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GL701 (prasterone) significantly reduces lupus flares

Philadelphia, Pa. - Oct. 31, 2000 - The incidence of debilitating flares or exacerbations that systemic lupus erythematosus (SLE or lupus) patients experience, some resulting in hospitalization, significantly declined with the use of GL701, according to a Phase III placebo-controlled, double-blind multicenter study conducted in Taiwan and presented at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia. The drug used in this study is similar to Genelabs Technologies, Inc. (Nasdaq:GNLB) formulation of its investigational drug GL701. The study reported here today was conducted by Genelabs Biotechnology Co., Ltd. of Taiwan, a licensee of Genelabs Technologies, Inc.

"GL701 significantly reduced the percent of patients with flares. Since flares can punctuate the remission periods that lupus patients experience, the potential for this investigational drug to increase the duration of remission and decrease the number of flares that require hospitalization is an important therapeutic advance," says Deh-Ming Chang, M.D., coauthor of the study and Professor and Director of Rheumatology/Immunology at the Tri-Service General Hospital, Taipei, Taiwan, R.O.C.

In the study, Chang and his colleagues compared GL701 to placebo among 119 Taiwanese women with lupus. Patients were evaluated in a randomized double-blind comparison of GL701, 200 mg or placebo daily for 24 weeks. Investigators evaluated efficacy based on change in Systemic Lupus Activity Measure (SLAM) and change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), which measure disease activity; physician and patient visual analog scales (VAS), which measure quality of life parameters; and percent of patients with definite flares.

Study results show that 18 percent of patients receiving GL701 experienced flares, compared to 34 percent of patients on placebo, a 46 percent reduction, which was significant (p=0.04). Moreover, no GL701 pa
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Contact: Beth Kaplan
212-601-8443
Porter Novelli
30-Oct-2000


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