Genelabs Technologies Inc completed the treatment phase of Study GL02-01, a double-blind, placebo controlled confirmatory Phase III clinical trial designed to measure the effect of its investigational drug Prestara on the bone mineral density of women with systemic lupus erythematosus (SLE or lupus) who are receiving glucocorticoids.

The final study visits among the patients enrolled in this study were completed this week. The clinical trial was conducted in order to address the key contingency raised in an approvable letter issued in 2002 by the US FDA in response to the Prestara New Drug Application (NDA).

The primary endpoint of this clinical trial is bone mineral density at the lumbar spine. Patients were treated for six months with either 200 mg per day of Prestara or a placebo. A total of 155 women were enrolled into the trial, a release from Genelabs said.

"Completing the clinical trial is a crucial milestone in our process of addressing the main contingency contained in the Prestara FDA approvable letter," stated James A D Smith, president and chief executive officer.

"We will now undertake a standard review of the data for completeness and accuracy. During this process, all of the data remain blinded. The patient bone scan data will remain at a third-party centralized reading site, where the data were sent on a blinded basis directly from the study sites. Once the review has been completed, the data will be un-blinded and analyzed to determine whether the study succeeded in demonstrating beneficial effects of Prestara in women with lupus. As previously indicated, we are on track to report these data during the fourth quarter," he added.

Genelabs earlier completed a one-year phase III clinical trial, designated Study GL95-02, which evaluated the ability of Prestara to improve or stabilize clinical outcome and disease symptoms in women with mild to moderate lupus. Because the most common form of organ damage in patients with lupus is musculoskeletal, nested within Study GL95-02 was a separate study to assess bone mineral density in women with lupus who were taking glucocorticoids.

In August 2002, the FDA issued an approvable letter for the Prestara NDA. The key contingency in the approvable letter is the successful completion of an additional clinical trial providing sufficient evidence to confirm a positive effect of Prestara on the bone mineral density of women with lupus who are receiving glucocorticoids. The current study, GL02-01, was designed to generate data that, if positive, would satisfy FDA's requirement for confirmation of the Study GL95-02 bone mineral density results, the release added.