HGS LymphoStat-B to begin Phase III in Q4
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Human Genome Sciences will begin a Phase III trial of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus in the fourth quarter of 2006, the company announces Aug. 9. HGS expects a $24 mil. milestone payment from development partner GlaxoSmithKline in the third quarter. HGS collaborated with GSK to design the Phase III study, which has an endpoint that combines response rate and elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. A Phase II study failed to show a clinical benefit at week 24, but HGS previously indicated its belief that the Phase II data are strong enough to move into Phase III studies (1Pharmaceutical Approvals Monthly July 2006, p. 16)...