Food and Drug Administration
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
October 26, 2001
Briefing Information
Food and Drug Administration
A Phase 1 Open-Label Clinical Trial of the Safety and Tolerability of Single Escalating Doses of Autologous T Cells Transduced with VRX496 in HIV Positive patient-Subjects: Cover Sheet, Contents pdf
RAC Review of Protocol #0107-488, Nancy M. P, King, JD pdf htm
Protocol 0107-488, A Phase 1a, randomized study of escalating single doses of VRX496 in subjects with AIDS, R. R. MacGregor pdf htm
Review of 0107-488, PI: Rob Roy MacGregor MD, Sponsor: VIRxSYS Corp "A phase I open-label clinical trial of the safety and tolerability of single escalating doses of autologous CD4 T cells transduced with VRX496 in Hiv positive subjects," M. Louise Markert, MD, PhD. pdf htm
Protocol 0107-488, A Phase 1a, randomized study of escalating single doses of VRX496 in subjects with AIDS, R R MacGregor pdf htm
Reply to Dr. King's comments our Protocol #01-07-488. "A phase 1 open label clinical trial of the safety and tolerability of single escalating doses of autologous T cells transduced with VRX496 in HIV positive patients." Rob Roy MacGregor, MD, Carl H June, MD, Boro Dropulic PhD pdf htm
Proposed protocol: Ex-vivo gene transfer of VRX496 into HIV-infected patient-subjects pdf
A Phase 1 Open Label Clinical Trial of the Safety and Tolerability of Single Escalating Doses of Autologous T Cells Transduced with VRX496 in HIV Positive Patients, Patient Consent Form pdf
September 25, 2001 letter to Boro Dropulic, PhD, VIRxSYS Corporation from Amy P. Patterson, MD, Director, Office of Biotechnology, NIH re: Public RAC Discussion of Protocol #0107-488 pdf doc
VIRxSYS Corporation Investigational New Drug Protocol, VRX496-01-01, Final, Date Prepared: September 5, 2001 pdf
Transcript of September 6, 2001, Afternoon Session, pages 201-325, "Discussion of Human Gene Transfer Protocol #01007-488 Entitled: A Phase I, Open-Label Clinical Trail of the Safety and Tolerability of Single Escalating Doses of Autologous CD4 T Cells Transduced with VRX496 in HIV-Positive Subjects" pdf htm
VIRxSYS Corporation
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Briefing Document pdf
October 26, 2001 Letter to The Editor, Molecular Therapy from Boro Dropulic, VIRxSYS Corporation pdf