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Monoclonal Antibody Has Promising Activity in Phase II Clinical Trial for Advanced Colon Cancer

PHILADELPHIA (May 30, 2003) — A monoclonal antibody called ABX-EGF shows anti-cancer activity in patients with advanced colorectal cancer and is well-tolerated. That is the result of a phase II clinical trial with ABX-EGF presented at the American Society of Clinical Oncology Annual Meeting in a poster discussion on May 31, 2003, beginning at 1:30 p.m. E.T.

Despite recent advances, metastatic colorectal cancer cannot be cured with current treatments. Researchers believe the epidermal growth factor receptor (EGFR) protein found on the surface of some colorectal cancer cells is involved in the growth of colorectal cancer. Therapy that is aimed at blocking this growth factor receptor may be an effective way to treat patients with the disease. ABX-EGF is a manufactured antibody directed against the EGF receptor. (ABX-EGF is developed by Amgen Corporation in partnership with Abgenix, Inc.)

"This study demonstrates that ABX-EGF has promising activity against advanced colorectal cancer and can be administered safely," explains Neal J. Meropol, M.D., director of the gastrointestinal cancer program at Fox Chase Cancer Center in Philadelphia, Pa., and principal investigator of the multi-center trial. The data from the study are available in the ASCO's Meeting Proceedings.

At the time of this planned interim analysis, 40 patients were treated and are evaluable for response in the Phase II study. All had advanced colorectal cancers that were resistant to a fluoropyrimidine (5-fluorouracil or capecitabine) and irinotecan or oxaliplatin, or both. ABX-EGF was administered intravenously once a week. The preliminary analysis shows 22 patients had stable disease and four patients had partial responses.

Cancer centers in addition to Fox Chase that participated in the study include Vanderbilt University Medical Center, Nashville, Tenn.; UCLA School of Medicine, Los Angeles, Calif.; Mayo Clinic, Rochester, Minn.; Cancer Therapy and Research Center, San Antonio, Tex.; and Amgen, Thousand Oaks, Calif.