InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, has announced successful completion of the first clinical development phase for VAC-3S immunotherapy in the treatment of HIV infections.
A phase I/IIa dose escalation study was performed in 24 patients living with HIV whose CD4 T-lymphocyte levels were higher than 200/mm3 and who were under antiretroviral therapy [ART].
The treatment was administered in 3 injections at 4-week intervals. The primary endpoint of this study was to assess the safety and tolerability of VAC-3S, four weeks after the third injection. Secondary endpoints included an evaluation of the immune response, the long-term safety of the treatment and the monitoring of different biological markers of infection (including viral load and the CD4 T-lymphocyte count). The study was carried out under double-blinded conditions in two AP-HP (Paris Public Hospitals System) academic reference clinical centers at Hôpital de la Pitié Salpêtrière and Hôpital Cochin.
The results showed that VAC-3S was well tolerated, thus meeting the primary endpoint of the study. Full results of this study will be presented at an international medical conference.
Release Date: November 29, 2012