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ADVR
Reports AVR118 Inhibits Inflammatory Arthritis in Animal Model
and in Rheumatoid Arthritis Patients in Human Clinical Trial
3 December 2003, 1:37pm ET
YONKERS, N.Y., Dec. 3 /PRNewswire-FirstCall/ -- Advanced Viral
Research Corp. (BB: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 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.
-0- 12/03/2003
/CONTACT: Eli Wilner Advanced Viral Research Corp.,
+1-914-376-7383/
/Company News On-Call:
http://www.prnewswire.com/comp/903002.html
/
/Web site:
http://www.adviral.com
/
(ADVR)
CO: Advanced Viral Research Corp.
ST: Israel, New York
IN: OTC BIO HEA MTC
SU: SVY
TC
-- NYW140 --
5856 12/03/2003 13:37 EST
http://www.prnewswire.com
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