SAFETY PHARMACOLOGY STUDY OF HER1-ECD THERAPEUTIC CANCER PEPTIDE VACCINE IN A HUMANIZED MOUSE MODEL
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Date
2015-05
Type of Work
Department
Hood College Biology
Program
Biomedical and Environmental Science
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Abstract
The purpose of this study is to conduct a Safety Pharmacology evaluation of HERT-ECD vaccine in a
humanized mouse model as a part of the Investigational New Drug package to be submitted to the Food and
Drug Administration (FDA). The humanized mice will be created via engraftment of human peripheral blood
mononuclear cells (PBMCs) into adult SNOD/Lt-scidnull mice. The Safety Pharmacology assessment will
consist of evaluation of the potential to cause undesirable effects on the cardiovascular and respiratory
systems and a special safety study, an in vivo cytokine release syndrome (CRS) assay. After receiving one
dose of treatment or controls, respectively, the mice will be bled at nine time intervals to obtain samples for
human cytokine evaluation using the MSD Th1/Th2 ELISA kit (Meso Scale Discoveries). Additionally, the
mice will be placed on an ECGenie (Mouse Specifics, Inc.) electrocardiogram for cardiovascular evaluation
and into a FinePointe whole-body plethysmograph (Buxco Electronics) chamber for respiratory evaluation.
Statistical appraisal of treatment versus control results will include two-way ANOVA and Student's t-test.