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By: FoxChase1803
13 Dec 2003, 09:49 AM EST
Msg. 130833 of 130834
(This msg. is a reply to 130832 by FoxChase1803.)
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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.

Eli Wilner

SOURCE Advanced Viral Research Corp.
-0- 12/03/2003
/CONTACT: Eli Wilner Advanced Viral Research Corp., +1-914-376-7383/
/Company News On-Call:


/Web site:



CO: Advanced Viral Research Corp.
ST: Israel, New York

-- NYW140 --
5856 12/03/2003 13:37 EST


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