Biological Response Modifiers Advisory Committee

Meeting #29

April 5-6, 2001



Attachment to Briefing Materials


Session I


3. Purcell, D.F.J., et al., An array of murine leukemia virus-related elements is transmitted and expressed in a primate recipient of retroviral gene transfer. Journal of Virology, 1996. 70(2): p. 887-897.

4. Hutchins, B., et al., Working toward an adenoviral vector testing standard. Molecular Therapy, 2000. 2(6):p.532-534.

5. Jensen, M., G. Tan, S. Forman, A.M. Wu, and A. Raubitschek. 1998. CD20 is a molecular target for scFvFc: receptor redirected T cells: implications for cellular immunotherapy of CD20+ malignancies. Biol. Bone Marrow Transplant. 4:75.

6. Jensen, M.C., P. Clarke, G. Tan, C. Wright, C.C. Wen, T.N. Clark, F.Y. Zhang, M.L. Slovak, A.M. Wu, S.J. Forman, and A. Raubitschek. 2000. Human T lymphocyte genetic modification with naked DNA. Molecular Therapy 1:49.

7. BŁeler, H. 1999. Adeno-associated viral vectors for gene transfer and gene therapy. Biol. Chem. 380:613.

8. Grimm, D., A. Kern, K. Rittner, and J.A. Kleinschmidt. 1998. Novel tools for production and purification of recombinant adeno-associated virus vectors. Human Gene Therapy 9:2745.

9. Soneoka, Y., P.M. Cannon, E.E. Ramsdale, J.C. Griffiths, G. Romano, S.M. Kingsman, and A.J. Kingsman. 1995. A transient three-plasmid expression system for the production of high titer retroviral vectors. Nucleic Acids Res. 23:628.

10. Hutchins, B., Sajadi, N., Seaver. S., Shepard, A., Bauer, S.R., Simek, S., Carson, K., Aguilar-Cordova, E. 2000. Working toward an adenoviral vector testing standard. Molecular Therapy: 2:532-534.

11. Foster, C.B., Choi, E.H., and Chanock, S.J. 2000. Adenovirus and marrow transplantation in children. Ped. Path Molec Med. 19:97-114.

12. Baldwin, A., Kingman, H., Darville, M., Foot, A.B.M.,Grier, D., Cornish, J.M., Goulden, N., Oakhill A., Pamphilon, D.H., Steward, C.G., and Marks, D.I. 2000. Outcome and clinical course of 100 patients with adenovirus infection following bone marrow transplantation. Bone Marrow Transplantation 26: 1333-1338.

13. Flomenberg, P., Gutierrez, E., Piaskowski, V., and Casper, J.T. 1997. Detection of adenovirus DNA in peripheral blood mononuclear cells by polymerase chain reaction assay. J.Med Virol. 51: 182-188.5.

14. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy - 3/30/98. (

16. FDA Gene Therapy Letter, March 6, 2000 (

Session III


4. Van Leewen, FE, et al., Long-term risk of second malignancy in survivors of Hodgkin's disease treated during adolescence or young adulthood. J Clin Oncol, 2000, 18: p. 487-497.

Session IV

1. Ravold, A., Special Article. Fatal results from diphtheria antitoxin in St. Louis., J.A.M.A., 1901, Nov. 9:p.1260-1261.

2. Proposed Rule - Availability for disclosure and submission to FDA for public disclosure of certain data and information related to human gene therapy or xenotransplantation. (