Study Evaluates Panitumumab Administered With Bevacizumab and Chemotherapy
THOUSAND OAKS, Calif. and FREMONT, Calif., April 26 /PRNewswire-FirstCall/
-- Amgen Inc. (Nasdaq: AMGN) and Abgenix, Inc. (Nasdaq: ABGX) today announced
the initiation of a Phase 3 clinical study to evaluate the potential benefits
of adding panitumumab, an experimental fully human monoclonal antibody,
administered every other week to bevacizumab (Avastin(TM), Genentech) and
either oxaliplatin- (Eloxatin(R), sanofi-aventis) or irinotecan-based
(Camptosar(R), Pfizer) chemotherapy for the first-line treatment of metastatic
colorectal cancer. The clinical trial, called the PACCE (Panitumumab Advanced
Colorectal Cancer Evaluation) study, is a randomized, multi-center, open-label
study, with endpoints of progression free survival, overall survival and
response rate. Enrollment in the study of approximately 1,000 patients is
already underway.
"Targeting multiple pathways that aid in tumor survival and growth at the
same time or in succession theoretically has advantages over targeting one
pathway alone," said Willard Dere, M.D., chief medical officer and senior vice
president of global development at Amgen. "In clinical studies to date,
panitumumab appears to be well tolerated, and interim Phase 2 data demonstrate
that objective tumor responses in metastatic colon cancer patients occurred
following panitumumab treatment."
"We are delighted with the initiation of this important clinical trial to
further explore the potential for our lead product, panitumumab, in the
first-line treatment of metastatic colorectal cancer," said Bill Ringo,
president and chief executive officer at Abgenix. "This study is a key step in
the overall clinical program for panitumumab, which we expect to be evaluated
with various chemotherapy agents and targeted therapies across multiple tumor
types."
Panitumumab inhibits the epidermal growth factor receptor (EGFr), while
bevacizumab targets the vascular endothelial growth factor involved in
angiogenesis. 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.
Patients and physicians can access http://www.amgentrials.com for more
information about ongoing panitumumab clinical trials.
About Panitumumab
Co-developed by Amgen and Abgenix, panitumumab is an investigational
product in a novel 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 Abgenix's XenoMouse(R) technology, which creates
a fully human monoclonal antibody that contains no murine (mouse) protein.
The fully human nature of panitumumab may result in a favorable safety profile
with a low incidence of infusion reactions, antigenicity and allergic
response. These are attributes currently being investigated in clinical
trials. Pivotal clinical studies evaluating panitumumab as a third-line
monotherapy in colorectal cancer patients are ongoing with an every-other-week
dosing regimen.
About Amgen
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
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 the
establishment of collaborations with multiple pharmaceutical and biotechnology
companies. For more information on Abgenix, visit the company's Web site at
http://www.abgenix.com.
Amgen Forward-Looking Statement
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
others that can be found in Amgen's Form 10-K for the year ended December 31,
2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is
providing this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements contained in
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No forward-looking statement can be guaranteed and actual results may
differ materially from those we project. Discovery or identification of new
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consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful
and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the human body
cannot be perfectly, or sometimes, even adequately modeled by computer or cell
culture systems or animal models. The length of time that it takes for us to
complete clinical trials and obtain regulatory approval for product marketing
has in the past varied and we expect similar variability in the future. We
develop product candidates internally and through licensing collaborations,
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Our stock price may be affected by actual or perceived market opportunity,
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The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the U.S. Food and Drug Administration (FDA), and no
conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates. Only the FDA can determine whether the product
candidates are safe and effective for the use(s) being investigated.
Further, the scientific information discussed in this news release
relating to new indications for our products is preliminary and investigative
and is not part of the labeling approved by the U.S. Food and Drug
Administration (FDA) for the products. The products are not approved for the
investigational use(s) discussed in this news release, and no conclusions can
or should be drawn regarding the safety or effectiveness of the products for
these uses. Only the FDA can determine whether the products are safe and
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Abgenix Forward Looking Statement
Certain statements in this press release are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These include forward-looking
statements about Abgenix's technologies, product development activities,
clinical trials and clinical trial results, the potential submission of a
biologic license application for panitumumab, collaborative arrangements,
process sciences and manufacturing activities, projected financial and
operating results, and achievement of milestone or similar payments or other
revenues. All such statements are subject to a number of uncertainties that
could cause actual results to differ materially from the statements made,
including risks associated with conducting clinical trials, regulatory
approval processes and meeting requirements for regulatory approval, the
progress of research and product development programs, product manufacturing,
competitive products and services, capital requirements, the extent and
breadth of Abgenix's patent portfolio, and other factors set forth in
Abgenix's public filings with the Securities and Exchange Commission,
including the risks described in Abgenix's annual report on Form 10-K for the
year ended December 31, 2004. Abgenix is providing this information as of the
date of this press release and does not undertake any obligation to update any
forward-looking statements.
SOURCE Abgenix, Inc.
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Related links:
http://www.abgenix.com
CONTACT:
Trish Hawkins, +1-805-447-4587 (media), or
Investor Relations, +1-805-447-1060, both of Amgen Inc.; or Ami
Knoefler of Abgenix, Inc., +1-510-284-6350 (Media & Investors)
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