Philadelphia, Pa. - Oct. 31, 2000 - Aslera™ (GL701 or prasterone) improves bone mineral density (BMD) and prevents BMD loss in female patients with systemic lupus erythematosus (SLE or lupus) who receive treatment with prednisone, according to data from a Phase III placebo-controlled, double-blind multicenter study presented at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia. Genelabs Technologies, Inc. (Nasdaq:GNLB) is developing GL701 for SLE and, if approved, it will be marketed under the name Aslera™.
Losses in BMD increase a person's risk of developing osteoporosis, making them susceptible to fractures of the hip, spine, and wrist. Female lupus patients are at risk of osteoporosis not only because they are frequently treated with bone-damaging corticosteroids, such as prednisone, to counter the abnormal immune response and inflammation that characterize lupus, but also because hormonal and other changes associated with the disease cause them to lose BMD at a higher rate.
"The improvement in BMD demonstrated in the GL701 group is an encouraging result in addition to the positive effects of GL701 for the treatment of lupus patients. Post-menopausal lupus patients are at particular risk for BMD loss, even with low dose steroid therapy, and currently available anti-resorptive agents may not be sufficiently protective, so we need alternatives that treat lupus and provide benefits, such as preserving BMD," says Ellen M. Ginzler, M.D., coauthor of the study and Professor and Chief of Rheumatology at the State University of New York Medical Center, Brooklyn.
In a placebo-controlled, double-blind multicenter Phase III study to determine whether Aslera™ would improve SLE disease activity and/or its symptoms, additional data were collected from eight sites to evaluate changes in BMD in 37 patients receiving steroid therapy. All patients were on prednisone at study entry and remained on
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Contact: Beth Kaplan
212-601-8443
Porter Novelli
30-Oct-2000