BIOLOGICALS RESPONSE MODIFIERS ADVISORY COMMITTEE

BIOLOGICALS RESPONSE MODIFIERS

ADVISORY COMMITTEE

Meeting #31, October 25-26, 2001

Lentivirus Vectors in Gene Transfer Clinical Trials

Table of Contents

Briefing Document

Introduction

Issues Related to Manufacture of Lentivirus Vectors

Preclinical Models for Safety Assessment of Lentivirus Vectors

Special Considerations for Clinical Development of

Lentivirus Vectors

References

Draft Questions for October 25, 2001

General Questions on Lentiviral Vectors

Draft Questions for October 26, 2001

Questions Specific to VIRxSYS’ Proposed Clinical Trial

September 25, 2001, Letter to Boro Dropolic, Ph.D.,

Chief Scientific Officer, VIRxSYS Corporation, from

Amy Patterson, M.D., Director, Office of Biotechnology Activities, NIH

Selected References Cited in Briefing Document