Genelabs Updates Development Options for Its Investigational Lupus Drug After FDA Meeting
January 13 2006 - 7:15AM
PR Newswire (US)
REDWOOD CITY, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Genelabs
Technologies, Inc. (Nasdaq: GNLB; GNLBD) today updated the future
development options for Prestara(TM) for women with systemic lupus
erythematosus (SLE or lupus) after the company's meeting with the
U.S. Food and Drug Administration (FDA). The FDA indicated that an
additional, adequate, well-controlled phase III clinical trial
would be necessary to support an indication for the treatment of
the signs and symptoms of lupus, and the FDA recommended that
Genelabs refer to the FDA's draft guidance for developing drugs for
SLE (issued March 2005) when designing this trial. The company also
discussed with the FDA its options for pursuing an indication of
prevention of loss of bone mineral density (BMD) in women with
lupus. Genelabs has pursued a BMD indication since receiving an
approvable letter for its Prestara New Drug Application (NDA) in
2002. The FDA stated that additional positive prospective phase III
clinical trial data would be necessary before the FDA would
consider reviewing an NDA for BMD in lupus. Based on the recent FDA
interaction, Genelabs believes that pursuit of an indication for
treating the signs and symptoms of lupus is a more viable route
forward for Prestara than an indication for prevention of BMD loss
in lupus. "I am pleased that the FDA has provided guidance on their
requirements for approval of Prestara for the treatment of lupus
signs and symptoms," stated James A.D. Smith, President and Chief
Executive Officer. "I believe the FDA recognizes the need for new
drugs for lupus, but at the same time they also must adhere to
their established standards for approval. They are indicating that
they will require one additional pivotal trial in order to approve
our NDA for the treatment of lupus. I am encouraged that the agency
has acknowledged the positive outcome from our previous study
evaluating Prestara's overall impact on women suffering from lupus.
Genelabs is potentially only one positive clinical trial from
approval for a difficult and debilitating disease that has very
limited and inadequate treatment options. To get there, our next
step is to determine the specifics of a new clinical trial
evaluating the impact of Prestara on the overall signs and symptoms
of lupus." Genelabs is presently in process of designing an
additional clinical trial for Prestara(TM) for the treatment of
lupus utilizing the FDA guidance document published in 2005. The
company plans to work with the FDA in the development of the
protocol, as suggested by the FDA in the recent meeting, and plans
to formally meet with the agency again regarding the prospective
clinical trial design. Because the company currently does not have
sufficient funds to conduct another clinical study of Prestara on
its own, if an additional clinical trial is conducted it would
likely be in conjunction with a new or existing collaborator, or,
alternatively, Genelabs may have to delay or discontinue future
development of Prestara. Regarding approval for the treatment of
lupus based on a single clinical trial, the FDA indicated that
robust demonstration of efficacy would be required to be considered
adequate evidence of efficacy. Background of Prestara for Disease
Activity in Women with Lupus Genelabs' first double-blind,
placebo-controlled clinical trial of Prestara for lupus, designated
Study GL94-01, enrolled 191 patients and evaluated Prestara's
ability to reduce the glucocorticoid dose in steroid-dependent
women with mild to moderate lupus while maintaining stable or
improved SLE disease activity. The primary endpoint was sustained
reduction in glucocorticoid dose to levels approximately equivalent
to those normally produced by the adrenal glands. Results showed
that patients who received the 200 mg daily doses of Prestara had a
higher response rate than patients who received placebo,
particularly for those patients with active disease at baseline.
