The results from a Phase III clinical trial of MedImmune Inc.'scytomegalovirus immune globulin (CMVIG) for treating CMVinfection in liver transplant patients demonstrated that CMVIGgiven intravenously reduced by 50 percent the rate of severeCMV-associated disease in pediatric and adult liver transplantpatients.
The length of hospital stay for the first year aftertransplantation also was reduced by 25 percent in patients whoreceived CMVIG. Of the 146 patients enrolled in the trial, 141completed it and were followed for one year after treatment.The data were reported in the latest edition of the Annals ofInternal Medicine.
The double-blind, placebo-controlled, randomized four-yeartrial was led by David Snydman, director of clinicalmicrobiology at New England Medical Center and professor ofmedicine and pathology at Tufts University School of Medicine.Snydman coordinated the trials for the Boston Center for LiverTransplantation.
Cytomegalovirus infection can cause pneumonia, hepatitis,colitis and blindness. It can also be associated withopportunistic fungal infection (which by itself can prove fatal),graft loss and increased mortality.
According to Snydman, "CMVIG use represents a significantadvance in helping to protect liver-transplant patients againstsevere CMV-associated disease, which left unprotected carriesa 60 percent chance of death." With CMVIG, rates of CMVdisease were reduced from 30 percent to 19 percent.
MedImmune (NASDAQ:MEDI) of Gaithersburg, Md., whichmarkets CMVIG as CytoGan, received FDA approval in 1991 forthe product for treating primary CMV disease in kidneytransplant patients. The company filed for FDA approval inJune 1992 for CytoGan for treating CMV infection in all solidorgan transplants, said David Mott, MedImmune's vicepresident of development and planning.
-- Jennifer Van Brunt Senior Editor
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