the classical receptor for HSV-1 and HSV-2. The Company found in its own work in cell culture studies that the same drug, in addition to working against HSV-1 and HSV-2, also worked against VZV, although it is not known in scientific literature whether VZV uses HVEM to infect cells. The Company intends to develop drugs for the HSV-2 ("genital ulcers") and HSV-1 ("cold sores") indications as the VZV program moves into the clinic.
The drug candidate NV-HHV-101 is a nanomedicine 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.
There is a significant unmet medical 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 Company currently intends to perform clinical studies for shingles rash reduction, which would enable a sub-billion dollar market opportunity. As experience with the drug is developed, it would be possible to extend the indication to cover PHN thereby expanding the market opportunity.
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. The Company's nanomedicines technologies are based on the TheraCour® polymeric-micelle based nanomedicine technologies of TheraCour Pharma, Inc., from which the Company has obtained licenses for developing drugs against a number of viruses. A license for VZV is in progress. 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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