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Results Better Than Combination Therapy in Double-Blind Animal Study
NanoViricides, Inc. (OTC BB: NNVC.OB), (the "Company") said that its lead anti-HIV drug candidate demonstrated markedly superior survival results in the test animals when compared to those animals given the anti-HIV "combo cocktail" in a double-blind animal study. The three-drug combo "cocktail" used for comparison is one of the most frequently used triple combination therapies in humans.
The Company reported that the best nanoviricide anti-HIV drug candidate improved total hours of survival time by 99% with respect to appropriate controls. In contrast, the combo therapy improved survival hours by only 52%. Furthermore, AZT, the first drug used in humans to treat HIV/AIDS, failed to show any survival improvement, as was expected, in this lethality-based animal model study.
The Company also reported that the average body weight loss, a measure of the degree of illness in the experimental subjects, was only 11.4% after treatment with this nanoviricide drug candidate, as compared to 12.9% in those treated with the combo cocktail, and to 23% average body weight loss seen in the untreated control mice.
"We believe these are dramatic results," said Eugene Seymour, MD, MPH, CEO of the Company, adding that "if these results can be duplicated in humans, triple combo therapy with its toxic side effects may well be replaced in the near future with a much safer single HivCide-I ™ nanoviricide therapy."
"Another advantage of the HivCide-I nanoviricide is that the treatment can be combined with other existing drug regimens for substantial added benefits," said Anil R. Diwan, PhD, President of the Company and inventor of the technology, explaining further that "strong improvements should be possible when a nanoviricide is combined with conventional regimen because nanoviricides are designed to act by a novel and completely different mechanism from existing anti-retroviral drugs."
"As for vaccines [against HIV], it was difficult to predict when they would be developed, but it could be some 10 years from the present time," remarked Dr. Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, at the United Nations General Assembly High Level HIV/AIDS Meeting held on June 10 (http://www0.un.org/News/briefings/docs/2008/080610_AIDS.doc.htm). Several high level officials have stressed the need for development of better drugs against HIV. Jean-Francois Delfraissy, Director of France's National Agency for Research on AIDS and Viral Hepatitis, said that research "must continue to develop new therapeutic strategies," in Senegal on May 27, according to xinhuanet (http://www.medicalnewstoday.com/articles/109257.php).
AZT is a well known anti-retroviral nucleoside reverse transcriptase inhibitor (NRTI). The combo cocktail employed as a positive control in this study consisted of AZT, 3TC (another NRTI), and Crixivan® (Merck, a Protease Inhibitor), administered orally. All other drugs were administered as injections. Treatment was started 24 hrs after the mice were infected with high (1200 LD50) levels of mouse-adapted HIV-I virus particles. Treatment was repeated twice more at 48 hr intervals.
The studies were performed at a Bio-Safety Level 3 Laboratory (BSL-3) facility in Boston, MA. These mouse model studies were conducted by Dr. Krishna Menon, PhD, VMD, MRCS, a world-renowned authority in preclinical and toxicological studies of innovative therapeutics. The Company plans to report additional results from this study as they become available over the next several weeks. The Company is now designing additional studies with the objective of filing an investigational new drug application (IND) to the FDA in the future.
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 (epidemic kerato-conjunctivitis or severe pink eye disease), 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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