Panitumumab Pivotal Trial Completes Patient Enrollment
18 März 2005 - 12:00PM
PR Newswire (US)
Panitumumab Pivotal Trial Completes Patient Enrollment FREMONT,
Calif., March 18 /PRNewswire-FirstCall/ -- Abgenix, Inc.
(NASDAQ:ABGX) 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. "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(R) 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 http://www.abgenix.com/.
Statements made in this press release about Abgenix's technologies,
product development activities, collaborative arrangements and
process science and manufacturing capabilities, other than
statements of historical fact, and about its projected financial
results and the achievement of milestone or similar payments, are
forward-looking statements and are subject to a number of
uncertainties that could cause actual results to differ materially
from the statements made, including risks associated with the
success of clinical trials, the progress of research and product
development programs, product manufacturing, regulatory approval
processes, competitive products and services, future capital
requirements and the extent and breadth of Abgenix's patent
portfolio. Please see Abgenix's public filings with the Securities
and Exchange Commission for information about risks that may affect
Abgenix. DATASOURCE: Abgenix, Inc. CONTACT: Ami Knoefler, Senior
Director of Corporate Communications and Investor Relations for
Abegenix, Inc., +1-510-284-6350 or +1-510-284-6605 Web site:
http://www.abgenix.com/
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