GeneLabs Technologies Inc. is enrolling steroid-dependent lupuspatients at 15 U.S. medical centers in a Phase II/III trial to determineif its drug, dehydroepiandrosterone (DHEA), can reduce reliance onprednisone, a corticosteroid that can have adverse side effects.Kenneth Gorelick, GeneLabs' vice president of medicine andregulatory affairs, said the Redwood City, Calif.-based companyhopes to reach full enrollment in the 200-patient trial over the next18 months. The participants will be women with mild to moderatesystemic lupus erythematosus who are receiving between 10milligrams and 30 milligrams of prednisone a day."This is a study to evaluate the ability of the drug [called GL701] toreduce steroid requirements," Gorelick told BioWorld.Lupus, he said, is a multi-system inflammatory disease, whichprimarily strikes women between 20 and 40 years old. Patients withmild to moderate lupus usually receive steroid treatments alone or incombination with other drugs for such problems as fatigue andarthritis as well as inflammation of the heart and lung linings andblood vessels.However, Gorelick said long-term treatments with steroids can haveserious side effects, including heart attacks, atherosclerosis, muscleweakness and increased risk of infections.DHEA, which GeneLabs licensed from Stanford University, is anaturally occurring hormone produced by the adrenal glands that ispresent in abnormally low levels of lupus patients. Gorelick saidresearchers don't know the precise mechanism of the drug, whichalso is a mild androgen.Phase II studies of GL701 in 28 patients did not show statisticalsignificance when compared with a placebo, but Gorelick added thatthose who received the drug showed improvement while those whodid not deteriorated.He said the patients, who received 200 milligrams of DHEA everyday for three months, improved in four areas: self-assessment,physician assessment, systemic lupus erythematosus disease activityindex and reduction of prednisone dosage.Lupus disease manifestations that tended to respond to GL701included proteinuria, pannicultis, lymphadenopathy, lupus headachesand fatigue.In the Phase II/III trial, patients will receive either 100 milligrams ofGL701, 200 milligrams or a placebo. The doses will be administeredorally every day for seven to nine months. During the trial theparticipants will be evaluated periodically to determine if theirprednisone dosage can be reduced. n
-- Charles Craig
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