NanoViricides Announces Successful Pre-IND Meeting with the US FDA
WEST HAVEN, CONNECTICUT -- April 2nd, 2011 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled. This pre-IND meeting focused on FluCide™, designated as NV-INF-1, the Company’s novel anti-influenza drug.
The Company received US FDA comments and exchanged a list of questions with the US FDA prior to the Meeting. The Company believes that the US FDA has given us a good roadmap for advancing towards an IND application.
The Company, with guidance from its regulatory consultants at the Biologics Consulting Group, Inc., had previously determined that filing a pre-IND at this stage was important in order to understand potential US FDA required studies that we will need to perform prior to filing an IND. Because of the novelty of the technology and approach, we requested this pre-IND meeting even before performing certain customary safety/toxicological studies.
The Company believes that it has received valuable guidance from the US FDA in this meeting. We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1. The Company will now plan and execute the studies identified based on this meeting.
The Company also intends to pursue licensing activities in countries other than the USA. Some of these countries have different procedures that may enable faster regulatory processes than at the US FDA.
The Company also said that its work on enabling cGMP manufacturing capabilities for the nanoviricides drugs for clinical trials is progressing satisfactorily.
(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
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 preclinical 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.
Amanda Schuon, 310-550-7200