SHELTON, CONNECTICUT -- Wednesday, April, 26, 2017 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), reports that Eugene Seymour, MD, MPH, CEO, will present information about the Company and its progress towards human trials at the Planet Microcap conference at the Planet Hollywood Hotel. His talk is scheduled for 12:30pm PDT on Thursday April 27th. The Planet MicroCap Showcase brings together the most promising companies and the top dealmakers in MicroCap Finance for three days of company presentations, one-on-one meetings, and networking.
NanoViricides, Inc. is a global leader developing antiviral nanomedicines for the treatment of a number of different viral infections.
The Company is currently focused on developing its broad spectrum anti-herpesvirus drug candidates. In particular, the Company is working on moving its dermal topical treatment for Shingles into human clinical trials as soon as possible.
NanoViricides has previously reported that its broad spectrum anti-herpesvirus drug candidates were highly effective in treating HSV-1 infection in a lethal animal model. In particular, topical treatment with a Herpecide™ program drug candidate led to 80~100% survival of animals lethally infected with HSV-1 H129c, wherein untreated animals had 0% survival. The Company has since improved on this candidate which has led to a franchise of topical drug development opportunities in different indications with herpesvirus infections.
The Company's HerpeCide™ program includes development of skin cream/lotion for the treatment of (a) herpes labialis ("cold sores") typically caused by HSV-1, (b) genital lesions typically caused by HSV-2, (c) shingles (zoster), caused by reactivation of the human herpesvirus-3 (HHV-3, aka Varicella-zoster virus or VZV, which causes chickenpox and then goes dormant); and eye drops or gel for the treatment of (d) herpes keratitis of the external eye (caused primarily by HSV-1). The Company believes these four indications encompass several billions of dollars in market opportunity.
Of these, the Company believes that its drug candidate for the topical (dermal) treatment of shingles would have the fastest drug development path towards human clinical trials, and is working on pre-clinical development of this drug candidate.
The Company believes that it is close to being able to declare a clinical development candidate for the treatment of shingles, and is now exploring further clinical development path for the resulting drug candidate.
Professor Moffat's Lab at the State University of New York Upstate Medical Center (SUNY-UMC) in Syracuse is performing studies of the NanoViricides shingles drug candidates in an ex vivo human skin patch model of VZV infection. We believe that these human skin patch studies should be highly predictive of human clinical trials success. In addition, cell culture studies for optimizing the drug candidates are being performed in our own laboratory. Certain preliminary studies have been completed and repeat studies to confirm the results are in progress.
The Company has also been working on scaling up production of this drug candidate with the goal of developing 500g to 1kg per batch production capability. The Company is currently performing the Chemistry, Manufacture and Controls (CMC) studies needed for filing an Investigational Drug Application (IND) for the shingles drug candidate with the US FDA or equivalent application(s) in other countries including Australia.
There is no effective treatment for shingles and the shingles related pain complication called PHN (post-herpetic neuralgia). The shingles associated debilitating pain usually lasts during the infection outbreak in most patients, although in 75% of patients over the age of 70, PHN can develop, which can last 90 days to even a year or more in some cases even after the skin has healed. Approved treatments for shingles and PHN include oral acyclovir related nucleoside analogs that are given in very high doses systemically for a week but with limited effect. A new oral nucleoside analog called FV-100 is in Phase 3 clinical trials. FV-100 development was previously abandoned by Bristol-Myers-Squibb and is now undertaken by a small pharma.
A vaccine for shingles is available, that may reduce occurrence of shingles as a preventive, but not as a treatment after an outbreak occurs. The chickenpox vaccine is now standard for children. In spite of this, the incidence of shingles in adolescents and young adults is rising. Shingles generally occurs in older people due age related decrease in immune function, and in patients with immune function compromising conditions from stress to organ transplant to other infections and HIV/AIDS.
Although in most patients, shingles is debilitating during the outbreak but not life-threatening, in a small percentage of patients, it can cause eye infections in the retina that can lead to blindness.
There is no topical treatment for shingles. We believe this is an unmet medical need. The market size for a successful topical treatment for shingles could be in the billion dollar to multi-billion dollar range.
The Company has eight different drugs in development, including four indications in the HerpeCide program. This deep and wide pipeline demonstrates the robustness of the nanoviricide® platform technology. A "nanoviricide®", as defined by the Company, is a chemical substance that mimics the receptors on human cell surface to which the virus binds, and upon virus binding, the nanoviricide is designed to engulf the virus and render it non-infectious, like a Venus-Fly-Trap.
A nanoviricide drug candidate, when properly designed, would be expected to continue to be effective in spite of the rapid mutations that a virus undergoes, thereby escaping conventional antiviral drugs, antibodies, and vaccines. This is because in spite of the mutations, the virus continues to bind to the same site on the same cell surface receptor(s), which a nanoviricide mimics.
The nanoviricides mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpesvirus drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs.
NanoViricides, Inc. is one of a few bio-pharma companies that has all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. Our campus at 1 Controls Drive, Shelton, CT, has state of the art nanomedicines characterization facilities that enable us to perform IND-enabling nanomedicine analysis and characterization studies of any of our various drug candidates in house.
All current topical drug candidates in our HerpeCide™ program are variants of the shingles drug further optimized for the specific herpesvirus and topical delivery constraints. These topical treatments are expected to provide a significantly faster path to human clinical stage than the injectable and oral drugs in our pipeline.
Topical treatments for the herpesvirus indications are important. Although the herpesviruses stay latent in a nerve ganglion, the pathology of an outbreak in a patient begins with reinfection in the skin layer from the reactivated virus, followed by further expansion of the virus in the skin layer. The newly produced virus then causes additional spread of the virus to more nerve cells, and would become latent there. Topical nanoviricide® treatment would stop further expansion of the virus at the site and therefore should also potentially decrease further recurrences. Also, topical treatment allows exposure of the virus to much higher concentrations of the drug locally, and thereby should produce greater effectiveness with less overall drug use, as compared to systemic treatments. All of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO). However, we now have our own capabilities to perform certain cell culture based drug candidate screening for BSL2 viruses, which includes herpesviruses. We believe that this is speeding up our drug development programs against such viruses significantly by removing the latencies of external testing in the earlier drug screening and the later drug optimization stages.
The Company has established additional collaborations towards IND-enabling development of drug candidates against the four HerpeCide program indications listed above. We now have collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at the University of Pittsburgh, for the evaluation of its nanoviricides® drug candidates in models of ocular herpesvirus and adenovirus infections. TransPharm Preclinical Solutions, a CRO, will continue to perform testing of our anti-herpes drug candidates in dermal infection models. In addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug candidates against shingles.
NanoViricides has previously reported that it has sufficient cash in hand to be able to take at least one of its drug candidates into initial human clinical trials. The Company believes that it continues to be on track with this goal.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.