Philadelphia, Pa. - Oct. 31, 2000 - Aslera™ (GL701 or prasterone) improves bone mineral density (BMD) and prevents BMD loss in female patients with systemic lupus erythematosus (SLE or lupus) who receive treatment with prednisone, according to data from a Phase III placebo-controlled, double-blind multicenter study presented at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia. Genelabs Technologies, Inc. (Nasdaq:GNLB) is developing GL701 for SLE and, if approved, it will be marketed under the name Aslera™.
Losses in BMD increase a person's risk of developing osteoporosis, making them susceptible to fractures of the hip, spine, and wrist. Female lupus patients are at risk of osteoporosis not only because they are frequently treated with bone-damaging corticosteroids, such as prednisone, to counter the abnormal immune response and inflammation that characterize lupus, but also because hormonal and other changes associated with the disease cause them to lose BMD at a higher rate.
"The improvement in BMD demonstrated in the GL701 group is an encouraging result in addition to the positive effects of GL701 for the treatment of lupus patients. 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," says Ellen M. Ginzler, M.D., coauthor of the study and Professor and Chief of Rheumatology at the State University of New York Medical Center, Brooklyn.
In a placebo-controlled, double-blind multicenter Phase III study to determine whether Aslera™ would improve SLE disease activity and/or its symptoms, additional data were collected from eight sites to evaluate changes in BMD in 37 patients receiving steroid therapy. All patients were on prednisone at study entry and remained on prednisone (<10 mg prednisone/day) throughout. During the study, patients took either 200 mg of Aslera™ or a placebo daily for 12 months and had BMD measurements of the spine and hips at the beginning and end of the study. Both groups had similar numbers of postmenopausal women, prednisone therapy levels and BMD scores.
In the study, female lupus patients experienced significant improvement their BMD after one year of therapy with Aslera™ compared to placebo, Ginzler and her colleagues found. Specifically, 18 Aslera™ patients showed increases of spinal BMD of 1.8 percent compared to a loss of 1.8 percent among 19 placebo patients (p=0.004). Hip scores also demonstrated differences, with an increase of 2.1 percent in Aslera™ patients compared to a loss of 0.2 percent among placebo patients (p=0.080).
Even greater differences in BMD scores occurred among the 19 postmenopausal patients. The 10 Aslera™ patients had spinal increases of 3.3 percent compared to a loss of 3.0 percent among 9 placebo patients (p=0.007). Hip scores demonstrated differences as well, with an increase of 2.4 percent among Aslera™ patients compared to a loss of 0.2 percent among placebo patients (p=0.237).
"We are encouraged by the results of increased BMD experienced among patients treated with Aslera™. These results add to the evidence that Aslera™ holds promise as a new lupus therapy. Genelabs developed GL701, which will be marketed under the name Aslera™ if approved, for the treatment of SLE and has filed a New Drug Application with the Food and Drug Administration for that indication," said Marc Gurwith, M.D., Genelabs Vice President, Drug Development and Chief Medical Officer.
Lupus patients develop antibodies that react against their own normal tissue, which can lead to inflammation, arthritis pain, tissue injury and major organ damage. In addition to the risk of osteoporosis from age and steroid drug therapy, lupus patients can experience disease symptoms including severe fatigue, arthritis, fever, seizures, headache, muscle weakness, memory loss, hair loss, facial rash, photosensitivity and depression, which can lead to poor quality of life. Lupus is characterized by flares of disease activity interspersed with periods of improvement or remission.
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.
Ginzler's coauthors include Philip J. Mease, M.D., of Minor & James Medical, PLLC, Seattle, WA; Oscar S. Gluck, M.D., Arizona Rheumatology Center, Phoenix, AZ; Michael H. Schiff, M.D., Director of Research, Denver Arthritis Clinic, CO; Peg Schemer, Northwest Bone Densitometry Consultants, Renton, WA; and Kenneth E. Schwartz, M.D., Senior Medical Director, and Marc Gurwith, M.D., Vice President, Drug Development and Chief Medical Officer, both at Genelabs, Redwood City, CA.
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 http://www.genelabs.com and http://www.prnewswire.com.
Media Contact:
Beth Kaplan
Porter Novelli
212-601-8443
Company Contact:
James A.D. Smith
Genelabs Technologies, Inc.
650-562-1424