Figure 7.
Safety profile of MyeloVec. (A) IVIM assay displaying the replating frequency (RF) of MyeloVec and CCLchim-gp91phox-WPRE and control samples (Mock and RSF91). Data are compared with a meta-analysis (MA) for control samples (MA-Mock, MA-RSF91, MA-LV-SF). Above the graph, the incidence of positive (RF >3.17 × 10−4) and negative plates (RF <3.17 × 10−4) according to the MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) assay are shown. (B) SAGA assay displaying gene expression analysis. A positive NES indicates an upregulation of oncogenic core set genes. Data are compared with a MA of a positive control (MARSF91) or SIN LV with an internal EFS promoter (MA-LV.EFS). Plates with no wells above the MTT threshold. Bars indicate means. Difference in the incidence of positive and negative IVIM assays relative to Mock-MA or RSF91-MA were analyzed by Fisher exact test with Benjamini-Hochberg correction. Statistical comparison with MA-RSF-91 in SAGA was analyzed by Kruskal-Wallis with Dunn correction; ∗P < .05, ∗∗P < .01, ∗∗∗P < .001, ∗∗∗∗P < .0001. RSF91, mutagenic gammaretroviral vector with enhancer/promoter of spleen focus–forming virus in both LTRs; LV-SF, self-inactivating LV under control of the spleen focus–forming virus internal promoter; EFS, self-inactivating LV under control of the shorten promoter of the EEF1A1 gene; LOD, limitation of detection.