Genelabs Technologies, Inc, of Redwood City, California, has announced positive results from a preliminary analysis of its open-label clinical trial of Prestaraâ„¢. The clinical trial (Study GL03-01) measured the effect of Prestara on bone mineral density (BMD) in systemic lupus erythematosus (SLE) patients taking glucocorticoids. Glucorticoids normally cause a decrease in BMD.

Study GL03-01 measured the effect of Prestara on BMD for a 12-month period following completion of the company's 6-month double-blind placebo-controlled clinical trial (Study GL02-01). The preliminary results of GL03-01 demonstrated that patients who received 200 mg/day of Prestara increased their BMD at the lumbar spine by approximately 0.9% during the 12 months of enrollment. However, patients receiving 100 mg/day of Prestara did not increase their BMD, and actually had lost a measurable amount of BMD by the end of the study.

Prestara, whose active ingredient is a synthetic form of the human hormone dehydroepiandrosterone (DHEA), has already received orphan-drug designation from the US Food and Drug Administration (FDA) for the indication of "prevention of loss of bone mineral density in systemic lupus erythematosus patients on glucocorticoids."

Future development plans for Prestara for SLE will be clarified after discussing the clinical results from GL03-01 with the FDA. The FDA normally does not consider open-label studies sufficient to support marketing approval of a new drug.