Shares in Celsion Corporation, an oncology drug development company, soared as it announced that the Food and Drug Administration (FDA) had accepted a submission for its latest ovarian cancer study.
The OVATION II Study is a planned phase I/II clinical trial of GEN-1, a DNA-based immunotherapy for the localised treatment of ovarian cancer. The study builds on the translational research data from the Phase IB dose-escalating OVATION Study where enrolled patients received escalating weekly doses of GEN-1.
The company plans to begin enrolling patients in the phase 1 part of the trial in the first half of the year, and expects to have a quarter of the study enrolled by the end of 2018.
Shares rose nearly 20% in premarket trade in reaction to the news.
Impressive clinical activity reported
Dr Nicholas Borys, Celsion's senior vice president and chief medical officer, said: "In previous clinical studies performed to date, GEN-1 has demonstrated excellent safety and impressive clinical activity supported with dose dependent, pro-immune improvement in the tumor micro environment.
"A one-time dose escalation may prove to be even more impressive. One of our patients in the OVATION Study even had a complete pathological response."
Due to the open label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study's investigators.