Multi-Center Trial Expected to Enroll 90 Patients
FREMONT, Calif., April 3 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX)
announced today that it has initiated its first Phase II clinical trial with
ABX-IL8. The multi-center, placebo controlled trial is expected to enroll
90 patients with moderate to severe psoriasis. An interim review of data is
possible by year-end 2000. Future additional Phase II trials for ABX-IL8 are
being evaluated in psoriasis and other indications including rheumatoid
arthritis and cancer.
In December 1999 Abgenix reported results of a multi-center, placebo
controlled Phase I/II trial involving 45 patients with moderate to severe
psoriasis. In this study, ABX-IL8 was safe and well tolerated at all dose
levels tested, and a dose-dependent improvement was seen in multiple measures
of disease. These efficacy measures included psoriasis area severity index
(PASI), total body surface area (BSA), Physician's Global Assessment (PGA),
and plaque photographs. PASI analysis is a widely accepted measure of drug
response in psoriasis patients. Fifty-eight percent (58%) of the patients who
received ABX-IL8 in doses of 1.0 mg/kg and 3.0 mg/kg, administered once every
three weeks for four consecutive doses, achieved a =>25% improvement, and
21% of patients achieved a =>50% improvement in PASI score. This compared
favorably to patients receiving a 0.3 mg/kg dose of ABX-IL8 (20% of patients
achieved a =>25% improvement and 0% a =>50% improvement) and to patients
receiving placebo (0% of patients with improvement of =>25%). BSA and PGA
measures and plaque photographs also showed dose dependent improvement.
"We are pleased with the development progress of ABX-IL8, a product
candidate potentially useful in several medical disorders," said
R. Scott Greer, chairman and CEO of Abgenix. "ABX-IL8 was the first fully
human antibody generated from transgenic mouse technology to be tested in a
human clinical trial and is now the first to move into Phase II studies."
ABX-IL8 is a proprietary fully human monoclonal antibody developed using
the company's XenoMouse(TM) technology. ABX-IL8 targets Interleukin-8
("IL-8"), which is a cytokine that can cause unwanted inflammation by first
enabling immune cells, including neutrophils, to migrate to inflammatory sites
and subsequently activating them. There is substantial evidence that
IL-8 contributes to a number of inflammatory diseases, including psoriasis,
rheumatoid arthritis, and inflammatory bowel disease.
ABX-IL8 is being studied initially in psoriasis because of its potential
to intervene at multiple steps in the disease pathology by blocking IL-8.
Scientific studies have shown that IL-8 levels can be elevated 150-fold in
psoriatic tissue when compared to normal tissue. In addition to contributing
to the inflammation process, IL-8 is also a growth factor for skin cells that
are proliferating in psoriatic tissue. Finally, IL-8 is a potent angiogenesis
factor, so it may be contributing to the ingrowth of blood vessels that
nourish psoriatic tissue.
Psoriasis is a chronic disease that results in plaques, a thickening and
scaling of the skin accompanied by local inflammation. The disease affects
approximately four to five million people in the United States and can be
debilitating in its most severe form. Approximately 500,000 psoriasis patients
suffer from a severe enough form of the disease to require systemic therapy
with immune suppressants and ultraviolet phototherapy. The risk of serious
adverse side effects associated with these therapies often requires the
patients to alternate between various therapeutic modalities as a
precautionary measure.
Abgenix is a biopharmaceutical company that develops and intends to
commercialize antibody therapies for the treatment of such conditions as
transplant-related diseases, inflammatory and autoimmune disorders,
cardiovascular disease, infectious diseases, and cancer. For more information
on Abgenix, visit the company's Web site at http://www.abgenix.com.
Abgenix developed XenoMouse technology to enable the rapid 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, genomics 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, rheumatoid arthritis, and cancer.
Statements made in this press release about 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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http://www.abgenix.com
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http://www.prnewswire.com/comp/126548.html or fax,
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CONTACT:
Kurt Leutzinger, Chief Financial Officer of
Abgenix Inc., 510-608-6575
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