William
News GNLB
Tuesday September 21, 8:28 am Eastern Time
Genelabs lupus drug trial positive
REDWOOD CITY, Calif., Sept 21 (Reuters) - Genelabs Technologies Inc. said Tuesday
that results of its second Phase III clinical trial of GL701, its investigational drug for lupus,
were positive.
The biopharmaceutical company said that it intends to submit a New Drug Application for
the drug to the U.S. Food and Drug Administration.
The study, which enrolled 381 women with systemic lupus erythematosus (SLE), was designed to determine whether GL701
can improve or stabilize clinical outcome and disease symptoms in people with SLE.
SLE, a disease that primarily affects women, causes the immune system attacks the body's own tissue, which can lead to
inflammation, pain and injury to tissues and major organs. Common symptoms include severe fatigue, arthritis, facial rash and
unusual sensitivity to sunlight.
About 200,000 people suffer from SLE in the United States and more than 1 million have it worldwide.
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.
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, but people with SLE generally have abnormally
low levels of DHEA.
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.
In 1994, GL701 received Orphan Drug designation from the FDA for the treatment of SLE, which provides seven years of
marketing exclusivity from the date of a drug's approval.
Genelabs said it 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 United States.
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