SHELTON, CT / ACCESSWIRE / April 6, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a leader in the development of highly effective antiviral drugs based on a novel, patented, nanomedicines platform, reports that U.S. Senator Richard Blumenthal visited the Company's facility in Shelton, Connecticut, on Tuesday, March 31, 2020.
The Honorable Senator Blumenthal visited the Company to receive an update regarding the coronavirus (COVID-19) drug development program and to tour the cGMP-capable manufacturing facility. The Senator, his staff, and members of the Press participated in a tour of the Company's lab and manufacturing facility.
Following the tour, the Senator held a press conference in front of the building.
"NanoViricides, Inc. must be given full and fair consideration for CARES funding because every approach that has strong potential for developing a treatment for COVID-19 must be supported immediately - it will save American lives. I am going to ask my staff in Washington, DC to do whatever we can to enable the Company to access such funding and I will do everything in my power to help NanoViricides get the attention and review they merit from BARDA, the FDA and other federal agencies," assured Senator Blumenthal.
Anil R. Diwan, PhD, President and Executive Chairman of the Company, welcomed the Senator and gave a brief overview of the Company's approach to coronavirus drug development to the Press. "We are developing what is effectively a ‘Venus-Fly-Trap' for the virus particle. Just as a fly is attracted to a Venus-Fly-Trap flower, and then the flower closes onto it, our material attracts the virus particle, and then wraps around the virus particle thereby rendering the virus particle incapable of infecting cells," said Dr. Diwan, adding, "Our material, i.e., a nanoviricide, mimics the human cell surface receptors to attract the virus."
"The beauty of this technology is that, a virus would not be able to escape a nanoviricide by mutations or genomic changes, because no matter how much it changes, the mutated virus still lands on the same cellular receptor in the same fashion as its earlier version," elaborated Ms. Meeta R. Vyas, SB, MBA, the Chief Financial Officer of the Company.
"I co-authored the $8.3 Billion CARES act to support the development of drugs, diagnostics, vaccines, and other measures to combat COVID-19," said Senator Blumenthal, adding, "The drug development by NanoViricides deserves to be supported."
In response to questions from reporters, Dr. Diwan explained that the Company had already identified some drug candidates that had strong activity against at least two coronaviruses that use different cellular receptors. One of these viruses uses the same receptor, namely ACE2 (angiotensin-converting enzyme 2), as SARS-CoV-2, the coronavirus that causes COVID-19 disease.
This broad-spectrum activity provides confidence that these candidates would be effective against SARS-CoV-2, he emphasized. Testing against SARS-CoV-2 itself is expected to be performed very soon. The Company is in the process of setting up collaborations with external BSL3/BSL4 labs that have developed assays for such testing, he added. Dr. Diwan also stated that the Company intends to publish its results once the verification experiments are completed. In parallel, the Company has already begun certain animal studies to help identify clinical drug candidates against SARS-CoV-2, in order to expedite the program.
When asked to comment on other drugs being considered to treat the virus, Dr. Diwan explained that the nanoviricides technology was complementary to other drugs because nanoviricides attack the virus outside the cell to prevent it from infecting the cell, while other drugs (except antibodies) work inside the cell to reduce virus replication. "A nanoviricide drug for attacking the SARS-CoV-2 virus particle and stopping the re-infection cycle taken together with another drug for limiting viral replication inside cells would make an even more effective treatment for COVID-19 than either one by itself," he explained.
"We can produce sufficient quantities of a drug to treat as many as a thousand patients in a single batch in our cGMP-compliant manufacturing facility," said Dr. Diwan, in response to a question from a reporter regarding manufacturing capacity of the Company, adding, "The manufacturing capacity can be substantially increased with additional resources."
The Company is negotiating with two Biological Safety Level 4 (BSL4) laboratories in the United States for conducting testing of its drug candidates against SARS-CoV-2, the virus that causes COVID-19 disease, in cell culture assays, and, if successful, in animal studies, as may be necessary for further development towards first-in-human use. We anticipate signing a Materials Transfer Agreement (MTA) with at least one of these two agencies as soon as the draft MTA is finalized by our respective legal teams. However, as with all negotiations, there can be no assurance that we will be successful in establishing the necessary collaborations. Also, as with any drug in development for any disease including COVID-19, there can be no assurance that our drug candidates will show sufficient effectiveness and safety for human clinical development at this time.
"We have been working on this project with limited internal resources while continuing our work on our lead drug against Shingles which is close to an IND," said Dr. Diwan. He added, "At this stage, we need help from government agencies, laboratories, and collaborators in order to quickly deliver our promising potential treatment to patients suffering from COVID-19. It is an honor to have Senator Blumenthal visit our facility. We are grateful for his commitment to assist us in accessing potential federal funding and support from agencies such as Biomedical Advanced Research and Development Authority (BARDA), the FDA and the NIH, in our efforts to save American lives in the fierce battle our country faces to defeat SARS-CoV-2."
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. 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. The Company does not currently have a license to the coronavirus field, however, TheraCour has not denied any licenses to the Company. The Company typically begins the licensing process only after demonstrating effectiveness of some candidates in optimization stage. 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 application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".
