Genelabs Technologies Inc. (NASDAQ:GNLB) told shareholders at itsannual meeting Thursday that steroids administered to subjectsparticipating in the Phase II trial of its anti-AIDS drug GLQ223 mayhave influenced the results."When steroid usage is taken into account in the statistical analysis,GLQ223 shows encouraging evidence of drug activity in this studypopulation," said Kenneth Gorelick, the company's vice president ofmedical and regulatory affairs.Genelabs was using the occasion of its annual meeting to announce thecompleted analysis of the GLQ223 (alpha-trichosanthin) trial, whichmay shed light on the preliminary results reported in October 1993 atthe 33rd Interscience Conference on Antimicrobial Agents andChemotherapy.At that time, the Redwood City, Calif. company said GLQ223 hadproven more effective in reducing viral load in AIDS patients thaneither AZT or a combination of AZT and GLQ223. However, theynoted, the results did not demonstrate a statistically significantadvantage. Viral load refers to the number of HIV viral particles thatcirculate in the blood, according to Gorelick.The study also found that viral load was a better predictor of diseaseprogression than CD4 cell count, a commonly-used measure.Generally, the lower the CD4 cell count, the further progressed thedisease.Gorelick told BioWorld that patients using AZT in the Phase II trial didnot use steroids, and had been on the drug for an average of two years.However, Gorelick said, after consultation with some AIDS-advocacygroups with whom Genelabs was working, subjects taking GLQ223were given steroids such as prednisone and dexamethasone to combatflu-like and allergic reactions to GLQ223.After accounting for the effect of steroids, which are known to lowerlymphocyte counts, Gorelick said, "It appeared that GLQ223, alone orin combination with AZT, had an effect on the primary endpoint thatwas encouraging. The endpoint was to improve the time to treatmentfailure, defined either as a 25 percent decline in CD4 counts sustainedfor at least six weeks, the development of AIDS related symptoms, ordeath."Gorelick said Genelabs intends to publish the results of the study in apeer-reviewed journal. The company will submit a full report to theFDA and meet with the agency regarding the requirements for a PhaseIII trial. Genelabs is also negotiating with potential corporate partnersto expedite the development and commercialization of GLQ223.
-- Philippa Maister
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