Abgenix Announces Initiation of Phase II Clinical Trial of ABX-EGF in Non-Small Cell Lung Cancer

01-Aug-2001

Abgenix, Inc. (Nasdaq: ABGX) announced today the initiation of a Phase II clinical trial of ABX-EGF in patients with non-small cell lung cancer (NSCLC). 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 second Phase II study of ABX-EGF, will assess the tolerability and efficacy of ABX-EGF in combination with standard chemotherapy in patients with NSCLC. ABX-EGF is being developed in collaboration with Immunex Corporation.

This multi-center Phase II study will enroll up to 210 patients across North America. Patients will receive weekly intravenous infusions of ABX-EGF in combination with standard chemotherapy or standard chemotherapy alone.

"We are happy to be moving forward with the second Phase II trial this year for ABX-EGF," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "We are pleased with the progress the joint development team has made in advancing clinical development of ABX-EGF in various cancer indications. 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 were presented at the American Society of Clinical Oncology (ASCO) annual meeting in May 2001, showing ABX-EGF to be safe and well tolerated. Thus far, two patients in the Phase I study have achieved stable disease. A Phase II study evaluating the safety and efficacy of ABX-EGF as a single agent in patients with kidney cancer was initiated by Abgenix and Immunex earlier this year.

About ABX-EGF

ABX-EGF is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), which is over-expressed on a variety of cancers including lung, breast, bladder, prostate, colorectal, kidney and head and neck cancer. It has been demonstrated that cancer cells can become dependent on growth signals mediated through the EGFr for

their survival. In mouse models, ABX-EGF monotherapy has been shown to both eradicate established human tumors and block the growth of human tumors.

Overexpression of the EGFr has been reported to occur in the tumor tissue of 60-80% of NSCLC patients. In 2000, there were approximately 120,000 deaths associated with NSCL cancer and approximately 125,000 new cases of NSCLC in the United States. Advanced NSCLC is characterized by a response rate of approximately 20-30% and a median survival time of less than one year with standard chemotherapy.

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