NanoViricides Inc. (NNVC)

[Rawnoc]

NanoViricides Anti-HIV Lead Drug Candidate Demonstrated Substantial Improvement in Survival Time in Animal Model
Results Better Than Combination Therapy in Double-Blind Animal Study

WEST HAVEN, CONNECTICUT--(Business Wire)—June 16, 2008 -- 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.


Press Release
Source: NanoViricides, Inc.


NanoViricides, Inc. Reports that HIVCide-I was Significantly Superior to the Current anti-HIV Three Drug Cocktail Standard
The novel mechanism of action of HIVCide-I defines a new class of anti-HIV drugs

WEST HAVEN, CONNECTICUT--(Business Wire)—August 11, 2008 -- NanoViricides, Inc. (OTC BB: NNVC.OB), (the “Company”) said that additional biological tests and data analysis have shown that animals treated with its lead anti-HIV drug candidate, HIVCide™-I, demonstrated a substantially greater reduction in viral load -- number of infectious virus particles per milliliter of blood -- when compared to the animals given the anti-HIV “combo cocktail” in a preliminary animal study. An important objective of anti-HIV treatment is to minimize the viral load.

These new data expand on the findings previously reported and are consistent with earlier results. The Company has previously reported that HIVCide-I was substantially superior to the combo therapy in improvement of survival time, as well as in reducing the body weight loss, in this preliminary animal study.

“We now know that HIVCide-I was clearly superior to the triple drug combo cocktail in all parameters we observed,” said Anil R. Diwan, PhD, President of the Company, adding, “The novel mechanism of action of HIVCide-I defines a new class of anti-HIV drugs. This enables that it can be combined with the existing cocktail. In such a combination, a much greater level of effectiveness could be achieved compared to what is possible today.”

”If our preliminary results can be duplicated in humans, it is quite possible that HIVCide-I, either alone or in combination with the current combo cocktail, may provide a ‘functional cure’ for HIV/AIDS,” said Eugene Seymour, MD, MPH, CEO of the Company.

Anthony S. Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH, recently described “functional cure” as a state short of true HIV cure that allows a patient to live a life practically free of HIV following prolonged treatment, although the infection may still be present in a latent fashion. True cure (complete freedom from HIV) may be much more difficult to achieve than functional cure because the virus hides in immune cells that make up “latent reservoirs” (http://www.cnn.com/2008/HEALTH/conditions/08/05/fauci.hiv.column/index.html).

The Company is now in discussions with renowned HIV scientists as to the nature of the additional experiments needed to develop the nanoviricide drug candidate for FDA approval.

These Bio-Safety Level 3 studies employing the well known SCID-hu Thy/Liv HIV mouse model were supervised by Dr. Krishna Menon, PhD, VMD, MRCS, a world-renowned authority in preclinical and toxicological studies of innovative therapeutics.