Recombinant DNA Advisory Committee- 9/12-13/94 
OPEN SESSION: The RAC approved a motion made by Dr. Smith and seconded by Dr. 
Doi to accept the protocol submitted by Dr. H. Kim Lyerly of Duke University Medical 
Center, Durham, North Carolina, by a vote of 13 in favor, 0 opposed, and 1 abstention. 
Approval of the protocol is contingent on approval of proprietary information presented 
during the closed session. 
Dr. Samulski abstained from voting since the protocol was submitted before he joined the 
RAC. 
EXECUTIVE SESSION/CLOSED: The RAC approved a motion made by Dr. Miller 
and seconded by Dr. Erickson to approve the proprietary information presented during 
the closed session by a vote of 14 in favor, 0 opposed, and no abstentions. 
Summary 
Dr. H. Kim Lyerly of Duke University Medical Center, Durham, North Carolina, may 
conduct gene transfer experiment on 20 subjects (> 18 years of age) with refractory or 
recurrent metastatic breast cancer. The autologous primary breast cancer cells will be 
transfected with a plasmid DNA vector in a liposome complex to produce human 
interleukin-2 (ID2). The plasmid DNA vector termed pMP6-IL2, encoding the human IL- 
2 gene is derived from the AAV. After transfection, the tumor cells will be lethally 
irradiated and administered subcutaneously to the patients in an escalating dose schedule. 
The primary objective is to evaluate the safety of treating patients with the transduced 
cells. The secondary objectives are to determine the effects on cytotoxic T lymphocytes 
and to evaluate clinical response and duration of responses to the treatment. 
XII. CHAIR REMARKS/DR. WALTERS 
Dr. Walters solicited input from the RAC regarding Dr. Varmus’ suggestion about an ad 
hoc committee to review RAC activities. Since this item was not announced in the 
Federal Register, no formal vote could be taken but suggestions were to be sent to Dr. 
Wivel or Dr. Walters in order to be transmitted to Dr. Varmus. 
Dr. Walters stated that the RAC recommended approval of Dr. Lyerly 5 s protocol following 
review of the proprietary information about the structure and sequence of the vector in 
the executive session of the RAC. 
Dr. Anderson found it ironic that the RAC as a public body had to hold a closed session 
to review a portion of Dr. Lyerl/s protocol. He suggested that Section IV-E-5, Protection 
of Proprietary Information, should be deleted from the NIH Guidelines. Companies should 
provide public access to all protocol information to allow a level playing field. If every 
company starts to request executive sessions, it would be contrary to the mission of the 
RAC to provide an open forum for discussion of human gene therapy protocols. The 
reason for the closed session cited by Dr. Lyerl/s sponsoring company was to protect 
patent information. Dr. Anderson said that once a patent application is submitted, 
company’s rights are protected. There was sufficient time for the company to file for 
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Recombinant DNA Research, Volume 20 
