SHELTON, CONNECTICUT -- March 21, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") announced today that its CEO, Dr. Eugene Seymour, was interviewed by Jane King of Small Cap Nation ("SCN"). SCN has published a video clip of this interview on March 1, 2016 on YouTube (https://www.youtube.com/watch?v=9Xc9nBGv4U4).
Dr. Seymour discussed the Company's current status and achievements. While the Company currently has approximately a dozen drug development programs in its research and development pipeline, it is still preclinical at present. NanoViricides is currently focused on developing a drug for the herpes infection of the eye, i.e. herpes keratitis, which can lead to blindness and the need for corneal transplants. NanoViricides has established collaborations with the University of Wisconsin at Madison, the University of Pittsburgh, and Baylor University to perform pre-clinical cell culture testing as well as animal studies of our eye drug candidates. Dr. Seymour suggested that if all things go well then the ocular herpes keratitis drug could go into human clinical trials sometime next year. The Company's expectations may differ significantly from actual results, because of several factors that may be outside of its control.
NanoViricides, Inc. has developed a platform technology that enables direct attack on the virus particle in circulation inside the body, thereby making it unable to infect human cells, and thus blocking progression of the viral disease. This platform technology enables the Company to rapidly develop viable drug candidates against a different virus in a relatively short period of time, which could be as little as a few months. A "nanoviricide®" is made up of two parts: a polymer that self-assembles into a "nanomicelle" that has the ability to attack and possibly dismantle the virus: and a ligand that enables zip-code-address-like targeting of the nanomicelle onto the virus surface. Developing new drug candidates against a new virus primarily involves designing and synthesizing ligands capable of binding to the virus surface. The Company can develop such ligands based on known or putative interactions of the virus with the cell surface to which the virus binds. With the Company's experience in this field and a library of proprietary small chemicals in hand, the Company believes that the design of novel ligands for initial cell culture studies can take as little as a couple of months. Synthesis of the corresponding nanoviricides thereafter usually takes a few additional months, depending upon the complexity of the project. In many cases, initial testing has led to strong candidates that could be developed for clinical application if there are no other drugs available. However, additional refining of the initial drug candidates may be required and that can substantially extend the development period.
Dr. Seymour also discussed the Company's state of the art pilot-scale manufacturing facility that is designed to enable production and supply of any of its drug candidates for human clinical trials and for preclinical studies. In addition, this facility also has sufficient production capacity to enable entry into the market should one of the Company's drugs receive FDA licensure.
In the context of the recent Zika virus epidemic, Dr. Seymour noted that the Company believes its Dengue drug development provides a good starting point for developing a Zika virus drug, if the Company decides to engage in such development. This is because the Zika virus belongs to the same family of viruses called Flaviviruses, which the Dengue viruses also belong to, and therefore share significant similarities. If our anti-dengue drug candidate is sufficiently broad in its spectrum, then it could potentially attack Zika virus as well. However, there are significant differences in the pathology of Zika and Dengue viruses. Zika viruses are neurotropic. Thus the cellular receptor(s) for Zika virus could be different from those for Dengue viruses.
Dr. Seymour alluded to the complexities of the normal drug development program. Additional optimization of the ligands and polymers, safety/toxicology studies, additional effectiveness studies in different animal model protocols, and other pre-clinical studies, need to be performed prior to selection of a drug candidate for further clinical development under regulatory processes.
Dr. Seymour also referenced the Company's several collaborations for each of its drug development programs that enable pre-clinical testing of its drug candidates. At the present time, the Company does not have any collaborations or other agreements with a pharmaceutical partner nor can there be any assurance that such a collaboration will ever be developed.
Dr. Seymour also advised that the Company is well financed and the cash on hand is expected to be sufficient to bring at least its first drug candidate into human clinical trials. This expectation is based on the Company's internal projections and informal estimates it has obtained from several collaborators and contract research organizations for the potential costs of intended studies. The Company has limited experience in clinical drug development and its actual drug development costs may differ from the estimated costs due to several factors that may be outside its control.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.