YES!!!!
GENELABS REPORTS STATISTICALLY SIGNIFICANT PHASE III TRIAL RESULTS FOR
GL701 IN LUPUS AT AUTOIMMUNITY CONFERENCE - BENEFITS EXTEND TO BONE
Density -
REDWOOD CITY, Calif., Feb 14, 2000 /PRNewswire via COMTEX/ --
Genelabs Technologies, Inc. (Nasdaq: GNLB) reported today statistically
significant results from its Phase III clinical trial of GL701
(prasterone, dehydroepiandrosterone), its investigational drug for
systemic lupus erythematosus (SLE), or lupus. Patients in the group
treated with GL701 had a statistically significant greater rate of
response than the group that received placebo. Response to treatment
was defined as improvement or stabilization of SLE disease activity and
symptoms, the study's primary endpoint.
(Photo: newscom.com ) In
addition, patients who received GL701 experienced fewer disease flares
and noted improved quality of life, according to results of a pivotal
Phase III study. Treatment with GL701 demonstrated a consistent pattern
of efficacy across a number of primary and secondary variables,
including fewer lupus- related signs and symptoms reported as adverse
events. Further evidence from the trial demonstrated that GL701
significantly increased bone density in patients receiving chronic
corticosteroid therapy, compared to placebo. Genelabs also reported
that GL701 appears to be well tolerated.
Study results were presented by Philip J. Mease, M.D., Associate
Clinical Professor, University of Washington and Director of Clinical
Research, Minor and James Medical Center, Seattle, at the Eighth
International Scientific Conference on Lymphocyte Activation and Immune
Regulation in Newport Beach, California. The February 11-13 scientific
conference was sponsored by the University of California at Irvine.
The Phase III trial evaluated disease activity; organ damage; quality
of life, such as severity of fatigue and the ability to conduct daily
activities; depression; and bouts of heightened disease symptoms,
called flares.
"The study showed that treatment with GL701 resulted in meaningful
improvements in important clinical and quality of life measures for
patients with lupus," said Dr. Mease. "No other drug currently being
used for the treatment of lupus is both anti-inflammatory and capable
of increasing bone density. We are enormously gratified to see such
positive and compelling results for patients who suffer from this
devastating disease yet have no adequate therapies."
GL701: Efficacy For Lupus Patients The objective of this Phase III
study was to determine whether GL701 would improve SLE disease activity
and/or its symptoms in women with clinically active disease, which was
principally measured by response to treatment. Patients treated with
GL701 showed a 35 percent greater response rate than the placebo group
(p=0.005): 66 percent of patients (87/132) responded to treatment with
GL701 compared to 49 percent (65/133) for patients who received
placebo. Incidence of flares, a serious manifestation of lupus, were
more than 24 percent lower in the GL701 patient group (31/132) compared
to patients who received placebo (41/133) (p=0.201).
Some ailments commonly associated with lupus and reported as adverse
events were less frequent in patients who were treated with GL701
compared with patients who received placebo. These included muscle
pain; nasal and mouth ulcers; and hair loss. Patients on placebo
experienced significantly (p<0.05) more frequent muscle pain (36
percent placebo vs. 22 percent GL701) and nasal and mouth ulcers (23
percent placebo vs. 15 percent GL701). Hair loss was experienced in 20
percent of patients receiving placebo vs. 15 percent of GL701 patients.
If cleared for marketing by the U.S. Food and Drug Administration
(FDA), GL701 will be the first drug in 40 years indicated for the
treatment of lupus, and will be available only by prescription. SLE is
a life-long, devastating autoimmune disease that primarily affects
women. Common signs and symptoms include severe fatigue, arthritis,
facial rash, unusual sensitivity to sunlight, as well as inflammation
of the lungs and heart. More serious, life- threatening organ damage
can lead to poor quality of life and ultimately death. There is no cure
for lupus. Current treatment is primarily with chronic use of steroids,
such as prednisone, which have many serious adverse consequences. |
