First EGFr Inhibitor to Demonstrate Improvement in Progression-Free Survival
as Monotherapy for Metastatic Colorectal Cancer
THOUSAND OAKS, Calif. and FREMONT, Calif., Nov. 3 /PRNewswire-FirstCall/ -
- Amgen (Nasdaq: AMGN) and Abgenix, Inc. (Nasdaq: ABGX) today announced that a
pivotal Phase 3 study of panitumumab met the primary endpoint of improving
progression-free survival in patients with metastatic colorectal cancer (mCRC)
who had failed standard chemotherapy. In this randomized Phase 3 trial
involving 463 patients, those who received panitumumab every two weeks showed
a 46 percent decrease in tumor progression rate versus those who received best
supportive care alone (p<0.000000001).
This result exceeded the pre-specified measure of progression-free
survival that the trial was designed to demonstrate (i.e., a 33 percent
decrease in tumor progression rate in patients receiving panitumumab versus
those receiving best supportive care, as assessed by central radiology
review). A secondary endpoint of objective response rate, as assessed by
central radiology review, was also met. Analysis of overall patient survival
in this study will occur 12 months after the last patient was randomized.
"Amgen is dedicated to developing safe and effective cancer therapies that
significantly improve cancer patients' outcomes," said Willard Dere, M.D.,
chief medical officer and senior vice president of Global Development at
Amgen. "We are excited that panitumumab, our most advanced investigational
cancer therapeutic, improved progression-free survival and response rate in
metastatic colorectal cancer patients who had failed multiple prior
chemotherapy regimens. These results will support a BLA submission, which we
plan to initiate by the end of the year."
"We are very encouraged by the results of this pivotal study and what
panitumumab could mean for patients with advanced colorectal cancer," said
Bill Ringo, president and chief executive officer of Abgenix. "The improvement
in progression-free survival shown by panitumumab in this study highlights the
value of our proprietary technology and product development capabilities. We
continue to work closely with our partner, Amgen, towards the regulatory
filing and potential commercialization of panitumumab."
Per protocol, administration of panitumumab did not require administration
of pre-medication or a loading dose and the incidence of infusion reactions
(of any severity) was low. An initial safety evaluation showed that the
adverse events observed were consistent with previous clinical studies of
panitumumab. The most common side effect was acneiform rash. Other side
effects less commonly observed were fatigue, nausea and mild diarrhea. No
human anti-human antibody (HAHA) or anti-panitumumab antibody formation was
observed.
Complete analyses of data from this trial will be submitted for
presentation at a medical meeting in 2006.
Panitumumab received Fast Track designation from the U.S. Food and Drug
Administration (FDA) in July 2005. Amgen and Abgenix are working toward
initiating the submission of the Biologics License Application (BLA) to the
FDA for panitumumab in patients who have failed prior standard chemotherapy,
including oxaliplatin and irinotecan, by the end of 2005. FDA has previously
indicated that data from one pivotal trial, once completed, could be
acceptable with additional data from other ongoing studies to support a
submission for marketing approval in the United States. The completed
submission of the BLA is expected in the first quarter of 2006.
Currently, panitumumab is being investigated as a single agent or in
combination with other agents across multiple lines of treatment for various
cancers. Patients and physicians can access http://www.amgentrials.com for more
information about ongoing panitumumab clinical trials.
About the Phase 3 Study
The international, multi-center, open-label, controlled Phase 3 study was
conducted in Europe, Australia and Canada, and enrolled 463 patients with
metastatic colorectal cancer who had failed standard chemotherapy, including
oxaliplatin and irinotecan. Patients were randomized to receive panitumumab
plus best supportive care (n=231) or best supportive care alone (n=232). Those
eligible received panitumumab by intravenous infusion at a dose of 6 mg/kg
once every two weeks. There was no requirement that patients receive any
pre-medication prior to panitumumab administration.
Best supportive care was defined as the best palliative care available, as
judged appropriate by the investigator, and could include antibiotics,
analgesics, radiation therapy for pain control (limited to bone metastases),
corticosteroids, transfusions, psychotherapy, growth factors, palliative
surgery, or any other symptomatic therapy as clinically indicated. For the
purposes of this study, best supportive care did not include anti-cancer
chemotherapy.
Conference Call Information
Amgen and Abgenix will host a conference call with the investment
community today at 8:00 a.m. Pacific Time. Participating in the call will be
Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and
Development at Amgen, and Bill Ringo, president and chief executive officer at
Abgenix.
Live audio of the conference call will be simultaneously broadcast over
the Internet and will be available to members of the news media, investors and
the general public.
To participate in the conference call, please dial 877-817-2450 or
706-634-7548 fifteen minutes before start time. The pass code for the live
call is 2201994. A telephonic replay of the call will be available by dialing
800-642-1687 or 706-645-9291. The replay participant code is 2201994.
The webcast of the conference can be found on Amgen's Web site,
http://www.amgen.com, under Investors, and on Abgenix's Web site, http://www.abgenix.com.
The webcast will be archived and available for replay at least 72 hours after
the event.
About Panitumumab
Co-developed by Amgen and Abgenix, panitumumab is the first fully human
monoclonal antibody that targets the epidermal growth factor receptor (EGFr),
a protein that plays an important role in cancer cell signaling. Panitumumab,
an IgG2 monoclonal antibody, binds with high affinity to the EGFr. Panitumumab
was generated with Abgenix's XenoMouse(R)(1) technology, which creates a fully
human monoclonal antibody that contains no murine (mouse) protein. The body's
immune system can recognize the mouse protein found in chimeric antibodies as
foreign and launches an immune response in the form of infusion reactions,
allergic reactions or anaphylaxis. The goal of developing fully human
monoclonal antibodies, which by definition contain no mouse protein, is to
offer effective, high affinity therapies that minimize the potential for this
type of immune response. Panitumumab is being evaluated in clinical trials as
both a monotherapy and in combination with other agents for the treatment of
various types of cancer, including colorectal, lung and kidney.
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different cells
in the body, EGFr also can 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, such as epidermal growth factor (EGF) or
transforming growth factor alpha (TGFa), 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 the natural
ligands such as EGF and TGFa 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 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 Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A
biotechnology pioneer since 1980, Amgen was one of the first companies to
realize the new science's promise by bringing safe and effective medicines
from lab, to manufacturing plant, to patient. Amgen therapeutics have changed
the practice of medicine, helping millions of people around the world in the
fight against cancer, kidney disease, rheumatoid arthritis, and other serious
illnesses. With a broad and deep pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve people's lives.
To learn more about our pioneering science and our vital medicines, visit
http://www.amgen.com.
About Abgenix
Abgenix is a biopharmaceutical company focused on the discovery,
development and manufacturing of fully 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.
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 Amgen projects. 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 Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects similar
variability in the future. Amgen develops 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 Amgen
may have believed at the time of entering into such relationship. Also, Amgen
or others could identify side effects or manufacturing problems with Amgen's
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implicate an entire class of products could have a material adverse effect on
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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 FDA for the products. The products are not
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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, timing and outcomes of 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.
(1) 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.abgenix.com
CONTACT:
media, Trish Hawkins, +1-805-447-4587, or
investors, Arvind Sood, +1-805-447-1060, both of Amgen; or Greg
Mann of Abgenix, +1-510-284-6566
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