Seattle-based IMRE Corp. said the FDA has approved a second stageclinical trial for its Prosorba column in the treatment of rheumatoidarthritis.IMRE's Joseph Balint said the trial, which will take about a year, willinvolve 15 patients and will attempt to collect more data on the safetyof PROSORBA in reducing inflammation. Balint told BioWorld IMREis in the process of selecting three U.S. sites for the tests. Balint said ifthe second stage trial is successful, it would be about three years beforeIMRE could apply for approval to market the PROSORBA column forthe treatment of rheumatoid arthritis.IMRE completed a pilot trial last year and reported that 10 of 11patients, who had not responded to conventional therapies, showedclinical response to treatment with PROSORBA. In a follow-up study,the company reported that seven of the original 10 responding patientsshowed long-term improvement and one patient was in clinicalremission.IMRE already is marketing PROSORBA for the treatment of immunethrombocytopenic purpura, an immune bleeding disorder. In additionto clinical trials in rheumatoid arthritis, IMRE is testing thePROSORBA column for other autoimmune diseases and cancers._Charles Craig
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