NanoViricides Inc. (NNVC)

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NanoViricides, Inc. is advancing its oral broad-spectrum anti-influenza drug candidate, NV-INF-2, towards IND-enabling studies. This may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.

In addition, the Company continues to develop its injectable anti-influenza drug, NV-INF-1, towards IND-enabling studies. This drug candidate has much greater activity than the oral drug, and is intended for use in hospitalized patients with influenza or potentially influenza-like illness. The Company believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication. Both of these drugs in the anti-influenza FluCide™ program have demonstrated very high effectiveness in a lethal influenza animal model, routinely showing substantial superiority to oseltamivir (Tamiflu®), the current standard of care. The Company believes that these drugs will be useable against most if not all types of influenza viruses, including seasonal (such as H1N1, H3N2), epidemic (such as H1N1/2009 “swine flu”, H3N2/2012), novel strains such as H7N9 that is currently circulating in China, and bird flu (such as H5N1, various clades). In addition, both of these drugs have shown extremely good safety profile in all of the animal studies that have been performed to date. This strong safety profile has necessitated a substantial scale-up in the Company’s current synthesis capabilities prior to commissioning a formal GLP safety and toxicology (“Tox Package”) study. The Company is in the process of developing the necessary scale-up synthesis laboratory.
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A cGMP manufacturing capability is projected to be soon complete/integrated (4Q 2013) for these and other nanoviricides drug candidates.
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The Company previously held a pre-IND meeting with the US FDA for its anti-influenza drug candidate, NV-INF-1, in the FluCide program on March 29, 2012. The Company believes it has received valuable input from the US FDA, applicable to the development of its anti-influenza drug candidates.

With the current strong cash position, the Company believes that it has sufficient funds available to perform the necessary IND enabling studies for its anti-influenza drug programs, to file an Investigational New Drug Application (“IND”) with the US FDA, and to conduct initial human clinical trials of its first anti-influenza drug.

Including the Flucide program, the Company currently has six commercially important drug candidates in its pipeline. These include the aforementioned drugs against all Influenzas, HIVCide™, HerpiCide™, DengiCide™, and a broad-spectrum nanoviricide eye drop formulation against viral infections of the eye. These programs are based on the Company’s platform technology that enables specifically targeting a particular type of virus with a novel mechanism of action. In addition, the Company continues its other research and development programs. These include (a) broad-spectrum nanoviricides against a number of Neglected Tropical Diseases, and (b) its novel ADIF™ (“Accurate Drug In Field”™) technologies which promise a way to attack novel viruses, whether man-made (bioterrorism) or natural (such as SARS), before they cause a pandemic.

source: http://www.nanoviricides.com/press%20releases/NanoViricides%20Files%20Quarterly%20Report%20-%20Reports%20Having%20Sufficient%20Funds%20and%20Satisfactory%20Progress%20in%20its%20Advancing%20Pipeline.html