Abgenix Announces ABX-EGF Enters Pivotal Trial in Advanced Colorectal Cancer Patients
Tuesday January 20, 8:55 am ET
FREMONT, Calif.--(BUSINESS WIRE)--Jan. 20, 2004--Abgenix, Inc. (Nasdaq:ABGX - News) today announced that its partner, Amgen, is beginning a pivotal trial for its fully human monoclonal antibody, ABX-EGF, as a third-line monotherapy in colorectal cancer patients, with enrollment expected to begin shortly. The trial initiation follows the receipt of a Special Protocol Assessment (SPA) letter from the U.S. Food and Drug Administration (FDA). The SPA endorses the design of the trial to support a regulatory submission for a potential accelerated approval. SPA was introduced by the FDA modernization act of 1997 and was first implemented in May 2002. A second pivotal trial is being initiated concurrently outside the US, as part of a comprehensive global development program for ABX-EGF.
"We are pleased that this important goal has been achieved early in the year," said Ray Withy, Ph.D., president and CEO of Abgenix. "We look forward to further progress on the program, as ABX-EGF moves toward commercialization."
About ABX-EGF
ABX-EGF is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), which is expressed in a variety of cancers including lung, breast, pancreatic, bladder, prostate, colorectal, kidney and head and neck cancers. Research has demonstrated that cancer cells can become dependent on growth signals mediated through EGFr for their survival. In preclinical research, ABX-EGF monotherapy has been shown to inhibit the growth of human tumors in mice. Clinical studies to date have demonstrated single-agent activity and a favorable pharmacokinetic and tolerability profile.
Co-developed by Abgenix and Amgen, ABX-EGF is being evaluated in a comprehensive global clinical program. |
