Human Genome Sciences and GSK Initiate Second Phase III Trial of Lupus Drug

Human Genome Sciences (HGS) announced that they have begun dosing in Asia, South America and Eastern Europe for BLISS-52, the second of two pivotal Phase III clinical trials of LymphoStat-B in patients with active systemic lupus erythematosus (SLE).

Dosing in BLISS-76, the first Phase III trial of LymphoStat-B, began in February in North America and Europe.

HGS and GlaxoSmithKline (GSK) are developing LymphoStat-B (belimumab) under a definitive development and commercialization agreement agreed to in August 2006.

“The Phase III trials of LymphoStat-B will enroll more than 1,600 patients worldwide, making this the largest double-blinded clinical development program ever undertaken in lupus patients,” said William W. Freimuth, vice president, clinical research, immunology, rheumatology and infectious diseases, HGS. “We expect these trials to enroll patients throughout 2007, and expect to complete enrollment of both of our Phase III trials of LymphoStat-B in 2008.”

In each of the two Phase III trials, patients will be randomized in one of three treatment groups: 1-mg/kg LymphoStat-B, 10-mg/kg LymphoStat-B or placebo. Patients will be dosed intravenously on Days 0, 14 and 28, then every 28 days for the duration of the study.

LymphoStat-B has received a fast-track product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA’s continuous marketing application Pilot 2 program.