Gene Electrotransfer to Muscle With Plasmid AMEP in Patients With Disseminated Cancer

Summary

Gene transfer by electroporation (gene electrotransfer) uses short electric pulses to transiently permeabilise the cell membrane enabling passage of plasmid DNA into the cell cytosol. It is an efficient non-viral method for gene delivery to various tissues. In this phase I dose-escalating study, patients will be treated with intramuscular gene electrotransfer of plasmid AMEP. Plasmid AMEP encodes protein AMEP which bind to α5β1 og αvβ3 integrins. Primary end point of the trial is safety and secondary end points are efficacy, pharmacokinetics and evaluation of potential discomfort associated with the treatment procedure using VAS (Visual Analogue Scale).

Timeline

Start

2012-07

Primary completion

2015-05

Completion

2015-05

Outcome

Outcome not reported

Stopped: “Production of the IMP (plasmid AMEP) has been terminated by the supplier (BioAlliance Pharma)”

Drugs

Indications