MedClone Inc. announced that it has begun Phase I clinicaltrials of MAb 3E10, a therapeutic vaccine for the treatment ofnephritis associated with systemic lupus erythematosus (SLE).
The U.S. study will divide 12 midstage SLE patients withnephritis into one of three dosage arms or a placebo arm.According to the company, the trial is intended to determine"the extent to which intradermal injection with MAb 3E10 istolerated by lupus patients, and to assess whether theirimmune systems produce anti-idiotype responses aftervaccination with MAb 3E10."
Patients selected for the trial have stable clinical SLE and areunder treatment with less than 20 mg daily of thecorticosteroid prednisone.
The trial will be conducted at two sites, the V.A. Medical Centerat Sepulveda, Calif., and the UCLA/Olive View Medical Center inSylmar, Calif., both under the direction of rheumatologistAlfred Petrocelli. Clinical trials with an additional 12 patientsbegan in November 1993 at the Centre HospitalierUniversitaire Vaudois in Lausanne, Switzerland.
MAb 3E10 is a monoclonal antibody that the company believesis involved in the pathogenesis of SLE. MedClone, a privatelyheld biopharmaceutical company based in Los Angeles, filed anIND for MAb 3E10 with FDA in August 1992 and receivedapproval in July 1993.
La Jolla Pharmaceutical Co. has a product for the treatment oflupus nephritis, LJP-394, in preclinicals. MedClone's presidentand chief executive, Peter Ulrich, told BioWorld that he is notaware of any other company developing a product exclusivelytargeted to lupus nephritis.
-- Karl A. Thiel Special to BioWorld
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