SHELTON, Conn., Feb. 11, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a company with a novel platform technology to treat difficult and life-threatening viral diseases, announces that its President Dr. Anil Diwan will present the Company at the BIO CEO & Investor Conference being held at the New York Marriott Marquis on Feb 11th and 12th, 2019.
Dr. Diwan's presentation is scheduled for Tuesday, February 12th, 2019, at 2:30pm in the Gramercy Room.
BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies.
Dr. Diwan will present the Company's technology platform and its progress in taking the first drug candidate into human clinical trials. The Company recently reported that its first drug candidate in the HerpeCide™ program has now entered IND-enabling Safety/Toxicology studies moving towards human clinical trials.
The first part of the IND-enabling Safety/Toxicology studies for the shingles drug candidate began towards the end of December, 2018. These studies are being conducted by BASi, Indiana, a Contract Research Organization specialized in IND-enabling safety/toxicology studies. The Company expects to report on these various studies as soon as the data become available to us and is reviewed by our scientists.
The Company's most advanced pre-clinical drug candidate is our anti-VZV nanoviricide for the topical treatment of shingles, being developed as a skin cream. In cell culture studies, it was as much as five times more effective than acyclovir, the current standard of care. These anti-VZV drug candidates have also shown strong effectiveness in studies involving VZV infection of human skin patches ex vivo. These studies were conducted by Professor Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized expert on varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. The work was presented at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.
The Company has chosen the candidate now called NV-HHV-101 as the clinical drug candidate based on these drug candidate optimization studies. Assuming that the current non-GLP safety/toxicology studies are successful, the Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash initially.
The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, to develop for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The Company has a license to the TheraCour® technologies for HSV-1 and HSV-2 and the license for VZV Shingles is expected to be completed soon.
NanoViricides, Inc. is a global leader in the development of nanomedicine drugs against viruses. The Company is focused on bringing its topical treatment for shingles into human clinical trials. Several additional indications in the HerpeCide™ program are expected to follow. In addition, the Company has drug candidates in development against severe influenzas (including bird flu), HIV, Dengue, Ebola/Marburg and other viruses at different preclinical stages, comprising a market size of $40~70 Billion. This broad pipeline is enabled by our unique post-immunotherapeutic "bind-encapsulate-destroy" technology platform.
We are a development-stage company creating special-purpose nanomaterials for anti-viral drugs based on a novel, first-in-class mechanism. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles, on the same sites that they use to bind to cells, and dismantle them. Our unique biomimetic approach promises that a virus cannot escape our nanoviricide drugs due to mutations.
NanoViricides is unique in the field also in that we have our own multi-kg-scale cGMP-capable clinical drug manufacturing facility. This facility is anticipated to enable rapid translation to the clinic (as opposed to using an external manufacturer) of our drug candidates. Further, it should allow production of initial marketing quantities and thus early revenues from our first drug when licensed, which could be in the range of $50MM to $500MM per year, depending upon the drug and pricing.
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 subsequently into human clinical trials.
The cell culture based evaluation of drug candidates for HSV-1, HSV-2 and VZV is performed in our own Virology lab. The animal studies for HSV-1 and HSV-2 indications will be performed by Professor Brandt at the CORL facility at the University of Wisconsin, Madison, WI. The Brandt team is currently working on optimizing their animal models so that drugs that may be superior to existing treatments can be discriminated from the existing treatments.
Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. Additionally, the virus would not escape such a drug by mutational changes without compromising its competence.
With the nanoviricide platform technology, the Company has previously established that highly effective anti-viral drugs can be created against complex diseases such as Influenza, HIV/AIDS, Dengue, and Ebola/Marburg, to name a few.
The Company anticipates achieving several additional important milestones in the current calendar year, now that we have successfully met the milestones of declaring our first clinical candidate and initiating IND-enabling Safety/Tox Package studies for the same. In brief, these include achieving successful cGMP-like production of the drug as required for the "Tox Package" studies and improving the same for further human clinical product batches, completion of the Tox Package studies, a "Pre-IND" meeting with the FDA, filing of an IND, and the beginning of initial human clinical trials.
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, shingles and chickenpox, 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. EMA refers to the European Union's office of European Medicines Agency.)
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