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.