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Abgenix Announces Initiation of Phase II Clinical Trial of ABX-EGF in Colorectal Cancer
12-28-2001: Abgenix, Inc. (Nasdaq: ABGX) announced today the initiation of a Phase II clinical trial of ABX-EGF in patients with colorectal cancer. ABX-EGF is a fully human monoclonal antibody against the epidermal growth factor receptor (EGFr), a receptor identified in many solid tumor types. This clinical trial, the third Phase II study of ABX-EGF, is designed to assess the safety and efficacy of ABX-EGF as monotherapy in patients with metastatic colorectal cancer who have previously failed chemotherapy. ABX-EGF is being developed in collaboration with Immunex Corporation.
This multi-center, open-label Phase II study will enroll up to 100 patients. Patients will receive intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week treatment cycle, for up to 6 cycles.
"We are pleased to advance our clinical oncology program with the start of this third Phase II trial for ABX-EGF," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "Our goal is to provide effective, antibody-based therapeutic options for cancer patients."
Preliminary results of an ongoing Phase I clinical trial of ABX-EGF show that it is well tolerated and shows biological activity at low doses. Thus far, three patients in the Phase I study have achieved stable disease/minor response. Other Phase II studies of ABX-EGF in kidney cancer and non-small cell lung cancer are currently ongoing.
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