| Jun 10th, 2002 |
Anticancer agent |
Kyowa Hakko Kogyo Co., Ltd. (Chiyoda-ku, Tokyo, Japan; President, Dr. Tadashi Hirata) has started a Phase I/early Phase II study of KW-2871 (code number) for the treatment of malignant melanoma in the US, following permission from the Food and Drug Administration (FDA) to conduct its clinical trials. KW-2871 is a chimeric monoclonal antibody developed at the Tokyo Research Laboratories, Kyowa Hakko. This antibody binds specifically to GD3, a cell surface antigen expressed in approximately 90% of melanoma cells, and exhibits anticancer effects mediated by its ability to activate the cells that can kill tumor cells [known as ADCC (antibody-dependent cell-mediated cytotoxicity) activity] and to disrupt the cell membrane through complement protein [known as CDC (complement-dependent cytotoxicity) activity]. With selective targeting of cancer cells, monoclonal antibodies in general are expected to be much safer and better tolerated than conventional anticancer agents available on the market. The results from the previous Phase I study, which was performed in Australia, demonstrate various advantages of KW-2871, such as long half-life, selective accumulation at the tumor site, and good safety profile free of serious adverse reactions even during repeated dosing. The planned Phase I/early Phase II study is to be managed by KPI (Kyowa Pharmaceutical, Inc.), one of Kyowa Hakko's subsidiaries in the US. We aim to file a New Drug Application (NDA) for marketing approval in the US around 2007 if the development goes smoothly. For the time being, our efforts will be focused on the development in the US, which has the largest population of malignant melanoma patients, and where the speed of development could be maximized. If the results from US studies are encouraging enough to support successful application, we plan to extend the development to Europe as well.
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