Argenes Initiates Phase I Clinical Study of ARG098 (anti-Fas IgM monoclonal antibody) for Rheumatoid Arthritis in Europe

09-Oct-2007

Argenes, Inc. announced that it has started Phase I clinical study of the novel anti-rheumatoid arthritis (RA) agent ARG098 in patients with RA in Belgium and has administered to the first patient. The clinical study intends to evaluate the safety and tolerability of ARG098 into the knee joint cavity of patients with RA and examine its efficacy and pharmacokinetics.

Efficacy of ARG098 on RA was found in the collaborative study with Santen Pharmaceutical Co., Ltd. and Prof. Kusuki Nishioka, Chairman of Argenes and Director of Institute Medical Science, St. Marianna University School of Medicine. Argenes was licensed the right of development from Santen Pharmaceutical Co., Ltd. in October 2004.

RA is a chronic, progressive, inflammatory disease, mainly characterized by inflammation of synovial membranes, causing pain and swelling. The inflammation of synovial membranes erodes through the cartilage and surround bone as it expands. It is well known that abnormally proliferated synovial cells produce inflammatory cytokines including TNFalpha, IL-1, and IL-6 resulting the disease progresses. Therefore, targeting of the abnormal proliferation of synovial cells is a reasonable strategy for the RA therapy.

ARG098 is an anti-Fas IgM monoclonal antibody that specifically targets the Fas (also known as APO-1 and CD95) molecule. The Fas molecule which is expressed and activated on the cell surface of inflammatory synovial cells plays a key role for induction of cell death known as apoptosis. Binding of ARG098 to Fas molecule of synovial cells causes apoptosis dramatically followed by reduction of the number of synovial cells and improvement of inflammatory symptoms of RA. Different from current biologics for RA targeting cytokines including anti-TNFalpha monoclonal antibody, targeting of inflammatory synovial cells will give a direct therapeutic efficacy.

Argenes will also start the clinical trial in Japan within this year for the NDA.

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