|
REDWOOD CITY, Calif., Sept. 9 /PRNewswire-FirstCall/ -- Genelabs
Technologies, Inc. (Nasdaq: GNLB - News) announced today that the
results of Genelabs' clinical trial GL95-02, which assessed the
ability of Prestara(TM) (prasterone) to improve or stabilize systemic
lupus erythematosus (SLE or lupus) disease activity and symptoms,
have been published in the journal Arthritis & Rheumatism (vol.
50, no. 9). Michelle A. Petri, M.D., M.P.H., Professor of Medicine,
Johns Hopkins University School of Medicine, is the lead author
of the paper which is entitled "Effects of Prasterone on Disease
Activity and Symptoms in Women with Active Systemic Lupus Erythematosus:
Results of a Multicenter Randomized, Double-Blind, Placebo-Controlled
Trial."
The objective of the clinical trial was to determine whether Prestara
improved or stabilized SLE disease activity and symptoms. This study
pioneered the integration of all three SLE domains -- disease activity,
organ damage and health-related quality of life -- into a single
outcome measure, referred to as "responder," which served
as the primary endpoint. Responders were patients who demonstrated
improvement or stabilization over the one-year duration of the study
across two disease activity measures and two health-related quality
of life measures while experiencing no clinical deterioration. A
total of 381 women with SLE were enrolled in the trial. All patients
in the clinical trial were allowed to continue taking their standard
SLE medications during the course of the study.
"Given the complexity of SLE, it was important to establish
a way to assess the disease in its entirety, and the responder endpoint
accomplished this goal," stated Kenneth E. Schwartz, M.D.,
Vice President of Medical Affairs and an author of the publication.
"As such, this study evaluated the treatment effect of Prestara
on overall lupus disease. We found that a greater percentage of
patients who received Prestara were responders than those who received
placebo, and the difference was statistically significant."
"This clinical study is an integral portion of our New Drug
Application for Prestara," stated Mumtaz Ahmed, M.D., Ph.D.,
Vice President of Drug Development. "I am pleased that detailed
information about this trial is now available for the broader medical
community to evaluate."
Background
The U.S. Food and Drug Administration (FDA) has issued an approvable
letter for the Prestara New Drug Application (NDA) submitted by
Genelabs. The key contingency in the approvable letter is the successful
completion of an additional clinical trial providing sufficient
evidence to confirm the positive effect of Prestara on the bone
mineral density of women with lupus who are receiving glucocorticoids.
A positive effect on the bone mineral density of women with lupus
who were receiving glucocorticoids was observed in a study nested
within Genelabs clinical trial GL95-02. Genelabs has recently completed
the treatment phase of a study designed to generate data that, if
positive, would satisfy FDA's requirement for confirmation of the
Study GL95-02 bone mineral density results. This confirmatory trial
has been designated Study GL02-01, and results are expected to be
available in the fourth quarter of 2004. Should approval of the
Prestara NDA be granted, it would permit our North American licensee,
Watson Pharmaceuticals, to commence marketing Prestara in the United
States.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company pioneering
the discovery and development of novel pharmaceutical products to
improve human health. We are concentrating our clinical development
capabilities on Prestara(TM), an investigational drug for women
with systemic lupus erythematosus. We are concentrating our drug
discovery capabilities on novel antiviral compounds for treatment
of hepatitis C virus infections.
NOTE: This press release contains forward-looking statements including
statements regarding the results of our clinical trial for Prestara,
the timing of the announcement of these results and the resubmission
of the NDA with the FDA, the potential response of the FDA, and
the potential marketing of Prestara. These forward-looking statements
are based on Genelabs' current expectations 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 company's capital requirements and history of operating losses;
errors, omissions or adverse events in the current Prestara(TM)
clinical trials; whether the results of the company's clinical trials
of Prestara(TM) and other supporting information will be sufficient
to support the approval of Prestara(TM) by the FDA, the European
Agency for Evaluation of Medicinal Products and other regulatory
authorities; delays regarding the regulatory approval process including
the timing and scope of approval received, if any; uncertainties
and risks regarding market acceptance of Prestara(TM) as a treatment
for SLE; uncertainties and risks regarding the company's ability
to consummate strategic or corporate partner transactions on favorable
terms or at all; the early stage of Genelabs' research programs
and uncertainties associated with the preclinical development of
compounds, including whether a compound will advance to preclinical
testing, clinical trials, or ultimately become a product, and the
uncertainty of the timing of any of these; and the validity, scope
and enforceability of patents related to the company's technologies.
The active ingredient in Prestara(TM) 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 currently does not have regulatory
applications submitted for review of Prestara(TM) outside the U.S.
In addition, neither U.S. nor other regulatory authorities have
made a determination as to the safety or efficacy of Prestara(TM)
for SLE. Please see the information appearing in the company's filings
with the Securities and Exchange Commission, including the most
recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K,
under the captions "Risk Factors," "Business Risks"
and "Forward-Looking Statements" for more discussion regarding
these uncertainties and risks and others associated with the company's
research programs, early stage of development and other risks which
may affect the company or cause actual results to differ from those
included in the forward-looking statements. Genelabs does not undertake
any obligation to update these forward-looking statements or risks
to reflect events or circumstances after the date of this release.
|
Message
Boards
