COVER SHEET FOR ACCELERATED REVIEW 
OF A HUMAN GENE TRANSFER EXPERIMENT 
Approval is requested only for Phase I portion of Phase I/ll study. An overview of 
study sequence is attached. 
A. BACKGROUND 
Title: Phase I/ll Study of Autologous Human GM-CSF Gene Transduced 
Prostate Cancer Vaccines in Patients with Metastatic Prostate 
Carcinoma 
Principal Investigator. Jonathan W. Simons, M.D. 
Participating Institutions: 
The Johns Hopkins Oncology Center, Baltimore, MD 
Somatix Therapy Corporation, Alameda, CA 
B. Vector, Target Cell, and Transduction Procedures 
1 . The replication defective retroviral vector is MFG-S. The gene is the human 
GM-CSF gene. 
2. The MFG-S vector containing the human GM-CSF gene has been N.I.H. 
RAC reviewed and approved in protocol 9303-040 in March, 1993. 
3. The vector and irradiated transduced prostate cancer vaccine cells are 
supplied by Somatix Therapy Corporation. The MFG-S-GM-CSF vector is 
approved for Phase I study in irradiated renal carcinoma vaccines under 
FDA IND BB5229. 
4. The target cells will be autologous human prostate cancer cells in primary 
culture. 
5. On average, copy number is 1-2 per cell at Somatix Therapy Corporation in 
PCA cells using a single transduction of a production lot of MFG-S-GM- 
CSF. 
6. The level of gene expression in the study is 40 - 1000 ng/10 6 cells/24 hours. 
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