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.
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, 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 pre-clinical 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.
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SOURCE NanoViricides, Inc.