Attachment VI - Page 9 
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designing the vector to minimize pathogenicity? Wiat 
laboratory studies have been performed to check for 
pathogenicity, and uhat is the sensitivity of the 
analyses? 
(d) Is there evidence frcm animal studies that vector CNA 
has entered untreated cells and specifically germline 
cells? Vhat is the sensitivity of the analyses? 
(e) Has a protocol similar to the one proposed for a clin- 
ical trial been earned out in non-human primates and 
with uhat results? Specifically, is there any evidence 
that the retroviral vector has recombined with any 
endogenous or other viral sequences in the animals? 
(2) If a non- retroviral delivery system is used: What animal 
studies have been done to determine if there are pathological 
or other undesirable consequences of the protocol (including 
insertion of DNA into cells other than those treated)? Hew 
long have the animals been studied after treatment? What 
tests have been used and uhat is their sensitivity? 
3 . Clinical procedures, including patient monitoring 
Describe the treatment that will be administered to patients and 
the diagnostic methods that will he used to monitor the success or 
failure of the treatment. If previous clinical studies using 
similar methods have been performed by yourself or others, indicate 
their relevance to the proposed study. 
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