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Recently we identified a novel vitamin D analog, 1alpha-hydroxy-24 ethyl vitamin D5 (1alpha(OH)D5) that showed potent growth inhibitory and cell- differentiating actions in breast cancer cells. Based on our findings in in vitro and in vivo experimental model systems, we hypothesized that 1alpha(OH)D5, when administered to women with breast cancer, will induce differentiation of dedifferentiated cells and thereby prevent progression of malignancy. In 1999- 2000, we completed the preclinical study in rats. Results showed that 1alpha(OH) D5 has no serious toxicity; a hypercalcemic effect was observed at high dose, which was reversible In vitro study in tissues obtained from patients show that 1alpha(OH)D5 has no effect on normal breast epithelial cells, but it induces apoptosis in breast cancer. It also showed apoptotic effect in fibroadenomas. We completed 5 steps in the synthesis of 1alpha(OH)D5 for preparation of 1alpha(OH) D5 for phase I clinical study. In 2000-2001, we completed preclinical toxicity studies in dogs under GMP. We have completed synthesis of 1alpha(OH)D5 under GMP for future clinical trial. In vitro studies in clinical specimens obtained from women suggest that 1alpha(OH)D5 has no effect on normal breast tissues; it inhibits cell proliferation in tumor cells. 1alpha(OH)D5 or its active metabolite possibly interacts with estrogen receptor. We will be submitting our IND application to the FDA.