Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Since its discovery in the 1980s, IL-12 has been touted as a promising drug for the treatment of infection with protozoa, fungi, bacteria and viruses, including HIV. Genetics Institute began Phase I testing of IL-12 for kidney cancer and AIDS over a year ago, and Hoffmann-La Roche started tests of the drug for kidney cancer in Europe in December 1994. However, neither company has announced results of these Phase I studies.

Because naturally-occurring IL-12 appears to play a role in the pathogenesis of HIV disease, some researchers believe that the recombinant cytokine may promote a strong, cell-mediated response against HIV among people with AIDS. Yet despite general enthusiasm for the drug, some scientists have urged caution. Like all cytokines, IL-12 may cause adverse side effects: if used in too high a dose at the wrong time, IL-12 can cause significant harm. Researchers have reported that high doses of IL-12 in mice can produce a reaction that resembles toxic shock syndrome. IL-12 administered to mice also has resulted in the dissemination of Candida infections, according to Italian investigators.

Clearly, the halting by Genetics Institute of its Phase II study due to the death of a study participant and the hospitalization of 10 others is cause enough to exercise extreme caution in future studies of IL-12. For more information on IL-12 and HIV disease, see the March 1994 issue of BETA.

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