DRAFT QUESTIONS FOR OCTOBER 26:
Questions Specific to VIRxSYS’ Proposed Clinical Trial
1. Is the VRX496 vector proposed for use in the clinical trial by VIRxSYS designed and manufactured in a manner to sufficiently address safety concerns relevant to generation of RCL? Please consider that the vector will be used in HIV-positive subjects.
How does the use of a transient transfection system vs. a stable packaging cell line for vector production affect the rate of recombination in a manner that would sufficiently compensate for the use of one plasmid to encode all helper functions?
2. Please discuss whether any additional safety testing of VRX496 should be performed prior to initiating the proposed clinical trial. In particular, please discuss the following:
3. Please discuss whether vector mobilization is considered an advantage or a safety concern for the proposed clinical trial? Please consider the following:
4. Please discuss whether there are any additional assays that should be used for safety assessment of the subjects in this clinical trial. In particular, should VIRxSYS monitor HIV variants present in the subject prior to and after treatment?