NEWS: Genelabs Announces Results From Preliminary Analysis of an Open Label Study of Its Lupus Drug Prestara

[Guest guest]

Genelabs Announces Results From Preliminary Analysis of an Open Label

Study of Its Lupus Drug Prestara

Thursday August 18, 8:05 am ET

REDWOOD CITY, Calif., Aug. 18 /PRNewswire-FirstCall/ -- Genelabs

Technologies, Inc. (Nasdaq: GNLB - News) today announced positive

results from a preliminary analysis of an open label clinical trial,

Study GL03-01, which has met its primary objective of maintaining the

bone mineral density (BMD) of women with systemic lupus erythematosus

(SLE or lupus) receiving glucocorticoids. This clinical trial 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 results of which were announced in

October 2004.

The primary endpoint of Study GL03-01 was maintenance of bone mineral

density at the lumbar spine for patients receiving 200 mg of Prestara

per day, which has been the standard dose Genelabs has used in clinical

evaluation of Prestara. All patients in Study GL03-01 received

Prestara, either 100 or 200 mg per day, with approximately

two-thirds of the patients receiving 200 mg per day. While the trial

was not designed with a placebo control, it was randomized and all of

the patients' BMD scans were sent to a centralized reading site. All

patients enrolled in Study GL03-01 were taking glucocorticoids, which

normally cause a decrease in bone mineral density.

Preliminary results of Study GL03-01 demonstrated that patients who

received 200 mg of Prestara per day increased their BMD at the lumbar

spine by approximately 0.9% during the 12 months they were enrolled in

Study GL03-01. Results of Study GL03-01 also demonstrated that patients

who received a lower dose of Prestara, 100 mg per day, did not increase

their BMD during the clinical trial, and in fact lost a measurable

amount of bone mineral density at the lumbar spine over the 12-month

period of Study GL03-01. The patients who had previously received 200

mg per day of Prestara in the earlier Study GL02-01 and who were then

randomized to continue receiving 200 mg of Prestara in Study GL03-01

experienced an increase in BMD at the lumbar spine over each successive

6-month interval in the 18-month duration of the combined studies. In

addition, the safety profile for Prestara in this study was consistent

with that seen in previous clinical studies.

" The preliminary analysis of the results from this clinical trial are

supportive of our belief that 200 mg per day of Prestara, the dose we

have used in most of our clinical studies, improves the bone mineral

density of women with lupus, and that these increases accumulate over

time, " stated A.D. , President and Chief Executive Officer.

" The validation provided by the data from this trial is an important

consideration as we evaluate the future development options for

Prestara for lupus. We strongly believe in the benefits that Prestara

provides to patients suffering from the debilitating effects of lupus,

and this trial indicates the protective effect of 200 mg of Prestara

daily on the patients' bone mineral density. However, in determining

our future development plans we must weigh these benefits against the

standards required by the FDA for approval of this investigational

drug. Our analyses of these study results are continuing, however we

expect to be able to submit them to the FDA in advance of an upcoming

meeting, which we hope will provide additional clarity on what may be

needed going forward. "

Study GL03-01 enrolled 115 women with lupus who were randomized into

one of two Prestara treatment groups. Genelabs conducted this open

label trial to determine the long-term effects of Prestara on bone

mineral density beyond an initial six-month period (which was measured

in the company's double-blind Phase III clinical trial, Study GL02-01).

While Study GL03-01 provides useful data on the positive effect of

Prestara on the BMD of women with lupus, the U.S. Food and Drug

Administration (FDA) normally does not consider open label studies to

be sufficient to support approval of a new drug. Genelabs has scheduled

a meeting with the FDA to discuss the company's options for the

development of Prestara for lupus, including the results of this

clinical trial.

Background of Prestara for Lupus and Bone Mineral Density

Genelabs previously completed a placebo-controlled 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. Nested within this

clinical trial was a separate study to assess the effect of Prestara on

bone mineral density in women with lupus who were taking

glucocorticoids. An analysis of the patients who had pre- and

post-treatment bone mineral density measurements showed that the group

of patients receiving Prestara had significantly increased bone mineral

density, compared to a decrease in bone density for the group of

patients on placebo. The FDA subsequently issued an approvable letter

to Genelabs, which required the successful completion of an additional

clinical trial providing sufficient evidence to confirm the positive

effect of Prestara on the patients' bone mineral density. Genelabs

conducted a double-blind Phase III clinical trial, designated Study

GL02-01, which was designed to satisfy FDA's requirement if the results

were positive. In October 2004 Genelabs announced that the results of

Study GL02-01 were not statistically significant in favor of Prestara.

Patients who completed Study GL02-01 were eligible to enroll in Study

GL03-01, a one-year follow-on clinical trial which treated all patients

with Prestara.

About Genelabs

Genelabs Technologies, Inc. is a biopharmaceutical company focused on

the discovery and development of pharmaceutical products to improve

human health. We have built drug discovery and clinical development

capabilities that can support various research and development

projects. Genelabs is currently concentrating its capabilities on

developing a late-stage product for lupus, discovering novel compounds

that selectively inhibit replication of the hepatitis C virus and

advancing preclinical development of compounds from this hepatitis C

virus drug discovery program. We believe that these high-risk,

potentially high reward programs focus our research and development

expertise in areas where we have the opportunity to generate either

first-in-class or best-in-class products that will address diseases for

which current therapies are inadequate. For more information, please

visit www.genelabs.com.

http://biz./prnews/050818/sfth028.html?.v=23