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Kyowa Medex Receives Approval for POTELIGEO® TEST IHC and POTELIGEO® TEST FCM, Companion Diagnostics of POTELIGEO® Injection in Japan



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March 30, 2012

Kyowa Medex Receives Approval for
POTELIGEO® TEST IHC and POTELIGEO® TEST FCM,
Companion Diagnostics of POTELIGEO® Injection in Japan

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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