Phase 3 complete on new lupus drug

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Genelabs Technologies Completes Enrollment in Confirmatory Phase III Clinical Trial of Prestara for Lupus

REDWOOD CITY, Calif., Feb. 9 /PRNewswire-FirstCall/ -- GenelabsTechnologies, Inc. (Nasdaq: GNLB) announced today that it has completedpatient enrollment in its confirmatory Phase III clinical trial ofPrestara (prasterone), Genelabs' investigational drug for women withsystemic lupus erythematosus (SLE or lupus). A total of 155 women with lupusare enrolled in the study among 26 study centers located in the United Statesand Mexico. The primary endpoint of this clinical trial is bone mineraldensity at the lumbar spine, and the treatment duration is six months witheither 200 mg per day of Prestara or placebo.Genelabs is developing Prestara as a proposed treatment to limit bone lossin women with SLE who are taking glucocorticoids. Because loss of bonemineral density is a common manifestation of SLE, patients with the diseaseare at greater risk of osteoporosis and other complications of bone loss. Inaddition, the use of glucocorticoids such as prednisone, one of the mostcommonly used medications to treat SLE, can cause further damage to bonehealth.In August 2002, the U.S. Food and Drug Administration (FDA) completed itsreview of Genelabs' New Drug Application for Prestara for women with SLE andissued an approvable letter to Genelabs. Approval is contingent upon, amongother things, the successful completion of a clinical trial providingsufficient evidence to confirm the positive effect of Prestara on bone mineraldensity that was observed in Genelabs' previous Phase III Study GL95-02. Thecurrent clinical trial, Study GL02-01, is designed to generate data that, ifpositive, would satisfy the FDA's requirement for confirmation of the StudyGL95-02 bone mineral density results."Completing enrollment of all patients into our confirmatory clinicaltrial is a major milestone that I am thrilled we have now accomplished. Ourdrug development team and outside clinical investigators have done anoutstanding job in recruiting patients while holding to the highest qualitystandards," stated Irene A. Chow, Ph.D., chairman and chief executive officer."Because patients will receive either Prestara or placebo for six months, thelast patients will finish treatment in August 2004. Afterwards, we willunblind and analyze the data following a standard review for completeness andaccuracy. I expect that we will have the results of this clinical trial in thefourth quarter of this year.In the meantime, we are working with our North American commercializationpartner, Pharmaceuticals, to initiate several important marketpreparation initiatives in anticipation of a potential launch.""We are delighted that Genelabs has achieved this important step in thedevelopment of Prestara," said Chao, Ph.D., 's chairman and chiefexecutive officer. "We are excited to have the opportunity to market thisproduct, which we believe addresses a significant unmet patient need."

About GenelabsGenelabs Technologies, Inc. is a biopharmaceutical company pioneering thediscovery and development of novel pharmaceutical products to improve humanhealth. We have built drug discovery and clinical development capabilitiesthat can support various research and development projects. We areconcentrating our capabilities on developing a late-stage product for lupusand discovering novel lead compounds that selectively inhibit replication ofthe hepatitis C virus (HCV). Through our drug discovery efforts we havesynthesized numerous antimicrobial lead compounds, one of which has beenselected for preclinical development, and are using high-throughput methodsfor the discovery of novel lead compounds for HCV. Our clinical developmentefforts are concentrated on Prestara (prasterone; Anastar in Europe)for systemic lupus erythematosus, for which we have received an approvableletter from the U.S. Food and Drug Administration (FDA) and for which we havesubmitted a Marketing Authorization Application in Europe. For moreinformation about Genelabs, please visit http://www.genelabs.com.

NOTE: This press release contains forward-looking statements includingstatements regarding the completion of our clinical trial of Prestara forsystemic lupus erythematosus (SLE or lupus), timing and plans for announcementof clinical trial results and the anticipation of the potential marketinglaunch of Prestara for SLE in the United States, if approved by the FDA.These forward-looking statements are based on Genelabs' current expectationsand are subject to uncertainties and risks that could cause actual results todiffer materially from the statements made. Uncertainties and risks include,without limitation, the company's capital requirements and history ofoperating losses; whether the results of the company's clinical trials ofPrestara and other supporting information will be sufficient to supportthe approval of Prestara by the FDA, the European Agency for Evaluation ofMedicinal Products and other regulatory authorities; delays regarding theregulatory approval process including the timing and scope of approvalreceived, if any; uncertainties and risks regarding market acceptance ofPrestara as a treatment for SLE; uncertainties and risks regarding thecompany's ability to consummate strategic or corporate partner transactions onfavorable terms or at all; the early stage of Genelabs' research programs anduncertainties associated with the preclinical development of compounds,including whether a compound will advance to preclinical testing, clinicaltrials, or ultimately become a product, and the uncertainty of the timing ofany of these; and the validity, scope and enforceability of patents related tothe company's technologies. The active ingredient in Prestara isprasterone, the synthetic equivalent of the androgenic hormonedehydroepiandrosterone (DHEA). Products containing DHEA are currently beingmarketed by others as dietary supplements. The company has not submittedapplications for regulatory review of Prestara outside the U.S. andEurope. In addition, neither U.S. nor other regulatory authorities have made adetermination as to the safety or efficacy of Prestara for SLE. Please seethe information appearing in the company's filings with the Securities andExchange Commission, including the most recent Quarterly Report on Form 10-Qand Annual Report on Form 10-K, under the captions "Risk Factors," "BusinessRisks" and "Forward-Looking Statements" for more discussion regarding theseuncertainties and risks and others associated with the company's researchprograms, early stage of development and other risks which may affect thecompany or cause actual results to differ from those included in theforward-looking statements. Genelabs does not undertake any obligation toupdate these forward-looking statements or risks to reflect events orcircumstances after the date of this release.

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