Imre Corp. announced that FDA is requiring more clinical trialdata on the Seattle company's Prosorba column for treatingcancer chemotherapy-associated thrombotic thrombocytopenicpurpura/hemolytic uremic syndrome (C-TTP/HUS).
FDA now requires that the clinical trial be randomized, whereasthere were no such requirements in 1989, when Imre filed itsinvestigational device exemption (IDE) for C-TTP/HUS, said LoisYoshida, Imre's vice president and chief administrative officer.Imre (NASDAQ:IMRE) will be submitting to FDA an amendedIDE, incorporating the new trial protocol, Yoshida told BioWorld.
Meanwhile, recent clinical trial results on using the Prosorbacolumn for treating C-TTP/HUS just appeared in the March1993 issue of the journal Cancer. In trials on 55 patients, 25responded to the therapy with an estimated one-year survivalrate of 61 percent, as opposed to an estimated rate of 22percent in patients who didn't respond to therapy. Three-quarters of the treatments did not produce any side effects; inthe others the effects were "mild to moderate and well-tolerated."
C-TTP/HUS develops in a small percent of cancer patients whoreceive certain chemotherapeutic agents. The syndrome ischaracterized by low platelet count, destruction of red bloodcells and kidney dysfunction. If left untreated, 80 percent ofthe patients with this disease die within one year. There is noknown therapy.
Imre received approval from FDA in 1987 to market itsProsorba column for treating immune thrombocytopenicpurpura, an immune-related bleeding disorder. The Prosorbacolumn contains a silica matrix bound to protein A molecules,which can remove immune suppresser molecules from apatient's blood plasma. A patient's plasma is separated fromthe blood cells, passed through the column, recombined withthe cells, and then re-infused.
-- Jennifer Van Brunt Senior Editor
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