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Phase III Clinical Trials in Progress for New Rheumatoid Arthritis Treatment

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By News Release • www.ProHealth.com • February 4, 2000


SUMMARY: phase III trials have been initiated to test the fully human anti-TNF monoclonal antibody D2E7 for the treatment of rheumatoid arthritis. D2E7 belongs to a new class of medicines that neutralize TNF (tumour necrosis factor alpha). TNF is a cell communications protein that plays a role in the immune system. In rheumatoid arthritis, TNF accumulates disproportionately in the joints and initiates an inflammatory response that causes swelling, pain and joint damage, often rendering the patient unable to perform daily activities. Anti-TNF drugs neutralize this reaction by blocking the chemical message sent from cell to cell that results in joint inflammation and swelling. Essentially, D2E7 captures TNF and interrupts the process that can lead to the symptoms of RA.

MELBOURN, England, Feb. 4 /PRNewswire/ -- Cambridge Antibody Technology (CAT) today announces that BASF Pharma has initiated phase III trials of the fully human anti-TNF monoclonal antibody D2E7 in rheumatoid arthritis. D2E7 belongs to a new class of medicines that neutralize TNF (tumour necrosis factor alpha). TNF is a cell communications protein that
plays a role in the immune system. In rheumatoid arthritis, TNF accumulates disproportionately in the joints and initiates an inflammatory response that causes swelling, pain and joint damage,
often rendering the patient unable to perform daily activities. Anti-TNF drugs neutralize this reaction by blocking the chemical message sent from cell to cell that results in joint inflammation and swelling. Essentially, D2E7 captures TNF and interrupts the process
that can lead to the symptoms of RA.

D2E7 was initially isolated and optimized as part of a research collaboration between BASF Pharma and CAT. BASF Pharma is solely responsible for the pre-clinical/clinical development of the product and its marketing, pending successful completion of the pivotal studies and regulatory approval.

Dr. David Chiswell, Chief Executive of CAT, commented, “D2E7 is the first fully human monoclonal antibody to enter phase III trials. Taken together with the three other human monoclonal antibodies developed with CAT's technology also in clinical trials, it cements CAT's technology as the leading technology platform in the development of fully human antibodies as drugs.”

Dr. Thorlef Spickschen, Head of BASF Pharma, commented, “The decision to start clinical phase III underlines our confidence in the clinical phase II data recently presented at the Annual Scientific Meeting of the American College of Rheumatology in Boston. At the same time, it demonstrates our strong commitment to the area of immunology.”
Rheumatoid arthritis is one of the most common forms of arthritis, affecting more than six million people worldwide.

SOURCE: Cambridge Antibody Technology Group



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