Genelabs' Aslera Improves Symptoms in Lupus Patients in Phase III Trials

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Genelabs' Aslera Improves Symptoms in Lupus Patients in Phase III Trials

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WASHINGTON (Reuters Health) Nov 1 - Genelabs Technologies announced on Tuesday

that results from two phase III trials indicate that its drug Aslera (GL701 or

prasterone) shows promise as a treatment for systemic lupus erythematosus (SLE).

Redwood City, California-based Genelabs is slated to present the studies at the

American College of Rheumatology Meeting in Philadelphia this week. The company

filed a new drug application for Aslera with the US Food and Drug Administration

(FDA) in September as a treatment for women with mild to moderate SLE.

The first trial showed that Aslera improves symptoms in lupus patients, Genelabs

said. In the study, 381 women with mild to moderate lupus received either Aslera

or placebo daily for 12 months.

Sixty-six percent of the Aslera group responded compared with 49% of the placebo

group. " Also, there was a consistent trend in favor of Aslera among other

efficacy variables including flare and the individual scoring instruments, "

Genelabs said.

Aslera was well tolerated, with adverse events consisting of acne and hirsutism.

The second study showed that Aslera improves bone mineral density (BMD) and

prevents BMD loss in female patients who take prednisone to treat the disease,

Genelabs said.

Female lupus patients are at increased risk of developing osteoporosis because

the disease itself decreases BMD and they are often treated with prednisone,

which can cause a loss of BMD. Osteoporosis increases the risk for fractures of

the hip, spine and wrist.

In the trial, 37 female lupus patients on prednisone received either Aslera or

placebo daily for 12 months. The 18 patients on Aslera showed an average 1.8%

increase in spinal BMD compared with an average 1.8% loss in the 19 patients who

received placebo.

Hip BMD increased by 2.1% in the Aslera group compared with a 0.2% loss in the

placebo group.

" Post-menopausal lupus patients are at particular risk for BMD loss, even with

low dose steroid therapy, and currently available anti-resorptive agents may not

be sufficiently protective, so we need alternatives that treat lupus and provide

benefits, such as preserving BMD,'' co-author of the study Dr. Ellen M. Ginzler,

rheumatologist at the State University of New York Medical Center, said.

According to Genelabs, about 200,000 people in the US and more than 1 million

worldwide have lupus. The disease primarily affects women, who often experience

its onset in their teens and twenties.

Genelabs shares dropped 11/32 or 6.18% to close at 5-7/32 on the NASDAQ exchange

on Tuesday.

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http://rheumatology.medscape.com/reuters/prof/2000/11/11.01/20001031drgd004.html