FREMONT, Calif., May 18 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX)
reported today additional results of a Phase II clinical trial of ABX-CBL in
graft versus host disease ("GVHD"). ABX-CBL is a proprietary in-licensed mouse
antibody that binds to the CBL antigen. The CBL antigen is upregulated on
activated immune cells, including T cells, B cells and natural killer cells.
The completed trial involved patients in four dose cohorts with severe GVHD,
an often fatal side effect of bone marrow transplants ("BMT"). Among patients
in the three higher dose cohorts, 56% (10 of 18) survived at least 100 days
from the start of treatment with ABX-CBL. This compared favorably to a 22%
(2 of 9) survival rate in the low dose cohort. Robert Rivkin, M.D. of the
Rocky Mountain Cancer Centers in Denver, Colorado, presented the details of
the clinical trial today at the 1999 Annual Meeting of the American Society of
Clinical Oncology
"We believe the survival data reported today strengthens the preliminary
safety and response rate data reported earlier," stated R. Scott Greer,
president and chief executive officer of Abgenix. "We plan to initiate a
pivotal Phase III clinical trial for ABX-CBL as soon as feasible after we have
approval from the FDA to proceed."
In March, at the International Bone Marrow Transplant Registry ("IBMTR")
meeting, it was reported that, among patients in the three higher dose
cohorts, 73% (11 of 15) had a two grade or better improvement in the IBMTR
GVHD Severity Scale. This compared favorably to a 25% (2 of 8) response rate
in the low dose cohort.
GVHD is a life threatening complication that frequently occurs following
an allogeneic BMT. BMTs are used in the treatment of patients with end stage
leukemia, certain other serious cancers and immune system disorders. An
allogeneic BMT procedure involves transferring marrow, the graft, from a
healthy person into an immunosuppressed patient, the host. The transplant is
intended to restore normal circulating immune cells to a patient whose own
immune system is functionally deficient or has been damaged by the treatment
of an underlying disease such as cancer and therefore does not have the
ability to mount a sufficient immune response. Often a portion of the graft
recognizes the host's own cells as foreign, becomes activated and attacks
them, resulting in GVHD. It typically involves damage to multiple organ
systems, including the skin, liver and intestines. GVHD causes extreme
suffering and is the primary cause of death in allogeneic BMT patients.
Abgenix is a biopharmaceutical company that develops and intends to
commercialize antibody therapeutic products for the treatment of a variety of
disease conditions, including transplant-related diseases, inflammatory and
autoimmune disorders, cardiovascular disease and cancer. Abgenix has developed
XenoMouse technology, which it believes enables quick generation of high
affinity, fully human antibody product candidates to essentially any disease
target appropriate for antibody therapy. Abgenix has collaborative
arrangements with multiple pharmaceutical and biotechnology companies
involving its XenoMouse technology. In addition, Abgenix has four proprietary
antibody product candidates that are under development internally, two of
which are in human clinical trials. For more information about the company,
visit its Web site at http://www.abgenix.com/.
Statements made in this press release about Abgenix's clinical trials for
ABX-CBL, XenoMouse technology, product development activities, clinical trials
for other product candidates, product pipelines 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 for ABX-CBL and Abgenix's other product
candidates, 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 Exchange Commission for information about
risks which may affect Abgenix.
SOURCE Abgenix, Inc.
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Related links:
http://www.abgenix.com
CONTACT:
investors, Stephanie Seiler, Ph.D.,
212-696-4455, ext. 212, or media, Amy Flood, 415-677-4455, ext.
211, both of Noonan/Russo Communications, for Abgenix; or Kurt
Leutzinger, Vice President and Chief Financial Officer of
Abgenix, 510-608-6575
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