Human Gene Therapy Subcommittee - 11/21-22/91 
added that the irradiated tumor cells alone produce an anti-tumor effect in these 
animals. 
Dr. Miller asked if the investigators considered injection of the irradiated tumor cells 
alone. Dr. Epstein inquired about the number of animals that have been treated. Dr. 
Royston responded that these effects are observations that have not been verified 
statistically because only five animals have been studied. These experiments are 
ongoing, and it is anticipated that the data will prove to be significant. Dr. Royston 
requested that the HGTS outline what they would consider to be an acceptable number 
of experiments to confirm these observations. Dr. Epstein responded that it is not the 
subcommittee's responsibility to decide the number of experiments an investigator should 
perform and added that an investigator should not even submit an abstract based on data 
from only five animals. 
Dr. Fakhrai continued to present data demonstrating that embryonic fibroblasts are 
capable of producing 162 nanograms per milliliter and that the IL-2 is biologically active. 
Data suggest that irradiated tumor cells alone inhibit tumor growth and that 
immunization with a mixture of IL-2 transduced fibroblasts and irradiated tumor cells 
protects against subsequent tumor challenges. Dr. Sobol acknowledged that more 
experimental data need to be obtained, and added that the researchers' intention was 
merely to update the HGTS on the preliminary data and to define those experiments 
that need to be performed prior to the RAC meeting. 
Dr. Miller stated that the investigators should bring their presentation to a close, because 
there were insufficient data to justify this protocol. Dr. Royston said that it is the 
responsibility of the HGTS to critique the protocol. Dr. Epstein replied that it is not the 
subcommittee's responsibility to critique a protocol that has been submitted with 
insufficient data. Dr. Childress suggested that perhaps there is a misconception on the 
part of the investigators about the role of the HGTS. In fact, the subcommittee is 
moving towards a more systematic review process than in the past. Dr. Royston asked if 
the HGTS would allow the investigators to go to the RAC with expanded data or require 
that they return to the HGTS. Dr. Miller responded that there were no data presented 
to suggest that the investigators are prepared to move to the clinical setting. 
Subcommittee Motion 
A motion was made by Dr. Mclvor and seconded by Mr. Capron to defer approval of the 
protocol. Dr. Parkman requested that in fairness to the investigators, the HGTS should 
allow them an opportunity to complete their presentation of their clinical protocol and 
receive constructive comments from the subcommittee members. 
Dr. Neiman stated that investigators submitting human gene transfer/therapy protocols 
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