Absence of RCA Isolated from Patients Treated with INGN 201 (Ad5CMV-p53)

7/27/01


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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

Introgenís 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

Author: Mhashilkar