N@N

NanoViricides Inc Files For Extension of Form 10-K Annual Report Submission Date

^{Published on 2011-09-29 04:27:59 - Market Wire}
 

WEST HAVEN, Conn.--([ BUSINESS WIRE ])--NanoViricides, Inc. (OTCBB: [ NNVC ]) (the "Company") announced that it has filed a request for an automatic extension of the filing date for its Form 10-K Annual Report. The Company now has until close of business on Thursday, October 13th to file its final report. The Company plans to file the final report prior to that date. The Company is taking advantage of the extended period to include all of the recent events in the annual report.

The Company also reports that it is making progress towards its pre-IND (Investigational New Drug) application to the US Food and Drug Administration (FDA). The Company is close to releasing a draft of the application to its Consultants for comments and edits towards finalization.

The Company has recently announced that it is working on enabling cGMP (acurrent Good Manufacturing Practicesa) capability for producing its drug candidates. cGMP manufactured materials will be required when the Company is ready to file an IND application with the US FDA. The Company has recently announced that Inno-Haven, LLC, a special purpose company, has acquired a building that the Company plans to lease for its new laboratory and cGMP manufacturing pilot plant.

The Company has recently announced that it has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCidea") to develop for regulatory submissions both domestically and internationally. The Company believes that a single course therapy easily administered by a medical office is feasible for out-patients. The Company believes that in most instances no follow-on treatment would be 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.

The Company has also recently announced significant successes in its anti-HIV (HIVCidea") drug program. The best HIVCide candidate in a recent SCID-hu Thy/Liv mouse model study showed effectiveness against HIV-1 similar to a three drug HAART (highly active anti-retroviral therapy) cocktail even when HIVCide was administered at a much lower total dosage. What is more significant, this nanoviricide drug candidate continued to work to suppress HIV viral load for at least 28 days beyond last drug administration. These data along with previous similar successes in anti-HIV drug development indicate that HIVCide may provide a afunctional curea of HIV/AIDS either alone or in combination with other drugs.

[ About NanoViricides ]:

[ 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 aforward-looking statementsa 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.