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| |  Early Results Of Clinical Trial Shows New Drug Helps Women With Lupus REDWOOD CITY, Calif., April 25, 1997 -- Researchers report a treatment response was observed in a group of women with clinically active systemic lupus erythematosus (SLE), which constituted the majority of patients enrolled in the first pivotal clinical trial for GL701 (DHEA). However, the study did not achieve statistical significance when all patients are included in the analysis, as an unexpectedly high response rate to placebo was observed among those patients with minimal or no disease activity at baseline. This Phase III trial was designed to show whether the use of GL701 in women with SLE would allow reduction in their steroid doses while maintaining stable or reduced disease activity. Preliminary analysis of patients stratified by baseline disease activity (SLEDAI - Systemic Lupus Erythematosus Disease Activity Index) indicates a positive trend favoring GL701 over placebo for patients with active disease. One hundred and ninety-one women with mild to moderate SLE, who were receiving daily doses of 10-30 mg of prednisone, were enrolled in this Phase III double-blind, placebo-controlled trial in 18 sites in the United States. Patients received either placebo or 100 mg or 200 mg of GL701 daily for seven to nine months. At enrollment, baseline SLEDAI scores were recorded for all patients, with scores ranging from 0 to 22 (0 indicating absence of recent disease activity) with a median of 4. During the study, steroid doses were required to be reduced at each visit according to the study protocol, provided a patient's SLEDAI score had not increased. Among those patients with baseline SLEDAI scores greater than 2 (approximately 72% of total patients), a clinically meaningful difference in the percent of responders (i.e., patients who achieved a sustained reduction of steroids to physiological levels) was observed between the 200 mg dose and placebo groups. No such difference between treatment groups was observed among patients with baseline SLEDAI scores of 2 or less. Preliminary results also indicate that GL701 was well tolerated in women with SLE. These safety results may not extrapolate to the general population because patients with SLE are believed to have abnormally low DHEA levels. This Phase III study, which is the first multi-center, placebo-controlled clinical trial for a new investigational compound for SLE in more than 30 years, suggests that daily administration of 200 mg of GL701 allowed reduction of steroid doses in those women with active disease. Many SLE patients depend heavily on steroids such as prednisone to control their disease. While life-saving, prednisone is implicated in many of the serious complications lupus patients encounter, including premature atherosclerosis, osteoporosis and sometimes fatal infections. This Phase III study was designed to include steroid-dependent women with mild to moderate SLE. Traditionally, it has been believed that treatment with steroids is necessary to achieve and maintain low disease activity (i.e., low SLEDAI scores) in some patients. This study also suggests, for the first time, that women with low disease activity (SLEDAI scores of 0 to 2) may be able to reduce their steroid usage, as no difference in the percentage of responders was observed between the placebo and GL701 treatment groups for women with low disease activity. Further detailed analysis of the study is continuing, which Genelabs Technologies, Inc., makers of DHEA, will be discussing with the Food and Drug Administration (FDA). A second Phase III study, to evaluate the use of GL701 for SLE using a different design and clinical endpoints, is ongoing. That trial, which was initiated by the company in March 1996, is designed to determine whether GL701 can improve clinical outcome or disease symptoms in patients with SLE. It is anticipated that 300 women with SLE will receive either GL701 or placebo for 12 months. Approximately 75% of the study participants have been enrolled in 24 sites in the US. DHEA is a naturally occurring hormone that is produced by the adrenal glands. Lupus patients generally have abnormally low levels of DHEA and studies have shown that hormonal influences may play a role in the development and progression of lupus. GL701 is manufactured for clinical testing under FDA regulations that govern the purity and content of drugs (current Good Manufacturing Practices). While Genelabs believes that DHEA is a drug that is subject to regulation and approval by the FDA, DHEA (or products claiming to include DHEA) is currently being marketed by others as a dietary supplement. Genelabs has retained the right to market GL701 in the United States and expects to seek partners for development and marketing of GL701 in other parts of the world. A U.S. patent for the use of GL701 in lupus patients to reduce concomitant steroid dosage has been granted and the Genelabs is seeking additional, broader patent protection in the U.S. Genelabs Technologies, Inc. is a global biopharmaceutical and diagnostics company focused on gene-regulating drug discovery; infectious diseases including hepatitis; and immunological disorders including lupus.
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