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(PR NEWSWIRE) DJ: Data Show Advanced Viral Research Drug Stimulates Immune
DJ: Data Show Advanced Viral Research Drug Stimulates Immune System Response in
Aids Patients
Abstract Highlighted at 98th Annual Meeting of the American
Society for Microbiology
ATLANTA, May 21 /PRNewswire/ -- Advanced Viral Research Corp. (OTC Bulletin
Board: ADVR) today announced results from the Phase 3 clinical trials of
Reticulose, a non-toxic peptide-nucleic acid that stimulates the cytocidal
(Th-1) arm of the immune system. Reticulose was evaluated for its
effectiveness in treating adults infected with HIV. In the trial,
Reticulose-treated patients showed early, sustained improvements in CD4 and
CD8 cell counts, significant decreases in viral loads, significant weight
gain, fewer opportunistic infections and lowered mortality, compared to
patients receiving placebo. The abstract describing these findings is one
of only 3% of submitted abstracts to be highlighted by the American Society
for Microbiology at its 98th Annual Meeting.
"As a group, patients in the Reticulose arm of the study experienced early,
sustained increases in their CD4 and CD8 cell counts and in body weight, as
well as decreased viral loads, compared to the placebo group. None of the
Reticulose-treated patients developed severe or life-threatening
opportunistic infections," said Paul N. Levett, M.D., of the Department of
Medicine, Queen Elizabeth Hospital, Barbados. "In addition to the
significant effects of Reticulose on the immune system, we observed no toxic
reactions to this agent."
Dr. Levett is first author of the abstract, "Controlled Clinical Trial of
Reticulose, a Peptide-Nucleic Acid with Immunomodulator Activity, in
Patients with HIV Infection." The other contributing authors are Timothy C.
Roach, Shalom Z. Hirschman, Hedy Broome and Henry S. Fraser. The clinical
trials were conducted at the Queen Elizabeth Hospital of the University of
the West Indies School of Medicine in Barbados. Reticulose is a
peptide-nucleic acid that acts as an immunomodulator, stimulating the
production of the group of cell-signaling proteins known as cytokines.
In the double-blind, placebo-controlled trial, Reticulose or placebo was
administered to 43 treatment-naive patients over the course of 60 days. At
the end of treatment, the patients randomly assigned to receive Reticulose
averaged a 37% increase in their CD4 cell counts, while the patients in the
placebo group experienced a 7% decline. Sixty days after cessation of
treatment, the mean CD4 cell count of the Reticulose group was up 53%. At
the end of treatment, there was also a 17% increase in the CD8 cell counts
of patients in the Reticulose group, compared to a 2% increase in the
placebo group.
Body weight increased in 71% percent of the Reticulose patients, while 60%
of the placebo patients lost weight. HIV viral loads decreased by at least
0.5 logs in four Reticulose treated patients, but in none of the placebo
group.
"Available treatments for AIDS have focused on eradicating HIV from the
body. Although there have been significant advances in anti-retroviral
treatment, attempts to stimulate recovery of the immune system -- the target
of HIV infection -- have been less successful," said Shalom Z. Hirschman,
M.D., President and Chief Executive Officer of ADVR. "The ability of the
body to stimulate immune system repair through internal cellular production
of cytokines may be an important missing piece of the AIDS treatment puzzle,
and may thus offer a new approach to treating this disease."
These clinical results build on the promise of earlier laboratory studies,
in which Reticulose appeared to mediate repair of the immune system. By
helping the immune system repair itself, Reticulose may offer a new approach
to treating HIV infection. Reticulose, which was initially developed in the
1930's to treat influenza, stimulates cytokine production. Internal
cellular production of cytokines may be more effective than externally
administered cytokines in treating viruses such as HIV.
"We are excited that the American Society for Microbiology made a special
acknowledgment of our results," said Shalom Hirschman, M.D. "We are
dedicated to developing Reticulose as an affordable, non-toxic treatment for
patients with AIDS and other viral infections world-wide."
ADVR, located in Yonkers, NY, is one of the leading biotechnology companies
specializing in the development of peptide nucleic acids (PNAs) for
pharmaceutical use. ADVR is developing Reticulose as an affordable,
broad-spectrum treatment for a variety of viral infections, beginning with
HIV, the virus that causes AIDS. Reticulose has no toxic side effects
reported by patients or observed by physicians, either in prior years of
clinical use or in recent clinical trials.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical
development, regulatory approvals, including applications to the FDA,
product commercialization and other risks described from time to time in the
SEC reports filed by ADVR. RETICULOSE is not yet approved by the U.S. Food
and Drug Administration or any comparable agencies of any other countries.
/CONTACT: Shalom Z. Hirschman, M.D. of Advanced Viral Research Corp.,
914-376-7383; or Russell LaMontagne of SCIENS Worldwide Public Relations,
212-771-5512, for Advanced Viral Research Corp./
10:00 EDT
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