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NanoViricides To Participate In Panel Discussion At The B. Riley FBR Virtual Infectious Disease Summit Today, July 21, 2020


Benzinga | Jul 21, 2020 06:17AM EDT

NanoViricides To Participate In Panel Discussion At The B. Riley FBR Virtual Infectious Disease Summit Today, July 21, 2020

SHELTON, CT / ACCESSWIRE / July 21, 2020 / NanoViricides, Inc. (NYSE:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that Anil R. Diwan, PhD, President and Executive Chairman of the Company, will participate in the "B. Riley FBR Virtual Infectious Disease Summit - Therapeutics Day" on Tuesday, July 21, 2020. The Conference is organized by B. Riley FBR, Inc. ( https://brileyfbr.com/).

Dr. Diwan is invited to participate in Panel #3 at 2020 at 2:10 p.m. ET, entitled "Taming the Severe Disease Presentations". He will briefly discuss the Company's novel nanomedicines platform and the Company's progress in the lead IND-ready candidate for the treatment of shingles rash, NV-HHV-101, as well as in developing a drug candidate against SARS-CoV-2, the cause of COVID-19 global pandemic.

The Company believes that it is close to selecting a clinical candidate worthy of advancing into human clinical trials for the treatment of SARS-CoV-2 infection, based on (i) cell culture effectiveness studies against multiple circulating coronaviruses that employ different cell surface receptors, (ii) a lethal lung infection animal model effectiveness study using hCoV-NL63 infection (a coronavirus that uses the same receptor, ACE2, as SARS-CoV-2, and produced similar disease in the animal model), and (iii) preliminary safety studies in animal model at maximum feasible dosage levels. The Company has disclosed its findings from these studies in previous press releases.

Prior to filing for human clinical trials, NanoViricides plans on conducting studies, towards clinical candidate selection, to further determine the effectiveness against SARS-CoV-2, perform additional drug development studies as may be necessary, and request a pre-IND Meeting with the US FDA for regulatory guidance.

The Company is also working with its regulatory consultants on completing an IND with the US FDA to advance its lead drug candidate NV-HHV-101 into human clinical trials for topical dermal treatment of Shingles rash as the initial indication. In particular, the Company is working on finalizing the clinical trials plan for the anticipated human clinical trials for shingles rash treatment. The Company is also in the process of finalizing clinical trial sites. This process has been adversely affected by the current global COVID-19 pandemic, and in particular, its effects across the USA.

Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the "Venus-fly-trap" flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients.

Additionally, it is well known that viruses escape antibody-drugs via mutations. The Company's "nanoviricide" drug candidates, in contrast, are designed to be broad-spectrum, and therefore virus escape by mutations is expected to be unlikely.

The market size for the treatment of shingles is estimated at approximately one billion dollars by various estimates. These estimates take into account the Shingrix(r) 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(tm) program is variously estimated at 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(tm) 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.

The Company develops its class of drugs, that we call nanoviricides(r), using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide(r) technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody.

In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of simultaneously (a) attacking extracellular virus to break the reinfection cycle, and (b) disrupting intracellular production of the virus, thus enabling complete control of a virus infection.






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