Genelabs Technologies Inc. added a third drug to its portfolio ofdrugs in clinical development with the acquisition of the lupusdrug DHEA (dehydroepiandrosterone) from StanfordUniversity.
Under an agreement announced Thursday, Genelabs hasobtained exclusive worldwide marketing and sublicensingrights to the compound and assumes management of itsdevelopment. In return, Stanford will receive milestone androyalty payments based on future clinical development goalsand sales figures.
Genelabs (NASDAQ:GNLB) of Redwood City, Calif., has twoproducts in clinicals. Its anti-AIDS compound GLQ223 is inPhase II trials, and a cancer therapeutic, GL331, is in Phase Itrials. GL331 was discovered by researchers at the Universityof North Carolina, Chapel Hill, and licensed to Genelabs in 1992.
Interim results of a Phase II study with DHEA were reportedthis week at the annual meeting of the American College ofRheumatology in San Antonio, Texas, by Stanford researcherRonald van Vollenhoven. Thirty women with mild to moderatelupus were randomized to receive 200 mg of DHEA or placebodaily for a three-month period. Of the 15 women who havecompleted the trial to date, one discontinued prematurelybecause of acne and one for personal reasons.
Vollenhoven said patients receiving placebo failed to improve,while DHEA-treated patients showed improvement in fourparameters: patient self-assessment, physician assessment,systemic lupus erythematosus disease activity index (SLEDAI)and dose of prednisone used to treat the lupus.
Vollenhoven also reported follow-up data on 20 patientstreated for three to 12 months (with a mean time of 6.4months). Two patients discontinued DHEA treatment becausethey had attained sustained remission, four because of sideeffects, four for lack of efficacy and two for other reasons.Fifteen patients (75 percent) felt that DHEA was helpful.
Disease manifestations that tended to respond to DHEAincluded proteinuria, pannicultis, lymphadenopathy, lupusheadaches, fatigue and lack of energy and cognitive symptoms.
The study was supported in part by the Northern CaliforniaArthritis Foundation, the National Lupus Foundation, the BayArea Lupus Foundation and the National Institutes of Health.
DHEA is a naturally occurring hormone produced by theadrenal glands that is present in abnormally low levels inpeople with lupus. "We thought that boosting the levels of thehormone might alleviate some of the symptoms of the disease,"said Vollenhoven.
Genelabs said the precise mechanism of action of the compoundis not yet known. Irene Chow, president of Genelabs'pharmaceutical division, noted that DHEA upregulatesinterleukin-2, which is also less prevalent in people with lupus.
Lupus is a chronic inflammatory disease that the LupusFoundation of America said affects one of every 500 Americansand strikes women 10-15 times more frequently than men. Anestimated 500,000 Americans have been diagnosed with it.
Stanford said that the disease is especially common amongAmericans of African, Asian and Hispanic heritage, and NativeAmericans. Patients are currently treated with corticosteroiddrugs and other immunosuppressives, which Stanford saidimprove life expectancy but also have severe side effects, suchas increasing susceptibility to infection.
Stanford researchers found that acne was the only frequentlyobserved side effect with DHEA, and they think it may beeliminated with a lower dose of the drug.
-- Brenda Sandburg News Editor
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