Viagene's HIV-IT(V) In Phase II Trials

US company Viagene, which focuses on developing gene therapy products for marketing by commercial partners, has begun Phase II trials of its HIV-IT(V) product, intended for the treatment of HIV infection. The product, an immunotherapeutic vector, is delivered intramuscularly. The trial will be funded by Japanese partner Green Cross Corp.

HIV-IT(V) comprises a non-replicating murine retroviral vector engineered to deliver the rev and env genes of HIV-1 to healthy non-infected cells, where the respective proteins are expressed and will hopefully lead to a cytotoxic T-lymphocyte response. About 190 HIV-positive patients will be enrolled at up to 15 clinical centers across the USA. The patients will be randomly assigned to active treatment or placebo within three strata based on their CD4 cell counts: CD4 counts of 100-249/mm3 receiving antiretroviral therapy; counts of 250-399/mm3 with 50% on antiretrovirals; and counts greater than 400/mm3 with no drug treatment.

The treatment will be given every four months and will involve three biweekly injections of the product. The total duration of the trial will be two years, and an interim analysis will be undertaken after patients have received two courses of treatment. A Phase I trials program involving 70 patients has already been successfully completed. The company does not need to secure National Institutes of Health Recombinant DNA Advisory Committee approval for its protocol because the trial is being exclusively funded by Green Cross, reports the Pink Sheet.