Tokyo, Japan, March 30 2012 --- Kyowa Medex Co., Ltd.
("Kyowa Medex") announced today that it has
received approval for a premarket approval application
(PMA) from the Ministry of Health, Labour and Welfare
(MHLW) for two in vitro diagnostic ("IVD")
reagents, POTELIGEO® TEST IHC and POTELIGEO® TEST
FCM("POTELIGEO® TEST"), on March 2.
POTELIGEO® TEST is designed to help physicians to identify
appropriate subpopulations of adult T-cell
leukemia-lymphoma (ATL) patients who are most likely to
respond to POTELIGEO® (Mogamulizumab) Injection
("POTELIGEO®"). POTELIGEO® is a therapeutic
antibody for which Kyowa Hakko Kirin has a new drug
application (NDA) approved today from the MHLW. The
combination of IVD and treatment has potential to
contribute a personalized medicine by providing better
treatment options with appropriate patients.
POTELIGEO® binds to CCR4 that is expressed on the surface
of ATL cells. ATL cells are killed by ADCC activity.
POTELIGEO® TEST can examine the presence of CCR4 expressed
by ATL cells before treatment of POTELIGEO®. Diagnostic
reagent having principle of immunohistochemistry (IHC) is
used to tissue samples such as lymph nodes or skins of ATL
patients. Diagnostic reagent based on flow cytometry (FCM)
can be applied to blood samples of ATL patients.
Kyowa Medex is working to support treatment for a wide
range of diseases and contribute to the improvement of
patients' QOL through the development of IVD reagents
and medical devices that meet the current clinical needs in
addition to conventional biochemistry reagents and
immunoassay reagents and measurement devices, which are its
current major products.
About companion diagnostics
An in vitro diagnostic reagent used for personalized
medicine. Identification of genes and biomarkers can allow
physicians to provide highly effective treatment for each
patient with fewer adverse drug reactions, and also allow
patients to choose the best treatment and therapeutic
agents. Companion diagnostics are already used for the
treatment of specific cancers.
About adult T-cell leukemia-lymphoma (ATL)
HTLV-1 (retrovirus)-induced peripheral T-cell lymphoma.
Currently, about 1150 people a year develop ATL in Japan.
Generally, combination chemotherapy such as mLSG15 therapy
is used, but no curative treatment has been established for
ATL, except transplantation, which is actively being
studied at present. For recurrent/relapsed ATL, different
types of chemotherapies are used based on the treatment of
malignant lymphoma, but no effective treatment has been
established.
About CCR4 (chemokine [C-C motif] receptor 4)
CCR4 is one of chemokine receptors involved in leukocyte
migration. It is known that in normal cells, CCR4 is
selectively expressed in type 2 helper T (Th2) cells that
produce cytokines such as IL-4 and IL-5 (CD4-positive). It
is also known that CCR4 is highly expressed in certain
hematological malignancies.
About Kyowa Medex
Kyowa Medex Co., Ltd. (ISO 9001 certified, Tokyo, Japan),
wholly owned subsidiary of Kyowa Hakko Kirin, was founded
in 1981 taking over the parent company's operation
related to diagnostic reagent. Kyowa Medex has been
focusing on developing, manufacturing and marketing of
clinical diagnostic reagents (immunological and
biochemical) and medical devices. Based upon its
accumulated biotechnological expertise, Kyowa Medex is
working on support for expansion of clinical laboratory
medicine through developing and improving, for example, a
series of assay reagent named as "Determiner" for
a HDL cholesterol direct measurement as well as other lipid
analysis, which are first launched in the world.
Please take a look at our Web (http://www.kyowamx.co.jp/eindex.html)
for more information.
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