WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC) (the “Company”) announced today that it has submitted a pre-IND Meeting Request to the US FDA. The Company has requested an initial meeting with the US FDA to review the Company’s proposed strategy and plan for conducting safety/toxicology studies and human clinical trials required for approval of its anti-influenza clinical drug candidate, FluCide™ (i.e. NV-INF-1).
“This submission is a major milestone in the Company’s program to obtain US FDA approval for FluCide™,” said Eugene Seymour, MD, MPH, CEO, adding, “FluCide has demonstrated excellent efficacy and safety when treating influenza infections in our animal studies. We anticipate similar strong results in humans when the drug becomes available for human use.”
The Company has submitted required introductory documentation with the meeting request letter in consultation with the Company’s regulatory matters consultants, viz. the Biologics Consulting Group. The Company plans to submit additional briefing documents at least thirty days before the FDA meeting, in compliance with the FDA guidelines.
This pre-IND meeting request submission follows the Company’s recent announcement that it has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCide™) to develop for regulatory submissions both domestically and internationally. It is estimated that there are about 50 million cases of influenza annually in the USA alone, and about 250,000 patients are hospitalized for influenza. The Company believes that a single course of therapy that can be easily administered by a medical office is likely to be feasible for out-patients, with no additional follow-on treatment necessary. This expectation is based on the following results from its animal studies: (1) the extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment after the drug is discontinued. In addition to out-patients, the Company also plans to develop an indication for hospitalized severe cases of influenza.
The Company has recently announced that it is working on developing cGMP (“current Good Manufacturing Practices”) manufacturing capability for the production of its drug candidates. cGMP manufactured materials will be required when the Company is ready to file an Investigational New Drug (IND) application to the US FDA.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral 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, Dengue fever, Hepatitis C, Rabies, 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.