CD80 (B7.1) is a membrane-bound molecule that is known for its role in regulating immune T-cell activity. Several studies have suggested that CD80 may also play a role in the regulation of normal and malignant B cells. CD80 is continuously expressed on a variety of lymphomas, including low grade B-cell lymphoma, making it an attractive target for lymphoma therapy. In lab studies, cross linking CD80 with anti-CD80 antibodies on lymphoma cells has been shown to inhibit cell proliferation, to induce cell death regulating (pro-apoptotic) molecules, and to induce antibody-dependent cell mediated cytotoxicity (ADCC). These observations constitute the rationale for development of an anti-CD80 therapy for B-cell lymphoma. Galiximab is a monoclonal antibody that binds and inhibits CD80. In a phase II study of single-agent galiximab in refractory low grade B-cell lymphoma, 11% of patients had response, with two complete responses. The most common side effects were fatigue, nausea, and headache. Low blood counts were rare.
The TARGET NHL Trial (Targeted Antibody Therapy with RITUXAN and Galiximab Efficacy Trial), continuing enrollment at CORT, is a randomized, double-blind, global multi-center study (114-NH-301) of galiximab in combination with rituximab compared with rituximab in combination with placebo. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed or refractory, follicular NHL. Progression-free survival (PFS) is the primary study endpoint. An open-label retreatment study (114-NH-302) with galiximab in combination with rituximab, will be available to subjects who progress on 114-NH-301 after experiencing at least a partial response (PR) with a time to progression (TTP) of six months or greater in either arm of the study.
For more information on these studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.
Tags: CD80, follicular lymphoma, galiximab, low grade lymphoma, Lymphoma, Rituxan, rituximab
