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| |  Clinical Trials of Gene Therapy-Based HIV Immunotherapeutic Broadened EMERYVILLE, Calif.-- Feb. 13, 1997-- Chiron Corp. (NASDAQ:CHIR) announced today that it and partner Green Cross Corp. of Osaka, Japan, have agreed to expand human clinical studies of their jointly developed immunotherapeutic, HIV-IT(V). Green Cross will provide an additional $4 million for the year to conduct a Phase 2 trail testing HIV-IT(V) in combination with new anti-retroviral protease inhibitor therapies, in approximately 200 HIV-positive patients. A Phase 2 trail initiated in December 1994 is ongoing testing HIV-IT(V) also in approximately 200 patients. While most of the patients were not on anti-retroviral therapies at the time of enrollment, all were allowed standard retroviral therapy during the course of the study. HIV-IT(V) is a non-replicating retroviral vector that delivers the genes encoding the HIV env and rev proteins. The product is administered via intramuscular injection. Preclinical and Phase 1 studies have indicated that administration of this product induces killer T-cells against HIV-infected cells. The project was initiated in 1991 and clinical trails started in 1993 as a collaboration between Viagene Inc. (acquired by Chiron in 1995) and Green Cross Corp. Green Cross also intends to initiate HIV-IT(V) clinical testing in Japan in 1997. Under the terms of the collaboration, Chiron performs research, development, and manufacturing for HIV-IT(V) and Green Cross retains worldwide marketing rights. "This project is an important component of our HIV gene therapy strategies," said Steven J. Mento, Ph.D., vice president of Chiron Corp. and head of Chiron Technologies Center for Gene Therapy. "Final results of both trails should be available early in 1998, and a Phase 3 trail, if warranted, could begin later in that year." "We are pleased that our partner Green Cross Corp. has committed to this trial which will test our gene delivery approach to immunotherapy in the context of recently developed multidrug treatment regimens for HIV," said Lewis T. "Rusty" Williams, M.D., Ph.D., president of Chiron Technologies. The Green Cross Corp. of Osaka, Japan is a public pharmaceutical company that mainly develops and markets human plasma derivatives, cardiovasculars including fibrinolytics, peripheral vasodilators and antihypertensives, immunologicals including anti-infectives, anti- allergies, anti-inflammatories and immunomodulators, and various kinds of transfusion fluids worldwide. Chiron Corp. is a biotechnology company headquartered in Emeryville, near San Francisco. Chiron is building a healthcare business that addresses needs in several markets: diagnostics, including immunodiagnostics and bDNA probe assays; vaccines, emphasizing adult and pediatric infectious diseases; therapeutics, with an emphasis on oncology, endocrinology, serious infectious and other diseases requiring critical care; and ophthalmic products for the surgical correction of vision. Additional research programs are underway in gene therapy and gene transfer, therapeutic recombinant, proteins, combinatorial chemistry and cardiovascular disease. This press release contains forward-looking statements relating to future events at Chiron. Actual events may differ materially from our expectations. We refer the reader to documents that Chironron files with the Securities and Exchange Commission, including the section, "Factors That May Affect Future Operating Results" from the company's most recent Form 10-Q report, for a further discussion of important factors that could cause actual performance to differ from our current expectations and the forward-looking statements contained in this press release.
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