Recombinant DNA Advisory Committee - 06/7-8/93 
request for autopsy. Dr. Post asked the investigators to elaborate on their statement that 
using a co-cultivation procedure, Viagene has detected RCR that has previously escaped 
detection by regular supernatant assays. He inquired whether antiviral drugs would be 
administered if patients' CD4( + ) counts fall below 400. He noted that the formulation 
of the virus preparation is proprietary information; therefore, it was not submitted for 
RAC review. He asked why Viagene submitted this protocol for RAC review if they do 
not receive NIH funding. 
Dr. Walters called on Dr. Wivel to explain the circumstances that led to this protocol 
being submitted for RAC review. Dr. Wivel explained that the NIH Guidelines requires 
RAC review only for those studies that: (1) are funded by the NIH, and (2) involve 
collaboration with NIH-funded investigators. Submission of this proposal is on a 
voluntary basis since no NIH funding is involved. As to the question of whether a vote 
should be taken for this protocol, Dr. Wivel answered that the standard voting procedure 
will be used, but the vote is not binding on the Pis if they have FDA approval to 
proceed with the study. Dr. Miller commented that it is an encouraging development 
that private companies are voluntarily submitting their human gene transfer protocols for 
RAC review. As to the proprietary information, RAC has previous experience with 
reviewing such materials in executive session. 
Investigator Response-Dr. Mento 
Dr. Steven Mento, Vice-President of Research and Development at Viagene, responded 
to the RACs questions and comments. He explained that Viagene is currently 
sponsoring an ongoing protocol which was not reviewed by the RAC, which is an ex vivo 
study involving a first generation product that will be used in a limited number of clinical 
trials. The current protocol utilizes a direct vector product that will be used for future 
trials involving NIH funded institutions. Therefore, Viagene has voluntarily complied 
with the RAC review process. After some discussion, the RAC adopted the position that 
it will review this protocol with the same standard as for other protocols. It was 
unnecessary for the RAC to go into executive session. 
Dr. Mento responded to Dr. Post's question regarding detection of RCR. The RCR 
safety data has been submitted to FDA as part of the master file. A co-cultivation assay 
using Mus dunni cells has been used as a sensitive method for the detection of RCR in 
packaging cell lines. Dr. Mento described an instance in which a producer cell line 
tested negative for all assays on supernatant. When the Mus dunni co-cultivation assay 
was employed, a low level of RCR contamination [1 RCR particle per 10 7 plaque 
for min g units (PFU)] was detected. A high standard of quality assurance is maintained 
for virus preparations; therefore, the producer line was discarded. Drs. Post and Miller 
inquired about the nature of the RCR breakout. Dr. Mento explained that the breakout 
appeared to be an amphotropic recombinant arising in the packaging cell line. Dr. 
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