Preliminary Results of Phase 1 Study Presented at American Society of Clinical
Oncology Annual Meeting
FREMONT, Calif. and SEATTLE, May 14 /PRNewswire/ -- Researchers presented
preliminary results from a Phase 1 clinical trial of ABX-EGF, the only fully
human monoclonal antibody in development against the epidermal growth factor
receptor (EGFr), a receptor identified in many solid tumor types.
Co-developed by Abgenix, Inc. (Nasdaq: ABGX) and
Immunex Corporation (Nasdaq: IMNX), ABX-EGF was studied as monotherapy
(without concomitant chemotherapy) in patients with various types of cancer.
Data were presented today at the 37th Annual Meeting of the American Society
of Clinical Oncology (ASCO).
Data from the ongoing, multiple-dose Phase 1 study of ABX-EGF included the
results from 28 patients with various types of advanced solid refractory
tumors, including kidney, prostate, pancreatic, non-small cell lung,
colorectal and esophageal cancer. Patients received ABX-EGF by intravenous
infusion every week for four weeks and were followed for safety for an
additional five weeks. Doses ranged from 0.01 mg/kg to 1.0 mg/kg of ABX-EGF
preceded by a loading dose. The primary objective of this Phase 1 study is to
evaluate the safety of ABX-EGF at multiple dose levels.
"ABX-EGF's role in targeting the EGF receptor and blocking the growth of
tumor cells make it an exciting and promising research candidate in the
treatment of cancer," said Robert Figlin, M.D., a researcher at UCLA's
Jonsson Cancer Center and a professor of medicine and urology at the UCLA
School of Medicine. "I am encouraged by plans to investigate its potential as
a single-agent against multiple tumor types."
The following data were presented at the ASCO meeting:
-- Multiple doses of ABX-EGF appear to be well tolerated at doses ranging
up to 0.75 mg/kg with a loading dose of 1.0 mg/kg.
-- No antibody formation to the molecule was detected in any patient
receiving ABX-EGF.
-- No allergic reactions or infusion-related reactions were observed in
any patient receiving ABX-EGF.
-- Pharmacokinetic observations indicated that serum levels of ABX-EGF
associated with efficacy in mouse xenograft models were attained in
patients at a dose of 1.0 mg/kg.
-- Skin rashes characteristic of EGF receptor targeting agents were
observed at a dose of 1.0 mg/kg of ABX-EGF when preceded by a 2.0 mg/kg
loading dose.
-- Stable disease has been achieved in two patients who received low doses
(0.1 and 0.75 mg/kg) of ABX-EGF as monotherapy.
Based on the preliminary results of the Phase 1 study, Abgenix and Immunex
initiated a Phase 2 study of ABX-EGF in kidney cancer. The companies plan to
initiate a series of Phase 2 clinical trials in additional cancer indications.
About ABX-EGF
ABX-EGF is a fully human monoclonal antibody generated using XenoMouse
(TM) technology that targets the epidermal growth factor receptor (EGFr),
which is over-expressed in a variety of cancers including lung, breast,
bladder, prostate, colorectal, kidney and head and neck cancer. It has been
demonstrated that cancer cells can become dependent on growth signals mediated
through the EGFr for their survival. In preclinical research, ABX-EGF
monotherapy has been shown to both eradicate established human tumors and
block the growth of human tumors.
An estimated 70-90% of kidney cancer, 60-80% of prostate cancer, 60-80% of
pancreatic non-small-cell lung, and esophageal cancers overexpress EGFr.
Abgenix is a biopharmaceutical company focused on the development and
commercialization of fully human monoclonal antibody therapies for a variety
of diseases. The company's antibody technology platform, which includes
XenoMouse(TM) technology, enables the rapid generation and selection of high
affinity, fully human antibody product candidates to essentially any disease
target appropriate for antibody therapy. Abgenix leverages its leadership
position in human antibody technology by building a large and diversified
product portfolio through the establishment of licensing arrangements with
multiple pharmaceutical, biotechnology and genomics companies and through the
development of its own internal proprietary products. For more information on
Abgenix, visit the company's website at http://www.abgenix.com.
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Statements made in this press release about ABX-EGF clinical trials,
Abgenix's XenoMouse technology, 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 success of clinical trials, the progress
of research and product development programs, the regulatory approval process,
competitive products, 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.
NOTE: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements. An electronic version of this
news release -- as well as additional information about Immunex of interest to
investors, customers, future employees and patients -- is available on the
Immunex home page at http://www.immunex.com.
SOURCE Immunex Corporation
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CONTACT:
Ina Cu, Media/Investor Relations of Abgenix,
Inc., 510-608-4662; or Media, Kris Greco of Immunex Corporation,
206-470-4871; or Investor Relations, Mark Leahy, 206-389-4363,
for Immunex Corporation
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