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Statistical Data Analysis Revealed Excellent Efficacy Using Clinical Scores in Animal Study; Confirmed Photographic Findings
NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company") reported today that excellent efficacy of its EKC-Cide™ nanoviricide drug candidate was revealed upon statistical analyses of clinical scores from the first animal study.
The EKC-Cide drug candidate clearly demonstrated prevention of conjunctival injection (redness, dilation and prominence of the conjunctival blood vessels) and blepharitis (crusting, discharge and inflammation of the eyelid margins) using mathematical clinical scores calculations. These data confirmed the excellent clinical response observed earlier in eye photographs. In contrast, the control group which received an inactive drop preparation ("negative control") displayed statistically significant higher clinical scores consistent with the expected strong progression of infection.
A rapid clinical response to the EKC-Cide treatment was also revealed by these data, confirming earlier photograph observations. Substantial differences in clinical scores, demonstrating clear prevention of serious infection and improvement upon treatment, were observed within three days after treatment. Moreover, while both scored parameters (conjunctivitis and blepharitis) were still significantly elevated even at day 10 in the "negative control" group; in the EKC-Cide treated group both parameters had returned to normal already at day 7, indicating full recovery.
These clinical scores were based on daily observations and recording of the animals by trained observers. Further biological analyses are in progress.
"These results confirm our earlier preliminary photographic evidence," said Eugene Seymour, MD, MPH, CEO of the Company, adding, "We now know that EKC-Cide efficacy is substantially superior to that of other drugs in development against EKC."
The Company has previously posted photos on its website which demonstrated the rapid response to treatment using the Company's nanoviricide drug candidate against Epidemic Kerato-Conjunctivitis (EKC) (www.nanoviricides.com/action_small_EKC_2008-06-09.html).
"EKC-Cide may have efficacy against other viral conjunctivitis as well," said Anil R. Diwan, Ph.D., President of the Company, "It uses a broad-spectrum ligand for finding the virus. Binding sites for this ligand may be present on a large number of viruses." The Company plans to evaluate this broad-spectrum eye-drop formulation against other viruses that cause eye diseases such as herpes simplex virus (HSV).
The Company has previously reported that it is in talks with certain pharmaceutical companies regarding potential licensing of a nanoviricide against adenoviral EKC.
The two clinical scores employed were for "conjunctival injection" i.e. redness and dilation or prominence of conjunctival blood vessels, and for "blepharitis" i.e. crusting, discharge and inflammation of eyelid margins. Both are classic signs of pathological infection.
While the Company currently has no approved product for the treatment of EKC and viral conjunctivitis, the treatment and prophylaxis market for these classes of eye disease is expected to be of the order of several billion dollars annually.
EKC is a highly contagious and very severe inflammation of the eyes that results in disabling red eyes, discharge and inflammation of the eyelids with clinical symptoms lasting several weeks. Bacterial conjunctivitis may be treated with antibiotics; however, there is no treatment currently available for viral EKC. Further, viral EKC, in some cases, may result in the formation of hazy spots in the cornea called "sub-epithelial infiltrates" which cause blurriness of vision, a condition that may last up to two years.
About NanoViricides, Inc.
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 H5N1 bird flu, seasonal influenza, HIV, EKC, hepatitis C, rabies, dengue fever, and Ebola virus, among others.
This 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. 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. These forward looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of the company to be different from those expressed or implied including the success of the Company's research and development efforts, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process, described in the “Management’s Discussion and Analysis” section of the Company’s Form 10-KSB and other reports and filings with the Securities and Exchange Commission.
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