Phase 3 Clinical Trial Initiated to Evaluate the Use of Panitumumab Therapy For First-Line Treatment of Metastatic Colorectal Ca
27 April 2005 - 1:30AM
PR Newswire (US)
Phase 3 Clinical Trial Initiated to Evaluate the Use of Panitumumab
Therapy For First-Line Treatment of Metastatic Colorectal Cancer
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 this document as a result of new
information, future events or otherwise. No forward-looking
statement can be guaranteed and actual results may differ
materially from those we project. Discovery or identification of
new product candidates or development of new indications for
existing products cannot be guaranteed and movement from concept to
product is uncertain; 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, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify side effects or
manufacturing problems with our products after they are on the
market. In addition, sales of our products are affected by the
availability of reimbursement and the reimbursement policies
imposed by third party payors, including governments, private
insurance plans and managed care providers, and may be affected by
domestic and international trends toward managed care and
healthcare cost containment as well as possible U.S. legislation
affecting pharmaceutical pricing and reimbursement. Government
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that it will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. 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 effective for these
uses. Healthcare professionals should refer to and rely upon the
FDA-approved labeling for the products, and not the information
discussed in this news release. 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. DATASOURCE: Abgenix, Inc. 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) Web site:
http://www.abgenix.com/
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