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Dockets Management


Volume 2

Reference List

Reference 1 - FDA Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors, October 2000 (http://www.fda.gov/cber/gdlns/retrogt1000.pdf).

Reference 2 - Donahue, R.E., et al. Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. Journal of Experimental Medicine 1992; 176: 1125-1135. Published Material

Reference 3 - Nyberg, K., et al. Workshop on long-term follow-up of participants in human gene transfer research. Molecular Therapy 2004; 10(6): 976-980. Published Material

Reference 4 - FDA Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Thelrapy, March 1998 (http://www.fda.gov/cber/gdlns/somgene.pdf).

Reference 5 - Bauer, S., Current FDA approach for preclinical vector biodistribution studies. March 12, 1999: Recombinant DNA Advisory Committee Meeting (http://wvwv4.od.nih.gov/oba/rac/minutes/3-99RAC.htm#IX).

Reference 6 - Shayakhmetov, D.M., et al. A high-capacity, capsid-modified hybrid adenovirus/adeno-associated virus vector for stable transduction of human hematopoietic cells. Journal of Virology 2002; 76(3): 1135-1143. Published Material

Reference 7 - Goncalves, M.A., et al. Stable transduction of large DNA by high-capacity adeno-associated virus/adenovirus hybrid vectors. Virology 2004; 321(2): 287-96. Published Material

Reference 8 - Picard-Maureau, M., et al. Foamy virus-adenovirus hybrid vectors. Gene Therapy 2004; 11(8): 722-8. Published Material

Reference 9 - Yam, S.R.., et al., Transposition from a gutless adeno-transposon vector stabilizes transgene expression in vivo. Nature Biotechnology 2002; 20(10): 999-1005. Published Material

Reference 10 - Wang, Z., et al., Detection of integretation of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Therapy 2004; 11(8): 711-21. Published Material

Reference 11 - Modlich, U., et al., Leukemias following retroviral transfer of multidrug resistance 1 (MDR1) are driven by combinatorial insertional mutagenesis. Blood. 2005; 1-38. Published Material

Reference 12 - Hacein-Bey-Abina, S., et al. LMO2-associated clonal T cell proliferation in two patients after gene therapy for SCID-Xl. Science 2003; 302(5644): 415-9. Published Material

Reference 13 - Couzin, J., Kaiser, J. As Gelsinger Case Ends, Gene Therapy Suffers Another
Blow. Science 2005; 307: 1028 Published Material

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