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Agenda
8:00 AM - Call to Order and Opening Remarks
Diane Wara, M.D., Chair, NIH RAC
8:05 AM - Introduction of New RAC Members
8:15
AM - Discussion of Human Gene Transfer Protocol #0401-624: A
Phase I Trial of Conditionally Replication-Competent
Adenovirus (Delta-24-RGD) for Recurrent Malignant
Gliomas
- PowerPoint Presentation (PDF)
PIs: Frederick F. Lang, Jr., M.D.
University of Texas M.D. Anderson Cancer Center,
Houston, TX
Charles A. Conrad, M.D.
University of Texas M.D. Anderson Cancer Center,
Houston, TX
RAC
Reviewers: Neal DeLuca, Ph.D.
Madison Powers, J.D., D.Phil.
Diane Wara, M.D.
Ad Hoc Reviewer: Richard G. Vile, Ph.D.
Mayo Clinic, Rochester, MN
Tab 2328 Protocol
Tab 2329OBA Summary
OBA Letter to PIs on In-Depth RAC Review and Public
Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. DeLuca, Powers, Wara, and Vile
PIs'/Sponsor's Response
9:50 AM - Public Comment
10:00 AM - BREAK
10:15
AM - RAC Recommendations
10:30
AM - Discussion of Human Gene Transfer Protocol
#0401-625: A Phase I Study of a Tropism-Modified
Conditionally Replicative Adenoviral Vector (Ad5-24RGD)
for Intraperitoneal Delivery in Ovarian and Extraovarian
Cancer Patients
Powerpoint Presentation (PDF)
PIs: Ronald D. Alvarez, M.D.
University of Alabama, Birmingham
Mack N. Barnes III, M.D.
University of Alabama, Birmingham
David T. Curiel, M.D., Ph.D.
University of Alabama, Birmingha
RAC Reviewers:
Maxine Linial, Ph.D.
Madison Powers, J.D., D.Phil.
David Sidransky, M.D.
Ad Hoc Reviewer:Richard G. Vile, Ph.D.
Mayo Clinic, Rochester, MN
Tab 2330Protocol
Wednesday, March 10, 2004 (continued)
Tab 2331OBA Summary
OBA Letter to PIs on In-Depth RAC Review and
Public Discussion
Outcome
of Initial Review by RAC Members
Reviews from Drs. Linial, Powers, Sidransky,
and Vile
PIs'/Sponsor's Response
12:05 PM - Public Comment
12:15 PM - BREAK
12:30
PM - RAC Recommendations
12:45 PM - LUNCH
1:45
PM - Discussion of Human Gene Transfer Protocol
#0311-614: First Time in Human Safety
Study of Streptococcus mutans Lactic Acid-Deficient
Effector Strain (A2JM) Administered in Conjunction
with Twice-Daily Dose of D-Alanine Mouthwash
in Healthy Adult Male Subjects for Replacement
Therapy as an Aid in the Protection Against
Dental Caries
Powerpoint Presentation (PDF)
Powerpoint Presentation (PDF)
PI: Constance E. Stone, D.M.D.
University of Florida, Gainesville, FL
Presenter: Jeffrey Hillman, D.M.D., Ph.D.
Oragenics, Inc.
RAC Reviewers: Emmett Barkley, Ph.D.
Thomas Gelehrter, M.D.
Terry Kwan, M.S.Ed.
Ad Hoc Reviewer: Suzanne M. Michalek, Ph.D.
University of Alabama, Birmingham
Tab 2332Protocol
Tab 2333OBA Summary
OBA Letter to PI on In-Depth RAC Review and Public Discussion
Outcome of Initial Review by RAC Members
Reviews from Drs. Barkley and Gelehrter, Ms. Kwan, and Dr. Michalek
PI's/Sponsor's Response
3:20 PM - Public Comment
3:30 PM - BREAK
3:45 PM - RAC Recommendations
4:00 PM - Update on the RAC Gene Transfer Clinical Trial Design Working Group
Presenters: David DeMets, Ph.D.
NIH RAC
Nancy M.P. King, J.D.
University of North Carolina, Chapel Hill (via teleconference)
Cheryl McDonald, M.D.
NIH Office of Biotechnology Activities
4:30 PM - Public Comment
4:45 PM - ADJOURNMENT
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