Chiron Corporation Center for Gene Therapy

12/5/00


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Table of Contents

Chiron Corporation Center for Gene Therapy

Overview : Risk of Germ Line Transduction After Direct Injection of Retroviral Vectors

Chironís 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

Author: Nelle Cronen