National Institutes of Health

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NATIONAL INSTITUTES OF HEALTH
RECOMBINANT DNA ADVISORY COMMITTEE (RAC)

Wednesday, March 10, 2004

Morning Session before Break (1 hr)

Morning Session after Break (1 hr 18 mins)

Vote Session (4 mins)

Afternoon Session before Break (1 hr 54 mins)

Afternoon Session after Break (36 mins)

 


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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