CORRECTING and REPLACING -- Celsion Files Immunotherapy Clinical Protocol for the Evaluation of GEN-1 to Treat Newly Diagnosed Ovarian Cancer
Expert Advisory Board Endorses Randomized Phase I/II Trial in Newly Diagnosed
Stage III and IV Ovarian Cancer
GEN-1 Immunotherapy to Enter Phase I/II Clinical Study in the First Half of 2018
Following a Phase IB Trial Demonstrating 100% Disease Control, 86% Objective Response Rate
and 86% R0 & R1 Surgical Resection Rate in All Patients Treated
"GEN-1 is designed to locally activate IL-12 production which can recruit and stimulate the patient's immune system to attack and destroy cancer," stated Dr.
The Phase I/II study builds on the highly promising clinical and translational research data for the recently completed Phase IB dose-escalating OVATION Study. This next Phase I/II study will have a dose escalating phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune response. The study protocol was unanimously supported by an expert medical advisory board and lead investigators from the Phase IB OVATION Study and is summarized below:
- Open label, 1:1 randomized design
- Enrollment up to 90 patients with Stage III/IV ovarian cancer patients at ten
- Primary endpoint of improvement in progression-free survival (PFS) comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone.
- PFS for patients treated per protocol in the Phase IB OVATION Study continues to be followed. Of the eight patients who received GEN-1 treatment over one year ago (cohort 1 - 3) and are being followed, only three patients' cancer has progressed. This compares favorably to the historical median progression-free survival of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Of the remaining five patients who have been on the OVATION Study for over one year, their median PFS as of
October 31, 2017is 18.8 months with the longest progression-free patient at 24 months.
The protocol has been submitted to the
"GEN-1 holds the potential of tremendous promise as a cancer treatment in the rapidly emerging area of immuno-oncology. Unlike the toxicities, poor tolerability, and poor pharmacokinetics of systemically administered recombinant IL-12, the beauty of GEN-1 is that it inspires secretion of highly-tolerable endogenous IL-12," said
About GEN-1 Immunotherapy
GEN-1, designed using
Celsion Investor Contact
Sr. Vice President and CFO
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