Table of Contents
Chiron Corporation Center for Gene Therapy
Overview : Risk of Germ Line Transduction After Direct Injection of Retroviral Vectors
Chiron’s Use of Retroviral Vectors in Clinical Development
Past Testing for Germ Line Transmission During Clinical Use of Retroviral Vectors
Choice of Retroviral Vector and I.V. Delivery for Factor VIII Gene Transfer
Retroviral Vector Expressing Human Factor FVIII [hFVIII(V)]
Preclinical Biolocalization Studies Using PCR to Detect Vector Sequences
Summary of Biolocalization Studies in Rabbits and Hemophilic Dogs
Probability of a Transduced Cell in Rabbit Testis Is Very Low and Decreases Over Time
Semen Analysis Study Design
Results of Rabbit Semen Study
PCR Results in Rabbit Testes and Semen
Phase I Multicenter Study of FVIII Retroviral Vector in Subjects With Severe Hemophilia A
Current Study Status
Clinical PCR Assay for Vector in Semen
Spermatogenesis Model Supporting the Semen Testing Protocol
Time Points for Semen Collection During First Cycle of Spermatogenesis
Human Semen PCR Results to Date
Semen Test Results Subject #01001 / F8V101
Possible Sources of Positive PCR Test Result in Subject #01001
Frequency Analysis of Human Semen Test Results From Dose Level 4*
Results of Human Semen PCR Analysis
Conclusions
Proposed Follow-Up for F8V101 Subjects With PCR-Positive Semen Testing
Contributors - FVIII Study
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