Some news:Genelabs Announces Positive Results of Pivotal Trial of Gl701 for Lupus
PR Newswire, Tuesday, September 21, 1999 at 07:16
Company Intends to Submit New Drug Application to FDA
REDWOOD CITY, Calif., Sept. 21 /PRNewswire/ -- Genelabs Technologies, Inc.
(NASDAQ:GNLB) today announced positive results of its second Phase III
clinical trial of GL701, its investigational drug for systemic lupus
erythematosus (SLE). Based on the strength of preliminary data from this study
and the results of the first Phase III clinical trial, the company intends to
submit a New Drug Application (NDA). Genelabs has requested a pre-NDA meeting
with the Food and Drug Administration (FDA) and intends to begin the
submission process as soon as possible following that meeting.
"Because of the current lack of effective therapies for patients with SLE,
we are delighted with these positive results," stated James A.D. Smith,
Genelabs President. "The favorable outcome of this study is truly a milestone
for both Genelabs and people with SLE as we work toward commercialization of
the first new treatment for lupus in many decades."
Marc Gurwith, M.D., Genelabs Vice President of Drug Development and
Chief Medical Officer commented, "I wish to thank all of the patients,
physicians and their medical teams who participated in this groundbreaking
clinical trial. We look forward to submitting the results of this study to the
FDA and presenting the data in an appropriate scientific forum."
Study Design
The study enrolled 381 women with SLE randomized to receive either an oral
dose of 200 mg of GL701 or placebo once a day for 12 months. The study was
designed to determine whether GL701 can improve or stabilize clinical outcome
and disease symptoms in people with SLE. Efficacy was measured by the response
of the patients to the treatment (disease activity was stable or improved)
utilizing measurement tools including Systemic Lupus Erythematosus Disease
Activity Index (SLEDAI), Systemic Lupus Activity Measure (SLAM), Krupp Fatigue
Severity Score (KFSS), and Patient Global Assessment.
Systemic Lupus Erythematosus (SLE)
SLE is a life-long, devastating autoimmune disease that primarily affects
women, many of whom experience the initial onset of disease in their late
teens and early twenties. There are approximately 200,000 people with SLE in
the United States and more than one million worldwide, according to various
government and private sector statistics. SLE causes the immune system to
attack the body's own tissue, which can lead to inflammation, pain and injury
to tissues and major organs. People with SLE can develop different
combinations of symptoms and organ involvement. Common signs and symptoms
include severe fatigue, arthritis, facial rash and unusual sensitivity to
sunlight as well as inflammation of the lungs and heart. More serious,
life-threatening organ damage, which involves inflammation of the brain tissue
and kidney failure, can lead to poor quality of life and ultimately death.
There is no cure for SLE. The multi-faceted manifestations and unknown
etiology of the disease have made SLE difficult to study and to treat. No drug
has been approved for the treatment of SLE in the US in the past 40 years.
Current treatment is primarily limited to inflammation suppression, most
commonly through chronic use of steroids such as prednisone. Long-term use of
steroids has many serious adverse consequences including premature
osteoporosis, atherosclerosis and diabetes.
GL701
Genelabs' therapeutic approach with GL701, through an exclusive license
from Stanford University, is to increase levels of dehydroepiandrosterone
(DHEA) in patients with SLE. GL701 is a pharmaceutical preparation that
contains prasterone, the pharmaceutical generic designation for DHEA, as the
active ingredient. DHEA is a naturally occurring hormone that is produced by
the adrenal glands. People with SLE generally have abnormally low levels of
DHEA and studies have shown that hormonal influences may play a role in the
development and progression of SLE.
Genelabs completed its first Phase III trial with GL701 in 1997. In the
first study, steroid-dependent SLE patients had a higher rate of response to
treatment with GL701 than patients on placebo, demonstrated by sustained
reduction of their prednisone dose to physiologic levels. Data from this study
were presented at the American College of Rheumatology National Scientific
Meeting in November 1997 and showed that, compared to the placebo group, a
greater percentage of patients who received daily doses of 200 mg of GL701
achieved the primary endpoint of a sustained reduction of their steroid dose
to 7.5 mg per day or less while improving or maintaining stable disease
activity. This beneficial effect was most evident in the group of SLE patients
with active disease (SLEDAI >2) at baseline. The ability to reduce steroid use
among people with SLE has been a major goal in lupus clinical research because
long-term use of steroids is responsible for many serious and life-threatening
toxicities.
Earlier this year the FDA granted Fast Track designation to GL701 for SLE,
which means that the FDA has determined that GL701 is intended to treat a
serious or life-threatening condition for which there is no adequate therapy
currently available. This designation also means that the FDA can take actions
to expedite the review of the NDA including assigning priority review status.
In 1994, GL701 received Orphan Drug designation from the FDA for the treatment
of SLE. Orphan Drug designation provides seven years of marketing exclusivity
from the date of a drug's approval.
Genelabs intends to retain the right to market GL701 in the United States
and is seeking partners for development and marketing of GL701 outside of the
U.S. The company is the exclusive licensee of two issued U.S. patents from
Stanford University which cover the use of GL701 in lupus patients to reduce
concomitant steroid dosage and for the treatment of lupus with or without
additional drug therapies.
Genelabs Technologies, Inc. is a biopharmaceutical company engaged in the
discovery of small molecule drugs that bind to DNA or RNA to regulate gene
expression or inactivate pathogens. The company's drug discovery program is
based on an integrated platform of technologies that encompasses genomics,
transcription biology, structure-biased combinatorial chemistry,
high-throughput screening and several proprietary validation and
characterization assays. The company's development efforts are focused on its
drug candidate, GL701, which has completed two Phase III clinical trials as a
new therapy for systemic lupus erythematosus.
NOTE
Except for historical information, the statements in this news release are
forward-looking 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 adequacy of the company's GL701
clinical trial processes and whether the results of those clinical trials and
other supporting information will be sufficient to support regulatory
submissions and/or approvals; delays regarding the regulatory approval process
including the timing and scope of approval received, if any; uncertainties and
risks regarding market acceptance of GL701 as a treatment for SLE; the
company's limited manufacturing and marketing experience; the validity, scope
and enforceability of patents related to GL701; the company's capital
requirements and history of operating losses; and uncertainties and risks
regarding the company's ability to raise needed additional capital or
consummate strategic or corporate partner transactions on favorable terms or
at all. The company has not submitted applications for regulatory review in
the US or other countries, and the regulatory authorities have not yet made a
determination as to the safety or efficacy of GL701 for SLE. Please see the
information appearing in the company's filings with the Securities and
Exchange Commission, in particular information under the caption "Risk
Factors" in the company's 1998 Form 10-K, for more discussion regarding these
uncertainties and risks and those associated with the company's research
programs, early stage of development and other risks which may affect the
company. The company does not undertake any obligation to update these
forward-looking statements to reflect events or circumstances after the date
of this release.
Genelabs' press releases are available by fax 24 hours a day at no charge
by calling PR Newswire's Company News On-Call at 800-758-5804, extension
115419. They are also posted on the Internet at genelabs.com and
prnewswire.com .
CONTACT: investors, Debra Catz Bannister of Genelabs Technologies, Inc.,
650-562-1424; or media, Kathy Lauri of Porter Novelli, 212-601-8121, for
Genelabs Technologies, Inc.
SOURCE Genelabs Technologies, Inc |
