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| |  IL-2 Therapy Produces Increases in CD4 Counts in People With HIV EMERYVILLE, Calif.-- Oct. 30, 1996 -- Chiron Corp. (NASDAQ:CHIR) announced today that infusions of recombinant interleukin-2 (IL-2) in people infected with HIV can produce substantial and sustained increases of CD4 cells, a measure of immune competency, according to a paper published by investigators from the National Institutes of Health (NIH) in tomorrow's New England Journal of Medicine. The NIH investigators reported that in a randomized, controlled study of 60 HIV infected patients, in 31 subjects mean CD4+ T-cell counts doubled from 428 cells at baseline to 916 cells per cubic millimeter at 12 months. These patients received IL-2 plus standard antiviral therapy, and had CD4 counts greater than 200 cells per cubic millimeter at the time they began treatment. Among 29 people receiving standard antiviral therapy alone, the mean CD4+ T-cell count decreased from 406 to 349 in the same period. Importantly, no significant differences in HIV RNA plasma (viral load) or p24 antigen levels were seen between the groups over the year of treatment. Furthermore, there was no increase in viral load in IL-2-treated patients over the course of the study. The study was reported by Joseph A. Kovacs, M.D., H. Clifford Lane, M.D., and their colleagues, including Gwen Fyfe, M.D., of Chiron, which supplied the IL-2 used in the study. Chiron markets recombinant IL-2 under the trade name of Proleukin (aldesleukin) for injection for treatment of metastatic renal cell cancer. The full text of the NIH press release describing the study's results is attached following this release. "These data underscore the potentially important and complementary role that IL-2 could play in the expanding array of weapons to fight HIV infection and its consequences," noted Magnus Lundberg, president of Chiron Therapeutics, which markets Proleukin. "Given the tremendous recent progress in reducing viral load through use of new protease inhibitors, the next step needed is to strengthen the immune system to fight the opportunistic infections that impact life. We look forward to continuing the evaluation of Proleukin therapy in people infected with HIV." Chiron has provided IL-2 for 12 NIH studies investigating IL-2 in people infected with HIV, and has sponsored nine other studies on its own. "Chiron has recently completed two randomized trials of outpatient continuous infusion IL-2 which have also shown substantial CD4 increases among the IL-2 treated patients compared to patients treated with antivirals alone," said Gwen Fyfe, M.D., director of clinical research. "These trials have focused on improving the tolerability of IL-2 therapy and its ease of use in this indication. We are now studying subcutaneous administration of IL-2 and have encouraging data regarding its immunologic activity. The current trial is part of our ongoing collaboration with the NIAID and highlights our commitment to optimizing the potential benefit and clinical utility of IL-2 in HIV disease." Study results, including those published today, have continued to show that IL-2 therapy leads to substantial increases in CD4+ T-cells in some people with HIV; these data suggest that IL-2 treatment may complement the actions of antiretrovirals, including protease inhibitors. Protease inhibitors were not used in this study. The clinical data from the NIH study suggests that the CD4+ T-cells induced by IL-2 therapy are functional, and thus may provide benefits by reducing opportunistic infections. In addition, the side effects of IL-2 infusion as reported in today's NEJM were more manageable than those seen in previous reported studies using a higher dose of IL-2 administered intravenously. "Our goal is to determine a tolerable dosing regimen that will deliver clinical benefits for patients," said Lundberg. "Recent studies have shown that IL-2's effects on the immune system can be sustained with regimens that are generally well-tolerated. Thus we are adding to the knowledge base with each succeeding study." Chiron's bDNA HIV RNA probe tests were used to measure virus in study subjects. Results from a series of clinical studies presented or published by Dr. John Mellors of the University Of Pittsburgh during 1995 and 1996 have established that viral load is an excellent predictor of disease progression and complements measurement of CD4 counts in the management of HIV infection. Chiron has a number of programs across its businesses directed at HIV infection as well as the opportunistic infections that frequently plague people with HIV. Chiron Vision markets the Vitrasert Implant, the first drug delivery system for localized, sustained therapy for cytomegalovirus (CMV) retinitis in people with AIDS. Chiron has candidate vaccines for CMV and HIV in Phase 2 clinical trials, and a vaccine for genital herpes in Phase 3 trials. A gene therapy approach for treating HIV infection is in clinical trials. Together with Johnson & Johnson, Chiron introduced the first home HIV test service, Confide. For additional information, the public can contact the Professional Services Group at Chiron by dialing 1-800/CHIRON-8 (1-800/244-7668). Chiron Corp., headquartered in Emeryville, near San Francisco, is a science-driven healthcare company that combines diagnostic, vaccine, and therapeutic strategies for controlling disease. Chiron participates in four global markets: diagnostics, including Chiron also has research programs underway in gene therapy and gene transfer, combinatorial transfer, combinatorial chemistry, cardiovascular disease and critical care.
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