title: A sequential multi-assay protocol for the preclinical assessment of natural product complex carbohydrate immunomodulators.
abstract: A major barrier to the understanding, development and utilization of natural product complex carbohydrate immunomodulators has been the lack of standardization during pre-clinical efficacy and safety testing. In addition, it has been our experience that no single assay system or model is adequate for assessing preclinical efficacy and safety of these agents. To address these important issues, our laboratory group has developed a sequential multi-assay protocol for the preclinical evaluation of natural product complex carbohydrate immunomodulators. This sequential multi-assay screening protocol is divided into four phases: 1) physiochemical characterization of the carbohydrate polymer; 2) evaluation of immune stimulatory activity; 3) assessing in vivo anti-microbial activity and anti-tumor efficacy and 4) preclinical safety evaluation. This sequential protocol provides an effective, reproducible and rational approach to the preclinical assessment of complex carbohydrate immunomodulators that, in our experience, is predictive of clinical safety and efficacy.
authors.affiliation: Department of Physiology, Tulane University School of Medicine, New Orleans, LA 70112.
authors.forename: D L
authors.initials: DL
authors.lastname: Williams
authors.forename: H A
authors.initials: HA
authors.lastname: Pretus
authors.forename: R B
authors.initials: RB
authors.lastname: McNamee
authors.forename: E L
authors.initials: EL
authors.lastname: Jones
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology* / Q000627:therapeutic use; D000465:Algorithms; D000818:Animals; D001853:Bone Marrow / Q000187:drug effects; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005936:Glucans / Q000494:pharmacology* / Q000627:therapeutic use; D007239:Infections / Q000628:therapy; D007694:Killer Cells, Natural / Q000187:drug effects; D008213:Lymphocyte Activation / Q000187:drug effects; D008262:Macrophage Activation / Q000187:drug effects; D008297:Male; D051379:Mice; D008806:Mice, Inbred AKR / Q000276:immunology; D008810:Mice, Inbred C57BL / Q000276:immunology; D009374:Neoplasms, Experimental / Q000628:therapy; D013154:Spleen / Q000166:cytology / Q000187:drug effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D005936:Glucans