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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
edited by Joint-Pain-Forum.com
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 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.
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.
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."
www.Joint-Pain-Forum.com from original press release.
Argenes will also start the clinical
trial in Japan within this year for the NDA.
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
 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.
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.
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
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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