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NNVC NanoViricides, Inc. Achieves Broad Success in Initial FluCide-I(TM) Anti-Influenza Studies; Company Says That Nanoviricides(TM) is Now a Proven Platform To Attack Bird Flu
Business Wire - March 20, 2006 7:30 AM (EDT)
WEST HAVEN, Conn., Mar 20, 2006 (BUSINESS WIRE) -- NanoViricides, Inc. (Pink Sheets:NNVC), today announced it has received additional results from its FluCide-I(TM) efficacy studies performed at a major US research facility. On the basis of these data, Dr. Krishna Menon, the Company's Chief Regulatory Officer, said that the drug candidate tested was worthy of filing an Investigational New Drug Application (INDA) with the FDA. "The results were so positive that with an appropriate dosage protocol, it may be possible to save human lives even in bird flu cases using this test nanoviricide itself," suggested Dr. Menon.
According to the company's President, Dr. Anil Diwan, "The study involved our nanomicelle to which a broad-spectrum, anti-influenza test ligand (virus targeting molecule) was attached. This combination of a micelle and ligand is called a nanoviricide(TM). While the objective of the study was to prove that the core technology worked, the results clearly exceeded our expectations. We feel that we have in development the world's best anti-influenza drug in our hands!"
In a Fast Protocol study, mice were infected with high levels of a human influenza virus. These levels resulted in an untreated survival period of only seven (7) days. A sub-group of these mice were treated with the test nanoviricide 24 hours after infection. The survival time of treated mice was increased significantly at relatively low and safe dosage levels. The safety of the dosage used was confirmed by gross histology as well as microscopic examination of a number of organs and tissues. These results suggest that the dosage can be increased several fold without significant adverse effects and that these higher dosage levels of our nanoviricide(TM) may already be capable of saving human lives in H5N1 bird flu cases.
"We can now say that the nanoviricide is a proven platform," stated Dr. Eugene Seymour, the company's CEO, "and believe that we can take any enveloped virus and attack it by attaching the right ligand (virus targeting molecule) to the nanomicelle. For instance, we can attack multiple subtypes of influenza by using a broad-spectrum ligand, as we have recently proven, or we can attack a specific virus subtype, such as Highly Pathogenic Avian Influenza (HPAI) and H5N1, with precise ligands that are intended for greater efficacy and specificity." Dr. Seymour also stated that "although the possible extent of any future bird flu pandemic is not at all clear, emergency preparedness purchases by agencies worldwide have been in several billions of dollars. More importantly, the market for a true targeted anti-viral for human influenza is enormous considering the tens of millions of cases diagnosed just in the US and Western Europe alone. Tens of thousands of people die of human influenza year after year."
The truly unique aspect of the technology is that once a drug to attack one virus is created, developing a new drug for another virus involves only changing the targeting molecule, not necessarily the underlying nanomicelle. This novel feature enables us to either respond to a mutating virus or else go after a completely new virus in a relatively short period of time. The Company is currently developing drugs against avian flu (H5N1), emerging highly pathogenic avian influenza threats (HPAI such as H9N2), common influenza, and rabies. The Company plans to develop additional drugs against HIV and Hepatitis C in the near future. "Our goal is to file two INDAs with the FDA within the next 12-18 months," said Dr. Seymour.
About NanoViricides - http://www.nanoviricides.com
NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for viral therapy. A NanoViricide(TM) is a specially designed, flexible, nanomaterial that contains an encapsulated active pharmaceutical ingredient and targets it to a specific type of virus, like a guided missile. NanoViricide drugs are designed to block and dismantle the virus particles before they can infect a cell, thereby controlling viremia. This is a completely novel approach that is proving to be superior to existing approaches.
his press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors including the success of the Company's research and development strategy, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
SOURCE: NanoViricides, Inc.
NanoViricides, Inc.
Leo Ehrlich, 917-853-6440
leo@nanoviricides.com
Copyright Business Wire 2006
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