Recombinant DNA Advisory Committee - 03/1-2/93 
the transduced cell line, (2) sterility data, (3) safety data on replication-competent virus, 
(4) vector identity data, and (5) data on the level of IL-2 production. The RAC 
requested that documentation submitted to the IRB and IBC should be included. 
Discussion 
Dr. Post asked Dr. Sobol if the materials submitted to the RAC are the same as those 
submitted to the FDA? Dr. Sobol responded that it was his understanding that the 
general information provided to the FDA should be submitted. Dr. Sobol said that the 
most of their discussions with the FDA were by way of telephone communication. Dr. 
Sobol stated that the document submitted to the RAC is not an exact duplicate of the 
FDA submission. Dr. Sobol stated that the FDA was supplied with a more detailed 
description of the protocol, procedures, assays, etc. Dr. Sobol said that the information 
provided to the RAC is a summary of the information that the FDA had at the time that 
compassionate approval was granted. 
Dr. Chase stated that the RAC never received the Points to Consider for this protocol. 
At the January 14 meeting, Dr. Sobol stated that the Points to Consider would be 
submitted in addition to the FDA-submission for review at the March RAC meeting. 
Dr. Royston stated at the January 14 meeting that the Points to Consider had been 
prepared and were back at his office. Dr. Wivel explained that the transcripts reflect the 
fact that Dr. Royston offered to submit the Points to Consider, however, the formal 
request was only for the FDA submission. 
Dr. Parkman asked if data had been provided to the FDA regarding the level of IL-2 
expression by either transduced tumor cells or fibroblasts. Dr. Sobol said that this data 
was submitted to the FDA Dr. Miller stated that the information provided to the RAC 
is deficient in several areas; the protocol would never have been approved by this 
committee. Dr. Miller asked if data was provided to the FDA about the effectiveness of 
irradiation in inhibiting growth of the injected tumor cells. Dr. Sobol stated that this 
information had been supplied to the FDA Dr. Sobol apologized for omitting this data 
from the RAC submission, and that this omission was an oversight. 
Dr. Miller asked the investigators if they submitted any in vivo efficacy data to the FDA 
Dr. Royston answered that no IL-2 efficacy data in a glioblastoma model was provided. 
The only efficacy data was the in vitro colorectal carcinoma data. Dr. Miller asked how 
they determined the number of IL-2-secreting cells used for injection if the level of IL-2 
expression in vivo is unknown. Dr. Royston said that the number of cells injection was 
based on information derived from literature and data derived from the in vitro 
colorectal carcinoma model. 
Dr. Royston said that this request was supported by many oncologists and scientists of 
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