Clinical and pharmacological experience with LJP-394.
LJP-394 is a synthetic biological with immunomodulatory functions. Composed of four double-stranded oligodeoxynucleotides attached to a central branched platform, the drug acts as an anti-"anti-ds-DNA" B-cell toleragen by rendering specific B-lymphocytes unresponsive to immunogen so they do not produce autoantibodies. Extensive animal studies and Phase II clinical trials suggested that the effects of LJP-394 are effective and safe when used as a weekly dose of 100 mg intravenously. Analysis of a multicentre, international Phase II/III clinical trial showed that patients with lupus nephritis and high affinity IgG antibodies to LJP-394 have clinical benefits. This includes increased time to renal flares, reduced number of renal flares, time to institution of high-dose corticosteroids and/or cyclophosphamide and lower anti-ds-DNA levels. A definitive trial is in progress. LJP-394 appears to be free of serious adverse reactions. Though promising, the role of LJP-394 in patients with active, organ-threatening lupus is still not known.
Wallace
D J
DJ
Clinical Professor of Medicine, Cedars-Sinai/University of California Los Angeles, 8737 Beverly Blvd, Suite 203, Los Angeles, CA 90048, USA. dwallace@ucla.edu
D000818:Animals; D002986:Clinical Trials as Topic; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy; D009841:Oligonucleotides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D009841:Oligonucleotides; C094104:abetimus