OT Rheumatoid Arthritis Abgenix releases results of a Phase 2a Study With ABX-IL8 and will NOT progress any further. Posted for people interested in RA.
-----------
Abgenix Releases Results of a Phase 2a Study With ABX-IL8 in Rheumatoid
Arthritis
FREMONT, Calif., Jan 3, 2002 (BW HealthWire) -- Abgenix, Inc. (Nasdaq:ABGX)
announced results of a Phase 2a study with ABX-IL8 in patients with rheumatoid
arthritis. ABX-IL8 is a fully human monoclonal antibody generated with Abgenix's
XenoMouse(R) technology that blocks the activity of interleukin-8 (IL-8), a
chemokine involved in several diseases. Phase 2 clinical studies have been
conducted or are underway in psoriasis, rheumatoid arthritis, chronic
obstructive pulmonary disease and metastatic cancer.
The double-blind, placebo-controlled Phase 2a study of ABX-IL8 randomized 153
rheumatoid arthritis patients at 23 sites in the U.S. One dose level, 300 mg of
ABX-IL8, was assessed. ABX-IL8 was administered every three weeks for a total of
four infusions; the first infusion was a 2x loading dose (600 mg). Patients were
evaluated at three-week intervals through Week 15. The objective of the Phase 2a
study was to evaluate the safety and efficacy of ABX-IL8 in patients with active
rheumatoid arthritis. To be eligible to participate in the study, patients must
have been receiving methotrexate and have had active rheumatoid arthritis
defined as greater than or equal to 8 swollen joints, greater than or equal to
10 tender joints and two out of three of the following: elevated CRP, morning
stiffness greater than or equal to 45 minutes, or patient assessment of disease
activity greater than or equal to 4 on a 1-10 scale.
Overall, ABX-IL8 was safe and well tolerated. The incidence of adverse events
was similar in both treatment groups and no human anti-human antibodies were
detected at any timepoint in any patient.
The primary efficacy endpoint was the proportion of patients achieving an ACR 20
response at Week 12. An ACR 20 response requires a greater than or equal to 20%
reduction in swollen joint count, a greater than or equal to 20% reduction in
tender joint count and a greater than or equal to 20% improvement in three out
of five of the following: patient's assessment of pain, patient's assessment of
disease activity, investigator's assessment of disease activity, acute phase
reactant (CRP) and patient's assessment of functional status (HAQ score). In an
analysis of all randomized patients, 31% of placebo-treated patients achieved an
ACR 20 response at Week 12 compared with 34% of ABX-IL8-treated patients. In a
subset analysis of patients with more active disease (the 70% of patients in the
study who had greater than or equal to 12 swollen joints at baseline) 41% of
ABX-IL8-treated-patients achieved an ACR 20 response compared with 27% of
placebo-treated patients. Additionally, a correlation between serum levels of
ABX-IL8 and clinical response was observed. Forty-seven percent of patients with
ABX-IL8 serum concentrations above the median level achieved an ACR 20 response
at Week 12, compared to a 33 percent ACR 20 response rate in patients below the
median. Despite this evidence of anti-inflammatory activity, the magnitude of
the benefit did not meet the company's criteria for moving forward to a Phase 2b
study.
"While we are disappointed by the clinical results achieved with ABX-IL8 in
rheumatoid arthritis, we remain enthusiastic about ABX-IL8 in the other
indications we are pursuing including psoriasis, COPD, and metastatic melanoma,"
stated R. Scott Greer, chairman and chief executive officer of Abgenix.
"Importantly, ABX-IL8 appears to be safe and well tolerated in patients with
active rheumatoid arthritis, supporting the strong safety profile we have seen
in psoriasis. In addition, data from this study continue to support the
anti-inflammatory effects of ABX-IL8.
"Abgenix's strategy of building a diversified clinical portfolio avoids
excessive reliance on any one indication," Greer continued. "Our goal is to
design Phase 2a trials that provide meaningful information about efficacy, but
which avoid overspending on our product candidates while we explore different
indications to determine the ones for which they are best suited."
ABX-IL8 is currently under investigation in the treatment of moderate to severe
plaque psoriasis, chronic obstructive pulmonary disease and metastatic melanoma.
The results of a Phase 2a study in psoriasis, presented early in 2001, indicated
that ABX-IL8 at the 3 mg/kg dose level was effective in reducing skin scores
over a 3-month treatment period. A Phase 2b study in patients with
moderate-to-severe plaque psoriasis completed enrollment in 4Q01. A Phase 2a
study in patients with COPD, a major unmet clinical need, began enrollment in
4Q01.
Abgenix is a biopharmaceutical company focused on the development and
commercialization of human therapeutic antibodies. The company's technology
platform, which includes XenoMouse(R) and XenoMax(TM) technologies, enables the
rapid generation and selection of high affinity, fully human antibody product
candidates to a variety of disease targets. Abgenix leverages its leadership
position in human antibody technology by building a diversified product
portfolio through the development of its own internal proprietary products and
through the establishment of licensing arrangements with multiple
pharmaceutical, biotechnology and genomics companies. Abgenix's proprietary
products are currently in clinical trials for the treatment of cancer and
inflammatory diseases. For more information on Abgenix, visit the company's
website at www.abgenix.com.
Statements made in this press release 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.
CONTACT: Abgenix
Ina Cu, 510/608-4662
URL: businesswire.com
Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
Copyright (C) 2002 Business Wire. All rights reserved. |
