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Argenes Initiates Phase I Clinical Study Of ARG098 (Anti-Fas IgM Monoclonal Antibody), A Novel Therapeutics For Rheumatoid Arthritis, In Europe

05 Oct 2007

As edited by

Tokyo, Japan - Argenes, Inc. announce 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[1] produce inflammatory cytokines[2] 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[3]. 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[4]. 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.

"This is a significant progress in the long history of Fas molecule research because ARG098 is the first Fas targeting antibody which is enter into a clinical study. IgM structure of ARG098 makes it possible because of more preferable characteristics for the therapeutics than IgG which is most common structure for existing antibody drug," says Dr. Kamishohara, President & CEO of Argenes. Prof. Nishioka also says "Establishing the clinical study network in Europe, we will accelerate the clinical development."

Article adapted by from original press release.

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

[1] Synovial cell: Cells constituting the synovial membrane enclosing the joint. Rheumatoid arthritis is known to induce abnormal growth of the synovial membrane and produce cytokines causing inflammation or joint bone destruction.

[2] Cytokines: A general term for various active substances produced by cells involved in inflammation or immunity. They are involved in expression or adjustment of cell-mediated immune responses or involved in inflammatory responses.

[3] Fas molecules: Fas molecules are also called CD95/APO-1 and are known as cellular surface receptor molecules inducing apoptosis. After Fas ligands or anti-Fas antibodies (ARG098, etc.) bind to Fas molecules, signals are transmitted to cells, and apoptosis of cells is induced.

[4] Apoptosis: A process which higher organisms actively kill cells for development or individual maintenance. It is a programmed cell death. Abnormalities of apoptosis are known in proliferative diseases such as cancer.

Argenes, Inc.

Argenes Inc. is a bio-venture company established in April 2004 focused on the development of new therapeutic drugs for intractable musculoskeletal illnesses such as rheumatoid arthritis and fibromyalgia syndrome. With our partners at the Institute Medical Science St. Marianna University School of Medicine, Argenes strives to create new scientific knowledge and intellectual property by developing new, cutting edge drugs and biotechnologies. Central to our way of doing business are strategic alliances with Santen Pharmaceutical Co., Ltd., and Nippon Zoki Pharmaceutical Co., Ltd. (a partner for the collaborative development of ARG171, a therapeutic drug for fibromyalgia syndrome) that better enable us to create and market new medicines that we hope will improve the health and enrich the lives of people the world over.

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