ABGX starts IL8 trial in RA
Thursday December 28, 4:30 pm Eastern Time
Press Release
SOURCE: Abgenix, Inc.
Abgenix Initiates Phase IIa Clinical Trial With ABX-IL8 For Patients With Rheumatoid Arthritis
Clinical Progress in Second Potential Indication for ABX-IL8
FREMONT, Calif., Dec. 28 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX - news) announced today the start of a Phase IIa multi-center clinical trial of ABX-IL8 in patients with rheumatoid arthritis. The company is also conducting a Phase IIa clinical trial with ABX-IL8 in patients with moderate-to-severe psoriasis, and expects to report results of this study in the first quarter of 2001.
``We are pleased with the potential utility of ABX-IL8 in various inflammatory diseases,'' stated R. Scott Greer, president and chief executive officer of Abgenix. ``ABX-IL8 is the first fully human antibody created using our XenoMouse(TM) technology, and we hope to broaden the number of patients who could benefit from this promising new therapy.''
The Phase IIa trial is a double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ABX-IL8 in rheumatoid arthritis. A total of 132 patients across 20 clinical sites in the U.S. will participate in the study. Patients will receive a total of four doses of ABX-IL8 every three weeks over a 12-week period. The primary efficacy analysis will be measured by percentage of patients who achieve the American College of Rheumatology 20% responder criteria (ACR20), defined as a minimum improvement of 20% in patients' rheumatoid arthritis.
ABX-IL8 is a fully human monoclonal antibody directed against Interleukin-8, a chemokine that is produced at sites of inflammation and attracts and activates inflammatory cells such as neutrophils. Elevated levels of IL-8 in the synovial fluid of rheumatoid arthritis patients have been correlated with the number of infiltrating neutrophils. Pre-clinical studies of antibodies to IL-8 were shown to block neutrophil infiltration and synovial membrane damage. |
