Imre Corp. said Monday that it has received Food and DrugAdministration approval to conduct two clinical studies of itsProsorba column to treat kidney transplant and multiplesclerosis patients.
To use the column, blood is removed from the patient and theplasma separated. The plasma is put through the column, whichcontains protein A bound to silica. Protein A has an affinity forthe IgG (gamma G immunoglobulin) antibody. The columnremoves IgG and IgG immune complexes, which are antibodiesbound with antigens.
In kidney transplant patients, the treatment might lowerantibodies against the transplanted organs, said EdwardYoshida, vice president of regulatory affairs.
In MS patients, Imre is working from the assumption that thedisease may be an immune system disorder and that Prosorbamight have a therapeutic effect.
Prosorba received FDA approval in 1987 to treat idiopathicthrombocytopenic purpura, a bleeding disorder. Sales ofProsorba for the second quarter ended June 30 were $627,889.
Stock of the Seattle-based company (NASDAQ:IMRE) closed up31 cents at $2.06 on Monday.
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