Leukoregulin has not been introduced into clinical trials yet; it has, however, been evaluated in a three-phase preclinical screen. This screen consisted of evaluation of leukoregulin’s growth inhibition of human tumor and normal cell lines, measurement of the inhibition of tumor stem cell colony formation in agar using freshly dissociated human tumor cells, and inhibition of human tumor xenograft growth in athymic nude mice. The data regarding the growth inhibition of human tumor cell lines were presented in the preceeding chapter on leukoregulin. Leukoregulin activity ranging from 1 to 1200 units inhibited human gastrointestinal, bladder, head, and neck carcinomas, glioblastomas, and leukemia cell lines, but not normal cell counterparts. The second phase of the screen, clonogenic growth of tumor cells in semisolid agar medium, has been used as an indicator of patient clinical response with a relatively high degree of correlation (1,2). This type of assay allows for the determination of the types of tumor cells that may respond clinically to a given therapeutic agent. The third phase of the screen, evaluation of growth inhibition of human tumor xenografts, further enables appropriate selection of dosage, route of administration, and length of exposure required for a clinical response.
KeywordsAgar Leukemia Adenocarcinoma Sarcoma Collagenase
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