Vacc-4x: Phase I/II data

Data from 6 patients with HIV-1 infection on cART with undetectable HIV-1 RNA levels in Part A of the open-label, Danish Phase I/II REDUC trial showed that 5 mg/m 2 IV Istodax romidepsin - a histone deacetylase (HDAC) inhibitor from Celgene Corp. (NASDAQ:CELG, Summit, N.J.) - successfully reactivated HIV transcription in all 6 patients. Specifically, Istodax given on days 0, 7 and 14 significantly increased cell-associated unspliced HIV-1 RNA levels from baseline by 2.1-3.9-fold after the second infusion (p=0.03). Additionally, Istodax increased plasma HIV-1 RNA levels from undetectable at baseline to quantifiable levels post-infusion in 5 of 6 patients (46-103 copies/mL after the second infusion, p=0.035). Istodax was safe and the most common adverse events reported were abdominal symptoms. Data were presented at the International AIDS Society meeting in Melbourne. Bionor said the data demonstrate for the first time that Istodax can reactivate latent HIV reservoirs in HIV-infected patients. ...