XOMA Initiates Phase II Clinical Trial with Raptiva -- Efalizumab -- in Psoriatic Arthritis
Thursday January 30, 7:30 am ET
BERKELEY, Calif.--(BUSINESS WIRE)--Jan. 30, 2003--XOMA Ltd. (Nasdaq:XOMA - News) announced today the initiation of a Phase II clinical trial that will evaluate Raptiva(TM) (efalizumab) in patients with active and progressive psoriatic arthritis (PsA). With the recent filing of a Biologics License Application (BLA), Raptiva(TM) is currently in the review process by the U.S. Food and Drug Adminstration (FDA) for the treatment of moderate-to-severe plaque psoriasis, and is under evaluation in a Phase II trial for the treatment of rheumatoid arthritis (RA).
The psoriatic arthritis trial is a multicenter, randomized, double-blind, and placebo-controlled study. The patients will remain on standard therapy and will receive weekly subcutaneous injections of Raptiva(TM) or placebo. The study is designed to evaluate the safety and efficacy of Raptiva(TM) in patients with moderate-to-severe psoriatic arthritis. The primary endpoint, a reduction in the signs and symptoms of the disease in patients with active PsA, will be measured after 12 weeks of treatment using the American College of Rheumatology (ACR) 20 composite score. The ACR 20 is a standard measurement of response utilized to evaluate improvement in RA patients. In addition, clinical study patients will be evaluated for improvement in the psoriasis area and severity index (PASI) score, which measures improvement in both the amount and severity of psoriatic skin lesions. The trial will also assess a variety of secondary endpoints.
"We're pleased to be moving forward in concert with Genentech to study the potential for Raptiva(TM) in another autoimmune indication," said Jack Castello, XOMA's Chairman, President and Chief Executive Officer. "We believe that since a fair percentage of psoriasis patients go on to develop psoriatic arthritis, Raptiva(TM) may address the need for additional therapies to treat this progressively disabling disease."
About Psoriatic Arthritis (PsA)
Psoriatic arthritis is an inflammatory arthritis associated with psoriasis that causes joint and eye inflammation. Inflammation in PsA is a result of the body's immune system attacking its own tissues. According to the American College of Rheumatology, psoriatic arthritis affects at least 10% of the people with some form of psoriasis in the United States. Psoriatic arthritis may precede the onset or the diagnosis of psoriasis in up to 15% of patients. The symptoms of PsA often include fatigue; pain, swelling, tenderness, and stiffness in the joints; nail changes - including pitting or lifting of the nail; and redness and pain of the eye, such as conjunctivitis. General motion can also be both painful and limited. If PsA is left untreated, irreversible joint destruction and bone deformities may occur with a number of associated systemic complications, as well as shortened life expectancy.
About Raptiva(TM)
Raptiva(TM) is designed to inhibit the adhesion of T-lymphocytes to other cell types by inhibiting the binding of LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon the cell type, which include: (1) inhibition of T-lymphocyte activation, proliferation and cytokine release, (2) inhibition of T-lymphocyte migration, (3) inhibition of T-lymphocyte interactions with tissue-specific cells. In Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous injection.
Raptiva(TM) is being developed in the U.S. for moderate-to-severe plaque psoriasis and is being explored for use in other autoimmune diseases through a collaboration between Genentech and XOMA. Serono S.A. (virt-x: SEO and NYSE: SRA) has an exclusive license to market Raptiva(TM) outside of the United States, Japan and certain other Asian countries. |
