Table of Contents
Absence of RCA Isolated from Patients Treated with INGN 201 (Ad5CMV-p53)
Presentation Outline
Origin of Replication Competent Adenovirus in INGN 201
How does RCA arise ?
Detection of RCA in Production Lots
Finding RCA
Consequence of Testing Near the Limit of Detection
RCA Results from Two Methods
RCA Profile for 35 Lots Tested at 3 X 1010 vp
Introgen’s Working Conclusion
Data Through June 2000
Estimated Patient Exposure to RCA
Assay for RCA in Patients Treated with INGN 201 in Phase I Clinical Trials
Analysis of Samples from 190 Phase II Subjects
Study T201
Study T202
Study T207
Incidence of CPE Positive Samples for T201, T202, and T207
Results of Biodistribution Analysis
Immune Response of Patients Treated with INGN 201
Conclusions
Recommendations
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