GL701 (prasterone) significantly reduces lupus flares

October 30, 2000

Philadelphia, Pa. - Oct. 31, 2000 - The incidence of debilitating flares or exacerbations that systemic lupus erythematosus (SLE or lupus) patients experience, some resulting in hospitalization, significantly declined with the use of GL701, according to a Phase III placebo-controlled, double-blind multicenter study conducted in Taiwan and presented at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia. The drug used in this study is similar to Genelabs Technologies, Inc. (Nasdaq:GNLB) formulation of its investigational drug GL701. The study reported here today was conducted by Genelabs Biotechnology Co., Ltd. of Taiwan, a licensee of Genelabs Technologies, Inc.

"GL701 significantly reduced the percent of patients with flares. Since flares can punctuate the remission periods that lupus patients experience, the potential for this investigational drug to increase the duration of remission and decrease the number of flares that require hospitalization is an important therapeutic advance," says Deh-Ming Chang, M.D., coauthor of the study and Professor and Director of Rheumatology/Immunology at the Tri-Service General Hospital, Taipei, Taiwan, R.O.C.

In the study, Chang and his colleagues compared GL701 to placebo among 119 Taiwanese women with lupus. Patients were evaluated in a randomized double-blind comparison of GL701, 200 mg or placebo daily for 24 weeks. Investigators evaluated efficacy based on change in Systemic Lupus Activity Measure (SLAM) and change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), which measure disease activity; physician and patient visual analog scales (VAS), which measure quality of life parameters; and percent of patients with definite flares.

Study results show that 18 percent of patients receiving GL701 experienced flares, compared to 34 percent of patients on placebo, a 46 percent reduction, which was significant (p=0.04). Moreover, no GL701 patients, compared to five placebo patients, experienced vasculitis flares, in which inflammation can destroy blood vessels. Three GL701 and eight placebo patients experienced flares that required hospitalization.

As a group, the GL701 patients demonstrated a significant improvement (p<0.05) in their assessment of overall disease status compared to the placebo group, as measured by changes in the patient Visual Analog Scale (VAS). At the study completion, patient VAS scores improved an average of 5.5 for GL701 patients and worsened an average of 5.4 for placebo patients.

During the study, GL701 was well tolerated. GL701 patients had higher rates of acne than those on placebo (59 percent vs. 29 percent, p<0.05), while headache (43 percent GL701 vs. 63 percent placebo) and infection (10 percent GL701 vs. 25 percent placebo) were reduced (p<0.05) in the GL701 group in comparison to placebo. No patients discontinued study medication due to acne, which was generally mild. There were statistically significant decreases in trigylceride and cholesterol levels observed in the group of patients receiving GL701.

Significantly fewer GL701 patients than placebo patients (11.5 percent GL701 vs 30.5 percent placebo) developed serious adverse events. In most cases, these adverse events were consistent with lupus progression or flares, Chang notes. Only one patient, who was in the placebo group, withdrew early due to an adverse event.

"By demonstrating a significant reduction in flares, these data add to the evidence that GL701 holds promise as a new lupus therapy," said James A.D. Smith, president and chief executive officer of Genelabs Technologies, Inc. "Genelabs recently completed its submission to the United States Food and Drug Administration (FDA) of its New Drug Application (NDA) for marketing approval of its formulation of GL701, which will be marketed in the U.S. under the name Aslera™, if approved. The NDA includes data from two Phase III clinical trials conducted in the U.S. and supporting data from the study reported on today, which was sponsored by our licensee and conducted in accordance with U.S. FDA standards (good clinical practices)."

The GL701 used in this Phase III study in Taiwan contains the same amount of active ingredient (prasterone) as in the GL701 used to support Genelabs Technologies, Inc. studies in the U.S., but in a slightly different formulation.

Approximately 200,000 people in the United States and more than one million worldwide have lupus, according to U.S. government and private sector statistics. Lupus primarily affects women, many of whom experience the initial onset in their late teens and early twenties.

In lupus, the body develops antibodies that react against a person's normal tissue, which can lead to inflammation, arthritis pain, tissue injury and major organ damage. The disease is characterized by flares of disease activity interspersed with periods of improvement or remission. Lupus can be mild but also can cause significant and potentially severe damage to organs such as the lungs, heart, kidney, and brain. Common signs and symptoms of disease that lupus sufferers experience - severe fatigue, arthritis, facial rash, fever, seizures, headache, muscle weakness, memory loss, hair loss, and photosensitivity - can lead to a poor quality of life.
Genelabs Technologies, Inc. is a biopharmaceutical company engaged in the discovery and development of a new class of pharmaceutical products that selectively regulate gene expression or inactivate pathogens by binding directly to DNA or RNA, the fundamental material of genes. By acting directly on the genetic material, Genelabs' technology can be applicable to a wide range of therapeutic applications including diseases such as cancer and autoimmune disorders and infectious diseases caused by bacteria and viruses. Originally licensed from Stanford University, the company has completed the clinical development of Aslera™, which is under review by the FDA for U.S. marketing approval. Genelabs is seeking approval of Aslera™ as new treatment for women with mild to moderate SLE.

NOTE: Except for historical information, the statements in this news release are forward-looking and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, whether the results of the company's clinical trials of Aslera™ and other supporting information will be sufficient to support the approval of Aslera™ by FDA; delays regarding the regulatory approval process including the timing and scope of approval received, if any; uncertainties and risks regarding market acceptance of Aslera™ as a treatment for SLE; the company's limited manufacturing and marketing experience; the validity, scope and enforceability of patents related to Aslera™; the company's capital requirements and history of operating losses; and uncertainties and risks regarding the company's ability to raise needed additional capital or consummate strategic or corporate partner transactions on favorable terms or at all. The active ingredient in Aslera™ is prasterone, the synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are currently being marketed by others as dietary supplements. The company has not submitted applications for regulatory review outside the U.S. In addition, neither U.S. nor foreign regulatory authorities have made a determination as to the safety or efficacy of Aslera™ for SLE. Please see the information appearing in the company's filings with the Securities and Exchange Commission for more discussion regarding these uncertainties and risks and those associated with the company's research programs, early stage of development and other risks which may affect the company. The company does not undertake any obligation to update these forward-looking statements to reflect events or circumstances after the date of this release.

Genelabs' press releases are available by fax 24 hours a day at no charge by calling PR Newswire's Company News On-Call at 800-758-5804, extension 115-419. They are also posted on the Internet at and

Media Contact:
Beth Kaplan
Porter Novelli

Company Contact:
James A.D. Smith
Genelabs Technologies, Inc.

Porter Novelli

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