Phase 2 Study of LymphoStat-B® Showed Significant Reductions in Disease Activity in Patients with Active Systemic Lupus

LymphoStat-B(R) (belimumab) significantly reduced disease activity, was well tolerated and improved quality of life in patients with active Systemic Lupus Erythematosus. These developments were presented at the annual congress of the European League against Rheumatism (EULAR), in Barcelona Spain on June 14^th. LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator.

Lupus is a chronic, life-threatening autoimmune disease. It is estimated that approximately 1.5 million Americans suffer from various forms of lupus, including SLE.

Phase 2

The Phase 2 Study is 52 weeks of treatment of a group that is randomized, double-blind, and placebo-controlled, and a 24-week extension phase. Of the people who participated in the 52-week Phase 2 trial, “96% elected to enter the 24-week open-label extension phase of the trial, and 92% of those who entered completed it. Of those completing the extension phase, 78% continue to receive LymphoStat-B in a long-term continuation study. The trial began in October 2003.”

Results of Phase 2 study

The primary objectives of the Phase 2 study were to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy.

In June 2006, HGS reported the 52-week data from the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity versus placebo in patients with serologically active SLE, exhibited clinically relevant biological activity, and appeared safe and well tolerated. The data presented at EULAR 2007 demonstrated that LymphoStat-B continued to reduce the signs and symptoms of SLE disease activity throughout the 24-week extension phase of the study

HGS is currently conducting two Phase 3 studies of LymphoStatB (52-weeks and 76-weeks). Results of this trail are not expected for at least another year.