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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
Genetics Institute Suspends Phase 2 Study of rhIL-12

June 12, 1995
PR Newswire (06/09/95)

On Friday, Genetics Institute, Inc. announced that it has suspended a Phase II clinical trial of recombinant human interleukin-12 (rhIL-12) due to reports that several patients had to be hospitalized after taking the experimental drug. The Phase II study for the treatment of advanced kidney cancer was undertaken in part on the basis of Phase I dosing studies of the drug in oncology and HIV. In those studies, rhIL-12 was well-tolerated over a wide range of biologically active doses. The Phase II study, however, used a different dosing schedule and dosage form than the Phase I studies. A total of 10 patients have been hospitalized and one has died. The company has notified the Food and Drug Administration of the suspension, and is conducting an investigation which will help determine the extent to which these events may have been caused by rhIL-12.