Abgenix to Seek a Corporate Partner to Commercialize ABX-CBL
FREMONT, Calif., Dec. 7 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX) is
initiating a Phase III clinical trial comparing its antibody, ABX-CBL, with
standard therapy for patients with steroid-resistant graft-versus-host disease
(srGVHD), a serious, life-threatening disorder. Abgenix also indicated that it
would seek a corporate partner to assist with the development and
commercialization of ABX-CBL.
Abgenix is pursuing the Phase III trial of ABX-CBL based on promising
results of a 59 patient Phase II trial of the drug. In that trial, srGVHD
patients receiving higher doses of ABX-CBL had more than twice the 180-day
survival rate observed in the lowest dose cohort, according to results
presented at the annual meeting of the American Society of Hematology (ASH).
Survival at 180 days for patients in the higher dose cohorts was 50% versus
22% in the lowest (presumed no effect) dose cohort.
"ABX-CBL demonstrated important clinical benefits as measured by response
rate and survival in the Phase II clinical trial," said H. Joachim Deeg, M.D.,
Department of Transplantation Biology at Fred Hutchinson Cancer Research
Center and Principal Investigator for the trial. "Given the limited options
available for treating srGVHD patients, ABX-CBL has the potential to be an
important new treatment for this disease."
"While we are enthusiastic about ABX-CBL's potential as a much needed
treatment for srGVHD, our business strategy is to find corporate partners to
commercialize the products we generate," stated R. Scott Greer, president and
CEO of Abgenix. "Therefore, we would like to identify a pharmaceutical or
biotech company with the development and marketing infrastructure to maximize
the commercial potential of ABX-CBL. We plan to begin the Phase III trial on
our own, but would like to have a partner on board before it is completed."
GVHD occurs in about 50 percent of patients receiving transplants of stem
cells, from which all blood cells derive, when the transplanted cells attack
the patient's tissues. Such transplants, or grafts, are used to treat patients
with leukemia, certain other serious cancers and immune system disorders.
Roughly half of GVHD patients fail to respond to current treatments, which
consist of steroid and other drug treatments to suppress the grafted immune
cells. Anti-thymocyte globulin (ATG), a horse polyclonal antibody mixture, is
a commonly used treatment for GVHD patients who do not respond to first line
steroid therapy.
GVHD frequently occurs following the transplantation of genetically
different (allogeneic) stem cells, which involves transferring stem cells from
the bone marrow or peripheral blood of a healthy donor into an
immunosuppressed patient, the host. The transplant is intended to restore
normal circulating blood cells and immune cells in patients whose own bone
marrow cells and immune system are suppressed by radiation and or chemotherapy
and therefore cannot mount a sufficient immune response. Often a portion of
the graft recognizes the host's own cells as foreign, becomes activated and
attacks the cells, resulting in GVHD. The disease typically involves damage to
multiple organ systems, including the skin, liver and intestines. GVHD causes
extreme suffering and is a frequent cause of death in allogeneic stem cell
transplant patients.
ABX-CBL is a monoclonal antibody that binds to CD147, a protein that is
upregulated on certain activated immune cells. After ABX-CBL attaches to the
CD147 antigen, the resulting complex signals to other immune cells to destroy
the tagged cell. By selectively eliminating these cells while leaving other
competent immune cells untouched, ABX-CBL may be useful in treating immune
system disorders like srGVHD.
In the Phase III trial, Abgenix will compare ABX-CBL to ATG among
92 patients expected to enroll in the multi-center, controlled trial.
Survival will be the trial's primary endpoint. The study is expected to take
approximately 18-24 months to complete.
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, infectious disease, and cancer.
Abgenix developed XenoMouse(TM) technology to enable 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 multiple,
proprietary antibody product candidates under development internally, three of
which are in human clinical trials for graft-versus-host disease, psoriasis
and rheumatoid arthritis. For more information, visit Abgenix' Web site at
http://www.abgenix.com.
The Fred Hutchinson Cancer Research Center is an independent, nonprofit
research institution dedicated to the development and advancement of
biomedical technology to eliminate cancer and other potentially fatal
diseases. Recognized internationally for its pioneering work in bone-marrow
transplantation, the Center's four scientific divisions collaborate to form a
unique environment for conducting basic and applied science. One of
35 National Cancer Institute-designated comprehensive cancer centers in the
nation, it is the only one in the Northwest. For more information, visit the
Center's Web site at http://www.fhcrc.org.
Statements made in this press release about the potential of ABX-CBL and
other antibody-based therapies as treatments for various diseases, 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.
SOURCE Abgenix, Inc.
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Related links:
http://www.abgenix.com
CONTACT:
Kurt Leutzinger, Vice President and Chief
Financial Officer of Abgenix, Inc., 510-608-6575; or Marion Glick
of Porter Novelli, 212-601-8273, for Abgenix, Inc.; or Kristen
Woodward, Media Relations of Fred Hutchinson Cancer Research
Center, 206-667-5095
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