Philadelphia, Pa. - Oct. 31, 2000 - Aslera, an investigational drug, significantly improves disease activity and symptoms of patients with the chronic autoimmune disease systemic lupus erythematosus (SLE or lupus), according to a Phase III placebo-controlled, double-blind multicenter study presented at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia. Aslera (GL701 or prasterone) is developed by Genelabs Technologies, Inc. (Nasdaq:GNLB).
"This study is particularly significant because it shows that GL701 is a promising new drug for people with lupus. The trial demonstrated clinically important benefits including improved disease activity and symptoms and improved bone mineral density for women on steroids. Current lupus treatment primarily relies on the chronic use of steroids, such as prednisone, that can have many serious adverse consequences for a lupus patient's health and quality of life," says Robert G. Lahita, M.D., coauthor of the study, Professor of Medicine, Saint Vincent's Medical Center, New York Medical College. "Furthermore, because lupus has been a very difficult disease to study, the GL701 clinical trial represents a breakthrough in the design of studies for new treatments for SLE."
In the study, Lahita and his colleagues compared Aslera to placebo among 381 women who had mild to moderate lupus. Patients were evaluated in a randomized double-blind comparison of Aslera, 200 mg or placebo daily for 12 months. Study criteria required that patients have active disease at baseline and permitted patients to remain on background therapy such as the corticosteroid prednisone, however prednisone dosage at study entry was limited to no more than 10 mg/day. In the study, the primary endpoint was proportion of responders, which was defined as improvement or stabilization, compared to baseline (allowing for small instrument variability), for all four scoring instruments: Sys
Contact: Beth Kaplan