Improvement Seen With Multiple Parameters of Disease Measurement
FREMONT, Calif., Nov. 30 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX)
today reported top level results of its Phase I/II clinical trial with
ABX-IL8, a fully human antibody developed with the company's XenoMouse(TM)
technology. Additional details will be presented at the Psoriasis: from Gene
to Clinic meeting in London on December 2, 1999. The multi-center, placebo
controlled trial involved 45 patients with moderate to severe psoriasis.
Abgenix reported that ABX-IL8 was safe and well tolerated at all dose levels
tested and that 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. The company also indicated that it plans to initiate
a Phase II clinical trial in psoriasis during the first half of 2000. Other
inflammatory disease indications including rheumatoid arthritis continue to be
evaluated.
PASI analysis is a widely accepted measure of drug response in psoriasis
patients. Fifty-eight percent (58%) of the patients who received ABX-IL8
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 0.3 mg/kg 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.
"The Phase I/II trial of ABX-IL8 was primarily designed to demonstrate
safety so it is a nice surprise to see such encouraging results on efficacy
parameters," stated R. Scott Greer, president and CEO of Abgenix. "We will be
optimizing the dose and regimen of ABX-IL8 for psoriasis treatment in one or
more Phase II trials to begin next year."
ABX-IL8 is a proprietary fully human monoclonal antibody developed using
the company's XenoMouse 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 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 multiple
proprietary antibody product candidates that are under development internally,
three of which are in human clinical trials.
Statements marelease about ABX-IL8, 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
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