Genelabs Announces Preliminary Results of Trial

GBL03-00 in Women Genelabs Technologies has announced results of a preliminary analysis of a Phase III clinical trial conducted by its licensee, Genovate Biotechnology. The trial did not demonstrate a statistically significant benefit among the patients receiving prasterone compared to the patients taking placebo, the company said.

The clinical trial, which was not conducted under an investigational new drug application, was a randomized, placebo-controlled, double-blind study conducted at six medical centers in Taiwan to determine the effect of prasterone on the bone mineral density of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids. The primary endpoint was bone mineral density at the lumbar spine and the treatment duration was nine months.