The results of this study were published in the July 2002 issue of
Arthritis and Rheumatism. Genelabs also completed a second
double-blind, placebo-controlled clinical trial, designated Study
GL95-02, which enrolled 381 patients and evaluated the ability of
Prestara to improve or stabilize clinical outcome and disease
symptoms in women with mild to moderate lupus. The primary endpoint
was stabilization or improvement in two lupus disease activity
measures, two health-related quality of life measures and no
clinical deterioration. There was a statistically significant
greater rate of response for Prestara patients than for those on
placebo, and in late 2002 the FDA advised Genelabs that it
considers Study GL95-02 to be positive, adequate and
well-controlled. The results of this clinical trial were published
in the September 2004 issue of Arthritis and Rheumatism. Background
of Prestara for Bone Mineral Density in Lupus and FDA Approvable
Letter Nested within Genelabs' clinical trial GL95-02 was a
separate study of 55 patients to assess the effect of Prestara on
the BMD of women with lupus who were taking glucocorticoids. An
analysis of the patients who had pre- and post-treatment bone
mineral density measurements showed that the group of patients
receiving Prestara had a statistically significant increase in bone
mineral density, compared to a decrease in bone density for the
group of patients on placebo. The results of this study were
published in the April 2005 issue of The Journal of Rheumatology.
In August 2002, the FDA issued an approvable letter to Genelabs
regarding the company's NDA for Prestara. In the approvable letter,
the FDA indicated that the approval of the NDA would require the
successful completion of an additional clinical trial providing
sufficient evidence to confirm the positive effect of Prestara on
the patients' bone mineral density. To address this requirement,
Genelabs conducted a double-blind clinical trial, designated Study
GL02-01, which was designed to satisfy FDA's requirement if the
results were positive. The results of Study GL02-01 were not
statistically significant in favor of Prestara. The patients who
completed Study GL02-01 were eligible to enroll in Study GL03-01,
an open-label one-year follow-on clinical trial which treated all
patients with Prestara. Study GL03-01 met its primary endpoint of
maintaining the BMD of women with lupus taking 200 mg per day of
Prestara and receiving glucocorticoids. Also in that study,
patients taking 200 mg per day of Prestara for 12 to 18 months
increased their BMD. About Genelabs Genelabs Technologies, Inc. is
a biopharmaceutical company focused on the discovery and
development of pharmaceutical products to improve human health. We
have built drug discovery capabilities that can support various
research and development projects. Genelabs is currently
concentrating these capabilities on discovering novel compounds
that selectively inhibit replication of the hepatitis C virus and
advancing preclinical development of compounds from this hepatitis
C virus drug discovery program, while also developing a late-stage
product for lupus. We believe that these high-risk, potentially
high reward programs focus our research and development expertise
in areas where we have the opportunity to generate either
first-in-class or best-in-class products that will address diseases
for which current therapies are inadequate. For more information,
please visit http://www.genelabs.com/. NOTE: Genelabs(R) and the
Genelabs logo are registered trademarks and Prestara(TM) is a
trademark of Genelabs Technologies, Inc. NOTE ON FORWARD LOOKING
STATEMENTS AND RISKS: This press release contains forward-looking
statements including statements regarding the future development of
Prestara(TM), designing a clinical trial protocol, future meetings
with the FDA, possible factors that could affect a future clinical
trial, and the future of the company's research and development
programs. 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, that Genelabs may not be able to raise sufficient funds
to continue operations; a determination to discontinue development
of Prestara; an adverse response from the FDA; regulatory problems
or delays regarding Prestara; potential de-listing from the Nasdaq
Capital Market; fluctuations in Genelabs' stock price; failures or
setbacks in our HCV research programs or in our collaboration with
Gilead; progress and announcements by competitors regarding their
HCV programs; increases in expenses and Genelabs' capital
requirements and history of operating losses. Please see the
information appearing in the Genelabs' filings with the Securities
and Exchange Commission, including our most recent Annual Report on
Form 10-K, under the captions "Risk Factors" 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.
Contact: Matthew M. Loar Chief Financial Officer Phone:
650-562-1424 DATASOURCE: Genelabs Technologies, Inc. CONTACT:
Matthew M. Loar, Chief Financial Officer of Genelabs Technologies,
Inc., +1-650-562-1424 Web site: http://www.genelabs.com/
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