The FDA granted fast track designation to a DNA-mediated interleukin-12 (IL-12) immunotherapy, GEN-1, to treat patients with advanced ovarian cancer, according to a press release from Celsion Corporation.
The drug is currently in phase 2 development and was designed using Celsion’s non-viral nanoparticle delivery system platform, TheraPlas.
“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” Michael H. Tardugno, chairman, president, and chief executive officer of Celsion, said in a press release. “Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design.”
Currently, GEN-1 is being investigated in the phase 1/2 OVATION 2 study…