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
â€œWe believe these are dramatic results,â€ said Eugene Seymour, MD,
MPH, CEO of the Company, adding that â€œif 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 â„¢ nanoviricide therapy.â€
â€œAnother advantage of the HivCide-I nanoviricide is that the treatment
can be combined with other existing drug regimens for substantial added benefits,â€
said Anil R. Diwan, PhD, President of the Company and inventor of the technology,
explaining further that â€œstrong 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
â€œAs 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,â€
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 CrixivanÂ® (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.