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Eisai announces Phase II data on E7389, a potential new therapy for the treatment of breast cancer

Researchers today presented preliminary safety and efficacy data for E7389 in the treatment of advanced, refractory breast cancer during the San Antonio Breast Cancer Symposium. E7389 is a synthetic analog of halichondrin B (HB), which is a natural product shown in preclinical studies to have highly potent anti-cancer activity in vitro and in vivo. Halichondrin B was originally isolated from a type of marine sponge.

This study was designed to evaluate E7389 as a monotherapy in patients with refractory breast cancer. The primary endpoint of this trial was response rate, measured using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria a group of standards used to measure responses to treatment in solid tumors.

Of the 65 evaluable patients, 10 partial responses were confirmed at the 4th cycle assessment. Twenty-one patients had stable disease (SD). In treatment-refractory patients with advanced breast cancer this preliminary response rate (15%) appears promising.

Based on the preliminary results of this study, the predominant serious side effect related to E7389 was neutropenia (low white blood cell counts). Other side effects were considered mild to moderate and included nausea, fatigue, dehydration, arthralgias, dyspnea and neuropathy. None of the patients discontinued the study due to hematological toxicity.

"The results from this study with E7389 appear promising, and clinical research on E7389 as a treatment for breast cancer is continuing," said Sandra Silberman, MD, PhD, Associate Vice President and Global Therapeutic Area Head, Oncology at Eisai Medical Research Inc. "E7389 is an example of Eisai's human health care (hhc) commitment to satisfy unmet medical needs of patients and their families. Eisai has targeted oncology/critical care as one of three key therapeutic areas of focus," she added.

Seventy-one women were enrolled in the 28-day cycle patient group. Preliminary efficacy data for
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Contact: Judee Shuler
judee_shuler@eisai.com
201-287-2241
JFK Communcations
9-Dec-2005


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