Primary Objectives Met in Preliminary Analysis of Phase IIa Study
FREMONT, Calif., Jan. 3 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX)
announced today the decision to proceed with a Phase IIb clinical trial of
ABX-IL8 in patients with moderate-to-severe psoriasis. The decision to move
forward is based on meeting pre-determined safety and efficacy criteria in an
interim analysis of an ongoing Phase IIa study. The company intends to
present the Phase IIa results in detail at the American Academy of Dermatology
meeting in March 2001. Abgenix plans to initiate the Phase IIb trial in the
first quarter of 2001.
"Abgenix is encouraged by the preliminary data from the Phase IIa trial in
psoriasis and looks forward to performing the next study," stated
R. Scott Greer, chairman and chief executive officer of Abgenix. "ABX-IL8 is
the first fully human antibody created using our XenoMouse(TM) technology, to
enter clinical testing. We are delighted by the clinical progress achieved
with this therapeutic candidate thus far, and plan to explore its utility in
several clinical indications."
The Phase IIa trial was a double-blind, placebo-controlled study designed
to evaluate the safety and preliminary efficacy of ABX-IL8 in
moderate-to-severe plaque psoriasis. It involved 100 patients at 20 sites in
the U.S. receiving one of two dose levels of ABX-IL8 or placebo. Study
medication was administered once every 3 weeks for five consecutive doses,
followed by a 24-week observation period.
The Phase IIb trial is designed to confirm the safety and efficacy of
ABX-IL8 and to determine the optimal dose. It will enroll 225 patients with
moderate-to-severe psoriasis who will be randomized to receive one of two dose
levels of ABX-IL8 or placebo. Treatment frequency and duration will be the
same as in the Phase IIa study. Efficacy analyses will include Psoriasis Area
Severity Index (PASI) scores and Physician Global Assessment (PGA), which are
standard measures of severity of psoriasis.
ABX-IL8 is a fully human monoclonal antibody that targets
interleukin-8 (IL-8), a chemokine involved in the inflammatory process by
first enabling immune cells, including neutrophils, to migrate to sites of
inflammation and subsequently activating them. Clinical data suggest that
excess of IL-8 may be associated with certain inflammatory disorders including
psoriasis, rheumatoid arthritis and pulmonary disorders.
Abgenix is testing ABX-IL8 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 and may be contributing to the formation of new blood vessels that are
found in psoriatic lesions.
In addition to psoriasis, Abgenix is concurrently conducting a Phase IIa
clinical trial of ABX-IL8 in patients with rheumatoid arthritis.
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 focused on the development and
commercialization of antibody therapies for a variety of diseases. The
company developed XenoMouse(TM) technology to enable the rapid generation of
high affinity, fully human antibody product candidates to essentially any
disease target appropriate for antibody therapy. Abgenix uses its XenoMouse
technology to build 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.
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:
Ina Cu-Unjieng, Manager, Investor/Public
Relations of Abgenix, 510-608-4662
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