7. Gene expression is measured in this trial both by ELISA for GM-CSF. 
Transduction efficiency is measured by copy number on Southern blots. 
8. RCR has not been detected by the attached FDA supervised assays at 
Somatix Therapy Corporation under IND BB5229. RCR testing at Somatix 
Therapy Corportation is attached as Appendix 1 . 
9. RCR has not been detected in production lots for vaccine generation. 
10. Sensitivity of testing and sensitivity under FDA supervised manufacturing at 
Somatix Therapy Corporation IND BB5229 is attached in Appendix 1. 
C. Clinical Protocol 
1 . The hormone refractory Dunning MAT-Ly-Lu prostate cancer model showed 
efficacy of MFG-GM-CSF transduced tumor vaccines against 
preestablished, hormonal and chemotherapy resistant tumor burdens. This 
data is published as well as presented in the protocol. 
2. Specific endpoints of the Phase I portion of the Phase I/ll study are: (1) To 
evaluate the safety of skin injections of cultured, lethally-irradiated, 
autologous MFG-S-GM-CSF gene transduced PCA cells secreting 
huGM-CSF at 40-1000ng/l0 6 vaccine cells/24 hrs; (2) To describe and 
quantitate the acute toxicities using NCI Common Toxicity Criteria, if any, of 
irradiated GM-CSF gene transduced PCA cell vaccine therapy; (3) To test 
for induced antitumor immune responses following therapy. 
3. The proposed study is to be conducted at The Johns Hopkins Oncology 
Center solely. 
4. The proposed study is similar to the RAC approved Phase I renal 
carcinoma protocol, protocol number 9303-040. The only major difference 
in this trial is (1) the schedule of vaccinations is every 21 days rather than 
28 days, and (2) the target cell for genetic modification prior to radiation are 
autologous prostate cancer cells. The cell dose range studied in the Phase 
I prostate cancer protocol (1 x 10 7 - 1 x 10 8 )is in the cell dose range under 
study in the ongoing renal cell trial (4x10-1 x 10 9 ). In clinical prostate 
cancer, 4 x 10 8 is the maximum obtainable PCA cell harvest from primary 
cancers. 
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