ORLANDO, Fla., May 17 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN),
the world's largest biotechnology company, and Abgenix, Inc. (Nasdaq: ABGX), a
leading antibody development company, today announced updated results from an
ongoing Phase 2 study of panitumumab, a fully human monoclonal antibody
directed against the epidermal growth factor receptor (EGFr). The results
demonstrate that panitumumab has antitumor activity when administered as a
single-agent treatment to patients with metastatic colorectal cancer (mCRC)
who have failed standard chemotherapy. An independent central radiology
review determined that treatment with panitumumab resulted in a nine percent
overall response rate and median time to progression of
11.4 weeks. [Abstract #3520]
The data were presented today at the 41st Annual Meeting of the American
Society of Clinical Oncology (ASCO). Investigators reported that patients
with mCRC tumors expressing the EGFr protein who received panitumumab
monotherapy demonstrated a median survival time of 37.6 weeks and a median
duration of tumor response of 18.1 weeks. Stabilization of disease was
observed in 29 percent of patients (n=43). Median progression-free survival
time was 13.6 weeks.
"These data confirm previously reported safety and response findings in
patients with metastatic colorectal cancer who have previously failed multiple
lines of chemotherapy," said Imtiaz A. Malik, MD, professor of medicine, Loma
Linda University Cancer Institute, Loma Linda, Calif. and one of the study's
lead investigators. "Panitumumab's efficacy and safety data from Phase 1 and
Phase 2 clinical trials to date suggest that panitumumab may provide an
additional avenue for oncologists to manage the disease."
Patients in the study (n=148) were previously treated with 5FU (with or
without leucovorin) and either irinotecan or oxaliplatin, or both. Patients
received 2.5 mg/kg of panitumumab by weekly one-hour intravenous infusion
without premedication. Tumor responses were confirmed no less than four weeks
after the initial response was observed.
In this Phase 2 study, the most common side effect was skin toxicity
(95 percent, 7 percent grade 3). Other side effects experienced by some
patients were fatigue, nausea and mild diarrhea. One infusion reaction
(grade 3) was reported per investigator assessment and the patient continued
on full-dose panitumumab with pre-medication. There were no instances of
anaphylaxis observed. In those patients tested who had a baseline and a
post-baseline assessment (n=107), no human antihuman antibodies (HAHAs)
formation was observed.
Phase 1 Open-Label Dose Escalation Trial Suggests Panitumumab May Provide
for Flexible Dosing Schedules in Cancer Patients [Poster K4, Abstract #3059]
Additional data from a Phase 1 open-label dose escalation trial were
presented by Louis M. Weiner, MD, chairman, department of medical oncology,
and vice president, translational research at Fox Chase Cancer Center,
Philadelphia, Pa. Exposure and tolerability profiles were similar between
weekly, every-other-week and every-three-week dosing schedules.
"We are very encouraged by the safety profile at various doses of this
antibody in cancer patients and in different types of cancers. We look forward
to the continued evaluation of panitumumab, a promising antibody cancer
therapeutic," said Dr. Weiner.
Patients (n=96) were randomized to receive four infusions of panitumumab
at different dose levels and schedules ranging from 0.01 to 5.0 mg/kg once per
week, 6.0 mg/kg once every two weeks or 9.0 mg/kg once every three weeks
administered by intravenous infusion with no premedication required.
For further information concerning ongoing clinical trials involving
panitumumab please visit, http://www.amgentrials.com/ .
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men and in
women in the United States. The American Cancer Society estimates that about
104,950 new cases of colon cancer (48,290 men and 56,660 women) and 40,340 new
cases of rectal cancer (25,530 men and 16,810 women) will be diagnosed in
2005.
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 was 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 safety profile
with a low incidence of infusion reactions and antigenicity. These are
attributes currently being investigated in clinical trials. Pivotal clinical
studies evaluating panitumumab as a monotherapy in colorectal cancer patients
who have failed standard chemotherapy are ongoing with an every-other-week
dosing regimen.
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 (TGFalpha), 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 TGFalpha 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 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 US 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
Statements made in this press release about Abgenix's technologies,
product development activities and collaborative arrangements, other than
statements of historical fact, 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
timing and success of clinical trials, the progress of research and product
development programs, product manufacturing, regulatory approval processes,
competitive products and services 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,
including its Form 10-K for the year ended December 31, 2004, and periodic
reports on Form 10-Q and Form 8-K.
NOTE: XenoMouse(R) is a registered trademark of Xenotech, a wholly-owned
subsidiary of Abgenix, Inc.
SOURCE Abgenix, Inc.
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Related links:
http://www.amgentrials.com
CONTACT:
media, Trish Hawkins, +1-805-447-4587, or
investors, Investor Relations, +1-805-447-1060, both of Amgen; or
media & investors, E. Blair Schoeb, +1-917-432-9275, for Abgenix
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