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REDWOOD CITY, Calif. - October 5, 2004 - Genelabs Technologies,
Inc. (Nasdaq:GNLB) announced today that a preliminary analysis of
its Phase III clinical trial, Study GL02-01, for its investigational
lupus drug Prestara™ (prasterone) indicated that the study
failed to meet its primary endpoint. This double-blind, placebo
controlled clinical trial was designed to measure the effect of
Prestara on the bone mineral density of women with systemic lupus
erythematosus (SLE or lupus) receiving glucocorticoids.
The company plans to continue its analysis of the data from Study
GL02-01 and will seek to meet with the U.S. Food and Drug Administration
(FDA) to determine its next steps.
“Although these preliminary results show that this study
failed to reach statistical significance, we are continuing to analyze
the data in order to gain further understanding of the results,”
stated James A.D. Smith, President and Chief Executive Officer.
“This process typically takes some time, and I regret that
we will likely not have further information to provide on Prestara
until we have completed these steps.”
Genelabs previously completed a one-year Phase III clinical trial,
designated Study GL95-02, which included a nested study that indicated
that the group of patients receiving Prestara had increased bone
mineral density, compared to a decrease in bone density for the
group of patients on placebo. Based on these results, the FDA issued
Genelabs an approvable letter, the key contingency of which was
a further clinical trial to confirm these results. Study GL02-01
was designed to generate data to confirm the Study GL95-02 bone
mineral density results.
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™, 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 preliminary results of our clinical trial
for Prestara, further analysis of the data from the clinical trial,
future discussions with the FDA and further actions which might
be taken regarding the clinical trial. 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, errors, omissions or adverse events in the current
Prestara™ clinical trials; whether the results of the company's
clinical trials of Prestara™ and other supporting information
will be sufficient to support the approval of Prestara™ 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™
as a treatment for SLE; and the company's capital requirements and
history of operating losses. The active ingredient in Prestara™
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™
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™ 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.
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