MedClone Inc. of Los Angeles entered into an agreement withInveresk Clinical Research Ltd. in which the Edinburgh,Scotland, company will help manage United Kingdom trials ofMedClone's lead product, Mab 3E10.Mab 3E10 is a vaccine immunotherapy for the treatment ofnephritis associated with systemic lupus. MedClone plans tostart Phase I clinical trials in the U.K. by Sept. 1. Phase I trialson the same product already are under way in the U.S. andSwitzerland."Mab 3E10 is the first lupus-specific therapy to be put intohuman clinical trials in the world," Peter Ulrich, MedClonepresident and chief executive officer, told BioWorld. He saidsome inflammatory agents have been tested on lupus patients,but this is the first specifically designed to treat the disease.Ulrich estimated a $625 million per year market for theproduct in the U.S. and about twice that worldwide. He said500,000 people in the U.S. have the disease.Inveresk will prepare a clinical trial exemption (the U.S.equivalent of an Investigational New Drug application) in theU.K., identify researchers to conduct the trials and monitorthem. Ulrich would not reveal terms of the agreement exceptto say it was a cash deal in which no rights are involved.032194 Medclone
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