TERMINAL PROCEDURES definition
TERMINAL PROCEDURES. On study day 2, three mice from groups 1 and 2 will be weighed, bled, and sacrificed by CO2 asphyxiation. Blood samples and tissue samples will be obtained and will be analyzed for presence of exogenous Test article DNA using PCR with primers specific for the vector and/or targeted gene. On study days 10 and 30 respectively, three mice per day from group 2 will be weighed, bled and sacrificed and blood and tissue samples obtained and analyzed for exogenous Test article DNA. o Gross necropsies will be performed only to obtain Tissues for PCR analysis. o A portion of the following tissues will be collected using clean sterile instruments (clean sterile set for each individual animal) and placed in vials and frozen at -80(Degree)C: Injection Site Spleen Small Intestine Ovaries Lymph node (1) Lung Heart Brain Bone Marrow Kidney Liver Blood PCR ANALYSIS: PCR analysis will be performed on the tissues using primers specific for genetic sequences of the Listeria monocytogenes vector. TEST ARTICLE DOSAGE VERIFICATION: Information to be supplied by the sponsor. BIODISTRIBUTION OF LM-LLO-E7 VECTOR IN MICE PURPOSE: To examine the biodistribution of Lm-LLO-E7 Vector following a single intravenous or s.c. injection to female Balb/C mice. SCOPE: 96 Female Mice REGULATORY STATUS: GLP TEST ARTICLE: Lm-LLO-E7 CONTROL ARTICLES: Control Buffer ROUTES OF ADMINISTRATION: Intravenous and Subcutaneous
TERMINAL PROCEDURES. On study days 2, 10 and 30 and 90, five mice per group will be weighed, bled, and sacrificed by CO2 asphyxiation. Blood samples will be analyzed for presence of exogenous Test article DNA using PCR with primers specific for the vector and target gene. Gross necropsies will be performed only to obtain Tissues for PCR analysis. A portion of the following tissues will be collected using clean sterile instruments (clean sterile set for each individual animal) and placed in small microcentrifuge vials and frozen at -80(Degree)C: Injection Site Spleen Blood Ovaries Mesentary lymph node Lung Heart Brain Bone Marrow Kidney Liver Small Intestine PCR ANALYSIS: Quantitative PCR will be performed on DNA extracted from above tissue samples and the presence of the vector sequence will be assessed.