Green Cross Therapy For HIV Starts Second Phase II Study

Green Cross of Japan plans to expand clinical testing of HIV-IT, itsgene therapy for HIV infection, in collaboration with US partner Chiron. Green Cross has supplied another $4 million in funding for 1997, which will be used to conduct a second Phase II trial of the immunotherapeutic, this time in combination with HIV protease inhibitor drugs.

Chiron and Green Cross started a Phase II trial of HIV-IT in December 1994 in approximately 200 patients. The therapy consists of a non-replicating retroviral vector that delivers the genes encoding the HIV env and rev proteins, which is delivered via intramuscular injection. Data from preclinical and Phase I trials suggest that this approach can induce a cytotoxic T lymphocyte response against HIV-infected cells.

Most of the patients enrolled into the first Phase II study were not on antiretroviral therapy at the outset, but were allowed to start treatment over the course of the study. The second trial will allow a more prospectively-defined appraisal of the combination of HIV-IT with antiretroviral regimens.