Dr. Robert Lahita Presents Data on Genelabs GL701 in Lupus at American College Of Rheumatology Meeting
(PR Newswire, Feb 25, 2000 08:16 hrs)
REDWOOD CITY, Calif., Feb. 25 /PRNewswire/ -- Speaking at the American College of Rheumatology conference "Clinical Update on New Therapies in Rheumatic Diseases," Robert Lahita, MD, PhD, Professor of Medicine, Saint Vincent's Medical Center, New York Medical College, presented a review of the role of DHEA in the pathogenesis and treatment of systemic lupus erythematosus (SLE), including the Phase III clinical trials of GL701 from Genelabs Technologies, Inc. (NASDAQ:GNLB), an investigational drug for SLE or lupus that contains prasterone, a pharmaceutical preparation of the human hormone DHEA.
(Photo: newscom.com )
Dr. Lahita described the role of DHEA in lupus beginning with his initial observations that women with lupus have abnormally low levels of DHEA. Dr. Lahita discussed the growing understanding of DHEA in lupus, from his early findings to recently reported results of the multi-center clinical trials of GL701, sponsored by Genelabs. He reported data from Genelabs' most recent Phase III clinical in women with active SLE, which demonstrated that SLE disease activity was improved or stabilized in significantly more patients who received GL701 than placebo. In addition, GL701 patients had fewer disease flares and GL701 significantly increased bone density in patients on chronic steroids compared to placebo. Dr. Lahita also reported that the study confirmed a favorable risk/benefit ratio seen in previous studies of GL701.
"We have been investigating the relationship of this androgenic hormone in patients with lupus for many years," Dr. Lahita said. "I am very encouraged that we now have results from two large clinical trials which demonstrate that treatment with GL701 provides meaningful benefits for lupus patients, including reduced disease activity, fewer flares and an impressive increase in bone density in patients on chronic steroids."
Dr. Lahita commented, "There is a great need for prevention and treatment of patients who are at risk to develop osteoporosis. In fact, a recently published study in the Annals of the Rheumatic Diseases indicated that lupus patients in general have lower bone mineral density than healthy controls, and premenopausal women with lupus who are taking corticosteroids are especially affected. Additionally, in a study published last year in Arthritis and Rheumatism, it was reported that women with lupus have an increased rate of osteoporotic fractures."
New Study Enrolling Male Lupus Patients
Due to the hormonal differences in male and female lupus patients, the groups have been studied separately. The two pivotal trials completed to date with GL701 have enrolled only women. Lupus primarily affects women, who represent approximately 90 percent of diagnosed patients. An ongoing study in men is currently being conducted at six medical centers in the US. St. Vincent's Medical Center is participating in this groundbreaking study.
For information regarding the male lupus study at St. Vincent's Medical Center in New York City, please contact Dr. Robert Lahita 212-604-2950 or Dr. Ellen Matzkin 212-604-7119. For information regarding the male lupus study at other sites, please contact Betty Quarles at Genelabs 650-562-1425.
GL701 New Drug Application in 2000
If approved for marketing by the FDA, GL701 will be the first drug indicated for lupus in four decades, and will be dispensed only by prescription. GL701 is a pharmaceutical preparation that contains prasterone, the pharmaceutical generic designation for dehydroepiandrosterone (DHEA) as the active ingredient. DHEA is a naturally occurring hormone that is produced by the adrenal glands. People with SLE generally have abnormally low levels of DHEA and studies have shown that hormonal influences may play a role in the development and progression of SLE.
Based on the positive results of its two Phase III clinical trials and its pre-NDA meeting with the FDA in November 1999, the company will submit a New Drug Application (NDA) to the FDA. The FDA has designated GL701 for SLE as a Fast Track drug, which, among other benefits, allows for submission of the NDA utilizing a rolling process. Genelabs plans to begin submission of a rolling NDA in the first half of this year and complete the submission in the second half of the year.
Genelabs Technologies, Inc.
Genelabs Technologies, Inc. is a biopharmaceutical company engaged in the discovery of small molecule drugs that bind to DNA or RNA to regulate gene expression or inactivate pathogens. The company's drug discovery program is based on an integrated platform of technologies that encompasses genomics, transcription biology, structure-biased combinatorial chemistry, high-throughput screening and several proprietary validation and characterization assays. The company's development efforts are focused on its drug candidate, GL701, which has completed two Phase III clinical trials as a new therapy for systemic lupus erythematosus.
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, the adequacy of the company's GL701 clinical trial processes and whether the results of those clinical trials and other supporting information will be sufficient to support regulatory submissions and/or approvals; delays regarding the regulatory approval process including the timing and scope of approval received, if any; uncertainties and risks regarding market acceptance of GL701 as a treatment for SLE; the company's limited manufacturing and marketing experience; the validity, scope and enforceability of patents related to GL701; 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 company has not submitted applications for regulatory review in the US or other countries, and the regulatory authorities have not yet made a determination as to the safety or efficacy of GL701 for SLE. Please see the information appearing in the company's filings with the Securities and Exchange Commission, in particular information under the caption "Risk Factors" in the company's 1998 Form 10-K, 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 genelabs.com and prnewswire.com . SOURCE Genelabs Technologies, Inc.
-0- 02/25/2000
/CONTACT: Debra Catz Bannister, Vice President, Corporate Communications and Investor Relations of Genelabs Technologies, Inc., 650-562-1424/
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