YONKERS, N.Y., Dec. 3 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced that its novel
immunomodulator AVR118 (formerly known as Product R) has exhibited therapeutic
effects in both an animal model of inflammatory arthritis and in a clinical
trial of patients with rheumatoid arthritis. In experiments with an animal
model of inflammatory arthritis, performed at The Weizmann Institute of
Research in Rehovot, Israel, the administration of AVR118 significantly
suppressed the development of inflammation in the animals' joints compared to
non-treated control animals. The results in the animal model were validated by
an open-label clinical trial conducted in Argentina in 27 patients. All
patients in the trial had improvement in quality of life including resolution
or significant decrease in intensity of pain, the ability to exercise, to
perform housework, and to engage in social activities. In addition, all
patients showed objective signs of decreased inflammation, and increased
mobility, of affected joints.
"These positive results highlight the anti-inflammatory properties of
AVR118 and underline the potential of AVR118 as an anti-inflammatory
therapeutic agent," said Eli Wilner, Chairman of the Board of ADVR.
Animal Model
In the Weizmann Institute animal model, inflammatory arthritis was induced
by injecting complete Freund's adjuvant containing inactivated Mycobacterium
tuberculosis into rats. AVR118 was administered for 14 days out of the
twenty-four days that the animals were observed for the full development of
inflammation. The anti-inflammatory effects of AVR118 were evident even for
the ten days following the discontinuation of the drug. This adjuvant
arthritis model in animals serves as an experimental model for human
rheumatoid arthritis.
Clinical Study
In the clinical trial, 27 female patients, ranging in age from 29 to
50 years, with mild to moderately severe rheumatoid arthritis, were treated
with AVR118 for a period of 90 days. These patients had previously been
treated with other anti-inflammatory drugs such as aspirin. By day 90, all
patients had either complete regression or significant decrease of joint
swelling. Measurements of joint mobility showed improvement in all patients.
All patients showed decreases in the level of the erythrocyte sedimentation
rate (ESR) by day 90 of therapy and most patients showed decreases in the
latex fixation test. There were no significant side effects of AVR118 observed
in this study.
"Inflammation and cachexia are inextricably linked by metabolic pathways
that have common origins and targets; areas where modulation can occur for
maximum impact on the process," said James T. D'Olimpio M.D., a clinical
consultant to ADVR and expert in the treatment of cachexia. "In addition, the
pathways involved with inflammation are not just confined to separate and
distinct disease entities, but are a common thread that impacts on quality of
life in many unrelated diseases such as AIDS, Cancer, Rheumatoid Arthritis and
other conditions in which weight loss, weakness, poor outcomes and non-
compliance to treatment are major clinical concerns. These results appear to
confirm the potent anti-inflammatory properties of AVR118."
Cytokines and chemokines play important roles in the progression of
rheumatoid arthritis. The development of clinical rheumatoid joint
inflammation is associated with increase of the chemokine interleukin-8 (IL-8)
in joint tissue. Pro-inflammatory cytokines such as interleukin-1 (IL-1),
tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) are present
at high levels in arthritic joints and their blood concentrations increase
with the severity of the disease. Monocytes migrate into the joints from the
blood and are activated to differentiate into macrophages in the joint tissue
by inflammatory cytokines and chemokines such as IL-1, IL-6, IL-8, and
TNF-alpha. Activated macrophages play an important role in joint inflammation
and destruction. The joint tissue attracts the monocytes into the joints
through the production of the chemokines monocyte chemoattractant protein-1
(MCP-1) and IL-8. In laboratory experiments ADVR scientists have shown that
AVR118 modulates the synthesis of cytokines and chemokines including MCP-1,
IL-8, IL-1 beta, and IL-6. Although AVR118 stimulates the synthesis of the
pro-inflammatory chemokines MCP-1 and IL-8 by native monocytes in cell
culture, highly activated macrophages are turned off with decreased synthesis
of MCP-1 and IL-8.
"Rheumatoid arthritis is a systemic disease that serves as a model for
other auto-immune diseases. The anti-inflammatory activity of AVR118 in the
animal model, and in the rheumatoid arthritis patients in the clinical trial,
including the amelioration of the systemic manifestations of the disease,
suggests the possibility of treating not only Rheumatoid Arthritis with AVR118
but also a broad range of inflammatory processes associated with human
diseases," explained Shalom Z. Hirschman, M.D., Chief Scientist at ADVR. "In
the laboratory, AVR118 modulates the synthesis of pro-inflammatory cytokines
and chemokines implicated in the inflammatory process in patients with
Rheumatoid Arthritis. If these clinical results are validated by future
clinical trials, then AVR118 would represent an important advance in the
treatment of this systemic disease marked by crippling arthritis."
"The potential of a non-toxic immunomodulator such as AVR118 in the
therapy of Rheumatoid Arthritis could be significant, as AVR118 appears to
lack the often toxic effects of currently used mainstay therapies such as
corticosteroids, COX inhibitors, gold compounds and methotrexate," stated
Irach Taraporewala, Ph.D., ADVR's head of structural chemistry. Dr.
Taraporewala is an experienced research scientist in the design of
anti-inflammatory small molecules for the treatment of rheumatoid arthritis.
Rheumatoid Arthritis Market
Rheumatoid arthritis usually begins between the ages of 25 to 55 years.
More than 85% of patients with rheumatoid arthritis are over the age of 50.
Among patients with rheumatoid arthritis, women outnumber men by three to one.
In the United States, approximately 1% of the population, or 2.5 million
people, have rheumatoid arthritis. It occurs in of all ethnic groups and in
all parts of the world. As the population in the developing world ages, and
with a rising incidence of the disease, the world market for safe and
effective rheumatoid arthritis treatment is projected to reach $6.6 billion
annually by the year 2009.
ADVR's AVR118 represents a biopolymer chemistry that possesses novel
immunomodulator activity. This peptide-nucleic acid, which to date has shown
no indication of human toxicity, appears to stimulate the proinflammatory
responses required to combat viral infections such as AIDS and human papilloma
virus and to dampen aberrant autoimmune-type inflammatory responses, such as
occur in patients with rheumatoid arthritis. Therefore, AVR118 has been
termed a "switch-type" immunomodulator. AVR118 is in clinical trials in
Israel for the treatment of cachexia (body wasting) in patients with AIDS.
For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.com.
Advanced Viral Research Corp., based in Yonkers, New York, is a
biopharmaceutical firm dedicated to improving patients' lives by researching,
developing and bringing to market new and effective therapies for viral and
other diseases.
Note: This news release contains forward-looking statements that involve
risks associated with clinical development, regulatory approvals, including
application to the FDA, product commercialization and other risks described
from time to time in the SEC reports filed by the Company. AVR118 (Product R)
is not approved by the U.S. Food and Drug Administration or any comparable
agencies of any other countries. There is no assurance that the Company will
be able to secure the financing necessary to continue and/or complete the
clinical trials of AVR118 or satisfy certain other conditions relating to
clinical trials including obtaining adequate insurance on terms acceptable to
the Company. The Company undertakes no obligation to update or revise the
information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.
Contact:
Eli Wilner
914-376-7383
SOURCE Advanced Viral Research Corp.
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http://www.adviral.com
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CONTACT:
Eli Wilner Advanced Viral Research Corp.,
+1-914-376-7383
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