As a group, the GL701 patients demonstrated a significant improvement (p<0.05) in their assessment of overall disease status compared to the placebo group, as measured by changes in the patient Visual Analog Scale (VAS). At the study completion, patient VAS scores improved an average of 5.5 for GL701 patients and worsened an average of 5.4 for placebo patients.
During the study, GL701 was well tolerated. GL701 patients had higher rates of acne than those on placebo (59 percent vs. 29 percent, p<0.05), while headache (43 percent GL701 vs. 63 percent placebo) and infection (10 percent GL701 vs. 25 percent placebo) were reduced (p<0.05) in the GL701 group in comparison to placebo. No patients discontinued study medication due to acne, which was generally mild. There were statistically significant decreases in trigylceride and cholesterol levels observed in the group of patients receiving GL701.
Significantly fewer GL701 patients than placebo patients (11.5 percent GL701 vs 30.5 percent placebo) developed serious adverse events. In most cases, these adverse events were consistent with lupus progression or flares, Chang notes. Only one patient, who was in the placebo group, withdrew early due to an adverse event.
"By demonstrating a significant reduction in flares, these data add to the evidence that GL701 holds promise as a new lupus therapy," said James A.D. Smith, president and chief executive officer of Genelabs Technologies, Inc. "Genelabs recently completed its submission to the United States Food and Drug Administration (FDA) of its New Drug Application (NDA) for marketing approval of its formulation of GL701, which will be marketed in the U.S. under the name Aslera™, if approved. The NDA include
'"/>
Contact: Beth Kaplan
212-601-8443
Porter Novelli
30-Oct-2000