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news.FIT Biotech, a biotechnology company developing new, proprietary immunotherapies for HIV/AIDS and other viral diseases, has released results from a Phase II clinical trial evaluating its immunomodulator FIT-06 which demonstrated long-term reductions in viral load and CD4 cell count increases in HIV-infected, previously untreated patients.
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In the study, which was carried out in South Africa, FIT-06 reduced viremia in previously untreated patients. This is expected to be an alternative to antiretroviral therapy (ART) for HIV-infected patients.
FIT-06 is a DNA-based vaccine developed by FIT Biotech based on its new proprietary GTU technology. FIT-06 is used to treat patients who are already infected.
FIT Biotech’s placebo-controlled Phase II study included 60 previously untreated volunteers recruited at the University of Witwatersrand Clinic in Soweto, Johannesburg, South Africa, who had a plasma viral load of greater than 38,000copies/ml and a CD4 cell count of more than 500cells/µl.
The patients were dosed either intramuscularly (IM) or intradermally (ID). The results were analysed at the end of the study, which concluded after 108 weeks. Viral loads were reduced by 0.47log with a p-value of 0.001 in the intramuscular group. CD4 cell counts increased by 72cells/µl with a p-value of 0.013.
Giuseppe Pantaleo, professor of medicine of the University of Lausanne, Switzerland and an investigator on the study, said: “This is the first demonstration that an immune-based therapy can interfere with HIV replication in infected people who have not yet started ART.
“By analysing these patients’ immune responses in detail, we will gain information to guide us in further improving the vaccine.”
Kalevi Reijonen, president and CEO of FIT Biotech, said: “Immediate benefits to patients include the possibility that the start of antiretroviral therapy could be delayed and that patients might be able to take longer drug holidays.
“Also, by reducing their lifetime drug burden, FIT-06 therapy might lessen the side effects associated with long-term use of antiretroviral therapy.”