Thursday January 3, 4:34 pm Eastern Time
Press Release
SOURCE: Abgenix
Abgenix Releases Results of a Phase 2a Study With ABX-IL8 in Rheumatoid Arthritis
FREMONT, Calif.--(BW HealthWire)--Jan. 3, 2002--Abgenix, Inc. (Nasdaq:ABGX - news) 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® 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® 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. |
