Nafazatrom was tested against a variety of human malignancies with the human tumor stem cell assay at one or more of the following concentrations: 1, 10, 25, and 100/xg/ml • 1 h or 0.05, 0.5, or 5/~g/ml by continuous exposure. Major (__> 70%) inhibition was noted in 7/52 adenocarcinomas, in 0/9 squamous carcinomas, and 1/17 other malignancies. Intermediate levels of inhibition (50 to 69%) were noted in 7/52, 4/9, and 6/17 of these respective subtypes. No clear trend toward superiority of any dose-schedule was noted. Since nafazatrom has proven non-toxic in our nearly completed Phase I study, and since this study suggests activity against several human cancers, Phase II level testing is warranted.
The B-16 melanoma animal cell line and HEC-1A human endometrial cell line treated with Nafazatrom (NFZ) (5/x/ml) and varying doses of ionizing radiation show a dose response curve of increased colony inhibition with increasing radiation dose. The B-16 line consistently demonstrated enhanced colony inhibition when NFZ was added prior to radiation. This colony inhibition by NFZ was not seen in the HEC-1A cell line. No adverse effect, i.e., increased tumor colony growth, was evident when NFZ and radiation were combined. This study suggests that ionizing radiation can be combined with NFZ without adverse effect on the cell killing effects of either modality.
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