Food and Drug Administration

Center for Biologics Evaluation and Research

Biological Response Modifiers Advisory Committee

October 24-26, 2001

Holiday Inn, Gaithersburg, MD

BIBLIOGRAPHY

L. Naldini, U. Blomer, P. Gallay, D. Ory, R. Mulligan, F.H. Gage, I.M. Verma, and D. Trono. 1996. In vivo gene delivery and stable transduction of nondividing cells by a lentiviral vector. Science. 272:263-267.

W.S. Hu and H.M. Temin. 1990. Retroviral recombination and reverse transcription.

Science. 250:1227-1233.

B.R. Gundlach, M.G. Lewis, S. Sopper, T. Schnell, J. Sodroski, C. Stahl-Henning and K. Uberla. 2000. Evidence for recombination of live, attenuated immundeficiency virus vaccine with challenge virus to a more virulent strain. J. Virol. 74(8):3537-3542.

T.K. Henriette van Praag, L.Ouyang, F.H. Gage and I. Verma. 1999. A packaging cell line for lentivirus vectors. J. Virol. 73(1):576-584.

R. Zufferey, T. Dull, R.J. Mandel, A. Bukovsky, D. Quiroz, L. Naldini and D. Trono. 1998. Self-activating lentivirus vector for safe and efficient in vivo gene delivery. J. Virol. 72(12):9873- 9880.

H. Miyoshi, U. Blomer, M. Takahashi, F.H. Gage and I.M. Verma. 1998. Development of a self-inactivating lentivirus vector. J. Virol. 72(10):8150-8157.

X. Wu, J.K. Wakefield, H. Liu, H. Xiao, R. Kralovics, J.T. Prchal, and J. C. Kappes. 2000. Development of a novel trans-lentiviral vector that affords predictable safety. Mol. Therapy 2(1):47-55.

T. Dull, R. Zufferey, M. Kelly, R.J. Mandel, M. Nguyen, D. Tronto and L. Naldini. 1998. A third-generation lentivirus vector with a conditional packaging system. J. Virol.72(11):8463-8471.

A.M. Pilaro and M.A. Serabian. 1999. Preclinical development strategies for novel gene therapeutic products. Tox. Path. 27(1):4-7.

J.T. Evans and J.V. Garcia. 2000. Lentivirus vector mobilization and spread by human immunodeficiency virus. Human Gene Therapy 11:2331-2339.

BRMAC, October 24-26, 2001

BIBLIOGRAPHY – PAGE 2

J.H. Kordower, M.E. Emborg, J. Bloch, S.Y. Ma, Y. Chu, L. Leventhal, J. McBride, E.Y. Chen, S. Palfi, B.Z. Roitberg, W.D. Brown, J.E. Holden, R. Pyzalski, M.D. Taylor,

P. Carvey, Z.D. Ling, D. Tronto, P. Hantraye, N. Deglon, P. Aebisher. 2000. Neurodegeneration prevented by lentiviral vector delivery of GDNF in primate models of Parkinson’s disease. Science 290:767-773

G.M. Podsakoff. 2001. Lentiviral vectors approach the clinic but fall back: National Institutes of Health Recombinant DNA Advisory Committee review of a first clinical protocol for use of a lentiviral vector. Mol. Therapy 4(4):282-283.