Human Gene Therapy Subcommittee - 7/30/90 
6. Do TNF-TIL respond to steroids? 
7. What is the current situation with respect to the 
availability of anti-TNF antibody? 
8. How were the TIL infections performed, considering the 
low titer of the virus? 
9. How many dry runs have been performed, and what is the 
Southern blot data on these? Is proviral structure and 
copy number maintained? Are these data available to 
review? 
10. What is the current status of marked TIL trafficking 
studies? Do they support homing at a level of .015% 
per gram? 
11. In human experiments, how will one determine what part 
of the efficacy can be attributed to TNF gene transfer 
and expression? 
12. How was the TNF level of 150 picograms per 10^ cells 
per day (minimum level of transduced TIL) calculated? 
Further, Dr. Mclvor made the following suggestions to the 
investigators : 
1. That there be an alternative assay for ecotropic and 
xenotropic virus; 
2. That an assay of transduced TIL supernatants and 
patients* sera for TNF (neo) virus be performed; and, 
3. That a small group of subcommittee members analyze the 
safety data. 
Dr. Mahoney said he reviewed the proposal and found that Dr. 
Mclvor had covered most of what he thought were the major issues. 
He did call the subcommittee's attention to the fact that this 
was a Phase I cancer therapy protocol and that the patients will 
be desperately ill with very short expected lifespans. He said 
that, because of this, it was important to closely review the 
safety issues. However, he did not believe prolonging 
experimental verification of possible efficacy was justified. He 
said the investigators had been asked to share information in 
three general areas: 
1. Ongoing toxicity studies in monkeys; 
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Recombinant DNA Research, Volume 14 
