Phase II clinical study of
an anti-cancer agent
KW-2170
will start in five countries including the US.

 Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Tadashi Hirata) is going to initiae phase II clinical study of an anticancer agent "KW-2170 (Kyowa Hakko*s development code)" in five countries including the US.

 Kyowa Hakko finished phase I clinical study of the compound as an anticancer agent in the US and obtained, in November, the approval of Investigational New Drug (IND) application for phase II clinical study which had been filed with the FDA. The company is also taking the necessary procedure for conducting phase II clinical study in Australia, Singapore, Taiwan, and Costa Rica based on the data obtained from Phase-I clinical study in the US.

 KW-2170 is a new anticancer agent which has been shown to inhibit the proliferation of cancer cells or to kill cancer cells through induction of apoptosis by directly binding with DNA and/or inhibiting the enzymes involved in duplication and recombination of DNA.

 The target indications will include five cancers: non-small cell lung, prostate, colorectal, uterine and breast. The development will be advanced also in Japan based on the overseas results.

 Leukopenia (neutropenia) was reported as a side effect of this compound. Alopecia and other side effects seem to be relatively infrequent.

 Kyowa Pharmaceutical, Inc., an affiliate of Kyowa Hakko in the US, is responsible for coordinating these clinical studies. The NDA submission is scheduled around 2006. The sales amount will vary depending on cancer type, but it is expected to be a large-selling product.

 Cancer is one of core therapeutic areas for Kyowa Hakko and we are expecting much the progress of clinical studies in future.