SHELTON, CT / ACCESSWIRE / December 2, 2019 / NanoViricides, Inc. (NYSE American: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.
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.
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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. 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.
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SOURCE: NanoViricides, Inc.