Dr. Robert Lahita Presents Data on Genelabs GL701 in Lupus at American College Of Rheumatology Meeting

25 Feb, 2000, 00:00 ET from Genelabs Technologies, Inc.

    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:  http://www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )
     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 http://www.genelabs.com and
 http://www.prnewswire.com .
 
 

SOURCE Genelabs Technologies, Inc.
    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:  http://www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )
     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 http://www.genelabs.com and
 http://www.prnewswire.com .
 
 SOURCE  Genelabs Technologies, Inc.