Panitumumab Pivotal Trial Completes Patient Enrollment
Friday March 18, 6:00 am ET
FREMONT, Calif., March 18 /PRNewswire-FirstCall/ -- Abgenix, Inc. (Nasdaq: ABGX - News) today announced that Amgen has completed patient enrollment in a pivotal trial evaluating panitumumab, an experimental fully human monoclonal antibody, as monotherapy for metastatic colorectal cancer patients who have failed standard chemotherapy. The randomized, controlled clinical trial, which has enrolled more than 460 patients in Europe, Australia and Canada, evaluates best supportive care plus panitumumab monotherapy administered every other week versus best supportive care alone in patients with advanced metastatic colorectal cancer who have failed previous therapies.
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"We are delighted Amgen has completed enrollment in this rigorously designed clinical trial, and await the study findings on the safety and efficacy of panitumumab in patients with advanced colorectal cancer. We hope to include the study as part of a potential BLA submission later this year, data pending," said Gisela Schwab, M.D., chief medical officer at Abgenix. "We look forward to the continued development of panitumumab and are working with Amgen to bring this potential new therapy to patients with advanced colorectal cancer."
About Panitumumab
Co-developed by Amgen and Abgenix, panitumumab is an investigational product in a new class of targeted cancer treatments called epidermal growth factor receptor (EGFr) inhibitors. Panitumumab (formerly ABX-EGF) is the first fully human monoclonal antibody directed against EGFr and is being evaluated as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and kidney. Panitumumab is generated with XenoMouse® technology, which creates a fully human monoclonal antibody that contains no murine (mouse) protein. The fully human nature of panitumumab is being investigated for its potential to reduce the incidence of infusion reactions and antigenicity, as well as reduce the likelihood of allergic response, compared with chimeric antibodies (monoclonal antibodies that contain murine protein).
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different cells in the body, EGFr can also stimulate cancer cells to grow. In fact, many cancer cells actually require signals mediated by EGFr for their survival. Residing on the surface of these tumor cells, EGFr is activated when naturally occurring proteins in the body, epidermal growth factor (EGF) or transforming growth factor alpha (TGF alpha), bind to it. This binding changes the shape of EGFr, which, in turn, triggers internal cellular signals that stimulate tumor cell growth.
Panitumumab binds to EGFr, preventing EGF and TGF alpha from binding to the receptor and interfering with the signals that would otherwise stimulate growth of the cancer cell and allow it to survive.
About Abgenix
Abgenix is a biopharmaceutical company focused on the discovery, development and manufacturing of human therapeutic antibodies. The company's antibody development platform includes a leading technology and state-of-the-art manufacturing capabilities that enable the rapid generation, selection and production of high affinity, fully human antibody product candidates to a variety of disease targets. Abgenix leverages its leadership position in human antibody technology to build a diversified product portfolio through its own development efforts and the establishment of collaborations with multiple pharmaceutical and biotechnology companies. For more information on Abgenix, visit the company's website at www.abgenix.com. |
