Genelabs' lupus protocol
Lupus has been a tough nut to crack in the clinic because of its unpredictable flares and propensity to strike different organs in different people. Genelabs Technologies Inc. on Sunday presented positive data from its latest Phase III trial of GL701 dehydroepiandrosterone (DHEA) to treat the disease. The company said that the trial, which was designed in collaboration with the FDA and lupus experts, represents the most valid existing method for testing the effects of a compound in lupus.
Disease-free periods unrelated to therapeutic interventions increase the likelihood of a placebo effect in a lupus trial. The indication also has lacked well-validated and widely used outcome measures. Because lupus patients generally receive steroid and sometimes cytotoxic therapies, another issue is whether to take patients off their standard treatments, which have debilitating side effects, during a trial (see BioCentury, Aug. 10, 1998)...